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

Trial Title: Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

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:~* Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy.~Exclusion criteria:~* Age \< 18 years~* LDL-C \< 160 mg/dL (\< 4.14 mmol/L) at the screening visit (Week-3).~* Fasting serum triglycerides \> 400 mg/dL (\> 4.52 mmol/L) during the screening period.~* Known history of homozygous familial hypercholesterolemia.~The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Study Arms:
- Placebo Q2W (Type: PLACEBO_COMPARATOR): Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
- Alirocumab 150 mg Q2W (Type: EXPERIMENTAL): Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 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: Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID

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: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160603. Participants who have discontinued rHuPH20 and reverted to intravenous or subcutaneous treatment due to an anti-rHuPH20 antibody also may enroll for long-term safety monitoring.~* Participant/caretaker has reviewed, signed and dated informed consent~* Participant is willing and able to comply with the requirements of the protocol~Exclusion Criteria:~* Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in Study 160902~* Participant is scheduled to participate in another non-Baxter clinical study involving an investigational product or investigational device during the course of this study~* If female of childbearing potential, participant is pregnant or has a negative pregnancy test and does not agree to employ adequate birth control measures for the duration of the study

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

Study Arms:
- SC/IGSC, 10% with rHuPH20 followed by SC of IGSC, 10% (safety) (Type: EXPERIMENTAL): Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20) followed by Safety of SC of IGSC, 10% only (safety follow-up)
- SC/IGSC, 10% with rHuPH20 followed by IV of IGSC, 10% (safety (Type: EXPERIMENTAL): Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20) followed by Safety of intravenous (IV) administration of IGSC, 10% only (safety follow-up)
- IV treatment with IGSC, 10% only (Type: EXPERIMENTAL): Partial efficacy (trough levels of immunoglobulin G \[IgG\] only) and safety of intravenous (IV) administration of IGSC, 10% only. This was for participants enrolled in the study who had anti-rHuPH20 andibody titer from study160603

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: Bisphosphonates Use After Total Joint Arthroplasty

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).~Exclusion Criteria:~1. Patients with total joint arthroplasty before the index date,~2. Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,~3. Patients who were lost to follow-up~4. Patients \< 40 years old

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: None

Study Arms:
- bisphosphonates users (Type: None): Patients who underwent primary total joint arthroplasty with bisphosphonates use
- bisphosphonates nonusers (Type: None): Patients who underwent primary total joint arthroplasty without bisphosphonates use

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 of YKP3089 in Patients With Photosensitive Epilepsy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female age 18-60 years.~* A diagnosis and history of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs.~* If the patient is taking two concomitant medications, the second drug must be levetiracetam, gabapentin or pregabalin.~* A reproducible IPS-induced photo-paroxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale (See Section 6.16) in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded over the 2 months prior to study entry in at least one eye condition.~* Patients in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.~* A body mass index (BMI) between 18 and 35.~* Able and willing to provide written informed consent to participate in the study in accordance with the ICH, GCP guidelines.~Exclusion Criteria:~* A history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures).~* Women who are pregnant or lactating.~* Women of reproductive potential who do not agree to use effective birth-control methods.~* Patients taking medications that are known substrates of CYP2B6 and CYP2C19 including but not limited to phenytoin, Phenobarbital, omeprazole, fluvoxamine and efavirenz.~* Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study.~* An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.~* Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study.~* Patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (AST and ALT).~* A history of alcoholism, drug abuse, or drug addiction (within the past 12 months).~* Patients who would normally be contraindicated for YKP3089 administration.~* Patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- YKP3089 (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: Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

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:
Inclusion Criteria:~* Successfully completed the entire treatment period in a qualifying study (TA-301 \[NCT00790751\] or TA-302 \[NCT00809471\]);~* Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;~* Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;~* Agree to make at least 4 attempts at intercourse each month through the course of this study;~* Agree not to use any other treatments for erectile dysfunction during participation in this study.~* Provide written informed consent;~* Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.~Exclusion Criteria:~* Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;~* Subjects requiring treatment with an excluded medication.

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

Study Arms:
- avanafil (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: Implementing Sleep Interventions for Older Veterans

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

Eligibility Criteria:
Inclusion Criteria:~Report symptoms that meet diagnostic criteria for insomnia and are:~* age \>=60,~* community-dwelling,~* live within a 30-mile radius of VA Greater Los Angeles Healthcare System (GLAHS), and~* have transportation to VA GLAHS to attend the intervention/control programs.~Exclusion Criteria:~* Significant cognitive impairment (MMSE score \<24) and have evidence of sleep apnea (by questionnaire and/or sleep monitoring).

- Gender: ALL
- Minimum Age: 60 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- CBT-I (Type: EXPERIMENTAL): Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.
- Control (Type: ACTIVE_COMPARATOR): Non-directive sleep education provided in 5 group sessions by a health educator.

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: EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

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

Eligibility Criteria:
Inclusion criteria:~* Male or female patient, age \>= 18 years at screening. For Japan only: Age \>=20 years at screening~* Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) \> 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) \> 300 pg/ml for patients without AF, OR \> 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1~* Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1~* Stable dose of oral diuretics, if prescribed~* Signed and dated written ICF (informed consent form)~* Further inclusion criteria apply~Exclusion criteria:~* Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1~* Heart transplant recipient or listed for heart transplant~* Acute decompensated HF (Heart Failure)~* Systolic blood pressure (SBP) \>= 180 mmHg at Visit 2.~* Symptomatic hypotension and/or a SBP \< 100 mmHg~* Indication of liver disease,~* Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis~* History of ketoacidosis~* Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor~* Currently enrolled in another investigational device or drug trial~* Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors~* Women who are pregnant, nursing, or who plan to become pregnant while in the trial~* Further exclusion criteria may apply

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

Study Arms:
- 10 mg Empagliflozin (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_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: Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

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

Eligibility Criteria:
Inclusion Criteria:~* Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures~Exclusion Criteria:~* Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
- 2 (Type: PLACEBO_COMPARATOR): Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
- 3 (Type: ACTIVE_COMPARATOR): Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).

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

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

Trial Title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients (\> 18 years old)~* With a diagnosis of AS~* With at least one of the following evidences for active inflammation, present within 3 months before inclusion: a serum C-reactive protein (CRP) level above twice the upper limit value of the normal range, a positive magnetic resonance imaging of the spine or sacro-iliac joints, a vascularized enthesitis by power-Doppler ultrasound technic.~* Presence of clinically active axial disease, as defined by 1) a Bath AS Disease Activity Index (BASDAI) (18) of ≥ 3/10, and 2) a score of ≥ 3/10 for axial pain (second item of BASDAI).~* Disease-modifying antirheumatic drugs (DMARDs), such as sulphasalazine, methotrexate, hydroxychloroquine, intra-muscular gold, thiol compound, cyclosporin, intravenous biphosphonate had to be discontinued for at least 4 weeks before inclusion.~* Dosages of NSAIDs and corticosteroid were required to remain stable for at least 4 weeks before inclusion.~* A negative pregnancy test result was required for non menopausal female patients, and contraception during the study period and for six months after the last infusion of infliximab was recommended to all patients of childbearing potential.~Exclusion Criteria:~* Pregnancy.~* Breastfeeding.~* Vaccination with a live organism during the last month.~* Present infection or any episode of serious infection within the last three months.~* Active malignancy within the previous five years.~* Alcohol or drug addiction.~* Severe chronic concomitant disease.~* Administration of an investigational drug within the last three months, or of any known TNF inhibitor therapy in the past (such as thalidomide, infliximab or etanercept).

- 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: A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria~* Subjects must have active disease at Screening as defined by~* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4~* Spinal pain \>= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)~* Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) \> upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria~* Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator~* Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline~Exclusion Criteria:~* Other inflammatory arthritis~* Secondary, noninflammatory condition that, in the Investigator's opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of axial spondyloarthritis (axSpA)~* Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA~* Any condition or complicating factor that may interfere with the AU assessment~* Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device~* Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit~* Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit~* Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit~* Cyclophosphamide within 30 days prior to the Baseline Visit~* Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit~* Intravitreal anti-vascular endothelial growth factor (VEGF) therapy

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

Study Arms:
- Certolizumab Pegol (Type: EXPERIMENTAL): Subjects will receive a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every two 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: Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* STEMI patients (defined as: Evidence of ischemic chest pain for \>30 minutes within \<12 hours and new ST-segment elevation for ≥2 mm in two or more contiguous electrocardiographic leads or in case of a true posterior infarction reciprocal ST-segment depressions in in V1 and V2 \>1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery.~Exclusion Criteria:~* Significant liver disease~* Thrombolytic therapy~* History of prior myocardial infarction~* Current atrial fibrillation~* History of congestive heart failure~* History of migraine headache~* Significant valvular heart disease, primary myocardial disease~* Cardiogenic shock (sRR \<90mmHg or need for inotropic support)~* Child-bearing potential~* Inability to read, understand and sign the informed consent~* Life expectancy \<3y~* Prior organ transplantation~* Medication with konazoles, ritonavir, rifampicin and sulfonyl-urea derivatives~* Participation in another clinical study~* Metal implants contraindicating CMR

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

Study Arms:
- 1 (Type: PLACEBO_COMPARATOR): Placebo
- 2 (Type: ACTIVE_COMPARATOR): BQ-123

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 3 /Seroquel SR Acute Mania Monotherapy - US

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

Eligibility Criteria:
Inclusion Criteria:~* Provision of written informed consent~* Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed~* Inpatient hospital admission for the first 4 days of study treatment~Exclusion Criteria:~* \>8 mood episodes within the last 12 months~* Use of prohibited medication~* Substance or alcohol abuse or dependence~* Current suicide risk or suicide attempt within last 6 months.

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

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

Answer: outcome: complete