bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: YKP3089; Placebo
Intervention description: Capsule, dose to be titrated Tablet, dose to be titrated; Placebo capsule Placebo tablet
Intervention MeSH terms: Cenobamate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: partial onset seizures; treatment resistant; partial epilepsy

Summary:

      This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared
      to baseline in subjects with partial onset seizures not fully controlled despite their
      treatment with 1 to 3 concomitant anti-epileptic drugs.

      Also to evaluate the safety and tolerability of YKP3089.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of treatment resistant partial epilepsy;

          -  History of epilepsy for at least 2 years;

          -  Have at least 3 simple partial with motor component, complex partial or secondarily
             generalized seizures per month with no consecutive 21 day seizure free period.

          -  Currently treated on a stable dose of :

               -  1 - 3 AED's for at least 12 weeks prior to randomization.

               -  VNS will not be counted as AED; however the parameters must remain stable for at
                  least 4 weeks prior to baseline.

               -  Benzodiazepines taken at least once per week for epilepsy, or for anxiety or
                  sleep disorder, will be counted as 1 AED. Therefore only a maximum of two
                  additional approved AEDs will be allowed.

        Exclusion Criteria:

          1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.

          2. Subject has had status epilepticus within past 1 year.

          3. Subject has had greater than 2 allergic reactions to an AED or one serious
             hypersensitivity reaction to an AED.

          4. Subjects taking felbamate with less than 18 months continuous exposure.

          5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.

          6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.

          7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide
             attempt.

          8. Subject meets criteria for current major depressive episode (within 6 months).

          9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a
             24-hour period is considered one rescue) in the one month period prior to Visit 1.
Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Brain Neoplasms
Intervention: MMSE; QOL via FACT-Br; MRI; Post-operative SRS
Intervention description: Neurocognitive function via MMSE done every 3 months for length of study.; Quality of Life via FACT-BR every 3 months for length of study.; MRI done every 3 months for the length of the study.; Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and
      cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill
      any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating
      patients with brain metastases.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years of age.

          2. Gross total resection (as verified by the lack of any enhancement in the resection
             cavity on post-operative MRI) of single brain metastasis confirmed by histology.
             Patients with up to 4 metastases are eligible if the largest mass is amenable to
             surgical resection and all non-resected masses are amenable to SRS.

          3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning
             analysis (RPA) Class 1 or 2.

          4. Life expectancy of at least 3 months.

        Exclusion Criteria:

          1. Radiographic or cytologic evidence of leptomeningeal disease.

          2. Patient with incomplete or partial resection.

          3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell
             tumors, lymphoma, leukemia, and multiple myeloma).

          4. Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted
             MRI scan.

          5. Lesion located in anatomic regions which are not amenable to SRS including the brain
             stem and optic apparatus.

          6. Pregnant or need to breast feed during the study period.

          7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive
             heart failure, unstable angina pectoris, or psychiatric illness.

          8. Brain surgery other than for resection of metastasis.

          9. Previous brain radiotherapy.

         10. Contraindication to SRS, WBRT, or MRI.
Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer
Condition: Hot Flashes; Hot Flushes; Vasomotor Symptoms
MeSH terms: Hot Flashes
Intervention: Stellate Ganglion Block injection with bupivicaine; Saline
Intervention description: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.; sham injection with saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 2.0
Sex: Female
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer
      survivors and negatively impact their quality of life. VMS in Hispanic women are
      significantly more severe as compared to non-Hispanic Caucasian women. Few effective
      treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking
      populations which is problematic, as Hispanics will comprise 20% of the U.S. population by
      2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for
      chronic pain indications, has shown promise as a potential treatment for menopausal women
      with VMS in previous clinical trials, but has not been investigated in Hispanic or
      Spanish-Speaking women with breast cancer in a controlled study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hispanic or Spanish speaking women aged 30 to 70 years

          2. 28 or more reported moderate-to-very severe hot flashes per week

          3. a minimum of two weeks of VMS diary recording prior to SGB

          4. current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer
             indication for at last six months

          5. willingness to undergo fluoroscopy-guided SGB or sham treatment.

          6. if participant is on an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for
             example), it must be a stable, unchanged dose for previous 3 months

        Exclusion Criteria:

        1. conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the
        anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute
        illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications
        to a local anesthetic or contrast dye); pregnancy 2. use of treatments in the past 2 months
        that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,

        -
Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: QCC374
Intervention description: 0.015mg and 0.06mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary hypertension (PH),; Increase blood pressure in the pulmonary artery; Increased blood pressure in the pulmonary vein; Increased blood pressure in the lung vasculature; Shortness of breath; Dizziness; Fainting; Leg swelling; Cough; Angina pector

Summary:

      This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in
      adult patients with PAH. This study provides the patients who completed the QCC374X2201 study
      with the option to continue receiving QCC374. The study will monitor the long-term safety,
      tolerability and efficacy of QCC374 in patients with PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  Subject was enrolled in the QCC374X2201 study and completed per protocol

        Exclusion Criteria:

          -  Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs
             (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e.
             selexipag) since the last study drug intake in the QCC374X2201 study.

          -  Females who are pregnant, or who plan to become pregnant during the study, or who are
             breastfeeding

          -  Any known factor or disease that may interfere with treatment compliance or study
             conduct (i.e. drug or alcohol dependence)

          -  Subjects who withdrew consent from the study QCC374X2201
Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Condition: Uveitis
MeSH terms: Uveitis
Intervention: Adalimumab
Intervention description: 40 mg delivered every 2 weeks by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with vision-threatening autoimmune uveitis.

