TrialPanorama/Dataset huggingface dataset:
Please assess the completion status of the following clinical trial:

Trial Title: A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Key Inclusion Criteria:~* Male or female, aged 18 years and older~* Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)~* Eastern Cooperative Oncology Group Performance Status score of 0-2~Key Exclusion Criteria:~* Pleural Effusion~* Uncontrolled cardiovascular disease~* Significant bleeding disorder unrelated to CML~* Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Dasatinib (Type: EXPERIMENTAL): None
- Imatinib (Type: ACTIVE_COMPARATOR): None

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Adult patients 18-75 years of age.~* Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.~* Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.~* At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes~* Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.~Exclusion Criteria:~* Rheumatic autoimmune disease other than RA.~* Use of any biological DMARDs for RA within past 6 months.~* Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate~* Active infection, or history of serious or chronic infection

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- SM03 600 mg*2 (Type: EXPERIMENTAL): SM03: 600 mg intravenous (IV) on week 0,2, and week 12,14; placebo: 600 mg intravenous (IV) on week 4 and16; Methotrexate: 7.5-20 mg/wk oral.
- SM03 600 mg*3 (Type: EXPERIMENTAL): SM03: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
- placebo*3 (Type: PLACEBO_COMPARATOR): placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Provision of informed consent prior to any study specific procedures~* Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization~Exclusion Criteria:~* Type 1 diabetes mellitus~* FPG \>240 mg/dL before randomization~* Subjects who have history of unstable or rapidly progressing renal disease~* Subjects who have severe hepatic insufficiency and/or significant abnormal liver function~* Significant cardiovascular history

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Dapagliflozin 5 mg
- 2 (Type: EXPERIMENTAL): Dapagliflozin 10 mg
- 3 (Type: PLACEBO_COMPARATOR): None

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Bivalirudin as a Procedural Anticoagulant in Pediatrics

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Male and non-pregnant females, with an age range of birth to 16 years of age.~* Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.~* Written informed consent from a legal guardian/parent.~* Life expectancy of at least 15 days at study entry.~* Assent of the patient if older than 8 years, whenever possible.~Exclusion Criteria:~* History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.~* Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.~* Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.~* Known congenital or acquired bleeding or clotting disorder.~* Patients undergoing renal dialysis.\*~* Weight \< 2.5 kg.~* Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).~* Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).~* Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.~* Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.~* Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is \> 1.5.~* Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.~* Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.~* Patients previously enrolled in the study.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 16 Years
- Healthy Volunteers: f

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Key Inclusion Criteria:~* 18 years of age or older with diabetic macular edema;~* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);~* Visual acuity in other eye no worse than 20/200~Key Exclusion Criteria:~* Known anticipated need for ocular surgery within next 12 months;~* History of glaucoma or current high eye pressure requiring more than 1 medication;~* Uncontrolled systemic disease;~* Known steroid-responder;~* Use of systemic steroids;~* Use of Warfarin/Heparin

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Dexamethasone 700 μg (Type: EXPERIMENTAL): 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
- Dexamethasone 350 μg (Type: EXPERIMENTAL): 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
- Sham (Type: SHAM_COMPARATOR): Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Classified as type 2 diabetes~* Written informed consent~* Age: for men and women 35-75 years; for women below 75 years should be postmenopausal (defined as no menstrual bleeding since at least one year).~* Body mass index 25-40 kg/m2~* At screening visit : HbA1c 6-10 %, equivalent to 41-86 mmol/mol~* Currently treated with metformin or diet~Exclusion Criteria:~* Treatment with insulin, other anti-diabetic treatment given as injections or any oral anti-diabetic treatment except metformin~* Fasting blood glucose at screening \> 15.0 mmol/L~* Active liver disease~* At screening or at any subsequent visit a level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) of more than three times the upper limit of the normal range~* Gastrointestinal ailments which may interfere with the ability to adequately absorb sulforaphane~* At screening visit creatinine \> 130 µmol/L~* Coagulation disorder or current anti-coagulant therapy with warfarin, which may be affected by the BSE~* Diagnosed with a cardiovascular disease or event within 6 months prior to enrolment~* Systemic glucocorticoid treatment~* Herbal treatment, defined as food supplement (except multivitamin treatment) with herbal or vegetable extracts that may contain sulforaphane~* Allergy to broccoli~* Mental disorder making the patient unable to understand the study information~* Participation in other clinical trial which may affect the outcome of the present study~* Any other physical or psychiatric condition or treatment that in the judgment of the investigator makes it difficult to participate in the study.

