bioihbjkbjnl/mcl2 huggingface dataset:
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin detemir; insulin aspart
Intervention description: Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.; Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of this research is to assess the safety of
      continuous treatment with insulin detemir following participation in trial NN304-1689
      (NCT00435019) on antibody development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent obtained before any trial-related activities. (Trial-related
             activities are any procedure that would not have been performed during normal
             management of the subject). The parents or legal representative of the subject must
             sign and date the Informed Consent Form.

          -  Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.

          -  Fertile females (girls who have had their first menstrual period) must use adequate
             contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if
             there is any risk of pregnancy in the opinion of the Investigator. For Denmark and
             France only contraceptive pills or intrauterine device are considered as adequate
             contraceptive methods.

        Exclusion Criteria:

          -  Significant concomitant disease such as endocrine, hepatic, renal, cardiac,
             respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as
             judged by the Investigator.

          -  Pregnant or the intention of becoming pregnant.

          -  Previous participation in this trial (defined as enrolment).
Second Open Label Extension to Bridging Study CTBM100C2303
Condition: Pulmonary Infections; Pseudomonas Aeruginosa
MeSH terms: Cystic Fibrosis
Intervention: Tobramycin inhalation powder
Intervention description: Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 6 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents; Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants

Summary:

      This was an open-label, single arm (uncontrolled) study in participants suffering from cystic
      fibrosis, who have completed their study participation in CTBM100C2303 and extension study
      one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at
      enrollment into CTBM100C2303.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study
             CTBM100C2303E1 took place not more than 5 days before enrollment into this study.

          -  Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.

          -  Forced Expiratory Volume in one second (FEV1) at screening (at start of study
             CTBM100C2303) must be between 25% and 80% of normal predicted values.

        Exclusion Criteria:

          -  Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial
             CTMB100C2303E1 and the enrollment into this study.

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
Condition: Urinary Retention Postoperative
MeSH terms: Urinary Retention; Prolapse
Intervention: Phenazopyridine
Intervention description: Phenazopyridine 200 mg on morning of postoperative day 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine if phenazopyridine reduces the rate of postoperative urinary retention after
      pelvic organ prolapse surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing overnight admission after prolapse surgery

        Exclusion Criteria:

          -  Unable to provide consent

          -  Under 18 years of age

          -  Pregnant women

          -  Prisoners

          -  Using intermittent self-catheterization preoperatively

          -  Neurological disease or spinal cord injury resulting in voiding dysfunction

          -  Undergoing spinal or epidural anesthesia for the procedure

          -  Allergy to phenazopyridine

          -  Renal insufficiency

          -  Liver disease

          -  Intra-operative bladder injury necessitating use of prolonged indwelling Foley
             catheter
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
Condition: Mania; Hypomania; Cocaine Abuse; Cocaine Dependence
MeSH terms: Mania; Cocaine-Related Disorders
Intervention: Citicoline; Placebo
Intervention description: Citicoline or placebo will be given beginning at one table (500mg)/day with an increase to two tablets (1000mg)/day at week 2, three tablets (1500mg)/day at week 4 and four tablets (2000mg)/day at week 6. Patients will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects.; Placebo matching active medication in all other aspects.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to determine if a citicoline supplement is associated with a
      reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder
      marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar
      type (a psychotic disturbance in which there is a mixture of schizophrenic and
      manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore
      if citicoline supplements are associated with greater improvement in symptoms of mania and on
      memory and cognition (the mental faculty of perception, reasoning, and judgement) in these
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 18-70 years

          -  History of mania or hypomania (bipolar I,II, not otherwise specified (NOS) or
             cyclothymic disorder or schizoaffective disorder/bipolar type)

          -  Early recovery for cocaine abuse/dependence (between 7 days and 12 weeks of
             enrollment).

          -  Any current mood state as indicated by structured diagnostic interview

          -  No psychotropic medication changes within 7 days prior to enrollment.

          -  English or Spanish speaking

        Exclusion Criteria:

          -  Pregnant/nursing woman

          -  Current or past citicoline therapy

          -  Active suicidal or homicidal ideation with plan and intent

          -  Dementia, mental retardation or other severe cognitive impairment

          -  Severe or life threatening medical condition
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Condition: Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Retigabine; Placebo
Intervention description: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase; Oral tablet.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Partial Seizures; Anticonvulsant; Complex Partial Seizures; Potassium Channels; Epilepsy

Summary:

      This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed
      at 1200 mg/day, in three equally divided doses, compared with placebo in patients with
      epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or
             without secondary generalization

          -  28-day partial seizure frequency rate of four or more partial seizures over the 8-week
             baseline phase

          -  Currently treated with up to three established AEDs

          -  Vagal Nerve Stimulator may be included

        Exclusion Criteria:

          -  Existing medical or psychiatric condition which could affect patient's health or
             compromise ability to participate in the study

          -  Clinically significant abnormalities on physical exam, vital signs, ECG, or liver
             function tests

          -  Impaired renal function (creatinine clearance less than 50 mL/minute)

          -  Evidence of progressive central nervous disease, lesion, or encephalopathy

          -  History of primary generalized seizures

          -  History of clustering or flurries or status epilepticus within 12 months of study
             entry
Multi-Center Study of New Medications to Treat Vaginal Infections
Condition: Vaginal Infection
MeSH terms: Infections
Intervention: Terconazole; Metronidazole; Terconazole/metronidazole
Intervention MeSH terms: Metronidazole; Terconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 475.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole
      gel in the treatment of vaginal infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

