bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Tremelimumab; Durvalumab; Bevacizumab
Intervention description: Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.; Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.; Bevacizumab 15 mg/kg will be administered by IV infusion every 3 weeks until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Intervention MeSH terms: Bevacizumab; Durvalumab; Tremelimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 433.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; Immunotherapy; Antibodies, Monoclonal; Tremelimumab; MEDI4736; Durvalumab

Summary:

      This is a multicenter, open-label, stratified, randomized study to evaluate the safety,
      tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of
      durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or
      bevacizumab in advanced hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants

          2. 18 years and older (Japan-20 years and older)

          3. Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from
             tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with
             noninvasive methods.

          4. Immunotherapy-naïve

          5. Have either progressed on, are intolerant to, or refused treatment with sorafenib or
             another approved TKI. For arm 5 only: Have not received any prior systemic therapy for
             HCC.

        Exclusion Criteria:

          1. Prior exposure to immune-mediated therapy

          2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent
             or control encephalopathy

          3. Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months

          4. Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain
             symptomatic control, within 6 months prior to the first scheduled dose.

          5. Main portal vein thrombosis (Vp4) as documented on imaging

          6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer
             treatment

          7. Active or prior documented autoimmune or inflammatory disease with some exceptions

          8. Current or prior use of immunosuppressive medication within 14 days with some
             exceptions
Extension 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
Intervention description: Received during weekly intravenous infusions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Low Dose cohort of 40 mg/kg and High Dose cohort of 80 mg/kg
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 4 Years
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once
      weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed Study NS-065/NCNP-01-201 through Week 25.

          2. Willing and able to comply with scheduled visits, investigational product
             administration plan, and study procedures.

          3. Stable dose of glucocorticoid (GC), and is expected to remain on the stable dose for
             the duration of the study.

        Exclusion Criteria:

          1. Serious or severe adverse event in Study NS-065/NCNP-01-201 that precludes safe use of
             NS-065/NCNP-01.

          2. Patient had a treatment which was made for the purpose of dystrophin or its related
             protein induction after completion of Study NS-065/NCNP-01-201.

          3. Patient took any other investigational drugs after completion of Study
             NS-065/NCNP-01-201.

          4. Patient was judged by the investigator and/or the Sponsor that it was not appropriate
             to participate in the extension study for other reasons.
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSK835726 10mg; GSK1004723 1000mcg; Cetirizine 10mg; placebo
Intervention description: GSK835726 10mg tablet; GSK1004723 1000mcg nasal spray solution; Cetirizine 10mg active comparator; placebo to match actives
Intervention MeSH terms: Cetirizine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Proof of concept

Summary:

      This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess
      the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg)
      and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal
      allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is healthy apart from seasonal allergic rhinitis, as determined by a
             physician. Can have mild asthma.

          -  Males or female using contraceptives

          -  Aged 18 - 65

          -  Weight 50kg+, BMI 19-32 kg/m2

          -  Exhibit response to Challenge Chamber and skin prick test.

          -  Non-smoker

          -  Capable of giving informed consent

          -  AST and ALT<2xULN; alkaline phosphatase and bilirubin <or=1.5xULN

        Exclusion Criteria:

          -  No nasal structural abnornmality/polyposis, surgery, infection.

          -  any respiratory disease, other than mild asthma or seasonal allergic rhinitis

          -  participated in another clinical study within 30 days.

          -  Subject has donated a unit of blood within 1 month

          -  Use of prescription or non-prescription drugs, including vitamins and st john's wort
             within 7 days of trial.

          -  History of sensitivty to drug

          -  History of alcohol/drug abuse within 12 months.

          -  Positive Hepatitis B antibody test

          -  Positive HIV antibody test

          -  Risk of non-compliance with study protocol

          -  Pregnant or llactating females

          -  Perenial allergic rhinitis

          -  Administration of oral, injectable or dermal corticosteriods within 8 weeks,
             intranasal or inhaled within 3 weeks.

          -  Past or present disease that may affect outcome, as judge by investigator

          -  Specific Immunotherapy within 2 years
Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
Condition: Neurogenic Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension
Intervention: Atomoxetine; Placebo
Intervention description: norepinephrine transporter inhibitor; placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: norepinephrine transporter inhibitors

Summary:

      Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic
      hypotension are scarce and not effective. If left untreated, these patients have the highest
      risk of syncope, falls and fall-related injuries. The proposed study will determine the
      clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated
      with neurogenic orthostatic hypotension in patients with autonomic failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  40 years old or older

          -  Neurogenic Orthostatic Hypotension (defined by a reduction of ≥20 mmHg drop in SBP
             within 3 minutes of standing, associated with impaired autonomic reflexes as assessed
             by autonomic function tests.

