bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Delirium in Inpatients Utilizing Melatonin
Condition: Delirium
MeSH terms: Delirium
Intervention: Melatonin; Placebo
Intervention description: 5 mg Melatonin nightly, beginning within 24 hours of admission; Blue capsule matching the melatonin arm
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: prevention; delirium; in-patients; melatonin,

Summary:

      A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo,
      given to patients at least 65 years old, admitted to the hospital on a general medical floor,
      to prevent delirium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inpatient admission to a general internal medicine service

        Exclusion Criteria:

          -  expected lifespan or length of stay ≤ 48 hours

          -  Non-English speaking

          -  Already taking melatonin or ramelteon at the time of randomization

          -  Presence of delirium at the time of randomization

          -  Unable to take oral medications

          -  Subject or proxy unable to provide informed consent within 18 hours of invitation or
             24 hours of admission

          -  ALT or AST (Liver function tests) > 3 times the upper limit of normal

          -  Taking warfarin, nifedipine or fluvoxamine

          -  Allergy to melatonin

          -  Unable to recall 3 words after distraction by naming the days of the week backwards
             beginning with Sunday
Actual Use Trial of Ibuprofen 400 mg
Condition: Patient Compliance
Intervention: Ibuprofen 400 mg caplet
Intervention description: 400 milligram (mg) caplet according to Drug Facts label
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Masking: None (Open Label)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ibuprofen 400 mg; actual use; compliance

Summary:

      This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in
      which subjects will use the product after making a purchase decision about ibuprofen 400 mg
      caplets based only on their reading of the Drug Facts Label (DFL) and other information on
      the package.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age (19 years of age in Alabama)

          -  Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief

        Exclusion Criteria:

          -  Current government-issued identification (ID)

          -  Pregnant or breastfeeding females
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis; Fibrosis
Intervention: Simeprevir; Sofosbuvir
Intervention description: 100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.; 100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus Infection; Simeprevir; Sofosbuvir; HCV; Cirrhosis

Summary:

      The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir
      (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV)
      genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or
      treatment-experienced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).

          -  HCV ribonucleic acid (RNA) greater than 10,000 IU/mL at screening

          -  Treatment-experienced participants must have at least 1 documented previous course of
             interferon-based regimen with or without ribavirin

          -  Participants must have an hepatic imaging procedure (ultrasound, computerized
             tomography scan or magnetic resonance imaging scan) within 6 months prior to the
             screening visit (or between screening and Day 1) with no findings suspicious for
             hepatocellular carcinoma

          -  Participant must be willing and able to comply with the protocol requirements

          -  Participants with liver cirrhosis

        Exclusion Criteria:

          -  Evidence of clinical hepatic decompensation (history or current evidence of ascites,
             bleeding varices or hepatic encephalopathy)

          -  Infection/co-infection with HCV non-genotype 1

          -  Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2)
             (positive HIV-1 or HIV-2 antibodies test at screening)

          -  Co-infection with hepatitis B virus (hepatitis B-surface-antigen positive)

          -  Previously been treated with any direct acting anti-HCV agent (approved or
             investigational) for chronic HCV infection
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Temozolomide; Dacarbazine
Intervention description: oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.; intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
Intervention MeSH terms: Temozolomide; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 859.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Melanoma

Summary:

      The purpose of this study is to ascertain if the extended schedule of Temozolomide, which
      allows increased doses and potential depletion of the enzyme underlaying resistance, is a
      more effective treatment of metastatic melanoma than single agent dacarbazine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, stage IV, surgically incurable melanoma

          -  Age 18 years or older

          -  World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance
             status of 0 or 1

          -  Meets protocol requirements for specified laboratory values

          -  Must be able to take oral medication

          -  Must be disease free from cancer for period of 5 years (except for surgically cured
             carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin).

          -  Women of childbearing potential and men must be practicing a medically approved
             contraception.

          -  Must provide written informed-consent to participate in the study.

          -  Must have full recovery from major surgery or adjuvant treatment

          -  No clinically uncontrolled infectious disease including HIV or AIDS-related illness

        Exclusion Criteria:

          -  Ocular melanomas

          -  Brain Metastases

          -  Prior cytokine or chemotherapy for stage IV disease

          -  Pregnant or nursing women
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Intervention: Enteric-coated mycophenolate sodium (EC-MPS); Tacrolimus; Corticosteroids
Intervention description: At a dose of at least 5 mg/day.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dose optimization; immune suppressive regimen; enteric-coated mycophenolate sodium; EC-MPS; renal transplantation; kidney; transplant; maintenance patients; Renal transplantation in maintenance

Summary:

      This study introduces a new optimization immunosuppressive regimen associating tacrolimus at
      a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow
      down renal function worsening and to prevent the progression of chronic allograft
      nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary or secondary kidney transplant

          -  Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough
             concentration [C0] ≥ 5.5 ng/mL)

          -  Creatinine clearance ≥ 30 mL/min and < 60 mL/min and stable renal function

        Exclusion Criteria:

          -  Multi-organ recipients or previous transplant with any other organ different from
             kidney

          -  Biopsy proven acute rejection or treated acute rejection within the last 3 months.

