bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: AKST4290; Placebo
Intervention description: Oral AKST4290; Oral Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CCR3 inhibition; Diabetic Retinopathy; Oral Treatment

Summary:

      A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in
      Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Type 1 or type 2 DM.

          3. BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.

          4. Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

        Exclusion Criteria:

          1. Evidence of neovascularization (NV) (including active iris or angle NV) requiring
             treatment, per investigator discretion.

          2. PRP or grid laser within 1000 microns of the foveal center.

          3. Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is
             defined as DME within 1,000 microns of the foveal center).

          4. Prior Intraocular of periocular steroid Injection

          5. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and
             assignment to a randomized treatment.

          6. History of vitreoretinal surgery.

          7. History of major ocular surgery (including cataract extraction, scleral buckle, any
             intraocular surgery, etc.) within prior 4 months or anticipated within the next 6
             months following randomization.

          8. History of DME or DR treatment with laser or intraocular injections of medication.

          9. Medical history or condition that, in the opinion of the investigator would preclude
             participation in the study.

         10. Clinically relevant abnormal laboratory value at Screening, including hematology,
             blood chemistry, or urinalysis (laboratory testing may be repeated once during the
             Screening phase).

         11. Malignancy for which the participant has undergone resection, radiation, or
             chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured
             squamous cell carcinoma are allowed).

         12. Concurrent participation in another interventional clinical trial; prior clinical
             trial participants must have been off study agents for at least 30 days for small
             molecules, 4 months for disease modifying therapies, and 1 year for vaccine or
             immunotherapy trials prior to Screening.
Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: nab-Paclitaxel; Gemcitabine; Chemoradiation; Capecitabine; Surgery
Intervention description: Surgical intervention
Intervention MeSH terms: Paclitaxel; Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Neoplasms; Pancreatic Cancer; Locally advanced pacriatic cancer; nab-Paclitaxel; Abraxane; Gemcitabine; ABI-007

Summary:

      This clinical study is in subjects who are 18 years old or older with locally advanced
      pancreatic cancer who have not received prior treatment for their pancreatic cancer. The
      study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of
      treatment. Subjects who complete the treatment will choose, with their treating physicians,
      what additional treatment should be given: more nab-Paclitaxel plus gemcitabine,
      Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients

          -  No prior anticancer therapy for pancreatic cancer

             •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts,
             hepatic function, and renal function

          -  Signed informed Consent

        Exclusion Criteria:

          -  Active bacterial, viral, or fungal infection

          -  Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV)
             infection, or receiving immunosuppressive or myelosuppressive

          -  Subjects with sensory neuropathy, ascites, or plastic biliary stent.

          -  Serious medical risk factors involving any of the major organ systems, or serious
             psychiatric disorders (including but not limited to connective tissue disorders, lung
             disease, and cardiac or seizure disorders)

          -  Women who are pregnant or breast feeding
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Condition: Symptomatic Focal Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: 2.0mg of ALG-1001; Balanced Salt Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human
      subjects with symptomatic focal vitreomacular adhesion
    

Eligibility criteria:

        Inclusion Criteria:

          1. Symptomatic focal vitreomacular adhesion

          2. Vitreomacular traction syndrome

          3. Stage 1 and 2 macular holes, ≤ 350 µm

          4. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study
             eye

          5. BCVA of 20/800 ETDRS or better in the fellow eye

          6. Male or female subjects, 18 years of age or older

          7. Signed Informed Consent

        Exclusion Criteria:

          1. High myopes > -8.0 D spherical equivalent

          2. History of prior vitrectomy in the study eye

          3. History of photocoagulation to the retina in the study eye

          4. Macular hole in the study eye > 350 µm

          5. Subjects with epiretinal membranes in the study eye

          6. Subjects with broad VMA, defined as VMA of >1500 µm

          7. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular
             Degeneration (AMD), or retinal vascular occlusion in the study eye

          8. Subjects with aphakia in the study eye

          9. Subjects with uncontrolled glaucoma

         10. Subjects with lenticular or zonular instability

         11. Subjects with prior ocular surgery or intravitreal injection in the study eye within
             90 days of study enrollment

         12. Pregnant or nursing women
Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Hypertension, Ocular
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: NCX 470; Latanoprost 0.005%
Intervention description: NCX 470 Ophthalmic Solution; Latanoprost 0.005% Ophthalmic Solution
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 656.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objective of this clinical study is to evaluate the safety and efficacy of NCX 470
      ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular
      hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic
      solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic
      solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma or ocular hypertension in both eyes

          -  Qualifying IOP at 3 time points throughout the day at 2 visits following washout of
             IOP-lowering medication, if applicable

          -  Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic
             Retinopathy Study (ETDRS) protocol in each eye

          -  Ability to provide informed consent and follow study instructions

        Exclusion Criteria:

          -  Pigmentary or pseudoexfoliative glaucoma

          -  Narrow anterior chamber angles or disqualifying corneal thickness in either eye

          -  Clinically significant ocular disease in either eye

          -  Previous complicated surgery or certain types of glaucoma surgery in either eye

          -  Incisional ocular surgery or severe trauma in either eye within the past 6 months

          -  Uncontrolled systemic disease
Fatty Acid Supplementation in Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: LCPUFA Oil Supplement; Canola Oil Placebo
Intervention description: 25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days; Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple
Enrollment: 72.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine how fatty acid supplementation alters biological
      signatures in children with ASD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2-6 years old

          -  ASD diagnosis at Nationwide Children's Hospital within the prior 6 months

          -  ADOS-2 score in "autism" (severe) range

          -  English is primary language

        Exclusion Criteria:

          -  Fatty acid supplementation in the past 6 months

          -  Consumes fatty fish more than 3 times per week

          -  Still breastfeeding or formula feeding

          -  Quadriparesis

          -  Deafness

          -  Blindness

          -  Seizure disorder diagnosis

          -  Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes,
             Tuberous Schlerosis

          -  Feeding problems precluding consumption of the supplement

          -  Ingredient allergy (canola, fish, or borage seed)

          -  Planned surgeries scheduled within the time frame of trial participation
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: MORAb-009 (Amatuximab); Pemetrexed; Cisplatin
Intervention description: MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.; Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles; Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research is being done to find out if pemetrexed and cisplatin work better when given
      together with an experimental drug called MORAb-009 in patients with malignant pleural
      mesothelioma.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following
             characteristics: unresectable disease (or otherwise not a candidate for curative
             surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.

          -  Measurable disease at Screening by computed tomography (CT)(or magnetic resonance
             imaging [MRI]).

          -  KPS of greater than or equal to 70% at Screening.

          -  Life expectancy of at least 3 months

        Primary Exclusion Criteria:

          -  Sarcomatous type of mesothelioma

          -  Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control
             (ie, non-curative intent) is permitted.

          -  Confirmed presence of CNS tumor involvement.

          -  Evidence of other active malignancy requiring treatment.
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Condition: Tobacco Use Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion-SR; Placebo
Intervention description: 150mg tablets taken orally twice daily for 9 weeks.; Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 12 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: adolescents, cigarettes, smoking, tobacco

Summary:

      Little is known about the best ways to help young people stop smoking. Bupropion (a
      medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The
      purpose of this study is to determine if bupropion is also effective in treating smokers
      between the ages of 12 and 25 years old. This study also compares the effectiveness of
      bupropion used as a supplement to behavioral treatment versus behavioral treatment used
      alone. In addition, the study evaluates whether hormonal response to stress measured prior to
      the start of treatment predicts whether individuals respond well to treatment with
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has smoked at least 10 cigarettes each day for 3 or more months

          -  Weighs at least 90 lbs

          -  Motivated to quit smoking and has had at least one previous failed attempt

          -  Speaks, reads, and writes English

          -  Either diagnosed as depressed OR no history of a psychiatric disorder

        Exclusion Criteria:

          -  History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder,
             autism, or non-nicotine substance use disorder in the 6 months prior to study entry

          -  Currently suicidal or with a history of a suicide attempt in the 6 months prior to
             study entry

          -  Psychotic symptoms

          -  Use of psychotropic medication(s)

          -  Serious medical condition

          -  Prior use of bupropion for smoking cessation

          -  Currently using other smoking cessation treatments
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Growth hormone; Placebo
Intervention description: growth hormone, Genotropin (Pfizer); placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)
Intervention MeSH terms: Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of
      alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates
      of about 30% of individuals in the United States. A subset of these will develop progressive
      disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis
      and liver failure. NAFLD is expected to be the most common indication for liver
      transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will
      decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy
      (1H-MRS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18 - 65 yr

          2. NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of
             significant alcohol consumption and other causes of hepatic steatosis. If liver
             imaging or biopsy has not been performed clinically, liver ultrasound will be
             performed as part of the screening visit.

        Exclusion Criteria:

          1. Serum creatinine > 2 times the upper limit of normal

          2. History of cancer, except for non-melanoma skin cancers

          3. Active carpel tunnel syndrome

          4. Diabetes mellitus, defined as a hemoglobin A1C >6.5 or use of any medications
             prescribed to treat hyperglycemia. The exception is that the use of metformin is
             acceptable in patients whose HbA1c has been =<6.0 on two visits and whose weight has
             remained stable for six months.

          5. Contraindications to magnetic resonance imaging (MRI).

          6. Pregnancy or desire to become pregnant. Participants of reproductive age must agree to
             use contraception.

          7. Breastfeeding

          8. Aspartate and aminotransferase levels >10x upper limit of normal
TXA and Corona Virus 2019 (COVID19) in Outpatients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Tranexamic acid tablets; Placebo oral tablet
Intervention description: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos; 2 tablets p.o. three times per day x 5 days
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind comparison
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Pharmacy prepares 5 day packs of medications that are coded
Enrollment: 5.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      A controlled trial of the drug tranexamic acid (TXA) in outpatients who were recently
      diagnosed with COVID-19. It is hypothesized that TXA will reduce the infectivity and
      virulence of the virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive COVID-19 test

          -  Outpatient

          -  Age >/= 19 y.o.

        Exclusion Criteria:

          -  Allergic reaction to tranexamic acid

          -  History of hypercoagulation disorders (deep venous thrombosis, pulmonary
             thromboembolism)

          -  Ongoing anticoagulation

          -  History of GI bleeding

          -  History of Seizures

          -  Cardiac or other vascular stents

          -  History of severe renal disease

          -  History of intracranial hemorrhage
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: K-877-ER (Dose A); K-877-ER (Dose B); K-877-IR
Intervention description: Dose A Oral Administration; Dose B Oral Administration; K-877-IR Oral Administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to
      K-877 immediate release (IR) twice daily (BID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent before any study-specific evaluation is
             performed

          -  At screening, have a mean fasting TG level of ≥180 mg/dL and <550 mg/dL; at subsequent
             Qualification Period visits confirm fasting TG level of ≥200 mg/dL and <500 mg/dL

          -  Able to meet all inclusion criteria outlined in clinical study protocol

        Exclusion Criteria:

          -  Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9
             inhibitors during the study

          -  Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated
             receptor alpha agonists

          -  Meet any other exclusion criteria outlined in clinical study protocol