bioihbjkbjnl/mcl2 huggingface dataset:
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Condition: Infections, Papillomavirus
Intervention: Blood sampling; Collection of cervical specimen; Cervarix
Intervention description: Blood sampling at Visit 3, 5 and 7.; Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.; Three doses administered intramuscularly at 0, 1 and 6 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 433.0
Sex: Female
Minimum age: 15 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy,
      safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of
      women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having
      participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in
      the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects
      were aged 15-25 years at the time of entry into the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  Subjects who participated in study 580299-007.

          -  Written informed consent obtained from the subject prior to enrollment.

        Exclusion Criteria:

          -  Use or planned use of any investigational or non-registered product other than the
             study vaccine.

          -  Decoding of the subject's 580299-001 treatment allocation to either the subject or the
             investigator.

          -  Administration or planned administration of any other HPV vaccine, other than the
             vaccine administered in study 580299-001.
IOK Treatment Study
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: IOK Killing Treatment; Wait list control group
Intervention description: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.; Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PTSD; Mental Health; War; Veterans

Summary:

      The goals of this project are

        -  1) to evaluate the effectiveness of a CBT treatment module addressing the mental health
           and functional impact of killing in the war zone,

        -  2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility
           of the CBT treatment module, which would be used to further refine the intervention, and

        -  3) to gather data on clinician stakeholders' perceptions of acceptability and
           feasibility of the CBT treatment module, which would be used to ensure that the module
           could be easily integrated into EBT for PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Combat Veterans ranging in age from 18-70 years will be recruited to participate in
             this study. Combat veterans ranging in age from 70 to 90 years will also be considered
             for enrollment in the study on a case-by-case basis.

          -  Veterans will need to endorse having taken a life in a war zone context, to meet
             criteria for PTSD, and to have received some prior treatment for PTSD to be included
             in the study.

          -  Participants in current PTSD treatment will not be excluded; however, if receiving
             medications, they will need to be stabilized on current medications for at least one
             month.

          -  If receiving Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), the two
             treatments the VA recognizes as evidence-based treatment for PTSD, individuals will
             need to wait two weeks after they have completed the treatment in order to enroll in
             the study, and new baseline measures will be obtained at that time.

        Exclusion Criteria:

          -  Potential participants will only be excluded if they meet current or lifetime criteria
             for a psychotic disorder.
Mechanisms of Refractory Hypertension (Reserpine)
Condition: Refractory Hypertension
MeSH terms: Hypertension
Intervention: Reserpine
Intervention description: Open label reserpine 0.1 mg pill orally
Intervention MeSH terms: Reserpine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, dose titration study
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; sympathetic tone; resperpine

Summary:

      The study is deigned to determine if refractory hypertension is attributable to heightened
      sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic
      agent, in patients failing other classes of antihypertensive agents.
    

Eligibility criteria:

        Inclusion Criteria:

        - adult with refractory hypertension defined as uncontrolled office blood pressure with use
        of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

        Exclusion Criteria:

          -  congestive heart failure (EF 40%)

          -  chronic kidney disease (GFR <40 ml/min/1.73 mm)

          -  stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months

          -  ongoing depression

          -  active peptic ulcer disease

          -  bradycardia <50 beats per minute

          -  2nd or 3rd degree heart block

          -  known intolerance of reserpine

          -  use of digoxin or tricycle antidepressants
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: IPX066; IR CD-LD
Intervention description: experimental drug product: extended-release carbidopa-levodopa capsules; active comparator: immediate-release carbidopa-levodopa capsules
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's

Summary:

      This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066
      compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced
      Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.

          2. If female and of childbearing potential, subject should be abstinent or continuing to
             practice and willing to continue throughout the study with appropriate contraceptives
             (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The
             subject must agree to take every precaution to ensure that pregnancy will not occur
             during the study.

          3. At least 30 years old at the time of diagnosis of PD.

          4. Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.

          5. A responder to LD and currently being chronically treated with stable dosage of
             commercially available standard, orally disintegrating, or controlled-release CD LD
             for at least 1 month.

