bioihbjkbjnl/mcl2 huggingface dataset:
Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
Condition: Metastatic Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: CS7017 tablets; Paclitaxel; Carboplatin; Placebo Tablets
Intervention description: CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months; Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks; IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks; Placebo tablets matching CS-7017 tablets
Intervention MeSH terms: Paclitaxel; Carboplatin; Efatutazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects
      with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in
      combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the
      study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin
      and paclitaxel to evaluate effectiveness and safety. The study will find out if adding
      CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in
      subjects with metastatic non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no
             significant pleural effusion or pleural involvement from the tumor

          -  Age greater than or equal to 18 years

          -  Adequate organ and bone marrow function

        Exclusion Criteria:

          -  Any prior systemic therapy for NSCLC

          -  Major surgical procedure or other investigational agents within 4 weeks before study
             enrollment

          -  Need for concomitant use of other thiazolidinediones during the study

          -  History of any of the following conditions within 6 months prior to initiating study
             treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or
             thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of
             cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease
             or partial bowel obstruction;

          -  Clinically active brain metastases, uncontrolled seizure disorder; spinal cord
             compression or carcinomatous meningitis
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
Condition: Acromegaly; Pituitary Gigantism
MeSH terms: Acromegaly; Gigantism; Pituitary Diseases
Intervention: Pasireotide LAR
Intervention description: Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 > ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SOM230; Pasireotide; acromegaly; Phase II; growth disorder; gigantism; Pituitary adenoma; pituitary gigantism

Summary:

      To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in
      Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to
      assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to <
      2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with medication naïve acromegaly or pituitary gigantism

          -  Patients with inadequately controlled acromegaly or pituitary gigantism

        Exclusion Criteria:

          -  Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%

          -  Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
             sustained ventricular tachycardia, ventricular fibrillation, clinically significant
             bradycardia, advanced heart block or a history of acute myocardial infarction within
             the six months preceding enrollment

          -  Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
             > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT
             syndrome, or patients receiving a concomitant medication known to prolong QT interval
Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency
Condition: Alpha-1-antitrypsin Deficiency; Liver Cirrhosis
MeSH terms: Liver Diseases; Liver Cirrhosis; Alpha 1-Antitrypsin Deficiency
Intervention: Drug-Carbamazepine (Tegretol XR); Carbamazepine (Tegretol XR) Placebo
Intervention description: To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..; Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.
Intervention MeSH terms: Carbamazepine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 14 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Carbamazepine (Tegretol) use; severe liver disease; alpha-1-antitrypsin deficiency

Summary:

      The primary objective is to determine if the medication Carbamazepine, can be used as a
      therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 14 years to less than or equal to 80 years of age.

          -  Alpha-1-Antitrypsin deficiency confirmed by ZZ or SZ phenotype & serum level

          -  < 83mg/dl.

          -  HVPG greater than or equal to 10 mmHg unless collateral vessels are visualized via
             transvenous biopsy.

        Exclusion Criteria:

          -  Child Pugh Score greater than or equal to 12. Serum total bilirubin > 5 mg/dl. INR >
             2.2.
X-82 to Treat Age-related Macular Degeneration
Condition: Age-Related Macular Degeneration (AMD); Macular Degeneration; Exudative Age-related Macular Degeneration; AMD; Macular Degeneration, Age-related, 10; Eye Diseases; Retinal Degeneration; Retinal Diseases
MeSH terms: Macular Degeneration; Eye Diseases; Retinal Diseases; Retinal Degeneration
Intervention: X-82; Anti-VEGF; Placebo
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Vascular Endothelial Growth Factor (VEGF); Platelet Derived Growth Factor (PDGF); AMD

Summary:

      The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of
      vision loss due to wet AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in
             one or both eyes for at least 6 months prior to joining the study and has required at
             least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater
             than 6 weeks for the past two injections in the eye that is selected to be the study
             eye.

