bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery
Condition: Cancer of Head and Neck; Narcotic Use
MeSH terms: Head and Neck Neoplasms
Intervention: Gabapentin; Placebo - Concentrate
Intervention description: Use of Gabapentin peri- and post-operatively.; Use of sugar-free Placebo peri- and post-operatively.
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: All staff involved including nursing, surgeons, pain management, participants and PI will be blinded. Unmasked personnel only include research pharmacy staff.
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gabapentin; Narcotic; Cancer; Placebo

Summary:

      Patients undergoing head and neck cancer surgery often have a lot of pain after surgery,
      which can lead to a need for a lot of narcotic pain medication. These medications can have
      many side effects that can make recovery more difficult including nausea, vomiting,
      dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have
      a bowel movement, longer time before being able to start walking. These side effects can make
      the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that
      focuses on nerve pain, has been used in smaller head and neck surgeries including removal of
      tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn
      surgery have shown improved pain control with gabapentin. Potential benefits to future
      patients include improved pain control, less narcotic associated side effects and faster
      functional recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing major head and neck surgery with concomitant free flap
             reconstruction surgery at UCDMC (oncology and non-oncologic): There will be two
             groups. Group 1 will include reconstruction with fibula free flap only. Group 2 will
             include any other free flap reconstruction, including scapular free flap, radial
             forearm free flap, anterolateral thigh free flap, anteromedial thigh free flap, and
             latissimus dorsi free flap.

          -  Patients naïve to gabapentin

          -  Adult patients >18 years of age and able to consent

        Exclusion Criteria:

          -  Patients who are already taking scheduled gabapentin

          -  Patients allergic to gabapentin

          -  Chronic opioid use not from active head and neck cancer

          -  Illicit drug use (per report)

          -  Patients with known renal compromise, such that Creatinine clearance is < 30

          -  Patient with known hepatic insufficiency or cirrhosis

          -  Adults unable to consent

          -  Individuals less than 18 years old

          -  Pregnant women

          -  Prisoners
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Cediranib; FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); XELOX (Capecitabine and Oxaliplatin); Cediranib Placebo
Intervention description: oral tablet; intravenous infusion; intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15); oral tablet
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin; Cediranib; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1254.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Colorectal Cancer; Cediranib; RECENTIN

Summary:

      The purpose of this study is to determine if Cediranib when added to chemotherapy is more
      effective than chemotherapy alone in prolonging life expectancy and slowing disease
      progression in patients with previously untreated metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written Informed Consent

          -  Carcinoma of the colon or rectum

          -  One or more measurable lesions

        Exclusion Criteria:

          -  Adjuvant/neoadjuvant therapy within 6-12 months of study entry

          -  Untreated unstable brain or meningeal metastases

          -  Specific laboratory ranges

          -  Specific cardiovascular problems

          -  Participation in other trials within 30 days
Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women
Condition: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Intervention: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL); Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered
      subcutaneously via auto-injector is associated with less pain as compared to intramuscular
      injections of Makena®
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.

          2. Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.

          3. Naturally or surgically postmenopausal with or without an intact uterus.

        Exclusion Criteria:

          1. Have history of or positive test results for HIV or hepatitis B or C.

          2. A significant history or current evidence of chronic infectious disease, organ
             dysfunction especially cardiovascular, renal, or hepatic disorders or other medical
             condition.

          3. Receiving or have received chronic opioid therapy within 12 months.

          4. Unwilling to stop taking/using:

               -  pain medication.

               -  topical analgesic or anti-inflammatory treatment. Topical analgesics must be
                  washed out by at least 72 hours in the areas to be treated before randomization.

          5. History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3
             oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.

          6. Currently taking any estrogen/progesterone hormone replacement therapy (HRT).

          7. History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any
             of the constituents of the study medications or history of any drug hypersensitivity
             or intolerance.

          8. Poorly controlled diabetes (Hgb A1C >8).

          9. Current or history of thrombosis or thromboembolic disorders.

         10. Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history
             of these conditions within the last 5 years.

         11. Any current or recent (within previous 12 months) vaginal bleeding.

         12. Uncontrolled hypertension.

         13. A chronic pain condition (i.e. chronic back pain) that may confound the assessments of
             injection pain.
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept
Intervention description: Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Etanercept; Long-term Safety; Enbrel

Summary:

      This is an open label, multicenter study for extended treatment of patients who have
      participated in the Immunex clinical study 016.0012. The primary objective of this study is
      to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage
      rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.

          -  No clinically significant adverse events thought to be due to etanercept (TNFR:Fc)
             during previous treatment.

          -  Negative serum pregnancy test not more than 14 days before the first dose of study
             drug in females of childbearing potential.

          -  No more than one NSAID at a dose not greater than the maximum recommended dose and
             stable for at least two weeks prior to administration of etanercept (TNFR:Fc).
             Exclusion Criteria:

          -  Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or
             diphtheria IL-2 fusion protein.

          -  Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within
             interval between study drug in 016.0012 and this study.

          -  Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine,
             cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than
             MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.

