bioihbjkbjnl/mcl2 huggingface dataset:
Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Furoate/GW642444; Fluticasone propionate
Intervention description: Combination inhaled corticosteroid and long-acting beta2-agonist; Inhaled corticosteroid
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 503.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of asthma

          -  Reversibility FEV1 of twelve percent or greater and two hundred milliliters and
             greater approximately ten to forty minutes following two to four inhalations of
             albuterol

          -  FEV1 greater than or equal to fifty percent of predicted

          -  Currently using moderate to high dose inhaled corticosteroid therapy

        Exclusion Criteria:

          -  History of life threatening asthma

          -  Respiratory infection or oral candidiasis

          -  Asthma exacerbation

          -  Uncontrolled disease or clinical abnormality

          -  Allergies

          -  Taking another investigational medication or prohibited medication
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Condition: Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
MeSH terms: Muscle Spasticity
Intervention: Botulinum toxin type A
Intervention description: Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 212.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport
      used in the treatment of upper limb spasticity (altered skeletal muscle performance) in
      children with cerebral palsy (CP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Upper limb spasticity due to cerebral palsy

          -  Body weight 10 kg or over

          -  MAS score of 2 or more in affected elbow or wrist flexors

        Exclusion Criteria:

          -  Fixed myocontracture

          -  Previous phenol or alcohol injection within 1 year

          -  Severe athetoid or dystonic movements

          -  Previous or planned surgery for spasticity in elbow or wrist flexors

          -  Neuromuscular disorders

          -  Previous Rhizotomy within 6 months

          -  Intrathecal baclofen within 30 days
Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Intervention: Epidural Blood Patch; Sphenopalatine Ganglion Block
Intervention description: A device: 17 gauge Tuohy needle will be placed to the epidural space using the loss of resistance technique. Once positioned a sterile stylet will be replaced within the needle to maintain the sterility of the epidural space. A tourniquet may be used to identify a peripheral venous site, which will be sterilely prepped with betadine x3 and then chloraprep. Venipuncture will be performed with a device: 20gauge or larger needle. 20mL of blood will be aspirated in a sterile system into an appropriately sized syringe. After sterile transfer, this autologous blood will be slowly injected into the epidural space.; The drug: 5% lidocaine ointment, a local anesthetic, will be applied to the end of a device: long channeled cotton tipped applicator inserted into both nares and placed over the mucosa in the area of posterior aspect of the middle ethmoid, toward the presumed anatomic location of the sphenopalatine ganglion, evidenced by a slight resistance at the appropriate depth. 5mL of drug: 1% lidocaine solution will then be injected into the hollow shaft of the device: applicator and allowed to topically anesthetize the ganglion by gravity flow for 30 minutes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 13 Years
Maximum age: 92 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare a pain block in the midface, versus the traditional,
      more invasive, therapeutic epidural patch for the treatment of headaches
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 13-92

          -  Subjects have medical diagnosis of PDPH and require treatment

          -  Subjects who signed consent/assent

        Exclusion Criteria:

          -  <13 years of age

          -  Pregnancy

          -  Subjects with heart failure

          -  Subjects already being treated with lidocaine patch or other vehicle for chronic pain

          -  Non-english speaking subjects

          -  Subjects with platelets <100,000

          -  Subjects that are septic

          -  Subjects with an allergy to lidocaine

          -  Subjects with known nasal polyps

          -  Subjects with recent neurological event

          -  Subjects on anticoagulant therapy

          -  Subjects that received prior therapy with SPG block or EBP
Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Comparator: Rosiglitazone; Comparator: Placebo; Comparator: Metformin
Intervention description: Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.; Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.; placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.; Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to test the safety and effectiveness of sitagliptin in patients
      with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has Type 2 diabetes

          -  Currently taking metformin >1500 mg/day for at least 10 weeks

          -  Male or female

        Exclusion Criteria:

          -  Patient has peripheral edema

          -  History of type 1 diabetes

          -  Patient required insulin within prior 8 weeks

          -  Have participated or are currently participating in another study with an
             investigational compound or device within 12 weeks of starting this study

          -  Participating in a weight loss program
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole 2%
Intervention description: Crisaborole 2% ointment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 7 Months
Healthy volunteers: No
Keywords: Eczema; Crisaborole

Summary:

      This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies
      C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate
      Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants;

          -  Who were patients with mild to moderate AD aged 2 years old or older and met
             eligibility criteria for study C3291032 at the time when entering Study C3291032, and
             completed treatment period in Study C3291032 without safety issues. Or

          -  Who were patients with mild to moderate AD aged 1 months to <24 months and met
             eligibility criteria for Study C3291031 at the time when entering Study C3291031, and
             completed treatment period in Study C3291031 without safety issues

        Exclusion Criteria:

          -  Has other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Condition: Hereditary Angioedema; Angioneurotic Edema; Genetic Disorders
MeSH terms: Angioedema; Angioedemas, Hereditary; Genetic Diseases, Inborn
Intervention: recombinant human C1 inhibitor; Placebo
Intervention description: IV; IV
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks
      of local swelling (angioedema). These attacks are often painful and disabling, and, in some
      cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a
      decrease in the blood level of functional "C1INH". This multi-center study was designed to
      assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of
      recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema
      attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clear clinical and laboratory diagnosis of HAE

          -  Baseline plasma level of functional C1INH of less than 50% of normal

          -  Evidence for exacerbation or development of a severe abdominal, oro-facial/
             pharyngeal/ laryngeal, genito-urinary and/or peripheral HAE attack

        Exclusion Criteria:

          -  Acquired angioedema

          -  Pregnancy or breastfeeding

          -  Participation in another clinical study within prior 3 months
Study to Investigate the Efficacy of Symbicort® SMART.
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort Turbuhaler; Terbutaline Turbuhaler
Intervention description: 160/4.5 µg; 0.4 mg
Intervention MeSH terms: Terbutaline; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2091.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Asthma; Symbicort Turbuhaler

Summary:

      The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort
      Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler
      160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma
      therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA)
             2007 with a documented history of at least 6 months duration.