          -  Must have demonstrated a reduction in macular fluid or macular thickness in the study
             eye 14 days following an anti-VEGF injection at Screening Visit 1

          -  Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25
             letters (20/320) or better in both eyes

        Exclusion Criteria:

          -  Previous vitrectomy to the study eye within 30 days of Screening Visit 1

          -  Choroidal neovascularization (CNV) due to causes other than AMD

          -  Proliferative diabetic retinopathy in either eye
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)
Condition: PCDH19-Related Epilepsy
MeSH terms: Epilepsy
Intervention: Ganaxolone; Placebo
Intervention description: active drug; inactive
Intervention MeSH terms: Pregnanolone; Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: Female
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: refractory seizures; epilepsy in children; seizure disorder

Summary:

      A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone
      therapy compared to placebo for the treatment of seizures in female children and young adults
      with genetically confirmed PCDH19 gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Molecular confirmation of a pathogenic or likely pathogenic PCDH19 variant

          -  Failure to control seizures despite 2 or more anti-seizure medications

          -  12 seizures over a 12-week period of primary seizure types prior to screening

          -  On a stable regimen of concomitant AEDs, Ketogenic diets, and modified Atkins diet
             should be unchanged for 3 months prior to screening)

        Exclusion Criteria:

          -  Previous exposure to ganaxolone

          -  > 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening

          -  Concurrent use of strong inducers or inhibitors of CYP3A4/5/7 is not permitted

          -  Use of tetrahydrocannabinol (THC) or non-approved cannabidiol (CBD) is prohibited
             during the double-blind phase

          -  Exposure to any other investigational drug within 30 days or fewer than 5 half-lives
             prior to screening
Masked Faces in Parkinson Disease: Mechanism and Treatment
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Respiratory muscle strength training
Intervention description: The Muscle Stength Training (MST)device is a mouthpiece that the participant uses to inspire against controlled resistance; Intervention involves use of this device for breathing exercises over 4 week period, 5 days a week, approximately 20 minutes/day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's disease; PD; masked faces; diminished facial expressivity; diminished facial expression; high intensity respiratory muscle strength training; MST

Summary:

      The purpose of this study is to examine the effectiveness of high intensity respiratory
      muscle strength training in treating blunted facial expression in people with Parkinson
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of idiopathic Parkinson disease

          -  Hoeh-Yahr Stage 1-3 when off medication

          -  Stable and optimal medical regimen for at least 3 months

          -  No previous surgical interventions for Parkinson's disease (i.e., deep brain
             stimulation, pallidotomy, stem cell implantation)

          -  Participants will include men and women between the ages of 45 and 80 years

        Exclusion Criteria:

          -  Evidence of dementia based on neurocognitive testing

          -  Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar
             disorder, substance abuse). Participants who are taking anti-depressants will not be
             excluded as long as they are not currently depressed (Beck Depression, SCID)

          -  Other neurologic disturbance (e.g., tumor, stroke, traumatic brain injury, epilepsy)
             or severe chronic medical illness (e.g., HIV, metastatic cancer)

          -  Presence of oro-facial dyskinesias

          -  Previous surgeries to the larynx that result in poor vocal fold closure and/or
             positive history of head and neck cancer

          -  History of smoking in the past 5 years

          -  Untreated hypertension

          -  Failing a baseline test of pulmonary function during baseline respiratory evaluation

          -  Known respiratory complications such as chronic obstructive pulmonary disease (POCD),
             asthma

          -  Previous surgical interventions for Parkinson's disease (i.e., deep brain stimulation,
             pallidotomy, stem cell implantation)
Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA; Placebo
Intervention description: LUM 400 mg/IVA 250 mg every 12 hours (q12h); No Active Drug
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study
      that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who
      have at least one A455E mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF

          -  All subjects must have an A455E mutation on at least 1 CFTR allele; no more than 10
             subjects may have an F508del mutation on 1 CFTR allele.

          -  Forced expiratory volume in one second (FEV1) ≥30% of predicted and ≤90% of predicted
             at the Screening Visit, based on the Global Lung Function Initiative (GLI)-2012 multi
             ethnic all-age reference equations.

