bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS; Placebo
Intervention description: active treatment; placebo treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared
      to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of
             mild to moderate plaque psoriasis

        Exclusion Criteria:

          -  patient is< 12 years old.
KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: KPI-121 1%; Prednisolone acetate
Intervention description: eye drops; eye drops
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Maximum age: 3 Years
Healthy volunteers: No

Summary:

      This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing
      inflammation after cataract surgery in young children. Approximately half the participants
      will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a candidate for routine, uncomplicated cataract surgery

        Exclusion Criteria:

          -  Have a post-traumatic cataract.

          -  Have suspected permanent low vision or blindness in the fellow non-study eye.

          -  Have active uveitis in either eye.

          -  Have an ocular neoplasm in either eye.

          -  Have the presence of viral, bacterial, or fungal disease in either eye.

          -  Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or
             elevated IOP
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)
Condition: Asthma
MeSH terms: Asthma
Intervention: salmeterol; beclomethasone HFA
Intervention description: 50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina); 240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)
Intervention MeSH terms: Beclomethasone; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine whether regularly scheduled use of an inhaled
      long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled
      corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental
      effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic
      receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly
      genotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ages 18 and older

          -  Clinical history consistent with asthma

          -  For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted,
             methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs
             of inhaled albuterol

          -  For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted,
             methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of
             inhaled albuterol

          -  Genotype eligibility (determined during screening)

        Exclusion Criteria:

          -  Smoker (total smoking history must be less than 10 pack years)

          -  Significant unstable medical condition other than asthma

          -  History of life-threatening asthma requiring treatment with intubation and mechanical
             ventilation in the past 10 years

          -  Pregnant or lactating
An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Desloratadine; Placebo
Intervention description: Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks; Placebo tablets, given orally, once daily in the evening for 2 weeks
Intervention MeSH terms: Desloratadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Urticaria; Skin Diseases, Vascular; Skin Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents

Summary:

      This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese
      participants with chronic urticaria. The primary hypothesis is that the efficacy of
      desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in
      the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic urticaria [rash (erythema, wheal) for more than 1 month without any known
             cause]

          -  Out-patient

        Exclusion Criteria:

          -  Stimulation-induced urticaria [physical urticaria (e.g. cold, solar, and heat
             urticaria), cholinergic urticaria, contact urticaria)]

          -  Hypersensitivity to antihistamines or ingredients of a study drug
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 647.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1 (GT-1); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Open Label; Sofosbuvir; Additional relevant MeSH terms:; Hepatitis; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action

Summary:

      This study is to evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV)
      administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18, with chronic genotype 1 HCV infection

          -  HCV treatment-naive

          -  HCV RNA > 10,000 IU/mL at screening

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Presence of cirrhosis

          -  Coinfection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol
Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
Condition: Migraine Disorders; Heart Disease; Cerebrovascular Accident; TIA (Transient Ischemic Attack); Vascular Diseases; Peripheral Vascular Diseases
MeSH terms: Migraine Disorders; Stroke; Ischemic Attack, Transient; Heart Diseases; Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Intervention: Telcagepant; Acetaminophen/Paracetamol; Placebo to Telcagepant; Placebo to Acetaminophen/Paracetamol
Intervention description: Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets); Acetaminophen/Paracetamol (500 mg X 2 dosage units); Placebo 300 mg soft gel capsules or placebo 280 mg tablet.; Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of telcagepant in the
      treatment of acute migraine in participants with stable vascular disease.
      Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The
      primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable coronary artery disease for 3 months or more

          -  18 years of age or older with a history of migraine with or without aura

          -  Must use acceptable contraception throughout the study

        Exclusion Criteria:

          -  Pregnant, breast-feeding, or planning to become pregnant during this study

          -  50 years of age or older when migraines began

          -  Other pain syndromes that might interfere with study assessments, uncontrolled
             psychiatric conditions, dementia, or significant neurological disorders (other than
             migraine)

          -  History of gastric, or small intestinal surgery, or has a disease that causes
             malabsorption
BOTOX® Treatment in Pediatric Upper Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: botulinum toxin Type A; Normal Saline (Placebo)
Intervention description: Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.; Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
      pediatric patients with upper limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 kg/22 lb

          -  Upper limb spasticity due to cerebral palsy or stroke

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 6 months

          -  Previous surgical treatment of the study limb (except tendon lengthening), or planned
             surgery of the study limb during the study

          -  Previous casting of the study limb for spasticity within 6 months or with a dynamic
             splint within 3 months, or planned casting or dynamic splinting for spasticity of the
             study limb or affected lower limb during the study
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Gynaecological follow-up; Cervarix; Placebo control
Intervention description: Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.; Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.; Subjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 28 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV; HPV vaccine; Cervical neoplasia; Human papillomavirus; Papillomavirus; Cervical cancer; Human papillomavirus (HPV) type 16/18 infections

Summary:

      This study is intended to provide up to a maximum of four years of annual oncogenic human
      papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study
      subjects who displayed normal cervical cytology but tested positive for oncogenic HPV
      infection at their concluding NCT00294047 study visit.

      Women who were pregnant at their concluding NCT00294047 study visit may also be included in
      this study, as no cervical sample could be collected at that visit.

      The objectives and outcome measures of the primary phase (NCT00294047) are presented in a
      separate protocol posting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained from the subject prior to enrolment.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A subject previously enrolled in the study NCT00294047 and who fulfils either of the
             following criteria:

               -  displayed normal cervical cytology but tested positive for oncogenic HPV
                  infection at her concluding NCT00294047 study visit

               -  was pregnant so that no cervical sample could be collected at her concluding
                  NCT00294047 study visit

        Exclusion Criteria:

          -  A subject who at the NCT00294047 concluding study visit displayed normal cervical
             cytology and who was negative for oncogenic HPV infection at that visit.

          -  A subject who at the NCT00294047 concluding study visit had a cervical lesion at that
             visit or who had a cervical lesion that required treatment at her NCT00294047 exit
             colposcopy.

          -  A subject for whom the cervical cytology results from the concluding NCT00294047 study
             visit were unavailable for reasons other than pregnancy.
A Degarelix Trial in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Goserelin acetate
Intervention description: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.; The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with
      the established therapy Zoladex 3 month implant in patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has given written consent prior to any trial-related activity is performed. (A
             trial-related activity is defined as any procedure that would not have been performed
             during the normal management of the patient).

          -  Has completed the CS35 trial.

        Exclusion Criteria:

          -  Has been withdrawn from the CS35 trial.

          -  Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
Condition: Breast Cancer; Fatigue; Sleep Disorders
MeSH terms: Breast Neoplasms; Sleep Wake Disorders; Parasomnias; Fatigue
Intervention: Tamoxifen; triptorelin; Exemestane
Intervention MeSH terms: Tamoxifen; Triptorelin Pamoate; Exemestane
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: Female
Maximum age: 120 Years
Healthy volunteers: No
Keywords: cognitive/functional effects; psychosocial effects of cancer and its treatment; fatigue; sleep disorders; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Summary:

      RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen
      with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression
      (E+ OFS) on brain function may help doctors plan cancer treatment.

      PURPOSE: This study is looking at brain function in premenopausal women who are receiving
      adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane
      (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical
      trial IBCSG-2402.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Completely resected disease

          -  Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal
             therapy

               -  Has not yet received any of the following adjuvant endocrine therapy, either
                  before or after registration on IBCSG-2402:

                    -  Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist

                    -  Ovarian irradiation

                    -  Bilateral oophorectomy

          -  Hormone receptor status:

               -  Estrogen and/or progesterone receptor positive

                    -  Each tumor must be hormone receptor positive

        PATIENT CHARACTERISTICS:

          -  Premenopausal

          -  Can speak and read the local language(s) fluently

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
Condition: Spasticity of the Upper and Lower Limb Due to Cerebral Causes
MeSH terms: Muscle Spasticity
Intervention: IncobotulinumtoxinA
Intervention description: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether injections with increasing doses (up to 800
      units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in
      treating patients with spasticity on one body side due to cerebral causes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Upper and lower limb spasticity of the same body side due to cerebral causes

          -  Time since event leading to spasticity in the target body side greater than 12 weeks

          -  Need for 800 units Botulinum toxin type A

        Exclusion Criteria:

          -  Body weight below 50kg

          -  Fixed contractures of the target joint

          -  Generalized disorders of muscle activity like Myasthenia gravis that preclude use of
             Botulinum toxin type A

          -  Infection at the injection site