bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy; Neuralgia
MeSH terms: Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies
Intervention: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream; placebo cream
Intervention description: topical cream applied daily for 4 weeks; inactive placebo cream applied two times daily
Intervention MeSH terms: Ketamine; Amitriptyline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DPN; Diabetic; Nerve Pain

Summary:

      This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1
      Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the
      lower extremities due to diabetic nerve pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at
             least 6 months duration are eligible if they have an average daily pain score of > 4
             during the baseline week.

        Exclusion Criteria:

          -  Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal,
             neurologic, hematologic, skeletal) that the investigator determines could interfere
             with the efficacy or safety assessments in this study
A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: risankizumab
Intervention description: Risankizumab administered by subcutaneous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: risankizumab; ABBV-066; BI655066

Summary:

      This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability
      of risankizumab in participants with psoriatic arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed all doses of study drug and Week 24 visit of the
             lead-in study.

          -  Women of childbearing potential who are sexually active, must agree to use at least
             one accepted method of contraception throughout the study, including 20 weeks after
             last dose of study drug is given.

          -  Women of childbearing potential must have a negative urine pregnancy test at Baseline
             (Week 0/V1).

          -  Participants must voluntarily sign and date an informed consent, approved by an
             Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the
             initiation of any study specific procedures.

          -  Participant is judged to be in good health as determined by the Investigator.

        Exclusion Criteria:

          -  Female participant who is pregnant, breastfeeding or is considering becoming pregnant
             during study participation, including 20 weeks after the last dose of study drug is
             given.

          -  Premature discontinuation of the study drug in the lead-in study for any reason.

          -  Use of a biologic treatment other than risankizumab since first dose of study drug in
             the lead-in study.

          -  Time elapsed is > 8 weeks since the Week 24 visit in the lead-in study.

          -  Active systemic infections during the last 2 weeks (exception: common cold) prior to
             the first dose, as assessed by the investigator.
Efficacy of an Intranasal Testosterone Product
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: 10.0 mg of Testosterone, 4.0% TID; 13.5 mg of Testosterone, 4.5% B.I.D; 11.25 mg of Testosterone, 4.5% T.I.D
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This clinical trial will compare the pharmacokinetic profile of testosterone after repeated
      intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
             testosterone levels >100 ng/dl and ≤ 300 ng/dL.

          -  Normal Otolaryngological nasal endoscopy examination.

          -  Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.

        Exclusion Criteria:

          -  Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
             hormones

          -  Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
             months

          -  History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
             sinus surgery.

          -  History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
             month, abuse of nasal decongestants) or sleep apnea.
Cannabinoids for Taxane Induced Peripheral Neuropathy
Condition: Chemotherapy-induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: Cannabinoids
Intervention description: Cannabinoids with THC and CBD versus placebo cannabinoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: Female
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing
      breast cancer treatment. Some patients may need to shorten their course of treatment, and do
      not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the
      cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The
      goal of this study is to investigate the cannabinoids THC and CBD for TIPN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.

          -  2) Participants must have an ECOG score of 2 or better. Participants must have a score
             of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria
             Adverse Events (CTCAE).

          -  3) Able to give informed consent and comply with all study procedures.

        Exclusion Criteria:

          -  1) Diagnosis of a major medical, neurological, or psychiatric disorder that would
             preclude study participation.

          -  2) Women who are not practicing an effective form of birth control (condoms,
             diaphragm, birth control pill, IUD) or currently pregnant.

          -  3) Subjects taking warfarin.

          -  4) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or
             neurodegenerative disorders.
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Condition: Solid Tumor
Intervention: Trabectedin; Placebo
Intervention description: Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2.; Participants will receive 3-hour placebo intravenous infusion on Day 1.
Intervention MeSH terms: Trabectedin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Solid tumor; Advanced solid tumor; Malignant tumors; Sarcoma; Breast tumor; Ovarian tumor; QT interval; Trabectedin; Yondelis; Ecteinascidin 743; ET743

Summary:

      The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc
      interval duration measured by electrocardiograms (ECGs) in participants with advanced solid
      tumor malignancies when administered at a therapeutic dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with locally advanced or metastatic solid tumors who have received three
             or less prior lines of systemic chemotherapy

          -  Participants must have relapsed or had progressive disease following standard of care
             treatment with chemotherapy prior to enrollment, or intolerant to prior standard of
             care treatment with chemotherapy

