bioihbjkbjnl/mcl2 huggingface dataset:
Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis
Condition: Sickle Cell Disease; Vaso-Occlusive Crisis
MeSH terms: Anemia, Sickle Cell
Intervention: Ketamine
Intervention description: The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ketamine; Sickle Cell Disease; Vaso-Occlusive Episode

Summary:

      Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with
      opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate
      (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist,
      ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing
      post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time
      to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy
      in adult opioid-refractory SCD patients. This study is investigating the safety and
      tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well
      as its efficacy in improving pain control and reducing hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All English-speaking, sickle cell patients who receive their care at UCSFBCHO in the
             Department of Hematology who are 8-to-25-years-old presenting to the emergency
             department for VOC were asked to enroll.

        Exclusion Criteria:

          -  Prior adverse reaction to ketamine

          -  Patients were asked during the consent process if they have ever received ketamine,
             and if so, if they had any serious adverse reaction, such as difficulty breathing,
             dysphoria, hallucinations, or allergic reaction. If they have, ketamine was not given
             to these patients.

          -  Patients who have received ketamine and experienced nausea or vomiting will be asked
             if they wish to receive the medication. If they do not, they did not receive ketamine.
LEO 124249 Ointment in the Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: LEO 124249; Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in
      the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have signed and dated informed consent after receiving verbal and
             written information about the clinical trial.

          -  Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia
             areata (patch type, totalis, universalis), as determined by the (sub) investigator,
             affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1,
             baseline).

          -  Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time
             limit.

          -  Subject must accept to not cut hair in the treated scalp areas during the trial.

        Exclusion Criteria:

          -  Females who are pregnant or are breast feeding.

          -  Current signs of spontaneous hair regrowth.

          -  Diffuse type alopecia areata.

          -  Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and
             Ludwig stage II and III)

          -  Subjects with changed or expected changes in medication for thyroid disease within 6
             month before Visit 1 (screening) or during the trial.

          -  Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine,
             azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy
             that in the opinion of the investigator could affect hair regrowth, within 6 weeks
             prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg
             prednisone for asthma or rhinitis may be used).
Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 177Lu-PSMA-617
Intervention description: Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research.
Intervention MeSH terms: 177Lu-PSMA-617
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was an open-label, multicenter, prospective trial to assess safety and efficacy of
      177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Prostate cancer proven by histopathology

          2. Unresectable metastases

          3. Progressive disease, both docetaxel naive and docetaxel treated.

          4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior
             androgen deprivation therapy (ADT)

          5. Positive 68Ga-PSMA-11 PET/CT (positron emission computed tomography ) or diagnostic
             177Lu-PSMA-617 scintigraphy

          6. ECOG 0-2

          7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT
             (platelet) count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and
             WBC≥2.000/ μl,PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent
             cycles

          8. Signing of the Informed Consent Form

          9. Patients enrolling in this trail should have received either Enzalutamide or
             Abiraterone

        Exclusion Criteria:

          1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel,
             Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.

          2. Glomerular Filtration Rate (GFR) <40 ml/min

          3. Serum creatinine > 1.5 ULN

          4. AST and ALT>5xULN

          5. Urinary tract obstruction or marked hydronephrosis

          6. Diffuse bone marrow involvement confirmed by super-scans
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate; Octreotide LAR Depot; Placebo
Intervention description: Telotristat etiprate capsules; orally 3 times daily.; A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.; Placebo-matching telotristat etiprate capsules; orally 3 times daily.
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate
      (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not
      managed by stable-dose long-acting octreotide therapy. Following determination of the
      maximally tolerated or effective dose, cohort expansion will occur to confirm effect on
      symptoms and safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, aged 18 and older

          -  Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with
             disease extent confirmed by computed tomography (CT), magnetic resonance imaging
             (MRI), or radionuclide imaging

          -  Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements
             per day)

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of
             volume contraction, dehydration, or hypotension compatible with a "pancreatic
             cholera"-type clinical syndrome

          -  Sponsor-unacceptable clinical laboratory values for hematology and liver function
             tests at screening

          -  Karnofsky status ≤70% - unable to care for self

          -  Surgery within 60 days prior to screening

          -  A history of short bowel syndrome

          -  Life expectancy <12 months

          -  History of substance or alcohol abuse within 2 years prior to screening

          -  Previous exposure to a tryptophan hydroxylase (TPH) inhibitor

          -  Administration of any investigational drug within 30 days of screening or any
             therapeutic protein or antibody within 90 days of screening
Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MGCD265
Intervention description: MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mirati; MGCD265; MET; NSCLC

Summary:

      MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and
      other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced,
      unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic
      changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing
      for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have
      previously received treatment with chemotherapy. The number of patients to be enrolled will
      depend on how many enrolled patients experience tumor size reduction. MGCD265 will be
      administered orally, twice daily. The study is designed to evaluate whether the number of
      patients experiencing tumor size reduction is substantially higher than would be expected
      with other available treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-small cell lung cancer

          -  Metastatic or locally advanced disease

          -  Prior platinum chemotherapy or immunotherapy

          -  Test result showing genetic change in MET tumor gene

          -  At least one tumor that can be measured on a radiographic scan

        Exclusion Criteria:

          -  Prior treatment with inhibitor of MET or HGF

          -  Prior positive test for EGFR mutation or ALK gene rearrangement

          -  Uncontrolled tumor in the brain
Treatment of Acute Pericarditis With Anakinra
Condition: Acute Pericarditis
MeSH terms: Pericarditis
Intervention: Anakinra; Placebo
Intervention description: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.
Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days; Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.
Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: anakinra; Kineret; pericarditis

Summary:

      The goal of this study is to determine the safety and efficacy of anakinra for the treatment
      of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7
      days.

