bioihbjkbjnl/mcl2 huggingface dataset:
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Spartalizumab; Capmatinib; spartalizumab placebo
Intervention description: Concentrate for solution for infusion; Film-coated tablet; dextrose 5% in water (D5W) for infusion
Intervention MeSH terms: Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Run-in part: single arm, open-label.
Randomized part: two-arms parallel assignment, double-blinded, placebo control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capmatinib; spartalizumab; MET mutation; EGFR wild-type; ALK negative mutation

Summary:

      A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and
      safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus
      capmatinib and placebo as first line treatment for locally advanced or metastatic non-small
      cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed locally advanced or metastatic NSCLC which is EGFR wild-type,
             ALK rearrangement negative and METΔex14 mutated

          -  No prior systemic therapy for advanced/metastatic disease (neo-adjuvant/adjuvant
             treatment completed > 12 months before relapse are permitted)

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  Measurable disease as per RECIST 1.1

          -  Known PD-L1 tumor expression status (applicable to Randomized part 2 only)

        Key Exclusion Criteria:

          -  Prior treatment with a PD-1/PD-L1 inhibitor, MET inhibitor or HGF inhibitor

          -  Presence of symptomatic CNS metastases or requiring local CNS-directed therapy
             (radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to
             study entry

          -  Impaired cardiac function or clinically significant cardiac disease

          -  Presence or history of interstitial lung disease, non-infectious pneumonitis or
             interstitial pneumonitis, including clinically significant radiation pneumonitis

          -  History of allogenic bone marrow or solid organ transplant

          -  Radiotherapy to lung fields ≤ 4 weeks or to any other anatomic site ≤ 2 weeks prior to
             start of study treatment (palliative radiotherapy for bone lesions is allowed)
Phase 2 Study for the Treatment of Superficial Lipomas
Condition: Lipoma
MeSH terms: Lipoma
Intervention: Deoxycholic Acid Injection; Placebo
Intervention description: Administered via intralipomal injection.; Matching vehicle placebo administered via intralipomal injection.
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to compare the safety and effectiveness of 3 different
      concentrations of deoxycholic acid for injection against a placebo in the treatment of
      superficial lipomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One or more lipomas, based on clinical and histological diagnosis, which are
             accessible for treatment and assessment, are quantifiable along at least 2
             perpendicular diameters, and have the following characteristics:

               -  History of slow growth followed by dormancy, and stable for at least 6 months

               -  Greatest length multiplied by greatest perpendicular width between 1 and 16 cm²,
                  inclusive

               -  Discrete, oval to rounded in shape, not hard or attached to underlying tissue

               -  Without changes in overlying skin (ie, inflammation, pain or tenderness,
                  hyperpigmentation)

               -  Located on the trunk, arms, legs, or neck

          -  Signed informed consent.

        Exclusion Criteria:

          -  Absence of significant medical conditions that could affect safety

          -  History of surgical or deoxycholate treatment for lipomas

          -  Treatment with an investigational agent within 30 days before ATX-101 treatment
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Clonazepam
Intervention description: 1 Dose
Intervention MeSH terms: Clonazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of refractory epilepsy

          -  No Nasal conditions that would preclude the use of intranasal product

        Exclusion Criteria:

          -  Subject with a clinical significant unstable medical abnormality

          -  Subject currently or regularly taking Clonazepam
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine Nasal Spray; Placebo Nasal Spray
Intervention description: Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution; Daily single dose of placebo delivered as single puff of nasal spray solution
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rotigotine; Rotigotine nasal spray; Efficacy, safety and tolerability; Restless Legs Syndrome

Summary:

      The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of
      rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment

        Exclusion Criteria:

          -  Patients with secondary RLS or clinically relevant concomitant diseases or medical
             conditions are excluded
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ruxolitinib
Intervention description: Ruxolitinib 1.5% cream BID for 28 days
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: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: psoriasis

Summary:

      This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in
      patients with active, stable plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have psoriatic lesions measuring protocol specific BSA

        Exclusion Criteria:

          -  Lesions solely involving the palms of the hands, the soles of the feet, the
             intertriginious areas, the scalp or the face

