bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
Condition: Corneal Epithelial Disorders
Intervention: High Dose SJP-0035 Ophthalmic Solution; Low Dose SJP-0035 Ophthalmic Solution; Vehicle of SJP-0035 Ophthalmic solution
Intervention description: 0.001% SJP-0035 Ophthalmic Solution; 0.0002% SJP-0035 Ophthalmic Solution; 0% SJP-0035 Ophthalmic Solution
Intervention MeSH terms: Pharmaceutical Solutions; 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: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective
      in promoting corneal epithelial wound healing in conditions associated with corneal
      epithelial disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is capable of understanding the written informed consent form (ICF), provides signed
             and witnessed written ICF, and agrees to comply with protocol requirements, including
             all required study visits

          -  Is a male or female 18 years of age or older

          -  Has a moderate to severe corneal epithelial disorder in both eyes

          -  Has blurred vision caused by corneal epithelial disorders in both eyes at Screening
             and Randomization

          -  Is a female of childbearing potential with a negative pregnancy test result at
             Screening and Randomization and agrees to use effective contraception throughout the
             study, or is a postmenopausal woman with a negative pregnancy test result at Screening
             and Randomization

        Exclusion Criteria:

          -  Has any corneal stromal or endothelial abnormalities including an active bacterial or
             viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the
             cornea in either eye at Screening and Randomization

          -  Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and
             eye structures in either eye at Screening and Randomization

          -  Has had intraocular surgery (including cataract or vitreous) in either eye within the
             last 30 days prior to the first dose of study drug

          -  Has had refractive surgery (including ocular surface laser surgery) in either eye
             within the last 6 months prior to the first dose of study drug

          -  Has used any ocular medication (except mydriatics, stain, and topical anesthesia used
             for study assessments) in either eye within 14 days prior to the first dose of study
             drug, or is anticipated to require such medications during the study.

          -  Is a contact lens wearer and cannot discontinue use in both eyes from Screening
             through EOS
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Condition: Infantile Colic
MeSH terms: Colic
Intervention: Simethicone Solution; Vivatlac Baby
Intervention description: Oral daily treatment for four weeks; Oral daily treatment for four weeks
Intervention MeSH terms: Simethicone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 3 Weeks
Maximum age: 6 Weeks
Healthy volunteers: No

Summary:

      Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in
      babies diagnosed for infantile colic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed for infantile colic according to Wessel's criteria

        Exclusion Criteria:

          -  previous treatment with probiotic or synbiotic

          -  previous treatment with antibiotics
A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: LCI699-matching placebo; LCI699
Intervention description: LCI699-matching placebo oral capsules; LCI699 oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Blood Pressure; Hypertension; Cortisol

Summary:

      This study determined the maximum dose of LCI6999 with respect to effect on the
      ACTH-stimulated cortisol response in participants with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg)
             and < 180/110 mmHg on current antihypertensive treatment

          -  Male and female participants 18-75 years of age

          -  Participants must weigh at least 50 kilograms (kg)

        Exclusion Criteria:

          -  Recent history of myocardial infarction, heart failure, unstable angina, coronary
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebral accident or transient ischemic attack

          -  Clinically significant electrocardiography (ECG) findings related to cardiac
             conduction defects

          -  Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] > 9%)

          -  Malignancies within the last 5 years (excluding basal cell skin cancer)

          -  Liver disease

        Other protocol-defined inclusion/exclusion criteria may apply.
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide; Matching Placebo
Intervention description: Oral, once daily; Oral, once daily
Intervention MeSH terms: Linaclotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 759.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety, efficacy, and dose response of two
      delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is
      DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C).
      Additional objectives include understanding how the two DR formulations compare with each
      other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of
      linaclotide).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy according to the American Gastroenterological
             Association (AGA) criteria, with no clinically significant findings

          -  Patient has no clinically significant findings on a physical examination and clinical
             laboratory tests

          -  Patient meets protocol criteria for diagnosis of IBS-C

          -  Patient demonstrates continued IBS-C through Pretreatment Period

          -  Patient maintains a minimum level of compliance with daily diary

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: 0.3% BOL-303242-X ophthalmic suspension; 2% BOL-303242-X ophthalmic suspension; Placebo Comparator: Vehicle; 1% BOL-303242-X ophthalmic suspension; 2% BOL-303242-X ophthalmic suspension AM; 2% BOL-303242-X ophthalmic suspension PM
Intervention description: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.; 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.; Placebo Comparator: Vehicle BID for 12 weeks.; 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.; 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.; Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to identify the concentration and daily dosing frequency of
      BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a diagnosis of dry eye disease.

          -  Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.

          -  Subjects who are willing and able to refrain from using contact lenses during the
             study.

        Exclusion Criteria:

          -  Subjects with known hypersensitivity or contraindication to any component of the study
             medication.

          -  Subjects who are expected to require concurrent treatment with ophthalmic medications
             (prescription or over the counter).

          -  Subjects who are expected to require treatment with corticosteroids during the study.

          -  Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid
             therapies within 30 days prior to the screening visit.

          -  Subjects who have undergone any type of ocular surgery within three months prior to
             screening.

          -  Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.

          -  Subjects with a history or presence of chronic generalized systemic or ocular disease
             that the Investigator feels might increase the risk to the subject or confound the
             result of the study.
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: acetyl-l-carnitine PLUS alpha-lipoic acide; Placebo
Intervention description: 1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid.; Placebo
Intervention MeSH terms: Acetylcarnitine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar disorder; Bipolar depression; Natural substances; Depression

Summary:

      The primary objective of this 15-week clinical trial is to test the hypothesis that treatment
      with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA),
      has significantly greater efficacy than placebo as an augmentation treatment in bipolar
      depressed patients who display an incomplete response to conventional treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18-65 years.

