bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
Condition: Type 1 Hyperlipoproteinemia
MeSH terms: Hyperlipoproteinemias; Hyperlipidemias
Intervention: SLx-4090 placebo; Orlistat Placebo; Orlistat; Slx-4090
Intervention description: Given for 4 weeks; Given for 4 weeks; Given for 4 weeks; Given for 4 weeks
Intervention MeSH terms: Orlistat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This trial is adaptive design/flexible design. The participants were randomized from the start of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: hypertriglyceridemia

Summary:

      Funding Source - FDA OOPD

      This study is being done to find out whether an investigational (not approved by FDA ) drug
      called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in
      combination can treat the high blood fat (elevated triglycerides)levels found in the
      condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone,
      the current standard medical care.

      It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in
      lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The
      researchers are interested in learning whether any one of these drugs when given alone or in
      combination is more effective and safe in treating T1HLP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type I hyperlipoproteinemia.

          -  Fasting serum triglyceride levels of greater than 1000 mg/dL.

          -  Age > 12 years

        Exclusion Criteria:

          -  Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism,
             alcoholism and drug therapy such as estrogens and estrogen analogues, steroids,
             HIV-protease inhibitors, retinoic acid derivatives and interferons.

          -  Pregnant or lactating women

          -  Significant liver disease (elevated transaminases > 2 times upper limit of normal)

          -  Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks for men or 168 g
             per week for men)

          -  Drug use (cocaine, marijuana, LSD, etc.)

          -  Major surgery in the past three months

          -  Congestive heart failure

          -  Serum creatinine greater than 2.5 mg/dL

          -  Cancer within the past five years

          -  Gastrointestinal surgery in the past

          -  Current therapy with anti-coagulants, digoxin and anti-arrhythmics

          -  Chronic malabsorption syndromes

          -  Cholestasis

          -  Acute illnesses such as acute pancreatitis in the last 8 weeks
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Condition: Keratoconus; Corneal Diseases; Eye Diseases; Photosensitizing Agents
MeSH terms: Eye Diseases; Keratoconus; Corneal Diseases; Dermatitis, Phototoxic
Intervention: CXLO Corneal Strengthening Solution and UVA Illumination Device
Intervention description: CXLO Corneal Strengthening Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.
Enrollment: 2228.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: Keratoconus; Forme fruste keratoconus; Post-LASIK ectasia; Pellucid marginal degeneration; Forme fruste pellucid marginal degeneration; Diurnal fluctuation post-radial keratotomy; Terrien's marginal degeneration

Summary:

      This study will assess changes in visual acuity and corneal symmetry after corneal collagen
      cross-linking (CXL) of asymmetric corneas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of at least one of the following conditions:

               1. Keratoconus

               2. Forme fruste keratoconus

               3. Post-LASIK ectasia

               4. Pellucid marginal degeneration

               5. Forme fruste pellucid marginal degeneration

               6. Diurnal fluctuation post-radial keratotomy

               7. Terrien's marginal degeneration

        Exclusion Criteria:

          1. Corneal thickness < 375 microns measured by ultrasound or Pentacam.

          2. Contraindications or hypersensitivities to any study medications or their components.

          3. Pregnancy or breastfeeding.

          4. Any history of herpes simplex corneal disease in an eye to be treated.

          5. Nystagmus or any other condition that would, in the judgement of the investigator,
             prevent a steady gaze during the treatment.

          6. Inability to cooperate with diagnostic tests.

          7. Enrollment in another ophthalmic clinical trial.
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Intervention: IRX-2; Cyclophosphamide; Indomethacin; Zinc; Omeprazole
Intervention description: IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.; Single i.v. injection of low-dose (300 mg/m2) on Day 1; 21 days of oral indomethacin, 25 mg. 3 times daily; 21 days of zinc gluconate (65 mg) as part of an oral multivitamin; 21 days of 20 mg. orally
Intervention MeSH terms: Zinc; Indomethacin; Cyclophosphamide; Omeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open Label Single Arm Phase 2a trial of Safety of IRX-2 in Patients with Operable Head and Neck Cancer
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Immunotherapy; IRX-2; Mouth Cancer; Throat Cancer

Summary:

      This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2
      Regimen in patients with untreated, resectable squamous cell cancer of the head and neck
      (HNSCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity,
             oropharynx, hypopharynx, or larynx.

          -  No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or
             emergency procedure required for supportive care.

          -  Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable
             with curative intent.

          -  Life Expectancy of greater than 6 months

        Exclusion Criteria:

          -  Stage IVB Squamous Cell Carcinoma

          -  Use of any investigational agent within the previous 30 days

          -  Uncontrolled cardiovascular disease

          -  Myocardial infarction within the last 3 months

          -  Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts

          -  Positive for hepatitis B or C or HIV

          -  Evidence of distant metastases

          -  Clinical gastritis or peptic ulcer within the last 6 months

          -  Stroke within the last six months
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: pazopanib eye drops; placebo; ranibizumab intravitreal injection
Intervention description: A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.; placebo eye drops; Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A
Intervention MeSH terms: Ranibizumab; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 510.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: ranibizumab; wet AMD; MD7110852; age related macular degeneration; age-related macular degeneration; macular degeneration; pazopanib

Summary:

      The purpose of this study is to determine the safety and efficacy of different dosage
      regimens of pazopanib eye drops for the treatment of neovascular age-related macular
      degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged ≥50 years.

          -  Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study
             eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area.

          -  Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and
             in need of re-treatment.

          -  Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320
             Snellen equivalents or better).

        Exclusion Criteria:

          -  Prior ocular investigational drug/device for choroidal neovascularization,
             photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser
             photocoagulation.

          -  Prior failure to anti-VEGF intravitreal injection therapy.

          -  Recent ocular investigational drug/device for non-CNV condition.

          -  Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt
             surgery). Cataract surgery permitted if ≥3 months and has posterior chamber
             intraocular lens.

          -  Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal
             pigment epithelial detachment, or retinal pigment epithelial tear.

          -  CNV in either eye due to other causes.

          -  Clinical evidence of diabetic retinopathy or diabetic macular edema.

          -  Recent myocardial infarction or cerebrovascular accident.

          -  Uncontrolled hypertension in spite of antihypertensive medications.
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Condition: Postmenopausal Women; Locally Advanced Metastatic Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Everolimus; Letrozole
Intervention description: Everolimus 10 mg (2 tablets of 5 mg) once daily; Letrozole 2.5 mg once daily
Intervention MeSH terms: Everolimus; Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAD001 (Everolimus); Letrozole; Breast cancer; Metastatic Breast cancer; Estrogen receptor positive; Failure of Tamoxifen; Anastrozole or Examestane

Summary:

      This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001
      (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence
      or progression on Tamoxifen, Anastrozole or Examestane.

      There were no treatments specifically approved after recurrence or progression on AIs.
      Available options, based on common clinical practice and several treatment guidelines (e.g.
      NCCN treatment guidelines 2008), included fulvestrant.

      Combining RAD001 with letrazole was a rational approach to the treatment of advanced Brest
      Cancer, offering the potential for inhibition of tumor cell growth\ proliferation and anti
      angiogenesis while at the same time potentially preventing the development of letrazole
      resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with estrogen receptor positive locally advanced or metastatic
             breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or
             Examestane.

               -  Refractory disease to hormonal therapy is defined as:

                    1. Recurrence while on, or within 12 month of end of, adjuvant treatment with
                       Tamoxifen , Anastrozole, or Exemestane.

                    2. Recurrence while on, or within 24 month of end of, adjuvant treatment with
                       Letrozole.

                    3. Progression while on Tamoxifen, Anastrozole or Exemestane treatment for
                       locally advanced or metastatic breast cancer.

        Exclusion Criteria:

          -  Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors
             as the last anticancer treatment prior to study entry.

