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

Trial Title: Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

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

Eligibility Criteria:
Inclusion Criteria:~* Participant of either gender aged ≥50 years~* Positive history of varicella or residence for \>30 years in a country with endemic VZV infection~* All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination~* Participant having signed the informed consent form prior to any study procedure~Exclusion Criteria:~* Febrile within 72 hours prior to vaccination~* Prior history of Herpes Zoster clinically diagnosed by a physician~* Previously received a varicella or zoster vaccine~* Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination~* Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study~* Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study~* Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study~* Taking any non topical antiviral therapy with activity against herpesviruses.~* On immunosuppressive therapy~* Known or suspected immune dysfunction caused by a medical condition, or any other cause~* History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin~* Known active tuberculosis~* Significant underlying illness preventing completion of the study

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

Study Arms:
- All Enrolled (Type: EXPERIMENTAL): Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)

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: Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis

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

Eligibility Criteria:
Inclusion Criteria:~1. /written informed consent (for individuals under 18 written informed consent of at least one of the parents is required),~2. /age between 13 and 25 years,~3. /ARMS as classified by the PACE criteria (Yung et al., 1998)~PACE criteria for ARMS include one or more of following characteristics which must have occurred within the last 12 months:~* Frank psychotic symptoms \< 1 week (Transient psychosis group)~* Attenuated psychotic symptoms \> 1 week, \> 2 times per week~* Decline in global function (drop in GAF of \> 30%) plus family history of psychosis or individual has schizotypal personality disorder To operationalize PACE criteria duration and severity ratings of psychotic symptoms will be performed using the Positive and Negative Syndromes of Schizophrenia Scale (PANSS) (Kay et al., 1987) applying following cut-off scores, following Morrison et al (2002): Ad 1) Transient psychosis is defined with the presence of symptoms that score 4 or more on hallucinations, 4 or more on delusions, or 5 or more on conceptual disorganizations, last less than one week and resolve without antipsychotic medication. Ad 2) Attenuated psychotic symptoms are defined by the presence of symptoms that score 3 on delusions, 2-3 on hallucinations, 3-4 on suspiciousness or 3-4 on conceptual disorganization.~Exclusion Criteria:~1. /Acute suicidal behaviour, aggressive behaviour (PANSS hostility, suicidality = 7),~2. /Drug abuse that contributed decisively to the presentation of the index episode, (dependency on morphine, cocaine, amphetamine, but not THC),~3. /Alcohol abuse if considered as major problem,~4. /Epilepsy,~5. /Mental Retardation (IQ\<80),~6. /Pregnancy and lactation,~7. /Structural changes in MRI or CT scan (e.g., tumours), expect for enlargement of ventricles or sulci,~8. /Previous history of antipsychotic drug (\>1 week) or mood stabilizer treatment,~9. /Laboratory values more than 10% outside the normal range for transaminases, CRP or bleeding parameters,~10. /Individuals with organic brain syndrome,~11. /Individuals who are taking anticoagulants,~12. /Individuals who are taking omega 3 supplements, currently or within 8 weeks of being included in the trial,~13. /Individuals who have other, severe, intercurrent illness which in the opinion of the investigator may put them at risk or influence the results of the trial or affect ability to take part in the trial.

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 25 Years
- Healthy Volunteers: f

Study Arms:
- A (Type: EXPERIMENTAL): None
- B (Type: PLACEBO_COMPARATOR): Coconut oil

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 Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

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:~* Aged ≥18 years at signing of informed consent.~* Histologically confirmed MBC, current stage IV.~* Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.~* Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.~Exclusion Criteria:~* Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.~Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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

Study Arms:
- neratinib plus capecitabine (Type: EXPERIMENTAL): neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
- lapatinib plus capecitabine (Type: ACTIVE_COMPARATOR): lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.

