bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: PF-00489791; Placebo
Intervention description: Tablet, 20 mg once daily for 12 weeks; Tablet, placebo once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic nephropathy; chronic kidney disease; PF-00489791; phosphodiesterase; PDE5

Summary:

      PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791
      will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,
      improving renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects greater than or equal to 18 years. Female subjects must be of
             non-child bearing potential.

          -  Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on
             an eGFR of 25-59 mL/min/1.73m2.

          -  Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to
             300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.

        Exclusion Criteria:

          -  Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

          -  Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.

          -  Subjects on combination ACE inhibitor/ARB therapy.
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Intervention: Sodium Oxybate; Sodium Oxybate; Placebo
Intervention description: Dose 1; Dose 2; Dose 3
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To determine the relationship between drug plasma levels and safety, tolerability and
      efficacy in patients with essential tremors after dosing with Sodium oxybate
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric
             postural or kinetic tremor involving hands and forearms.

          -  Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to
             Days 1 and 4 and on inpatient days

        Exclusion Criteria:

          -  Subjects with a clinically significant unstable medical abnormality, chronic disease
             or history or presence of significant hepatic, renal, endocrine, cardiovascular,
             gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other
             abnormality

          -  Subjects who are on sodium-restricted diets

          -  Subjects with a known history of sleep apnea
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg; Lansoprazole; Calcium carbonate/magnesium hydroxide; Placebo
Intervention description: Tablet; Tablet; Tablet; Tablet
Intervention MeSH terms: Calcium, Dietary; Lansoprazole; Dexlansoprazole; Calcium Carbonate; Magnesium Hydroxide; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heartburn; antacid; PPI; Lansoprazole; calcium carbonate; magnesium hydroxide; Relief of heartburn following ingestion of a heartburn-inducing meal

Summary:

      This study will investigate the safety and efficacy of an antacid/Lansoprazole combination
      product for the relief of heartburn after consuming a heartburn-inducing meal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Experiencing heartburn in the past month if untreated

          -  Having heartburn that responds to heartburn medication

          -  Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion
             in the study.

        Exclusion Criteria:

          -  Having history of erosive esophagitis or gastroesophageal reflux disease (GERD)
             diagnosed by a physician and confirmed by testing (endoscopy)

          -  Be unwilling to take only the study medication, and antacid provided as a rescue
             medication for relief of acute heartburn during the study.

        "Other protocol-defined inclusion/exclusion criteria may apply"
A Study to Test if TEV-48574 is Effective in Relieving Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: TEV-48574; Placebo
Intervention description: subcutaneous infusion; Matching Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2 low, non-T2 asthma

Summary:

      The primary objective of the study is to evaluate the effect of TEV-48574 compared with
      placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe
      asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).

      The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo
      on a range of clinical measures of asthma control.

      The duration of participant participation in the study is planned to be up to approximately
      30 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a diagnosis of asthma for at least 12 months prior to the initial
             screening visit.

          -  The participant is able to perform technically acceptable and repeatable spirometry,
             including with a hand-held spirometer, after training

          -  The participant has had at least one documented clinical asthma exacerbation in the 18
             months prior to (but not within 30 days of) the initial screening visit.

          -  The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years,
             with no current ecigarette or marijuana use.

        NOTE- Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  The participant has any concomitant conditions or treatments that could interfere with
             study conduct.

          -  The participant is currently pregnant or lactating or is planning to become pregnant
             during the study.

          -  The participant has received any live or attenuated vaccine within 15 days of the
             initial screening visit.

        NOTE- Additional criteria apply, please contact the investigator for more information
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
Condition: Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms
Intervention: GRN1005
Intervention description: 650 mg/m2 IV every 3 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GRN1005; ANG1005; LRP-1; Targeted Therapy; Brain Tumor; Blood Brain Barrier; Peptide-Drug Conjugate (PDC); Brain Metastases; Paclitaxel; Taxol; NSCLC; Non-Small Cell Lung Cancer

Summary:

      The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in
      patients with brain metastases from non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Adult patients (≥ 18 years)

          2. Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)

          3. Brain metastases from NSCLC, which:

             have radiologically-progressed after WBRT or are present without prior WBRT

          4. At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest
             diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as
             follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed
             by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter)
             confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is
             allowed; however, metastatic brain lesions previously treated with SRS are not allowed
             as target or as non-target lesions.

          5. Patients must be neurologically stable, defined as being on stable doses of
             corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol,
             carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining
             the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose of GRN1005 (Cycle 1,
             Day 1).

          6. Karnofsky Performance Score (KPS) ≥ 80%

          7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005
             (with the exception of local radiation therapy for palliation to extra-cranial sites,
             i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE
             v4.0 Grade 1.0.

        Key Exclusion Criteria:

          1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy

          2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt
             placement, etc.)

