bioihbjkbjnl/mcl2 huggingface dataset:
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Brinzolamide ophthalmic suspension, 1%; Brimonidine tartrate ophthalmic solution, 0.2%
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1062.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-Angle Glaucoma; Ocular Hypertension; Brinzolamide; Brimonidine; Intraocular pressure

Summary:

      The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic
      suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual
      active components in subjects with open-angle glaucoma and/or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign Informed Consent document.

          -  Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular
             pressure within protocol-specified range at eligibility visit/s.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential if pregnant, lactating, or not using highly
             effective birth control measures.

          -  Any form of glaucoma other than open-angle glaucoma.

          -  Severe central vision loss in either eye.

          -  Chronic, recurrent, or severe inflammatory eye disease.

          -  Ocular trauma within the preceding 6 months.

          -  Ocular infection or ocular inflammation within the preceding 3 months.

          -  Clinically significant or progressive retinal disease such as retinal degeneration,
             diabetic retinopathy, or retinal detachment.

          -  Best-corrected visual acuity score worse than 55 letters using the Early Treatment
             Diabetic Retinopathy Study chart.

          -  Other ocular pathology (including severe dry eye) that may, in the opinion of the
             Investigator, preclude the administration of study product.

          -  Ocular surgery within the preceding 6 months.

          -  Ocular laser surgery within the preceding 3 months.

          -  Any abnormality preventing reliable applanation tonometry.

          -  Any other conditions, including severe illness, which could make the subject, in the
             opinion of the Investigator, unsuitable for the study.

          -  Other protocol-specified exclusion criteria may apply.
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: SPD476; Asacol
Intervention description: 2.4 g/day Once Daily (QD); 1.6g/day administered 800 mg Twice Daily (BID)
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 829.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of
      the bowel becomes red and swollen. Over time, patients with this disease may experience acute
      episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without
      disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is
      an experimental drug designed to gradually release 5-ASA into the areas of large bowel
      associated with ulcerative colitis. This study will test the safety and efficacy of
      mesalazine in keeping ulcerative colitis in remission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  previous diagnosis of ulcerative colitis confirmed by histology that has been
             considered to be in remission for => 30 days

          -  female subjects must be post-menopausal, surgically or biologically sterile, or with a
             negative urine pregnancy test at screening and on adequate contraception

        Exclusion Criteria:

          -  proctitis

          -  previous resective colonic surgery

          -  Crohn's disease

          -  hypersensitivity to salicylates

          -  moderate/severe renal impairment
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: sitagliptin 100 mg; Comparator: sitagliptin 200 mg; Comparator: placebo; Comparator: pioglitazone
Intervention description: sitagliptin 100 mg oral tablet once daily for 54 weeks; sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks; placebo oral tablet once daily during Phase A (Weeks 0-18); pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 521.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and effectiveness of an investigational
      drug in patients with Type 2 Diabetes Mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age and not older than 75 who have a specific type of
             diabetes called Type 2 Diabetes Mellitus

        Exclusion Criteria:

          -  Younger than 18 years of age or older than 75

          -  Any condition, which in the opinion of the investigator, may not be in the patient's
             best interest to participate
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: T2762; Vismed®
Intervention description: 1 drop in each eye 3 to 6 times daily during 84 days; 1 drop in each eye 3 to 6 times daily during 84 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to
      severe Dry Eye Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Male or female aged from ≥ 18 years old.

          -  Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to
             study selection.

        Exclusion Criteria:

          -  Best far corrected visual acuity < 1/10

          -  Severe blepharitis

          -  Severe Dry Eye
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
Condition: Non-Infectious Uveitis of the Posterior Segment of the Eye
MeSH terms: Uveitis
Intervention: DE-109 440 μg
Intervention description: Medium Dose
Intervention MeSH terms: Sirolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this extension study is to evaluate the long-term safety of treatment with
      DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye
      who have participated in the SAKURA development program.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participated in the SAKURA study

          2. Received clinical benefit from treatment in the SAKURA study

          3. Ability to sign informed consent and attend all study visits

        Exclusion Criteria:

          1. Uveitis of infectious etiology

          2. Implanted device

          3. Suspected or confirmed central nervous system or ocular lymphoma

          4. Uncontrolled glaucoma

          5. Significant ocular disease

          6. Intravitreal injections in the past 60 days

          7. Intraocular surgery or treatment

          8. Ocular or periocular infection

          9. History of herpetic infection

         10. Toxoplasmosis or toxoplasmosis scar

         11. Ocular malignancy

         12. Vitrectomy

         13. Allergy or hypersensitivity to study drug

         14. Participation in other uveitis device clinical trials within 30 days

         15. Any recent systemic condition/infection

         16. Immunosuppressive therapy or immunocomprimised

         17. Cytomegalovirus infection

         18. Malignancy in remission

         19. Females who are pregnant or lactating and who are not using adequate contraceptive

         20. Medical marijuana or illegal drug use

         21. Systemic saroidosis

         22. Therapeutic radiation to the head or neck
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Condition: Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Valproate; Naltrexone
Intervention description: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60 mg per kg per day. Usual dosage is between 1250mg to 2000mg per day; 25mg per day, taken by mouth for 7 days, then 50mg per day
Intervention MeSH terms: Naltrexone; Valproic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 62.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Alcohol Use Disorders; Traumatic Brain Injury; Mood and Anxiety Disorders

Summary:

      The purpose of this research study is to understand the effectiveness of valproate (a common
      mood stabilizer) to further reduce alcohol misuse when given in addition to attending an
      alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main
      goal of this project is to understand if people receiving valproate will have a better
      recovery than people receiving the standard treatment for alcohol dependence: naltrexone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans attending alcohol use disorders rehabilitation treatment within the VA

          -  Presence of a diagnosis of alcohol dependence according to DSM-IV

          -  A history of heavy drinking

          -  Absence of withdrawal symptoms

        Exclusion Criteria:

          -  Evidence of other substance abuse different from nicotine or cannabis (DSM-IV
             criteria) or by 2 consecutive positive urine drug screens

          -  Unstable medical conditions such as severe heart disease, liver or renal failure or
             evidence of neoplasia.

          -  Liver Enzymes (ALT, AST) serum levels >3 times the upper limit of normal

          -  Unstable psychiatric conditions that requires treatment in a more structured setting
             (i.e. active SI, worsening psychotic symptoms or acute mania)

          -  Diagnosis of schizophrenia or schizoaffective disorder

          -  Requiring therapy with valproate or naltrexone or has a history of significant side
             effects from either study drug

          -  Requiring therapy with topiramate, lamotrigine or carbamazepine

          -  Requiring chronic treatment with opioid analgesics for refractory pain

          -  Failed 3 previous intensive alcohol rehabilitation programs in the past 2 years

          -  Females
Vitamin K Supplementation in Post-Menopausal Osteopenia
Condition: Post-Menopausal Osteoporosis; Post-Menopausal Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Intervention: vitamin K1 (phylloquinone); placebo
Intervention description: 1 pill daily
Intervention MeSH terms: Vitamin K; Vitamin K 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 440.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin K; bone mineral density; post-menopausal women; randomized double blind placebo controlled trial; osteoporosis; women's health

Summary:

      The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily
      over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.
    

Eligibility criteria:

        Inclusion Criteria:

        Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with either
        postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2. Osteopenic:
        T-score at baseline has to be between (and including) -1.0 and

        -2.0 in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the
        above three measurements must be between -1.0 and -2.0

        Exclusion Criteria:

          1. Women ever having had a fragility fracture after age 40;

          2. Women currently on anticoagulants, previously on anticoagulants in the past 3 months,
             or expected to be on anticoagulants in the near future;

          3. Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during
             the past 3 months;

          4. Women who have ever been on a bisphosphonate for more than 6 months;

          5. Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism
             or other metabolic bone diseases;

          6. Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart;

          7. Women with a history of active cancer in the past 5 years;

          8. Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400
             iu per day);

          9. Women involved in other clinical trials;

         10. Any women who, in the opinion of the principal investigator, is at poor medical or
             psychiatric risk for the study.
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: CSF-1; Vehicle
Intervention description: One drop bilaterally twice daily for approximately 2 weeks.; One drop bilaterally twice daily for approximately 2 weeks.
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 45 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study
      evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have presbyopia.

        Exclusion Criteria:

        Subjects must not:

          -  Have any contraindications to the study medications or diagnoses that would confound
             the study.
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Experimental: Tezepelumab; Placebo
Intervention description: Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-Blind
Enrollment: 1061.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Summary:

      A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to
      Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe
      Uncontrolled Asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age. 12-80

          -  Documented physician-diagnosed asthma for at least 12 months

          -  Subjects who have received a physician-prescribed asthma controller medication with
             medium or high dose ICS for at least 12 months.

          -  Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500
             µg fluticasone propionate dry powder formulation equivalent total daily dose) for at
             least 3 months.

          -  At least one additional maintenance asthma controller medication is required according
             to standard practice of care and must be documented for at least 3 months.

          -  Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)

          -  Evidence of asthma as documented by either: Documented historical reversibility of
             FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol)
             reversibility of FEV1 ≥12% and ≥200 mL during screening.

          -  Documented history of at least 2 asthma exacerbation events within 12 months.

          -  ACQ-6 score ≥1.5 at screening and on day of randomization

        Exclusion Criteria:

          -  Pulmonary disease other than asthma.

          -  History of cancer.

          -  History of a clinically significant infection.

          -  Current smokers or subjects with smoking history ≥10 pack-years and subjects using
             vaping products, including electronic cigarettes.

          -  History of chronic alcohol or drug abuse within 12 months.

          -  Hepatitis B, C or HIV.

          -  Pregnant or breastfeeding.

          -  History of anaphylaxis following any biologic therapy.

          -  Subject randomized in the current study or previous tezepelumab studies.
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
Condition: Radiotherapy Induced Mucositis; Head and Neck Cancer
MeSH terms: Mucositis; Stomatitis
Intervention: manuka honey; placebo gel
Intervention description: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.; Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study was blinded to all except necessary pharmacy staff until after the study was closed.
Enrollment: 106.0
Sex: All
Healthy volunteers: No
Keywords: Mucositis; Radiation; Honey

Summary:

      The primary hypothesis of this study is that regular topical oral application of Manuka Honey
      will reduce the severity and duration of oral mucositis in patients who are undergoing
      mucotoxic radiation therapy for cancer treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients commencing radiation therapy of 50 Gy or higher with the dosage field
             affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites
             affected).

          -  Patients willing and able to attend weekly assessments throughout their treatment,
             plus one week after completion of treatment.

        Exclusion Criteria:

          -  Patients unable to understand the consent process (translators will be used if
             necessary so being English-speaking is not required).

          -  Patients unable to attend the follow-up visits

          -  Patients participating in other clinical trials which might affect the severity of
             mucositis

          -  Patients allergic to honey, multiple pollens, or to celery
Telotristat Etiprate for Carcinoid Syndrome Therapy
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate; Placebo
Intervention description: Telotristat etiprate tablets; Placebo-matching telotristat etiprate tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on
      the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA)
      levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years of age

          -  All patients of reproductive potential must agree to use an adequate method of
             contraception during the study and for 12 weeks after the Follow-up visit.

          -  Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

          -  Documented history of carcinoid syndrome

          -  Patient is able and willing to provide written informed consent prior to participation

        Exclusion Criteria:

          -  Presence of diarrhea attributed to any condition other than carcinoid syndrome.

          -  Presence of 12 or more watery bowel movements per day

          -  Positive stool examination for enteric pathogens, pathogenic ova or parasites, of
             Clostridium difficile at Screening

          -  Karnofsky Performance Status ≤ 60%

          -  Presence of any clinically significant laboratory, medical history, or physical
             examination findings deemed unacceptable by the Investigator

          -  A history of short bowel syndrome

          -  History of constipation within 2 years of Screening

          -  Life expectancy < 12 months from Screening