          -  Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to
             baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg
             terbutaline Turbuhaler

          -  Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12
             weeks.

        Exclusion Criteria:

          -  Respiratory infection affecting the asthma, as judged by the investigator, within 4
             weeks.

          -  Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS
             within 12 weeks.
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Triptorelin Pamoate PR 3-month; Triptorelin Acetate PR 1-month
Intervention description: 15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).; 3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 300.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in
      Chinese female subjects with endometriosis by demonstrating the non-inferiority of
      triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate
      PR 1-month formulation injected 3 times consecutively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects aged from 18 to 45 years inclusive at the date of informed consent.

          -  A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6
             months prior to the screening visit.

          -  A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years
             prior to the screening visit.

          -  Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period
             of 6 months in the judgement of the investigator.

        Exclusion Criteria:

          -  A current history of undiagnosed abnormal genital bleeding.

          -  Received treatment with a GnRH agonist within 6 months prior to the screening visit.

          -  Received any other hormonal treatment within 3 months prior to the screening visit
             (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).

          -  Chronic pelvic pain that is not caused by endometriosis, that would interfere with the
             assessment of endometriosis-associated pelvic pain.
Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
Condition: Heroin Dependence
MeSH terms: Heroin Dependence
Intervention: Intranasal challenge drug
Intervention description: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this study's design, all participants received each of the 9 intranasal test drugs under investigation. This study employed a Latin-square randomization procedure, therefore, the sequence of testing for the 9 intranasal drugs was unique for each participant.
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: opioid dependence

Summary:

      The study is designed to compare the abuse liabilities of intranasal buprenorphine and
      buprenorphine/naloxone in individuals who are physically dependent on sublingual
      buprenorphine. The investigators hypothesize that the abuse liability of
      buprenorphine/naloxone is lower than that of buprenorphine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM IV criteria for heroin dependence

          -  No major mood, psychotic, or anxiety disorder

          -  Physically healthy

          -  Able to perform study procedures

          -  21-45 years of age

          -  Normal body weight

          -  Current use of opioids in amounts and/or frequencies that meet or exceed those used in
             the proposed study (e.g., 1-2 bags of heroin per occasion at least twice per day)

          -  Self-administer IN buprenorphine above placebo levels during the qualification phase
             (see below)

        Exclusion Criteria:

          -  DSM IV criteria for dependence on drugs other than opioids, nicotine or caffeine

          -  Participants requesting treatment

          -  Participants on parole or probation

          -  Pregnancy or lactation

          -  Birth, miscarriage or abortion within 6 months

          -  Current or recent history of significant violent behavior

          -  Current major Axis I psychopathology, other than opioid dependence (e.g., mood
             disorder with functional impairment or suicide risk, schizophrenia), that might
             interfere with ability to participate in the study

          -  AST or ALT > 3 times the upper limit of normal

          -  Significant suicide risk

          -  Current chronic pain

          -  Sensitivity, allergy, or contraindication to opioids

          -  Current or recent (past 30 days) physical dependence on or treatment with methadone,
             buprenorphine, or the buprenorphine/naloxone combination
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Condition: Epilepsies; Partial
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam
Intervention description: Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 398.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsies; Partial; Keppra; levetiracetam

Summary:

      This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in
      long-term administration in patients who completed N01020 [NCT00160165] or N01221
      [NCT00280696].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in study N01221 [NCT00280696] and completed the evaluation
             period and transition period or patients who participated in study N01020
             [NCT00160615]

        Exclusion Criteria:

          -  Female patients during pregnancy, delivery and lactation, or suspected of pregnancy
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: ranibizumab; Laser
Intervention description: Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.; Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME; visual impairment; diabetes; macular edema; diabetic macular edema; ranibizumab; laser; photocoagulation; retinopathy; retina

Summary:

      To evaluate, specifically within the Canadian medical environment, the efficacy, safety and
      cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus
      laser photocoagulation), or as monotherapy in comparison with the current standard of care
      (laser photocoagulation monotherapy), in patients with visual impairment due to DME.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable Type 1 or Type 2 diabetes mellitus

          -  Visual impairment due to focal or diffuse DME in at least one eye

        Exclusion Criteria:

          -  Active conditions in the study eye that could prevent the improvement of visual acuity
             on study treatment

          -  Active eye infection or inflammation

          -  History of stroke, renal failure or uncontrolled hypertension

        Other protocol-defined inclusion/exclusion criteria may apply
Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
Condition: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Intervention: Inotersen
Intervention description: Inotersen SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary:

      This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in
      patients with Familial Amyloid Polyneuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfactory completion of dosing & efficacy assessments in ISIS 420915-CS2

        Exclusion Criteria:

          -  Any new condition or worsening of existing condition that could make the patient
             unsuitable for participation, or interfere with the patient participating in and/or
             completing the study