bioihbjkbjnl/mcl2 huggingface dataset:
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Condition: Hepatic Cirrhosis; Hepatic Encephalopathy (HE)
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Intervention: MNK6106; Rifaximin
Intervention description: 1 gram tablet of MNK6106 for oral administration; 550 mg tablet of rifaximin for oral administration
Intervention MeSH terms: Rifaximin; Phenylacetic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main reason for this study is to see how the study drug interacts with the body.

      It will compare different doses of the study drug with a drug already in use.

      Participants will be adults with liver disease that has affected the brain in the past.
    

Eligibility criteria:

        Key Inclusion Criteria:

        A potential participant may only be included if (at screening), he/she:

          1. Understands the study and has signed informed consent

          2. Is an adult, not pregnant or lactating

          3. Has cirrhosis of the liver

          4. Has had 1 instance of HE within 12 months

          5. Has hyperammonaemia defined as ≥37 μmol/L at screening

        Key Exclusion Criteria:

        A potential participant will be excluded if (at screening), he/she:

          1. Has contraindicated allergies

          2. Expects liver transplant within 1 month

          3. Has had a liver shunt within the last 3 months

          4. Has inadequate kidney, gastrointestinal, or cardiac function

          5. Has cancer, infection, lab abnormalities, or any other condition that, per protocol or
             in the opinion of the investigator might compromise:

               1. the safety and well-being of the participant or potential offspring

               2. the safety of study staff

               3. the analysis of results
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: BMS-986036; BMS-986036; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: First Line Therapy; NASH

Summary:

      The purpose of this study is to determine whether BMS-986036 is effective in the treatment of
      subjects with Non-alcoholic Steatohepatitis (NASH).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female between 21 and 75 years old

          -  Body Mass Index (BMI) of 25 or more

        Exclusion Criteria:

          -  Chronic Liver disease other than NASH

          -  Uncontrolled diabetes

          -  Any major surgery within 6 weeks of screening

          -  Unable to self-administer under the skin injections

          -  Any bone trauma, fracture or bone surgery within 8 weeks of screening
Safety and Dose Finding Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: NS-065/NCNP-01; 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: 16.0
Sex: Male
Minimum age: 4 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to evaluate the safety of a high (80mg/kg) and low
      (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with
      Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives
      include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male ≥ 4 years and <10 years of age

          -  Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon
             53 to restore the dystrophin mRNA reading frame;

          -  Able to walk independently without assistive devices;

          -  Ability to complete the time to stand, time to run/walk and time to climb assessments;

          -  Stable dose of glucocorticoid for at least 3 months

        Exclusion Criteria:

          -  Acute illness within 4 weeks prior to the first dose of study medication;

          -  Evidence of symptomatic cardiomyopathy. [Note: Asymptomatic cardiac abnormality on
             investigation would not be exclusionary];

          -  Severe allergy or hypersensitivity to medications;

          -  Severe behavioral or cognitive problems that preclude participation in the study, in
             the opinion of the Investigator;

          -  Previous or ongoing medical condition, medical history, physical findings or
             laboratory abnormalities that could affect safety, make it unlikely that treatment and
             follow-up will be correctly completed or impair the assessment of study results, in
             the opinion of the Investigator;

          -  Patient is taking any other investigational drug currently or within 3 months prior to
             the start of study treatment; or

          -  Patient has had surgery within the 3 months prior to the first anticipated
             administration of study medication or surgery is planned for anytime during the
             duration of the study;

          -  Patient has previously participated in this study or any other study during which
             NS-065/NCNP-01 was administered.
Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
Condition: Leiomyoma
MeSH terms: Leiomyoma
Intervention: Superior hypogastric nerve block; 0.75% Ropivacaine; Subcutaneous injection; 1% Xylocaine
Intervention description: 21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.; 20 ml of 0.75% Ropivacaine; Injection into subcutaneous tissues in periumbilical region; 5ml of 1% Xylocaine
Intervention MeSH terms: Lidocaine; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 44.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: embolization; analgesia