          -  Stable CF disease as judged by the investigator.

          -  Willing to remain on a stable medication regimen for CF from 4 weeks before Day 1
             through the Follow up Visit.

        Exclusion Criteria:

          -  History of any comorbidity reviewed at the Screening Visit that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject.

          -  A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation
             on at least one CFTR allele.

          -  Pregnant or breastfeeding.

          -  Any abnormal laboratory values at the Screening Visit.

          -  History of cataract/lens opacity, or evidence of cataract/lens opacity determined to
             be clinically significant by the ophthalmologist or optometrist during the
             ophthalmologic examination at the Screening Visit.

          -  Use of strong inhibitors or strong inducers of CYP3A, including consumption of certain
             herbal medications and certain fruit and fruit juices, within 14 days before Day 1

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: AL-60371/AL-817 otic suspension; Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Intervention description: CIPRODEX®
Intervention MeSH terms: Ciprofloxacin; Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No
Keywords: AOMT; tympanostomy tubes; Otorrhea; anti-infective

Summary:

      The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic
      Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological
      success, and time to cessation of otorrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent or guardian: Read and sign the informed consent. When required by the
             Institutional Review Board, child must agree to sign an approved assent form;

          -  Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;

          -  Presence of patent tympanostomy tubes;

          -  Refrain from water immersion of the ears following surgery without the use of adequate
             ear protection during swimming, bathing, showering and other water-related activities;

          -  Parent or guardian: Agree to comply with the requirements of the study, administer the
             study medication as directed, complete required study visits, and comply with the
             protocol;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  NOT otorrhea-free for at least seven days following tympanostomy tube surgery;

          -  Menarcheal females;

          -  Previous otologic surgery, except tympanic membrane, within one year of study entry;

          -  History of/or current acute or chronic non-tube otorrhea (through existing perforation
             of the eardrum);

          -  Current acute otitis externa, malignant otitis externa, or other conditions which
             could interfere with evaluation of the study drug;

          -  Diabetic (controlled or uncontrolled);

          -  Use of prohibited medications;

          -  Other protocol-defined exclusion criteria may apply.
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: 1650-G Vaccine
Intervention description: .6ml injection administered intradermally in the thigh at week 0 and week 4
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer Vaccine; Early Stage Lung Cancer; Lung Cancer

Summary:

      Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective
      immune response to kill tumor cells.

      The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients
      with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial
      definitive therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer

          -  Surgically resected at least 4 weeks ago but not more than 6 months ago

          -  Bronchoalveolar carcinomas allowed

          -  Completion of any chemotherapy or radiation given in conjunction with Surgery
             (neoadjuvant or adjuvant)

          -  No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan
             within 6 weeks of enrollment

          -  ECOG performance status of 0 to 2

          -  Adequate organ and marrow function defined as follows:

               -  Hemoglobin ≥9.0 gm/dL

               -  Bilirubin < 2.5 x upper limit of normal

               -  AST <2.5 x upper limit of normal

               -  ALT <2.5 x upper limit of normal

               -  Creatinine <3 mg/dL

          -  Women of childbearing potential must have a negative pregnancy test and be willing to
             use acceptable methods of contraception through week 16.

        Exclusion Criteria:

          -  Cardiovascular disease defined as:

               -  New York Heart Association Class III or IV (Section 19.2) congestive heart
                  failure

               -  hemodynamically significant valvular heart disease

               -  myocardial infarction within the last six months

               -  active angina pectoris

               -  uncontrolled ventricular arrhythmias

               -  stroke within one year

               -  known cerebrovascular disease

          -  History of HIV, infectious hepatitis, or chronic immunosuppressive disease

          -  concurrent shorter courses of immunosuppressive medications during and for 16 weeks
             after study treatment

          -  History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)

          -  Female patients must not be pregnant or breastfeeding.

          -  History of participation in any investigational drug study within 4 weeks preceding
             initiation of study treatment.