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

Trial Title: Phase 3 Study of MAP0004 in Adult Migraineurs

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:
Major Inclusion Criteria:~* Male or female between 18 and 65 years of age.~* History of episodic, acute migraine (with or without aura) with onset prior to 50~Major Exclusion Criteria:~* Known allergy or sensitivity or contraindication to study drugs or their formulations~* History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.~* Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation

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

Study Arms:
- MAP0004 (Type: EXPERIMENTAL): MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
- Placebo (Type: OTHER): Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 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: Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

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:~1. Documented PAF:~   * Diagnosis of paroxysmal atrial fibrillation (PAF), AND~  * 2 or more episodes of AF during the 3 months preceding the consent Date, AND~  * At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.~2. Age 18 years or older~3. Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.~Exclusion Criteria:~1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)~2. Any previous LA surgery~3. Current intracardiac thrombus (can be treated after thrombus is resolved)~4. Presence of any pulmonary vein stents~5. Presence of any pre-existing pulmonary vein stenosis~6. Pre-existing hemidiaphragmatic paralysis~7. Anteroposterior LA diameter \> 5.5 cm by TTE~8. Presence of any cardiac valve prosthesis~9. Clinically significant mitral valve regurgitation or stenosis~10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date~11. Unstable angina~12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date~13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)~14. NYHA class III or IV congestive heart failure~15. Left ventricular ejection fraction (LVEF) \< 40%~16. 2º (Type II) or 3º atrioventricular block~17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)~18. Brugada syndrome~19. Long QT syndrome~20. Arrhythmogenic right ventricular dysplasia~21. Sarcoidosis~22. Hypertrophic cardiomyopathy~23. Known cryoglobulinemia~24. Uncontrolled hyperthyroidism~25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.~26. Any woman known to be pregnant~27. Life expectancy less than one (1) year~28. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic~29. Unwilling or unable to comply fully with study procedures and followup

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

Study Arms:
- Single Arm (Type: OTHER): Cryoablation

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 BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis

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:~* Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS~* Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive~* Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment~Key Exclusion Criteria:~* Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg~* History of treatment with Daclizumab High Yield Process (Dac HYP)~* History of malignancy~* History of severe allergic or anaphylactic reactions~* Known hypersensitivity to study drugs or their excipients~* History of abnormal laboratory results indicative of any significant disease~* History of human immunodeficiency virus (HIV) or other immunodeficient conditions~* History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization~* History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline~* History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1~* An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization~* Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus~* Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening~* Exposure to varicella zoster virus within 21 days before screening~NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

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

Study Arms:
- Daclizumab High Yield Process 150 mg SC (Type: EXPERIMENTAL): Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
- IFN β-1a 30 µg IM (Type: ACTIVE_COMPARATOR): Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 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: Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

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:~* Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male or female subjects of any race, 12 to 16 years of age (inclusive).~* Verbal and written informed consent/assent obtained from the subject and/or their parent or legal guardian.~* Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests.~* Target great toenail for all subjects, and both great toenails for subjects in the PK subset, must have evidence of toenail growth, per subject's report that monthly clipping is needed.~* Subjects and their parents/legal guardians are willing to comply with study instructions and return to the investigational center for all required visits (a visit schedule with the length of each visit will be provided to ensure that the subject can meet the requirements and have adequate transportation).~Key Exclusion Criteria:~* Females who are pregnant, nursing an infant, or planning a pregnancy during the study period.~* History of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the investigator, or known human immunodeficiency virus infection.~* History of diabetes that is uncontrolled as determined by the investigator (diabetes that is controlled by diet or medication does not exclude a subject).~* Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 16 Years
- Healthy Volunteers: t

Study Arms:
- Efinaconazole (Type: EXPERIMENTAL): Efinaconazole

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: Techniques to Improve Efficacy of Second Trimester Medical Termination

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

Eligibility Criteria:
Inclusion Criteria:~* 14-24 weeks pregnant~* planned medical termination~* able to speak and understand English~* no contraindication to prostaglandins~Exclusion Criteria:~* gestation \< 13 weeks~* allergy/contraindication to misoprostol~* allergy/contraindication to mifepristone~* fetal demise

- Gender: FEMALE
- Minimum Age: 16 Years
- Maximum Age: 50 Years
- Healthy Volunteers: f

Study Arms:
- Vaginal misoprostol (Type: ACTIVE_COMPARATOR): Women allocated to the vaginal misoprostol management protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 4 hours by 400 mcg vaginal misoprostol, the latter repeated every 4 hours for a maximum of 4 doses.~If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated.~If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs.
- Oral misoprostol (Type: ACTIVE_COMPARATOR): Women allocated to the standard management protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 3 hours by 400 mcg misoprostol orally, the latter repeated every 3-hours to a maximum of 4 oral doses.~If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated.~If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs.
- Sublingual misoprostol (Type: ACTIVE_COMPARATOR): Women allocated to the sublingual misoprostol protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 3 hours by 400 mcg sublingual misoprostol, the latter repeated every 3 hours for a maximum of 4 doses.~If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated.~If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs.

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: Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

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

Eligibility Criteria:
Inclusion criteria~1. Patients who are recipients of a renal transplant.~2. Patients treated with an immunosuppressive regiment including MMF before recruitment.~3. Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.~4. Patients 18 years or older.~5. Patients who have given written informed consent to participate in the study~6. Patients complying with all study requirements including completing questionnaires and attending to the three study visits.~Exclusion criteria~1. Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)~2. Acute rejection less than 1 week before recruitment.~3. Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.~4. Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.~5. Patients undergoing surgery due to acute illness or hospitalized.~6. Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration.~7. Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit.~Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- EC MPS (Type: EXPERIMENTAL): Up to 1440mg taken in two doses
- Mycophenolate mofetil (Type: ACTIVE_COMPARATOR): 250 mg or 500 mg in two equal doses

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: Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma

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:~* Age above 55 years old.~* Diagnosis of MM (Appendix A) and staging (Appendix B), previously untreated.~* Performance status ECOG, 0, 1, or 2 (Appendix C).~* Written informed consent to the study medications and bone marrow biopsy at diagnosis, 12 weeks and 6 months and/or off-study assessment.~* Women who are pregnant or lactating at the time of diagnosis are ineligible. All women of child-bearing potential must have a negative pregnancy test within 24hrs of commencing the thalidomide and must take adequate precautions to prevent pregnancy and should not plan on conceiving children during the treatment program:~  * Adequate precautions are defined as at least one highly effective method i.e., IUD, hormonal (birth control pills, injections, or implants), tubal ligation, partner's vasectomy AND one additional effective method i.e., latex condom, diaphragm, cervical cap.~ * Women becoming pregnant on protocol will be removed immediately from protocol.~ * Male patients (including patients having had a vasectomy) must use barrier contraception during and for four weeks after completing the thalidomide.~* Patients remain eligible in the presence of abnormal renal function and/or liver function at time of enrollment.~* Absence of severe dementia, able to take medication at home.~* Absence of systemic disorders (gastrointestinal, pulmonary, cardiac and neurological).~Exclusion Criteria:~* Asymptomatic myeloma or solitary plasmacytoma of bone or extramedullary plasmacytoma (without evidence of myeloma).~* Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas.~* Previous treatment for myeloma, except minimal local radiotherapy to relieve bone pain.~* Other illnesses which would preclude chemotherapy administration or patient compliance.~* Any other serious medical or psychiatric illness which would prevent informed consent.~* Peripheral neuropathy \> NCI criteria grade 2.~* Pregnant or lactating women and patients of childbearing age who refuse to use contraception.~* History of hypersensitivity to thalidomide or any component of the medications.

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Thalidomide (Type: EXPERIMENTAL): MPT
- Control (Type: ACTIVE_COMPARATOR): MP

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 Infusion Paracetamol Protocols in PDA

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

Eligibility Criteria:
Inclusion Criteria:~birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks at birth~Exclusion Criteria:~birth weight (BW) \>1500 g and gestational age (GA) \>32 weeks at birth

- Gender: ALL
- Minimum Age: None
- Maximum Age: 1 Month
- Healthy Volunteers: None

Study Arms:
- standard IV intermittent bolus infusion group (Type: None): None
- continuousIV intermittent bolus infusion group (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: Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 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:~* Patients with type 1 diabetes mellitus~Exclusion criteria:~* Age \< 18 years at screening visit;~* HbA1c \< 7.0 % or \> 10.0 % (national glycohemoglobin standardization program \[NGSP\] value) at screening visit;~* Patients less than 1 year before screening visit on any basal plus mealtime insulin;~* Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;~* Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;~* Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;~* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;~* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eq, laser, surgical treatment or injectable drugs) during the study period.~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Study Arms:
- New formulation of insulin glargine (Type: EXPERIMENTAL): once daily in the evening on-top of mealtime insulin
- Lantus (insulin glargine) (Type: ACTIVE_COMPARATOR): once daily in the evening on-top of mealtime insulin

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 Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride 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: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Type 2 diabetes~* Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months~* Ongoing stable treatment with metformin for at least 2 months~* Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months~* Insulin naive~* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)~Exclusion Criteria:~* Metformin contraindication according to local practice~* TZD (thiazolidinedione) treatment for the last 5 months before trial start~* Systemic treatment with any corticosteroid 3 months before trial start~* Any disease or condition which according to the Investigator would interfere with the trial

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

Study Arms:
- BIAsp 30 (Type: EXPERIMENTAL): None
- Glargine (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: Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* ACR criteria for fibromyalgia~* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries~Exclusion Criteria:~* Patients with other severe pain conditions~* Patients with severe depression~* Patients taking excluded medications

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (Type: EXPERIMENTAL): None
- 3 (Type: EXPERIMENTAL): None
- 4 (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: complete