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

Trial Title: Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy Chinese males~* aged ≥ 18 and ≤ 45~* body mass index (BMI) ≥ 19 and ≤ 26 kg/m2~* LVEF≥ 55%~Exclusion Criteria:~* A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases~* Use of a monoclonal antibody or any biological product within 6 months before study drug administration~* A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study~* Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration~* A history of blood donation within 3 months before study drug administration~* Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration~* Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody~* A history of drug abuse~* Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- HLX11 group (Type: EXPERIMENTAL): HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
- CN-Perjeta group (Type: ACTIVE_COMPARATOR): CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
- EU-Perjeta group (Type: ACTIVE_COMPARATOR): EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
- US-Perjeta group (Type: ACTIVE_COMPARATOR): US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).

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 Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

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:~* Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy;~* Intubated and on mechanical ventilation at the time of randomization;~* New or progressive infiltrate on chest radiography consistent with pneumonia;~* Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia.~Key Exclusion Criteria:~* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;~* Prior non-study antibiotics for \> 24 hours;~* Gram stain of lower respiratory tract specimen showing only gram positive bacteria;~* Active immunosuppression;~* End-stage renal disease or requirement for dialysis;~* Expected survival \< 72 hours;~* Severe confounding respiratory condition (i.e., chest trauma with paradoxical respiration);~* Known or suspected community-acquired bacterial pneumonia.~* Anticipated concomitant use of any of the following medications during the course of study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor agonists (triptans), meperidine, or buspirone during the course of linezolid treatment.~* Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of study drug or anticipated concomitant use during the course of linezolid therapy.

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

Study Arms:
- Ceftolozane/tazobactam (Type: EXPERIMENTAL): Participants receive 3000 mg ceftolozane/tazobactam intravenous IV (comprising 2000 mg ceftolozane and 1000 mg tazobactam) every 8 hours for 8-14 days.
- Meropenem (Type: ACTIVE_COMPARATOR): Participants receive 1000 mg meropenem IV every 8 hours for 8-14 days.

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: Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)~* BMI (Body Mass Index) between 19-29 kg/m\^2, both inclusive~* Fasting plasma glucose from 70-115 mg/dl~* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data~Exclusion Criteria:~* Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease~* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening~* Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody~* Positive results on the drug abuse/alcohol screen~* Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study~* Subject is currently a smoker (more than one cigarette per day or equivalent)~* Use of grapefruit or grapefruit juice within 7 days of trial product dose administration~* Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- Treatment period 1 (Type: EXPERIMENTAL): None
- Treatment period 2 (Type: EXPERIMENTAL): None
- Treatment period 3 (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: Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion criteria:~1. Healthy male and female subjects~2. Subjects must be able to understand and comply with study requirements~3. Age 18 to 50 years~4. Body mass index (BMI) 18.5 to 29.9 kg/m2~Exclusion criteria:~1. Any relevant deviation from healthy conditions

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- FDC empagliflozin dose 1 and metformin (Type: EXPERIMENTAL): fix dose combination tablet after intake of a high fat, high caloric meal
- empagliflozin dose 1 + metformin tablets (Type: ACTIVE_COMPARATOR): single tablets after intake of a high fat, high caloric meal
- FDC empagliflozin dose 2 and metformin (Type: EXPERIMENTAL): fix dose combination tablet after intake of a high fat, high caloric meal
- empagliflozin dose 2 + metformin tablets (Type: ACTIVE_COMPARATOR): single tablets after intake of a high fat, high caloric meal

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: Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

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:~* Receiving care pre- or post-lung transplant at University of Wisconsin Hospital~* Healthy adult~Exclusion Criteria:~* Allergy to eggs~* Moderate to severe febrile illness~* Active treatment for acute rejection~* Received season's influenza vaccine prior to enrollment

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

Study Arms:
- Vaccine, Pre-transplant (Type: None): cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
- Vaccine, Post-transplant (Type: None): Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
- Vaccine, Healthy Controls (Type: None): Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.

