bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Treatment Study of Topiramate in Migraine Participants
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Topiramate
Intervention description: Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Topiramate

Summary:

      The purpose of this study is to evaluate the safety and efficacy of topiramate in
      participants with migraine (type of severe headache that occurs periodically and is often
      associated with nausea, vomiting and constipation or diarrhea) who completed the
      JNS019-JPN-02 study.
    

Eligibility criteria:

        Inclusion Criteria:

        - Participants who completed the JNS019-JPN-02 study or discontinued the study at Week 4 or
        after in fixed-dose period because of insufficient efficacy

        Exclusion Criteria:

          -  Participants who discontinued the JNS019-JPN-02 study for an adverse event unrelated
             to the underlying disease

          -  Participants judged unfavorable to be transferred to this study because of the safety
             assessments in the JNS019-JPN-02 study

          -  Pregnant (carrying an unborn baby) female participants

          -  Other participants who were considered ineligible as per Investigator's discretion
An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005)
Condition: Lung Diseases; Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: MK-0873 2.5 mg; MK-0873 1.25 mg; MK-0873 0.75 mg; Placebo to MK-0873; Usual Care
Intervention MeSH terms: MK 0873
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 604.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the effectiveness and tolerability of a once-daily oral
      medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to
      determine whether the study drug leads to an improvement in pulmonary (lung) function, as
      well as symptoms, and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 40 to 75 years old, with a history consistent with COPD (chronic
             obstructive pulmonary disease)

          -  Lung function tests that meet the requirements of the study

        Exclusion Criteria:

          -  Severe and unstable medical conditions other than COPD (chronic obstructive pulmonary
             disease)

          -  Use of continuous oxygen therapy

          -  Cardiac (heart) arrhythmias

          -  Other lung disease

          -  History of colitis (inflammation of the colon)
Phase II Study of TAS-106 to Treat Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: TAS-106
Intervention description: 6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether TAS-106 is effective to patients with
      recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 ≤ years old at study entry

          -  Histologically confirmed head and neck carcinoma

          -  Received prior platinum based regimen and developed disease progression or recurrence

          -  Measurable disease according to RECIST guidelines

        Exclusion Criteria:

          -  Radiological or clinical evidence of brain involvement or leptomeningeal disease

          -  ≥ grade 2 peripheral neuropathy

          -  History of another malignancy
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Bevacizumab; Standard platinum-based chemotherapy
Intervention description: 150 mg, PO, daily; 15 mg/kg, IV, Day 1 of Cycles 1 through 7; At the discretion of the investigator
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and
      chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small
      cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus
      Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus
      Avastin. The anticipated time on study treatment is until disease progression, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  advanced (stage IIIb and IV) non-small cell lung cancer;

          -  measurable disease;

          -  ECOG PS 0-1.

        Exclusion Criteria:

          -  prior chemotherapy or treatment with another systemic anti-cancer agent;

          -  radiotherapy within 4 weeks prior to first dose of study treatment;

          -  CNS metastases;

          -  other malignancies in past 5 years, except for adequately treated cancer in situ of
             the cervix, basal or squamous cell skin cancer.
Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
Condition: Thymoma; Thymic Carcinoma
MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms
Intervention: carboplatin; paclitaxel
Intervention description: Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles; 225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: thymoma; thymic carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one chemotherapy drug may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in
      treating patients who have advanced thymoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic
             carcinoma not amenable to potentially curative therapy by surgery

          -  Extensive disease (distant disease, pleural disease, pulmonary with or without
             mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)

          -  Advanced limited disease allowed if ineligible for primary radiotherapy or surgery

          -  Measurable disease

          -  Age 18 and over

          -  ECOG Performance Status 0-1

          -  Granulocyte count at least 1,500 cells/mm^3

          -  Platelet count at least 100,000 cells/mm^3

          -  Bilirubin no greater than 1.5 mg/dL

          -  Creatinine no greater than 2.0 mg/dL

          -  Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

        Exclusion Criteria:

          -  Acute concurrent complications such as infection or post-surgical complications

          -  Other prior malignancy within the past 5 years unless curatively treated with no
             evidence of recurrence

          -  Pregnant or nursing. A negative pregnancy test was required, and fertile patients must
             use effective contraception

          -  Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy
             allowed if disease-free survival prior to recurrence was more than 1 year
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Spesolimab; Placebo
Intervention description: 12 weeks treatment; 12 weeks treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives of this trial are safety and efficacy (proof-of-concept) of induction of
      mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative
      colitis and persisting endoscopic activity despite pre-existing TNFi treatment.

      This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to
      achieve the similar exposures as the highest exposures tested and found safe and tolerable in
      preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing
      TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include
      assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific
      biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help
      understand BI 655130's mode of action.
    

Eligibility criteria:

        Inclusion Criteria

          -  18 - 75 years at screening and randomisation

          -  Diagnosis of ulcerative colitis >= 5 months prior to screening

          -  Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4
             months (Infliximab) or >= 2 Monaten (Adalimumab or Golimumab) prior to randomisation

          -  Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10)

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Prior use of more than two different TNF inhibitors or vedolizumab

          -  Extensive colonic resection

          -  Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to
             screening

          -  Active or latent tuberculosis

          -  Further exclusion criteria apply
Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Endostatin
Intervention description: 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Intervention MeSH terms: Endostatins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Stage III; Unresectable; Non-small cell lung cancer

Summary:

      To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy
      (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

               -  untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC

               -  weight loss of less than 10% in the past 6 months

               -  performance status (PS) of 0 to 1

               -  forced vital capacity in 1 second (FEV1) higher than 0.8 L

               -  measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).

