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

Trial Title: A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

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:
Inclusion Criteria:~* Have diagnosis of T2D according to the World Health Organization Criteria~* Have an HbA1c of 7.0% - 10.5% inclusive, at screening~* Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study~* These antihyperglycemic medications are accepted in the study~  * DPP-4 inhibitors~ * SGLT2 inhibitors~ * biguanides, such as metformin~ * alpha-glucosidase inhibitors~ * GLP-1 receptor agonists, oral or injectable~ * Sulfonylureas, or~ * Thiazolidinediones.~* Are insulin naïve.~Exceptions:~* short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes~  * Have a body mass index of ≤45 kg/m².~Exclusion Criteria:~* Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.~* Have a history of \>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.~* Have had severe hypoglycemia episodes within 6 months prior to screening.~* Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.~* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.~* Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening~  * acute myocardial infarction~ * cerebrovascular accident (stroke), or~ * coronary bypass surgery.~* Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening~* Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.

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

Study Arms:
- Insulin Efsitora Alfa (Type: EXPERIMENTAL): Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
- Insulin Degludec (Type: ACTIVE_COMPARATOR): Participants will receive insulin degludec SC once daily

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 Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

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:~* Clinical diagnosis of complicated skin or skin structure infection~* Male or female, 18 years or older~* Need for intravenous treatment for 4 to 14 days~Exclusion Criteria:~* Skin infection that can be treated by surgery \& wound care alone~* Diabetic foot ulcers or bedsores where the infection is present longer than 1 week~* Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Arm 1: Tigecycline
- 2 (Type: ACTIVE_COMPARATOR): Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide

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: Bupropion and Weight Control for Smoking Cessation - 1

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

Eligibility Criteria:
Inclusion Criteria:~* Smoke at least 10 cigarettes per day~* Report concern about cessation-related weight gain~* Motivated to quit smoking~Exclusion Criteria:~* Currently pregnant, lactating, or no medically approved method of contraception~* Major medical problem~* History of seizure disorder or head injury~* Current or historical psychosis or bipolar disorder~* History of alcohol or substance abuse within previous year~* Current or historical eating disorder~* Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month~* Multiple Drug Allergies~* Current major depressive disorder

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

Study Arms:
- Bupropion and Weight Concerns intervention (Type: EXPERIMENTAL): Bupropion SR and a weight concerns psychosocial intervention
- Placebo and Weight Concerns (Type: ACTIVE_COMPARATOR): A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
- Bupropion and standard smoking cessation (Type: ACTIVE_COMPARATOR): Bupropion SR and a time and attention controlled smoking cessation intervention
- Placebo and standard smoking cessation (Type: PLACEBO_COMPARATOR): A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention

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 and Safety of MT-5199 in Subjects With Tardive Dyskinesia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, Bipolar Disorder, or Depressive Disorders.~* Have a clinical diagnosis of neuroleptic-induced TD.~* Have moderate or severe TD.~* If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or bipolar disorder, or depressive disorders, be on stable doses.~Exclusion Criteria:~* Have an active, clinically significant unstable medical condition in screening period.~* Have a significant risk of suicidal or violent behavior.~* Have a known history of long QT syndrome or cardiac tachy-arrhythmia.~* Are currently pregnant or breastfeeding.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- MT-5199 40 mg (Double-Blind Placebo-Controlled Period) (Type: EXPERIMENTAL): MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.
- MT-5199 80 mg (Double-Blind Placebo-Controlled Period) (Type: EXPERIMENTAL): Subjects randomized to the MT-5199 80 mg dose will receive MT-5199 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by MT-5199 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning for 5 weeks.
- Placebo (Double-Blind Placebo-Controlled Period) (Type: EXPERIMENTAL): Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
- MT-5199 40 mg (Double-Blind Extension Period) (Type: EXPERIMENTAL): At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose.
- MT-5199 80 mg (Double-Blind Extension Period) (Type: EXPERIMENTAL): At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose. Subjects re-randomized to receive MT-5199 80 mg will receive 40 mg for the first week.

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: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit~Exclusion Criteria:~* Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental~* Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262~* Current infection requiring the use of oral or intravenous antibiotics~Other Inclusion/Exclusion criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 81 Years
- Healthy Volunteers: f

Study Arms:
- ABP 501 (Type: EXPERIMENTAL): Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 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: Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female aged 4 years to less than 18 years of age.~2. Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.~3. If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.~Exclusion Criteria:~1. Individuals recently vaccinated against influenza~2. Subjects with contraindications to receive influenza vaccine

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 18 Years
- Healthy Volunteers: t

Study Arms:
- QIVc (≥4 to <18 years) (Type: EXPERIMENTAL): Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season
- TIV1c (≥4 to <18 years) (Type: ACTIVE_COMPARATOR): Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage (B1 strain) recommended for 2013-2014 season
- TIV2c (≥4 to <18 years) (Type: ACTIVE_COMPARATOR): Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage (B2 strain) recommended for 2013-2014

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: EXPAREL® for Pain After Tonsillectomy

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:~* Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy~* Willing and able to understand and provide written informed consent~Exclusion Criteria:~* Known pregnancy~* Women who are currently nursing a child~* History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder~* Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation~* Inability to provide informed consent (patients under guardianship)~* Known hypersensitivity to local anesthetics~* History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.~* History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.~* Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate \< 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.~* History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.