        1. to determine the efficacy of anakinra with respect to chest pain resolution

        2. to determine the safety of anakinra with respect to adverse drug events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥12 years in presence of a parent able to provide consent or age >18 years

          -  First or recurrent episode of acute pericarditis, defined as the presence of at least
             2 of the following:

          -  Chest pain (suggestive of pericarditis and not explained by another condition)

          -  Pericardial friction rub on physical exam

          -  ST-segment elevation and/or PR depression on ECG

          -  New or worsening pericardial effusion

          -  Pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is no
             pain at all and 10 is the worst pain ever experienced) at time on enrollment

          -  Ability to provide written informed consent if 18 years or older or to provide assent
             in presence of parental consent if 12-17 years of age

        Exclusion Criteria:

          -  Pericarditis due to known bacterial or fungal infection

          -  Pericarditis due to known malignancy

          -  Pericarditis after cardiac surgery

          -  Tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes

          -  Pregnancy or breastfeeding

          -  Hypersensitivity to anakinra, latex or products derived from Escherichia coli

          -  Chronic pain syndrome or chronic use of analgesic drugs
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan; Placebo
Intervention description: Administered as intravenous infusion; Administered as intravenous infusion
Intervention MeSH terms: Lasmiditan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine

Summary:

      This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment
      of migraine headache in order to select a dose range for further studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1
             and 1.2.1 (2004)

          -  History of migraine of at least 1 year

          -  Migraine onset before the age of 50 years

          -  History of 1 - 8 migraine attacks per month

          -  Male or female subjects aged 18 to 65 years

          -  Female patients of child-bearing potential must be using a highly effective form of
             contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner)

          -  Able and willing to return to the clinic for treatment within 4 hours of the onset of
             a migraine headache

          -  Able and willing to give written informed consent

        Exclusion Criteria:

          -  History of life threatening or intolerable adverse reaction to any triptan

          -  Use of prescription migraine prophylactic drugs

          -  Pregnant or breast-feeding women

          -  Women of child-bearing potential not using highly effective contraception

          -  History or evidence of coronary artery disease, ischemic or hemorrhagic stroke,
             epilepsy or any other condition placing the patient at increased risk of seizures

          -  History of hypertension (controlled or uncontrolled)

          -  Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated measurements at
             screening

          -  Current use of hemodynamically active cardiovascular drugs

          -  History within the previous 3 years or current evidence of abuse of any drug,
             prescription or illicit, or alcohol

          -  Significant renal impairment

          -  Previous participation in this clinical trial

          -  Participation in any clinical trial of an experimental drug or device in the previous
             30 days

          -  Any medical condition or laboratory test which in the judgment of the investigator
             makes the patient unsuitable for the study

          -  Relatives of, or staff directly reporting to, the investigator

          -  Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to
             any excipient of COL-144
Safety Evaluation of 3K3A-APC in Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: 3K3A-APC; Placebo
Intervention description: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion; Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Intervention MeSH terms: Protein C
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: ischemic stroke; stroke; APC; 3K3A; 3K3A-APC; activated protein C; RHAPSODY

Summary:

      The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary
      efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human
      activated protein C (APC), in in the treatment of acute ischemic stroke following treatment
      with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute ischemic stroke

          -  Able to receive IV tPA, mechanical thrombectomy or both

          -  National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5

          -  Signed informed consent

          -  Mechanical thrombectomy subjects only: onset time to arterial puncture time < 6 hours

        Exclusion Criteria:

          -  History of stroke or penetrating head injury within 90 days prior to enrollment

          -  History of previous or current diagnosis of intracranial hemorrhage that represents a
             potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical
             thrombectomy

          -  Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm
             requiring intervention during the acute study period

          -  Presence of other neurological or non-neurological co-morbidities that may lead,
             independently of the current stroke, to further deterioration in the subject's
             neurological status during the trial period

          -  Presence of premorbid neurological deficits and functional limitations assessed by a
             retrospective Modified Rankin Scale (mRS) score of ≥ 2

          -  Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large
             core occlusion as defined by local protocol

          -  Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)

          -  Severe hypertension or hypotension

          -  Glomerular filtration rate (GFR) <35 mL/min

          -  Blood glucose concentration < 50 mg/dL

          -  Prior exposure to any exogenous form of APC
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Intervention: Kuvan; Diet
Intervention description: 20mg/kg by mouth once daily; Phenylalanine-restricted diet (4-10 mg/kg/day phenylalanine) using the prescribed phenylalanine-free medical formula and low protein foods tested with the patients for taste and acceptance to lower blood phenylalanine levels below 600 umol/l.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: PKU; Kuvan; BH4; tetrahydrobiopterin

Summary:

      The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness
      in the same patients with PKU when their blood phenylalanine concentrations are altered by
      diet.

      Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will
      increase the frequency of Kuvan responsiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients with a diagnosis of phenylketonuria

          -  patients who are over the age of 4 years,

          -  patients with a fasting blood phenylalanine ≥600µmol/l

        Exclusion Criteria:

          -  female patients who are pregnant or attempting to become pregnant

          -  children under four years of age

          -  Concurrent disease of condition that would interfere with study participation or
             safety such as history of neurological compromise or major medical, psychiatric or
             learning disorder unrelated to PKU

          -  Any condition that, in the view of the Investigators, places subject at high risk of
             poor treatment compliance or of not completing the study

          -  Use of L-Dopa, methotrexate, or other drugs that may inhibit folate metabolism