bioihbjkbjnl/mcl2 huggingface dataset:
Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457; Placebo
Intervention description: AIN457 was administered intravenously.; Matching placebo to AIN457 was administered intravenously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Plaque; psoriasis; inflammatory skin disease; skin condition, thickening; flaking; scaly patches; skin disease

Summary:

      Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing
      single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to
      severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients
             must meet all of the following criterion:

               1. Coverage of the body surface area (BSA) of 10% or more with plaques

               2. A score of 3 or more on the IGA scale

               3. A PASI score of at least 12 at baseline

                  Exclusion Criteria:

          -  Have forms of psoriasis other than the required "plaque psoriasis"

          -  Women of childbearing potential

          -  Recent use of investigational drugs or treatment with other biological therapies
             (wash-out periods required)

          -  Previous treatment with this investigational drug

          -  Subjects with active or history of clinically significant cardiac, kidney or liver
             abnormalities;

        Other protocol-defined inclusion/exclusion criteria may apply
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
Condition: Lymphangioleiomyomatosis; Lymphangiomyomas; Pleural Effusions; Ascites
MeSH terms: Lymphangioleiomyomatosis; Lymphangiomyoma; Pleural Effusion; Ascites
Intervention: Octreotide
Intervention description: Treatment with octreotide starts at a dose of 50 micrograms(ug) twice a day which is increased to 100 ug twice a day after two weeks and to 200 ug twice a day two weeks later. After two months, if there is no response the dose shall be increased to 400 ug twice a day.
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chylous Ascites; Chylous Pleural Effusion; Inhibitory Effects; Lymphangioleiomyoma; Somatostatin; Lymphangioleiomyomatosis (LAM)

Summary:

      Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is
      characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the
      LAM patient population is a subset of patients who develop chylous effusions and
      lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous
      studies with somatostatin and octreotide in other clinical settings have shown reduction in
      chylous effusions. This study assesses the effectiveness of octreotide in symptomatic
      patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral
      lymphedema and chyluria.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have
        symptoms associated with one of the following:

          1. lymphangioleiomyomas

          2. chylous pleural effusions

          3. peripheral lymph-edema

          4. chyloptysis

          5. protein-losing enteropathy

          6. chyluria

        Patients will be included in this protocol if symptoms are attributed to the above
        processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other
        endocrine-related disorders will be included if justified clinically based on severity of
        symptoms.

        EXCLUSION CRITERIA:

          1. Hypersensitivity to somatostatin, octreotide or its analogues

          2. Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases

          3. Transplant patients

          4. Pregnant women or women who are beast-feeding

          5. Patient or another responsible party is unable to give the subcutaneous injection

          6. Patient unwilling to be followed per the guidelines set forth

          7. Patients with decreased renal function (creatinine greater than 1.5)

          8. Patients with HIV infection

          9. Immunosuppressed patients
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Condition: Partial Epilepsies
MeSH terms: Seizures; Epilepsies, Partial
Intervention: lacosamide
Intervention description: 50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 370.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine whether lacosamide is safe and effective for
      long-term use in patients with partial-seizures from epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of parent clinical trial for treatment of partial seizures.

        Exclusion Criteria:

          -  Receiving any study drug or experimental device other than lacosamide.

          -  Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse
             event.
Study of Pemetrexed for Second-Line Pancreas Cancer
Condition: Pancreas Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: pemetrexed
Intervention description: pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreas; metastatic; recurrent

Summary:

      This study is for patients with pancreatic cancer that has grown and/or spread after having
      previously received the standard chemotherapy drug called gemcitabine.

      In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for
      use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps
      pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will
      receive pemetrexed IV once every 21 days until disease progression or unacceptable side
      effects occur.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the pancreas

          -  Prior treatment for distant or locally advanced disease with gemcitabine-based therapy

          -  Measurable or evaluable disease

          -  ECOG performance status 0-2

          -  Adequate hematological parameters

          -  Adequate baseline liver function

          -  At least 28 days from any major surgery

          -  At least 2 weeks from the last radiation treatment

          -  Must have recovered from reversible toxicities of prior chemotherapy

          -  Must be able to discontinue any nonsteroidal anti-inflammatory medications

          -  Must be willing to receive intramuscular vitamin B12 shots and take oral folate
             supplements