          -  Pustular psoriasis or erythroderma
Essential Oils for Enhancing QOL in ASD
Condition: Autism Spectrum Disorder; Quality of Life; Sleep; Anxiety
MeSH terms: Autism Spectrum Disorder
Intervention: Reconnect; Coconut oil Comparator
Intervention description: Topical Essential Oils mixture and aromatic method; Topical Essential Oils mixture and aromatic method
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Relaxation

Summary:

      Essential oils (aromatic oils extracted from plant parts) are routinely used by the public
      and are available on the market. Investigators are conducting this study because it is
      unknown whether the essential oils formulations will be safe and effective for improving
      quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and
      sleep.

      Children invited to participate in this study must be between 3-9 years of age and have been
      diagnosed with Autism Spectrum Disorder. Twenty eight children and their families will be
      enrolled in the study.

      Participants will try two different fragrant oils in a double-blind randomized order. Each
      child will receive each treatment for 3 months, with a 1-month "washout" period in between
      during which no oil is used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients between 3 and 9 years of age, inclusive;

          -  Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V;

          -  Mean item score of > or = 1.5 PedsQL Inventory;

          -  Care provider who can reliably bring subject to clinic visits and provide trustworthy
             ratings.

        Exclusion Criteria:

          -  Bipolar disorder by Child & Adolescent Symptom Inventory (CASI, Gadow & Sprafkin,
             1997) and clinical interview/history, or major depression accompanied by family
             history of bipolar disorder;

          -  Children with allergies to essential oils;

          -  Children with seizure disorder/epilepsy;

          -  Significant physical illness (e.g., serious cardiovascular, liver or renal pathology);

          -  Medications specifically given for insomnia and exogenous melatonin, which have the
             potential to confound study results, within the previous 2 weeks before baseline;

          -  Anticipated changes of doses of medication or other medical treatments or supplements;

          -  Weight less than 10 kg;

          -  Sleep Disordered Breathing (SDB) as defined by a total score of > or = 3 on the CSHQ
             SDB subscale and parent report;

          -  Nut allergies;

          -  Allergy to vanilla;

          -  A substantial trial of essential oil use within the past 6 months (i.e., consistent
             use for 6 weeks).
The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Placebo; Pancreatic Polypeptide (PP)
Intervention description: 2pmol/kg-1/min-1 placebo infused continuously over 72 hours.; 2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Intervention MeSH terms: Pancreatic Polypeptide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Insulin pump therapy; Type 1 diabetic; Chronic pancreatitis; Pancreatic resection; Pancreatic polypeptide

Summary:

      The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is
      naturally produced by the pancreas and that works to control the amount of glucose that the
      liver makes, will reduce the amount of insulin required for people who must take insulin to
      maintain their normal blood glucose level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female volunteers between the ages of 18-75 with:

          -  10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1
             diabetic for > 8 years (volunteers must have a stable glycemic profile that includes
             use of an insulin pump to control their blood glucose) with or without prior
             pancreatic resection.

          -  HbA1c levels ≤ 8.5.

        Exclusion Criteria:

          -  Lactating or pregnant females.

          -  Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose
             control with large fluctuations in glucose levels for no obvious reason.

          -  Allergy to beef or beef by-products.

          -  Hypoglycemia within the past year requiring medical or other assistance to correct.

          -  Known autonomic neuropathy.

          -  Documented blood glucose under 60 mg within the past year and hypoglycemic
             unawareness.

          -  Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.

          -  Not currently on pump therapy.

          -  Type 1 DM who has a BMI ≥ 35.
Study of Quetiapine Treatment for Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: quetiapine
Intervention description: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cannabis; quetiapine

Summary:

      Marijuana is the most commonly used illicit drug in the United States. However, the treatment
      options for cannabis dependence are limited; notably, no effective pharmacotherapy has been
      developed. Conceptually, the ideal medication treatment for cannabis dependence would:

        1. be safe when administered to patients actively using cannabis

        2. reduce cannabis intake and promote abstinence

        3. treat the symptoms of cannabis withdrawal

        4. reduce craving and relapse risk

        5. have a low abuse liability.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Between the ages of 18-65