Summary:

      Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However
      the procedure is often very painful and, in many centres, patients are admitted overnight
      with patient controlled analgesic (PCA) pumps for pain control and discharged the next day
      with heavy pain medications. The goal of this study is to evaluate the effectiveness of a
      superior hypogastric nerve block (SHGNB) in controlling the pain post-UFE.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All women with symptomatic fibroids or adenomyosis that have requested and been
             approved for uterine artery embolization

          2. Ability to comply with the requirements of the study procedures

        Exclusion Criteria:

          1. Patients in whom the vascular anatomy prevents access to the superior hypogastric
             nerve plexus safely

          2. Patients who have known allergy to the anesthetic agent

          3. Patients with signs of skin infection at the entry site of the needle used to place
             the nerve block

          4. Patients with signs of infection such as fever

          5. Patients with history of inflammatory bowel disease of with signs of colitis

          6. Patients with uncorrectable abnormal coagulation status (INR >1.5 and plt < 50000
             without use of anticoagulation agents)

          7. Patients with preexisting conditions, which, in the opinion of the investigator,
             interfere with the conduct of the study.

          8. Patients who are uncooperative, cannot follow instructions, or who are unlikely to
             comply with follow-up appointments or fill-out the post-procedural pain
             questionnaires.

          9. Patients with a mental state that may preclude completion of the study procedure or is
             unable to provide informed consent
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
Condition: Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Gemcitabine; Lurbinectedin (PM01183)
Intervention description: Powder for solution for infusion; Powder for solution for infusion; Powder for concentrate for solution for infusion
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in
      comparison to docetaxel for the treatment of unresectable non-small cell lung cancer
      (NSCLC)patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed unresectable NSCLC

          -  Patients must have failed one prior line of CT-based therapy for unresectable disease

          -  Age between 18 and 75 years

          -  Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1

          -  Adequate hematological, renal, metabolic and hepatic function

          -  At least three weeks since the last prior therapy, at least four weeks since
             completion of any prior radiotherapy

          -  Negative pregnancy test for pre-menopausal women

        Exclusion Criteria:

          -  Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic
             congestive heart failure or asymptomatic with left ventricular ejection fraction
             (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active
             hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled
             infection, pleural or pericardial effusions, myopathy, limitation of the patient's
             ability to comply with the treatment or to follow-up the protocol, any other major
             illness

          -  Histological features of neuroendocrine or bronchioalveolar differentiation.

          -  Unknown epidermal growth factor receptor (EGFR)mutation status or previously known
             EGFR mutated status in patients with adenocarcinoma.

          -  Prior or concurrent invasive malignant disease, unless in complete remission for more
             than three years.

          -  Significant cancer-related weight loss (≥10%)within four weeks prior to treatment
             start

          -  Prior treatment with docetaxel-containing therapy

          -  Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement

          -  Paraneoplastic syndromes
D-serine and Cognitive Remediation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: D-serine
Intervention description: D-serine 60 mg/kg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: cognitive remediation

Summary:

      The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in
      a sensory based remediation (SBR) paradigm
    

Eligibility criteria:

        Inclusion criteria:

          -  18 to 64 years old,

          -  IQ≥85 and

          -  estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics
             (with the exception of clozapine) are allowable. Patients must be on their
             antipsychotic medication for 1 month and stable on dose of antipsychotic and
             adjunctive medications for 2 weeks prior to study entry.