          -  Patients must have radiological evidence of recurrence or progression on last therapy
             prior to study entry.
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Condition: Acute Unilateral Vestibulopathy (AUV)
Intervention: SENS-111 100mg; SENS-111 200mg; Placebo Oral Tablet
Intervention description: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.; SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.; Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute unilateral vestibulopathy, AUV

Summary:

      A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and
      safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4
      days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
    

Eligibility criteria:

        Inclusion criteria includes, but is not limited to:

        * Subject has a diagnosis of definite Acute Unilateral Vestibulopathy

        Exclusion criteria includes, but is not limited to:

          -  Acute continuous vertigo lasting more than 72 hours prior to randomization

          -  History of acute or chronic vestibular diseases

          -  History of prior acute central vestibular lesion

          -  Acute or chronic disease of middle ear
Eltrombopag for Post Transplant Thrombocytopenia
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Eltrombopag; Placebo
Intervention description: Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily.; Once a day, orally for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transplant Thrombocytopenia; Hematopoietic cell transplantation; HCT; Low platelet count; Bleeding; Blood clot; Stem Cell Transplant; Blood And Marrow Transplantation; Eltrombopag; Promacta

Summary:

      The goal of this clinical research study is to learn if eltrombopag can help to improve
      platelet counts in patients with low platelets after they have had a stem cell transplant.
      The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients >/= 35 days post HCT with Platelet count </= 20 x 10^9/l sustained for 7 days
             or patients are platelet transfusion dependent, and

          2. Neutrophil count >/= 1.5 x 10^9/l anytime within the last seven days before
             enrollment. Patients can be on myeloid or erythroid growth factors for example
             filgrastim), and

          3. Age >/= 18

        Exclusion Criteria:

          1. Recurrence or progression of primary malignancy after HCT

          2. ALT >/= 2.5 times the ULN

          3. Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)

          4. Documented deep vein thrombosis within 1 year before enrollment on the study, except
             if upper arm thrombosis related to central venous catheters, within 3 months before
             enrollment on the study.

          5. ECOG Performance status >2

          6. Pregnancy: Women of child-bearing potential and men must agree to use contraception
             prior to study entry and for the duration of study participation. A woman of
             child-bearing potential is defined as a woman who has not been naturally
             post-menopausal for at least 12 consecutive months or with no previous surgical
             sterilization. A negative pregnancy test result will be required before any study drug
             is given.
Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin; Definitive Surgery; Radiotherapy
Intervention description: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks; Standard of care definitive surgery as determined by medical provider; Standard of care RADIATION THERAPY as indicated
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Triple negative (ER/PR negative; HER2 negative)

Summary:

      This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone
      will gather a foundation of primary tumor and axillary lymph nodal response to primary
      chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome
      data. This comparative data can then be used in building subsequent trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative
             invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH
             preferred; HER2 0 or 1+ by IHC acceptable)

          -  Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note:
             Locally advanced T4 or inflammatory breast cancer is eligible.)

          -  Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable
             or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam
             acceptable.)

          -  Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3

          -  Normal myocardial left ventricular function

          -  Serum creatinine < 2.0 mg/dl

          -  Total bilirubin and AST < 3X upper limits normal

        Exclusion Criteria:

          -  Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a
             second breast primary, patient eligible for this protocol)

          -  Another active cancer present

          -  Medical contraindications to chemotherapy or surgery

          -  First trimester pregnancy

          -  Breast feeding
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: mAb hOKT3gamma1(Ala-Ala), Teplizumab; Placebo Arm
Intervention description: This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 8 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: immune therapy; autoimmunity; insulin secretion; diabetes mellitus

Summary:

      This is a randomized placebo controlled study to test whether a single 14 course of treatment
      with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss
      of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration
      since diagnosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 8 - 30,

          -  duration of diabetes 4 - 12 months,

          -  weight greater than 27.5 kg,

          -  stimulated C-peptide >= 0.2 pmol/ml

        Exclusion Criteria:

          -  asthma,

          -  history of hepatitis C, hepatitis B, HIV