bioihbjkbjnl/mcl2 huggingface dataset:
Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
Condition: Hemorrhage; Shock; Wounds and Injuries
MeSH terms: Hemorrhage; Wounds and Injuries
Intervention: Tranexamic Acid; Placebo
Intervention description: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.; Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of TXA on the immune system, its
      pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with traumatic injury that are ordered to receive at least 1 blood product
             and/or

          2. Patients admitted to the Emergency Department with a traumatic injury and require
             immediate transfer to the operating room to control the bleeding

          3. Able to receive the study drug within 2 hours from estimated time of injury **Please
             note that in circumstances where the patient initially met inclusion/exclusion
             criteria (i.e. received blood products in the ED before a full evaluation of their
             injuries is complete) but is later found to only have a soft tissue involved injury or
             does not have a traumatic bleeding source), the Investigator may determine that the
             patient should not be randomized into the trial and the patient should be considered a
             screen failure

        Exclusion Criteria:

          1. Patients known to be < 18 years of age

          2. Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission

          3. Known inherited coagulation disorders

          4. Known history of thromboembolic events (DVT, PE, MI, Stroke)

             • Please note that past medical history of hemorrhagic stroke is permitted, but not
             current admission with hemorrhagic stroke

          5. Known history of seizures and/or seizure after injury/on admission related to this
             hospitalization

          6. Suspected or known pregnancy

          7. Known to be lactating

          8. Suspected or known prisoners

          9. Futile care

         10. Known current state of immunosuppression (i.e. on high dose steroids,
             chemotherapeutics, etc.)

         11. Unknown estimated time of injury 12). Patients wearing an "Opt Out" TAMPITI Study
             bracelet 13). Known presence of subarachnoid hemorrhage.

        14.) Isolated injuries to hands and/or feet (distal) 15.) Administration of
        antifibrinolytics pre-hospital and/or during this ED admission prior to enrollment
Safety and Efficacy of TOP1630 for Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: TOP1630 Ophthalmic Solution; Placebo to TOP1630 Ophthalmic Solution
Intervention description: Bilateral ocular drug administration; Bilateral ocular drug administration
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: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In subjects with Dry Eye Syndrome:

      The primary objective of this study is to compare the safety and tolerability of TOP1630
      Ophthalmic Solution to placebo.

      The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to
      placebo for the treatment of the signs and symptoms of dry eye syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a reported history of dry eye;

          -  Have a history of use of eye drops for dry eye symptoms;

        Additionally for Part 2

        Symptoms of dry eye syndrome including:

          -  Ocular discomfort

          -  Conjunctival redness

          -  Tear film break up time

          -  Schirmer test score

        Signs of dry eye syndrome including:

        Conjunctival staining score

        Exclusion Criteria:

          -  Have any clinically significant slit lamp findings at entry visit ;

          -  Be diagnosed with an ongoing ocular infection;

          -  Have any significant ocular lesion that could interfere with assessment of safety or
             efficacy or prevent study conduct in the opinion of the PI;

          -  Have any planned ocular and/or lid surgeries over the study period;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a known allergy and/or sensitivity to the test article or its components;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
Condition: Alzheimer's Disease; Dementia With Lewy Bodies; Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Alzheimer Disease; Dementia; Lewy Body Disease
Intervention: RVT-101 35 mg; Placebo
Intervention description: RVT-101 once daily, oral, 35-mg tablets; Placebo once daily, oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: RVT-101; intepirdine; Alzheimer's disease; Dementia with Lewy bodies; Lewy body dementia; Parkinson's Disease Dementia

Summary:

      This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in
      patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with
        Lewy bodies (DLB), or Parkinson's disease dementia (PDD).

