bioihbjkbjnl/mcl2 huggingface dataset:
Study Of Sunitinib With Capecitabine In Breast Cancer
Condition: Advanced/Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; Sunitinib
Intervention description: Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles; Sunitinib 37.5 mg daily, continuous dosing
Intervention MeSH terms: Capecitabine; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese
      patients with advanced/metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not
             amenable to surgery, radiation, or combined modality therapy with curative intent

          -  Measurable disease as per RECIST. Measurable lesions that have been previously
             irradiated will not be considered target lesions unless increase in size has been
             observed following completion of radiation therapy.

          -  Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or
             metastatic disease settings.

        Exclusion Criteria:

          -  Histology of inflammatory carcinoma with no other measurable disease. Patients with
             histology of inflammatory carcinoma are allowed on study if they have measurable
             disease.

          -  Brain metastases, spinal cord compression, or carcinomatous meningitis, or
             leptomeningeal disease.

          -  Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon
             (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1
             (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Spesolimab
Intervention description: 12 weeks treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to understand the mechanism of action of BI655130 in
      patients with UC

      Secondary objectives are to explore clinical effect, safety and tolerability (including
      immunogenicity) of BI 655130 treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 75 years at screening

          -  Diagnosis of UC >= 3 months prior to screening.

          -  Moderately to severely active UC as confirmed by Mayo Score ≥6

          -  Receiving conventional, non-biologic therapy for UC.

          -  Negative colon cancer screening

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or
             IL23 inhibitors, any investigational biological drugs)

          -  Extensive colonic resection

          -  Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior
             to screening

          -  Active or latent tuberculosis

          -  Further exclusion criteria apply
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Placebo; Pravastatin; Dalcetrapib; Dalcetrapib; Dalcetrapib
Intervention description: po daily for 12 weeks; 40mg po daily for 12 weeks; 300mg po daily for 12 weeks; 600mg po daily for 12 weeks; 900mg po daily for 12 weeks
Intervention MeSH terms: Pravastatin; Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 292.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with
      pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised
      to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po
      daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The
      anticipated time on study treatment is 3 months and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-75 years of age;

          -  dyslipidemic patients with low or relatively low HDL-C levels during treatment with
             pravastatin.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding, or of child-bearing potential;

          -  morbid obesity;

          -  uncontrolled hypertension;

          -  poorly controlled or insulin-treated diabetes;

          -  high creatinine levels or history of statin-associated myopathy.
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Condition: Smoking, Marijuana
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: CBD
Intervention description: Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: reinforcement, good drug effect, high, mood, cannabidiol

Summary:

      The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400,
      800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and
      cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when
      combined with placebo marijuana, as well as its ability to modulate the behavioral effects of
      active marijuana.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between the ages of 18 and 50.

          -  Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during
             the preceding 4 weeks.

          -  Able to perform study procedures

          -  Women practicing an effective form of birth control

        Exclusion Criteria:

          -  Female subjects who are currently pregnant or breastfeeding.

          -  Current, repeated illicit drug use other than marijuana

          -  Presence of significant medical illness

          -  History of heart disease

          -  Request for drug treatment

          -  Current parole or probation

          -  Recent history of significant violent behavior

          -  Major psychiatric disorder
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab
Intervention description: 40 mg every other week (eow), subcutaneous (sc)
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study is to assess the long-term safety, tolerability, and efficacy of
      repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in the prior adalimumab study

          -  Body weight less than 100 kg.

          -  Subject's who wished to continue the study drug administration

          -  Females must be postmenopausal for at least 1 year, surgically sterile, or practicing
             birth control throughout the study and for 90 days after study completion.

        Exclusion Criteria:

          -  A subject who experienced any of the following during the prior adalimumab sc dosing
             study:

               -  Advanced or poorly controlled diabetes

               -  Any poorly controlled medical condition

               -  Intra-articular, intramuscular or iv administration of corticosteroids

               -  Joint surgery.

          -  A subject who has been prescribed excluded medications during previous adalimumab
             study.

          -  History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse,
             active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any
             malignancy with the exception of successfully treated non- metastatic basal cell
             carcinoma of the skin.

          -  A subject who experienced chronic or active infection or any major episode of
             infection requiring hospitalization or treatment with intravenous (iv) antibiotics
             within 30 days of entry into study or chronic use of oral antibiotics within 14 days
             of entry into study.

          -  Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.
Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Rare Chronic Anemia Patients
Condition: Anemia; Hemosiderosis
MeSH terms: Anemia; Thalassemia; beta-Thalassemia; Hemochromatosis; Hemosiderosis
Intervention: Deferasirox
Intervention description: Deferasirox available as 125 mg, 250 mg or 500 mg tablets
Intervention MeSH terms: Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: β-thalassemia; rare chronic anemia; iron overload; deferasirox; chronic anemias; transfusional hemosiderosis

Summary:

      A 1-year randomized Phase II core trial was conducted to investigate the efficacy of
      deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia
      2 years of age and older. Patients who successfully completed the main trial may continue in
      the extension trial to receive chelation therapy with deferasirox for up to 3 years.
      Extension was prolonged to 4 years.

      The objective of this study is to assess the long-term safety and efficacy of deferasirox in
      these patient groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients completed the planned 12-month core study

          -  Female patients who have reached menarche and who are sexually active must use
             double-barrier contraception, oral contraceptive plus barrier contraceptive, or must
             have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal
             ligation

          -  Written informed consent obtained from the patient and/or legal guardian on the
             patient's behalf in accordance with the national legislation

        Exclusion Criteria:

          -  Pregnant or breast feeding patients

        Other protocol-defined inclusion/exclusion criteria may apply
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
Condition: Appendicitis
MeSH terms: Appendicitis
Intervention: Ropivacaine; Bupivacaine
Intervention description: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally; The local anesthetic at the incision sites will be injected by the surgeon.
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Healthy volunteers: No
Keywords: Transversus abdominis plane block; TAP block; Local anesthetic infiltration; Appendectomy; Laparoscopic appendectomy

Summary:

      This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One
      group of patients will receive a transversus abdominis plane (TAP) block. The second group
      will receive local anesthetic infiltration injected at the surgical site by the surgeon at
      the end of surgery for a laparoscopic appendectomy. The purpose of this study is to
      prospectively compare post-operative pain relief in pediatric patients undergoing
      laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block
      or local anesthetic infiltration by the surgeon for analgesia to compare the most appropriate
      delivery of effective analgesia. In an effort to improve postoperative analgesia while
      limiting opioid-related adverse effects, there continues to be an increased use of multimodal
      techniques in infants and children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA physical status I or II

          -  Patients > 4 years of age

          -  Weight less than or equal to 60 kg

          -  Presenting for laparoscopic appendectomy

        Exclusion Criteria:

          -  ASA physical status > II

          -  Patients < 4 years of age

          -  Weight greater than 60 kg

          -  Patients presenting for ruptured appendectomy surgical procedures

          -  Co-morbid diseases (cardiac, pulmonary (not including asthma), neurological disease)

          -  Patients having concomitant procedures (circumcision, orchiopexy, etc.)
Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia
Condition: Invasive Pulmonary Aspergillosis; Lymphoblastic Leukaemia; Myeloblastic Leukaemia; Lymphoblastic Leukemia; Myeloblastic Leukemia
MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid
Intervention: AMPHOTERICIN B
Intervention description: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Invasive pulmonary aspergillosis; IFI; Leukaemia; Leukemia; Pediatric; Paediatrics; Amphotericin B; Aspergillosis; Pulmonary Aspergillosis; Invasive Aspergillosis; Antifungal agents; Fungal infections; Invasive Fungal Infection

Summary:

      The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised
      amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary
      aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: patients between 3 and 18 years.

          2. Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy.

          3. Informed consent of parents/guardians and/or assent of the patient has been obtained.

        Exclusion Criteria:

          1. Probable or proven invasive pulmonary fungal infection before entering the trial.

          2. Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL

          3. Severe hepatic impairment.

          4. Moderate-severe asthma being treated pharmacologically.

          5. Antifungal treatment for filamentous fungi in the last 4 weeks.

          6. Participating or have participated in a clinical trial during the last 4 weeks.

          7. Mentally retarded

          8. Known allergy or hypersensitivity to the active ingredient of the study drug or to any
             of its excipients.

          9. Any serious concomitant disease that in the investigator's opinion could compromise
             the completion of the trial or affect the patient's tolerability to this treatment.

         10. Pregnancy (in women of fertile age).

         11. Breast-feeding.

        Patients are defined as having probable IFI when their radiological image is suggestive of
        fungal infection and they have positive antigenemia for Aspergillus. IFI would be proven
        when the presence of Aspergillus is confirmed in aspirate culture or by lung biopsy.
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Condition: Nocturia; Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Nocturia
Intervention: silodosin
Intervention description: α1-adrenergic antagonist
Intervention MeSH terms: Silodosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 215.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: nocturia; BPH; benign prostate hyperplasia; nocturia in men with benign prostate hyperplasia

Summary:

      Silodosin is compared to placebo to determine if it is safe and effective for the treatment
      of nighttime urination (nocturia) in men with BPH
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males in good general health and at least 50 years of age, with symptoms of moderate
             to severe BPH and nocturia (>=2 episodes per night)

        Exclusion Criteria:

          -  Medical conditions that would confound the efficacy evaluation.

          -  Medical conditions in which it would be unsafe to use an alpha-blocker.

          -  The use of concomitant drugs that would confound the efficacy evaluation.

          -  The use of concomitant drugs that would be unsafe with this alpha-blocker.
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Condition: Lateral Canthal Lines; Crow's Feet
Intervention: botulinum toxin, Type A; Vehicle
Intervention description: topical liniment; Vehicle Formulation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential cohort, dose escalating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: Female
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  females 25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet on contraction

          -  adequate vision to assess facial wrinkles in a mirror

          -  willingness to refrain from products affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating

          -  subjects should be in good general health

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
Condition: Recurrent Glioblastoma or Other Glioma Subtypes
MeSH terms: Glioblastoma; Recurrence
Intervention: BGJ398
Intervention description: Capsule for oral use.
Intervention MeSH terms: Infigratinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BGJ398,; recurrent glioblastoma'; recurrent GBM,; FGFR,

Summary:

      This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to
      adult patients with histologically confirmed GBM and/or other glioma subtypes with
      FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of
             diagnosis or prior relapse.

          2. Written documentation of local or central laboratory determination of amplification or
             translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1,
             FGFR2,or FGFR3

          3. RANO defined tumor progression by MRI in comparison to a prior scan

          4. Patients must have received prior external beam radiotherapy and temozolomide.

        Exclusion criteria:

          1. History of another primary malignancy

          2. Prior or current treatment with a FGFR inhibitor

          3. Neurological symptoms related to underlying disease requiring increasing doses of
             corticosteroids

          4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously
             on an EIAED, the patient must be off of it for at least two weeks prior to study
             treatment.
Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Intervention: Placebo; Dalfampridine
Intervention description: Placebo 3 hrs before sleep; Dalfampridine 10 mg extended release 3 hrs before sleep
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this protocol the investigators will test the effect of dalfampridine (a potassium channel
      blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy
      control subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy control subjects

        Exclusion Criteria:

          -  Cardiovascular disease other than well controlled hypertension

          -  History of seizures