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

Trial Title: Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 8.0

Eligibility Criteria:
Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV - heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes, poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- A5 Placebo Q2W (Type: PLACEBO_COMPARATOR): Participants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
- A5 Placebo QM (Type: PLACEBO_COMPARATOR): Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
- A5 Evolocumab Q2W (Type: EXPERIMENTAL): Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
- A5 Evolocumab QM (Type: EXPERIMENTAL): Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
- A20 Placebo Q2W (Type: PLACEBO_COMPARATOR): Participants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
- A20 Placebo QM (Type: OTHER): Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
- A20 Evolocumab Q2W (Type: EXPERIMENTAL): Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
- A20 Evolocumab QM (Type: EXPERIMENTAL): Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 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: Depakote-ER for Depressive and Bipolar Depression

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

Eligibility Criteria:
Inclusion Criteria:~* DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS \< 12; MADRS \> 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics~Exclusion Criteria:~* Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality

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

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: Rainbow Extension Study

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

Eligibility Criteria:
Inclusion Criteria:~* Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements~* The patient successfully completed the core study H2301, as defined by providing assessments at the Visit 112 (the last scheduled visit in the core study) or, if appropriate, at the last of the additional assessment visits as per protocol in H2301, whichever was latest~* The patient received study treatment in both eyes at baseline of study H2301~Exclusion Criteria:~* Patient had a medical condition or personal circumstance which precluded study participation or compliance with study procedures, as assessed by the Investigator~* Patient had been discontinued from the core study H2301 at any time

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 5 Years
- Healthy Volunteers: f

Study Arms:
- Ranibizumab 0.2 mg (Type: EXPERIMENTAL): 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
- Ranibizumab 0.1 mg (Type: EXPERIMENTAL): 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
- Laser therapy (Type: NO_INTERVENTION): Laser 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: Alisertib for Acute Myeloid Leukemia

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:~* Pathologically confirmed, newly diagnosed acute myelogenous leukemia~* Agree to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237~* Able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration~Exclusion Criteria:~* Have received systemic antineoplastic therapy, including radiotherapy within 14 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction~* Pregnant or breastfeeding~* Presence of favorable or better risk cytogenic prognosis~* Prior allogeneic bone marrow or organ transplantation~* Diagnosis of acute bilineal/biphenotypic leukemia~* History of a different malignancy except if disease-free for at least 5 years and at low risk or recurrence; or cervical cancer in situ, basal cell or squamous cell carcinoma of the skin within the past 5 years~* Uncontrolled intercurrent illness~* HIV positive on combination antiretroviral therapy~* Diagnosis of active hepatitis B or C~* Current or history of congestive heart failure NYHA class 3 or 4, or documented diastolic or systolic dysfunction~* Current or history of ventricular or life threatening arrhythmias or diagnosis of long QT syndrome~* Known history of uncontrolled sleep apnea syndrome or other condition that could result in excessive daytime sleepiness~* Requirement for constant administration of proton pump inhibitor, H2 antagonist or pancreatic enzymes~* Systemic infection requiring IV antibiotic therapy within 14 days of first dose of study drug~* Treatment with clinically significant enzyme inducers

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

Study Arms:
- Treatment (Type: EXPERIMENTAL): Induction: 100 mg/m2/day Cytarabine intravenous, days 1-7 of induction cycle. 12 mg/m2/day Idarubicin intravenous, days 1-3. Alisertib orally, twice a day for one week starting on day 8, dose escalation-starting dose 10 mg PO BID.~Consolidation: Cytarabine 3 g/m2 by IV infusion over 3 hours given every 12 hours on Days 1, 3 and 5 (subjects younger than age 60) or Cytarabine 2 g/m2 per day by IV infusion over 3 hours on days 1-5 (subjects at or older than age 60)

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 Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients, ≥ 18 years of age.~* Rheumatoid arthritis of \> 6 months duration.~* Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.~* All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.~* Weight ≤ 150 kg.~Exclusion Criteria:~* Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.~* History of or current inflammatory joint disease other than rheumatoid arthritis (RA).~* Treatment with a biologic agent at any time prior to baseline.~* Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.~* Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.

