bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Intervention: Trans-Sodium Crocetinate; Placebo
Intervention description: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.; The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Intervention MeSH terms: Trans-sodium crocetinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomized, placebo-controlled, double-blind, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: TSC injections will be prepared and injected by unblinded personnel on each ambulance. All other study personnel will be blinded
Enrollment: 6.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will assess the potential efficacy and safety of TSC as early treatment for both
      ischemic and hemorrhagic stroke when administered while subject is in ambulance being
      transported to hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 40-85, inclusive

          2. Last known well time 15-120 minutes before anticipated study drug injection

          3. Suspected stroke identified by the LAPSS

          4. Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher

          5. No seizure

        Exclusion Criteria:

          1. Coma

          2. Rapidly improving neurologic deficit

          3. History of seizures or epilepsy

          4. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound
             the neurological or functional outcome evaluations

          5. SBP < 90 or > 220

          6. Major head trauma in the last 24 hours

          7. Recent stroke within 30 days

          8. Known to be pregnant or lactating
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Condition: Urinary Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Intervention: Nivolumab; BCG; BMS-986205
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder Cancer; BCG-unresponsive; Nivolumab; Intravesical BCG; NMIBC; Non-Muscle Invasive; BMS-986205; CheckMate 9UT

Summary:

      A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205
      with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing
             high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without
             papillary component

          -  Participants must have CIS to be eligible.

          -  Predominant histologic component (> 50%) must be urothelial (transitional cell)
             carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

        Exclusion Criteria:

          -  Sign of locally advanced disease or metastatic bladder cancer

          -  Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting
             systems, ureters) within 24 months of enrollment

          -  Prior immuno-oncology therapy

        Other protocol-defined inclusion/exclusion criteria apply
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Intervention: DUR-928 30 mg; DUR-928 90 mg; DUR-928 150 mg
Intervention description: Lowest dose of 3 dose escalation arms.; Middle dose of 3 dose escalation arms.; Highest dose of 3 dose escalation arms.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Staggered parallel design.
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Alcoholic Hepatitis; acute alcoholic liver disease; progressive inflammatory liver injury; IV infusion

Summary:

      This is a research trial testing DUR-928 (an experimental medication). The purpose of this
      trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928
      in patients with moderate and severe alcoholic hepatitis (AH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide written informed consent (either from patient or patient's legally
             acceptable representative)

          2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2

          3. Patients with alcoholic hepatitis defined as:

               1. History of heavy alcohol abuse: > 40 g/day in females or > 60 g/day in males for
                  a minimum period of 6 months, AND

               2. Consumed alcohol within 12 weeks of entry into the study, AND

               3. Serum bilirubin > 3 mg/dL AND AST > ALT, but less than 300 U/L AND

               4. MELD score between 11-30, inclusive

          4. No evidence of active infection as determined by the investigator.

          5. Women of child-bearing potential must utilize appropriate birth control throughout the
             study duration.

          6. Male patients must agree to use a medically acceptable method of contraception/birth
             control throughout the study duration

        Exclusion Criteria:

          1. Other or concomitant cause(s) of liver disease as a result of:

               1. Autoimmune liver disease

               2. Wilson disease

               3. Vascular liver disease

               4. Drug induced liver disease

          2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B

          3. Any active malignancies other than curatively treated skin cancer (basal cell or
             squamous cell carcinomas)

          4. If female, known pregnancy, or has a positive serum pregnancy test, or
             lactating/breastfeeding

          5. Serum creatinine > 2.5 mg/dL

          6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone
             marrow, or stem cell etc.), other than cornea transplant

          7. Stage 3 or greater encephalopathy by West Haven criteria
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Condition: Neoplasm, Gastrointestinal
MeSH terms: Adenocarcinoma; Gastrointestinal Neoplasms; Digestive System Neoplasms
Intervention: DS-8201a; Physician's Choice
Intervention description: DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.; Either:
Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted)
Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted)
Intervention MeSH terms: Trastuzumab deruxtecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized investigative arms will run in parallel (DS-8201a and Physician's Choice), with participants who have disease progression after two previous regimens.
Two non-randomized exploratory arms will run with HER2 treatment-naive participants.
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Adenocarcinoma Metastatic; Adenocarcinoma of the Stomach; Adenocarcinoma of the Gastroesophageal Junction; HER2 Overexpression; Adenocarcinoma, Locally Advanced; DESTINY - Gastric 01

Summary:

      The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and
      physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal
      junction adenocarcinoma patients who have progressed on two prior treatment regimens
      including fluoropyrimidine agent, platinum agent, and trastuzumab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of
             gastric or gastroesophageal junction

          2. Progression on and after at least 2 prior regimens

          3. Has an adequate tumor sample

          4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST)
             version 1.1

        Exclusion Criteria:

          1. Has a medical history of myocardial infarction, symptomatic congestive heart failure
             (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia

          2. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females

          3. Has a medical history of clinically significant lung disease

          4. Is suspected to have certain other protocol-defined diseases based on imaging at
             screening period

          5. Has history of any disease, metastatic condition, drug/medication use or other
             condition that might, per protocol or in the opinion of the investigator, compromise:

               1. safety or well-being of the participant or offspring

               2. safety of study staff

               3. analysis of results
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Marijuana blunt; marijuana cigarette
Intervention description: Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).; Marijuana cigarettes were provided by the National Institute on Drug Abuse.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Marijuana; Comparison between joints and blunts; Pharmacokinetic effects

Summary:

      The purpose of this study is to investigate whether or not marijuana blunts will produce
      comparable plasma THC levels as marijuana joints and if blunts will produce larger
      cardiovascular and subjective effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current blunt marijuana use (minimum of twice/week) drug screen

