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

Trial Title: Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

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

Eligibility Criteria:
Inclusion Criteria:~* is a healthy Japanese male or female ≥20 years of age at time of randomization~* male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention~* female participants must not be pregnant or breastfeeding, and is either:~* not a woman of childbearing potential (WOCBP) or~* a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention~Exclusion Criteria:~* has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1~* has a known hypersensitivity to any vaccine components~* has impaired immunological function~* has a coagulation disorder~* had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1~* has a known malignancy that is progressing/requiring treatment~* has received, or is expected to receive, a pneumococcal vaccine outside the study protocol~* has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1~* is receiving immunosuppressive therapy~* has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine~* has received any live vaccine from 30 days prior to Day 1~* has received a blood transfusion or blood products~* has participated in another clinical trial within 2 months of this study~* has clinically relevant drug or alcohol abuse~* has any condition that, in the opinion of the investigator, precludes participation in this study

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- V116 (Type: EXPERIMENTAL): Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
- PNEUMOVAX™23 (Type: ACTIVE_COMPARATOR): Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.

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: Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study

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:~1. Subject is willing and capable of providing informed consent~2. Subject is planned to be implanted with an ACUITY X4® lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator~3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP~4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law~Exclusion Criteria:~1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate~2. Subject is enrolled in any other concurrent study without prior written approval from BSC, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:~   * Schedule of procedures for the RALLY X4 Study (i.e. should not cause additional or missed visits);~  * RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);~  * Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable~3. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure~4. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.~5. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center~6. Subject does not anticipate being a resident of the area for the scheduled duration of the trial~7. Subject's physician does not allow participation~   -

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

Study Arms:
- Heart failure patients (Type: None): * Subjects with art failure who receive stable optimal pharmacologic therapy~* Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms~* Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.~The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .

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: Antidepressant Therapy in Treating Bipolar Type II Major Depression

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

Eligibility Criteria:
Inclusion Criteria:~* Meets DSM-IV criteria for Axis I bipolar II disorder~* Meets DSM-IV criteria for Axis I major depressive episode~* Score of 16 on 17-item HAM-D rating scale~* Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry~* Willing to use an effective form of birth control throughout the study~Exclusion Criteria:~* History of mania~* Current primary Axis I diagnosis other than bipolar II disorder~* Alcohol or drug dependence within 3 months prior to study entry~* Contraindication to treatment with venlafaxine or lithium~* Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)~* Pregnant or breastfeeding~* Experiencing suicidal thoughts~* Requires hospitalization~* Requires concurrent neuroleptic or MS therapy~* Requires concurrent AD therapy~* Current psychotic features~* Inadequate trial of therapy at the time of initial screening visit~* History of intolerance to either venlafaxine or lithium~* Unlikely to participate in a 36-week trial~* Presence of apparent secondary gain

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

Study Arms:
- I (Type: EXPERIMENTAL): Antidepressant therapy
- II (Type: ACTIVE_COMPARATOR): Mood stabilizer therapy

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 Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Plaque psoriasis involving up to 2 to 20% Body Surface Area~Exclusion Criteria:~* Lesions solely involving intertriginous areas, the scalp or the face~* Systemic therapy for their psoriasis~* Pustular psoriasis or erythroderma~* Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the first dose of study medication~* Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis~* Receiving systemic triazole antifungals except fluconazole

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

Study Arms:
- Vehicle Cream (Type: PLACEBO_COMPARATOR): Vehicle cream, applied topically, once daily from Day 1 to Week 12.
- Ruxolitinib Phosphate 0.5% Cream (Type: EXPERIMENTAL): Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
- Ruxolitinib Phosphate 1.0% Cream (Type: EXPERIMENTAL): Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
- Ruxolitinib Phosphate 1.5% Cream (Type: EXPERIMENTAL): Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.

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: Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

Study Design Characteristics:
- Allocation: None
- 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:~* Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical resection~* Ambulatory and capable of all self-care but may be unable to carry out any work activities.~* Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell medical center for purposes of volumetric measurements.~* Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.~* 18 years and older.~* Women of child-bearing potential must be taking adequate contraceptive precautions prior to study entry and for the duration of study participation. A negative serum or urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen or agree to abstain from heterosexual intercourse while taking study drug and for 30 days following the last dose of study drug.~Exclusion Criteria:~* Cannot be on any other anti-cancer treatment during this study.~* Prior treatment with any EGFR inhibitor.~* Patients who had prior treatment with chemotherapy or radiation for this disease.~* Other active cancers.~* Tumors with a mixed histology of small cell and non-small cell carcinoma as well as patients with pulmonary carcinoid tumors.~* Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel disease.~* Hypersensitivity to compounds similar in chemical composition to Tarceva®.~* Active infection or serious underlying medical conditions which would impair protocol treatment.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Erlotinib (Type: EXPERIMENTAL): Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

