bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study of 3 Different Bowel Cleansing Preparations
Condition: Colonoscopy; Bowel Preparation; Endoscopy
Intervention: PEG-3350 based bowel preparation; BLI800 approved preparation regimen; BLI800 investigational preparation regimen
Intervention description: solution for oral administration prior to colonoscopy; solution for oral administration prior to colonoscopy; solution for oral administration prior to colonoscopy
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 541.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colonoscopy; bowel preparation; endoscopy

Summary:

      The objective of this study is to compare the safety, tolerance and efficacy of BLI800
      (approved and investigational regimens) to an approved control preparation as bowel
      preparations prior to colonoscopy in adult patients, particularly including the elderly and
      those with renal and/or hepatic impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication.

          -  At least 18 years of age

          -  If female, and of child-bearing potential, is using an acceptable form of birth
             control

          -  Negative urine pregnancy test at screening, if applicable

          -  In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Exclusion Criteria:

          -  Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

          -  Subjects who had previous significant gastrointestinal surgeries.

          -  Subjects who have uncontrolled clinically significant pre-existing electrolyte
             disturbances.

          -  Subjects with severe liver or renal insufficiency.

          -  Subjects with a history of congestive heart failure or other clinically significant
             cardiac abnormality.

          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          -  Subjects undergoing colonoscopy for foreign body removal and decompression.

          -  Subjects who are pregnant or lactating, or intending to become pregnant during the
             study.

          -  Subjects of childbearing potential who refuse a pregnancy test.

          -  Subjects allergic to any preparation components

          -  Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

          -  Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (Adempas, BAY63-2521); Placebo
Intervention description: BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.; Matching Placebo tid orally for 16 weeks
Intervention MeSH terms: Riociguat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 262.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic pulmonary hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

Summary:

      The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521,
      given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension
      (CTEPH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with CTEPH either inoperable or with persistent or recurrent
             PH after surgery.

        Exclusion Criteria:

          -  All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical
             Classification of Pulmonary Hypertension.
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL
Intervention description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC)
      for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

          -  Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)

          -  HCV treatment-naive or treatment-experienced

          -  Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to
             exclude hepatocellular carcinoma (HCC)

        Key Exclusion Criteria:

          -  Current or prior history of clinically-significant illness (other than HCV),
             gastrointestinal disorder, clinical hepatic decompensation, or post-operative
             condition that could interfere with the absorption of the study drug

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non HCV etiology

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Nepafenac Once Daily for Macular Edema - Study 2
Condition: Non-Proliferative Diabetic Retinopathy; Cataract
MeSH terms: Cataract; Retinal Diseases; Diabetic Retinopathy
Intervention: Nepafenac Ophthalmic Suspension, 0.3%; Vehicle; Prednisolone acetate
Intervention description: Inactive ingredients used as placebo comparator; 1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 819.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Type I; Diabetes Type II; Non-proliferative diabetic retinopathy; Macular edema; Cataract

Summary:

      The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,
      0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among
      diabetic participants following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned cataract extraction by phacoemulsification with implantation of a posterior
             chamber intraocular lens;

          -  History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR)
             (mild, moderate, or severe) in the study eye;

          -  Best-corrected visual acuity (BCVA) of 73 letters or worse in the study eye with
             expectation of improvement after surgery;

          -  Understand and sign an informed consent document;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Pre-existing macular edema in the study eye;

          -  History in the study eye of retinal detachment, wet age-related macular degeneration,
             chronic or recurrent inflammatory eye disease, or prior procedures;

          -  Planned cataract surgery in the fellow eye prior to the Day 90 postoperative study
             visit or through study exit;

          -  Planned multiple procedures for the study eye during the cataract/intraocular lens;

          -  Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs
             (NSAIDs) and steroids, as specified in protocol.

          -  Participation in any other clinical study within 30 days of the screening visit;

          -  Females of childbearing potential who are breast feeding, have a positive urine
             pregnancy test at screening, are not willing to undergo a urine pregnancy test upon
             entering or exiting the study, intend to become pregnant during the study, or do not
             agree to use adequate birth control methods for the duration of the study;

          -  Other protocol-defined exclusion criteria may apply.
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C; Cirrhosis; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Fibrosis
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; Ribavirin
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Interferon-Free; Hepatitis C Genotype 1; Hepatitis C Virus; Hepatitis C; Cirrhosis

Summary:

      The purpose of this study is to evaluate the safety and efficacy of
      ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with
      genotype 1 chronic hepatitis C virus infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  US military veteran currently receiving healthcare through the Veterans Health
             Administration

          -  Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection

          -  Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and
             HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of
             Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy
             performed prior to enrollment with evidence of chronic hepatitis C disease)

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies
             (HIV Ab)

          -  Prior or current use of any investigational or commercially available anti-HCV agents
             other than IFN, pegIFN, RBV or sofosbuvir

