bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: U0267 Foam; Vehicle foam
Intervention description: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).; All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Plaque-type Psoriasis; psoriasis

Summary:

      The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with
      plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects at least 12 years old and in good general health.

          -  Mild to moderate plaque-type psoriasis

        Exclusion Criteria:

          -  Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs;
             or to any component of the investigational formulations

          -  History of hypercalcemia or of vitamin D toxicity.

          -  Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.

          -  Other serious skin disorder or any chronic medical condition that is not well
             controlled.

          -  Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four
             weeks of enrollment.

          -  Use of topical therapies that have a known beneficial effect on psoriasis, within 2
             weeks of enrollment.

          -  Systemic medications for other medical conditions that are known to affect psoriasis
             within the past four weeks of enrollment.

          -  Use of any investigational therapy within 4 weeks of enrollment.

          -  Pregnant women, women who are breast feeding, or sexually active women of child
             bearing potential who are not practicing an acceptable method of birth control.
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
Condition: Oropharynx Cancer
MeSH terms: Oropharyngeal Neoplasms
Intervention: Gabapentin; Placebo Oral Capsule
Intervention description: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures; Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Strategies to minimize and mitigate external beam radiation therapy related mucositis and
      pain during the treatment of head and neck cancer remain limited. The investigators
      hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance
      on opioid medication, and improve the quality of life for these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients being treated with combination chemotherapy and radiation therapy daily for
             locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.

          -  Age ≥ 18.

          -  ECOG performance status ≤ 1.

          -  Patients must provide study specific informed consent prior to study entry and be able
             to fill out toxicity and quality of life related questionnaires.

        Exclusion Criteria:

          -  Patients may not be receiving gabapentin, any other investigational agents, or other
             anticonvulsants.

          -  Patients with metastatic disease are excluded from this clinical trial.

          -  Patient with allergies or hypersensitivity to gabapentin.

          -  Patients receiving surgery as part of their definitive management.

          -  Patients who have received prior chemotherapy or radiation therapy.

          -  Patients unable to complete the required forms; however, verbal completion is adequate
             if recorded on the form daily.

          -  Uncontrolled serious illness including, but not limited to, ongoing or serious active
             infection requiring IV antibiotics for over 30 days, symptomatic congestive heart
             failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable
             atrial fibrillation, or psychiatric illness/social situations that would limit
             compliance with study requirements.
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: IPV; f-IPV
Intervention description: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID); Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 773.0
Sex: All
Minimum age: 5 Weeks
Maximum age: 7 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will assess and compare the immune response to full-dose inactivated polio vaccines
      (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated
      poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule
      combinations in the Expanded Program on Immunization (EPI) primary series.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.

          2. Healthy, as assessed from medical history and physical examination by a study
             physician,

          3. Written informed consent obtained from parents or legal representatives who have been
             properly informed about the study and are able to comply with planned study
             procedures.

        Exclusion Criteria:

          1. Vaccinated with any poliovirus vaccine prior to inclusion,

          2. A household contact with OPV vaccination history in the past 4 weeks,

          3. HIV infection or pharmacologic immunosuppression,

          4. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),

          5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and
             intradermal injections,

          6. Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be
             a contraindication for vaccination,

          7. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion
             of the investigator(s).
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lumateperone; Placebo
Intervention description: Lumateperone 42 mg (ITI-007 60 mg tosylate); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,
      parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I
      or Bipolar II disorder having a major depressive episode.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis
             of Bipolar I or Bipolar II disorder

          -  experiencing a current major depressive episode

          -  able to provide written informed consent

        Major Exclusion Criteria:

          -  any female subject who is pregnant or breast-feeding

          -  any subject judged to be medically inappropriate for study participation
Desensitization and Cross-Desensitization During Oral Grass or Ragweed Pollen Immunotherapy
Condition: Immunologic Desensitization
Intervention: allergen extract tablet; Placebo tablet
Intervention description: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet; 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Allergic rhinitis; Immunotherapy, Allergen; Sublingual Immunotherapy

Summary:

      The purpose of this study is to determine if sublingual allergen immunotherapy tablets work
      by inducing a state of desensitization in mast cells and basophils.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Verified allergic sensitivity to either Timothy Grass or Short Ragweed pollen (primary
             allergen)

          -  Verified allergic sensitivity to at least one allergen in addition to the primary
             allergen

        Exclusion Criteria:

          -  Negative skin testing to Timothy Grass or Short Ragweed pollen and at least one other
             environmental allergen

          -  Dermatographism

          -  Severe dermatologic condition that may interfere with skin testing

          -  Pregnancy

          -  H1 receptor antihistamine taken within 7 days of testing

          -  Systemic steroids

          -  Omalizumab taken at any time in the past

          -  Receiving or received allergen immunotherapy

          -  Desensitized to any drug within 6 months

          -  Current uncontrolled or severe asthma

          -  Eosinophilic esophagitis

          -  Significant pulmonary, cardiovascular, renal, hepatobiliary, or neurological diseases,
             or another disease process felt to put a subject at increased risk for adverse events