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

Study Arms:
- Tocilizumab 8 mg/kg (Type: EXPERIMENTAL): Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
- Adalimumab 40 mg (Type: ACTIVE_COMPARATOR): Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 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: Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria~* Screening pain criteria sufficient as assessed by WOMAC and VAS scores~* Ability to read and understand the informed consent~Exclusion Criteria:~* Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception~* Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation~* Body mass index \>40~* Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period~* History of malignancy within the last 5 years~* Participation in a clinical research trial within 12 weeks prior~* Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months~* Effusion of the target knee requiring aspiration within 3 months~* Use of electrotherapy or acupuncture for OA within 4 weeks~* Significant and clinically evident misalignment of the target knee~* Any known active infections~* Any chronic condition that has not been well controlled for a minimum of 3 months

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- SM04690, 0.03mg/2mL (Type: EXPERIMENTAL): Single, intra-articular injection of SM04690, 0.03mg/2mL
- SM04690, 0.07mg/2mL (Type: EXPERIMENTAL): Single, intra-articular injection of SM04690, 0.07mg/2mL
- SM04690, 0.23mg/2mL (Type: EXPERIMENTAL): Single, intra-articular injection of SM04690, 0.23mg/2mL
- Placebo (Type: PLACEBO_COMPARATOR): Single, intra-articular injection of placebo

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: Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

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

Eligibility Criteria:
Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will be eligible to participate if they meet the inclusion and exclusion criteria given below.~Inclusion Criteria~* Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months~* Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit~* Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.~Exclusion Criteria~* Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)~* Missed 2 or more investigational product doses during the 20030216 study~* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures~* Developed sensitivity to mammalian cell derived drug products during the 20030216 study~* Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)~* Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study~* Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone~* For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives

- Gender: FEMALE
- Minimum Age: 60 Years
- Maximum Age: 94 Years
- Healthy Volunteers: f

Study Arms:
- Denosumab (Type: EXPERIMENTAL): Participants received a 60 mg subcutaneous injection of denosumab every 6 months for seven years.

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: E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

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:~* Patients must have fully completed C07-001 study 12-week treatment period~Exclusion Criteria:~* Patients who terminated early from the C07-001 study

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Eculizumab (Type: EXPERIMENTAL): Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol

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: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload

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

Eligibility Criteria:
Inclusion criteria~* Patients who completed the 12-month core study (NCT00061750)~* Female patients after menarche and who were sexually active, if they used double-barrier contraception, oral contraceptive plus barrier contraceptive, or had undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation~* Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation~Exclusion criteria~* Pregnant or breast feeding patients~* Patients with a history of non-compliance to medical regimens or those considered to be potentially unreliable

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Deferasirox (Type: EXPERIMENTAL): All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight.

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: Canakinumab in Patients With Active Hyper-IgD Syndrome

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: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients with a diagnosis of HIDS proven by DNA analysis and/or enzymatic studies.~2. At time of start of drug treatment: active HIDS as evidenced by a physician global assessment of HIDS flare severity ≥ 2 and CRP values \>10 mg/L (normal CRP \< or = 10 mg/L).~3. Patients who have a history of \> or = 3 febrile acute HIDS flares in a 6-month period when not receiving prophylaxis treatment (e.g. anakinra daily treatment) with a duration of each flare lasting \> or = 4 days and limiting the normal daily activities.~Exclusion Criteria:~1. Pregnant or nursing (lactating) women.~2. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.~3. Positive Hepatitis B or Hepatitis C.~4. Live vaccinations within 3 months prior to the start of the trial~5. Positive tuberculosis screening test.~Other protocol-defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 24 Months
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Canakinumab (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: Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:~  1. Relieved with defecation~ 2. Onset associated with a change in frequency of stool~ 3. Onset associated with a change in form (appearance) of stool~* Patient reports \< 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs~* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)~* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms~Exclusion Criteria:~* Patient has history of loose or watery stools for \>25% of BMs~* Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility~* Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments

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

Study Arms:
- Linaclotide (Type: EXPERIMENTAL): Linaclotide 290 micrograms
- Placebo (Type: PLACEBO_COMPARATOR): Matching placebo

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: BIOTRONIK Conduction System Pacing with the Solia Lead

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:~* Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.~* Patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent~* Patient is able to understand the nature of the study and provide written informed consent~* Patient is available for follow-up visits on a regular basis for the expected duration of follow-up~* Patient accepts Home Monitoring® concept~* Patient age is greater than or equal to 18 years at time of consent~Exclusion Criteria:~* Patient meets a standard contraindication for pacemaker system implant~* Patient is currently implanted with a pacemaker or ICD device~* Patient has had a previous unsuccessful attempt to place a lead in the LBB area~* Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant~* Patient is expected to receive a heart transplant within 12 months~* Patient life expectancy less than 12 months~* Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder~* Patient reports pregnancy at the time of enrollment~* Patient is enrolled in any other investigational cardiac clinical study during the course of the study

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

Study Arms:
- Solia S LBB lead (Type: OTHER): None

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

Answer: outcome: complete