          -  Any current or past clinical evidence of Child-Pugh B or C classification

          -  Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within
             3 months prior to Screening or on an ultrasound performed at Screening for
             participants with cirrhosis
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Stratus Microflow Ethmoid Spacer
Intervention description: The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

Summary:

      Study Design:

      A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety
      and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System
      used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects age 17 years or older

          -  Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of
             scheduled surgery)

          -  Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of
             antibiotics)

        Exclusion Criteria:

          -  Age < 17 years old

          -  History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21
             mmHg)

          -  Adequate anatomical distances for treatment

          -  Patient received oral steroid treatment within two weeks prior to day of surgery

          -  Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent
             device placement

          -  Sinonasal tumors or obstructive lesions

          -  History of facial trauma that distorts sinus anatomy and precludes access to the
             ethmoid sinus

          -  Contracted/underdeveloped ethmoid sinus

          -  Dehiscent lamina orbitalis

          -  Previous ethmoid surgery

          -  Ethmoid mucocele

          -  Extensive Nasal Polyps

          -  Asthmatic patients with aspirin sensitivity

          -  Pregnant or lactating females
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: adalimumab
Intervention description: adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 592.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis

Summary:

      To assess the long-term safety and maintenance of response of adalimumab in subjects with
      ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or
      M06-827 (NCT00408629).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have successfully enrolled and completed either study M06-826
             (NCT00385736) or study M06-827 (NCT00408629)

          -  Subject is judged to be in generally good health as determined by the principal
             investigator

        Exclusion Criteria:

          -  Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or
             M06-827 (NCT00408629)

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Condition: Parenteral Nutrition Associated Cholestasis
MeSH terms: Cholestasis
Intervention: intravenous lipid
Intervention description: intravenous given daily for 6 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.
Enrollment: 40.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No

Summary:

      The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in
      late preterm and term neonates with major GI surgical disorders
    

Eligibility criteria:

        Inclusion Criteria:

        All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis,
        omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal
        atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI
        perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible
        for this study

        Exclusion Criteria:

          1. If does not need TPN by 72 hours;

          2. Direct hyperbilirubinemia within the first 72 hours after birth;

          3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);

          4. Biliary tract disorders leading to direct hyperbilirubinemia;

          5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such
             as Galactosemia, α-1 antitrypsin deficiency, etc
Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Trifarotene
Intervention description: Topical Cream
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with
      Moderate Facial and Truncal Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant was a male or female, 9 years of age or older, at Screening visit.

          -  The participant had moderate acne at Screening and Baseline.

          -  The participant was a female of non childbearing potential.

          -  The participant was a female of childbearing potential with a negative pregnancy test
             and who was strictly abstinent or who agreed to use an effective and approved
             contraceptive method for the duration of the study and at least 1 months after the
             last study drug application.

        Exclusion Criteria:

          -  The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or
             secondary acne form (e.g., chloracne, drug induced acne, etc.).

          -  The participant had any uncontrolled or serious disease or any medical or surgical
             condition that may either interfere with the interpretation of the trial results
             and/or put the participant at significant risk (according to the Investigator's
             judgment) if the participant took part to the trial.

          -  The participant had been exposed to excessive ultraviolet (UV) radiation within one
             month prior to the Baseline visit or the participant was planning intense UV exposure
             during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon
             use, phototherapy, etc.).

          -  The participant was unwilling to refrain from use of prohibited medication during the
             Clinical Trial.
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Placebo; Prednisone
Intervention description: 1000 mg per day (4 x 250-mg tablets) taken orally.; 4 placebo tablets per day taken orally.; 5 mg tablet orally twice daily.
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1088.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Abiraterone acetate; CB7630; CRPC; Metastatic castration-resistant prostate cancer; hormone refractory prostate cancer

Summary:

      This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus
      prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with
      metastatic castration-resistant prostate cancer (CRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic castration-resistant prostate cancer (CRPC)

          -  Previous anti-androgen therapy and progression after withdrawal

          -  ECOG performance status of either 0 or 1

          -  Medical or surgical castration with testosterone less than 50 ng/dL

          -  Life expectancy of at least 6 months

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy or biologic therapy for CRPC

          -  Prior ketoconazole for prostate cancer

          -  Known brain metastasis or visceral organ metastasis

          -  Use of opiate analgesics for cancer-related pain, including codeine and
             dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Condition: Post Ocular Surgical Inflammation and Pain
MeSH terms: Inflammation
Intervention: Dexamethasone; Punctum Plug
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)
      depot when placed in the canaliculus of the eyelid for the treatment of post-surgical
      inflammation and pain in subjects who have undergone cataract extraction with intra-ocular
      lens implantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a cataract and is expected to undergo clear corneal cataract surgery with
             phacoemulsification and implantation of a posterior chamber intraocular lens

          -  Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or
             better in both eyes

        Exclusion Criteria:

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination

          -  Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination