bioihbjkbjnl/mcl2 huggingface dataset:
An Expert System to Reduce Depression in Primary Care
Condition: Depression; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Computer-tailored intervention
Intervention description: Stage-based manual and three computer-tailored reports
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: depression; stage of change; intervention; randomized clinical trial; population-based; expert system

Summary:

      The purpose of this study is to determine whether a home-based intervention matched to stage
      of change (readiness) for using effective methods to prevent or reduce depression can improve
      depression outcomes in primary care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At risk for or experiencing depression (i.e., Beck Depression Inventory-II (BDI) score
             of 10 or higher; current major depression, minor depression, or dysthymia; or past
             major depression, minor depression, or dysthymia)

        Exclusion Criteria:

          -  Younger than age 18

          -  Involved in counseling or planning counseling in the next 30 days

          -  Taking antidepressant medication or planning to take antidepressants in the next 30
             days (exclusion criterion for Untreated Sample only)

          -  Suicidal ideation

          -  Severe depression (BDI > 28) and deemed inappropriate for study by site clinician

          -  BDI <10 and in the Maintenance stage for using effective methods to prevent or reduce
             depression

          -  History of bipolar disorder
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001 + QS-21; QS-21; Diluent: Phosphate Buffered Saline; ACC-001
Intervention description: IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52; IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52; IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52; IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active
      immunization, in subjects with mild to moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mild to moderate Alzheimer's disease

          -  Age 50-85

          -  Mini Mental State Examination (MMSE) 16-26 Other criteria apply

        Exclusion Criteria:

          -  Significant Neurological Disease

          -  Major psychiatric disorder

          -  Clinically significant systemic illness Other exclusion criteria apply.
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: ZPL-3893787; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects
      with moderate to severe psoriasis with a PASI score of at least 10. Following run-in,
      subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo
      once daily for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A documented history of moderate to severe plaque psoriasis for at least 6 months
             prior to screening.

          -  Male or female, aged ≥18 years.

          -  Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0.

          -  An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

          -  Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.

        Exclusion Criteria:

          -  Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail
             psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.

          -  Concurrent skin disease (e.g. acne) of such severity in the study area that it could
             interfere with the study evaluation or presence of skin comorbidities that may
             interfere with study assessments.

          -  Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent
             infections.

          -  Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3
             months of the start of the Run-In.

          -  Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.

          -  Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine,
             methotrexate) within 4 weeks of the start of the Run-In.

          -  Systemic corticosteroids within 4 weeks of the start of the Run-In.

          -  Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1
             week of the start of the Run-In.

          -  Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus,
             pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations,
             topical and oral retinoids and vitamin D derivatives, within 1 week of the start of
             the Run-In.
Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)
Condition: Arterial Stiffness; Vitamin K2 Deficiency
Intervention: Vitamin K2 (MK7)
Intervention MeSH terms: Vitamin K; Vitamin K 2
Phase: Phase 2
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:

      This study is a single arm, single center clinical trial that aims to evaluate the effect of
      8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in
      stable renal transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Functional renal graft

          -  Stable renal function for at least 3 months prior to enrollment

        Exclusion Criteria:

          -  History of thrombotic events

          -  Diagnosed coagulopathy

          -  Cardiovascular event in the past month prior to enrollment

          -  Current or planned pregnancy

          -  Lactation

          -  Soy allergy

          -  Concomitant or recent (past 6 months) use of supplements that contain vitamin K

          -  Warfarin treatment

          -  Known intestinal malabsorption or hypomotility syndromes
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Condition: Non-small Cell Lung Cancer; Mesothelioma; Lung Neoplasms
MeSH terms: Lung Neoplasms; Mesothelioma; Mesothelioma, Malignant
Intervention: pemetrexed
Intervention description: 500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer
      patients with fluid around their lungs or abdomen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
             lung cancer (NSCLC) or mesothelioma

          -  Presence of third-space fluid (fluid around the lungs or abdomen).

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1.

          -  Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior
             to study enrollment, and the patient must have recovered from the sharp toxic effects
             the anticancer treatment.

          -  Estimated life expectancy of at least 8 weeks.

        Exclusion Criteria:

          -  Have received treatment within the last 30 days with a drug that was not a marketed
             product.

          -  Active infection that, in the opinion of the investigator, would not allow the patient
             to tolerate therapy.

          -  Pregnancy.

          -  Breast-feeding.

          -  Significant weight loss (that is, greater than or equal to 10% of body weight) over
             the 6 weeks before study entry.

          -  Brain metastases.
Study Evaluating Bapineuzumab In Alzheimer Disease Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: bapineuzumab; bapineuzumab; placebo
Intervention description: 5 mg bapineuzumab subcutaneous injection once per week for 6 months; 10 mg bapineuzumab subcutaneous injection once per week for 6 months; Placebo subcutaneous injection once per week for 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: antibody; immunotherapy

Summary:

      The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of
      mild to moderate Alzheimer disease. Subjects will be in the study for six months and will
      receive subcutaneous injections once per week.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer Disease according to National Institute of
             Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related
             Disorders Association (NINCDS/ADRDA) criteria

          -  Mini-Mental State Examination (MMSE) score 16-26

        Exclusion Criteria:

          -  Magnetic Resonance Imaging (MRI) showing other brain abnormalities

          -  Other diagnosed neurological or psychiatric disorders
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Condition: Preterm Infants; Parenteral Nutrition n-3 Fatty Acids
MeSH terms: Premature Birth
Intervention: Lipofundin MCT/LCT 20 %; Lipidem 20%
Intervention description: daily i.v. infusion for up to 5 days; daily i.v. infusion for up to 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 5 Hours
Maximum age: 3 Days
Healthy volunteers: No
Keywords: n-3 Polyunsaturated Fatty Acids (PUFA); parenteral nutrition; preterm infant

