bioihbjkbjnl/mcl2 huggingface dataset:
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Condition: Diarrhea-Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Glutamine
Intervention description: Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Glutamine; Intestinal Permeability

Summary:

      New and effective treatments are needed for patients with post-infectious irritable bowel
      syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy
      and safety of glutamine, an abundant amino acid in the body and the principal fuel for
      enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with
      increased intestinal permeability following an enteric infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and women age 18-72 years old who developed post-infectious diarrhea-predominant
             IBS (D-IBS)

          -  increased intestinal permeability on Lactulose/Mannitol permeability test

          -  able and willing to cooperate with the study

          -  *absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and
             throughout the study duration

        Exclusion Criteria:

          -  current participation in another research protocol or unable to give informed consent

          -  women with a positive urine pregnancy test or breastfeeding

          -  history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue

          -  + hydrogen breath test for bacterial overgrowth

          -  + antiendomysial antibody titer

          -  use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study

          -  known allergy to glutamine

          -  abdominal surgery except for removal of gallbladder, uterus, or appendix

          -  Abnormal blood urea nitrogen(BUN) and/or creatinine
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DSXS topical
Intervention description: topical treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following
      Treatment with DSXS in Patients with Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent/legal guardian has signed informed consent form, which meets all criteria of
             current FDA regulations.

        Exclusion Criteria:

          -  Females who are pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child-bearing potential and sexually active and not prepared to
             use appropriate contraceptive methods to avoid pregnancy
Study Of Ispinesib In Subjects With Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: Ispinesib
Intervention description: Given intravenously at a dose of 18 milligram (mg)/ meter square (m^2).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer

Summary:

      The purpose of this research study is to find how breast cancer responds to the
      investigational drug, Ispinesib. An investigational drug is a drug that has not been approved
      by the Food and Drug Administration (FDA) and is available for research use only. In
      particular, this study will try is to find the answers to the following research questions:

        1. Does breast cancer respond to Ispinesib?

        2. What are the side effects of Ispinesib?

        3. How much Ispinesib is in the blood at specific times after it is taken?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB or Stage IV breast cancer

          -  Previously received anthracycline and taxane therapy

        Exclusion criteria:

          -  Actively receiving anti-cancer therapy agent(s).
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Drug: SHR0302
Intervention description: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel,
      multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment
      for patients with moderate to severe atopic dermatitis.

      The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will
      be compared to placebo and improvement in atopic dermatitis will be assessed using the
      Investigator's Global Score (IGA)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18-75 years of age (inclusive), male or female, at the time of
             informed consent

          -  Moderate to severe atopic dermatitis

          -  Capable of providing a signed and dated informed consent form indicating the subject
             has been informed of all pertinent aspect of the study

        Exclusion Criteria:

          -  Subjects with historical or current evidence of clinically significant cardiovascular,
             neurological, psychiatric, renal, hepatic, immunological, gastrointestinal,
             urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including
             uncontrolled diabetes or thyroid disease) or hematological abnormalities that are
             uncontrolled. Significant is defined as any disease that, in the opinion of the
             Investigator, would put the safety of the subject at risk through participation, or
             which would affect the efficacy or safety analysis if the disease/condition
             exacerbated during the study

          -  Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus
             erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the
             evaluation of atopic dermatitis

          -  Subject has a severe comorbidity that may require systemic steroids therapy or other
             interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Donanemab; Placebo; LY3202626
Intervention description: Administered IV; Administered IV; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: TRAILBLAZER-ALZ

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813
      in early symptomatic Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gradual and progressive change in memory function reported by participants or
             informants for ≥ 6 months.

          -  MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical
             flortaucipir PET scan within 6 months prior to baseline that meets the central read
             criteria.

          -  Meet 18F flortaucipir PET scan eligibility criteria.

          -  Meet 18F florbetapir PET scan (central read) eligibility criteria.

        Exclusion Criteria:

          -  Have a history of long QT syndrome.

          -  Have received treatment with a stable dose of an acetylcholinesterase inhibitor
             (AChEI) and/or memantine for less than 2 months before randomization.

          -  Contraindication to MRI.
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms
Condition: Menopause; Hot Flashes; Night Waking
MeSH terms: Hot Flashes
Intervention: Elinzanetant (BAY3427080); Placebo
Intervention description: BAY3427080 capsules; Placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken
      once a day, in the treatment of troublesome post-menopausal symptoms.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Postmenopausal

          -  Body mass index between 18 and 38 kg/m2, inclusive

          -  Subject experiences moderate or severe hot flashes

        Key Exclusion Criteria:

          -  Inability to comply with the use of prohibited and allowed medications as described in
             the protocol.

          -  Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12
             months of Screening.

          -  Any clinically significant prior or ongoing history of arrhythmias, either determined
             through clinical history or on ECG evaluation.

          -  Any clinically significant abnormal laboratory test result(s) measured at Screening.

          -  Any active ongoing condition that could have caused difficulty in interpreting
             vasomotor symptoms.

          -  Uncontrolled hypertension.

          -  A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at
             Screening. Treated hypothyroidism with normal thyroid function test results at
             Screening is acceptable.
Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Etanercept; Placebo
Intervention description: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week; Hemodialysis patients will receive Saline by subcutaneous injection twice a week
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double Blind Study
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: etanercept; malnutrition; inflammation; hemodialysis

Summary:

      Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid
      arthritis. We are examining whether Etanercept is effective in improving the nutritional
      status of hemodialysis patients as a consequence of its ability to decrease inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of end stage renal disease

        Exclusion Criteria:

          -  History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within
             previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus
             erythematosis, presence of transcutaneous access (external catheter)
Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%
Condition: Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Capmatinib; Pembrolizumab
Intervention description: INC280 tablets were administered orally at 400 mg on a continuous twice daily (BID) dosing schedule, from Day 1 until Day 21 of each 21-day cycle.; Pembrolizumab was administered by intravenous infusion at 200 mg once every 3 weeks (Q3W).
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capmatinib; pembrolizumab; NSCLC; PD-L1; EGFR; ALK; MET,; squamous; non-squamous

Summary:

      The purpose was to evaluate the efficacy and safety of the combination of capmatinib with
      pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with
      locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR
      mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when
      combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET
      dysregulation. The combination of capmatinib with checkpoint inhibitors has been established
      to be tolerable and could provide additional clinical benefit to the subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed and documented locally advanced stage III (not candidates for
             surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per
             AJCC/IASLC v.8) for treatment in the first-line setting

          -  Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild
             type status and ALK- negative rearrangement statu

          -  Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1
             expression (TPS ≥ 50%)

          -  ECOG performance status score ≤ 1

          -  Have at least 1 measurable lesion by RECIST 1.1

          -  Have adequate organ function

        Exclusion Criteria:

          -  Prior treatment with a MET inhibitor or HGF-targeting therapy

          -  Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell co-stimulation or immune
             checkpoint pathways)

          -  Have untreated symptomatic central nervous system (CNS) metastases

          -  Clinically significant, uncontrolled heart diseases

          -  Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study
             treatment
A Pilot Study of TRV130 for the Treatment of Fracture Pain
Condition: Pain
MeSH terms: Fractures, Bone
Intervention: TRV130
Intervention description: Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Long bone; Fracture

Summary:

      The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe
      acute pain in patients presenting to the emergency department (ED) with a suspected/known,
      unilateral, closed long bone fracture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years, inclusive

          -  Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both)
             OR tibia, fibula (or both) BUT not fractures in more than 1 extremity

          -  Able to understand and comply with study procedures and requirements, and provide
             written informed consent

        Exclusion Criteria:

          -  Significant concomitant head, chest, or abdominal trauma

          -  Multiple extremity trauma

          -  Open fracture

          -  Clinically significant medical condition or history of such condition that may place
             the patient at an unacceptable risk in the trial, may interfere with the
             interpretation of efficacy, safety, or tolerability data obtained in the trial, or may
             interfere with the absorption, distribution, metabolism, or excretion of drugs
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: ACP-196; Nab-paclitaxel; Gemcitabine
Intervention description: ACP-196 capsule; Nab-paclitaxel infusion; Gemcitabine infusion
Intervention MeSH terms: Paclitaxel; Gemcitabine; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acalabrutinib

Summary:

      To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects
      with previously untreated metastatic pancreatic cancer using standard response criteria
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  ECOG performance status of 0 or 1.

          -  Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.

          -  No previous radiotherapy, chemotherapy or investigational therapy for the treatment of
             metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a
             radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months
             have elapsed since completion of the last dose and no lingering toxicities are
             present.

        Exclusion Criteria:

          -  Prior malignancy (other than pancreatic cancer), except for adequately treated basal
             cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which
             the subject has been disease free for ≥ 2 years or which will not limit survival to <
             2 years.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction, or gastric restrictions and bariatric surgery,
             such as gastric bypass.

          -  Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with
             endobiliary stents may participate as long the enrollment criterion relating to serum
             bilirubin concentration is met.

          -  Breastfeeding or pregnant
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Lymphoseek; Single Photon Emission Computed Tomography (SPECT); Indocyanine Green (ICG); Neoprobe Gamma Detection System NPB11L(Model1102)
Intervention description: Radioactive diagnostic agent; Imaging test; Cyanine dye used in medical diagnostics manufactured by Akorn Inc.; Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce
      additional surgical dissection that is needed in case a sentinel lymph node cannot be
      detected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has histological diagnosis of cancer of the endometrium of any histology
             or grade.

          -  The patient should have received no prior treatment for her endometrial cancer.

          -  The patient has clinically uterine confined disease.

          -  The patient is a candidate for minimal invasive surgery, with sentinel lymph node
             assessment with IC-GREEN planned as part of standard of care.

          -  The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2.

          -  If age less than or equal to 55 years, the patient has a negative pregnancy test
             within 72 hours before administration of Lymphoseek, has been surgically sterilized,
             or has been postmenopausal for at least 1 year.

          -  The patient has provided written informed consent.

          -  The patient is at least 18 years of age at the time of consent

        Exclusion Criteria:

          -  The patient has clinical or radiological evidence of metastatic disease.

          -  The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or
             cone procedure performed on her cervix.

          -  The patient has participated in another investigational drug study within 30 days of
             scheduled surgery.

          -  The patient has an iodine allergy.

          -  The patient is pregnant or lactating.