bioihbjkbjnl/mcl2 huggingface dataset:
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
Condition: Hemorrhage
MeSH terms: Emergencies; Hemorrhage
Intervention: Idarucizumab
Intervention description: Intravenous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in
      patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding
      requiring urgent intervention, and in patients treated with dabigatran etexilate who require
      emergency surgery or other invasive procedure.

      The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the
      clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of
      idarucizumab.
    

Eligibility criteria:

        Inclusion criteria:

          -  ≥ 18 years at screening.

          -  Male or female patients. Women of childbearing potential (WOCBP) and men able to
             father a child must be ready and able to use highly effective methods of birth control
             per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used
             consistently and correctly. A list of contraception methods meeting these criteria is
             provided in the patient information.

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial

          -  Currently taking dabigatran etexilate

          -  They meet the following criteria:

               -  Group A: Overt bleeding judged by the physician to require a reversal agent. OR

               -  Group B: A condition requiring emergency surgery or invasive procedure where
                  adequate hemostasis is required. Emergency is defined as within the following 8
                  hours.

        Exclusion criteria:

        Group A:

          -  Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with
             standard supportive care.

          -  Patients with no clinical signs of bleeding.

          -  Contraindications to study medication including known hypersensitivity to the drug or
             its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

        Group B:

          -  A surgery or procedure which is elective or where the risk of uncontrolled or
             unmanageable bleeding is low.

          -  Contraindications to study medication including known hypersensitivity to the drug or
             its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ivacaftor; Placebo
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI),
      in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance
      regulator (CFTR) gating mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF.

          -  Must have 1 of the following CFTR gating mutations on at least 1 allele: G551D, G178R,
             S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D.

          -  Hematology, serum chemistry, and coagulation at Screening with no clinically
             significant abnormalities or concomitant diagnosis that would interfere with the LCI
             and CT scan study assessments, as judged by the investigator.

        Exclusion Criteria:

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1

          -  Any clinically significant laboratory abnormalities at the Screening Visit that would
             interfere with the study assessments or pose an undue risk for the subject (in the
             opinion of the investigator)

          -  Abnormal liver function, at Screening, defined as ≥3 × upper limit of normal (ULN), of
             any 3 or more of the following: serum aspartate transaminase (AST), serum alanine
             transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase
             (ALP), and total bilirubin

          -  History of solid organ or hematological transplantation

          -  Any clinically significant "non-CF-related" illness within 2 weeks before Day 1

          -  Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A
             within 2 weeks before Day 1

          -  Participation in a clinical study involving administration of either an
             investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever
             is longer or as determined by the local requirements) before Screening
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: RVT-101 35 mg tablets
Intervention description: once daily, oral tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1099.0
Sex: All
Minimum age: 50 Years
Maximum age: 86 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; RVT-101; donepezil

Summary:

      This 12-month open-label study will provide further information regarding the long-term
      safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who
      have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind
      study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed last on-treatment visit of the lead-in study RVT-101-3001

        Exclusion Criteria:

          -  Any clinically relevant concomitant disease, which, in the opinion of the
             investigator, makes the subject unsuitable for inclusion in the study.
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Ocular Hypertension
Intervention: Bimatoprost; Lumigan®
Intervention description: Eyedrops; Eyedrops
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent signed and dated.

          -  Both eyes with diagnosed open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  History of trauma, infection, clinically significant inflammation within the 3
             previous months.

          -  Uncontrolled diabetic patient.

          -  Pregnancy or breast feeding.
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Condition: Rosacea
MeSH terms: Rosacea
Intervention: CLS001 (Omiganan); Vehicle
Intervention description: Topical gel; Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel
      compared to vehicle gel in subjects with severe papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

          2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
             Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

          3. Subjects with the presence of telangiectasia at Baseline.

          4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
             Erythema scale at Baseline.

          5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

        Exclusion Criteria:

          1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

          2. Subjects with nodular rosacea.

          3. Standard exclusion criteria.
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Intervention: Neugranin; Pegfilgrastim; Chemotherapy
Intervention description: Neugranin will be administered per dose and schedule specified in the arm description.; Pegfilgrastim will be administered per dose and schedule specified in the arm description.; The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
Intervention MeSH terms: Docetaxel; Doxorubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Determination of the effect of neugranin on the duration and severity of severe neutropenia
      in participants receiving doxorubicin in combination with docetaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer participants scheduled to receive the AT regimen (doxorubicin/
             docetaxel)

        Exclusion Criteria:

          -  Participants may have received no more than 1 prior chemotherapy regimen (including
             adjuvant therapy if given within the last 12 months)
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome
Intervention: Rufinamide
Intervention description: The target dosage is approximately 45 mg/kg/day, taken orally twice a day.
Intervention MeSH terms: Rufinamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 4 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Epilepsy; Seizures

Summary:

      To investigate the safety of long term administration of E2080 in the patients with
      Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
    

Eligibility criteria:

        Inclusion criteria:

          1. Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.

          2. Male participants with reproductive ability and female participants with child-bearing
             potential, or their partners, had to be able to take medically appropriate
             contraceptive measures.

          3. Participants who have provided a written informed consent to participate in this
             clinical trial until the evaluation of week 12 of the E2080-J081-304 study.

          4. Participants who had a family member or a caregiver capable of recording the reporting
             diary, providing participant information necessary for the study, assisting treatment
             compliance, and accompanying the participant on scheduled visit days during the study
             period.

