bioihbjkbjnl/mcl2 huggingface dataset:
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Gynaecological follow-up; Cervarix; Placebo control
Intervention description: Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.; Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.; Subjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 28 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV; HPV vaccine; Cervical neoplasia; Human papillomavirus; Papillomavirus; Cervical cancer; Human papillomavirus (HPV) type 16/18 infections

Summary:

      This study is intended to provide up to a maximum of four years of annual oncogenic human
      papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study
      subjects who displayed normal cervical cytology but tested positive for oncogenic HPV
      infection at their concluding NCT00294047 study visit.

      Women who were pregnant at their concluding NCT00294047 study visit may also be included in
      this study, as no cervical sample could be collected at that visit.

      The objectives and outcome measures of the primary phase (NCT00294047) are presented in a
      separate protocol posting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained from the subject prior to enrolment.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A subject previously enrolled in the study NCT00294047 and who fulfils either of the
             following criteria:

               -  displayed normal cervical cytology but tested positive for oncogenic HPV
                  infection at her concluding NCT00294047 study visit

               -  was pregnant so that no cervical sample could be collected at her concluding
                  NCT00294047 study visit

        Exclusion Criteria:

          -  A subject who at the NCT00294047 concluding study visit displayed normal cervical
             cytology and who was negative for oncogenic HPV infection at that visit.

          -  A subject who at the NCT00294047 concluding study visit had a cervical lesion at that
             visit or who had a cervical lesion that required treatment at her NCT00294047 exit
             colposcopy.

          -  A subject for whom the cervical cytology results from the concluding NCT00294047 study
             visit were unavailable for reasons other than pregnancy.
Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
Condition: Thromboembolism
MeSH terms: Thromboembolism; Hip Fractures
Intervention: Fondaparinux
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Xa factor; VTE; MOSLL; pentasaccharide

Summary:

      This study is requested by PMDA to confirm the efficacy and the safety for HFS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing hip fracture surgery within 10 days following the time of fracture
             of the hip (proximal femur) (or following the time of fracture estimated from trauma).

        Exclusion Criteria:

          -  Active, clinically significant bleeding (excluding drainage).
Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum Toxins, Type A
Intervention description: Intramuscular Injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2691.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glabellar lines, frown lines

Summary:

      This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of
      moderate to severe glabellar lines following single and repeat administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent including authorization to release health information

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient
             Frown Wrinkle Severity (PFWS) scale

          -  Willing and able to follow all trial procedures, attend all scheduled visits, and
             successfully complete the trial

        Exclusion Criteria:

          -  Any neurological condition that may place the subject at increased risk with exposure
             to botulinum toxin type A, including peripheral motor neuropathic diseases such as
             amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional
             disorders such as Lambert-Eaton syndrome and myasthenia gravis

          -  Active skin disease, infections or inflammation at the injection sites

          -  Plan to receive botulinum toxin type A anywhere in the face through the duration of
             the study

          -  History of allergy or sensitivity to any botulinum toxin preparations or to any
             component of the test article

          -  Current enrollment in an investigational drug or device trial or participation in such
             a trial within the last 30 days prior to screening through end of trial
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Condition: Refractory Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: TAS-102; Placebo
Intervention description: 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.; 35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastric Cancer; Metastatic Gastric Cancer

Summary:

      The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC)
      with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma
             including adenocarcinoma of the gastroesophageal junction.

          2. Has previously received at least 2 prior regimens for advanced disease and were
             refractory to or unable to tolerate their last prior therapy.

          3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in
             Solid Tumors (RECIST) 1.1 criteria.

          4. Is able to take medications orally (ie, no feeding tube).

          5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.

          6. Has adequate organ function as defined by protocol defined labs.

          7. Women of childbearing potential must have a negative pregnancy test and must agree to
             adequate birth control if conception is possible. Males must agree to adequate birth
             control.

        Exclusion Criteria:

          1. Has certain serious illnesses or medical conditions

          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,
             extended field radiation, received investigational agent within the specified time
             frames prior to study drug administration.

          3. Has previously received TAS-102.

          4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for
             Adverse Events Grade 2 attributed to any prior therapies.

          5. Is a pregnant or lactating female.
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Bilastine Ophthalmic Solution 0.6%; Ketotifen Ophthalmic Solution 0.025% (Zaditen); Vehicle of Bilastine Ophthalmic Solution
Intervention description: 1 drop in each eye at 2 separate times during an 8 day period.; 1 drop in each eye at 2 separate times during an 8 day period.; 1 drop in each eye at 2 separate times during an 8 day period.
Intervention MeSH terms: Ketotifen; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and
      Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of
      allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years old

          -  be willing and able to avoid all disallowed medications and contact lenses

          -  must have a pregnancy test if of childbearing potential

          -  must be able to read an eye chart from 10 feet away

        Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used immunotherapy in the last 2 years