Summary:

      The study shall provide evidence for the save and efficient use of a fish oil containing
      lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by
      monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed
      by monitoring of inflammatory parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  prematurity (birth weight 500 - 1500 g)

          -  postnatal age <= 72 h

          -  need for cumulative parenteral energy supply of at least 70% during study duration

          -  signed informed consent form

        Exclusion Criteria:

          -  simultaneous participation in another clinical study

          -  platelet count below 50000 /ml

          -  cumulative enteral energy supply of > 30 % during study duration

          -  serious congenital infections and/or diseases

          -  serious metabolic disturbances

          -  severe cranial bleeding (Papile III, IV)

          -  need for administration of blood products

          -  contra-indication for iv lipid administration

          -  withdrawal of consent
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Drotrecogin alfa (activated)
Intervention description: intravenous
Intervention MeSH terms: Drotrecogin alfa activated
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 486.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin
      alfa (activated) at the normal, approved dose and time of administration [24
      microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose
      or higher doses than the approved dose for a longer administration time. After the drug
      administration is complete, the protein C levels from the patients receiving the normal,
      approved dose will be compared to protein C levels from patients receiving the normal,
      approved dose or higher dose for a longer duration to determine if the protein C levels
      improve faster if given higher dose and/or longer administration time.

      Note: The protocol was amended to remove the option of shorter infusion durations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 years or older

          -  Must have a suspected or proven infection

          -  Must have two or more sepsis-associated organ dysfunctions

        Exclusion Criteria:

          -  Documented multiple organ dysfunction greater than 24 hours prior to start of study
             drug

          -  Actual body weight less than 30 kg or more than 135 kg

          -  Platelet count less than 30,000/mm^3

          -  Active internal bleeding or at increased risk of bleeding

          -  Not expected to survive 28 days given the patient's pre-existing uncorrectable medical
             condition
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: Fidaxomicin 200 mg; fecal microbiota transplantation (FMT)
Intervention description: Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.; Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles
Intervention MeSH terms: Fidaxomicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fecal microbiota transplantation; Fidaxomicin

Summary:

      Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from
      mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in
      treating severe and fulminant CDI. Current evidence suggests that FMT in combination with
      vancomycin is required, and that multiple treatments are necessary. The investigators think
      fidaxomicin may be a better option in the context and may potentially reduce the number of
      FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In
      this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to
      determine efficacy and safety in treating patients with severe or fulminant CDI. The
      investigators want to see if this approach may reduce the number of FMT treatment required,
      and/or the length of hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years with severe1 or fulminant2 CDI, without an adequate response to
             metronidazole IV 500 mg q8H and vancomycin 500 mg PO q6h for at least 2 days or after
             Fecal Microbiota Transplant (FMT). An adequate response is defined as a decrease in
             stool frequency or inflammatory markers (WBC or C reactive protein) by 10% over 48
             hours

          -  Those with ability to provide informed consent or an alternative decision maker
             providing assent

        Exclusion Criteria:

          -  Those with bowel perforation

          -  Those taking chemotherapy or radiation treatment with absolute neutrophil count of <
             1000 cells/mm3

          -  Those with known colonic strictures

          -  Those with subtotal colectomy or planning to have a colectomy

          -  Those with significant ileus
Crizanlizumab for Treating COVID-19 Vasculopathy
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Crizanlizumab; 0.9% saline
Intervention description: Crizanlizumab 5.0 mg/kg in 100 ml IV once.; 0.9% saline 100 ml IV once.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, randomized interventional trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronavirus

Summary:

      The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients
      hospitalized with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to provide written informed consent

          2. Willing to comply with all study procedures and be available for the duration of the
             study

          3. Male or female ≥ 18 years of age

          4. SARS-CoV-2 infection (COVID-19) within the past 10 d documented by laboratory test
             (nucleic acid test (NAT) or reverse transcriptase-polymerase chain reaction (RT-PCR))

          5. Currently hospitalized

          6. Symptoms of acute respiratory infection (at least one of the following: cough, fever >
             37.5°C, dyspnea, sore throat, anosmia),

          7. Radiographic evidence of pulmonary infiltrates

          8. Requiring supplemental oxygen or the peripheral capillary oxygenation saturation
             (SpO2) < 94% on room air at screening

          9. Elevated D-Dimer > 0.49 mg/L

         10. Negative pregnancy test for females of childbearing potential

        Exclusion Criteria:

          1. Use of home oxygen at baseline

          2. Current use of mechanical ventilation

          3. Inability to provide consent

          4. Do not intubate status

          5. Prisoner or incarcerated

          6. Pregnancy or Breast Feeding

          7. Participation in other interventional therapy trials for COVID-19.

          8. International normalized ratio (INR) > 3 or activated partial thromboplastin time
             (aPTT) > 60
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Standard radiotherapy; Capecitabine [Xeloda]
Intervention description: Administered as prescribed according to normal clinical practice.; 825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of treatment with Xeloda plus
      standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible
      participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for
      5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated
      time on study treatment is < 3 months, and the target sample size is < 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-80 years of age;

          -  rectal cancer;

          -  planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

        Exclusion Criteria:

          -  previous radiotherapy or chemotherapy for colorectal cancer;

          -  clinically significant cardiovascular disease;

          -  significant gastric or small intestine disease;

          -  serious uncontrolled active infection