          6. Must have predictable fluctuations between "on" and "off" states.

          7. Hoehn and Yahr Stage I-IV when "on".

          8. Able to provide informed consent and willing to sign Health Insurance Portability and
             Accountability Act (HIPAA) authorization.

          9. Able and willing to comply with the protocol, including availability for all scheduled
             study visits and blood sample collections.

        Exclusion Criteria:

          1. Pregnant or breastfeeding.

          2. Diagnosed with atypical parkinsonism.

          3. History, physical findings or laboratory results suggesting a diagnosis other than PD.

          4. Allergic or nonresponsive to previous CD-LD therapy.

          5. Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history
             that, in the Investigator's opinion, may jeopardize the subject's safety.

          6. Exposure to any investigational agent within 30 days prior to Visit 1.

          7. Donated blood or plasma within 28 days.

          8. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain
             Stimulation).
Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
Condition: INFECTION
MeSH terms: Infections; Communicable Diseases; Wound Infection
Intervention: Vancomycin; No Vancomycin
Intervention description: Topical prophylactic antibiotic; Placebo: Sterile water. No Vancomycin.
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1037.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to determine if using the antibiotic vancomycin as a
      preventative topical (on the surface of the skin) treatment during open-heart surgery will
      reduce the risk of developing a sternal wound infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to sign Informed Consent and Release of Medical Information Form

          -  Age ≥ 18 years

          -  Undergoing cardiac surgery with complete sternotomy (including re-operations)

        Exclusion Criteria:

          -  Evidence of active infection (any culture positive or blood positive infection)

          -  Undergoing organ transplantation

          -  Patients with known hypersensitivity to vancomycin

          -  Pregnant or nursing women

          -  Mental impairment or other conditions that may not allow participant to understand the
             nature, significance, and scope of study
Transcranial Magnetic Stimulation for "Voices"
Condition: Schizophrenia; Hallucinations
MeSH terms: Hallucinations; Schizophrenia
Intervention: 1-hertz Repetitive Transcranial Magnetic Stimulation; Active 1-Hertz Repetitive transcranial magnetic stimulation
Intervention description: Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.; Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Auditory Hallucinations; Schizophrenia; Schizoaffective Disorder; Repetitive Transcranial Magnetic Stimulation; Wernicke's Area; Superior Temporal Gyrus

Summary:

      This study will determine the efficacy of MRI-guided transcranial magnetic stimulation
      (TMS)in reducing "voices" and other symptoms experienced by people with schizophrenia and
      schizoaffective disorder. In addition, the study will determine duration of improvement
      obtained during the course of trial participation via on-going monthly contact with study
      participants for up to 1 year after the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Auditory hallucinations that occur at least five times per day, on average

          -  Diagnosis of schizophrenia or schizoaffective disorder

        Exclusion Criteria:

          -  Pregnant

          -  History of seizure that is not drug-induced or secondary to alcohol withdrawal

          -  Drug or alcohol abuse within 6 weeks of study entry (prior history of drug or alcohol
             abuse is not an exclusion)

          -  Changes in antipsychotic drug dosages within 4 weeks of study entry (patients do not
             need to be on antipsychotic medication to be included)

          -  Current significant untreated or unstable medical illness (e.g., poorly controlled
             diabetes mellitus, severe hypertension, unstable cardiac arrhythmia)

          -  Inability to understand the nature of the study due to severe psychotic
             disorganization, mental retardation, etc.

