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

Trial Title: Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

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

Eligibility Criteria:
Inclusion Criteria:~1. Healthy infants aged between 6 and 35 months~2. full-term birth with birth weight above 2,500 grams~3. Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures~Exclusion Criteria:~1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination~2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg~3. History of progressive or severe neurologic disorder~4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain~5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation~6. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids~7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws~8. History of thyroidectomy or thyroid disease that required medication within the past 12 months~9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years~10. Guillain-Barre Syndrome~11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C~12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment~13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination~14. Any conditions may influence the evaluation

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 36 Months
- Healthy Volunteers: t

Study Arms:
- split-virion, non-adjuvanted vaccine of 7.5 μg (Type: EXPERIMENTAL): split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.
- split-virion, non-adjuvanted vaccine of 15 μg (Type: EXPERIMENTAL): split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
- split-virion, non-adjuvanted vaccine of seasonal influenza (Type: PLACEBO_COMPARATOR): split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.

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 Dexamethasone to Treat the Acute Respiratory Distress Syndrome

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:~* Age ≥18 years old~* Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS: (i) having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.; (ii) bilateral infiltrates on frontal chest radiograph; (iii) absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure; (iv) severe hypoxemia (a PaO2/FIO2 \<200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)~* Be intubated and mechanically ventilated~* Have provided signed written informed consent from the patient or the patient's personal legal representative~Exclusion Criteria:~* Be a woman known to be pregnant or lactating~* Take part in another experimental treatment protocol (simultaneously)~* Brain death~* Terminal-stage cancer or other terminal disease~* Having do-not-resuscitate orders~* Being immune-compromised~* Receiving corticosteroids or immunosuppressive drugs~* Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.~* Have severe chronic obstructive pulmonary disease (COPD)~* Have congestive heart failure

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

Study Arms:
- No dexamethasone (Type: NO_INTERVENTION): Patients will be treated with conventional treatment
- Dexamethasone (Type: ACTIVE_COMPARATOR): Conventional treatment plus dexamethasone

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: Alternate Dosing Regimens of BG00012 in Healthy Volunteers

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

Eligibility Criteria:
Inclusion Criteria:~* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.~* Aged 18 to 55 years old, inclusive, at the time of informed consent.~* Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.~* Must have a body mass index of 18 to 34 kg/m2, inclusive.~* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.~Exclusion Criteria:~* History of any clinically significant cardiac, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.~* History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).~* Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day 1.~* Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day 1.~* History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- BG00012 plus ASA (Type: EXPERIMENTAL): None
- BG00012 plus ASA matching placebo (Type: EXPERIMENTAL): None
- BG00012 Placebo plus ASA (Type: PLACEBO_COMPARATOR): None
- BG00012 Placebo plus ASA matching placebo (Type: EXPERIMENTAL): None
- BG00012 (Type: EXPERIMENTAL): modified dose regimen

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: De-implementing Inhaled Steroids to Improve Care and Safety in COPD

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

Eligibility Criteria:
Inclusion Criteria:~Provider:~Primary care provider (medical doctor/osteopathic physician, nurse practitioner, physician assistant \[MD/DO, NP, PA\]) assigned to a PACT from VA Puget Sound Health Care System or Edith Nourse Rogers Memorial Veterans Hospital (Bedford VA).~Patient:~* Patient is a Veteran who is assigned a VA PCP and has received Rx for an inhaled corticosteroid within the past 180 days.~* Patient has an inpatient or outpatient diagnosis of COPD in the prior two years.~* Patient has undergone spirometry in the past 5 years that indicates either no airflow obstruction or mild to moderate airflow obstruction indicated by a forced expiratory volume 1 (FEV1)/\[greater of forced vital capacity (FVC) or vital capacity (VC)\] =\< 0.7 \& FEV1% predicted \>= 30%.~Exclusion Criteria:~Patients:~* Very severe airflow obstruction (\<30% FEV1 % predicted)~* Severe disease as indicated by 1 inpatient COPD exacerbation in the year prior~* Severe disease as indicated by 2 outpatient COPD exacerbations in the year prior~* International Classification of Diseases (ICD) 9 and/or 10 diagnosed or clinically indicated asthmatics~* Significant bronchodilator response on spirometry (\>12% increase in FEV1 post bronchodilator; \>375 mL post-bronchodilator improvement)