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo containing maltodextrine but no active sulforaphane
- BSE (Type: ACTIVE_COMPARATOR): Broccoli sprout extract once daily for 12 weeks

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy, ambulatory, male or female volunteers 16-40 years of age;~* Body mass index 18.0 to 30.0 kg/m\^2 inclusive;~* Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;~* Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;~Exclusion Criteria:~* History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;~* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;~* Relevant concomitant disease such as asthma (exercise induced asthma is permitted)

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: 40 Years
- Healthy Volunteers: f

Study Arms:
- Naproxen Sodium (Aleve, BAY117031) (Type: EXPERIMENTAL): Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
- Ibuprofen (Advil) (Type: ACTIVE_COMPARATOR): Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
- Placebo (Type: PLACEBO_COMPARATOR): Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion criteria:~* Patients undergoing valve- and/or coronary bypass surgery~* Signed patient informed consent~* Only patients will be enrolled who won't have an emergency surgery on the same day~Exclusion criteria:~* Participation in another clinical trial within the last 4 weeks prior to enrollment~* Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial~* Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.~* Patients who have not reached the age of legal majority~* Pregnant or lactating women~* Jehovah's Witnesses~* Patients with endocarditis~* Existing allergy or intolerance to ferric carboxymaltose or mannitol

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Anemia (Type: ACTIVE_COMPARATOR): Hb \< 120 g/L in women, Hb \< 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
- Iron deficiency (Type: ACTIVE_COMPARATOR): ferritin \< 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
- Natural comparison group (Type: NO_INTERVENTION): Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* ASA status I-II~* aged 2-5 yr~* Undergoing unilateral orchiopexy/inguinal hernia repair~Exclusion Criteria:~* Hypersensitivity to any local anesthetics~* Patient has history of allergy, intolerance, or reaction to dexmedetomidine~* Infections at puncture sites~* Bleeding diathesis~* Preexisting neurological disease~* Diabetes mellitus~* Children with uncorrected cardiac lesions~* Children with heart block or liver impairment

- Gender: MALE
- Minimum Age: 2 Years
- Maximum Age: 5 Years
- Healthy Volunteers: f

Study Arms:
- Caudal Dexmedetomidine (Type: EXPERIMENTAL): Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg~Intravenous: 10 ml normal saline~Anesthesia was induced and maintained with sevoflurane
- Intravenous Dexmedetomidine (Type: EXPERIMENTAL): Caudal: Levobupivacaine 0.25% 1ml/kg~Intravenous: dexmedetomidine 1µg/kg~Anesthesia was induced and maintained with sevoflurane
- Placebo (Type: PLACEBO_COMPARATOR): Caudal: Levobupivacaine 0.25% 1ml/kg~Intravenous: 10 ml normal saline~Anesthesia was induced and maintained with sevoflurane

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Age 12 to 24 months at the time of enrollment~* Healthy child, determined by clinical history~* Availability to do study visits and blood sampling on days 28 + 7 and 56 + 14~* Informed consent signed by parents~Exclusion Criteria:~* Previous vaccination against yellow fever, measles, mumps, or rubella~* History of yellow fever, measles, mumps or rubella~* Contraindication for any of the study vaccines: yellow fever vaccine or triple viral vaccine, including:~  1. Allergy to eggs, gelatin, or neomycin~ 2. Weakened immunological function, including HIV infection, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulators or chemotherapeutic agents~ 3. Thymus disease~ 4. Serious illness/fever (mild illness without fever is not an exclusion criterion)~* Administration of immunoglobulins or other blood derivative within 6 months of enrollment in the study or during the study~  a. Exception: children with a history of Kawasaki disease who received gammaglobulin cannot be enrolled if they received it in the previous 11 months.~* Administration of any other attenuated viral vaccine (i.e., for chickenpox) in the month prior to enrollment, or if the administration of any other attenuated viral vaccine is expected during the study (up to 3 months)~* Not being available for the entire study period (up to 3 months), or not able to make the scheduled visits or complete the study procedures~* Participating in another clinical drug trial of a drug, vaccine, or medical device~* Any condition that, in opinion of the study staff, represents a health risk to the participant or interferes with the evaluation of the response to the vaccine (i.e., children in percentile ≤ 3 in the height/weight tables will be considered undernourished and cannot be selected)

- Gender: ALL
- Minimum Age: 12 Months
- Maximum Age: 24 Months
- Healthy Volunteers: t

Study Arms:
- Co-administration of MMR/YF (Type: EXPERIMENTAL): Participants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0.
- MMR followed by YF (Type: ACTIVE_COMPARATOR): Participants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28.
- YF followed by MMR (Type: ACTIVE_COMPARATOR): Participants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: COHORT
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Naïve patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).~Exclusion Criteria:~* Exclusion criteria as listed in the local SPC. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.~* Any concomitant therapy with another agent to treat wet AMD in the study eye.~* Any prior or concomitant therapy with another drug for wAMD.

- Gender: ALL
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Cohort 1 (Type: None): According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Men and women ≥18 years of age at the time of the screening visit~2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)~3. Willing to consistently maintain usual diet for the duration of the study~Exclusion Criteria:~1. Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit~2. Having undergone lipid apheresis within 4 weeks prior to the screening visit~3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit~4. Previous participation in any clinical trial of REGN1500~Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Open-label (Type: EXPERIMENTAL): Open-label REGN1500

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_CONTROL
- Primary Purpose: None
- Time Perspective: CROSS_SECTIONAL
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Patients with clinically diagnosed oral premalignant lesions (oral leukoplakia and oral lichen planus).~Exclusion Criteria:~* Patients with OSMF~* bleeding disorders and~* other systemic diseases

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Rose Bengal positive lesion and biopsy (Type: None): Lesions that were stained positive with rose bengal were biopsied and assessed for dysplasia
- Toluidine blue positive lesion and biopsy (Type: None): Lesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete