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

Trial Title: Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

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

Eligibility Criteria:
Inclusion criteria:~* Diagnosis of type 2 diabetes mellitus~* Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening~* Fasting C-peptide must be \> 0.5 ng/mL~* HbA1c at screening in Patients who are treated with insulin alone must be \>=7.5% and \<=10.0%~* HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be \>=7.0% and \<=9.5% at screening, and \>=7.5% and \<=10.0% at placebo run-in period~* Age at informed consent must be \>=20 and \<75 years~* BMI at screening must be \>22 and \<=40 kg/m2~* Further inclusion criteria apply~Exclusion criteria:~* Patients who experience uncontrolled hyperglycaemia before randomization~* Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor~* Patients with recent cardiovascular and/or stroke events~* Patients with hepatic and/or renal dysfunction~* Patients who received anti-obesity drugs or other treatment leading to unstable body weight~* Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin~* Pre-menopausal women who are nursing or pregnant~* Further exclusion criteria apply

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- empagliflozin 10 mg (Type: EXPERIMENTAL): None
- empagliflozin 25 mg (Type: EXPERIMENTAL): None
- placebo (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: Reduce Bolus Injection of Bivalirudin

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* 1 Age 18 to 80 years old; 2 Medically judge to require coronary angiography; 3 Patients agree to use bivalirudin 4 Patients signe informed consent.~Exclusion Criteria:~* 1.Cardiogenic shock; 2.Thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; 3.Active or recent major bleeding or bleeding predisposition; 4.Major surgery within 1 month; 5.Clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; blood pressure higher than 180/110 mm Hg; 6.Known hemoglobin less than 10 g/dL,platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal; 7.History of heparin-induced thrombocytopenia; 8.Ellergy to any of the study drugs or devices; 9.Eregnancy or lactation; 10.Any condition making PCI unsuitable or that might interfere with study adherence; 11.Patient unwilling or unable to provide written informed consent 12. Researchers think it is not suitable to participate in this study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Low dose group with eGFR ≥60ml/min (Type: EXPERIMENTAL): This arm, we will choose the patients who's eGFR ≥60ml/min and reduce the bivalirudin bolus injection dose to 80% of the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery to reduce the ACT value caused by the bolus injection.
- Standard dose group with eGFR ≥ 60ml/min (Type: ACTIVE_COMPARATOR): This arm, we will choose the patients who's eGFR ≥60ml/min and use the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery .
- Standard dose group with eGFR <60ml/min (Type: ACTIVE_COMPARATOR): This arm, we will choose the patients who's eGFR \<60ml/min and use the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery .
- Low dose group with eGFR <60ml/min (Type: EXPERIMENTAL): This arm, we will choose the patients who's eGFR \<60ml/min and reduce the bivalirudin bolus injection dose to 80% of the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery to reduce the ACT value caused by the bolus injection.

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: Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

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

Eligibility Criteria:
Inclusion Criteria:~* 18 to 65 years~* Meet 1984 NewYork modified criteria for AS~* BASDAI≥4 or ASDAS score ≥ 2.1~* CRP\>6 mg/L or ESR\>28 mm/h~* Syndesmophyte quantity ≥2 and \<16 of spine~* Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception~* No active or latent tuberculosis infection.~Exclusion Criteria:~* Pregnant or breastfeeding women~* current or previous history of psoriasis or inflammatory bowel disease.~* infection with clinical significance within 24 weeks before screening~* receipt any bio-agents treatment within 12 weeks before screening~* corticosteroids intra-articular injections in last 3 months before the trial~* Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.~* Alcohol and drug abuse

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- celebrex (Type: ACTIVE_COMPARATOR): celebrex capsule, 0.2 gram bid, 52 weeks
- Enbrel (Type: ACTIVE_COMPARATOR): etanercept injection, 25mg per injection, 50mg/week, 52 weeks
- Enbrel plus Celebrex (Type: ACTIVE_COMPARATOR): 50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 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: Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* secondary Raynaud's phenomenon~Exclusion Criteria:~* primary raynaud phenomenon~* active infection~* hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)~* elevated AST/ALT (3 times above the upper normal limit)~* severe renal failure~* patients on nitrite or nitric oxide (NO) donor treatment~* recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery~* hypotension (less than 90/50 mmHg) or uncontrolled hypertension

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

Study Arms:
- Amlodipine-Udenafil (AU) arm (Type: EXPERIMENTAL): Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
- Udenafil-Amlodipine (UA) arm (Type: EXPERIMENTAL): Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 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: Tomato Consumption and High Density Lipoprotein-cholesterol

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

Eligibility Criteria:
Inclusion Criteria:~* Males with HDL-c less than 40 mg/dl~* Females with HDL-c less than 50 mg/dl~* Age between 18 to 65 years old~* Acceptance for participation with signed informed consent~Exclusion Criteria:~Previous diagnosis of:~* Diabetes,~* Hypertension,~* Kidney, liver or heart insufficiency,~* Hyperuricemia,~* Hyperandrogenic anovulation,~* Thyroid dysfunction (hypo or hyperthyroidism),~* Any difficulty to swallow appropriately, or~* Hospitalization in the previous six months.~Additionally, those subjects under current treatment with fibrates, statins, nicotinic acid, steroids, allopurinol, hormone replacement therapy (testosterone, estrogens or progesterone), metformin, other oral hypoglycemic agents, insulin, sibutramine, or orlistat treatment and those with daily consumption of any non-steroidal anti-inflammatory drug were also excluded.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Tomato consumption (Type: EXPERIMENTAL): Daily consumption of 300g of uncooked roma tomatoes during one month.
- Cucumber consumption (Type: PLACEBO_COMPARATOR): Daily consumption of 300g of cucumber.

