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

Trial Title: Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Key Inclusion Criteria:~* Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease).~* Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤) 500 mg/dL (≥ 5.7 mmol/L) at Screening.~* Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.~* Must be on standard-of-care preventative therapy for known CVD risk factors.~Key Exclusion Criteria:~* Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/transient ischemic attack (TIA).~* Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis.~* Heart failure New York Heart Association (NYHA) class IV.~* Type 1 diabetes mellitus.~* Type 2 diabetes mellitus with any of the following:~  * Newly diagnosed within 12 weeks of Screening.~ * Glycated hemoglobin (HbA1c) ≥ 9.0% at Screening.~ * Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of new medication within 12 weeks of Screening \[with the exception of ± 10 units of insulin\].~* Body Mass Index (BMI) greater than (\>) 40 kilograms per square meter (kg/m\^2).

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

Study Arms:
- Pooled Placebo (Type: PLACEBO_COMPARATOR): Participants in each cohort (A, B, C and D) were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
- Cohort A: ISIS 678354: 10 mg Q4W (Type: EXPERIMENTAL): Cohort A participants received 10 milligrams (mg) ISIS 678354, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
- Cohort C: ISIS 678354: 15 mg Q2W (Type: EXPERIMENTAL): Cohort C participants received 15 mg ISIS 678354, SC injection, once every 2 weeks (Q2W) for up to 51 weeks and a maximum of 26 doses.
- Cohort D: ISIS 678354: 10 mg QW (Type: EXPERIMENTAL): Cohort D participants received 10 mg ISIS 678354, SC injection, once weekly (QW) for up to 52 weeks and a maximum of 52 doses.
- Cohort B: ISIS 678354: 50 mg Q4W (Type: PLACEBO_COMPARATOR): Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 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: Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study

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

Eligibility Criteria:
Inclusion Criteria:~* Patients after roux-y-gastric bypass or biliopancreatic diversion with documented hypoglycemia, i. e. ≤ 2.5 mmol/l and hypoglycaemic symptoms.~* For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study~Exclusion Criteria:~* Signs of current infection~* Use of any investigational drug in the last four weeks prior to enrolment~* Use of any anti-diabetic drugs~* adrenal insufficiency and/or substitution with glucocorticoids~* Neutropenia (leukocyte count \< 1.5 × 109/L or absolute neutrophil count (ANC) \< 0.5 × 109/L)~* Anemia (hemoglobin \< 11 g/dL for males, \< 10 g/dL for females)~* Clinically significant kidney or liver disease (creatinine \> 1.5 mg/dL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 × ULN, alkaline phosphatase \> 2 × ULN, or total bilirubin \[tBili\] \> 1.5 × ULN)~* Current immunosuppressive treatment or documented immunodeficiency~* Uncontrolled congestive heart failure~* Uncontrolled malignant disease~* Currently pregnant or breastfeeding~* known lactose intolerance

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

Study Arms:
- Placebo-Placebo (Type: PLACEBO_COMPARATOR): subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an oral placebo (winthrop tablet) 2 hours before the test meal will be administered by an Independent nurse to the blinded patient
- Investigational Drug A Empagliflozin (Type: ACTIVE_COMPARATOR): subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an 10mg of empagliflozin 2 hours before the test meal will be administered by an independent nurse to the blinded patient
- Investigational Drug B Anakinra (Type: ACTIVE_COMPARATOR): subcutaneous injection of 100mg anakinra 3 hours before the test meal and an oral placebo (winthrop tablet)before the test meal will be administered by an Independent nurse to the blinded patient

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 Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion

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:~* Patients who present to Wake Forest Baptist Medical Center for a direct current cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as atrial flutter.~Exclusion Criteria:~* Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV~* Hemodynamically compromised patients (as defined by hypotension \<90/50 mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure)

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

Study Arms:
- Sedation with propofol group (Type: EXPERIMENTAL): Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
- Sedation with methohexital group (Type: EXPERIMENTAL): Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.

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 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A

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:
Key Inclusion Criteria:~* Severe hemophilia A defined as \<1 IU/dL (\<1%) endogenous FVIII~* Male \<12 years of age and weight ≥13 kg~* History of at least 50 documented prior exposure days to FVIII~* No current, or history of, inhibitor development to FVIII~Key Exclusion Criteria:~* Other coagulation disorders in addition to Hemophilia A~* History of anaphylaxis associated with any FVIII or IV immunoglobulin administration~NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

- Gender: MALE
- Minimum Age: None
- Maximum Age: 11 Years
- Healthy Volunteers: f

Study Arms:
- All participants (Type: EXPERIMENTAL): PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.

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: Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living

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:
Inclusion Criteria:~* To be eligible, participants much be between 25 and 100 years of age, physically able to walk without limitations~Exclusion Criteria:~* Patients with cognitive or physical limitations that prohibit walking and visual or cognitive impairments causing inability to read.

- Gender: ALL
- Minimum Age: 25 Years
- Maximum Age: 100 Years
- Healthy Volunteers: t

Study Arms:
- MapTrek (Type: EXPERIMENTAL): None

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

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

Trial Title: Efficacy of Baclofen in the Treatment of Alcohol Addiction

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* age ranging from 18 to 75 years~* diagnosis of alcohol dependence according to DSM IV criteria~* diagnosis of liver cirrhosis~* alcohol intake of at least 2 heavy drinking days (men \> 5 drinks/days; women \> 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment~* presence of a referred family member~Exclusion Criteria:~* severe heart or lung disease~* kidney alterations and/or hepato-renal syndrome~* tumours, including hepatocellular carcinoma~* metabolic diseases, including diabetes~* clinical signs of hepatic encephalopathy~* patients treated with interferon or corticosteroids within the last 60 days~* psychopathological illness undergoing treatment with psychoactive drugs~* epilepsy or epileptiform convulsions~* addiction to drugs other than nicotine

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

Study Arms:
- 2 (Type: PLACEBO_COMPARATOR): A total of 42 alcoholic patients with liver cirrhosis treated with placebo
- 1 (Type: ACTIVE_COMPARATOR): a total of 42 alcoholic patients with liver cirrhosis treated by baclofen

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 Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

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:~* Diagnosis of moderate to severe low back pain for ≥6 months~* Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)~* Stable health, as determined by Principal Investigator~* Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year~* Willing and able to comply with all protocol required visits and assessments~Exclusion Criteria:~* Current cancer related pain or received chemotherapy with 6 months of screening~* Receiving opioid analgesic medication \>10 mg MSE per day within 28 days of screening~* Subjects with a history of other chronic painful conditions~* Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis~* Allergy or contraindications to any opioid or acetaminophen~* Surgical procedure for relief of pain with 6 months~* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia~* QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)~* History of long QT syndrome or a family member with this condition~* Moderate to severe hepatic impairment~* Moderate to severe renal impairment~* Current or past history of alcohol abuse~* Positive urine toxicology screen for drug of abuse~* History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Twice Daily Dosing
- Buprenorphine HCl Buccal Film (Type: EXPERIMENTAL): Twice Daily Dosing

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: Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children

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

Eligibility Criteria:
Inclusion Criteria:~* All of below Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade Aged between 2 and 17 American Society of Anesthesiologists Physical Status Classification 1 and 2~Exclusion Criteria:~* Any of below One or more legal guardian declines to enroll in the study History of hypersensitivity to any anesthetic agents including rocuronium Presence of underlying cardiovascular or genitourinary disease Under usage of neuromuscular blocking agents before surgery Under usage of drugs influencing the effect of neuromuscular blocking agents History of malignant hyperthermia Anticipation of massive hemorrhage during surgery

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Sugammadex 2mg (Type: EXPERIMENTAL): Administer 2mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
- Sugammadex 4mg (Type: EXPERIMENTAL): Administer 4mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
- Sugammadex 8mg (Type: EXPERIMENTAL): Administer 8mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
- Conventional reversal (Type: ACTIVE_COMPARATOR): Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) on reappearance of T2 by Train-of-Four stimulation

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 Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)

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

Eligibility Criteria:
Key Inclusion Criteria:~1. Male or female adults ages 18 to 64 years with Chronic AD (according to the American Academy of Dermatology Consensus Criteria, \[Eichenfeld 2004\])that has been present for at least 3 years before the screening visit~2. Participants with documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s), or for whom topical AD therapies are otherwise inadvisable (e.g., because of side effects or safety risks).~3. Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit~4. Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits~5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits~Key Exclusion Criteria:~1. Prior treatment with dupilumab (REGN668/ SAR231893)~2. Patients needing \>10 mg of daily prednisone (including equivalent doses of other steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer during the 16 week treatment period of the study~3. History of Guillain-Barre syndrome~4. History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol~5. Patients with a severe reaction to natural rubber latex products (some packaging components of the vaccines contain rubber latex and may cause a reaction in susceptible individuals)~6. Treatment with biologics within 4 months of baseline visit~7. Chronic or acute infection requiring treatment with antibiotics, antivirals, antiparasitics, antifungals within 4 weeks before screening visit or superficial skin infections within 1 week of screening visit~The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

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

Study Arms:
- Placebo qw (Type: EXPERIMENTAL): Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
- Dupilumab 300 mg qw (Type: EXPERIMENTAL): Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.

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 of Idiopathic Angioedema With Xolair as Add-on Therapy

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:~* Adults or adolescents who are 18 years or older at the time of screening with physician diagnosis of idiopathic angioedema~* Minimum of two episodes of idiopathic angioedema in the past 6 months at the time of screening~* Management of idiopathic angioedema with a stable controller treatment plan for the prior 6 months~* Complement profile (C1 Esterase inhibitor panel) within normal reference values~* If a woman is of child-bearing potential, she must agree to a reliable form of birth control including: abstinence, oral contraceptives (birth control pills), Depo-provera, an intrauterine device (IUD), or double-barrier contraception (partner using condom and participant using diaphragm, contraceptive sponge or cervical cap, and spermicidal)~Exclusion Criteria:~* Diagnosis of Hereditary Angioedema (HAE), Acquired Angioedema, or Ace-inhibitor associated angioedema, which are forms of angioedema with known mechanisms and alternate treatment options~* Chronic Urticaria (itching and/or hives) with or without Angioedema which are known mast cell mediated processes previously shown to be responsive to the use of omalizumab~* Previous usage of omalizumab in the last 3 months which can affect the patient-related outcomes and biomarker assessments if not washed out of the system~* Patients, who in the judgment of the investigator, have a history or condition that might compromise patient safety or compliance, interfere with evaluations, or preclude completion of the study

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.
- Omalizumab (Type: ACTIVE_COMPARATOR): Omalizumab is a sterile, white, preservative-free, lyophilized powder, contained in a single-use vial that will be reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous injection. Each omalizumab vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.

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: Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Scheduled cardiac surgery.~Exclusion Criteria:~* - surgery in emergency~* thoracotomy~* cardiac graft~* redo~* pregnancy~* patient's refusal~* minor or adult under legal protection~* psychiatric ongoing disease~* addiction to opiates~* ongoing opiate treatment~* inability to use a PCA device~* respiratory insuffiency (Vital capacity or maximal expired volume per sec. \< 50% of the expected value, or mean PAP \> 50 mmHg)~* intra-aortic balloon~* severe renal insuffiency~* history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- ropivacaine (Type: EXPERIMENTAL): None
- normal saline (Type: OTHER): None

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

Answer: outcome: complete