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

Study Arms:
- Liposomal Bupivacaine (Type: ACTIVE_COMPARATOR): Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
- No treatment (Type: NO_INTERVENTION): Patient will not be given any medications in the tonsillar fossae after tonsillectomy

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: Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer

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

Eligibility Criteria:
Inclusion Criteria:~1. Histologically or cytologically confirmed pancreatic cancer;~2. Unresectable locally advanced or metastatic disease ;~3. Documented disease progression after first-line treatment gemcitabine based therapy~4. ECOG: 0-1;~5. Adequate organ and bone marrow function;~6. sign an informed consent.~Exclusion Criteria:~1. Active CNS metastasis;~2. Uncontrolled tumor-related pain;~3. Clinically significant GI disorders;~4. Significant cardiovascular disease;~5. Active infection or uncontrolled fever;~6. Pregnant or breast feeding patients;~7. Allergic to a drug ingredient or component;~8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

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

Study Arms:
- Treatment group A (Type: EXPERIMENTAL): Irinotecan liposome plus 5-fluorouracil, Leucovorin
- Treatment group B (Type: ACTIVE_COMPARATOR): Placebo plus 5-fluorouracil, Leucovorin

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 Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Must be 50 to 59 years of age~* No fever on vaccination days~* Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years~* Females of child-bearing potential must use acceptable forms of birth control~Exclusion Criteria:~* Prior history of shingles~* Prior receipt of any chickenpox or shingles vaccine~* Pregnant or breastfeeding~* Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit~* Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit~* Received immunoglobulin or blood products~* Receiving treatment that may weaken the immune system~* Have an immune system disorder

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 59 Years
- Healthy Volunteers: t

Study Arms:
- Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine (Type: EXPERIMENTAL): Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine A; 4-dose regimen administered \~30 days apart.
- Part 1: Gamma- Irradiated VZV Vaccine A (Type: EXPERIMENTAL): Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.
- Part 1: Placebo (Type: PLACEBO_COMPARATOR): Participants received a 4-dose placebo regimen administered \~30 days apart.
- Part 2: Gamma- Irradiated VZV Vaccine B (Type: EXPERIMENTAL): Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.
- Part 2: Gamma- Irradiated VZV Vaccine C (Type: EXPERIMENTAL): Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.

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: Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

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

Eligibility Criteria:
Key Inclusion Criteria:~* Male or female, of any race, at least 18 years of age (inclusive).~* Freely provides both verbal and written informed consent.~* Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.~* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.~* Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).~Key Exclusion Criteria:~* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.~* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.~* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.~* Is pregnant, nursing an infant, or planning a pregnancy during the study period.~* Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.

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

Study Arms:
- IDP-118 Lotion (Type: EXPERIMENTAL): Lotion
- IDP-118 Vehicle Lotion (Type: ACTIVE_COMPARATOR): Vehicle Lotion

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: Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS (International Prognostic Scoring System) - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles Exclusion Criteria:~* Prior exposure to \>3 cycles hypomethylating agents~* Prior history of leukemia or aplastic anemia~* Prior history of bone marrow transplantation~* Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization~* Active or uncontrolled infections~* Unstable angina, congestive heart failure \[NYHA (New York Heart Association) \> class II\], uncontrolled hypertension \[diastolic \> 100 mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction~* History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year~* History of venous thrombosis that currently requires anti-coagulation therapy~* Received IL-11 within 4 weeks of screening~* Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication~* Have previously received any other thrombopoietic growth factor

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

Study Arms:
- Dose level 1 500 AMG 531 (Part A - azacitidine) (Type: ACTIVE_COMPARATOR): 500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles
- Dose level 1 750 AMG 531 (Part B - decitabine) (Type: ACTIVE_COMPARATOR): 750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles
- Dose level 2 750 AMG 531 (Part A - azacitidine) (Type: ACTIVE_COMPARATOR): 750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles
- Placebo (Part A - azacitidine) (Type: PLACEBO_COMPARATOR): Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles
- Placebo (Part B - decitabine) (Type: PLACEBO_COMPARATOR): Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles

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

Answer: outcome: complete