          -  21-45 years of age

          -  Practicing an effective form of birth control (condoms, diaphragm, birth control pill,
             IUD)

        Exclusion Criteria:

          -  Current, repeated illicit drug use(excluding marijuana)

          -  Heavy cigarette use (> 10 cigarettes/day)

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
             hypertension)

          -  Laboratory tests outside normal limits that are clinically unacceptable to the study
             physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)

          -  Significant adverse reaction to marijuana

          -  Current parole or probation

          -  Pregnancy or current lactation

          -  History of significant violent behavior

          -  Major current Axis I psychopathology(e.g., mood disorder with functional impairment or
             suicide risk, anxiety disorder, schizophrenia)

          -  History of heart disease

          -  Current use of any over-the-counter or prescription
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: TDF; Vesatolimod; Placebo
Intervention description: 300 mg tablets administered orally once daily; Tablets administered orally once a week (every 7 days) for 12 doses; Placebo administered orally once a week (every 7 days) for 12 doses
Intervention MeSH terms: Vesatolimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HBV; Hepatitis; Liver Disease

Summary:

      The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
      of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are
      currently not being treated.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adult males or females between the ages of 18-65

          -  Chronic hepatitis B virus (HBV) infection

          -  HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening

        Key Exclusion Criteria:

          -  Extensive bridging fibrosis or cirrhosis

          -  Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators
             or biologics within 3 months of screening

          -  Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or
             hepatitis D virus (HDV)

          -  Chronic liver disease other than HBV

          -  Lactating or pregnant females or those that wish to become pregnant during the course
             of the study

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Intervention: Levetiracetam 62.5mg; Levetiracetam 125mg; Levetiracetam 250mg; Placebo
Intervention description: 62.5mg twice daily (2 weeks); 125mg twice daily (2 weeks); 250mg twice daily (2 weeks); placebo capsule twice daily (2 weeks)
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mild Cognitive Impairment; Amnestic Mild Cognitive Impairment; Functional Magnetic Resonance Imaging; Levetiracetam; Keppra; Medial Temporal Lobe; Memory Impairment; Alzheimer's Disease; AD

Summary:

      This research is being done to find out if daily use of the drug levetiracetam can improve
      memory function in individuals with memory problems like those associated with Mild Cognitive
      Impairment (MCI) and Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All: English as a first language; right handed; able to complete written informed
             consent.

          -  MCI subjects: In addition to above, must meet criteria for amnestic Mild Cognitive
             Impairment (MCI). This includes a memory complaint corroborated by an informant;
             impaired memory function for age and educational level; preserved general cognitive
             function; intact abilities of daily living; no clinical dementia.

          -  Age matched Controls: Must have memory and cognitive status that is normal for their
             age.

        Exclusion Criteria:

          -  Familial Alzheimer's Disease (AD) due to known genetic mutations

          -  AD with Parkinsonian features; major psychiatric or behavioral disorders (e.g.
             depression, agitation, psychosis, manic-depressive disorder)

          -  Primary or metastatic intracranial neoplasm

          -  History of severe head trauma

          -  Intra-cerebral hemorrhage

          -  Seizure disorder

          -  Hemispheric stroke

          -  Presence of a progressive central nervous system disease

          -  Presence of lacunar infarcts

          -  Medical contraindications to MRI including cardiac pacemaker, presence of intraocular
             or intracranial metallic objects

          -  Any known allergy to levetiracetam or behavioral problems that are a contraindication
             to taking Levetiracetam (e.g. agitation)

          -  Prescribed use of anti-seizure medications.
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Condition: Depressive Disorder; Depression; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorder; Pregnancy Complications; Postpartum Blues; PPD; Postpartum Disorder
MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms
Intervention: Ganaxolone; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Postpartum Care; Postpartum Depression

Summary:

      A clinical study to evaluate safety, tolerability and efficacy of oral administration of
      ganaxolone in women with postpartum depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Experiencing a major depressive episode, which started between the start of the third
             trimester and 4 weeks following delivery. The major depressive episode must be
             diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0
             interview

          -  Given birth in the last 6 months

          -  HAMD17 score of ≥ 20 at screening but < 26

          -  Must agree to stop breastfeeding from start of study treatment or must agree to
             temporarily cease giving breast milk to her infant(s)

        Exclusion Criteria:

          -  Current history of any psychotic illness, including major depressive episode with
             psychotic features

          -  History of suicide attempt within the past 3 years

          -  History of bipolar I disorder

          -  History of seizure discorder
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Intervention description: Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic hepatitis B

Summary:

      A prospective, randomised, open-label phase IIb clinical trial assessing the effect of
      pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing
      nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

      The primary objective of the trial is to investigate whether the add-on of pegylated
      interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the
      percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48
      weeks.

      170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an
      oral antiviral regimen and having a nondetectable viral load for at least 12 months are
      included.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis B, HBe antigen negative

          -  treatment with a stable oral antiviral treatment (not containing telbivudine) and a
             fully suppressed viral load for at least 12 months (below limit of detection in
             conventional HBV-PCR assays, i.e. <116 IU / ml).

          -  18-70 ys

          -  willingness and ability to give informed consent and to follow study procedures

          -  willingness to use adequate contraception

        Exclusion Criteria:

          -  contraindications against treatment with pegylated interferon, e.g. depression,
             uncontrolled epilepsy, autoimmune diseases, pregnancy, leukocytopenia or
             thrombocytopenia at screening, etc.

          -  active alcohol or drug abuse

          -  preexisting polyneuropathy