bioihbjkbjnl/mcl2 huggingface dataset:
Early Treatment for Acute ACL Tear
Condition: Anterior Cruciate Ligament (ACL) Tears
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: Kenalog or placebo; Kenalog then Placebo; Kenalog; Placebo
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Pharmaceutical Solutions; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 14 Years
Maximum age: 33 Years
Healthy volunteers: No

Summary:

      This research study is the first of its kind and will allow health care professionals and
      researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)
      injury leads to knee pain and disability and osteoarthritis. We also hope that this study
      will be the beginning of new, more powerful and safer drugs to help patients with ACL
      injuries heal sooner and return to sports or daily activities pain free. Study participants
      will be recruited from the University of Kentucky and Vanderbilt University.

      The purpose of this research is to gather information on how safe and effective Kenalog® is
      in alleviating knee pain following ACL rupture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently participating in sporting activities

          -  Normal contralateral knee status

          -  Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity

        Exclusion Criteria:

          -  underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)

          -  have been diagnosed with hepatitis B or tuberculosis

          -  currently have an infection, including infection of the skin

          -  have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs

          -  other major medical condition requiring treatment with immunosuppressant or modulating
             drugs.

          -  A history of chronic use of non-steroidal anti-inflammatory drugs

          -  previous exposure or allergic reaction to Kenalog

          -  prior knee surgery (Ipsilateral or contralateral)

          -  have received any investigational drug with 4 weeks of study Visit 1
Esmolol to Treat the Hemodynamic Effects of Septic Shock
Condition: Septic Shock; Hypotension; Tachycardia
MeSH terms: Shock, Septic; Hypotension; Tachycardia; Shock
Intervention: Esmolol; Saline
Intervention MeSH terms: Esmolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esmolol; Septic Shock; Hypotension; Tachycardia

Summary:

      The main purpose of this study is to determine the effects of controlling the heart rate of
      patients with septic shock using an intravenous medication called esmolol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years)

          -  Sepsis defined as suspected or confirmed infection with at least two systemic
             inflammatory response syndrome (SIRS) criteria

          -  Norepinephrine (minimum 0.1 mcg/kg/min) support to maintain a mean arterial pressure ≥
             65 mmHg despite appropriate volume resuscitation (as defined by the clinical team,
             however at least 30mL/kg intravenous fluid

          -  Heart rate ≥ 95 per minute for at least 2 hours prior to enrollment

          -  6-24 hours since ICU admission

        Exclusion Criteria:

          -  Intravenous β-blocker therapy prior to randomization

          -  Pronounced cardiac dysfunction (i.e. cardiac index [CI] ≤ 2.2 L/min/m2)

          -  Known significant valvular heart disease

          -  Research-protected populations (pregnant women, prisoners, intellectually disabled)

          -  Known "Do-not-resuscitate" or "do-not-intubate" order at the time of enrollment

          -  Infusion of epinephrine, dopamine, dobutamine or milrinone at time of enrollment

          -  Known allergy/sensitivity to esmolol or history of asthma/COPD
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Condition: Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: NRX 194204
Intervention description: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HRPC (Hormone refractory prostate cancer); Androgen independent prostate cancer; CRPC (Castration and Taxane Resistant Prostate Cancer)

Summary:

      This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing
      down/stopping/reversing progression of the castration resistant and taxane resistant prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed prostate cancer

          -  Documented progression on at least one prior hormone treatment, AND at least one
             taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment

          -  Male, Age > 18 years

          -  ECOG (Eastern Cooperative Oncology Group) performance score of 0-2

          -  Adequate bone marrow, renal and hepatic function

          -  Men of childbearing potential must consent to use barrier contraception while on
             treatment and for 90 days thereafter

        Exclusion Criteria:

          -  Prior treatment with NRX 194204 or bexarotene (Targretin)

          -  Presence of parenchymal brain metastases

          -  History of prior malignancy within the past 5 years with the exception of curatively
             treated basal cell or squamous cell carcinoma of the skin or superficial bladder or
             other stage I or stage II cancer in complete remission for at least 12 months

          -  Patients with a history of unstable or newly diagnosed angina pectoris, documented
             history of current serious arrhythmia or congestive heart failure or myocardial
             infarction within 6 months of enrollment

          -  Known HIV or hepatitis B or C infection

          -  Life expectancy < 3 months

          -  Patients with any history of thyroid disease, pituitary disease or treatment with
             thyroid replacement hormone

          -  Patients with a history of pancreatitis or at significant risk of developing
             pancreatitis
An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Pomalidomide; Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pomalidomide; Elotuzumab; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose
      dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma
      compared to pomalidomide and low-dose dexamethasone by itself.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of
             lenalidomide and a proteosome inhibitor alone or in combination

          -  Documented refractory or relapsed and refractory multiple myeloma

          -  Refractory to proteosome inhibitor and lenalidomide, and to last treatment

          -  Relapsed and refractory patients must have achieved at least a partial response to
             previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed
             within 6 months, and were refractory to their last treatment

          -  Measurable disease at screening

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

        Exclusion Criteria:

          -  Active plasma cell leukemia

          -  Prior treatment with pomalidomide

          -  Unable to tolerate thromboembolic prophylaxis while on the study

          -  Prior autologous stem cell transplant within 12 weeks

          -  Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab; placebo; ICS/LABA therapy; Salbutamol/albuterol; Levosalbutamol/levalbuterol
Intervention description: Solution for injection, Subcutaneous injection; Solution for injection, Subcutaneous injection; Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose; Oral inhalation as needed; Oral inhalation as needed
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 776.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of different doses and regimens of dupilumab in participants with
      moderate to severe uncontrolled asthma.

      Secondary Objective:

      To evaluate different doses and regimens of dupilumab in participants with moderate to severe
      uncontrolled asthma, with regard to:

        -  Safety and tolerability

        -  Dupilumab systemic exposure and anti-drug antibodies
    

Eligibility criteria:

        Inclusion criteria:

        Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12
        months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

          -  Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting
             beta-2 agonist

          -  Forced expiratory volume (FEV1) 40 to 80% of predicted normal

          -  Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5

          -  Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)

          -  Had experienced, within prior year: hospitalization, emergency or urgent care visit or
             systemic corticosteroid treatment for worsening asthma

        Exclusion criteria:

          -  Participants <18 years

          -  Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema,
             idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary
             aspergillosis) which impaired pulmonary function tests

          -  Chest X-ray within 12 months of screening visit or at screening visit with clinically
             significant findings of lung disease(s) other than asthma

          -  Current smoker or cessation of smoking within 6 months prior to Visit 1

          -  Previous smoker with a smoking history >10 pack-years

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus
Condition: Barretts Esophagus With Dysplasia
MeSH terms: Barrett Esophagus
Intervention: Alginates
Intervention description: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a pilot prospective cohort study at a single tertiary center who will be compared to historical controls.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Barrett's; GERD; reflux; alginate solution; proton pump inhibitor

Summary:

      This study evaluates the addition of an alginate based solution to twice daily proton pump
      inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's
      esophagus. The investigators hypothesize that the addition of this medication will help to
      achieve complete remission of Barrett's over a shorter period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  (1) Age 18 (2) Biopsy-proven complicated BE (low/high grade grade dysplasia or IMC,
             confirmed by our institution's GI pathologist) As part of standard of care, all
             patients' biopsies will be confirmed with the institutions' GI pathologist and, either
             with outside biopsies or from biopsies completed at the primary institution.

        Exclusion Criteria:

          -  1) Moderate to severe renal impairment, as defined by eGFR< 60 for 2 consecutive
             readings (2) Lack of capacity for decision-making (3) Allergy to hydroxybenzoates (4)
             Patients with uncontrolled hypertension or decompensated heart failure (5) Pregnancy-
             patients of child-bearing potential will be tested. (6) Patients with elevated calcium
             or potassium on screening laboratory testing (labs completed within the last month)
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: BMS-986166; Branebrutinib; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Branebrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; BMS-986166; BMS-986195; Branebrutinib

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166
      and of branebrutinib, each versus placebo, for the treatment of participants with moderate to
      severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of
             Hanifin's and Rajka's (E-HR) criteria at Screening

