bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001; QS-21; QS-21
Intervention description: IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12; IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12; IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, tolerability, and immunogenicity of
      ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in
      Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mild to moderate Alzheimer's Disease

          -  Mini-Mental State Examination (MMSE) 16-26

        Exclusion Criteria:

          -  Significant Neurological Disease other than Alzheimer's disease

          -  Major psychiatric disorder

          -  Clinically significant systemic illness
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: lapatinib; BIBW 2992; trastuzumab
Intervention description: lapatinib tablets 1500 mg daily; BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE); trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly
Intervention MeSH terms: Trastuzumab; Lapatinib; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a
      single agent versus lapatinib versus trastuzumab in patients with HER2-positive
      treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be
      obtained on the safety profile and pharmacokinetics of BIBW 2992.
    

Eligibility criteria:

        Inclusion criteria:

          1. Female, age 18 years or older.

          2. Histologically proven breast cancer who have not received any prior therapy.

          3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease
             other than anatomical site lymph nodes.

          4. HER2-positive.

        Exclusion criteria:

          1. Absolute neutrophil count (ANC) less than 1500/mm3.

          2. Platelet count less than 100 000/ mm3.

          3. Hemoglobin level less than 9.0 g/dl.

          4. Bilirubin greater than 1.5 mg/dI.

          5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than
             twice the upper limit of normal.

          6. Serum creatinine greater than 1.5 times of the upper normal limit.

          7. Significant or recent acute gastrointestinal disorders with diarrhea

          8. Pregnancy or breast-feeding.

          9. Organ system dysfunction including cardiac (LVEF < 50%).

         10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with
             trastuzumab, EGFR, or EGFR/HER2-inhibitors.

         11. Other malignancies diagnosed within the past five years.

         12. Serious active infection. HIV, active hepatitis B or C.
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353; Placebo
Intervention description: Plasma kallikrein inhibitor
Intervention MeSH terms: Berotralstat
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in
      preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the
      study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks.
      Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to
      one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one
      of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in
      each treatment group, as well as a number of other clinical and pharmacologic outcomes, and
      the safety and tolerability of each dose of BCX7353 compared to placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of HAE type I or II

          -  Documented HAE attacks within a defined calendar period

          -  Access to acute attack medications

          -  Sexually active women of child-bearing potential and sexually active men must utilize
             effective contraception

        Key Exclusion Criteria:

          -  Women who are pregnant or breast-feeding

          -  Any clinical condition or medical history that would interfere with the subject's
             safety or ability to participate in the study

          -  Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks

          -  History of or current alcohol or drug abuse

          -  Infection with hepatitis B, hepatitis C or HIV

          -  Participation in any other investigational drug study currently or within the last 30
             days
Choroideremia Gene Therapy Clinical Trial
Condition: Choroideremia
MeSH terms: Choroideremia
Intervention: Injection of AAV2-REP1 (10e11 vg)
Intervention description: Single Group: single arm study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: choroideremia, gene therapy

Summary:

      Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The
      study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients
      will be required to attend a total of 11 study visits over a 24 month period with an
      additional 3 year follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 Years and older

          -  Male

          -  Able to give informed consent

          -  Genetically confirmed diagnosis of choroideremia

          -  Active disease visible clinically within the macula region

          -  Best-corrected visual acuity equal to or worse than 20/32 but better than or equal to
             20/200 in the study eye.

        Exclusion Criteria:

          -  Female

          -  Under the age of 18

          -  History of amblyopia in the study eye

          -  Men unwilling to use barrier contraception methods

          -  Relevant grossly asymmetrical disease or other ocular morbidity which might confound
             use of the fellow eye as a long-term control

          -  Any other significant ocular and non-ocular disease/disorder or retinal surgery

          -  Contraindication to use of medications or contrast agents

          -  Participated in research study involving an investigational product in the past 12
             weeks

          -  Having had gene or cellular therapy at any time prior to this study.
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Condition: Small Bowel Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Filgotinib; Placebo to match filgotinib
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib, when compared
      to placebo, in establishing clinical remission defined as Crohn's disease activity index
      (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants
      will have the option to enter a separate long-term extension study if they meet eligibility
      requirements.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on
             the date of screening visit

          -  Moderately or severely active CD

          -  Minimum duration of CD of at least 6 months

          -  Presence of diseased small bowel (SB) segments in at least 1 of the following
             segments: terminal ileum, distal ileum, or jejunum

          -  Patients with additional colonic involvement of CD are permitted in study as long as
             SBCD is present

          -  Previously demonstrated an inadequate clinical response, loss of response to, or
             intolerance to at least 1 of the following agents (depending on current country
             treatment recommendations/guidelines):

               -  Corticosteroids

               -  Immunomodulators

               -  Tumor necrosis factor-alpha (TNFα) antagonists

               -  Vedolizumab

               -  Ustekinumab

          -  Willing and able to undergo magnetic resonance enterography (MRE) per protocol
             requirements

        Key Exclusion Criteria:

          -  Presence of symptomatic or clinically significant (eg, obstructive or symptomatic)
             strictures or stenosis.