          3. Known intra-cranial hemorrhage

          4. Known leptomeningeal disease
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Condition: Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum
Intervention: Gabapentin; Metoclopramide
Intervention MeSH terms: Gabapentin; Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pregnancy; nausea; vomiting; hyperemesis; treatment; gabapentin; metoclopramide; safety

Summary:

      The investigators will compare the effectiveness of gabapentin to metoclopramide for 1 week
      among 60 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial.
      After completion of the 1-week double-blind phase, subjects will be offered open-label
      gabapentin with rescue metoclopramide until their symptoms no longer require treatment.
      Enrollment will occur at the University's at Buffalo, of Rochester and of Wisconsin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have received at least 2 administrations of intravenous (iv) hydration separated by at
             least 1 week or daily emesis for at least the last 14 days and 1 administration of iv
             hydration.

          2. Have at least one of the following: 2-4+ ketonuria, serum potassium < 3.4mmol, or >5%
             weight loss from weight upon entry to prenatal care.

          3. Have failed therapy with at least one antiemetic.

          4. Have fetal ultrasound within 6 weeks prior to enrollment confirming a
             normal-appearing, intrauterine, singleton pregnancy of gestational age < 16 weeks at
             time of enrollment.

          5. Felt by the patient's obstetrician or emergency room attending physician not to have
             other medical problems such as bowel obstruction, pancreatitis, biliary colic, or
             peptic ulcer disease that could be contributing to the patient's symptoms.

          6. Be >18 years old and not decided to terminate the pregnancy.

          7. Have not received or planning to receive a peripherally inserted central catheter (PIC
             line).

          8. Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.

          9. Felt not to have any other significant medical, psychiatric or substance abuse problem
             that would preclude participation in the study.

         10. Denies drinking any alcohol after learning about current pregnancy.

         11. Agrees to discontinue any current anti-emetic treatments (including antihistamines,
             ginger, > 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics,
             acupuncture, hypnosis, or wrist bands) for the next 4 weeks.

         12. Pregnancy not conceived through in-vitro fertilization.

         13. Able to understand and comply with the study procedures and give informed consent.

        Exclusion Criteria:

        None not mentioned under Inclusion Criteria.
Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: AGN-223575 ophthalmic solution; AGN-223575 vehicle ophthalmic solution
Intervention description: AGN-223575 ophthalmic solution once or twice daily; Vehicle to AGN22375 ophthalmic solution once or twice daily.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of
      3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle
      in patients with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signs and symptoms of dry eye disease

          -  Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60
             days.

        Exclusion Criteria:

          -  History of glaucoma, or ocular hypertension

          -  Diagnosis of ocular infection

          -  Use of contact lenses in the past 14 days or expected use during the study

          -  Use of any topical ophthalmic medications in the past 30 days

          -  Use of corticosteroids in the past 30 days.
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).
Verapamil as Therapy for Children and Young Adults With Dravet Syndrome
Condition: Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Intervention: Verapamil
Intervention description: Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used.
Children will start on a 4 weeks titration period:
Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID
In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study.
Intervention MeSH terms: Verapamil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 2 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Dravet; seizures; verapamil

Summary:

      This study will assess how well the drug verapamil can improve control of seizures and
      dysautonomia symptoms in children and young adults diagnosed with Dravet syndrome. The safety
      of verapamil when given with all concomitant medications will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 to 25 years old

          -  Onset of seizures in first year of life

          -  seizure type usually generalized tonic-clonic, clonic, or hemiclonic, often prolonged
             (>10 minutes)

          -  myoclonic jerks/myoclonic seizures

          -  history of normal development at seizure onset with subsequent developmental delay or
             regression which occurs after seizure onset

          -  presence of documented abnormality on the SCN1A gene

          -  medically intractable epilepsy: must have been on at least 2 prior antiepileptic
             medications without adequate control of epilepsy

          -  subject is capable of giving informed consent (or assent if possible) or has an
             acceptable surrogate capable of giving informed consent on the subject's behalf

        Exclusion Criteria:

          -  use of clonidine, propranolol, carbamazepine, oxcarbazine, stiripentol, lamotrigine,
             or cyclosporine

          -  Abnormalities of cardiac conduction or rhythm (excluding sinus arrhythmia) on
             screening EKG

          -  significant use of grapefruit juice

          -  ketogenic diet

          -  pregnancy
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Colchicine Tablets; Current care per UCLA treating physicians
Intervention description: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.; Current care
Intervention MeSH terms: Colchicine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random assignment to study arms in a 1:1 ratio
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per
      UCLA treating physicians versus current care per UCLA treating physicians alone (control
      arm). Importantly, this adaptive trial design allows for patients in either study arm to
      receive other investigational drugs for COVID-19 as new science emerges.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 infection by polymerase chain reaction

          -  Cardiac injury, including any of the following:

               -  Elevated troponin level

               -  Elevated B-type natriuretic peptide (BNP) level

               -  New ischemic or arrhythmogenic changes on ECG/telemetry

               -  New decrease in left ventricular ejection fraction (LVEF) or new pericardial
                  effusion on echocardiogram

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use
             2 forms of contraception, which includes:

               -  Intrauterine devices (IUD), contraceptive implants, or tubal sterilization

               -  Hormone methods with a barrier method

               -  Two barrier methods

               -  If a partner's vasectomy is the chosen method of contraception, a hormone or
                  barrier method must also be used in conjunction

          -  Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein (P-gp) transport
             system inhibitors

          -  Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic
             impairment;

          -  Severe hematologic or neuromuscular disorders

          -  Severe renal impairment with concomitant hepatic impairment