bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell
Intervention: Daratumumab
Intervention description: Participants will receive daratumumab 16 mg/kg as intravenous infusion.
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the clinical efficacy and safety of daratumumab in
      relapsed or refractory natural killer/T-cell lymphomas (NKTCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented as histologically confirmed extranodal natural killer/T-cell lymphomas
             (NK/T)-cell lymphoma, nasal type according to the World Health Organization (WHO)
             classification and the pathology report will be verified by the Sponsor

          -  Failed at least 1 line of chemotherapy and who, according to treating physician or
             investigator, is not candidate to receive other treatment modalities

          -  At least 1 measurable site of disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 and
             life expectancy greater than or equal to (>=) 3 months

        Exclusion Criteria:

          -  Received daratumumab or other antiCD38 therapies previously

          -  Previous allogenic stem cell transplant or autologous stem cell transplantation within
             12 weeks before the first administration of the study drug

          -  Clinical symptoms of central nervous system involvement

          -  Known chronic obstructive pulmonary disease, known moderate or severe persistent
             asthma within the past 2 years, or uncontrolled asthma of any classification

          -  Clinically significant cardiac disease, including:Myocardial infarction within 6
             months before the first study agent administration, or unstable or uncontrolled
             disease/condition related to or affecting cardiac function (eg, unstable angina,
             congestive heart failure, New York Heart Association Class III-IV); Uncontrolled
             cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] [most
             recent version] Grade 3 or higher) or clinically significant ECG abnormalities;
             Screening 12-lead ECG showing a baseline QT interval as corrected QTc >470 msec

          -  Seropositive for human immunodeficiency virus

          -  Seropositive for hepatitis B or hepatitis C

          -  Abnormal laboratory values according to protocol defined parameters at screening
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Placebo; Sotagliflozin
Intervention description: Placebo, once daily, before the first meal of the day; Sotagliflozin,once daily, before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to define the dose leading to desirable efficacy, as
      measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had given written informed consent to participate in the study in
             accordance with local regulations.

          -  Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus
             (T1D) made at least 1 year prior to informed consent.

          -  Participants were being treated with insulin or insulin analog delivered via
             continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).

          -  At the Screening Visit, A1C had to be between 7.0% and 10.0%.

          -  Females of childbearing potential had to use an adequate method of contraception and
             have a negative pregnancy test.

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             screening.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
             Investigator.
A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue
Condition: Leukemia; CLL
MeSH terms: Leukemia; Dyssomnias; Parasomnias
Intervention: Lenalidomide
Intervention description: 5 mg daily for 56 days.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Lenalidomide; Actigraph; Sleep Test Study; Chronic Lymphocytic Leukemia; CC-5013; Revlimid

Summary:

      The goal of this clinical research study is to learn if treatments to kill cancer cells
      including lenalidomide and/or radiation therapy can help to control symptoms such as sleep
      problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Describe fatigue as being present every day for most of day for a minimum of 2 weeks
             and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue
             and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).

          2. Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer
             receiving new cytotoxic or radiation therapy

          3. Patients will be eligible to participate in this study if they rate sleep disturbance
             greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present
             and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.

          4. Have a MDAS of 13 or less.

          5. Able to understand the description of the study and give written informed consent.

        Exclusion Criteria:

          1. Patients who are unable to complete the assessment measures or refuse to participate

          2. Patients with known history of brain metastasis.

          3. Patients with known history of sleep apnea.
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: PF-04457845; Placebo
Intervention description: Study medication will be administered at 4mg by mouth daily for four weeks.; Sugar pill
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Cannabis dependence is associated with changes in the brain's cannabinoid system. When
      cannabis dependent individuals try to quit using cannabis, some of them experience problems
      that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the
      problems related to quitting cannabis may facilitate abstinence. One way to do this is by
      harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.
      One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the
      problems related to quitting cannabis use will be reduced by increasing the brain levels of
      anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will
      be less likely to relapse. Brain anandamide levels will be increased by blocking the
      breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of
      a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied
      in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent
      subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The
      trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient
      treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis
      use and urinary THC-COOH levels will be measured during the entire study. The treatment phase
      will be followed by a safety follow up phase of 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male

          2. Ages 18-55 (inclusive)

          3. Cannabis Dependence

        Exclusion Criteria:

          1. Allergies or intolerance to FAAH-Inhibitors

          2. Current significant medical or other comorbidities
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: NBI-98854
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, rollover study to collect long-term safety, tolerability, and
      investigator- and participant-reported pharmacodynamic (PD) data after chronic administration
      of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide
      open-label access to NBI-98854 for the treatment of TS for pediatric participants who have
      taken part in a Phase 2 NBI-98854 study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies

          3. If using maintenance medication(s) for TS and/or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          4. Be in good general health

          5. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month
             before screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7
             days, before the start of the study

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse within
             3 months before the start of the study

          8. Have a significant risk of suicidal or violent behavior

          9. Have received an investigational drug within 30 days before the start of the study or
             plan to use an investigational drug (other than NBI-98854) during the study

         10. Are currently participating in another NBI-98854 clinical study

         11. Are pregnant (for females)
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo oral capsule; NYX-783
Intervention description: Matching placebo capsules.; NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive placebo or NYX-783.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic
      Stress Disorder population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A primary diagnosis of PTSD [Post Traumatic Stress Disorder, according to DSM-5
             (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic
             event occurring ≥12 months prior to screening.

          -  PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.

          -  CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

        Exclusion Criteria:

          -  Complex PTSD.

          -  Trauma focused psychotherapies.

          -  Primary traumatic event occurred prior to 2001.

          -  Primary traumatic event was followed by further major traumatic life episodes.

          -  Other psychiatric disorders that is the primary focus of treatment or
             followed/worsened since exposure to the trauma (except for major depressive disorder
             or anxiety disorders that followed exposure to the trauma or an anxiety disorder that
             showed a worsening after trauma)

          -  Current use of medications with primarily central nervous system activities

          -  Other clinically significant medical histories that may interfere with completing the
             study.
Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)
Condition: Advanced Cancers
MeSH terms: Neoplasms
Intervention: Ridaforolimus Tablet; Ridaforolimus Intravenous (IV) Infusion
Intervention description: Ridaforolimus 10 mg oral tablet; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Intervention MeSH terms: Sirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for
      whom a clinical benefit has been established in a prior parent trial (MK-8669-013,
      NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or
      in those who remain in long-term follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have participated on a deforolimus (ridaforolimus) parent trial

          -  Must have derived a clinical benefit from the parent trial

          -  Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the
             parent protocol

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
             if the participant is scheduled to receive treatment with deforolimus; no requirement
             if the participant is included for follow-up purposes only

          -  Participant of childbearing potential must have a negative pregnancy test within 7
             days prior to screening and must use approved contraceptive from screening until 30
             days after the last dose of study drug

          -  Signed informed consent

        Exclusion Criteria:

          -  Has not participated on a parent trial

          -  Women who are to receive study drug who are pregnant or lactating

          -  Any condition in the Investigator's judgment that renders the participant unable to
             fully understand and provide informed consent and/or comply with the protocol
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Sagramostim; Saline -- placebo comparator
Intervention description: 5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs; subcutaneous injection
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; neuropsychological assessment; Granulocyte-Macrophage Colony-Stimulating Factor; Leukine

Summary:

      A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested
      for its ability to be tolerated by Alzheimer's disease patients and potentially to improve
      their memory.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 55 to 85 years;

          2. should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);

          3. should have evidence of elevated cortical amyloid by PET using florbetapir F18
             (Amyvid) [i.e. a positive scan], assessed qualitatively according to the Amyvid
             product label.

          4. if on anti-dementia treatment should be on stable treatment for at least 2 months
             (i.e. cholinesterase inhibitor and/or Memantine or Axona);

          5. stable on all other medications for at least 30 days prior to screen;

          6. should be fluent in English;

          7. should be physically able to participate by medical history, clinical exam and tests;

          8. should have a study partner to accompany them to scheduled visits.

        Exclusion Criteria:

          1. clinically relevant arrhythmias;

          2. a resting pulse less than 50;

          3. active cancer other than non-melanoma skin cancers;

          4. use of another investigatory drug within 2 months of screening;

          5. significant stroke or head trauma by history or MRI;

          6. contraindication for having a MRI;

          7. diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major
             psychiatric disorder;

          8. sensitivity to yeast or yeast products;

          9. impaired kidney function as measured by a Glomerular Filtration Rate less than 60
             milliliters/min;

         10. preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;

         11. history of moderate-to-severe lung disease;

         12. history of moderate-to-severe liver disease;

         13. pregnant women, or any women who feel they are likely to become pregnant during the
             study;

         14. prisoners.
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Condition: COVID-19 Pulmonary Complications; COVID-19
MeSH terms: COVID-19
Intervention: Zanubrutinib; Supportive Care; Placebo
Intervention description: 320 mg (4 x 80 mg) capsules administered orally once daily; Supportive care treatment was selected and administered as deemed appropriate by the study investigator; Placebo to match zanubrutinib
Intervention MeSH terms: Zanubrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Corona Virus; COVID-19

Summary:

      The primary objective of this study was to evaluate if the addition of zanubrutinib to
      supportive care increases the respiratory failure-free survival rate at Day 28 in
      participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not
      receiving mechanical ventilation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Hospitalization for COVID-19 infection

          2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
             polymerase chain reaction (PCR)

          3. Participant requires supplemental oxygen for pulmonary distress related to COVID-19
             infection, and has been on supplemental oxygen for no more than 96 hours from time of
             screening

        Key Exclusion Criteria:

          1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease or
             ulcerative colitis, or partial or complete bowel obstruction

          2. On a Bruton's tyrosine kinase (BTK) inhibitor

          3. Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20
             monoclonal antibody treatment

          4. Participants with prior of current hematologic malignancy or solid tumor malignancy
             with treatment within 6 months prior to study entry

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Rollover Protocol of Dacomitinib For Patients In Japan
Condition: NSCLC
Intervention: Dacomitinib
Intervention description: Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study to permit continued access to dacomitinib for patients who
      participated in other dacomitinib monotherapy treatment protocols in Japan and have the
      potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who received dacomitinib on another clinical trial in Japan

          -  Evidence of a personally signed and dated informed consent document

        Exclusion Criteria:

          -  Patients who meet one or more study withdrawal criteria on the prior study

          -  Participation in other studies involving other investigational drug(s) during study
             participation