          -  Hypersensitivity to any of the inactive ingredients in the allergen extract tablets

          -  History of mental illness or drug or alcohol abuse that could interfere with the
             ability to comply with study requirements

          -  Inability or unwillingness to give written informed consent
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Condition: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Dyslipidemias
Intervention: ABT-335 and rosuvastatin calcium; ABT-335 and atorvastatin calcium; ABT-335 and simvastatin
Intervention description: ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks; ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks; ABT-335 135 mg plus simvastatin daily, 52 weeks
Intervention MeSH terms: Calcium, Dietary; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Fenofibrate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1911.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to test the safety and the effects of using an
      investigational drug regimen; once daily ABT-335 (Investigational drug) administered in
      combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in
      patients with abnormal lipid levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects who voluntarily sign the informed consent.

          -  Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin
             and atorvastatin combination therapy studies.

        Exclusion Criteria:

          -  Subject is using or will use investigational medications, except as approved by
             Abbott.

          -  Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335,
             rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Condition: Hepatitis C Virus; HIV
MeSH terms: Hepatitis C; Coinfection; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: genotype 1; genotype 4; HIV

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in
      hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment
      intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with
      HIV-1.

      Participants who experience confirmed post-treatment virologic failure (relapse) at or before
      Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive
      LDV/SOF plus ribavirin (RBV) for 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV RNA ≥ 10,000 IU/mL at screening

          -  HCV genotype 1 or 4

          -  HIV-1 infection

          -  Cirrhosis determination, a fibroscan or liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of protocol specified method(s) of contraception if female of childbearing
             potential or sexually active male

        Exclusion Criteria:

          -  Clinically-significant illness (other than HCV or HIV) or any other major medical
             disorder that may interfere with subject treatment, assessment, or compliance with the
             protocol

          -  Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma
             (HCC), or other malignancy (with the exception of certain resolved skin cancers)

          -  Hepatitis B virus (HBV) infection

          -  Pregnant or nursing female

          -  Chronic use of systemically administered immunosuppressive agents
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Alendronate Sodium; Placebo; Placebo
Intervention description: 20 micrograms/day, injection, 36 months; 10 mg/day, oral, 36 months; Oral placebo, daily, 36 months; Injection placebo, daily, 36 months
Intervention MeSH terms: Alendronate; Teriparatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 428.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and
      there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed
      to treat a large number of conditions such as arthritis and asthma. When taken for several
      months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis
      called "glucocorticoid-induced osteoporosis." This study compared the effects of
      teriparatide, the study drug, with alendronate, an approved drug for treating
      glucocorticoid-induced osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age 21 years or older

          -  Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to
             screening

        Exclusion Criteria:

          -  Taking bisphosphonates within past 6 months

          -  More than 30 micrograms/day of estradiol or equivalent in past 3 months

          -  History of alcoholism or drug abuse in past year

          -  Pregnant women or nursing mothers
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
Condition: Fungemia; Neutropenia; Candidiasis
MeSH terms: Infections; Candidiasis; Fungemia; Neutropenia
Intervention: Active Anidulafungin; Active Caspofungin
Intervention description: Subjects in this arm will receive active anidulafungin and placebo caspofungin; Subjects in this arm will receive active caspofungin and placebo anidulafungin
Intervention MeSH terms: Caspofungin; Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia

Summary:

      The purpose of this study is to gather information on the use of anidulafungin for the
      treatment of Candida infection in patients with an abnormal immune system. It is expected
      that anidulafungin will be at least as safe and as effective as the comparator drug,
      caspofungin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dysfunctional immune system (reduced neutrophils).

          -  Confirmed Candida infection, defined as growth of Candida from a normally sterile site
             accompanied by signs and symptoms of infection.

          -  Male of female ≥16 years of age.

          -  Expected hospitalization for at least ten (10) days.

        Exclusion Criteria:

          -  Pregnancy or breast feeding or planning to become pregnant during the study.

          -  Recent treatment with one of the study drugs over the last 30 days.

          -  Allergy to either study drug or to this class of drugs.

          -  Significant liver dysfunction.

          -  Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of
             the central nervous system.
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: sitagliptin phosphate (sitagliptin); sitagliptin phosphate (+) metformin hydrochloride; Comparator: pioglitazone; Matching placebo to pioglitazone; Matching placebo to sitagliptin; Matching Placebo to Sita/Met FDC
Intervention description: sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period; sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period; pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.; matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.
Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks.; matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.; matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 492.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A
      in comparison to a commonly used medication in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between the ages of 18 and 78 with type 2 diabetes mellitus

          -  Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3
             months

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis

          -  Patient has previously been treated with sitagliptin or has previously been in a study
             using a DPP-4 inhibitor