        Mini Mental State Examination score 14 to 26 Gait impairment, as assessed by history
        gathered by the clinical investigator and quantitative measurements Subjects must be on
        stable background acetylcholinesterase inhibitor therapy

        Key Exclusion Criteria:

        History and/or evidence of any other CNS disorder that could be interpreted as a cause of
        dementia (in the opinion of the investigator) Any clinically relevant concomitant disease
        which, in the opinion of the investigator, makes the subject unsuitable for inclusion in
        the study.
A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
Condition: Pemphigoid, Bullous
MeSH terms: Pemphigoid, Bullous
Intervention: Mometasone furoate; AKST4290; Placebo
Intervention description: Topical mometasone furoate; Oral AKST4290; Oral placebo
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Autoimmune disease; Skin disease; Vesiculobullous

Summary:

      This study will evaluate the therapeutic effect and safety of adjunctive AKST4290 in subjects
      with bullous pemphigoid (BP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of mild to moderate BP at screening.

          -  Treatment naïve or initiation of whole-body high potency topical steroid treatment ≤ 7
             days of screening (lesion-only treatment for any amount of time with any topical
             steroids prior to screening is allowed without restriction).

          -  Provide a signed and dated informed consent form in accordance with local regulations
             and/or IRB/IEC guidelines.

        Exclusion Criteria:

          -  Severe BP.

          -  Initiation of gliptins and other treatments (e.g., etanercept, sulfasalazine,
             furosemide, penicillin) that can trigger BP if this treatment was started within 4
             weeks prior to screening and is considered possibly related to the onset of BP.

          -  Any concomitant medications in the last 3 months prior to screening and assessed by
             the investigator as possibly related to the development of BP.

          -  Planned use of intravenous immunoglobulin or other concomitant treatments for BP
             (i.e., doxycycline, dapsone) during the study period.

          -  Use of systemic immunosuppressants (i.e., mycophenolate, azathioprine, methotrexate)
             within 4 weeks prior to screening.

          -  Treatment with rituximab within 1 year prior to screening.

          -  Subjects taking warfarin.

          -  Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first
             dose of study agent or known diseases (other than BP) that could require the use of
             systemic steroids within the study period.

          -  Clinically relevant abnormal laboratory value at screening, including hematology,
             blood chemistry, or urinalysis (laboratory testing may be repeated once during the
             screening phase).

          -  Participation in studies of investigational drugs must have been discontinued within
             30 days or 5 half lives of the drug (whichever was longer) prior to screening.
Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Blood sample
Intervention description: Blood sample will be collected at Month 48, Month 60 and Month 72
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Zoster; vaccine; safety; immunogenicity

Summary:

      The subjects included in this study are subjects that participated in study NCT00434577.
      These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and
      Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for
      safety and immunogenicity.

      This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and
      safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

      The study visits will be scheduled at approximately one year intervals after the first visit
      in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be
      taken from all subjects at each visit. Information on safety and the occurrence of HZ will
      also be collected during these visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  Previous participation in study NCT00434577 as a member of the intermediate dose
             active vaccine group

          -  Written informed consent obtained from the subject

        Exclusion Criteria:

          -  Having participated in another study at any time after NCT00434577 study end in which
             the subject was exposed to an investigational or non-investigational product or;
             concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first blood draw

          -  Having received a vaccine containing some vaccine components, any time after study end
             of study NCT00434577

          -  Having received a vaccine against HZ any time after study end of study NCT00434577

          -  Subject who did not receive a complete vaccination course of 2 doses of the
             intermediate dose active vaccine in study NCT00434577
HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68-Ga RM2.; 68-Ga PSMA11; PET/MRI
Intervention description: PET radiopharmaceutical; PET radiopharmaceutical; PET/MR scanner by GE healthcare
Intervention MeSH terms: Gallium 68 PSMA-11; Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to determine whether the combination of imaging agents 68-Ga
      RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy
      than standard imaging or biopsy in patients with known prostate cancer (PC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age;

          -  Patients must be able to provide informed consent;

          -  Histologically proven low-grade or intermediate-grade prostate cancer (PC)

          -  Scheduled to undergo targeted local therapy (HDR brachytherapy).