          -  Meets DSM-IV criteria for Bipolar Disorder, type I with current episode depressed.

          -  Current score of greater than or equal to 18 on the 21-Item Hamilton Depression Rating
             Scale at Visits 1 and 2.

          -  Maintained on a stable treatment regimen with no changes in medication dosages for at
             least two weeks prior to study entry.

        Exclusion Criteria:

          -  Unwilling or unable to provide informed consent

          -  Score of greater than or equal to 12 on the Young Mania Rating Scale at Visit 1 or 2.

          -  Current suicidal or homicidal ideation.

          -  Active psychotic symptoms.

          -  Lifetime history of schizophrenia or obsessive-compulsive disorder.

          -  DSM-IV diagnosis of alcohol or substance dependence in the 3 months prior to
             screening.

          -  Clinically significant medical condition that would interfere with study
             participation.

          -  History of hypersensitivity to ACLCAR or ALA.

          -  Pregnant or lactating.
Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Minimally Invasive Total Knee Arthroplasty [TKA Min]; Total Knee Arthroplasty (TKA) Traditional
Intervention description: TKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.; TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Knee Replacement; Knee OA; OA

Summary:

      Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of
      people over the age of 60 and compromises the quality of life of more than 20 million
      Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of
      the knee joint is replaced by plastic or metal, has been successful in restoring comfort and
      mobility to formerly arthritic joints. This study will compare quadriceps muscle strength,
      knee range of motion, and pain in people who have had a traditional TKA with those who have
      had a minimally invasive TKA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of osteoarthritis

          -  Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael
             Dayton (University of Colorado Hospital)

          -  Minimum of 110 degrees of active knee flexion

          -  No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10
             degrees flexion contracture

          -  Body mass index less ≤ 40 kg/m2

        Exclusion Criteria:

          -  Any brain, circulation, or heart problems that limit function

          -  Severe osteoarthritis or other orthopedic conditions that limit function in the lower
             extremity that is not undergoing the TKA
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Condition: Pan Tumor
MeSH terms: Neoplasms
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 212.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: TMB-H

Summary:

      The purpose of this study is to demonstrate the clinical activity of nivolumab in combination
      with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a refractory, metastatic, or unresectable histologically or
             cytologically confirmed solid malignant tumor with high tumor mutational burden
             (TMB-H) who are refractory to standard local therapies, or for which no standard
             treatment is available.

          -  Must be able to provide tissue and blood TMB-H testing results

          -  Must have measurable disease for response assessment

        Exclusion Criteria:

          -  Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma
             (RCC) or hematological malignancy as primary site of disease

          -  Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1),
             anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2
             (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4
             (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell
             co-stimulation or checkpoint pathways

          -  Treatment with any chemotherapy, radiation therapy, biologics for cancer, or
             investigational therapy within 28 days of first administration of study treatment

        Other protocol defined inclusion/exclusion criteria apply.
Efficacy of Varenicline in Ambivalent Smokers
Condition: Tobacco Use Disorder; Tobacco Use Cessation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Placebo
Intervention description: 0.5 milligrams two times per day for 3 days, then 1.0 milligrams two times per day for an addition 11 days - 2 months; same as Varenicline arm
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine; Smoking; Smoking Cessation

Summary:

      The purpose of this study is to test whether Varenicline can help ambivalent smokers (those
      who are interested in quitting at some point in the future but have no current plans to quit)
      to reduce their smoking and eventually quit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  Able to get to research lab in Burlington, Vermont or Omaha, Nebraska

          -  Daily smoker

          -  Smoke at least 8 cigarettes per day

          -  No reduction in smoking in last 30 days

          -  No intention to quit in the next 30 days

          -  Never used Varenicline before

          -  Not currently using smoking cessation medications or nicotine replacement therapy

          -  Willing to use Varenicline for at least 2 weeks

          -  Fluent in English

        Exclusion Criteria:

          -  Cannot be currently pregnant or breastfeeding

          -  Kidney disease

          -  Frequent nausea

          -  On certain medications for asthma and/or depression

          -  Another household member in study
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Condition: Alcohol Reactivity
MeSH terms: Alcoholism
Intervention: varenicline; placebo
Intervention description: 1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.; placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol; reactivity; smoking cessation medications

Summary:

      The purpose of this study is the examine the effect of varenicline on cognition to a high
      dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of
      the blood alcohol curve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years old or older

          -  Able to read and write in English

          -  Smokers and nonsmokers

          -  Meet criteria for alcohol use disorders

          -  Currently enrolled in NCT00580645

        Exclusion Criteria:

          -  Any significant current medical or psychiatric conditions that would contraindicate
             the consumption of alcohol

          -  Significant hepatocellular injury

          -  Positive test results at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal, or evidence of severe mental illness

          -  Prescription of any psychotropic drug in the 30 days prior to study enrollment

          -  Blood donation within the past 8 weeks

          -  Individuals who are seeking treatment for drinking or smoking or who have attempted to
             quit drinking or smoking within the past 3 months

          -  Known allergy to varenicline or taking H2blockers

          -  Participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current protocol

          -  Subjects likely to exhibit clinically significant alcohol withdrawal during the study