bioihbjkbjnl/mcl2 huggingface dataset:
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Condition: Severe Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Intervention: QTI571
Intervention description: QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension, QTI571, open label study

Summary:

      To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are
      benefitting from treatment with QTI571.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH)
             and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.

          -  Patient is currently benifitting form the treatment with QTI571 in the opinion of the
             investigator.

        Exclusion Criteria:

          -  Patient has been permanently discontinued from QTI571 study treatment in the parent
             study.

          -  Concomitant use of oral vitamin K antagonist medication.
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Botulinum Toxin Type A; placebo (saline)
Intervention description: Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.; Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
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: 705.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 60 week study including a double-blind phase followed by an open-label phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Frequent migraine (>=15 headache days per month)

          -  >=4 distinct headache episodes lasting >=4 hours

          -  >=50% of baseline headache days migraine/probable migraine days

        Exclusion Criteria:

          -  Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin
             serotype

          -  Any medical condition that puts the patient at increased risk with exposure to BOTOX

          -  Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache,
             hemicrania continua, new daily persistent headache

          -  Use of prophylactic headache medication within 28 days prior to week -4

          -  Unremitting headache lasting continuously throughout the 4-week baseline period

          -  Known or suspected TMD

          -  Diagnosis of fibromyalgia

          -  Beck depression inventory score >24 at week-4

          -  Psychiatric problems that may have interfered with study participation
Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
Condition: Diarrhea-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: LACTEOL® 340 mg; PLACEBO
Intervention description: LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.; Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      Irritable bowel syndrome is a complex condition with a high unmet medical need for effective
      and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and
      symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a
      potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  IBS-D diagnosis using the Rome III questionnaire

          -  IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400

          -  Bristol Stool Form Scale score exceeding two (> 2) but less than seven (< 7)

          -  Stable diet

          -  Mental and legal ability to sign informed consent

        Exclusion Criteria:

          -  Diagnosis of Inflammatory Bowel Disease (IBD)

          -  Chronic use of systemic steroids

          -  Diagnosis of autoimmune Diseases or Disorders

          -  Invasive abdominal surgery

          -  Use of antibiotics prior to screening

          -  Allergy to active substance or any other ingredient in LACTEOL® 340 mg

          -  Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome,
             lactase deficiency or lactose intolerance

          -  Diagnosis of exocrine pancreatic insufficiency

          -  Use of any experimental drug within the 30 days prior to screening
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
Condition: Genital Herpes
MeSH terms: Herpes Simplex; Herpes Genitalis
Intervention: Famciclovir; Valacyclovir; Placebo matching famciclovir; Placebo matching valacyclovir
Intervention description: Famciclovir 500 mg tablet; Valacyclovir 500 mg capsule; Famciclovir placebo, matching in size, color and forms of famciclovir tablet.; Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Intervention MeSH terms: Valacyclovir; Famciclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes simplex; genital herpes; famciclovir; valacyclovir; Recurrent genital herpes

Summary:

      This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day
      (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms
      compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  History of at least 4 recurrences of genital herpes in the preceding 12 months

          -  Lesions located on the external genitalia or anogenital region

          -  Willing to discontinue suppressive treatment

          -  Documented positive herpes simplex virus (HSV)

          -  General good health, and history of normal renal function

        Exclusion Criteria:

          -  Women of childbearing potential not using approved form of contraceptive

          -  Pregnant or nursing women

          -  History of hypersensitivity to famciclovir, valacyclovir, or acyclovir

          -  Known to be immunosuppressed

          -  Known to have renal dysfunction

          -  Receiving anti-herpes therapy

          -  Known to have other genital tract disorders

          -  Known to have condition which could interfere with drug absorption

        Additional protocol-defined inclusion/exclusion criteria may apply.
BOTOX® in the Treatment of Crow's Feet Lines in China
Condition: Lateral Canthal Lines; Crow's Feet Lines
Intervention: botulinum toxin Type A; Normal Saline
Intervention description: botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.; Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared
      with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
    

Eligibility criteria:

        Inclusion Criteria:

        -Moderate to severe Crow's Feet Lines.

        Exclusion Criteria:

          -  Current or previous treatment with botulinum toxin of any serotype for any condition
             within the last year

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

          -  Facial laser or light treatment, microdermabrasion or chemical peels within 3 months

          -  Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related
             procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent
             soft tissue fillers within 1 year

          -  Any medium-depth or deep facial peels within 5 years

          -  Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent
             soft tissue fillers, synthetic implants or autologous fat transplant.
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol
Intervention description: IV Ferumoxytol
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 634.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; Ferumoxytol; IDA

Summary:

      To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron
      deficiency anemia (IDA).
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]

          2. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control and agree to remain on birth control until
             completion of participation in the study

        Key Exclusion Criteria include:

          1. Experienced a serious adverse event (SAE) related to ferumoxytol in study
             AMAG-FER-IDA-301

          2. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or
             have a positive serum/urine pregnancy test
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Condition: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan (OPC-41061); Placebo
Intervention description: Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.; Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1370.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease

Summary:

      The purpose of the study is to determine whether tolvaptan is effective and safe for the
      treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney
      disease (ADPKD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or
             eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66)

          -  Tolvaptan naïve

          -  Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography
             or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any
             radiologic method and exclusion of other cystic kidney diseases if without family
             history

        Exclusion Criteria:

          -  Women of childbearing potential who do not agree to practice 2 different methods of
             birth control or remain abstinent during the trial and for 30 days after the last dose
             of Investigational medicinal product (IMP)

          -  Women who are breast-feeding and/or who have a positive pregnancy test prior to
             receiving IMP

          -  Need for chronic diuretic use

          -  Hepatic impairment or liver function abnormalities other than that expected for ADPKD
             with typical cystic liver disease

          -  Advanced diabetes, evidence of additional significant renal disease, renal cancer,
             single kidney, recent renal surgery or acute kidney injury

          -  Contraindications to required trial assessments

          -  Medical history or medical findings inconsistent with safety or compliance with trial
             assessments
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Vilaprisan (BAY1002670); Placebo
Intervention description: Orally, coated tablet 2 mg, once daily; Orally, coated tablet, once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heavy menstrual bleeding

Summary:

      The primary objective of this study was to show superiority of vilaprisan in the treatment of
      heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo

      The secondary objectives of this study were to additionally evaluate the efficacy and safety
      of vilaprisan in subjects with uterine fibroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women, 18 years or older in good general health

          -  Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1
             fibroid with largest diameter more than 30 mm and less than 120 mm

          -  Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening
             period each with blood loss volume of >80.00 mL documented by the alkaline hematin
             (AH) method

          -  An endometrial biopsy performed during the screening period without significant
             histological disorder such as endometrial hyperplasia (including simple hyperplasia)
             or other significant endometrial pathology

          -  Use of an acceptable non-hormonal method of contraception (ie, either male condom,
             cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1
             until the end of the study

        Exclusion Criteria:

          -  Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation
             before start of treatment)

          -  Hypersensitivity to any ingredient of the study drug

          -  Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion
             (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron
             supplementation)

          -  Any diseases, conditions, or medications that can compromise the function of the body
             systems and could result in altered absorption, excessive accumulation, impaired
             metabolism, or altered excretion of the study drug

          -  Any diseases or conditions that might interfere with the conduct of the study or the
             interpretation of the results

          -  Abuse of alcohol, drugs or medicines (e.g. laxatives)

          -  Use of other treatments that might interfere with the conduct of the study or the
             interpretation of results

          -  Undiagnosed abnormal genital bleeding
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: montelukast sodium; Comparator: loratadine; Comparator: Placebo
Intervention description: Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.; Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.; placebo tablet orally once daily at bedtime for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1214.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will assess the treatment effect of montelukast versus placebo over a 2 week
      period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an
      active comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a documented history of season allergic rhinitis symptoms that flare up
             during the study season

          -  Patient is a nonsmoker

          -  Patient is in good general health

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is a woman who is <8 weeks postpartum or is breast-feeding

          -  Patient has had major surgery in the past 4 weeks

          -  Patient intends to move or vacation away during the study

          -  Patient is a current or past abuser of alcohol or illicit drugs
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Intervention: Blood sampling
Intervention description: Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 632.0
Sex: Female
Minimum age: 15 Years
Maximum age: 24 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine; cervical cancer

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. This study is designed to evaluate the long-term immunogenicity and
      safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV
      vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals
      with objectives & outcome measures of the extension phase from Month 60 to Month 120. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month
      48 are presented in a separate protocol posting (NCT00316706).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parents or legally
             acceptable representative (LAR) can and will comply with the requirements of the
             protocol should be enrolled in the study.

          -  A female enrolled in the immunogenicity subset of study 580299-013, who received three
             doses of HPV vaccine and participated in the extension study of 580299-013.

          -  Written informed assent obtained from the subject. For subjects below the legal age of
             consent, written informed consent must be obtained from a parent or legally acceptable
             representative of the subject.

        Exclusion Criteria:

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.

          -  Use of any investigational or non-registered product (drug or vaccine) or planned use
             during the study period.

          -  Administration or planned administration of any HPV vaccine, other than the vaccine
             administered in study 580299-013.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs occurring
             within the three months preceding study entry.

          -  Administration of immunoglobulins and/or any blood products occurring within the three
             months preceding study entry.