        Exclusion Criteria:

          -  Inability to lie still for the entire imaging time;

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance;

          -  Metallic implants (contraindicated for MRI).
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Condition: Bladder Cancer; Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Renal Pelvis Carcinoma; Ureter Carcinoma; Urinary Bladder Carcinoma; Urethra Carcinoma; Muscle Invasive Bladder Cancer
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Intervention: Rucaparib
Intervention description: Rucaparib will be administered daily.
Intervention MeSH terms: Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PARP inhibitor; PARPi; HRD; ATLAS; homologous recombination; DNA repair; LOH; DNA defect; DNA anomaly; Rucaparib; MIBC

Summary:

      The purpose of the ATLAS study is to determine how patients with locally advanced
      unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed locally advanced unresectable or
             metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter,
             urinary bladder or urethra)

          -  Received 1 or 2 prior treatment regimens for advanced or metastatic disease

          -  Confirmed radiologic disease progression during or following recent treatment

          -  Mandatory biopsy is required during screening

          -  Measurable disease per RECIST v1.1

          -  Adequate organ function

          -  ECOG 0 or 1

        Exclusion Criteria:

          -  Prior treatment with a PARP inhibitor

          -  Symptomatic and/or untreated CNS metastases

          -  Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption
             of rucaparib
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
Condition: Colon Cancer; Rectal Cancer; Cancer Survivor; Colorectal Adenocarcinoma; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8
MeSH terms: Colorectal Neoplasms
Intervention: Dietary Intervention (resistant starch); Dietary Intervention (regular starch); Questionnaire Administration
Intervention description: Eat foods with resistant starch; Eat foods with regular corn starch; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded, block randomization based on sex and BMI.
Masking: Double (Participant, Investigator)
Masking description: Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Resistant Starch; Colorectal Cancer

Summary:

      This phase II, randomized pilot trial studies the effect of the consumption of foods made
      with resistant starch compared to foods made with corn starch on biomarkers that may be
      related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods
      made with resistant starch may beneficially influence markers of inflammation, insulin
      resistance, and the composition of gut bacteria in colorectal cancer survivors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal
             adenocarcinoma.

          -  Completed all treatment of colorectal adenocarcinoma within past 4-36 months.

          -  Current Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
             (per physician).

          -  Ability to consent and follow study protocol.

        Exclusion Criteria:

          -  Active cancer.

          -  Prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin
             [Hgb] A1c > 8.0).

          -  Active inflammatory bowel disease (i.e., patients who are symptomatic despite medical
             therapy). This includes irritable bowel syndrome, Crohn's disease, or any other
             inflammatory bowel disorder.

          -  Known food allergy/intolerances to wheat, gluten, dairy or eggs.

          -  Use of antibiotic(s) within the last 3 months prior to enrollment.

          -  Women who are pregnant and/or breastfeeding.

          -  Current body mass index (BMI) < 18.5 kg/m^2.

          -  Uncontrolled constipation.

          -  Inability to speak and fully understand English.
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: piclozotan; 0.9% sodium chloride (normal saline)
Intervention description: piclozotan, intravenous (IV) infusion; 0.9% sodium chloride (normal saline) intravenous (IV) infusion
Intervention MeSH terms: Piclozotan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; motor complications; dyskinesia; Motor complications associated with Parkinson's

Summary:

      The purpose of this study is to obtain preliminary information on the effect of piclozotan on
      motor complications associated with Parkinson's Disease.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Idiopathic Parkinson's disease for at least 5 years

          -  Presence of motor fluctuations and dyskinesia

          -  Stable regimen of levodopa/carbidopa for 30 days

          -  At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS)
             part III scores after dosing with regular Parkinson's disease (PD) medications

          -  Mini-Mental State Examination (MMSE) score of 25 or higher

        Main Exclusion Criteria:

          -  Atypical or secondary parkinsonism.

          -  Prior use of neuroleptic agents.

          -  History of intracranial procedures for PD.

          -  Active psychosis.

          -  History of drug or alcohol abuse in past 12 months.

          -  Cardiac conduction system abnormality.

          -  Predisposing medical condition that causes nausea or vomiting or routine use of an
             anti-emetic.