          2. Meets DSM-IV criteria for current cannabis dependence

          3. Seeking treatment for cannabis dependence

          4. Reports using cannabis an average of five days per week over the past 28 days

          5. Capable of giving informed consent and complying with study procedures

        Exclusion Criteria:

          1. Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or
             bipolar disorder

          2. Current DSM-IV criteria for any other psychiatric disorder that may, according to the
             investigator's judgment, require either pharmacological or non-pharmacological
             intervention over the course of the study

          3. Receiving prescribed psychotropic medication

          4. Known history of allergy, intolerance, or hypersensitivity to quetiapine

          5. Pregnancy, lactation, or failure to use adequate contraceptive methods in female
             patients who are currently engaging in sexual activity with men

          6. Unstable medical conditions, such as poorly controlled diabetes or hypertension, which
             might make participation hazardous

          7. Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine
             dependence

          8. Are legally mandated to participate in a substance use disorder treatment program

          9. Increased risk for suicide

         10. Diabetes (whether controlled or not), hyperglycemia (fasting glucose > 100 mg/dl),
             obesity (BMI > 30) and elevated lipids (cholesterol > 200 mg/dl; triglycerides > 150
             mg/dl).
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Placebo; Statin; PF-04950615 (RN316); Statin; PF-04950615 (RN316); Statin; PF-04950615 (RN316); Satin; PF-04950615 (RN316); Statin
Intervention description: Intravenous placebo monthly during treatment phase.; Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.; Intravenous 10mg/mL based on weight monthly during treatment phase.; Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.; Intravenous 10mg/mL based on weight monthly during treatment phase.; Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.; Intravenous 10mg/mL based on weight monthly during treatment phase.; Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.; Intravenous 10mg/mL based on weight monthly during treatment phase.; Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Intervention MeSH terms: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bococizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PF-04950615; RN316

Summary:

      This study will investigate the effect of PF-04950615, a new investigational lipid lowering
      agent, on LDL-C and other lipids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.

          -  Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C
             greater than 100 mg/dL and fasting TG less than 400 mg/dL

        Exclusion Criteria:

          -  History of a cardiovascular or cerebrovascular event or procedure during the past
             year.

          -  Poorly controlled type 1 or type 2 diabetes mellitus.

          -  Poorly controlled hypertension.
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Condition: Ureaplasma Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Ureaplasma Infections
Intervention: Azithromycin; Placebo
Intervention description: Azithromycin intravenous 20 mg/kg every 24 h x 3 days; D5W
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 2 Hours
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: Ureaplasma parvum; Ureaplasma urealyticum; prematurity; bronchopulmonary dysplasia; azithromycin

Summary:

      The purpose of this study is to determine whether intravenous azithromycin is effective in
      eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks
      gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate

          -  <72 h age

          -  Positive pressure ventilation for at least 1 hour duration during the first 72 hours
             of life

          -  Presence of indwelling intravenous line for drug administration

        Exclusion Criteria:

          -  Any patient judged to be non-viable or for whom withdrawal of life support is planned

          -  Patients with major lethal congenital anomalies

          -  Triplets or higher order multiples

          -  Patients delivered for maternal indications (low risk of Ureaplasma colonization)

          -  Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms

          -  Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)

          -  Patients exposed to other systemic macrolide

          -  Patients with clinically suspected Ureaplasma central nervous system (CNS) infection
             or other confirmed bacterial/viral infection

          -  Patients participating in other clinical trials involving investigational products.
A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: MK-6213; Atorvastatin calcium; Placebo for MK-6312 160 mg; Placebo for Atorvastatin 20 mg
Intervention description: MK-6213 160 mg for 4 weeks.; atorvastatin calcium 20mg for 4 weeks.
Intervention MeSH terms: Atorvastatin; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to
      MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 75 years of age at the time of the study with high cholesterol

          -  Can have diabetes mellitus but is not currently on lipid lowering therapy

          -  Have a stable weight for >6 weeks

        Exclusion Criteria:

          -  Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system),
             respiratory (lung), hepatic (liver) or metabolic disease

          -  history of mental instability or drug/alcohol abuse within the past 5 years

          -  Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer
             within the past 5 years or participation in an investigational trial within the last
             30 days