          -  Presence of fistulae

          -  Evidence of short bowel syndrome

          -  Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
             colitis, or toxic mega-colon

          -  History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or
             likely requirement for surgery during the study

          -  Use of any prohibited concomitant medications as described in the study protocol

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)
Condition: Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: LDE225 0.75%; Vehicle
Intervention description: 0.75% cream; matching placebo cream to 0.75% LDE225 cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Basal cell carcinomas,; sporadic,; superficial and nodular,; skin

Summary:

      This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC
      (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a
      treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post
      treatment biopsies, as safety visit one week after final study drug administration (Day 50),
      a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with one histologically confirmed superficial and nodular basal cell
             carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm,
             frontal trunk, posterior trunk, upper legs)

        Exclusion Criteria:

          -  Previous treatment of the sBCC that are selected for treatment.

          -  Any systemic treatment which is known to affect BCCs esp. cytostatic treatments,
             retinoids and photodynamic treatments.

          -  Dark-skinned persons whose skin color prevents readily assessment of skin reactions

        Other protocol defined Incl./Excl. criteria may apply.
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Condition: Inflammation and Pain Following Ocular Surgery
MeSH terms: Inflammation
Intervention: Omaveloxolone Ophthalmic Suspension 1.0%; Omaveloxolone Opthalmic Suspension 0.5%; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RTA 408; Ocular surgery; Cataract surgery; Ocular inflammation; Ocular pain; Eye inflammation; omaveloxolone

Summary:

      This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic
      Suspension in the treatment of patients who have inflammation and pain following ocular
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be greater than or equal to 18 years of age of either sex or any race;

          2. Have undergone unilateral cataract extraction via phacoemulsification on the day prior
             to study enrollment/randomization;

          3. Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);

          4. Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0
             logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow
             eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;

        Exclusion Criteria:

          1. Have any intraocular inflammation present in the study eye during the screening slit
             lamp examination;

          2. Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study
             eye;

          3. Have an immunosuppressive disease or an autoimmune disease that in the opinion of the
             Investigator could affect the quality of the ocular surface;

          4. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and
             will likely affect wound healing;

          5. Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;

          6. Require the use of a contact lens or a collagen shield within 72 hours of
             investigational drug treatment or during the study period in the study eye; be
             unwilling to discontinue use of contact lenses during study period in the study eye;

          7. Require use of non-diagnostic topical ophthalmic solutions (other than perioperative
             mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild
             blepharitis, or artificial tears for the management of dry eye) in the study eye for
             the duration of the study;
NAD+ Precursor Supplementation in Friedreich's Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: MIB-626
Intervention description: Two (2) 500 mg Tablets, By Mouth, Daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Open Label, 14 Days (+/- 2 Days)
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The primary objective is to test the safety and tolerability of short-term therapy with a
      nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's
      Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%.
      A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle
      bioenergetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Molecular diagnosis of Friedreich's Ataxia (FA).

          -  Males and females, ages 18 years to < 65 years.

        Exclusion Criteria:

          -  Known sensitivity to nicotinamide-containing compounds.

          -  Concurrent use of Vitamin B3 supplements and/or any medications likely to increase
             risk of MIB-626 toxicity.

          -  HgbA1c > (great than or equal to) 8.5% and or Diabetes Mellitus (DM) requiring insulin
             or insulin secretagogue.

          -  Kidney disease (Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73 m2) using
             serum creatinine and MDRD equation. The eGFR levels will be calculated using the
             Modified Diet in Renal Disease Study (MDRD) equation, which is the equation used by
             the Children's Hospital Of Philadelphia laboratory.

          -  Liver disease (Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) > 3 x
             Upper Limit of Normal)

          -  Severe co-existing cardiac disease (Ejection Fraction (EF) < 40%, known arrhythmia) as
             demonstrated by an echocardiogram within 12 months of screening.

          -  Any contraindication to MRI, including spinal rods (related to unknown safety
             considerations for cardiac 31-Phosphorus -MRS).

          -  Use of any investigational agent within 4 weeks of enrollment.

          -  Females: Pregnant/lactating or planning to become pregnant during their participation.

          -  Any medical condition that, in the opinion of the investigator, will interfere with
             the safe completion of the study.
Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Ixabepilone
Intervention description: Vial, Injection, Intravenous (IV), 40 mg/m^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine whether ixabepilone is effective in the treatment
      of unresectable or metastatic gastric cancer in Asian participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed gastric carcinoma originating from the stomach or
             gastroesophageal junction

          -  Must have unresectable or metastatic disease

          -  Asian ethnicity

          -  Must have failed prior fluoropyrimidine-based chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST)
             guidelines

        Exclusion Criteria:

          -  >1 prior chemotherapy regimen in the metastatic setting or >2 prior chemotherapy if
             subject also received adjuvant therapy

          -  Receipt of prior ixabepilone

          -  ECOG ≥2

          -  Known brain or meningeal metastasis

          -  Known viral hepatitis

          -  Prior taxane therapy

          -  Uncontrolled non-cancer related medical condition

          -  Second malignancy

          -  Peripheral neuropathy ≥ grade 2

          -  Inadequate hematologic, renal and hepatic function
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: dalcetrapib (RO4607381); placebo
Intervention description: 900mg po daily for 24 weeks; po daily for 24 weeks
Intervention MeSH terms: Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with
      coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed
      study NC19453. Patients eligible to participate in the extension study will continue on the
      treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with
      concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6
      months post study NC19453, and the target sample size is approximately 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who have completed treatment on study NC19453.

        Exclusion Criteria:

          -  any significant lymph node abnormalities at the end of study NC19453.