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

Study Arms:
- Proactive patient-tailored electronic consult (E-consult) (Type: OTHER): Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
- Usual care (Type: NO_INTERVENTION): Standard practice (usual care). Primary care providers treat their patients as usual.

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: Effect of Valproic Acid Concentration on Photic Response

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female patients~* Aged 15 to 65 years~* Patients with a diagnosis of epilepsy for which they are either taking up two AEDs, not including VPA/divalproex, or no AEDs~* Patients with a reproducible IPS-induced photo-paroxysmal responses of at least 7 SPR-EEG units as measured at two different time points in the day (pm screening Study Visit 1 and am of Visit 2).~* Are in good health (with the exception of epilepsy).~* Able and willing to provide written informed consent.~Exclusion Criteria:~* Patients not exhibiting a photo-paroxysmal-EEG response~* Patients with active psychogenic seizures~* Women who are pregnant or lactating~* Women of reproductive potential who do not agree to use effective birth-control methods during the study and for one week after receiving study drug.~* Patients taking any dosage form of VPA/divalproex within 4 weeks prior to the study~* Patients taking more than two concomitant AEDs~* Patients with any clinically significant laboratory abnormality, which in the opinion of the investigator, will exclude the patient from the study~* Patients who are suffering from active liver disease indicated by abnormal liver function tests greater than three times the upper limit of normal (AST and ALT), patients with porphyria, or patients with a family history of severe hepatic dysfunction~* Patients with a history of alcoholism, drug abuse, or drug addiction (within the past 12 months)~* Patients with a history of sensitivity or allergic reaction to valproate / divalproex~* Patients who have a medical history which would contraindicate sodium valproate (VPA) administration~* Patients who have participated in any other trials involving an investigational product or device within 30 days of screening.~* Patients with clinically significant ECG abnormalities, as judged by the PI, at screening visit~* Patients with such poor intravenous access that the insertion of two intravenous catheters (one for sodium valproate infusion and one, in a contralateral arm vein, for serial blood sampling) for a 12-hour period is not possible.~* Patients who received benzodiazepines within one week of study initiation~* Status epilepticus within one year of screening~* Generalized tonic-clonic seizure within 24 hours of photic stimulation procedure

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Placebo then Valproic Acid (VPA) (Type: EXPERIMENTAL): all patients will have placebo on day 1 and VPA infusion on day 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: Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate~Exclusion Criteria:~* Current treatment with insulin~* Known or suspected allergy to Levemir® or excipients~* Children below the age of 6 years~* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

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

Study Arms:
- Insulin detemir (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: A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

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

Eligibility Criteria:
Inclusion Criteria:~* Participants 10-70 years of age~* Diagnosis of AD~* History of AD for at least 3 years~* AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline~* Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)~Exclusion Criteria:~* Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.~* Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- 0.3% OPA-15406 (Type: EXPERIMENTAL): OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
- 1% OPA-15406 (Type: EXPERIMENTAL): OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
- Vehicle Ointment (Type: PLACEBO_COMPARATOR): OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 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 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Total body weight \>40 kg (88 lb)~* Men and woman age 18-75~* Men and Women must use highly effective methods of contraception for the entirety of the study~Exclusion Criteria:~* History of malignancy within the last 5 years~* Positive for HIV, Hepatitis B or C~* History of tuberculosis~* Diagnosis of non-plaque psoriasis~* Patients with QTcF \>450 msec (males) or \>470 msec (females) at screening~* Live vaccines

