bioihbjkbjnl/mcl2 huggingface dataset:
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Medisorb naltrexone 190 mg; Medisorb naltrexone 380 mg
Intervention description: naltrexone for extended-release injectable suspension; naltrexone for extended-release injectable suspension
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol Dependence

Summary:

      This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base
      study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4
      weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study
      ALK21-003.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Completed study drug treatment in Study ALK21-003 (base study [NCT01218958])

          -  Written informed consent for this extension study

          -  Stable address and telephone; reconfirmation of contact's address and phone

          -  Women with childbearing potential must agree to continue to use an approved method of
             birth control throughout study participation

        Primary Exclusion Criteria:

          -  Positive urine drug screen for opioids at Visit 1

          -  Early termination of study drug in the base study

          -  Pregnancy or lactation
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Everolimus; Everolimus placebo; Best Supportive Care (BSC)
Intervention description: Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.; Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.; Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
Intervention MeSH terms: Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 656.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastric cancer,; advanced gastric cancer,; stomach neoplasm,; stomach disease,; adenocarcinoma of stomach,; GI neoplasm

Summary:

      This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients
      with advanced gastric cancer which has progressed after one or two lines of prior
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients > 18 years old

          -  Histologically or cytologically confirmed and documented gastric adenocarcinoma

          -  Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease

          -  ECOG Performance Status of < 2

          -  Lab parameters within specifically defined intervals

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Patients who have received > 2 prior systemic therapies for advanced disease

          -  Administration of another anticancer therapy within 3 weeks prior to randomization

          -  Chronic treatment with steroids or another immunosuppressive agent

          -  Major surgery within 2 weeks prior to randomization

          -  Patients with CNS metastases

          -  Any other severe and/or uncontrolled medical condition

        Other protocol-defined inclusion/exclusion criteria may apply
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Bapineuzumab 0.5 mg/kg; Bapineuzumab 1.0 m/kg
Intervention description: Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.; I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No
Keywords: antibody

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab
      in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over
      250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each
      subject's participation will last approximately 4 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI)
             scan consistent with the diagnosis of Alzheimer Disease

          -  Mini-Mental Status Examination (MMSE) >=10 at screening

          -  Caregiver able to attend all clinic visits with subject

        Exclusion Criteria:

          -  Any medical or psychiatric contraindication or clinically significant abnormality
             that, in the investigator's judgment, will substantially increase the risk associated
             with the subject's participation in and completion of the study or could preclude the
             evaluation of the subject's response.

          -  Any significant brain MRI abnormality.

          -  Use of any investigational drugs or devices, other than bapineuzumab within the last
             60 days prior to screening
In Vivo Efficacy Study of Patient Preoperative Preps
Condition: Bacterial Reduction Post-product Application
Intervention: 3M CHG/IPA Prep C; 3M CHG/IPA Prep CH; ChloraPrep; Normal Saline
Intervention description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: surgical skin prep; CHG; IPA

Summary:

      The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA
      Prep on skin flora of the abdominal and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on abdomen and groin

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test area

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Carboxymaltose (FCM); Standard Medical Care (SMC) for the treatment of IDA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety of FCM in patients with anemia who are
      not dialysis dependent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age and able to give informed consent

          -  Iron deficiency is the primary etiology of anemia

          -  Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL

          -  Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

        Exclusion Criteria:

          -  Previous participation in a FCM trial

          -  Known hypersensitivity reaction to FCM

          -  Requires dialysis for treatment of chronic kidney disease

          -  Current anemia not attributed to iron deficiency

          -  Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the
             screening phase

          -  Anticipated need for surgery

          -  AST or ALT greater than 1.5 times the upper limit of normal

          -  Received an investigational drug within 30 days of screening

          -  Pregnant or sexually-active females who are not willing to use an effective form of
             birth control
Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Intervention: Straight Wire Excision of Transformation Zone; Large Loop Excision of Transformation Zone (cone biopsy)
Intervention description: Straight wire excision of transformation zone is a electrosurgical conization method,which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.; LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20-25 mm depth. The loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Healthy volunteers: No
Keywords: Cone biopsy; Conization; Loop electrosurgical excisional procedures; Large Loop Excision of Transformation Zone; Needle Excision of Transformation Zone; Straight Wire Excision of Transformation Zone; Electrosurgery

Summary:

      The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of
      Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of
      Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.

      SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be
      compared to LLETZ cone, which is performed with a large loop electrode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Incompletely visible transformation zone in women with High grade Squamous
             Intraepithelial Lesion (HSIL)

          -  Suspicion of microinvasive carcinoma or occult invasive carcinoma

          -  Suspicion of glandular disease

        Exclusion Criteria:

          -  Pregnancy

          -  Coagulation disorders

          -  Cervicitis were present

          -  Refusal to participate in the study
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone furoate 50mcg; Fluticasone propionate 100mcg; Placebo
Intervention description: Once daily inhalation powder via Novel Dry Powder Inhaler; Twice daily inhalation powder via DISKUS/ACCUHALER; Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate
      the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate
      inhalation powder in the treatment of asthma in adults and adolescents not currently treated
      with inhaled corticosteroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior
             to first visit

          -  Both genders; females of child bearing potential must be willing to use appropriate
             contraception during the study

          -  Pre-bronchodilator FEV1 of at least 60% predicted

          -  FEV1 reversibility of at least 12% and 200ml

          -  Current asthma therapy that includes a non-corticosteroid controller and/or short
             acting beta-agonist

        Exclusion Criteria:

          -  History of life-threatening asthma exacerbation with the past 10 years

          -  Asthma exacerbation requiring oral corticosteroids within the past 3 months or
             overnight hospital stay within the past 6 months

          -  Current or recent respiratory infection or current oral candida infection

          -  Presence of a significant respiratory disease or other medical condition that is
             uncontrolled or that could affect subject safety or study outcome

          -  Known or suspected allergy to study medication or materials

          -  Taking another investigational medication or prohibited medication during the study

          -  Current smokers or former smokers with significant tobacco exposure

          -  Previous treatment with fluticasone furoate in a phase II or III study

          -  Children in Care
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Condition: Unresectable or Metastatic Melanoma
MeSH terms: Melanoma
Intervention: BMS-936558; Dacarbazine; Carboplatin; Paclitaxel
Intervention MeSH terms: Paclitaxel; Carboplatin; Nivolumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to estimate the response rate and compare overall survival of
      patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or
      Carboplatin and Paclitaxel
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men & women ≥ 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

          -  Histologically confirmed Stage III (unresectable)/Stage IV melanoma

          -  Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

          -  Objective evidence of disease progression (clinical or radiological) during or after
             at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment
             regimens

          -  Pre-treatment fresh core, excision or punch tumor biopsy

          -  Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

        Exclusion Criteria:

          -  Any treatment in a BMS-936558 (Nivolumab) trial

          -  Subjects with condition requiring systemic treatment with either corticosteroids (>
             10mg daily prednisone/equivalent) or other immunosuppressive medications within 14
             days of study drug administration

          -  Active, known or suspected autoimmune disease

          -  Unknown BRAF status

          -  Active brain metastasis or leptomeningeal metastasis

          -  Ocular melanoma

          -  Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1
             (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
Compare the Clinical Efficacy of Prototype Toothpastes
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Fluoride; Triclosan, fluoride; Metal salt
Intervention description: Brush twice daily; Brush twice daily; Brush twice daily
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival
      inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers 18-65 years of age.

          -  Good general health.

          -  Must sign informed consent form.

          -  Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Subject unable or unwilling to sign the informed consent form.

          -  Medical condition which requires pre-medication prior to dental visits/procedures.

          -  Moderate or advanced periodontal disease.

          -  5 or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that currently affect salivary flow.

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 1 week prior to enrollment into this
             study.

          -  Use of tobacco products.

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  Presence of an orthodontic appliance.

          -  History of allergy to common dentifrice ingredients.

          -  History of allergy to zinc.

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Daptomycin Versus Placebo in Patients With Neutropenia and Fever
Condition: Febrile Neutropenia
MeSH terms: Neutropenia; Febrile Neutropenia
Intervention: Daptomycin; Saline Placebo; Daptomycin
Intervention description: 8 MG/KG IV; 50 ml normal saline once daily; 8 mg/kg once daily
Intervention MeSH terms: Daptomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the benefits and side effects of daptomycin compared
      to placebo for the treatment of neutropenic fever.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients in the above categories who are currently undergoing chemotherapy.

          2. Patients at least 18 of age.

          3. Patient expected to reach an absolute granulocyte count of <100 cells/mm3

          4. Patients who have given written consent because of the above criteria must have at
             least one temperature of greater or equal to 38.3° or temperatures > 38o on at least
             two occasions before study drug is administered.

        Exclusion Criteria:

          1. Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their
             neutropenia is of insufficient duration for adequate test of the value of an anti-gram
             positive antibiotic.

          2. Patients undergoing auto-transplantation, for the same reason as above.

          3. Patients with evidence of a clinical infection such as presence of a pulmonary
             infiltrate by x-ray or clinical evidence for the presence of cellulitis.

          4. Patients who have received daptomycin in the two weeks prior to enrollment.

          5. Patients with concomitant use of vancomycin.

          6. Patients with creatinine clearance < 30 ml/min or CPK > 3x normal

          7. Patients with significant hepatic dysfunction, defined as baseline liver function
             tests > 5x above normal.

          8. Patients with known allergy to daptomycin.

          9. Patients previously in this study.

         10. Women of child bearing age who are either lactating or pregnant (as evidenced by a
             positive urine pregnancy test or positive serum beta-HCG).

         11. Patients previously enrolled in this study.