          -  Significant neurological condition (e.g., traumatic brain injury, multiple sclerosis)

          -  Factors that would preclude an MRI scan (e.g., severe obesity, claustrophobia, certain
             surgical implants with metallic components, metal shavings in the eye acquired while
             working as machinist)

          -  Cardiac pacemaker
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections
Intervention: Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO); V710 Comparator: Placebo (PBO)
Intervention description: Group 6: Placebo (PBO / PBO / PBO); Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA; Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
Group 4B: V710 (60 mcg / PBO / PBO) with MAA; Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA; Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
Group 2B: V710 (60 mcg / PBO / PBO) without MAA; Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and immunogenicity of V710 with and without Merck
      Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on
      hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with end stage kidney disease and is on hemodialysis

          -  Female patients who are able to have children must have a negative urine pregnancy
             tests

        Exclusion Criteria:

          -  Developed a serious infection within the past 12 months; allergy to the components of
             the vaccine

          -  Has been vaccinated with a live virus within the past 30 days or are scheduled to be
             vaccinated with a live virus in the next 60 days

          -  Received V710 vaccine before
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Disease Progression
Intervention: Polyphenon E
Intervention description: Four 200mg capsules daily taken with a meal, for the duration of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: breast cancer; EGCG; Polyphenon E; c-Met; VEGF; HGF

Summary:

      To see if an extract of green tea can affect certain markers of breast cancer and breast
      cancer progression in women with a recent biopsy positive for cancer and who are scheduled
      for surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definitive biopsy demonstrating primary breast cancer

          -  Residual breast cancer requiring additional surgical resection

          -  Stage I, II or III disease

          -  Patient has ability to give signed informed consent

          -  Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper
             limit of normal).

          -  ECOG Performance status of 0 or 1.

          -  Age ≥ 21 years and less than 75

        Exclusion Criteria:

          -  Prior hormonal or surgical therapy for breast cancer

          -  Abnormal liver function test

          -  Liver or kidney problems that would interfere with metabolism of study drug

          -  Any condition that would hamper informed consent or ability to comply with study
             protocol

          -  Participation in another research study in the last three months

          -  Known malignancy at any site other than breast

          -  Recent consumption of green tea (5 or more cups per day, within one week prior to
             biopsy)

          -  Allergy or intolerance to any component of green tea

          -  Inability or refusal to comply with definitive surgical therapy
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Pulmonary Fibrosis; Fibrosis
Intervention: Lucinactant first; Placebo first
Intervention description: lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours, then washout period x 14 days, then vehicle x 5 doses over 24 hrs; 6 mL normal saline x 5 doses over 24 hours, then washout period x 14 days, then lucinactant x 5 doses over 24 hours
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No

Summary:

      Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive
      forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve
      lung health. The investigators propose to measure mucus clearance before and after
      lucinactant or vehicle administration in patients with cystic fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cystic fibrosis

          -  FEV1>40%

        Exclusion Criteria:

          -  Unstable lung disease

          -  Unable or unwilling to stop hypertonic saline and dornase alfa for 3 days prior to
             each study period

          -  Relevant drug allergy or intolerance

          -  Recent investigational drug use (30 days)
A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
Condition: Thrombosis
MeSH terms: Heart Diseases; Thrombosis
Intervention: Apixaban; Vitamin K Antagonist (VKA); Low Molecular Weight Heparin (LMWH)
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Vitamin K; Heparin; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Warfarin; Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 28 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To investigate the safety and pharmacokinetics of apixaban in children with congenital or
      acquired heart disease who have a need for anticoagulation.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females, 28 days to < 18 years of age, inclusive

          -  Congenital or acquired heart diseases requiring chronic anticoagulation for
             thromboprophylaxis (eg, single ventricle physiology including all 3 stages of
             palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and
             pulmonary hypertension)

          -  Eligible participants include those who newly start anticoagulants and those who are
             currently on VKA or LMWH or other anticoagulants for thromboprophylaxis

          -  Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]

          -  Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube
             (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization

        Exclusion Criteria:

          -  Recent thromboembolic events less than 6 months prior to enrollment

          -  Weight < 3 kg

          -  Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or
             extracorporeal membrane oxygenation (ECMO) at the time of enrollment

          -  Artificial heart valves and mechanical heart valves

          -  Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand
             disease, etc.)

          -  Active bleeding at the time of enrollment

          -  Any major bleeding other than perioperative in the preceding 3 months

          -  Known intracranial congenital vascular malformation or tumor

          -  Confirmed diagnosis of a GI ulcer

          -  Known antiphospholipid syndrome (APS).

        Other protocol defined inclusion/exclusion criteria apply