          -  Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept
             (TNFR:Fc) in this study.
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Enoxaparin followed by VKA
Intervention description: During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.; Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
Intervention MeSH terms: Enoxaparin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority
      program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with
      confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed acute symptomatic proximal DVT without symptomatic PE

        Exclusion Criteria:

          -  Legal lower age limitations (country specific)

          -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
             current episode of DVT and/or PE

          -  Other indication for VKA than DVT and/or PE

          -  The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from
             36 hours to a maximum of 48 hours.
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Intervention: Oxytocin Infusion
Intervention description: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
Intervention MeSH terms: Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oxytocin; blood loss; Cesarean delivery

Summary:

      Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to
      initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to
      maintain adequate uterine tone after delivery. The study investigators aim to compare two
      different infusion rates of oxytocin to assess the optimal infusion regimen for reducing
      blood loss in women undergoing elective Cesarean delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy pregnant patients with uncomplicated pregnancies:

          -  ASA (American Association of Anesthesiologists) class 1 or 2 patients.

          -  Singleton pregnancies.

        Exclusion Criteria:

          -  ASA class 3 or 4 patients.

          -  Known drug allergy to intravenous oxytocin.

          -  Significant medical or obstetric disease.

          -  Known uterine abnormality.

          -  Known placental abnormality.
A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Quadrivalent Influenza Vaccine (QIV); Trivalent Influenza Vaccine (TIV-1); Trivalent Influenza Vaccine (TIV-2)
Intervention description: One 0.5 mL intramuscular dose into the deltoid muscle; One 0.5 mL intramuscular dose into the deltoid muscle.; One 0.5 mL intramuscular dose into the deltoid muscle.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,
      inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015
      trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the
      alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or non-pregnant females aged ≥ 18 years at the time of vaccination.

          -  Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen for the duration of the On-study period. Females of child-bearing potential
             must return a negative urine pregnancy test result prior to vaccination with the
             vaccine.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs,
             chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.

          -  Vaccination against influenza in the previous 6 months.

          -  Known history of Guillain-Barré Syndrome or other demyelinating disease.

          -  Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).

          -  A clinically significant medical condition.

          -  Pregnant or lactating females.
A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
Condition: Travelers' Diarrhea
MeSH terms: Dysentery; Diarrhea
Intervention: Rifaximin (Sandoz GmbH) tablet; Rifaximin (Xifaxan); Placebo
Intervention description: 200 mg tablet administered orally.; 200 mg tablet administered orally; Matching Placebo tablet administered orally
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Travelers; diarrhea; rifaximin; equivalence

Summary:

      This study compared safety and efficacy of a generic rifaximin tablet to the reference listed
      drug in the treatment of travelers' diarrhea. Additionally both the generic and reference
      formulations were tested for superiority against a placebo tablet.

      It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of
      these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The
      remaining 27 patients received study drug and 25 patients completed the study.

      The study was terminated due to slow enrolment. The final analysis included only safety
      analysis in the Safety population, due to the low number of randomized patients. No efficacy
      analysis was performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is able to read and understood the language of the Informed Consent Form and
             Patient Information.

          -  International travelers with a duration of stay in host country long enough to attend
             schedules visits.

          -  Affected by naturally acquired acute diarrhea, defined as the passage of at least 3
             unformed stools within 24 hours immediately preceding randomization preceding
             randomization

        Exclusion Criteria:

          -  Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any
             of the excipients of the study drug.

          -  Pregnant, breast feeding or planning pregnancy

          -  Acute diarrhea for > 72 hours immediately prior to randomization.

          -  Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually)
             or clinical findings suggesting moderate or severe dehydration.
Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Condition: Thrombocytopenia; Idiopathic Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Romiplostim
Intervention description: Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic

Summary:

      The purpose of this study is to determine the safety of romiplostim as a long-term treatment
      in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to
      romiplostim, and to evaluate changes in patient reported outcomes due to the use of
      romiplostim. Participants must have previously completed a romiplostim ITP study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have previously completed a romiplostim ITP study

          -  Platelet count ≤ 50 x 10 ^9/L

          -  Written informed consent

        Exclusion Criteria:

          -  Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment
             in the previous romiplostim ITP study

          -  Received any alkylating agents within 4 weeks before screening visit or anticipated
             use during the time of the proposed study

          -  Currently enrolled in or has not yet completed at least 4 weeks since ending device or
             drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving
             other investigational agent(s) other than romiplostim

          -  Not using adequate contraceptive precautions

          -  Not available for follow-up assessments

          -  Has any kind of disorder that compromises the ability of the participant to give
             informed consent and does not have a legally-acceptable representative and/or is
             unable to comply with study procedures.
A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Galantamine; Placebo
Intervention description: 8mg/ day oral capsule increased to 16mg/day then to 24 mg per day; Matching placebo
Intervention MeSH terms: Galantamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2051.0
Sex: All
Minimum age: 45 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Galantamine; Dementia, Alzheimer type; Memory loss

Summary:

      The purpose of this study is to compare the effectiveness and safety of 2 years of treatment
      with galantamine as compared with placebo of patients who have mild to moderately severe
      Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients

          -  diagnosed with mild to moderately-severe, probable or possible AD, established in
             accordance with the criteria defined by the National Institute of Neurological and
             Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders
             Association or the Diagnostic and Statistical Manual, Fourth Edition

          -  living with or have regular and frequent visits from a responsible caregiver.

        Exclusion Criteria:

          -  Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal
             Dementia or Huntington's disease

          -  Any of specified conditions which may contribute to dementia

          -  any of specified coexisting diseases, including significant cardiovascular disease.