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: Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Adults greater than 18 years of age~* Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia~Exclusion Criteria:~* Pregnant or nursing~* Allergy to bupivacaine~* History of drug/alcohol abuse~* Severe cardiovascular, hepatic, renal disease, or neurological impairment~* Long-acting opioid within 3 days or any opioid use within 24 hours before surgery~* Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID)~* Administration of an investigational drug within 30 days before study~* Chronic pain syndromes~* Daily NSAID/opioid use~* Patients having concomitant procedures or not undergoing general anesthesia

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

Study Arms:
- Liposomal Bupivacaine (Type: EXPERIMENTAL): The placement of the retropublic sling will be placed in routine fashion under general anesthesia. If randomized to liposomal bupivacaine, the standard 20 milliliter (ml) vial (266mg dose) will be diluted with 10ml of preservative-free, sterile normal saline (0.9%) for injection to a reconstituted volume of 30ml. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have the 30ml dilutional volume injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed.
- Saline Placebo (Type: PLACEBO_COMPARATOR): The placement of the retropublic sling will be placed in routine fashion under general anesthesia. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the saline placebo arm will receive 30ml normal saline injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed.

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 Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

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

Eligibility Criteria:
Inclusion Criteria:~* Confirmed diagnosis of CF~* Homozygous for the F508del CFTR mutation~* Forced expiratory volume in 1 second (FEV1) greater than or equal to (\>=) 40 percent (%) and less than or equal to (=\<) 90% of predicted normal for age, sex, and height~* Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit~Exclusion Criteria:~* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug~* History of solid organ or hematological transplantation~* History of alcohol or drug abuse in the past year~* Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening.~* Use of strong inhibitors, moderate inducers, or strong inducers of Cytochrome P450 3A (CYP3A) within 14 days before Day 1 of dosing

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
- LUM 600 mg qd/IVA 250 mg q12h (Type: EXPERIMENTAL): LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
- LUM 400 mg q12h/ IVA 250 mg q12h (Type: EXPERIMENTAL): LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.

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 an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment~Exclusion Criteria:~* History of allergy to any vaccine component~* Prior receipt of a varicella or zoster vaccine~* Ability to defend against infection is suppressed by a medical condition or medication

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- ZOSTAVAX™ / Placebo (Type: EXPERIMENTAL): Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
- Placebo / ZOSTAVAX™ (Type: EXPERIMENTAL): Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)

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: Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Stable coronary heart disease.~Exclusion Criteria:~* Renal and Liver failure~* Hypothyroidism~* Diabetes mellitus~* Neoplasia~* Heart failure.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- group1 ezetimibe (Type: EXPERIMENTAL): 6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
- group 2 simvastatin (Type: ACTIVE_COMPARATOR): 6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.

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: Double Blind Atorvastatin Amlodipine Study

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

Eligibility Criteria:
Inclusion Criteria:~* Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours.~* Total cholesterol \> 5.2 mmol/L (200 mg/dL) on diet alone.~Exclusion Criteria:~* Myocardial infarction within 2 months prior to the study.~* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 80 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: Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients who have histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer.~2. Patients who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen)~3. Patients who have underwent chemotherapy of either weekly paclitaxel + bevacizumab, topotecan + bevacizumab, pegylated liposomal doxorubicin + bevacizumab in 2nd line or 3rd line chemotherapy.~Exclusion Criteria:~1. Patients with previous treatment with bevacizumab.~2. Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.

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

Study Arms:
- Weekly paclitaxel + bevacizumab (Type: None): None
- Topotecan + bevacizumab (Type: None): None
- Pegylated liposomal doxorubicin + bevacizumab (Type: None): 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: Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Stable heterosexual relationship~* History of erectile dysfunction for at least 6 months~* IIEF- EF Domain entry score (at Visit 2): \>21 points~* Documented metabolic syndrome according to the IDF (International Diabetes Foundation)~* Subjects motivated for erectile dysfunction treatment~* Documented, dated, written informed consent~Exclusion Criteria:~* Any underlying cardiovascular condition~* History of myocardial infarction~* Uncontrolled atrial fibrillation~* Resting hypotension~* Postural hypotension within 6 months of Visit 1~* History of congenital QT prolongation~* Bleeding disorder~* History of prostatectomy because of prostate cancer~* Hereditary degenerative retinal disorders~* History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)~* 29 Additional Exclusion Criteria

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- Vardenafil (Levitra, BAY38-9456) (Type: EXPERIMENTAL): Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks

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

Answer: outcome: complete