          -  Capable of providing written informed consent or assent

          -  Currently not menstruating and not anticipating menses during treatment

          -  If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically
             sterile, or practicing an acceptable form of birth control

          -  Negative pregnancy test

          -  Other criteria as identified in the protocol

        Exclusion Criteria:

          -  Other infectious causes of vulvovaginitis

          -  Subject has recently used, or is expected to require the concomitant use of prohibited
             medications/products

          -  Nursing mother

          -  Use of any investigational drug within 30 days of enrollment

          -  History of hypersensitivity to any ingredient/component of the formulations

          -  Other criteria as identified in the protocol
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Condition: Metrorrhagia
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Intervention: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027); Placebo
Intervention description: 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle); Matching placebo to be taken orally daily.
Intervention MeSH terms: Dienogest; 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: Double (Participant, Investigator)
Enrollment: 190.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dysfunctional Uterine Bleeding

Summary:

      The purpose of this study is to determine whether the study drug is safe and effective in the
      treatment of dysfunctional uterine bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 years or older

          -  With diagnosis of dysfunctional uterine bleeding without organic pathology

          -  And with at least one of the following symptoms: prolonged, frequent, or excessive
             bleeding

        Exclusion Criteria:

          -  The use of steroidal oral contraceptives, or any drug that could alter oral
             contraception metabolism will be prohibited during the study.

          -  Women with history of endometrial ablation or dilatation or curettage within 2 months
             prior to study start will be excluded.
Treatments for Depression: Drug Versus Psychotherapy
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Supportive Expressive Therapy; Sertraline; Pill Placebo; Venlafaxine
Intervention description: The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.; Participants will receive sertraline.; Participants will receive a pill placebo.; Participants will receive venlafaxine.
Intervention MeSH terms: Sertraline; Venlafaxine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder

Summary:

      This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®),
      venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which
      is more effective in treating major depression.
    

Eligibility criteria:

        Inclusion criteria:

          -  Major Depressive Disorder diagnosis

        Exclusion criteria:

          -  Psychotic or bipolar disorder diagnosis

          -  Substance dependence in the last 6 months
Fluticasone Nasal Spray Patient Preference Study
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: fluticasone propionate (FP); fluticasone furoate (FF)
Intervention description: 200 micrograms (mcg); an aqueous suspension of microfine FP; 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: taste; questionnaire; preference; attributes; odor; after taste; scent

Summary:

      The objectives of this study are to evaluate and compare patient preference for FF
      (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of
      allergic rhinitis following single-dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  allergic rhinitis

          -  literate

        Exclusion Criteria:

          -  clinical significant uncontrolled disease

          -  Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week
             exposure to FF, <4 weeks use of other INS)

          -  Use of intranasal medications <1 week

          -  Use of meds that significantly inhibit CYP4503A4

          -  Use of perfume or oral rinse on study day

          -  Allergy/intolerance to INS, antihistamines, or excipients

          -  Positive pregnancy test or female who is breastfeeding

          -  Affiliation with investigational site
A Long Term Safety Extension Study (CHS-0214-05)
Condition: Rheumatoid Arthritis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: CHS-0214
Intervention description: Open label
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and
      durability of response of subjects who completed 48 weeks of evaluations in the confirmatory
      safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with
      rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an
             ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at
             least a PASI-50

        Exclusion Criteria:

          -  None
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: bimatoprost ophthalmic solution formulation A; timolol ophthalmic solution; bimatoprost vehicle
Intervention description: 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks.; 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.; 1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.
Intervention MeSH terms: Timolol; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 2 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of a new formulation of
      bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of
      paediatric patients with glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of congenital, juvenile glaucoma

          -  Requires treatment with IOP-lowering medication in one or both eyes

        Exclusion Criteria:

          -  Surgical intervention is indicated or planned to lower IOP

          -  Abnormally low body weight (below 5th percentile)

          -  Any active eye infection or disease

          -  Anticipated use of contact lenses during the study

          -  Topical ocular steroid use within 2 months

          -  History of ocular trauma in either eye

          -  Required chronic use of ocular medications (other than study medication) during the
             study (intermittent use of artificial tears permitted)
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Condition: Open Angle Glaucoma or Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-111 ophthalmic solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 20 Years

Summary:

      Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be
      evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label,
      multicenter study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open angle glaucoma or ocular hypertension

          -  Provided signed, written informed consent

          -  20 years of age and older

          -  If a subject is a female of childbearing potential, she must utilize reliable
             contraceptive throughout the study, and must have a negative urine pregnancy test
             prior to enrollment into this study

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
             potential who are not using a reliable method of contraception.

          -  Presence of any abnormality or significant illness that could be expected to interfere
             with the study.
DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: DS-5565; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 854.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetic Peripheral Neuropathic Pain

Summary:

      Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral
      Neuropathic Pain (DPNP) in comparison to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or type 2 diabetes mellitus at screening

          -  Painful distal symmetric polyneuropathy

          -  At screening, a pain scale of ≥ 40 mm

        Exclusion Criteria:

          -  HbA1c (National Glycohemoglobin Standardization Program) > 10.0%