bioihbjkbjnl/mcl2 huggingface dataset:
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Condition: Head and Neck Carcinoma; Radiation-Induced Dermatitis
MeSH terms: Head and Neck Neoplasms; Dermatitis; Radiodermatitis
Intervention: Dakin's solution; Placebo
Intervention description: Apply modified Dakin's solution (0.005 to 0.01%) topically; Applied topically
Intervention MeSH terms: Sodium Hypochlorite; Eusol; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase 3 trial studies how well modified Dakin's solution works in reducing
      radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with
      head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce
      inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.

      Radiation therapy in this study is regulatory medical care based on the patient's needs and
      the radiation oncologist's judgment. It is not possible nor necessary to explicitly define
      the dose or duration of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Head and neck cancer who plan to undergo radiation therapy to the head and neck region

          -  At least 18 years of age

          -  Able to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Prior radiation therapy to the head and neck region or prior chemotherapy for head and
             neck cancer (induction chemotherapy NOT excluded)

          -  The physician-approved radiation treatment plan indicates a maximum prescription dose
             of less than 45 Gy

          -  Scleroderma or discoid lupus
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Glimepiride; Placebo; Placebo; Placebo; Linagliptin
Intervention description: 1-4 mg daily after 12 weeks; Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily; Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment; Placebo mach to 5 mg linagliptin once daily after 12 weeks; 5 mg once daily
Intervention MeSH terms: Glimepiride; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or
      previously treated type 2 diabetic patients with moderate to severe renal impairment and
      insufficient glycaemic control. In addition safety in this patient population with longer
      term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
    

Eligibility criteria:

        Inclusion criteria:

          1. Type 2 diabetes mellitus

          2. GFR<60 ml/min

          3. HbA1c >=7.0% to <= 10%

          4. Age >= 18 years

          5. BMI <=45 kg/m2

          6. Signed and dated written informed consent

        Exclusion criteria:

          1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

          2. Renal impairment requiring dialysis

          3. Bariatric surgery

          4. Impaired hepatic function

          5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors

          6. Treatment with anti-obesity drugs

          7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent
Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
Condition: HIV-1 Infection
Intervention: ABC/DTG/3TC; B/F/TAF; ABC/DTG/3TC Placebo; B/F/TAF Placebo
Intervention description: 600/50/300 mg FDC tablets administered orally once daily without regard to food; 50/200/25 mg FDC tablets administered orally once daily without regard to food; Tablets administered orally once daily without regard to food; Tablets administered orally once daily without regard to food
Intervention MeSH terms: Tenofovir; Emtricitabine; Lamivudine; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching from a regimen
      of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of
      abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of
      bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC
      as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1)
      infected adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).

          -  Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for
             ≥ 3 months prior to the screening visit.

          -  HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.

          -  Currently on a stable regimen for ≥ 3 months preceding the screening visit with
             documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening
             visit (or undetectable HIV-1 RNA level according to the local assay being used if the
             limit of detection is ≥ 50 copies/mL).

          -  Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV),
             DTG, ABC or 3TC.

        Key Exclusion Criteria:

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance.

          -  Active tuberculosis infection.

          -  Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
             variceal bleeding).

          -  Females who are pregnant.

          -  Females who are breastfeeding.

          -  Acute hepatitis in the 30 days prior to study entry.

          -  Chronic Hepatitis B Virus (HBV) infection.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Condition: Staphylococcal Skin Infection
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections
Intervention: Telavancin; Vancomycin
Intervention description: Telavancin 10 mg/kg/day, IV for up to 14 days.; Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
Intervention MeSH terms: Vancomycin; Telavancin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1035.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cSSSI (complicated Skin and Skin Structure Infections); Staph (Staphylococcus); MRSA (Methicillin-resistant Staphylococcus Aureus)

Summary:

      Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug,
      telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin
      structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of one of the following complicated skin and skin
             structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either
             suspected or confirmed as the major cause of the infection:

               -  major abscess requiring surgical incision and drainage;

               -  infected burn (see exclusion criteria for important qualifications);

               -  deep/extensive cellulitis;

               -  infected ulcer (see exclusion criteria for important qualifications);

               -  wound infections

          -  Patients must be expected to require at least 7 days of intravenous antibiotic
             treatment.

        Exclusion Criteria:

          -  Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic
             therapy

          -  Burns involving > 20% of body surface area or third degree/full thickness in nature,
             diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or
             mediastinitis.
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine
Intervention description: Encapsulated vortioxetine immediate-release tablets
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 836.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Melancholia; Mood Disorder; Dysthymic Disorder; Drug Therapy

Summary:

      The purpose of this study is to determine the long-term efficacy and safety of vortioxetine,
      once daily (QD), in adults with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed the double blind treatment period of either study Lu AA21004_304
             (NCT00672620) or LuAA21004_305 (NCT00735709) immediately prior to enrollment in the
             extension study (ie, the baseline visit is the same visit as the completion visit of
             the double blind treatment of the preceding protocol).

          -  Suffers from a major depressive episode as the primary diagnosis according to
             Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
             (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu
             AA21004_304 or Lu AA21004_305 study.

        Exclusion Criteria:

          -  In addition to meeting the exclusion criteria for studies Lu AA21004_304 or Lu
             AA21004_305 at the time of enrollment into those studies respectively, with the
             exception of the criteria prohibiting previous exposure to Lu AA21004 and
             investigational drugs, and the criteria prohibiting patients with increased
             intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion
             criteria apply:

               -  Has Major Depressive Disorder for whom other psychiatric disorders (mania,
                  bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed
                  during the prior study.

               -  The participant, in the investigator's opinion, has a significant risk of suicide
                  and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery
                  Åsberg Depression Rating Scale.

               -  The participant, in the opinion of the investigator, is unlikely to comply with
                  the clinical study protocol or is unsuitable for any reason.

               -  Has a clinically significant moderate or severe ongoing adverse event related to
                  study medication from the prior study.

               -  Has used/uses disallowed concomitant medication.
Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
Condition: Herpes Zoster; Shingles
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine, Live (AMP); Zoster Vaccine, Live
Intervention description: One approximately 0.65-mL injection subcutaneously on Day 1; One approximately 0.65-mL injection subcutaneously on Day 1
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 498.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process
      [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to
      ZOSTAVAX™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No fever on day of vaccination

          -  History of varicella or residence in a VZV-endemic area for ≥30 years

          -  Females of reproductive potential must have a negative pregnancy test and must agree
             to use acceptable methods of birth control

        Exclusion Criteria:

          -  History of hypersensitivity reaction to any vaccine component

          -  Prior receipt of any varicella or zoster vaccine

          -  Prior history of herpes zoster

          -  Have recently had another vaccination

          -  Pregnant or breastfeeding

          -  Use of immunosuppressive therapy

          -  Known or suspected immune dysfunction

          -  Concomitant antiviral therapy
An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Condition: Diabetes Mellitus, Type 2; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin; Placebo
Intervention description: One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information; One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 272.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Canagliflozin; JNJ 28431754; Placebo; Sodium-Glucose Transporter 2; hemoglobin A1c protein, Blood Glucose; reduced kidney function, Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have
      reduced kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy
             (including oral or non oral agents)

          -  Patients with reduced kidney function

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  Have proliferative diabetic retinopathy for which treatment is planned during the
             course of the study

          -  Kidney disease that required treatment with immunosuppressive therapy, history of
             dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria
             with hypoalbuminemia and/or edema), or inflammatory kidney disease

          -  Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen

          -  History of a severe hypoglycemic episode within 6 months before screening
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Condition: Renal Anemia, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta; Darbepoetin alfa
Intervention description: 1.2 mcg/kg SC monthly, starting dose; 0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous
      darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who
      are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants
      will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2
      micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45
      mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is
      3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance [CrCl]/
             glomerular filtration rate [GFR] 30 to 59 milliliter per minutes per 1.73 meter square
             [mL/min/1.73m^2]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m^2) who did not require
             dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated
             Modification of Diet in Renal Disease (MDRD) equation

          -  Anemia defined as baseline Hb concentration less than (<) 10.5 gram per deciliter
             (g/dL)

        Exclusion Criteria:

          -  Previous therapy with any ESA within 12 weeks prior to screening

          -  Renal allograft in place

          -  Immunosuppressive therapy in the 12 weeks prior to screening

          -  Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks
             before screening
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
Condition: Asthma
Intervention: Placebo Inhalation Powder; Fluticasone Furoate/GW642444 Inhalation Powder; Fluticasone Furoate/GW642444 Inhalation Powder; Placebo Oral Capsule; Prednisolone Oral Capsule
Intervention description: Placebo Inhalation powder inhaled once daily for 6 weeks' treatment; Dose B inhaled once daily for 6 weeks' treatment; Dose A inhaled once daily for 6 weeks' treatment; One placebo capsule taken each day on the last 7 days of the study; Prednisolone 10mg oral capsule taken each day on the last 7 days of the study
Intervention MeSH terms: Fluticasone; Xhance; Prednisolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HPA axis

Summary:

      The purpose of this study is to assess the effect of six weeks' treatment with two once-daily
      strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient with ability to comply with study requirements and complete two 24-hour
             clinic visits

          -  Clinical diagnosis of asthma for greater than/equal to 12 weeks

          -  Reversibility FEV1 of at least twelve percent and two hundred milliliters

          -  FEV1 greater than or equal to fifty percent of predicted

        Exclusion Criteria:

          -  History of life threatening asthma

          -  Respiratory infection or oral candidiasis

          -  Asthma exacerbation

          -  Uncontrolled disease or clinical abnormality

          -  Allergies to study drugs, study drugs' excipients, medications related to study drugs

          -  Taking another investigational medication or prohibited medication
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin + Metformin; Saxagliptin + Metformin; Saxagliptin + Metformin; Placebo + Metformin; Pioglitazone
Intervention description: Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 15 - 45 mg (as needed for rescue)
Intervention MeSH terms: Metformin; Pioglitazone; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1462.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn whether Saxagliptin added to
      Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic
      subjects who are not sufficiently controlled with Metformin alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater
             than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks
             prior to screening.

          -  HbA1c >= 7.0% and <= 10.0 %

          -  Body mass index <= 40 kg/m2

          -  Fasting C-peptide >= 1 ng/dL

        Exclusion Criteria:

          -  Symptomatic poorly controlled diabetes

          -  Recent cardiac or cerebrovascular event

          -  Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females