bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Spesolimab; Placebo
Intervention description: 12 weeks treatment; 12 weeks treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives of this trial are safety and efficacy (proof-of-concept) of induction of
      mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative
      colitis and persisting endoscopic activity despite pre-existing TNFi treatment.

      This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to
      achieve the similar exposures as the highest exposures tested and found safe and tolerable in
      preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing
      TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include
      assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific
      biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help
      understand BI 655130's mode of action.
    

Eligibility criteria:

        Inclusion Criteria

          -  18 - 75 years at screening and randomisation

          -  Diagnosis of ulcerative colitis >= 5 months prior to screening

          -  Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4
             months (Infliximab) or >= 2 Monaten (Adalimumab or Golimumab) prior to randomisation

          -  Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10)

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Prior use of more than two different TNF inhibitors or vedolizumab

          -  Extensive colonic resection

          -  Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to
             screening

          -  Active or latent tuberculosis

          -  Further exclusion criteria apply
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Intervention: Stannsoporfin; Placebo; PhotoTherapy (as needed)
Intervention description: Stannsoporfin administered as a single IM injection; Placebo (sterile saline solution) administered as a single IM injection; PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Intervention MeSH terms: Tin mesoporphyrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sequential experimental cohorts are run in parallel with placebo controls.
Masking: Double (Participant, Investigator)
Masking description: Clinical personnel at the site (including investigator, study coordinator and central cardiologist) were blinded to treatment group.
The research pharmacy and the health care provider responsible for giving the injection to patients knew what the treatment was (they were not blinded).
Enrollment: 58.0
Sex: All
Minimum age: 1 Minute
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: Hemolysis

Summary:

      It is a normal process in the human body for red blood cells to die, which makes bilirubin.

      Bilirubin is cleared away through the liver.

      Some babies are born with livers that don't work well enough yet, or their red blood cells
      are dying too fast, so the baby looks yellow (jaundice).

      This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin
      gets too high.

      Phototherapy is what they call the lights they shine on newborn babies to help the liver get
      rid of bilirubin.

      This study tests an experimental drug to see if it can reduce how much bilirubin is being
      made in the first place.
    

Eligibility criteria:

        Inclusion Criteria:

        Babies may only participate if they meet all the following criteria:

          -  Is a term or late preterm baby

          -  Is at risk for protocol-defined hemolytic disease

          -  Weighs at least 2500 g (5.5 lbs)

          -  Has total serum bilirubin (TSB) a specified amount lower than the phototherapy
             threshold for the age

          -  Has parents/guardians who are willing to follow light precautions and sign informed
             consent

        Exclusion Criteria:

        The following criteria will make a baby not eligible to participate:

          -  Needs medications that may prolong the QT interval

          -  Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome,
             or Porphyrias

          -  Has an Apgar score of 6 or below at age 5 minutes

          -  Has abnormalities or infections (in mother or child) that per protocol or in the
             opinion of the investigator may compromise the safety and well-being of the baby or
             analysis of study results
Low Dose Aprepitant for Patients Receiving Carboplatin
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Aprepitant 125 mg; Fosaprepitant 115 MG; Dexamethasone; Ondansetron 16 MG
Intervention description: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting; Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting; Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy; Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Intervention MeSH terms: Dexamethasone; Ondansetron; Aprepitant; Fosaprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive 125mg of oral aprepitant or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: emesis; aprepitant; carboplatin; chemotherapy-induced nausea and vomiting

Summary:

      This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are
      getting carboplatin based chemotherapy. In addition to standard oral Dexamethasone and oral
      Ondansetron, participants will be given a third neurokinin 1 (NK1) antagonist agent, either a
      single dose of oral Aprepitant or intravenous (IV) Fosaprepitant (they have been shown to be
      equally effective) to improve prevention of nausea and vomiting. No medications need to be
      taken beyond day 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No prior chemotherapy

          -  Confirmed malignancy, scheduled to receive carboplatin monotherapy, or carboplatin in
             combination with agents of minimal, low, or moderate emetic potential

          -  Laboratory parameters adequate for chemotherapy

        Exclusion Criteria:

          -  Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3
             or 4

          -  Presence of nausea and vomiting or use of major antiemetic agents during the 24 hours
             before chemotherapy administration

          -  Patients receiving radiotherapy within 5 days prior to the carboplatin

          -  Pregnancy or lactation

          -  Known allergy to any of the 3 antiemetics
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
Condition: Idiopathic Pulmonary Fibrosis; Hypoxemia
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Hypoxia
Intervention: GBT440
Intervention description: GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Idiopathic pulmonary fibrosis; hypoxemia; oxygen

Summary:

      This is an open label study in which eligible IPF subjects who are using supplemental oxygen
      at rest will receive GBT440 orally daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of IPF.

          -  Receiving supplemental oxygen for use at rest.

          -  Weight ≥ 40 kg.

          -  Male or female of child bearing potential willing and able to use highly effective
             methods of contraception from study start to 30 days after the last dose of study
             drug.

        Exclusion Criteria:

          -  FEV1/FVC < 70%

          -  History of other interstitial lung diseases.

          -  Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of
             screening.

          -  Corticosteroid (> 10 mg per day of prednisone or an equivalent) administered for 7
             days or longer, within 30 days of screening.

          -  Participated in another clinical trial of an investigational drug (or medical device)
             within 30 days or 5-half-lives, whichever is longer, prior to screening, or is
             currently participating in another trial of an investigational drug (or medical
             device).

          -  Female who is breast-feeding or pregnant

          -  Current smoker or history of smoking within 3 months from screening
OPTIMA-TBI Pilot Study
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Intervention: Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.; Placebo - Cap
Intervention description: Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA & 100 mg EPA) or placebo capsules.; Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA & 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty
      acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals presenting to the emergency department (ED) within 24 hours of injury, who
             meet the American Congress of Rehabilitation Medicine (ACRM)'s definition of having
             mild traumatic brain injury (mTBI) will be eligible

          -  The ACRM defines mTBI as a traumatically-induced physiological disruption of brain
             function as a consequence of the head being struck, striking an object, or undergoing
             an acceleration/deceleration movement without direct external head trauma and
             resulting in at least one of the following:

          -  any period of loss of consciousness (LOC)

          -  any loss of memory for events immediately before or after the injury

          -  any alteration in mental state at the time of the injury (eg, feeling dazed,
             disoriented, or confused)

          -  focal neurological deficit(s) that may or may not be transient

        Exclusion Criteria:

          -  GCS<13 at any time during ED stay.

          -  Significant polytrauma including: bony fracture or solid organ injury

          -  Study medication cannot be administered within 24 hours of injury

          -  Patient cannot be relied on to complete follow-up (i.e. no reliable telephone number,
             substance dependence, homeless)

          -  Cannot communicate in English

          -  Take an anticoagulant (coumadin or a novel oral anticoagulant) daily

          -  Age less than 18 years or greater than 65 years

          -  Patients already taking fish oil supplements daily

          -  History of cognitive impairment

          -  Allergic to fish/fish oil

          -  Pregnant women (self-reported)
A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Epstein-Barr Virus Infections; Carcinoma; Nasopharyngeal Carcinoma
Intervention: Epstein-Barr Virus Specific Immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epstein-Barr Virus; NPC; EBV; immunotherapy

Summary:

      The purpose of this research study is to determine how effective and how safe it is to give
      an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal
      carcinoma (NPC) associated with EBV that has come back or spread to other parts of the
      participant's body. This is phase II study with the aim of establishing a baseline of
      efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven NPC of an WHO grade, associated with EBV
             infection documented by the presence of EBER expression by in situ hybridization in
             the tumor. Positive EBER staining from another institution must be confirmed by
             pathology review at Brigham and Women's Hospital. Other confirmation of EBV-associated
             disease is acceptable, such as EBV DNA in situ hybridization, if EBER analysis is not
             adequate

          -  Incurable NPC

          -  Recovery from toxicity from any prior NPC therapy to grade 1 or better

          -  18 years of age or older

          -  Evaluable or measurable disease, according to modified RECIST

          -  ECOG Performance Status of 0 or 1

          -  Adequate bone marrow, liver and renal function as outlined in protocol

        Exclusion Criteria:

          -  Radiotherapy for primary NPC within 8 weeks of enrollment, or radiotherapy for any
             other reason within 6 weeks

          -  Chemotherapy for NPC within 2 weeks of enrollment

          -  Other cancer in the past 5 years, except for carcinoma in situ of the cervix or
             bladder, or non-melanomatous skin cancer

          -  Uncontrolled central nervous system metastases

          -  Active hepatitis, known HIV, or other condition that requires immunosuppressive
             therapy, including current use of high dose systemic corticosteroids

          -  Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that
             is active and requires current immunosuppressive therapy

          -  Active uncontrolled serious infection

          -  Women of child-bearing potential who have a positive pregnancy test or are
             breast-feeding
Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
Condition: Parkinson Disease; Multiple System Atrophy
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: Intranasal Insulin
Intervention description: treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
placebo arm: normal saline, daily, intranasally, for 4 weeks.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson disease; Multiple system atrophy; Intranasal; Insulin

Summary:

      Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative
      disorders characterized by abnormal accumulation of α-synuclein. There is no effective
      treatment that can slow down the disease progression and both disorders are associated with
      severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and
      memory in healthy and cognitively impaired non-diabetic adults.

      The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322)
      has shown that a single 40 international units dose of intranasal insulin improves
      visuospatial memory in diabetes and control subjects.

      This proposal includes randomized, double blinded, placebo-controlled trial of intranasal
      insulin (40 international units daily) in treatment of PD and MSA.

      The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the
      study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of
      cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of
      the cognitive scale ratings.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females older than 17 years.

          2. Clinical diagnosis of Parkinson disease or multiple system atrophy.

          3. Provide written informed consent to participate in the study.

          4. Understand that they may withdraw their consent at any time.

        Exclusion Criteria:

          1. Women who are pregnant or lactating.

          2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular,
             renal or other illness that can interfere based on investigator judgment with the
             trial.

          3. History of dementia.

          4. Unable to walk without help for at least 1 minute.

          5. History of allergic reaction to insulin.

          6. The presence of inflammation of nasal cavity that may prevents absorption of insulin.
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Miricorilant; Placebo
Intervention description: Tablets taken orally; Placebo tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Nonalcoholic Steatohepatitis; NASH; Nonalcoholic Fatty Liver Disease

Summary:

      This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and
      efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis
      (NASH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of NASH based on a biopsy obtained within the last year OR

          -  Have a diagnosis of presumed NASH based on blood tests and scans

        Exclusion Criteria:

          -  Have participated in another clinical trial within the last year and received active
             treatment for NASH

          -  Have participated in another clinical trial for any other indication within the last 3
             months

          -  Are pregnant or lactating women

          -  Have a BMI <18 kg/m^2

          -  Have had liver transplantation or plan to have liver transplantation during the study

          -  Have type 1 diabetes or poorly controlled type 2 diabetes.
Heart Rate Variability in Response to Metformin Challenge
Condition: Fibromyalgia; Mitochondrial Diseases; Movement Disorders; Diabetes Mellitus, Type 2
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Movement Disorders; Diabetes Mellitus, Type 2; Mitochondrial Diseases
Intervention: Metformin
Intervention description: 500 mg orally after baseline testing of heart rate
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metformin; mitochondria; complex 1; fibromyalgia; neurogenic pain; diabetes; tardive dyskinesia; heart rate variability

Summary:

      Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to
      familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated
      with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will
      provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then
      provide an additional sample 2 hours later.
    

Eligibility criteria:

        Inclusion Criteria:

        EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for
        fibromyalgia or previous/current exposure to antipsychotic medications

        Exclusion Criteria:

          -  recent infection,

          -  renal failure,

          -  pre-existing cardiac disease,

          -  chronic obstructive pulmonary disease

          -  inability to participate in informed consent,

          -  lack of transport to return home from study site,

          -  severe fasting intolerance or hypoglycemia,

          -  history of stroke-alike episode,

          -  uncontrolled migraine or cyclic vomiting,

          -  diabetes on insulin or sulfonylurea,

          -  non-English speaker,

          -  medications with strong effects on baseline heart rate variability