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

Study Arms:
- ESK-001 Dose Level 1 (Type: EXPERIMENTAL): ESK-001 administered as an oral tablet
- ESK-001 Dose Level 2 (Type: EXPERIMENTAL): ESK-001 administered as an oral tablet
- ESK-001 Dose Level 3 (Type: EXPERIMENTAL): ESK-001 administered as an oral tablet
- ESK-001 Dose Level 4 (Type: EXPERIMENTAL): ESK-001 administered as an oral tablet
- ESK-001 Dose Level 5 (Type: EXPERIMENTAL): ESK-001 administered as an oral tablet
- Placebo (Type: PLACEBO_COMPARATOR): Placebo administered as an oral tablet

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: The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

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:~* age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)~Exclusion Criteria:~* successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases

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

Study Arms:
- nicorandil group (Type: EXPERIMENTAL): None
- control group (Type: NO_INTERVENTION): 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: Gastric Acid Suppression and Probiotic Colonization

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy volunteers ages 18 years and ≤ 75 years.~* Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.~Exclusion Criteria:~* Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity~* Previous abdominal surgery~* Currently pregnant or nursing~* Had H. Pylori Infection~* Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia~* Currently consuming herbs or probiotics

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

Study Arms:
- Omeprazole and VSL #3 (Type: ACTIVE_COMPARATOR): Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
- Placebo and VSL #3 (Type: PLACEBO_COMPARATOR): Participants will receive placebo and VSL #3 Probiotics

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, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Metastatic breast cancer (Stage IV)~2. Histologically confirmed estrogen receptor positive disease~3. Female~4. Serum 25(OH) \<30 ng/ml~5. Age ≥ 18 years~6. Pre or post-menopausal~7. ECOG Performance status 0-2~8. Adequate organ function as defined as GFR\> 30 mls/min and serum calcium ≤ 10.4 mg/dl~9. Any race/ethnicity~10. English speaking~11. No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician~12. Willingness to sign a written informed consent and complete questionnaires~13. Cease ingestion of vitamin D supplementation not study related~Exclusion Criteria:~1. Women with Stage I-III breast cancer~2. Serum 25(OH)D levels ≥ 30 ng/ml~3. Untreated CNS involvement~4. History of kidney stones~5. History of renal failure~6. History of hyperparathyroidism~7. History of hypersensitivity to vitamin D~8. Non-English speaking~9. Currently pregnant or lactating, or anticipating pregnancy~10. Unwilling to cease ingestion of calcium supplements (\>1000 mg/d)~11. Unwilling or unable to complete informed consent or study questionnaires~12. Psychiatric or other clinical conditions that preclude study compliance~13. Other important medical or safety considerations at the discretion of the investigator and/or study physician, including non-compliance with the study therapy or other activities

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

Study Arms:
- Cholecalciferol (Type: EXPERIMENTAL): All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.
- Vitamin D sufficient (Type: NO_INTERVENTION): All participants were ineligible for the intervention due to sufficient serum 25(OH)D levels at screening/baseline.

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 to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa

Study Design Characteristics:
- Allocation: RANDOMIZED
- 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:~* Non-myeloid malignancies~* Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy~* Plan to receive cyclic chemotherapy for an additional 8 weeks~* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1~* Adequate renal and liver function~* Ability to participate in the MHST based on clinical judgement of investigator~* At least 18 years of age~Exclusion Criteria:~* Iron deficiency~* Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment~* Unstable cardiac disease~* Current active condition creating clinical danger for the subject to participate in the MHST~* known positive test for HIV infection~* Previous hematologic disorder associated with anemia~* Currently receiving beta-blockers~* Use of drugs or devices not approved by the FDA for any indication~* Pregnant or breast feeding~* Known hypersensitivity to any recombinant mammalian-derived product

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

Study Arms:
- darbepoetin alfa (Type: EXPERIMENTAL): None

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

Answer: outcome: complete