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 Two Doses of Intravenous NATRECOR hBNP (Nesiritide) in Patients With Worsening Congestive Heart Failure Who Have Difficulty Breathing at Rest

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

Eligibility Criteria:
Inclusion Criteria:~* History of chronic congestive heart failure (CHF)~* symptomatic, decompensated CHF for which intravenous therapy is deemed appropriate for the hospitalized patient~* documentation of pulmonary capillary wedge pressure (PCWP) \>= 18 mm Hg, Cl \<= 2.7 mL/min/m² and systolic blood pressure \>= 90 mm Hg with consistent baseline hemodynamic measurements.~Exclusion Criteria:~* Had a myocardial infarction within the previous 48 hours or unstable angina~* stroke within the previous 3 months or other evidence of significantly compromised central nervous system perfusion~* has significant valvular stenosis hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, biopsy-proven active myocarditis, or complex congenital heart disease~* receiving ongoing treatment with an intravenous vasostrictive agent for this episode of decompressed CHF that could not be discontinued for an appropriate washout period to permit the reassessment of baseline hemodynamic and clinical status prior to initiating drug study~* clinical status so unstable that the subject can not tolerate placement of a Swan-Ganz catheter.

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

Study Arms:
- 001 (Type: EXPERIMENTAL): nesiritide

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: CNS10-NPC-GDNF for the Treatment of ALS

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Confirmed diagnosis of ALS (Lab-supported Probable, Probable or Definite EI Escorial Criteria)~2. Duration of symptoms ≤ 36 months~3. Progressive weakness in lower extremities, with EMG supported evidence of denervation in both lower extremities.~4. Forced Vital Capacity \>60% of predicted normal in supine.~5. Male/Female; Age: 18 and older~6. Able to provide Informed Consent~7. Be geographically accessible to the study site and able to travel to study site for required visits~8. Have caregiver to assist in the transportation and care required by participation in the study~9. Not taking riluzole or on a stable dose for ≥ 30 days~10. For women of child bearing capacity, negative pregnancy test prior to surgery~11. Medically able to undergo thoracolumbar laminectomy or laminoplasty as determined by the site PI and Neurosurgeon~12. Medically able to tolerate the immunosuppression regimen as determined by the site PI~Exclusion Criteria:~1. Using invasive ventilatory assistance~2. Diagnosis of another active or unstable medical illness that may interfere with study participation at discretion of PI~3. Presence of any of the following conditions:~   1. Current drug or alcohol abuse~  2. Any known immunodeficiency syndrome~  3. Unstable medical condition~  4. Unstable psychiatric illness including psychosis and untreated major depression within 90 days of screening~4. Persons of child bearing capacity not willing to practice birth control~5. Receiving any investigational device/biologic/drug in past 30 days or any previous exposure to stem cell therapy~6. Any condition in the lower extremities which precludes serial strength testing~7. Any condition that the Neurosurgeon feels may pose complications for the surgery~8. Any condition or ALS disease phenotype that the site PI feels may interfere with participation in the study or in the interpretation of study endpoints

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

Study Arms:
- Stem cell implantation (Type: EXPERIMENTAL): Subjects meeting all Eligibility Criteria and providing Informed Consent will be enrolled in one of two sequential dosing groups (Group A and B). Subjects will be treated sequentially with a minimum of one month interval between surgeries for the first three subjects in each dosing cohort. The remaining subjects in the cohort will be treated with a minimum interval of at least one week between surgeries. There will be 9 subjects in each group. No control group is included. All patients will received unilateral lumbar spinal cord injections of CNS10-NPC-GDNF cells.

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: Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

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

Eligibility Criteria:
Inclusion Criteria:~* Premenopausal~* Not pregnant or breastfeeding~* Sexually active at risk of pregnancy~Exclusion Criteria:~* Any contraindication to the use of oral contraceptives~* Pregnancy within the last 3 months~* Smoking \> 10 cigarettes per day

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- DR-1011 (Type: EXPERIMENTAL): Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.

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: Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder

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

Eligibility Criteria:
Inclusion Criteria:~1. Being the parent of at least one child with a diagnosed autism spectrum disorder~2. Age 18 or older~Exclusion Criteria:~1. Unable or unwilling to sign the informed consent documents

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

Study Arms:
- Experimental: 3RP treatment (Type: EXPERIMENTAL): An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.~Experimental arm participated in the 8-week 3RP program starting immediately after enrollment.
- Waitlist control (Type: ACTIVE_COMPARATOR): An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.~The waitlist arm participated in the 8-week 3RP program starting 3 months after enrollment.