        Exclusion criteria:

          1. Participants who were judged by the investigator that they are unfit to participate in
             this clinical study for safety reasons based on the information up to the evaluation
             of week 12 of the E2080-J081-304 Study.

          2. Participants who were judged by the investigator that they are likely to become
             non-compliant with administration during the clinical trial period.

          3. Participants who were judged by the investigator that they were unfit to participate
             in this clinical trial.
Effect of Omega-3 Fatty Acid on Cortical Function in ADHD
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: DHA Omega-3; Placebo
Intervention description: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks; corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      The study hypothesis is that DHA is more effective than placebo in increasing brain
      activation and reducing symptoms in psychostimulant-free children with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent/assent

          -  Ages 5-15 years old

          -  Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

        Exclusion Criteria:

          -  Contraindication to an MRI scan (i.e., braces, claustrophobia)

          -  A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)

          -  Greater than 1 year outside appropriate age/grade level

          -  A history of intolerance or hypersensitivity to omega-3 fatty acids

          -  Currently taking omega-3 supplements

          -  Not proficient in English language

          -  Any history of a hematological disorder or concomitant use of anticoagulant
             medications

          -  Personal history of an Axis I psychiatric disorder other than ADHD

          -  Inability to swallow capsules
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Condition: Periodontitis
MeSH terms: Periodontitis
Intervention: Triclosan/copolymer/fluoride; Fluoride
Intervention description: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.; Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride
      toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2
      diabetic population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of
             >200mg/dl.

          -  Minimum of 16 teeth

          -  Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6
             teeth

        Exclusion Criteria:

          -  Any condition requiring antibiotic cover for dental treatment

          -  Other serious illness
Safety and Efficacy of Emixustat in Stargardt Disease
Condition: Stargardt Disease
MeSH terms: Stargardt Disease; Macular Degeneration
Intervention: Emixustat; Placebo
Intervention description: Once daily oral tablet taken for 24 months; Once daily oral tablet taken for 24 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, double-masked, placebo-controlled study to evaluate the efficacy and safety of emixustat compared to placebo in subjects who have Macular Atrophy secondary to Stargardt disease.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-Masked
Enrollment: 194.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Stargardt Disease; STGD; ABCA4

Summary:

      The purpose of this study is to determine if emixustat hydrochloride reduces the rate of
      progression of macular atrophy compared to placebo in subjects with Stargardt disease.

      Funding Source -- FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of macular atrophy secondary to Stargardt disease (STGD)

          -  Macular atrophy measured to fall within a defined size range

          -  Two mutations of the ABCA4 gene. If only one mutation, a typical STGD appearance of
             the retina.

          -  Visual acuity in the study eye of at least 20/320

        Exclusion Criteria:

          -  Macular atrophy secondary to a disease other than STGD

          -  Mutations of genes, other than ABCA4, that are associated with retinal degeneration

          -  Surgery in the study eye in the past 3 months

          -  Prior participation in a gene therapy or stem cell clinical trial for STGD

          -  Recent participation in a clinical trial for STGD evaluating a complement inhibitor or
             vitamin A derivative

          -  Use of certain medications in the past 4 weeks that might interfere with emixustat

          -  An abnormal electrocardiogram (ECG)

          -  Certain abnormalities on laboratory blood testing

          -  Female subjects who are pregnant or nursing
A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vinflunine+Gemcitabine; Paclitaxel+Gemcitabine
Intervention description: Vinflunine 320 mg/m² IV on day 1 and.Gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks; paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1004.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to
      paclitaxel and gemcitabine is based on the following points: the significant antitumour
      activity of vinflunine in metastatic breast cancer (MBC) as single agent after
      anthracycline-taxane exposure and recent phase I study results of the vinflunine plus
      gemcitabine is at least additive and both drugs have a distinct mechanism of action; since
      taxanes have been approved in the adjuvant setting and are widely used in the treatment of
      early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first
      line therapy for metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients

          -  18 years or older but less than 75 years old

          -  histologically/cytologically confirmed breast cancer

          -  documented locally recurrent or metastatic breast cancer

          -  HER-2 negative or unknown

          -  prior neo- and/or adjuvant anthracycline-based chemotherapy

          -  measurable or non-measurable disease according to Response Evaluation Criteria In
             Solid Tumors (RECIST) 1.0

          -  adequate haematological, hepatic and renal functions

          -  ECG without any clinically relevant abnormality

        Exclusion Criteria:

          -  known or clinical evidence of brain metastases or leptomeningeal involvement

          -  history of second primary malignancy

          -  patients having as sole tumour lesion: malignant effusion, lymphangitis, cystic
             lesion, bone lesion, and any other lesion not assessed by imaging techniques or colour
             photography

          -  pre-existing motor/sensory grade > 1 peripheral neuropathy

          -  prior therapy with vinca alkaloids and/or gemcitabine

          -  history of severe hypersensitivity to vinca alkaloids and/or gemcitabine or
             contraindication to any of these drugs

          -  pregnancy or breast feeding
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: SPARC0921; Placebo0921
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spasticity

Summary:

      The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in
      the treatment of spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18 years and older

          -  Able and willing to comply with the protocol, including availability for a scheduled
             clinic visits

          -  Willingness and giving of written informed consent

        Exclusion Criteria:

          -  In relapse or history of unstable course over the prior 30 days prior to the Screening
             Visit

          -  Concomitant neurologic conditions causing spasticity

          -  Has received an investigational drug or device within 30 days that would interfere
             with the study goals prior to the Screening Visit

          -  Unable to comply with study procedures in the opinion of the investigator