          2. Failure to respond to prednisone and at least one other systemic immunosuppressive
             (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine,
             cyclophosphamide, or chlorambucil), or intolerance to such medications due to side
             effects.

        Exclusion Criteria:

          1. Serious concomitant illness that could interfere with the subject's participation in
             the trial.

          2. Previous or current use of cyclophosphamide.

          3. Unable or unwilling to undergo multiple injections.
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Tamoxifen; Vorinostat; Antiretroviral drugs
Intervention description: 20 mg orally; 400 mg orally; Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Intervention MeSH terms: Tamoxifen; Anti-Retroviral Agents; Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study evaluated the effects of tamoxifen exposure in combination with vorinostat on
      viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on
      antiretroviral therapy (ART), when compared to vorinostat alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection

          -  Postmenopausal at study entry with agreement not to participate in assisted
             reproductive technology in the future.

          -  CD4+ cell count greater than 300 cells/uL obtained within 90 days prior to study
             entry.

          -  Continuous antiretroviral therapy (ART) for at least 2 years prior to enrollment with
             no known interruption in therapy for greater than 7 days within 90 days prior to study
             entry.

          -  Plasma HIV-1 RNA level of less than 20 copies/mL obtained by Roche HIV-1 viral load
             assay or less than 40 copies/mL obtained by the Abbott assay, within 90 days prior to
             study entry.

          -  Ability and willingness of potential participant to provide written informed consent.

        Exclusion Criteria:

          -  History of venous thromboembolism.

          -  History of stroke.

          -  Known history of hypercoagulable state.

          -  Tobacco smoking or e-cigarette use within 90 days prior to study entry.

          -  History of any malignancy requiring systemic chemotherapy or systemic immunotherapy.

          -  History of endometrial or breast cancer or known genetic testing with BRCA positive
             results indicating an increased risk for breast and ovarian cancer.

          -  Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine,
             or investigational therapy within 60 days prior to study entry.

          -  Any systemic hormonal therapy defined as oral or injectable contraceptives, estrogen
             and combined estrogen-progesterone replacement therapy in the prior 12 months, or a
             hormone containing intrauterine device (IUD) within 6 months prior to study entry.

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulations.
Toradol v. Celecoxib for Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Celecoxib; Ketorolac
Intervention MeSH terms: Celecoxib; Ketorolac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized control trial between ketorolac versus celecoxib for postoperative pain following
      hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing hysterectomy

        Exclusion Criteria:

          -  Coronary Artery Disease

          -  Peptic Ulcer Disease

          -  Chronic Renal Disease

          -  Liver disease

          -  Alcohol Abuse

          -  Daily narcotic usage

          -  Narcotic use 24 hours prior to surgery

          -  Crohn's Disease

          -  History of myocardial infarction

          -  History of stroke

          -  Preoperative hematocrit less than 24

          -  Asthma

          -  Ulcerative Colitis

          -  Diverticulitis

          -  Aspirin Allergy

          -  Sulfonamide Allergy

          -  Pre-operative pain score of greater than 3

          -  Patients undergoing procedures that may involve bowel resection or bowel
             reanastomosis.

          -  Allergy to any non-steroidal anti-inflammatory drug

          -  Cardiac anomaly or disease

          -  Congestive Heart Failure
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Keppra XR
Intervention description: Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Levetiracetam; Epilepsy; Children; Adults

Summary:

      To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both
      children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs

          -  Subjects on levetiracetam immediate release (IR) can be enrolled if on a stable dose
             for 7 days

        Exclusion Criteria:

          -  Subjects with a history of status epilepticus within 3 months of Visit 1

          -  Subject has difficult venous accessibility
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
Condition: Anemia
Intervention: Venofer
Intervention description: Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron
      Sucrose Injection) in NDD-CKD pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > or = 12 to < or = 16 years

          -  Parent and/or legal guardian able to give informed consent

          -  Subject able to give written assent for participating in the study

          -  NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or
             longer

          -  Hemoglobin indicative of anemia

          -  Ferritin indicative of iron deficiency anemia

          -  If appropriate, subject must be willing to use an accepted form of birth control from
             time of screening through the follow-up period

        Exclusion Criteria:

          -  Known history of hypersensitivity to any component of Venofer

          -  Parenteral iron within 14 days of the screening visit

          -  Dialysis dependent-CKD

          -  Chronic or serious active infection

          -  Pregnancy or lactation

          -  Subjects with causes of iron deficiency anemia other than CKD

          -  Blood transfusion within the last month or anticipated during the study

          -  Body weight < 55 pounds

          -  Received an investigational drug within 30 days before screening
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Condition: SARS-CoV-2; COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine Sulfate + Azithromycin; Hydroxychloroquine Sulfate
Intervention description: Given PO; Given PO
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a three-arm randomized trial comparing the efficacy of single agent
      hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a
      delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive
      care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of
      treatment in order to determine which regimen is more effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms
             consistent with COVID-19

          -  Ability to measure and quantify viral load by quantitative PCR

          -  Age 18 to 89

          -  Ability to swallow oral medications

          -  Patients must read, understand and sign IRB approved informed consent

        Exclusion Criteria:

          -  Pregnancy or women who are breast feeding

          -  Two consecutive negative assays for SARS-CoV-2 infection

          -  Patients that lack decision-making capacity will not be approached to participate in
             this study

          -  Inability to tolerate oral medications

          -  Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate

          -  QTc interval > 470 mSEC

          -  History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI
             CTCAE 5.0 criteria

          -  History of serious ventricular arrhythmia (VT or VF > 3 beats in a row)