        Exclusion Criteria:

          -  Any prior treatment with pemetrexed

          -  More than one prior chemotherapy regimen

          -  HIV positive on antiretroviral therapy

          -  Pregnant or lactating

          -  Prior organ allograft

          -  On concurrent antitumor therapy including radiation therapy or other chemotherapies

          -  Creatinine clearance 45 ml/min or less

          -  Absolute neutrophil count < 1500

          -  Platelets < 75,000

          -  Bilirubin > 1.5 times the upper limit of normal

          -  Transaminases > 3 times the upper limit of normal except in known liver metastasis
             wherein they may be </= 5 times upper limit of normal

          -  Clinically significant ascites or pleural effusion that cannot be drained

          -  Any medical or psychiatric condition that may interfere with the ability to comply
             with protocol treatment
Transfusion Strategies in Pediatric Cardiothoracic Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: transfusion strategy; Low Hb transfusion group
Intervention description: For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl; RBCs will not be transfused unless the Hb < 9.0 g/dl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 4 Months
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Single ventricle; Bidirectional Glenn; Fontan; Congenital cardiac disease; Red blood cell transfusion; oxygen utilization; lactate level; hemoglobin level

Summary:

      The purpose of this study is to determine the best red blood cell(hemoglobin) level for
      infants and children following surgical repair of particular heart defects. These children
      often receive red blood cell transfusions after surgery, but what the best hemoglobin level
      is for them remains unknown.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4 months to 6.99 years of age

          -  surgical candidates for cavopulmonary connection

          -  English speaking

        Exclusion Criteria:

          -  presence of known bleeding disorder

          -  presence of known coagulopathy

          -  age < 4 months

          -  age > 7 years

          -  non-English speaking
Photodynamic Therapy in Treating Patients With Skin Cancer
Condition: Non-melanomatous Skin Cancer; Precancerous Condition
MeSH terms: Skin Neoplasms; Precancerous Conditions
Intervention: aminolevulinic acid
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Healthy volunteers: No
Keywords: basal cell carcinoma of the skin; squamous cell carcinoma of the skin; actinic keratosis

Summary:

      RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to
      light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in
      treating patients with skin cancer.

      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that
      includes aminolevulinic acid works in treating patients with skin cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of 1 of the following:

               -  Actinic keratoses

               -  Histologically proven superficial or nodular basal cell carcinoma (BCC), squamous
                  cell carcinoma in situ (Bowen's disease), or microinvasive squamous cell
                  carcinoma

          -  No nodular BCC greater than 4 mm thick that will not be surgically removed

          -  No carcinoma with uncertain margins requiring Moh's surgery

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  No known photosensitivity disease

          -  No porphyria or hypersensitivity to porphyrins

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  Not specified

        Surgery:

          -  Not specified

        Other:

          -  No prior treatment with systemic photosensitizer that would cause residual cutaneous
             photosensitivity during study participation
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
Condition: 15q Duplication Syndrome; CDKL5 Deficiency Disease
MeSH terms: Deficiency Diseases; Syndrome
Intervention: Soticlestat
Intervention description: TAK-935 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Drug Therapy; 15q Duplication Syndrome (Dup15q); CDKL5 Deficiency Disorder (CDD); Brain Diseases; Epilepsy; Central Nervous System Diseases; Autism; Cholesterol 24S-hydroxylase inhibitor; Anti-epilepsy drug; Anticonvulsants

Summary:

      The purpose of this study is to investigate the effect of soticlestat on the frequency of
      motor seizures for participants with Dup15q or CDD during the Maintenance Period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.

          2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.

        Exclusion Criteria:

          1. Two or more episodes of convulsive status epilepticus per 3 months requiring
             hospitalization and intubation.

          2. Currently receiving a study drug or participated in a clinical study involving another
             investigational product in the previous month.
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
Condition: Treatment for Prevention of Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: Administered once a month subcutaneously by authorized investigational site study staff.; Administered once a month subcutaneously by authorized investigational site study staff.
Intervention MeSH terms: Erenumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Migraine

Summary:

      To evaluate the effect of erenumab compared to placebo on the change from baseline in the
      number of monthly migraine days in adults with chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of at least 5 attacks of migraine without aura and/or migraine with visual
             sensory, speech and/or language, retinal or brainstem aura.

          -  History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by
             the subject as migraine day.

          -  ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with
             use of a triptan or ergot-derivative on the same calendar day based on the eDiary
             calculations.

          -  Demonstrated at least 80% compliance with the eDiary.

        Exclusion Criteria:

          -  History of cluster headache or hemiplegic migraine headache

          -  Unable to differentiate migraine from other headaches

          -  Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of
             migraine .

          -  Received botulinum toxinin head or neck region within 4 months prior to screening.

          -  Used a prohibited migraine prophylactic medication, device or procedure within 2
             months prior to the start of the baseline phase
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Fluoride Varnish; Glass Ionomer Sealant
Intervention description: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.; Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 597.0
Sex: All
Minimum age: 2 Years
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Fluoride varnish; Glass ionomer sealant; Prevention

Summary:

      The goal of this project is to conduct a community-based randomized clinical trial to compare
      the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride
      varnish applied every six months and fluoride releasing glass ionomer sealants applied
      annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Family resides in the South Bay or Central San Diego area

          -  Parent/Guardian can consent in English or Spanish

          -  Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no
             restoration)

          -  Child is cooperative and behaviorally suited for the clinical trial interventions

          -  Child is a registered patient at San Ysidro Health Center Inc.

        Exclusion Criteria:

          -  Any siblings of participants

          -  Child with cavitated lesions

          -  Child with a health condition, special need, or with a complicated factor that will
             prevent from completing the required number of visits during a 36-month follow-up
             period

          -  Anything, that in the opinion of the investigator, would preclude the child from
             complying with the protocol or jeopardize the safety of the child while on the
             protocol
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Talimogene Laherparepvec
Intervention description: Administered by intratumoral injection.
Intervention MeSH terms: Talimogene laherparepvec
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this extension study was to further assess the safety and
      tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor
      response rate and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previously participated in Study 002/03 and met 1 of the following:

               1. Received the maximum 24 treatment injections in Study 002/03 and had not yet
                  achieved a complete response (CR) and whose response to OncoVEX^GM-CSF indicated
                  that treatment beyond 12 months was warranted, or

               2. Did achieve a CR in Study 002/03 and developed disease progression within 12
                  months of achieving a CR, or

               3. Terminated treatment in Study 002/03 to allow for treatment of brain metastases.
                  Treatment for brain metastases was no longer ongoing and the patient was able to
                  return to OncoVEX^GM-CSF injections within 3 months of completing treatment for
                  brain metastases.

          2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.

        Exclusion Criteria:

          1. Prior Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or 4 toxicity
             related to OncoVEX^GM-CSF of any organ system (with the exception of injection site
             reactions, fever and vomiting);

          2. History of Grade 3 fatigue lasting > 1 week while on OncoVEX^GM-CSF treatment;

          3. History of Grade 3 arthralgia/myalgias while on OncoVEX^GM-CSF treatment;

          4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other
             OncoVEX^GM-CSF-related non-hematological toxicities while on OncoVEX^GM-CSF treatment
             that required a dose delay or discontinuation of OncoVEX^GM-CSF therapy;

          5. Symptomatic malignant disease progression that required alternative melanoma
             treatment;

          6. Primary malignancy disease progression despite treatment with OncoVEX^GM-CSF;

          7. Patient requested to be withdrawn from or was unable to comply with the demands of
             Study 002/03.

          8. Patient was withdrawn from Study 002/03 at the discretion of the Investigator.
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Condition: Large Polyps in the Gastrointestinal Tract
Intervention: Autologous blood injection; Normal saline; HPMC
Intervention description: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion; Normal saline will be injected under the lesion to create submucosal cushion; Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: submucosal cushion; polypectomy; endoscopic mucosal resection

Summary:

      For removal of large flat lesions of the gastro-intestinal tract injection of a solution
      under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal
      tract wall. Various solutions are currently used, but some of them are easy to inject but
      quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl
      methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive
      and not always available. The investigators performed previously animal experiments which
      demonstrated that blood is easy to inject and creates a protective cushion which lasts longer
      than other fluids which are currently used for protective cushion creation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Polyps equal or larger than 1 cm

        Exclusion Criteria:

          -  Coagulopathy

          -  Inability to sign informed consent