bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: CD2027 Ointment 3 mcg/g, twice daily; Vehicle Ointment, twice daily
Intervention description: Topical Ointment; Topical Ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dermatitis, Atopic

Summary:

      This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives:
      To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus
      its vehicle in adult participants with at least moderate atopic dermatitis.

      Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over
      4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding
      Head/Neck) in adult participants with at least moderate atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participant, 18 years of age or older

          -  Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at
             least moderate intensity according to Investigator Global Assessment (IGA greater or
             equal to 3)

          -  Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of
             Nine's, excluding Head/Neck

          -  At least one area (Target Lesion) which was representative of the participant's
             disease state, was not located on the hands, feet or genitalia, measures at least 10
             cm^2, presented a Total Severity Score of at least 6/15 (total severity score defined
             as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and
             Lichenification) with oozing/crusting severity at most 1

        Exclusion Criteria:

          -  The participant had albumin-adjusted calcium above the upper normal range from
             screening evaluation

          -  The participant had history/signs/symptoms suggestive of an abnormality of calcium
             homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency,
             hyperthyroidism)

          -  The participant had signs/symptoms of urinary stones or has a history of urinary
             stones within the past 5 years prior to the Screening Visit
Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Acetaminophen 1000mg IV; Hydromorphone 0.5 mg IV
Intervention description: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push; 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push
Intervention MeSH terms: Acetaminophen; Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments
      (ED) across the country. Acetaminophen, given orally, has also been used for treatment of
      mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely
      used in Europe for more than 20 years as post-surgical analgesia and received full FDA
      approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize
      treatment of pain among elderly ED patients, this randomized study will compare efficacy and
      safety of IV acetaminophen to IV hydromorphone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age equal to 65 or greater

          2. Pain onset within 7 days with severe pain

          3. Has capacity to provide informed consent

          4. Understanding English or Spanish

        Exclusion Criteria:

          1. Use of tramadol or opioids within 7 days

          2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours

          3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis,
             fibromyalgia, and peripheral neuropathies

          4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis
             (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or
             severe dehydration

          5. Alcohol intoxication

          6. Systolic blood pressure: < 100 mmHg

          7. Heart rate: < 60 beats per minute

          8. Oxygen saturation: < 95% on room air

          9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days

         10. Use of transdermal pain patch or oral opioid > 10 days in the prior month

         11. Prior enrollment in the same study
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Chemotherapy
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether additional doses of ipilimumab have a
      positive effect on survival in the treatment of advanced melanoma that has progressed after
      successful initial treatment with ipilimumab.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Key Inclusion Criteria:

          -  Histologic diagnosis of unresectable stage III or IV metastatic melanoma

          -  Prior ipilimumab induction treatment (3 mg/kg)

          -  Documented disease control [Stable Disease ≥3 months or Partial Response/Complete
             Response] after ipilimumab induction

          -  Documented progressive disease following disease control

        Key Exclusion Criteria:

          -  Patients with brain metastasis are excluded, unless they are free of neurologic
             symptoms related to metastatic brain lesions and do not receive systemic
             corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10
             days prior to beginning retreatment with ipilimumab

          -  Any intervening anticancer therapy between last dose of ipilimumab induction and
             ipilimumab retreatment on study

          -  Patients who experienced any grade 3 immune-related adverse event (irAE) (except for
             endocrinopathies where clinical symptoms were controlled with appropriate hormone
             replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab

          -  Patients with a prior irAE that has not improved to grade 1 or better at randomization
A Clinical Trial to Assess Subjects With Dry Eye Disease.
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Reproxalap Ophthalmic Solution (0.25%); Vehicle Ophthalmic Solution
Intervention description: Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.; Vehicle Ophthalmic Solution administered 7 times over two consecutive days.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2
      Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution
      Compared to Vehicle in Subjects with Dry Eye Disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age (either gender and any race);

          2. Reported history of dry eye for at least 6 months prior to Visit 1;

          3. Reported history of use or desire to use eye drops for dry eye symptoms within 6
             months of Visit 1.

        Exclusion Criteria:

          1. Clinically significant slit lamp findings at Visit 1 that may include active
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active
             ocular allergies that require therapeutic treatment, and/or in the opinion of the
             investigator may interfere with study parameters;

          2. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1;

          3. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during
             the trial;

          4. Eye drop use within 2 hours of Visit 1;

          5. Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12
             months;

          6. Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days
             of Visit 1;

          7. Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids)
             within 14 days of Visit 1 or anticipate such therapy throughout the study period;

          8. Planned ocular and/or lid surgeries over the study period or any ocular surgery within
             6 months of Visit 1;

          9. Temporary punctal plugs during the study that have not been stable within 30 days of
             Visit 1.
Puerarin Effects on Alcohol Drinking
Condition: Alcohol Abuse
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Puerarin, Placebo
Intervention description: 400 mg, three times a day for 7 days
Intervention MeSH terms: Puerarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a
      major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment
      with this compound will reduce alcohol self-administration in a simulated natural settings
      laboratory.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderate to heavy alcohol drinkers (20+ drinks per week)

        Exclusion Criteria:

          -  alcohol dependence or treatment-seeking drinkers

          -  other drug abuse or dependence

          -  psychiatric disorders
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
Condition: Allergic Rhinitis; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: placebo; AllerT low dose; AllerT full dose
Intervention description: SC injections of placebo on days 1, 7, 14, 28 and 56; SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56; SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: allergic rhinitis; birch pollen; immunotherapy

Summary:

      The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal
      treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic
      rhinoconjunctivitis during the following birch pollen season
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderate to severe allergic rhinoconjunctivitis to birch pollen:

               1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the
                  two preceding birch pollen seasons

               2. Previous use of anti-allergy medications during the two preceding birch pollen
                  seasons

               3. Positive SPT to birch pollen extract

               4. Positive specific IgE CAP test for Bet v 1

        Exclusion Criteria:

          -  uncontrolled asthma, FEV1 < 80% of predicted

          -  previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years

          -  clinical symptoms due to allergens other than birch pollen during the whole trial
             period

          -  history of anaphylaxis

          -  positive skin prick test to AllerT

          -  any other treatment or conditions which may increase the risk of the study for the
             subject or affect the efficacy assessments during the birch pollen season
Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: 20 mg BID of PF-02545920
Intervention description: All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 30 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms

Summary:

      This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following
      study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and
      tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from
      baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC)
      assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of
      treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of
      treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding
      A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will
      be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15
      mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260
      subjects may take part in this open label extension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have completed study A8241021

          -  Diagnosis of HD, including ≥36 CAG repeats.

        Exclusion Criteria:

          -  Significant neurological disorder other than Huntington's disease.

          -  WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or
             myeolo-proliferative disorders.

          -  Any drug related SAE experienced during study A8241021 which were not approved as
             acceptable for enrollment in A8241022.
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Condition: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy
MeSH terms: Dust Mite Allergy; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Intervention: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10); House dust mite allergen extract in combination with CYT003-QbG10-placebo; CYT003-AllQbG10 in combination with house dust mite allergen extract placebo; CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Intervention description: subcutaneous injections at 6 visits; subcutaneous injections at 6 visits; subcutaneous injections at 6 visits; subcutaneous injections at 6 visits
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in
      patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a
      double-blind, placebo-controlled setting
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization
             towards house dust mite allergens

        Exclusion Criteria:

          -  Clinically relevant other allergies (perennial or seasonal) that could potentially
             interfere with the patient's study treatment schedule or assessments

          -  Use of any concomitant medication that could affect the patient's study treatment
             response or assessment results
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Herceptin; Docetaxel; Pertuzumab
Intervention description: 8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly; 75mg/m2 iv escalating to 100mg/m2 iv 3-weekly; 840mg iv loading dose, followed by 420mg iv 3-weekly
Intervention MeSH terms: Docetaxel; Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 417.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in
      female patients with locally advanced, inflammatory or early stage HER2 positive breast
      cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4
      cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin +
      pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of
      840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg
      3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the
      entire pre- and post-surgery period all patients will receive adequate chemotherapy as per
      standard of care, as well as any surgery and/or radiotherapy as required. The anticipated
      time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=18 years of age;

          -  locally advanced, inflammatory or early stage invasive breast cancer;

          -  HER2 positive (HER2+++ by IHC or FISH/CISH+).

        Exclusion Criteria:

          -  metastatic disease (Stage IV) or bilateral breast cancer;

          -  previous anticancer therapy or radiotherapy for any malignancy;

          -  other malignancy, other than cancer in situ of the cervix, or basal cell cancer;

          -  insulin-dependent diabetes;

          -  clinically relevant cardiovascular disease.
Clinical Trial of Tolcapone for Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Tolcapone
Intervention description: Placebo: One capsule 3 times a day from Day 1 to Day 7; Tolcapone: One capsule 3 times a day from Day 1 to Day 7
Intervention MeSH terms: Tolcapone
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Catecholamines; Dopamine; Clinical Trial; fMRI; PFC; Vitamin B2; Riboflavin; Tolcapone; Placebo; Normal Volunteers; Schizophrenia; Healthy Volunteers; HV

Summary:

      This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well
      as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention
      Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the
      frontal cortex of the brain.

      ...
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Prior participation under NIH protocol number 95-M-0150, or new normal volunteers
                  or schizophrenic patients that meet criteria for NIH protocol number 95-M-0150
                  (NCT00001486).

               2. No Axis I or Axis II diagnosis in normal volunteers.

               3. Age range: 18-50 years.

        EXCLUSION CRITERIA:

          1. Normal volunteers with an Axis I or Axis II disorder obtained either from prior SCID
             interview in Protocol 95-M-0150 or through a screening interview will be excluded.

          2. Subjects with a history of cardiovascular disease, liver disease and other medical
             illnesses, and untreated or uncontrolled hypertension will be excluded. An
             electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will
             be checked on all subjects prior to participation in the study. Individuals with
             persistent tardive dyskinesia or abnormal LFTs, or individuals with significant
             history of alcoholism or liver enzyme elevation will be excluded from the study.

          3. Schizophrenic patients taking clozapine, a COMT inhibitor, any illicit drugs of abuse,
             or MAO inhibitors will be excluded.

          4. Normal control subjects taking any medications other than occasional NSAI will be
             excluded.

          5. Pregnant women. Women of childbearing potential will undergo a urine pregnancy test
             the day the study initiates and screened by history for the possibility of pregnancy.