bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
Condition: Transfusional Iron Overload in β-thalassemia
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Intervention: Deferasirox
Intervention description: Tablets taken orally once a day.
Intervention MeSH terms: Deferasirox
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: β-thalassemia; iron overload; deferasirox

Summary:

      A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator
      was conducted to investigate the efficacy of deferasirox in regularly transfused patients
      with β-thalassemia 2 years of age and older. Patients who successfully completed this main
      trial may continue in this extension trial to receive chelation therapy with deferasirox for
      an additional 4 years.

      The objective of this study is to assess the efficacy and long-term safety of deferasirox in
      regularly transfused patients with β-thalassemia 2 years of age and older.
    

Eligibility criteria:

        Inclusion criteria

          -  Patients who completed the 12-month core study (NCT00061750)

          -  Female patients after menarche and who were sexually active, if they used
             double-barrier contraception, oral contraceptive plus barrier contraceptive, or had
             undergone clinically documented total hysterectomy and/or ovariectomy, or tubal
             ligation

          -  Written informed consent obtained from the patient and/or legal guardian on the
             patient's behalf in accordance with the national legislation

        Exclusion criteria

          -  Pregnant or breast feeding patients

          -  Patients with a history of non-compliance to medical regimens or those considered to
             be potentially unreliable
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: diclofenac potassium (XP21L); Placebo
Intervention description: 25 mg every 6 hours; Placebo every 6 hours
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bunionectomy; Bunion surgery; Post-operative pain

Summary:

      A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain
      following bunionectomy surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  Have undergone bunionectomy surgery

          -  Have achieved adequate post-surgical pain

        Exclusion Criteria:

          -  Confounding medical conditions which preclude study participation

          -  Participated in a study of another investigational drug or device within 30 days prior
             to randomization
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Condition: Sexual Dysfunction; Breast Cancer Survivors
MeSH terms: Breast Neoplasms
Intervention: Lactate-containing vaginal lubricant; Placebo vaginal lubricant
Intervention description: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week); vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: Female
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: dyspareunia; breast cancer; sexual dysfunction; vaginal lubricant

Summary:

      The purpose of this study is to determine whether lactate-containing vaginal lubricant is
      effective in the treatment of young breast cancer survivors with sexual dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  breast cancer survivors over 20 years-old

          -  premenopausal at the time of diagnosis

          -  treated with operation and chemotherapy

          -  newly developed dyspareunia after cancer treatment

        Exclusion Criteria:

          -  recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)

          -  depression or other psychological problems

          -  active vaginal infection

          -  evidence of cancer recurrence

          -  previously use of lactate-containing lubricants

          -  other chronic diseases which severely disturb the sexual life
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
Condition: Meningitis, Meningococcal, Serogroup B
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Intervention description: One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to
      collect blood donation. Sera panel obtained from blood donations will be used as a control to
      measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals of 18 through 50 years of age on the day of informed consent;

          2. Individuals who had voluntarily given written informed consent after the nature of the
             study had been explained according to local regulatory requirements, prior to study
             entry;

          3. Individuals who could comply with study procedures including follow-up;

          4. Males, females of non-childbearing potential or females of childbearing potential who
             are using an effective birth control method.

        Exclusion Criteria:

          1. Progressive, unstable or uncontrolled clinical conditions;

          2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment
             whose use is foreseen in this study;

          3. Abnormal function of the immune system;

          4. Chronic clinical significant conditions;

        4. Been administered any group B meningococcal vaccine at any time prior to informed
        consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Condition: Partial Onset Seizures
MeSH terms: Seizures
Intervention: Pregabalin Dose Level 1; Pregabalin Dose Level 2; Placebo
Intervention description: Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase; Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase; Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 175.0
Sex: All
Minimum age: 1 Month
Maximum age: 3 Years
Healthy volunteers: No
Keywords: Partial Onset Seizures; Epilepsy; Safety; Efficacy; Tolerability; Pregabalin; Lyrica; Adjunctive treatment; Placebo controlled; blinded; Eligibility Criteria

Summary:

      This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce
      seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with
      refractory partial onset seizures. It is hypothesized that both doses of pregabalin will
      demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure
      frequency and that pregabalin will be safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have 3 partial onset seizures in the month prior to screening.

          -  Subject must have 2 partial onset seizures during the 48 hour baseline phase.

          -  Signed Informed Consent.

          -  On 1-3 stable anti-epileptic drugs at screening.

        Exclusion Criteria:

          -  Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile
             seizures, and infantile spasms.

          -  Lennox-Gasteau, BECTS, and Dravet's syndrome.

          -  Status epliepticus within 1 year of screening.

          -  Any change in AED regimen with 7 days of screening.

          -  Progressive structural central nervous system (CNS) lesion or a progressive
             encephalopathy.

          -  Progressive errors of metabolism.
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Condition: Idiopathic Short Stature (ISS)
MeSH terms: Dwarfism
Intervention: somatropin; leuprorelin
Intervention description: 0.05 mg/kg/day; 11.25 mg/3 months
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 8 Years
Maximum age: 171 Months
Healthy volunteers: No

Summary:

      The present randomized trial was initially intended to study the benefits of a combined
      treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for
      pubertal children with idiopathic short stature. However, treatments were stopped in January
      2012 at the request of the French drug agency. Therefore, a protocol amendment divided the
      study in two study periods.

      Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with
      somatropin alone. Participants from France who participated in this Period 1 of the study
      were asked to participate in a long term safety follow up defined as a Period 2 of the study.
      Participants from the Netherlands were offered participation in Genetics and
      Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov
      Identifier: NCT01088412) for long term safety follow up independent of this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female children with ISS

          -  age greater than or equal to 8 years and less than or equal to 12 years and 3 months
             for girls and greater than or equal to 9 years and less than or equal to 14 years and
             3 months for boys

          -  bone age less than or equal to 12.0 years for girls and less than or equal to 14.0
             years for boys based on a central reading of an X-ray of the left hand and wrist

          -  Pubertal stage B2 and B3 for girls based on the Tanner method

          -  Pubertal stage G2 and G3 for boys based on the Tanner method

        Exclusion Criteria:

          -  Growth hormone deficiency (GHD)

          -  Insulin-like growth factor-I levels greater than 3 SDS

          -  Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to
             eliminate a Turner syndrome, is mandatory

          -  Small for gestational age (SGA)

          -  Has reached menarche (had her first menstrual period)

          -  Have any significant concomitant disease that is likely to interfere with growth or
             with the study, or is a known contraindication to Growth Hormone treatment
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene lotion 0.1%; Adapalene Lotion Vehicle
Intervention description: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks; Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
Intervention MeSH terms: Adapalene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1075.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Adapalene

Summary:

      The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in
      the treatment of Acne Vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Moderate or Severe Acne Vulgaris,

          -  20-50 papules and pustules in total on the face excluding the nose

          -  30-100 non-inflammatory lesions on the face excluding the nose.

          -  Negative urine pregnancy test for all females.

        Exclusion Criteria:

          -  Subjects with more than one acne nodule.

          -  Subjects with any acne cyst on the face.

          -  Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
             acne, etc.), or severe acne requiring systemic treatment.

          -  Subjects with underlying diseases or other dermatologic conditions that require the
             use of interfering topical or systemic therapy, such as, but not limited to, atopic
             dermatitis, perioral dermatitis or rosacea.

          -  Subjects who are pregnant, nursing, or planning a pregnancy.
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
Condition: Epilepsy; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam (LEV)
Intervention description: Active Substance: Levetiracetam
Pharmaceutical Form: Film-coated tablet
Concentration: LEV 250 mg, LEV 500 mg
Frequency: Twice daily
Route of Administration: Oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as
      monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in
      the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female and aged ≥ 16 years at Visit 1

          -  Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked
             Partial Seizures (IA, IB, IC), that are classifiable according to the International
             League Against Epilepsy (ILAE) classification of Epileptic Seizures

          -  Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the
             year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3
             months prior to Visit 1

          -  Minimum body weight of 40 kg at Visit 1

        Exclusion Criteria:

          -  Subject has a history or presence of seizure types other than partial (IA, IB, IC)

          -  Subject has an experience of any type of brain surgery in the consecutive 2 years
             prior to Visit 1

          -  Subject has a history or presence of known Pseudo-Seizures

          -  Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6
             months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted
             for a maximum use of 2 weeks, if the treatments are stopped for the week prior to
             Visit 1

          -  Subject has a known clinically significant acute or chronic illness, such as but not
             restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric
             illness, and that may impair reliable participation in the study or necessitate the
             use of medication not allowed by the protocol
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
Condition: Depression; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Desvenlafaxine succinate sustained-release (DVS SR); Escitalopram
Intervention description: flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.; Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
Intervention MeSH terms: Desvenlafaxine Succinate; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 595.0
Sex: Female
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: MDD; Major Depressive Disorder; Depression

Summary:

      Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine
      reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability
      of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are
      postmenopausal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women between the ages of 40 and 70 years, inclusive.

          -  A primary diagnosis of MDD, single or recurrent episode, without psychotic features
             using the modified MINI International Neuropsychiatric Interview (MINI).

          -  Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the
             screening and baseline visit.

        Exclusion Criteria:

          -  Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator
             (SERM)-containing drug products 8 weeks before baseline.

          -  Current (within 12 months) psychoactive substance abuse or dependence (including
             alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive
             disorder, or a lifetime diagnosis of bipolar or psychotic disorder.

          -  A history or active presence of clinically important medical disease.

        Additional criteria apply.
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer; Ulcer
Intervention: HZT-501; Ibuprofen
Intervention description: HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks; Ibuprofen 800mg orally 3 times daily for 24 weeks
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 627.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ibuprofen; famotidine; ulcers; NSAIDS; pain; arthritis; chronic regional pain syndrome; chronic soft tissue pain; osteoarthritis; rheumatoid arthritis; chronic low back pain

Summary:

      The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of
      development of ibuprofen-associated ulcers in patients who require long-term daily use of
      ibuprofen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected to require daily administration of a nonsteroidal anti-inflammatory drug
             (NSAID) for at least the coming six months for conditions such as osteoarthritis,
             rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and
             chronic soft tissue pain.

          -  Did not use a NSAID within the 30 days prior to study entry

        Exclusion Criteria:

          -  History of erosive esophagitis

          -  History of any of the following serious gastrointestinal complications:

               -  perforation of ulcers,

               -  gastric outlet obstruction due to ulcers,

               -  gastrointestinal bleeding.

          -  Active cardiac, renal, and/or hepatic disease

          -  Current Helicobacter pylori (H. pylori) infection

          -  Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin
             within the 14 days prior to study entry.

          -  Uncontrolled diabetes

          -  Uncontrolled hypertension

          -  Positive pregnancy test at screening

          -  Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C.

          -  Currently participating, or participation within 30 days prior to study entry, in an
             investigational drug study

        Please note that there are other additional criteria. The study center will determine if
        patients meet all of the criteria.