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: Gap Junction Potentiation of Endothelial Function With Rotigaptide

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy volunteers aged between 18-64 years.~Exclusion Criteria:~* Lack of informed consent~* Age \<18 or \>64 years~* Current involvement in a clinical trial~* Clinically significant comorbidity: heart failure, hypertension, known hyperlipidaemia, diabetes mellitus, asthma, coagulopathy or bleeding disorders\*~* Smoker\*~* Current intake of aspirin, other non steroid anti inflammatory medications or vasodilators\*~* Recent infective/inflammatory condition\*~* Women of child bearing age~* Recent blood donation (preceding three months) \*All cause confounding effects on vascular/endothelial function.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: t

Study Arms:
- Rotigaptide (Type: ACTIVE_COMPARATOR): Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, rotigaptide will be infused for 30mins. During the ischaemic period no drug will be infused but the infusion will be restarted once the blood pressure cuff has been deflated and blood flow returns to the limb.
- Saline (Type: PLACEBO_COMPARATOR): Saline will be infused through-out the study.

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: Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain

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

Eligibility Criteria:
Inclusion Criteria:~* All patients Suffered radicular leg pain and some reported additional back pain.~* All patients are non-responsive to conservative treatment modalities with VAS more than 7.~Exclusion criteria~* presence of bleeding disorder~* local infection~* uncontrolled or degenerative spine disease~* pregnancy~* multilevel disk involvement~* patient refusal.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- group A (Type: ACTIVE_COMPARATOR): percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
- group B (Type: ACTIVE_COMPARATOR): percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.

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: Myocardial Infarction, COmbined-device, Recovery Enhancement Study

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

Eligibility Criteria:
Corrie Health Digital Platform group~Inclusion Criteria:~* Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)~* 18 years or older~* English-speaking~* Own any type of smartphone~Exclusion Criteria:~* Visual, hearing, or motor impairment which precludes the use of the intervention~* Inability to participate due to severity of illness (e.g., intubated and on sedation in the setting of cardiogenic shock). If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member returns at a later date to determine whether this status has changed.~Historical Standard of Care Comparison group~Inclusion Criteria:~* Admitted for acute myocardial infarction (STEMI or NSTEMI)~* 18 years or older~* English-speaking~Exclusion Criteria:~* None

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

Study Arms:
- Corrie Health Digital Platform group (Type: EXPERIMENTAL): Receives the Corrie Health intervention plus the standard of care

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: Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

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

Eligibility Criteria:
Inclusion Criteria:~* Adults with RA (ACR criteria) for greater than or equal to 6 months~* Infliximab treatment for at least 18 weeks~* Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)~* Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints~* Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening~* Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening~* Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening~* Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to 1 week prior to screening~Exclusion Criteria:~* ACR functional class IV - Prior treatment with etanercept~* Receipt of any investigational drug/biologic within 28 days of study drug initiation~* Active infection or predisposition to infection~* Elective surgery planned during study period~* Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening~* Contraindications to etanercept as defined in the package insert~* Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis

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

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis

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:
Key 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 in accordance with national and local subject privacy regulations.~* Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting multiple sclerosis (MS) per revised McDonald Committee criteria (\[Polman et al, 2011\]) as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration.~* Have a walking impairment as determined by the Investigator.~* Able to perform the Timed 25-foot Walk Test with or without a walking aid.~* Female 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.~* Able to understand and comply with the requirements of the protocol.~Key Exclusion Criteria:~* Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet.~* Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.~* An estimated creatinine clearance of \<80 mL/minute.~* Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 \[e.g., cimetidine\]).~* Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study.~* Female subjects who are currently breastfeeding.~* Previous exposure to fampridine.~NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Arms:
- (BIIB041) Fampridine (Type: EXPERIMENTAL): All participants take 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, a participant continues 10 mg fampridine twice daily for 44 weeks. Treatment non-responders can continue without treatment by completing quality of life questionnaires.

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: Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes

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

Eligibility Criteria:
Type 1 diabetes, HbA1c \< 7.8%, who have had prior instruction in a complex insulin program, and presently using a MDI insulin program with basal insulin preparations of Glargine or Ultralente and Humalog as the short acting insulin, should be free of hepatorenal abnormalities and hypoglycemia unawareness; non-pregnant, and should be able to perform frequent self monitoring of blood glucose (SMBG) and accept the use of continuous glucose monitoring system (CGMS). They should also possess the skill and understanding of insulin dose adjustments and supplementation.

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

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

Answer: outcome: complete