          -  Normal cardiac conduction and function as documented on a 12-lead electrocardiogram

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

          -  Adequate organ function as evidenced by laboratory tests

          -  Able to receive dexamethasone or its equivalent

          -  Agrees to protocol-defined use of effective contraception

        Exclusion Criteria:

          -  Participants treated with more than three prior chemotherapy regimens (including
             adjuvant therapy)

          -  Previous exposure to trabectedin

          -  Central nervous system (CNS) metastasis

          -  Known hypersensitivity to any of the components of the trabectedin intravenous
             formulation or dexamethasone

          -  Heart rhythm disturbances, unusual T wave and U wave (if present) morphology, blood
             pressure outside of normal range, a history of cardiac failure, myocardial infarction,
             or cardiomyopathy, or a history of additional risk factors for torsade de pointes (eg,
             heart failure, electrolyte abnormalities, family history of Long QT Syndrome)

          -  Participants who at screening are on medication that is known to prolong the QT
             interval or who is on CYP3A4 inhibitors or inducers
Dysport in Hallux Abducto Valgus (HAV) Phase IIa
Condition: Hallux Abducto Valgus
Intervention: Botulinum toxin type A; Placebo
Intervention description: Investigators will inject the reconstituted solution into foot muscles.; Investigators will inject the reconstituted solution into foot muscles.
Intervention MeSH terms: Hemagglutinins; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of treatment with
      multiple doses of Dysport in adults suffering from clinically significant pain associated
      with HAV who have not undergone surgery for their condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of HAV

          -  Painful HAV in the study foot at Baseline

        Exclusion Criteria:

          -  Flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in
             the study foot

          -  Other podiatric or orthopedic condition which would interfere with the evaluation of
             pain and/or function

          -  Medical history or clinical evidence of any vascular disease and/or diabetic condition
Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: paclitaxel; microarray analysis; biopsy; neoadjuvant therapy; Paclitaxel
Intervention description: subjects will receive paclitaxel neoadjuvantly; subjects will have a biopsy to collect tissue for gene microarray analysis; All subjects will have a biopsy to collect tissue; paclitaxel is given neoadjuvantly; All patients will receive paclitaxel neoadjuvantly
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; stage IA breast cancer; stage IB breast cancer; HER2-negative breast cancer; HER2-positive breast cancer

Summary:

      RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict
      a patient's response to treatment and help plan the most effective treatment.

      PURPOSE: This clinical trial is studying how well genetic testing works in predicting
      response to paclitaxel in women who have unresected breast cancer.
    

Eligibility criteria:

        Inclusion:

          -  Histologically confirmed infiltrating carcinoma of the breast

               -  Unresected disease

               -  High-risk (> 50% risk of relapse) disease, including any of the following
                  high-risk markers:

                    -  Estrogen receptor- and progesterone receptor- negative

                    -  Palpable axillary lymph nodes

                    -  Grade 3 histology

                    -  S phase fraction > 10%

                    -  Ki67 > 30%

          -  Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and
             paclitaxel

          -  HER2/neu negative or positive

          -  Hormone receptor status:

               -  Not specified

        Menopausal status

          -  Known

        Performance status

          -  ECOG 0-2

          -  Absolute neutrophil count > 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1. 5 times normal (except for patients with known Gilbert's disease)

          -  Creatinine ≤ 1.5 times normal

        Exclusion:

          -  uncontrolled congestive heart failure

          -  myocardial infarction within the past 6 months

          -  unstable angina

          -  uncontrolled hypertension

          -  pregnant or nursing

          -  serious bacterial, viral, or fungal infection requiring ongoing treatment

          -  severe peripheral neuropathy

          -  poor psychiatric risk

          -  history of any other known serious co-morbid medical or psychiatric condition

          -  prior cytotoxic therapy for breast cancer
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: meningococcal B rLP2086 vaccine.; meningococcal B rLP2086 vaccine.; meningococcal B rLP2086 vaccine.; normal saline (placebo)
Intervention description: vaccine, 0.5 mL, 0 - 2 - 6 to 9 months; vaccine, 0.5 mL, 0 - 2 - 6 to 9 months; vaccine, 0.5 mL, 0 - 2 - 6 to 9 months; vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 538.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of an investigational
      meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects between the ages of >=11 and <=18 years at the time of
             enrollment.