        Exclusion criteria:

          -  history of neurological visual or hearing impairment,

          -  active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),

          -  current alcohol or drug abuse (<1 month) or substance dependence (<4 months). All
             women of child-bearing potential must have a negative urine pregnancy test at the
             baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity
             to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of
             candidates, suggesting that this is not an overly restrictive criterion.
Guadecitabine Extension Study
Condition: Acute Myeloid Leukemia; Myeloid Dysplastic Syndrome
Intervention: Guadecitabine
Intervention description: Guadecitabine
Intervention MeSH terms: Guadecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Guadecitabine

Summary:

      This is a multicenter, open-label extension study for participants who participated in a
      previous Astex-sponsored guadecitabine clinical study [including but not limited to
      SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07
      (NCT02907359)].
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous participation in an Astex-sponsored guadecitabine clinical trial [including
             but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05,
             SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)], in which the participant was
             treated with guadecitabine and was still on active treatment with guadecitabine at the
             time of database close for the prior study.

          2. Participant is considered to be benefitting from guadecitabine treatment in the
             opinion of the treating investigator.

          3. Able to understand and comply with the study procedures, understand the risks involved
             in the study, and provide written informed consent before any study-specific
             procedure.

          4. Women of child-bearing potential (according to recommendations of the Clinical Trial
             Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a
             negative pregnancy test at screening. Women of child-bearing potential and men with
             female partners of child-bearing potential must agree to practice 2 highly effective
             contraceptive measures while receiving treatment with guadecitabine and for at least 3
             months after completing treatment and must agree not to become pregnant or father a
             child while receiving study treatment and for at least 3 months after completing
             guadecitabine treatment.

        Exclusion Criteria:

          -  1. Any participant who, in the opinion of the investigator, may have other conditions,
             organ dysfunction, or have safety data from their prior study participation that
             suggest that the risks of continuing treatment with guadecitabine may outweigh the
             benefits.
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Dronabinol and Palmitoylethanolamide
Intervention description: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
Intervention MeSH terms: Palmidrol; Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Motor tics; Vocal tics; Cannabinoids; Dronabinol; PEA; Palmitoylethanolamide; Tourettes; TS

Summary:

      This is an investigator-initiated proof of concept study with the purpose to examine the
      safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the
      treatment of adults with Tourette syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult between 18-60 years of age

          -  Meet DSM-5 criteria for the diagnosis of Tourette syndrome

          -  Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at
             baseline

          -  On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning
             the trial

          -  Accepted method of birth control

        Exclusion Criteria:

          -  Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental
             disorder or intellectual disability (IQ<70)

          -  Recent change (less than 4 weeks) in other medications that have potential effects on
             tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs,
             clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication
             change is defined to include dose changes or medication discontinuation.

          -  Recent change in behavioral treatment for Tourette syndrome or comorbid conditions
             (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within
             the last 12 weeks.

          -  Taking any co-medications (over the counter or prescription), food
             supplements/additives which can have a drug interaction with dronabinol or PEA.

          -  Positive pregnancy test or drug screening test

          -  History of cannabis dependence

          -  Significant Medical Comorbidity

          -  History of hypersensitivity to any cannabinoid or sesame oil
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Condition: Acquired Hyperinsulinemic Hypoglycemia
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia
Intervention: Avexitide
Intervention description: Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post Bariatric Hypoglycemia; avexitide; Post-Bariatric Hypoglycemia; Post-gastrectomy hypoglycemia; Post gastrectomy hypoglycemia; Post-esophagectomy hypoglycemia; Post esophagectomy hypoglycemia; Post-Nissen Fundoplication hypoglycemia; Post Nissen Fundoplication hypoglycemia; Exendin (9-39); Exendin 9-39

Summary:

      The primary goal of this study is to evaluate the safety and efficacy of two different dosing
      regimens of an investigational drug called Avexitide in treating low blood sugar in patients
      with Acquired Hyperinsulinemic Hypoglycemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy,
             esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of
             Screening

          -  History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as
             documented in the medical record.

          -  Body mass index (BMI) of up to 40 kg/m2

          -  If female, must not be breastfeeding and must have a negative urine pregnancy test
             result

        Exclusion Criteria:

          -  Major surgery within 6 months before randomization.

          -  History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g.,
             insulin autoimmune hypoglycemia).

          -  Use of agents that may interfere with glucose metabolism