          -  must not have used an investigational drug or device in the past 30 days or
             concurrently enrolled in another investigational trial
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Odanacatib; Placebo for Odanacatib; Vitamin D3; Calcium carbonate
Intervention description: 50 mg tablet orally once weekly (OW); 50 mg tablet orally OW; 5600 IU orally OW; If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16071.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the event-driven base study is to determine the safety and efficacy,
      especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with
      osteoporosis. In a placebo-controlled extension of the base study, participants continued to
      receive the same blinded study medication for a total of up to 5 years of blinded study
      medication combined between the base study and the extension. After participants received 5
      years of blinded study medication, they received open-label odanacatib through the end of the
      first extension. Participants were then invited to enroll in a second extension study in
      which they received open-label odanacatib for an additional 5 years. Two imaging substudies
      (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study.
      Additional safety information was collected for participants who discontinued from the base
      study or the blinded first extension in an observational follow-up study, MK-0822-083
      (EudraCT number: 2007-002693-66) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone
             mineral density

          -  Ambulatory (able to walk)

        Exclusion Criteria:

          -  Must not be taking osteoporosis therapy or have a metabolic bone disorder other than
             osteoporosis

          -  Has or has had a hip fracture

          -  Currently participating in another drug study
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide capsules
Intervention description: Octreotide was provided in hard gelatin capsules.
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: acromegaly; IGF-1; growth hormone; Octreolin; octreotide; somatostatin analog

Summary:

      MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical
      product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety
      of MYCAPSSA™ treatment in patients with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects, aged 18 to 75 years old, inclusive.

          -  Subjects with acromegaly defined as documented evidence of growth hormone-secreting
             pituitary tumor that is abnormally responsive to glucose, or documented elevated
             insulin-like growth factor-1 (IGF-1), who are currently receiving a stable dose of a
             somatostatin analog for at least the previous 3 months.

          -  A serum IGF-1 level < 1.3 x the upper limit of normal (ULN) and a serum growth hormone
             (GH) level < 2.5 ng/mL.

          -  Subjects able and willing to comply with the requirements of the protocol.

          -  Subjects able to swallow capsules.

          -  Subjects able to understand and sign written informed consent to participate in the
             study.

        Exclusion Criteria:

          -  Receiving regular injections of a somatostatin analog less frequently than once a
             month, ie, longer than every 4 weeks.

          -  Symptomatic cholelithiasis.

          -  Received pituitary radiotherapy within ten years prior to screening.

          -  Undergone pituitary surgery within the prior 6 months.

          -  Any condition that may jeopardize study participation.

          -  Clinically significant gastrointestinal (GI), renal, or hepatic disease as determined
             by the Investigator.

          -  Conditions (eg, bariatric surgery) significantly affecting gastric acidity or
             emptying.

          -  Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use
             of H2-antagonists.

          -  Female patients who are pregnant or lactating.

          -  Current or recent (< 3 months) therapy with pegvisomant.

          -  Current or recent (< 2 months) therapy with cabergoline.
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
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Disease Progression
Intervention: Laquinimod
Intervention description: One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 839.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis

Summary:

      The purpose of this study is to make laquinimod 0.6 mg available for all subjects who
      completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate
      the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6
      mg in subjects with relapsing multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all
             Termination visit activities) according to the MS-LAQ-301 protocol.

          2. Women of child-bearing potential must practice an acceptable method of birth control
             [acceptable methods of birth control in this open label extension phase include:
             surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch
             (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's
             vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the
             study and up to 30 days after the last dose of the study drug..

          3. Subjects must be willing and able to comply with the protocol requirements for the
             duration of the study.

          4. Subjects must be able to comprehend, sign and date a written informed consent prior to
             entering the MS-LAQ-301E study.

        Exclusion Criteria:

          1. Premature discontinuation from the MS-LAQ-301 study, for any reason.

          2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E)
             visit] or breastfeeding.

          3. Subjects with clinically significant or unstable medical or surgical condition
             detected or worsened during the MS-LAQ-301 study, which preclude safe participation
             and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude
             participation in the MS-LAQ-301E study.

          4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: IPX203
Intervention description: IPX203 extended release capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: motor fluctuations; IPX203

Summary:

      The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203
      in the treatment of participants with advanced Parkinson's disease (PD) who have motor
      fluctuations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed Study IPX203-B16-02

          -  Able to provide written informed consent prior to the conduct of any study-specific
             procedures.

          -  Female participants of childbearing potential must have a negative urine pregnancy
             test at the baseline visit (Visit 1).

          -  Agrees to use a medically acceptable method of contraception throughout the study and
             for 6 weeks after completing the study.

        Exclusion Criteria:

          -  Intends to use any doses of Rytary® or Duopa™ during this study.

          -  Plans to use an investigational treatment other than IPX203 during the course of this
             study.

          -  Neurosurgical ablation treatment for PD is planned or anticipated during the study
             period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is
             permitted during this study.

          -  Participants who, in the opinion of the clinical investigator, should not participate
             in the study.