          -  Negative urine pregnancy test for all female subjects.

          -  Parent/legal guardian or subject under supervision of the parent/legal guardian must
             be able to complete all relevant study procedures during study participation.

        Exclusion Criteria:

          -  History of any invasive meningococcal disease.

          -  A previous anaphylactic or severe vaccine-associated adverse reaction.

          -  Any clinically significant chronic disease.

          -  A known or suspected disease of the immune system or those receiving immunosuppressive
             therapy, including systemic corticosteroids. Topical, inhaled or intra-articular
             corticosteroids are allowed.

          -  Participation in another investigational study in the 1-month (30-day) period before
             study visit 1 and during the conduct of the study.
Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo
Condition: Sickle Cell Disease; Vaso-occlusive Crisis
MeSH terms: Anemia, Sickle Cell
Intervention: Placebo; Dalteparin
Intervention description: Normal saline solution, administered by nursing staff once daily; Low molecular weight heparin (LMWH), 5000 unites subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sickle cell disease; vaso-occlusive crisis; anticoagulation

Summary:

      Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and exhibits
      highest frequency in people of African descent. Patients with SCD currently have few
      treatment options, with hydroxyurea being the only medication approved to reduce the
      frequency of vaso-occlusive crisis (VOC) and prevent other SCD complications such as acute
      chest syndrome. Once patients develop VOC, hospitalizations aim to alleviate pain; no
      specific therapy is currently available to otherwise affect the course of the VOC. However,
      there has been increasing interest in the role of coagulation in the pathogenesis of SCD. The
      investigators hypothesize that low dose anticoagulant therapy, such as prophylactic dose
      low-molecular-weight heparin (LMWH), could be a novel way to ameliorate the vaso-occlusive
      process and thereby hasten the resolution of pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HgbSS or HgbS-beta0 thalassemia by previous hemoglobin electrophoresis,

          -  age greater than 18 years old, and

          -  admit diagnosis of vaso-occlusive crisis.

        Labs must be drawn within 36 hours of admission and randomization to treatment arm must
        occur during this time.

        Exclusion Criteria:

          -  End stage renal disease (creatinine >3.0 mg/dL),

          -  use of antiplatelet or anticoagulation medication for an alternative indication,

          -  use of steroids or immunosuppressive medications,

          -  platelet count less than 100 X 109/L,

          -  history or development of heparin induced thrombocytopenia, packed red blood cell
             transfusion in the past one month, or

          -  recent hospitalization with discharge within the past 1 week.

        Patients with re-admissions will not be enrolled again and will have no further samples
        drawn.
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Condition: Noninfectious Uveitis
MeSH terms: Uveitis
Intervention: Filgotinib; Placebo to match filgotinib; Prednisone
Intervention description: Tablet(s) administered orally; Tablet(s) administered orally; Tablet(s) administered orally
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo
      for the treatment of the signs and symptoms of noninfectious uveitis as measured by the
      percentage of participants failing treatment for active noninfectious uveitis by Week 24.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis

          -  Must have active uveitic disease at the Day 1/Baseline visit as defined by the
             presence of at least 1 of the following parameters in at least one eye despite 2 weeks
             of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral
             corticosteroid equivalent:

               -  Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion

               -  ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN)
                  criteria

               -  ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis
                  Nomenclature (NEI/SUN) criteria

          -  No evidence of active tuberculosis (TB) or untreated latent TB

        Key Exclusion Criteria:

          -  Participants with elevated intraocular pressures and/or severe glaucoma

          -  Confirmed or suspected infectious uveitis, including but not limited to infectious
             uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1),
             Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes
             simplex virus (HSV)

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD
Intervention: AZD3199; formoterol; Placebo
Intervention description: Dry powder for inhalation, o.d., 4 weeks; Dry powder for inhalation, b.i.d., 4 weeks; Dry powder for inhalation, b.i.d., 4 weeks
Intervention MeSH terms: Formoterol Fumarate; AZD-3199
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: 40 Years
Healthy volunteers: No
Keywords: COPD; Efficacy; Safety; Inhalation

Summary:

      The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks
      treatment with AZD3199 in moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COPD

          -  Current or exsmokers, 10 pack years

        Exclusion Criteria:

          -  Asthma

          -  Any clinically relevant abnormal findings at screening examinations

          -  Recent COPD exacerbation