bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Tovaxin
Intervention description: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Healthy volunteers: No
Keywords: Tovaxin; Autologous; T-cell vaccine (TCV)

Summary:

      The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the
      treatment of relapsing forms of multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed the TERMS study and received at least 1 study treatment
             injection

          -  Signed and dated statement of informed consent

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin
             in the TERMS study.

          -  Withdrew from TERMS study and did not continue participating in the remaining 52-week
             core TERMS study assessments.

          -  Non-compliant with TERMS study.

          -  Diagnosis of progressive-relapsing, secondary progressive or primary progressive
             Multiple Sclerosis (MS) while enrolled in the TERMS study.

          -  Medical, psychiatric or other conditions that compromise the subject's ability to give
             informed consent, to understand the patient information, to comply with the study
             protocol, or to complete the study.

          -  Any significant change in the subject's medical condition after enrollment in the
             TERMS study which would have lead to his/her exclusion from participation in that
             study.
AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; AG-013736; Gemcitabine
Intervention description: Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks; Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.; Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Intervention MeSH terms: Gemcitabine; Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer

Summary:

      This is a Phase 2 study being conducted at multiple centers in the United States, Europe and
      Canada. Patients having pancreatic cancer that is locally advanced or that has spread to
      other parts of the body (i.e., metastatic) are eligible to participate. Patients must have
      not had any prior systemic treatment for advanced disease. The purpose of the study is to
      test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine
      is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall
      survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with advanced (localized but surgically unresectable or metastatic)
             histologically/cytologically proven epithelial cancer of the exocrine pancreas

          -  no prior therapy for metastatic disease

        Exclusion Criteria:

          -  patients with locally advanced disease who are candidates for radiation therapy.

          -  uncontrolled brain metastases (a controlled brain metastasis must be previously
             treated, asymptomatic, and without growth for 4 months)
Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth
Condition: Posttraumatic Stress Disorders; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: D-cycloserine; Placebo pill; CBT
Intervention description: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.; Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.; 12-session CBT protocol, called Youth PTSD Treatment.
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 7 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Cognitive Behavior Therapy; Children; Pharmacotherapy

Summary:

      The purpose of this study is to show whether D-cycloserine in combination with cognitive
      behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of
      posttraumatic stress disorder (PTSD) in 7-12 year old children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Certain number of PTSD symptoms plus functional impairment

          -  Must be able to swallow pills

        Exclusion Criteria:

          -  Serious kidney or liver disease

          -  Epilepsy

          -  Bipolar

          -  Psychosis
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Potassium nitrate and sodium fluoride; Standard fluoride dentifrice
Intervention description: 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride; Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate
      mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice
      for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard
      fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner
      blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity
      Score of the two selected test teeth) study in participants with at least two sensitive teeth
      that meet all the criteria at the Screening and Baseline visit. Participants will be assessed
      at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants in good general health, with self-reported history of dentinal
             hypersensitivity lasting more than 6 months but not more than 10 years.

          -  Participants with minimum of 20 natural teeth.

          -  At screening, a minimum of four, non-adjacent teeth.

               1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion
                  or abrasion.

               2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.

               3. Teeth that are determined to be sensitive by the participant following a 1 second
                  air blast to the cervical margin.

        Exclusion Criteria:

          -  Presence of chronic debilitating disease which, in the opinion of the investigator,
             could affect study outcomes.

          -  Any condition which, in the opinion of the investigator, causes dry mouth.

          -  Tooth with evidence of current or recent caries, or reported treatment of decay in 12
             months of screening.

          -  In the 8 weeks prior to screening use of an oral care product indicated for the relief
             of DH.
Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Nilotinib; Placebo to nilotinib
Intervention description: Nilotinib capsules for oral administration at 50 mg, 150 mg twice a day and 300 mg (2 capsules of 150 mg) twice a day.; Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Nilotinib; 6MWD; Pulmonary Hypertension

Summary:

      The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in
      this population and to test the hypothesis that 6 months treatment with nilotinib will
      significantly reduce pulmonary artery resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  World Health Organization (WHO) Functional Class II or III

          -  6MWD ≥ 150 m and ≤ 450 m at screening

          -  Current diagnosis of PAH according to Dana Point 2008 Meeting

          -  Inadequate clinical response on one or more class(es) of PAH drug

          -  Stabilization of pulmonary hypertension medications for ≥ 2 months on approved
             therapeutic dose of at least one PAH drug and still symptomatic with WHO functional
             Class II or III performance.

        Exclusion Criteria:

          -  Women of child-bearing potential not practicing birth control

          -  In treatment with chronic nitric oxide therapy

          -  Pre-existing lung disease

          -  Use of drugs prolonging the QT interval or strong CYP3A4 inhibitors

          -  Long QT syndrome or QTc > 450 ms males; > 470 ms females.

          -  WHO Class IV

          -  Pulmonary capillary wedge pressure > 15 mm Hg

          -  Other diagnosis of PAH in WHO Diagnostic Group 1

          -  PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO
             Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group
             IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis,
             histiocytosis X, lymphangiomatosis, compression of pulmonary vessels)

          -  Thrombocytopenia < 50 x109/L (50 x 103/µL)

          -  Uncontrolled systemic arterial hypertension, systolic > 160 mm Hg or diastolic >90 mm
             Hg

          -  Any advanced, severe, or unstable disease of any type that may interfere with the
             primary and secondary endpoint evaluations.

        Other protocol-defined inclusion/exclusion criteria may apply
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
Condition: Nasopharyngeal Neoplasms; Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Intervention: docetaxel; cisplatin; 5-fluorouracil
Intervention description: Pharmaceutical form:solution for infusion
Route of administration:intravenous; Pharmaceutical form:solution for infusion
Route of administration:intravenous; Pharmaceutical form:solution for infusion
Route of administration:intravenous
Intervention MeSH terms: Docetaxel; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 1 Month
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Nasopharyngeal carcinoma

Summary:

      The primary objective is to estimate the Complete Response rate of docetaxel to the
      combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in
      the Induction treatment of Nasopharyngeal Carcinoma (NPC).

      The secondary objectives are to determine:

        -  the safety of TCF in comparison to CF after induction treatment of NPC,

        -  the pharmacokinetics of docetaxel when added to CF,

        -  the Overall Response rate of TCF and CF on completion of induction and consolidation
           (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and
           CF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO)
             type II or III

          -  Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable
             disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France,
             participants must be ≥1 year to ≤21 years of age at the time of diagnosis

        Exclusion Criteria:

          -  Participants with short life expectancy

          -  Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of
             nasopharyngeal carcinoma

          -  Inadequate renal function evidenced by unacceptable laboratory results

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Candidate Influenza Vaccine GSK1247446A - 3 different formulations; Fluarix TM
Intervention description: Single dose, Intramuscular injection; Single dose, Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 3124.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza vaccine

Summary:

      The purpose of this phase IIb study is to demonstrate the consistency of three lots of an
      adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to
      Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female age 60 years or older at the time of the vaccination.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the administration of the study vaccine, or planned use during the study
             period.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or laboratory screening tests.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within three months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrolment in this study. Planned administration
             of a vaccine not foreseen by the study protocol up to 30 days after vaccination.

          -  History of hypersensitivity to a previous dose of influenza vaccine.

          -  History of confirmed influenza infection within the last 12 months.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine(s)

          -  Acute disease at the time of enrolment
Effects of Melatonin on Insomnia Symptoms in Older Adults
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Melatonin 0.4 mg; Melatonin 4.0 mg; Placebo
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aged; Sleep; Insomnia; Melatonin; Neurobehavioral Manifestations; Circadian Rhythms; Human; Polysomnography; Elderly

Summary:

      This study will determine whether melatonin tablets will increase the sleep of older adults
      with insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of insomnia

          -  Low melatonin levels at study entry

        Exclusion Criteria:

          -  History of sleep apnea (temporary cessation of breathing during sleep)

          -  Diagnosis of restless legs syndrome

          -  Current alcohol or substance abuse

          -  Dementia

          -  Anemia

          -  Liver disease

          -  Leukemia or lymphoma

          -  Asthma
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: BIBF 1120; sunitinib
Intervention description: VEGF inhibitor; VEGF inhibitor
Intervention MeSH terms: Sunitinib; Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and
      to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no
             previous systemic anti-cancer treatment.

          2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.

          3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow
             sunitinib/BIBF 1120 treatment.

        Exclusion criteria:

          1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment

          2. Treatment with other investigational drugs or participation in another clinical study
             within the past 4 weeks before start of therapy or concomitantly with this study.

          3. Patients unable to comply with the 1199.26 protocol.

          4. Pregnancy or breast feeding.

          5. Active alcohol or drug abuse.

          6. Women of child bearing potential, or men who are able to father a child, unwilling to
             use a medically acceptable form of contraception during the study period.
Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: INTRAVENOUS GSK679586; INTRAVENOUS PLACEBO; FLUTICASONE PROPIONATE
Intervention description: GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump; Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump; Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Asthma control questionnaire

Summary:

      Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of asthma for ≥ 6 months

          -  taking inhaled corticosteroids

          -  non-smoking

          -  Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening.

          -  Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline
             after nebulised salbutamol or albuterol.

          -  symptomatic according to the ACQ-7

        Exclusion Criteria:

          -  Unstable severe asthma

          -  Recent respiratory illness

          -  Presence of other respiratory disease or chronic pulmonary condition other than asthma

          -  Treatment with omalizumab within 4 months of study

          -  Recent gastrointestinal or respiratory parasitic infestation

          -  History of severe allergy to food or drugs

        Other protocol-defined inclusion/exclusion criteria may apply
Cognitive Stimulation
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Intervention: Computerized cognitively stimulating activities
Intervention description: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This research is being done to learn if computer tasks that challenge the brain (cognitively
      stimulating tasks) can improve memory and other types of thinking. The study will compare the
      effects of different versions of the computer tasks. It also will compare the task
      performance of different groups of people.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-55

          -  in methadone maintenance or healthy volunteers

          -  healthy

        Exclusion Criteria:

          -  Axis I disorder (except substance abuse and dependence in methadone maintenance
             patients)

          -  severe cognitive impairment

          -  serious untreated medical condition