          -  Disease duration of at least 24 months since diagnosis by any criteria

          -  Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of
             topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of
             randomization, or inappropriateness of therapy due to side effects or safety risks
             leading to prior discontinuation

          -  Application of fixed doses of an additive-free, basic bland emollient twice-daily for
             ≥ 7 days before baseline visit and for the duration of the study

        Exclusion Criteria:

          -  Any major illness/condition or evidence of an unstable clinical condition or local
             active infection/infectious illness that, in the investigator's judgment, will
             substantially increase the risk to the participant if he or she participates in the
             study or interfere with the interpretation of study results

          -  Clinically relevant cardiovascular conditions or pulmonary conditions

          -  High likelihood - based on participant history, and investigator judgement - of
             requiring rescue therapy in < 4 weeks prior to randomization

          -  Evidence of acute flare between the Screening and Baseline/ Randomization

          -  Skin lesion(s) and/or pruritus due to conditions other than AD that would interfere
             with the study specified assessments

        Other protocol-defined inclusion/exclusion criteria apply
Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: LIK066
Intervention description: LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: renal function; sodium-glucose co-transporter; pharmacokinetics; decreased renal function; decreased kidney function; kidney disease; urinary glucose excretion; UGE

Summary:

      The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose
      excretion in urine in patients with varying degrees of decreased kidney function and in
      subjects with normal kidney function. Blood samples were collected to measure the
      concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is
      meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the
      body does to the drug. The results of this study may be used to help determine whether LIK066
      can be used to treat people with reduced kidney function and the proper dosing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  Male and female subjects age 18-78 years, inclusive, with controlled health condition
             as determined by past medical history, physical examination, electrocardiogram and
             laboratory test at screening.

          -  patients with Type 2 diabetes, HbA1c <10% at screening.

          -  Body mass index (BMI) ≤ 50 kg/m^2 at screening.

        Exclusion Criteria:

          -  Patients with Type 1 diabetes

          -  Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline
             phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.

          -  Patients undergoing any method of dialysis

          -  clinically significant GI disorder related to malabsorption or that may affect drug or
             glucose absorption.

          -  subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6
             months of screening visit.
Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
Condition: Pterygium
MeSH terms: Pterygium
Intervention: CBT-001 single dose; Vehicle; CBT-001 Multi-dose
Intervention description: One drop in the study administered one time; One drop in the study administered three times daily (TID) for 4 weeks; One drop in the study administered three times daily (TID) for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24)

      Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup
      (n=51)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary pterygium with moderate vascularity (Pterygium Hyperemia Grading Scale ≥ 3)

        Exclusion Criteria:

          -  Active ocular disease, corneal abnormalities other than pterygium, active ocular
             infection, or any ocular pathology unrelated to pterygium in either eye that could
             affect the assessment of the pterygium

          -  History of ocular herpes disease in either eye

          -  Any ocular surgical procedure within the last 3 months

          -  Female patients who are pregnant, nursing, or planning a pregnancy during the study
Test of Novel Drug for Smoking Cessation
Condition: Smoking Cessation
Intervention: Active JNJ Drug; Placebo pill
Intervention description: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.; Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover of active JNJ vs. placebo for 2 weeks each, involving 1 week of dose run-up and 1 week of attempting to quit each day on that drug condition. A one-week washout separates these drug conditions, which are administered in counter-balanced order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: crossover

Summary:

      The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid
      cessation during a one-week "practice" quit period for each condition in smokers with a high
      interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and
      cognitive impairment will help assess the mechanism to support quit smoking attempts.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy male and female dependent smokers wanting to quit soon

        -

        Exclusion Criteria:

          -  Use of non-smoked nicotine products

          -  Already enrolled in cessation program.

               -  Recent alcohol or substance dependence (≤ 3 months)

               -  Women who are pregnant, planning a pregnancy, or lactating; all female
                  participants shall undergo a pregnancy test at screening and will be excluded if
                  positive.

               -  Serious or unstable medical disorder within the past 3 months

          -  Epilepsy

               -  Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable
                  cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months

               -  Evidence impaired liver function test (LFT)

               -  Evidence of kidney failure

               -  Any subject with a history of hematological cancers examples: leukemia, lymphoma
                  etc.

               -  Any clinically significant hematological laboratory abnormality.