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  Hypersensitivity to atomoxetine (severe allergic reaction, rash, urticaria,
             anaphylaxis)

          -  Use of other norepinephrine transporter inhibitors such as Wellbutrin (Bupropion),
             Cymbalta (Duloxetine), Effexor (venlafaxine), Pristiq (desvenlafaxine), Savella
             (milnacipran)

          -  Previous history (within 14 days prior to enrollment) and current use of monoamine
             oxidase inhibitors

          -  Concomitant use of strong CYP2D6 inhibitors such as delavirdine, paroxetine,
             fluoxetine, quinidine

          -  Pre-existing sustained severe hypertension (BP ≥ 140/80 mmhg in the sitting position)

          -  Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino
             transaminase [ALT] >2 x upper limit of normal range)

          -  Impaired renal function (serum creatinine equal or more than 1.6 mg/dl)

          -  Myocardial infarction within 6 months prior to enrollment

          -  Congestive heart failure (LV hypertrophy acceptable)

          -  History of serious neurologic disease such as cerebral hemorrhage, or stroke

          -  Inability to comply with the protocol, e.g., uncooperative attitude, inability to
             return for follow-up visits, unlikelihood of completing the study, and mental
             conditions rendering the subject unable to understand the nature, scope, and possible
             consequences of the study

          -  Narrow-angle glaucoma
Chloroprocaine Spinal for Outpatient Knee Surgery
Condition: Knee Arthroscopy
Intervention: Chloroprocaine; Mepivacaine; General Anesthetics
Intervention description: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed; A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed; General anesthetics will be administered intravenously
Intervention MeSH terms: Anesthetics; Mepivacaine; Chloroprocaine; Anesthetics, General
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of
      spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating
      a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize
      that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while
      avoiding the side effects of a general anesthetic, thus promoting earlier discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for a knee arthroscopy that is anticipated to be less than one hour

          -  Age 18 to 80 years

          -  Ability to follow study protocol

          -  English speaking

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 18 years old and older than 80

          -  Allergy or intolerance to one of the study medications

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months)

          -  Patients unable to undergo a spinal anesthetic or Laryngeal Mask Airway (LMA)/GA or
             patient refusal to spinal anesthesia or LMA/GA
SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
Condition: Parkinson's Disease Dementia (PDD)
MeSH terms: Parkinson Disease; Dementia
Intervention: SYN120; Placebo
Intervention description: SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).; Placebo QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: PDD; Parkinson's Disease Dementia; patients taking a cholinesterase inhibitor.

Summary:

      The purpose of this study placebo-controlled, randomized, double-blind study is to assess the
      safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already
      treated with a stable dose of a cholinesterase inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parkinson's Disease Dementia

          -  Patient has a routine caregiver

          -  Taking a stable cholinesterase inhibitor.

          -  Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

        Exclusion Criteria:

          -  History of any significant neurologic or psychiatric disease other than PD

          -  Any other condition or clinically significant abnormal findings that would make the
             patient unsuitable for the study

          -  Unpredictable motor fluctuations that would interfere with administering assessments
Crizanlizumab for Treating COVID-19 Vasculopathy
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Crizanlizumab; 0.9% saline
Intervention description: Crizanlizumab 5.0 mg/kg in 100 ml IV once.; 0.9% saline 100 ml IV once.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, randomized interventional trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronavirus

Summary:

      The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients
      hospitalized with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to provide written informed consent

          2. Willing to comply with all study procedures and be available for the duration of the
             study

          3. Male or female ≥ 18 years of age

          4. SARS-CoV-2 infection (COVID-19) within the past 10 d documented by laboratory test
             (nucleic acid test (NAT) or reverse transcriptase-polymerase chain reaction (RT-PCR))

          5. Currently hospitalized

          6. Symptoms of acute respiratory infection (at least one of the following: cough, fever >
             37.5°C, dyspnea, sore throat, anosmia),

          7. Radiographic evidence of pulmonary infiltrates

          8. Requiring supplemental oxygen or the peripheral capillary oxygenation saturation
             (SpO2) < 94% on room air at screening

          9. Elevated D-Dimer > 0.49 mg/L

         10. Negative pregnancy test for females of childbearing potential

        Exclusion Criteria:

          1. Use of home oxygen at baseline

          2. Current use of mechanical ventilation

          3. Inability to provide consent

          4. Do not intubate status

          5. Prisoner or incarcerated

          6. Pregnancy or Breast Feeding

          7. Participation in other interventional therapy trials for COVID-19.

          8. International normalized ratio (INR) > 3 or activated partial thromboplastin time
             (aPTT) > 60
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GW642444; Placebo
Intervention description: GW642444H; Placebo administered twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD); COPD

Summary:

      The compound GW642444 has previously been found to be well tolerated with no significant side
      effects in subjects with asthma and healthy volunteers. This study will assess the safety and
      tolerability of GW642444 in subjects with COPD in order to obtain information to support
      dosing in a broader population of subjects with COPD
    

Eligibility criteria:

        Inclusion criteria:

          -  females must be of non-childbearing potential

          -  moderately severe COPD

        Exclusion criteria:

          -  Subjects with a main diagnosis of asthma

          -  subjects with poorly controlled COPD

          -  subjects with significant heart, renal, endocrine, psychiatric, immunological or
             neurological disease.
Topical Capsaicin for Cyclical Vomiting
Condition: Cyclical Vomiting
MeSH terms: Vomiting
Intervention: Capsaicin 0.1% Cream; Placebos
Intervention description: Topical application; placebo cream
Intervention MeSH terms: Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Identical appearing placebo cream used for control
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the
      relieve of nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  suspected cyclical vomiting syndrome / cannabinoid hyperemesis

          -  active severe nausea or vomiting in the emergency department

        Exclusion Criteria:

          -  pregnant women, children < 18 years, no prior history of similar symptoms, suspected
             surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy
             to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours,
             abdominal pain alone (without nausea or vomiting)
A Study of TAK-994 in Adults With Narcolepsy
Condition: Narcolepsy Type 1 (NT 1)
MeSH terms: Narcolepsy
Intervention: TAK-994; Placebo
Intervention description: TAK-994 tablets.; Placebo-matching tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in
      this study.

      The main aim of this study is to check if participants have side effects from TAK-994.

      Participants will take one of 3 different TAK-994 dose for 8 weeks.

      Then, half the participants will continue with their dose of TAK-994 and half will take a
      placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any
      medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

      Participants will visit the clinic for a final check-up 2 weeks after their last dose of
      TAK-994 or placebo.

      The study doctors will check for side effects from TAK-994 and placebo throughout the study.

      Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK
      994-1501 study.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501
        Part B before enrollment (which will occur immediately following the final TAK-994-1501
        assessments), and for whom the investigator has no clinical objection they be enrolled.

        Exclusion Criteria:

        1. Participant has a clinically significant moderate or severe ongoing AE related to the
        study drug from the prior study.
Red Blood Cell ATP Release and Vascular Function in Humans
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Fasudil Hydrochloride; Saline
Intervention description: 10 mg/mL vial of fasudil hydrochloride. 6 mL (60 mg) of fasudil hydrochloride are added to a 100 mL saline bag for delivery to subjects.; 100 mL saline bag.
Intervention MeSH terms: Fasudil
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled, crossover study. Approximately 20 young and 20 older adults will be recruited for participation and randomly assigned to either a placebo (saline) infusion or a fasudil hydrochloride infusion. The dose of fasudil hydrochloride is 60 mg/ 60 min.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: A person not associated with any data collection or data analysis is randomizing the treatment and preparing it in a separate room. All data is collected as visit 1 or visit 2.
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Previous work demonstrates that the red blood cells of older adults do not release a potent
      vasodilator (ATP) as well as the red blood cells of younger adults. The investigators are
      targeting a pathway within the red blood cell using fasudil hydrochloride to determine if
      both the release of ATP from red blood cells and blood flow responses to low oxygen (hypoxia)
      and exercise in older adults can be improved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy

          -  Sedentary to moderately active

          -  18 to 30 years old for young subjects

          -  60 to 80 years old for older subjects

        Exclusion Criteria:

          -  Obesity (BMI ≥ 30 kg/m^2)

          -  Cardiovascular disease

          -  Metabolic disease

          -  Use of medications that can influence cardiovascular function

          -  Blood pressure greater than or equal to 140/90

          -  Smoker

          -  Use of hormone replacement therapy