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 Sirolimus to Vascular Anomalies

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

Eligibility Criteria:
Inclusion Criteria:~* All patients included in the present research must be diagnosed with one of the following vascular anomalies:~  1. Kaposiform Hemangioendotheliomas without Kasabach-Merritt Phenomenon~ 2. Tufted Angioma without Kasabach-Merritt Phenomenon~ 3. Capillary Malformations~ 4. Lymphatic Malformations~ 5. Venous Malformations~ 6. Capillary-Venous Malformation (CVM)~ 7. Capillary-Lymphatic Malformation (CLM)~ 8. Lymphatic-Venous Malformation (LVM)~ 9. Capillary-Lymphatic-Venous Malformation (CLVM)~ 10. Multifocal Lymphangiomatosis and Thrombocytopenia (MLT)~* Patients must be 0 - 18 years of age at the time of study entry.~* Without functional impairment requiring treatment of corticosteroid.~* Organ function requirements:~* Adequate liver function Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)for age, and alanine transaminase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x upper limit normal (ULN) for age.~* Adequate renal function 0-5 years of age maximum serum creatinine (mg/dL) of 0.8 6-10 years of age maximum serum creatinine (mg/dL) of 1.0 11-15 years of age maximum serum creatinine (mg/dL) of 1.2 16-18 years of age maximum serum creatinine (mg/dL) of 1.5~* Adequate bone marrow function:~Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10 to the ninth/Liter~* Consent of parents (or the person having parental authority in families): Signed and dated written informed consent.~Exclusion Criteria:~* Allergy to sirolimus or other rapamycin analogues.~* Allergy to sirolimus or other rapamycin analogues.~* Any known evidence of significant local or systemic uncontrolled infection, defined as receiving intravenous antibiotics at the time of randomization.~* Patients must not be known to be Human Immunodeficiency Virus positive or known immunodeficiency. Testing is not required unless a condition is suspected.~* Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal tract ulceration).~* Impairment of gastrointestinal function or chronic gastrointestinal disease that may significantly alter the absorption of sirolimus.~* Patients who have a history of malignancy.~* Patients with an inability to participate or to follow the study treatment and assessment plan.~* Patients who have a history of treatment with sirolimus or other mTOR inhibitor.

- Gender: ALL
- Minimum Age: 0 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Sirolimus (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: Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement

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

Eligibility Criteria:
Inclusion Criteria:~* Adults ≥ 18 years with type 1 or 2 diabetes mellitus~* Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye~* Decrease in vision determined to be primarily the result of DME in the study eye~* Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye~Exclusion Criteria:~* Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1~* More than 2 previous macular laser treatments in the study eye~* Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1~* Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1~* Active proliferative diabetic retinopathy (PDR) in the study eye~* Uncontrolled diabetes mellitus, as defined by HbA1c \>12%~* Only 1 functional eye even if that eye is otherwise eligible for the study

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

Study Arms:
- Intravitreal Aflibercept Injection 2Q4 (Type: EXPERIMENTAL): Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
- Intravitreal Aflibercept Injection 2Q8 (Type: EXPERIMENTAL): Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
- Macular Laser Photocoagulation (Type: ACTIVE_COMPARATOR): Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 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: The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes

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:~* Type 2 diabetic patients with hemoglobin A1c levels within the range 7% - 10%

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Vildagliptin + Metformin (Type: EXPERIMENTAL): Adding Vildagliptin to metformin users
- Glimepiride + Metformin (Type: ACTIVE_COMPARATOR): Adding Glimepiride to metformin users

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 Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Males and non-pregnant females ages 18 years of age or older~* Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m~* Serum phosphate \> 3.5 mg/dL~* Fibroblast growth factor 2 (FGF2) \> 100 relative units per milliliter (RU/mL)~* Corrected serum calcium \>8.0mg/dL~Exclusion Criteria:~* Current use of a phosphate binder~* Corrected serum calcium \<8.0mg/dL~* Current use of prescription-based vitamin D therapy~* Acute kidney injury in last 3 months~* Significant GI disorder~* History of allergic reaction or sensitivity to lanthanum carbonate~* History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator~* Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

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

Study Arms:
- Lanthanum Carbonate (Fosrenol) (Type: ACTIVE_COMPARATOR): Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)
- Placebo (Type: PLACEBO_COMPARATOR): Subject will receive placebo

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

Answer: outcome: complete