          -  Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to
             adverse event occurrence when higher doses were administered

        Other protocol-defined inclusion/exclusion criteria may apply.
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Condition: Diabetic Peripheral Neuropathic Pain; Post-herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic; Diabetic Neuropathies; Renal Insufficiency
Intervention: DS-5565
Intervention description: DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetic peripheral neuropathic pain; post-herpetic neuralgia; renal impairment

Summary:

      Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral
      Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal
      impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min

          -  At screening, a pain scale of ≥ 40 mm

          -  Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral
             neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients
             with DPNP only)

          -  post-herpetic neuralgia PHN defined as pain present for more than 3 months after
             herpes zoster skin rash at screening (for patients with PHN only)

        Exclusion Criteria:

          -  HbA1c (National Glycohemoglobin Standardization Program) > 10.0% (for patients with
             DPNP only)

          -  Previous use of neurolytic block (for patients with PHN only)
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: ACYC; ACYC vehicle
Intervention description: ACYC active, topically applied to the face for 12 weeks; ACYC vehicle (placebo), topically applied to the face for 12 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 498.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Acne

Summary:

      The primary objective of this study is to compare the efficacy and safety and tolerability of
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between the ages of 12 and 40 (inclusive)

          -  Written and verbal informed consent must be obtained.

          -  Subjects less than 18 years of age must sign an assent for the study and a parent or a
             legal guardian must sign the informed consent

          -  Subject must have moderate to severe acne at the baseline visit

          -  Women of childbearing potential must be willing to practice effective contraception
             for the duration of the study

        Key Exclusion Criteria:

          -  Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study

          -  Dermatological conditions on the face that could interfere with clinical evaluations
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Condition: Smoking Cessation
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: placebo; varenicline (CP-526,555)
Intervention description: Randomization 2:1 treatment to placebo; One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Study will determine whether patients with schizophrenia or schizoaffective disorder can be
      helped to quit smoking safely while using varenicline and receiving smoking cessation
      counseling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or
             schizoaffective disorder and judged to be stable (without hospitalization or acute
             exacerbation and functioning in society) on psychiatric treatment for at least the
             past 6 month.

          -  Current cigarette smokers (at least 15/day during the past year with no period of
             abstinence greater than 3 months in the past year) male or female, between the ages of
             18 and 75 inclusive, who are motivated to stop smoking.

          -  Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline
             Visits.

        Exclusion Criteria:

          -  PANSS score >70 at Screen or Baseline Visit.

          -  Subjects hospitalized within the past six months due to suicidal ideation or suicidal
             behavior or subjects considered to have serious suicidal ideation or suicidal behavior
             within the past six moth.

          -  Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or
             Baseline Visit.

          -  Subjects taking Bupropion.
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide; Placebo
Intervention description: Oral capsule; Matching placebo oral capsule
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 614.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and
      abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has no clinically significant findings on a physical examination and clinical
             laboratory tests

          -  Female patients of childbearing potential must agree to use one of the following
             methods of birth control:

               1. Hormonal contraception

               2. Double-barrier birth control

               3. Maintenance of a monogamous relationship with a male partner who has been
                  surgically sterilized by vasectomy

          -  Patient meets protocol criteria for diagnosis of IBS-C

          -  Patient demonstrates continued IBS-C symptoms through Pretreatment Period

          -  Patient maintains a minimum level of compliance with daily diary

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
Condition: Ventral Hernia Repair
MeSH terms: Infections; Hernia; Hernia, Ventral
Intervention: Gemcitabine/ clindamycin; Normal saline
Intervention description: Comparison of saline solution rinse vs antibiotic rinse; Comparison of saline solution rinse vs antibiotic rinse
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design would be a registry-based RCT through the AHSQC to evaluate the effect of dual antibiotic irrigation at the time of mesh placement during open RM +/-TAR OVHR.
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Infection; hernia repair

Summary:

      This is a study to determine if the incidence of infection at the Surgical SitE is impacted
      if with Antibiotic Irrigation is used during Ventral Hernia Repair (RINSE Trial)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 y/o.

          -  Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.

          -  Clean, clean-contaminated, or contaminated wounds.

        Exclusion Criteria:

          -  Age <18 y/o.

          -  Pregnancy.

          -  Emergency hernia repair.

          -  Laparoscopic, robotic, or hybrid approach.

          -  Dirty wounds.

          -  Use of biologic or absorbable synthetic mesh.

          -  Onlay, intraperitoneal or preperitoneal mesh placement.
A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Glucagon Nasal Powder; Glucagon Hydrochloride Solution
Intervention description: Administered intranasally; Administered IM
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of nasal glucagon compared
      to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese
      participants with diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)

          -  Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or
             18.5 to 35.0 kg/m2 for T2D

          -  Hemoglobin A1c (HbA1c) ≤10%

        Exclusion Criteria:

          -  Have significant changes in insulin regimen and/ or unstable blood sugar control
             within the past 3 month

          -  Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A; Placebo
Intervention description: 500 units; 500 units
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport
      manufactured at a new manufacturing facility in Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cervical dystonia with at least 18 months since onset, and previously untreated with
             botulinum toxin or previously treated with botulinum toxin type A or B with a minimum
             interval of 16 weeks since the last injection and having returned at least to their
             usual pre-treatment status

          -  TWSTRS severity, disability and total scores meeting the defined criteria at baseline

        Exclusion Criteria:

          -  Pure anterocollis or pure retrocollis

          -  In apparent remission from cervical dystonia

          -  Previous poor response to the last two botulinum toxin type A or type B treatments

          -  Being treated with type B toxin due to lack of efficacy to type A toxin or have known
             neutralizing antibodies to type A toxin