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 Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

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:~* male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder~* experiencing a current major depressive episode~* treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms~Exclusion Criteria:~* any subject unable to provide informed consent~* any female subject who is pregnant or breastfeeding~* any subject judged to be medically inappropriate for study participation

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

Study Arms:
- Lumateperone 28 mg (ITI-007 40 mg tosylate) (Type: EXPERIMENTAL): Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
- Lumateperone 42 mg (ITI-007 60 mg tosylate) (Type: EXPERIMENTAL): Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo administered orally as visually-matched capsules once daily for 6 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: Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia

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:~Subjects are required to meet the following inclusion criteria:~* Community-acquired pneumonia~* initial hospitalization, or treatment in an emergency room or urgent care setting~* infection would require initial treatment with IV antimicrobials.~Exclusion Criteria:~Subjects must NOT meet any of the following exclusion criteria:~* CAP suitable for outpatient therapy with an oral antimicrobial agent~* respiratory tract infections not due to community-acquired bacterial~* Non-infectious causes of pulmonary infiltrates~* Pleural empyema~* Infection with an atypical organism~* History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial~* History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

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

Study Arms:
- Ceftaroline fosamil for Injection (Type: EXPERIMENTAL): Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).~In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
- IV Ceftriaxone (Type: ACTIVE_COMPARATOR): Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).~In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

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 Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.~* Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years~* Body weight above or equal to 16.0 kg and below or equal to 50.0 kg~* Stable GH replacement treatment for at least 3 months~Exclusion Criteria:~* History or presence of malignancy~* Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 13 Years
- Healthy Volunteers: f

Study Arms:
- NNC0195-0092 (somapacitan) (Type: EXPERIMENTAL): None
- Norditropin® (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: Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)

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

Eligibility Criteria:
Inclusion Criteria:~* Ages 10-20 years~* BMI\>85%~Exclusion Criteria:~* Endocrine disorder~* On psychotropic medications

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 20 Years
- Healthy Volunteers: t

Study Arms:
- Intervention (Type: EXPERIMENTAL): This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
- Standard of Care/Control (Type: NO_INTERVENTION): Education on physical activity and nutrition in a primary care office setting

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: Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities

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

Eligibility Criteria:
Inclusion Criteria:~* Age ≥3 months~* Willingness to comply with trial procedures and written informed consent to be obtained at the beginning of the study~Exclusion Criteria:~* Severe illness or self-reported chronic illness (e.g., HIV, tuberculosis, heart/liver/kidney disease, and severe malnutrition)~* Known hypersensitivity to study drug~Additional exclusion criteria for DHA-PPQ:~* First trimester pregnancy assessed by history and/or urine pregnancy testing~* Concurrent artemisinin-based combination therapy (ACT) use~* Taking drugs that influence cardiac function or prolong QTc interval~Additional exclusion criteria for PQ:~* Pregnancy (any trimester) or currently breastfeeding an infant \<6 months of age assessed by history and/or urine pregnancy testing~* \<2 years of age

- Gender: ALL
- Minimum Age: 3 Months
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- MDA with DHA-PPQ + SLD-PQ (Type: EXPERIMENTAL): Participants in intervention villages will be given three rounds of MDA with DHA-PPQ and SLD-PQ. Prior to the intervention, participants will have received piperonyl butoxide (PBO) treated LLINs and proactive community case management. Unlike control villages, MDA-randomized villages will not receive SMC.
- Standard malaria control interventions (Type: NO_INTERVENTION): Participants in the control villages will receive standard malaria control interventions as implemented by the Senegal PNLP. This will include the distribution of PBO LLINs, proactive case management, and SMC.

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 of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

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:~* For MAIN period (NN5401-3590):~* Diagnosis of type 2 diabetes mellitus for at least 6 months~* Insulin naïve subjects~* Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start~* Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)~* Body Mass Index (BMI) no higher than 40.0 kg/m\^2~* For EXTENSION period (NN5401-3726):~* Informed consent obtained before any trial-related activities~* Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590~Exclusion Criteria:~* For MAIN period (NN5401-3590):~* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start~* Cardiovascular disease diagnosed within 6 months before trial start~* For EXTENSION period (NN5401-3726):~* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors~* Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)~* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

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

Study Arms:
- IDegAsp OD (Type: EXPERIMENTAL): None
- IGlar OD (Type: EXPERIMENTAL): 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: Comparison of Two Insulin Degludec Formulations in Subjects 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: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)~* Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)~* HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis~* Body mass index (BMI) below or equal to 45 kg/m\^2~* Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol~Exclusion Criteria:~* Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)~* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)~* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)~* Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period~* Known or suspected hypersensitivity to trial products or related products~* The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)

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

Study Arms:
- IDeg 200 U/mL (Type: EXPERIMENTAL): None
- IDeg 100 U/mL (Type: EXPERIMENTAL): None

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

Answer: outcome: complete