bioihbjkbjnl/mcl2 huggingface dataset:
Coping Skills Training for Adolescents With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Coping Skills Training; Education
Intervention description: 8 weekly sessions of behavioral treatment; 8 weekly sessions of fibromyalgia education
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Juvenile Fibromyalgia Syndrome; JPFS; Fibromyalgia; Chronic Pain; Pediatric Pain; Juvenile Fibromyalgia

Summary:

      Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and
      difficulty in an adolescent's day-to-day activities. The purpose of this study is to
      determine whether coping skills training, when combined with usual medical care, can reduce
      pain and disability in adolescents with fibromyalgia.

      Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual
      medical care will show significantly greater reductions in functional disability, pain, and
      depressive symptoms at the end of the acute treatment phase than adolescents who receive
      fibromyalgia education with their usual medical care. 2) Adolescents who receive coping
      skills training with their usual medical care will show significantly lower levels of
      functional disability, pain, and depressive symptoms at the end of a six-month maintenance
      phase than adolescents who receive fibromyalgia education with their usual medical care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of JPFS based upon widespread pain for over 3 months, at least 5 tender
             points, and associated features such as sleep difficulty, fatigue, and abdominal
             discomfort

          -  Average pain intensity greater than 4 on the Visual Analog Scale

          -  Functional disability score greater than 7

          -  Stable medications for 8 weeks prior to study entry

        Exclusion Criteria:

          -  Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus

          -  Significant developmental delay or impairments, such as autism, cerebral palsy, or
             mental retardation

          -  Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic
             disorder, bipolar disorder, major depressive disorder, or psychosis

          -  Opioid medications are disallowed when used on an ongoing basis for treatment of
             fibromyalgia pain
Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Genuair® (Almirall S.A.); HandiHaler® (Boehringer Ingelheim's)
Intervention description: Inhaler with only placebo, once daily, 14 days; Inhaler with only placebo, once daily, 14 days
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Preference study: Genuair vs HandiHaler inhalers in COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female patients aged ≥ 40 with stable COPD

          -  Naïve patients to the use of study inhalers

          -  Patients agreeing on participating and signing the Informed Consent Form

        Exclusion Criteria:

          -  Patients with other clinically significant disease, particularly body malformations or
             diseases affecting coordination and/or motor system

          -  Patients unable to read product package instructions and answer patient reported
             questionnaires
Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
Condition: Obesity; Premature Recovery From Anesthesia
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Nuvigil; Placebo
Intervention description: Patients will receive Nuvigil before the surgery; Placebo will be given before surgery
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea; Anesthesia Recovery Period

Summary:

      Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative
      morbidity and mortality. This group of patients is at risk of perioperative desaturations
      which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA
      patients might also need to spend the night in intensive care for more frequent monitoring
      for any desaturations episodes especially if the patient will be requiring multiple
      intravenous narcotic boluses for pain control. Several studies have looked into the most
      appropriate way to manage these patients and some recommendations have been made to avoid
      outpatient surgery with close monitoring for first 24 hours after surgery specifically if
      patient will require intravenous postoperative narcotics.

      Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA
      approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and
      obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or
      modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown.

      Nuvigil is longer acting product which is similar in action to Modafinil however is much
      cheaper. Nuvigil has not been previously studied for postoperative recovery. The
      investigators intend to study the effects of Nuvigil on postoperative recovery time and
      wakefulness in obstructive sleep apnea and obese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient presented for surgery under general anesthesia

          -  Documented OSA

          -  Patients with BMI above 35

        Exclusion Criteria:

          -  Coronary Artery Disease or Myocardial infarcts

          -  Mitral valve prolapse

          -  Cyclosporine, contraceptive drugs

          -  Known allergic reaction to Modafinil or any of its products
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab 1 mg/kg; Belimumab 10 mg/kg
Intervention description: Belimumab 1 mg/kg IV over one hour every 28 days; Belimumab 10 mg/kg IV over one hour every 28 days
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus; Belimumab; SLE; Antibodies; Lupus; Autoimmune Diseases

Summary:

      This is a continuation study to provide continuing treatment to subjects who completed study
      HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of
      belimumab(LymphoStat-B™) in subjects with SLE disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.

          -  Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose
             in HGS1006-c1056.

        Exclusion Criteria:

          -  Have developed any other medical disease or condition that has made the subject
             unsuitable for this study in the opinion of their physician.
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa
Condition: Hemophilia A With Inhibitors; Hemophilia B With Inhibitors
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Coagulation FVIIa (Recombinant)
Intervention description: A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate
      dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the
      treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII
      or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years
      old).
    

Eligibility criteria:

        Inclusion Criteria:

          -  be male with a diagnosis of congenital hemophilia A or B of any severity

          -  have one of the following:

          -  a positive inhibitor test BU ≥5, OR

          -  a Bethesda Unit (BU) <5 but expected to have a high anamnestic response to FVIII or
             FIX, as demonstrated from the patient's medical history, precluding the use of factor
             VIII or IX products to treat bleeding episodes, OR

          -  a BU <5 but expected to be refractory to increased dosing of FVIII or FIX, as
             demonstrated from the patient's medical history, precluding the use of factor VIII or
             IX products to treat bleeding episodes

          -  be aged from birth to <12 years old

          -  have experienced at least 3 bleeding episodes of any severity in the past 6 months

          -  parents or legal guardians must be capable of understanding and be willing to comply
             with the conditions of the protocol

          -  parents or legal guardians must have read, understood, and provided written informed
             consent

        Exclusion Criteria:

          -  have any coagulation disorder other than hemophilia A or B

          -  be immunosuppressed (i.e., the patient may not be receiving systemic immunosuppressive
             medication; cluster of differentiation 4 (CD4) counts at screening must be >200/µL)

          -  have a known allergy or hypersensitivity to rabbits

          -  have platelet count <100,000/mL

          -  have had a major surgical procedure (e.g. orthopedic, abdominal) within 1 month prior
             to first administration of study drug

          -  have received an investigational drug within 30 days of first study drug
             administration, or be expected to receive such drug during participation in this study
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: AL-60371, 0.3% otic suspension; AL-60371 Vehicle
Intervention description: Investigational otic suspension intended for the treatment of acute otitis externa; Inactive ingredients used as placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 589.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Acute otitis externa

Summary:

      The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle
      based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa
      (AOE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 6 months of age.

          -  Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of
             presumed bacterial origin in at least one ear.

          -  Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for
             tenderness, erythema, and edema.

          -  Agree to refrain from water immersion of the ears during the conduct of the entire
             study.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as
             reported by patient or parent/guardian.

          -  Presence of a tympanostomy tube or perforated tympanic membrane in the affected
             ear(s).

          -  Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the
             affected ear(s).

          -  Known or suspected ear infection of yeast, fungal or mycobacterial origin in the
             affected ear(s).

          -  Prior otologic surgery within 6 months of study entry in the affected ear(s).

          -  Known or suspected allergy or hypersensitivity to quinolones or other ingredients
             present in the medications to be used in the study.

          -  Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue
             their use during the study period.

          -  Other protocol-defined exclusion criteria may apply.
Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria
Condition: Hereditary Orotic Aciduria
MeSH terms: Purine-Pyrimidine Metabolism, Inborn Errors
Intervention: uridine triacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 6 Months
Maximum age: 19 Years
Healthy volunteers: No

Summary:

      This protocol has two parts - the Main Study which is 42 days in length and the Treatment
      Extension which allows the patients who complete the Main Study to continue receiving
      treatment with uridine triacetate. The purpose of this study is to replace oral
      administration of uridine with oral administration of uridine triacetate in patients with
      hereditary orotic aciduria who have received (or would reasonably be expected to receive)
      clinical benefit from treatment with exogenous uridine. It is also to document the continued
      clinical benefit of exogenous uridine when patients are switched from oral administration of
      uridine to oral administration of uridine triacetate.
    

Eligibility criteria:

        Inclusion Criteria (Main Study):

          -  Patients with diagnosed hereditary orotic aciduria

          -  Judged by the investigator to have the initiative and means to be compliant with the
             protocol

          -  Able to take oral medications

          -  Able to provide written informed consent (patient or legally authorized
             representative)

          -  Females of childbearing potential must have a negative pregnancy test at screening

          -  Females of childbearing potential or males with partners of childbearing potential are
             to use one of the following acceptable birth control methods:

          -  Surgically sterile or partner is surgically sterile

          -  Using adequate contraception (hormonal contraceptives, double barrier methods, or
             intra-uterine devices)

          -  Patients who claim to be sexually inactive agree to use an acceptable method of
             contraception should she or he become sexually active from 14 days prior to first
             dosing, throughout the study and for 14 days after the last dose administration

        Exclusion Criteria (Main Study):

          -  Has a known allergy to uridine triacetate or any of its excipients

          -  Known to have ornithine transcarbamoylase deficiency

          -  Unable to have the initiative and means to be compliant with the protocol

          -  Unable to be compliant with taking oral medications

          -  Unable to provide written informed consent (patient or legally authorized
             representative)

          -  Female who is pregnant or lactating

        Inclusion Criteria (Treatment Extension)

          -  Patient successfully completed the Main Study

        Exclusion Criteria (Treatment Extension)

          -  Patient did not successfully complete the Main Study
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: MCI-186; Placebo of MCI-186
Intervention description: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.; Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.
Intervention MeSH terms: Edaravone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Amyotrophic lateral sclerosis (ALS)

Summary:

      This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This
      study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3,
      randomized, double-blind, placebo control, parallel assignment, 24-week study in the
      treatment of ALS. The objectives of this study are to assess the efficacy and safety of
      long-term intermittent therapy with 60 mg MCI-186 to ALS patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who ware completed drug administration without discontinuation in the
             preceding confirmatory study NCT00330681.

        Exclusion Criteria:

          -  Patients with such complications as Parkinson's disease, schizophrenia, dementia,
             renal failure, or other severe complication, and patients who have the anamnesis of
             hypersensitivity to edaravone.

          -  Patients whose creatinine clearance is 50mL/min or less at the time of completion of
             drug administration in the study NCT00330681.

          -  Pregnant, lactating, and probably pregnant patients, and patients who want to become
             pregnant, and patients who can not agree to contraception.

          -  Patients who are participating in other clinical trials except the study NCT00330681.

          -  In addition to the above exclusion criteria, patients judged to be inadequate to
             participate in this study by their physician.
Re-Engineering Systems for the Primary Care Treatment for PTSD
Condition: Stress Disorders, Posttraumatic; Depression
MeSH terms: Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Three Component Model of Collaborative Care
Intervention description: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stress Disorders, Posttraumatic; Delivery of Health Care, Integrated; Primary Health Care; Veterans; Depression

Summary:

      The study is an evaluation of a systemic intervention to enhance the delivery of care
      according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate
      objectives are to (1) implement three component model (3CM) in VA primary care clinics; and
      (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term
      objectives are to generate information to support implementation research on the RESPECT
      model for treating PTSD in primary care and ultimately, the implementation of the model in
      VHA to provide care to veterans with PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one
             of the 5 sites in Texas where this study is being conducted.

          -  Must have regular access to a telephone and speak English.

        Exclusion Criteria:

          -  Cognitive impairment

          -  A history of psychosis or mania

          -  Prominent current suicidal ideation

          -  Current substance dependence

          -  Current engagement in mental health treatment
Duragen Versus Duraguard in Chiari Surgery
Condition: Chiari Malformation
MeSH terms: Arnold-Chiari Malformation; Congenital Abnormalities
Intervention: Duragen duraplasty; Duraguard duraplasty
Intervention description: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen); Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chiari malformation;; Duraplasty;; Posterior fossa decompression;; Duragen;; Duraguard

Summary:

      The study evaluates two materials used for duraplasty of the posterior cranial fossa in
      treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix
      that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out
      of bovine pericardium and has to be sutured during application. The study compares these two
      materials used for duraplasty of patients undergoing Chiari surgery in a prospective
      randomized fashion to check the rate of surgical complications associated with each material,
      patient's outcomes, length of surgery and the hospital stay, etc.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic Chiari malformation

        Exclusion Criteria:

          -  Presence of ventriculoperitoneal shunt

          -  Pregnancy