               -  absolute neutrophil count (ANC) of ≥ 1500/μL

               -  hemoglobin ≥ 10 mg/dL

               -  platelet ≥ 100,000/μL

               -  serum creatinine ≤ 1.25 times of upper limit of normal (ULN)

               -  calculated creatinine clearance (CrCl) of ≥ 60 ml/min

               -  bilirubin 1.5×ULN

               -  AST and ALT less than 2.5×ULN

               -  alkaline phosphatase less than 5×ULN.

        Exclusion Criteria:

          -  active infection

          -  history of significant cardiac disease (unstable angina, congestive heart failure,
             myocardial infarction within the previous 6 months, ventricular arrhythmias)

          -  malnutrition (loss of ≥ 20% of the original body weight)

          -  sensor or motor neuropathy > grade I

          -  second primary malignancy, except for non-melanoma skin cancer

          -  psychiatric illness or social situation that would preclude study compliance

          -  pregnant or lactating women

          -  preexisting bleeding diatheses or coagulopathy

          -  Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal
             growth factor receptor pathway
Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease
Condition: Hyperlipidemia
MeSH terms: Proteinuria; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Rosuvastatin; Atorvastatin
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperlipidemia; Proteinuria; Diabetes Mellitus

Summary:

      The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor)
      atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate
      proteinuria and hypercholesterolaemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  greater than or equal to 18 years of age

          -  Hyperlipidemia

          -  Urinary protein

        Exclusion Criteria:

          -  Previous rosuvastatin treatment < 6 months prior to Visit 1

          -  Statin intolerance

          -  Severe hypertension

          -  Diabetes
Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: AG013736
Intervention description: AG013736, tablets 5 mg BID daily until tumor progression or toxicity
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 study being conducted at multiple centers in the United States. Patients
      having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are
      eligible to participate. Patients must have disease that was not controlled by previous
      treatment with radioactive iodine (131I) or not be good candidates for such treatment. The
      purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective
      treatment for metastatic thyroid cancer as shown by the number of patients in the study who
      experience significant and durable tumor shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented thyroid cancer with metastases.

          -  Failure of radioactive iodine (131I) to control the disease or radioactive iodine
             (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

        Exclusion Criteria:

          -  Central lung lesions involving major blood vessels (arteries or veins).(Central
             lesions that maintain the structural integrity of vessels have the potential to bleed
             if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
             case where there is any question as to whether blood vessels are involved.)

          -  Patients with a history of hemoptysis
A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Placebo; Allegra; Allegra-D; PF-03654746
Intervention description: A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.; A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.; A single oral dose of Allegra-D is dosed to subjects as an active comparator.; A single oral dose of PF-03654746 is the investigational drug being studied.
Intervention MeSH terms: Fexofenadine; Terfenadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A
      nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic
      rhinometry will be used to measure the congestion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 19-55 years with allergic rhinitis requiring treatment within
             the previous 2 years.

          -  Subjects that respond to a ragweed nasal allergen challenge at screening.

        Exclusion Criteria:

          -  History of asthma or FEV1 < 80% predicted.

          -  Significant concomitant disease or medications.

          -  Symptoms of allergic rhinitis within 2 weeks prior to screening.
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Placebo; 100mg SPN-812; 200mg SPN-812; 300mg SPN-812; 400mg SPN-812
Intervention description: Placebo was administered once daily; 100mg SPN-812 was administered once daily and compared to placebo; 200mg SPN-812 was administered once daily and compared to placebo; 300mg SPN-812 was administered once daily and compared to placebo; 400mg SPN-812 was administered once daily and compared to placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group,
      dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release
      Capsule) in children 6-12 years of age with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of
             ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM
             IV), confirmed with the Mini International Neuropsychiatric Interview for Children and
             Adolescents (MINI-KID).

          2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.

          3. CGI-S score of at least 4

          4. Weight of at least 20 kg.

          5. Free of medication for the treatment of ADHD or any psychosis for at least one week
             prior to enrollment.

        Exclusion Criteria:

          1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder,
             personality disorder, Tourette's disorder, or psychosis not otherwise specified.

          2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive
             compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as
             primary diagnosis.

          3. Significant systemic disease.

          4. Evidence of suicidality within the six months before Screening or at Screening.

          5. BMI greater than 95th percentile for the appropriate age and gender.

          6. Pregnancy or refusal to practice abstinence during the study for female subjects of
             childbearing potential (FOCP).

          7. Substance or alcohol use during the last three months.

          8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
Condition: Psoriasis; Eczema
MeSH terms: Psoriasis; Eczema
Intervention: Neuroskin Forte; Placebo Application
Intervention description: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks; Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; dry skin; eczema; atopic dermatitis

Summary:

      The purpose of this study is to assess the efficacy of Neuroskin Forte in relieving the
      symptoms of dry skin in adults with psoriasis or eczema.
    

Eligibility criteria:

        Inclusion Criteria

          -  Must be at least 18 years of age

          -  Have psoriasis or eczema on both sides of the body, with a pair of roughly symmetrical
             bilateral "target" lesions at least 1.5 cm in diameter

        Exclusion Criteria

          -  Inability to understand the consent form and/or comply with the requirements of this
             study

          -  Use of moisturizers/emollients within 2 days of beginning study