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

Trial Title: Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

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~* Child-Pugh (CP) score \>= 7~* Hepatitis B virus (HBV) viremia~Exclusion~* Alanine aminotransferase (ALT) \> 15 x upper limit of normal (ULN)~* Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- A1 (Type: EXPERIMENTAL): None
- A2 (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: Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

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:
Main Inclusion Criteria:~* History of COPD for at least 12 months prior to baseline visit~* FEV1/FVC ratio (post-bronchodilator) ≤ 70%~* FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted~Main Exclusion Criteria:~* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

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

Study Arms:
- Roflumilast (Type: ACTIVE_COMPARATOR): Roflumilast 500 µg~underlying medication: salmeterol 50 μg, twice daily, inhaled
- Placebo (Type: PLACEBO_COMPARATOR): Placebo~underlying medication: salmeterol 50 μg, twice daily, inhaled

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 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Male or female volunteers aged 18 - 49 years, inclusive~2. Able to give written informed consent~3. Healthy (no clinically significant health concerns)~4. Safety laboratory values within the following range criteria normal range~5. Body mass index between 17 and 35 at screening~Exclusion Criteria:~1. Receipt of any investigational norovirus vaccine within two years prior to study~2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination~3. Administration of any licensed vaccine within 30 days prior to study~4. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline~5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination~6. Presence of a fever ≥ 38oC measured orally at baseline~7. Stool sample with occult blood at screening -

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 49 Years
- Healthy Volunteers: t

Study Arms:
- H1N1 (high dose) Oral Vaccine Tablet (Type: EXPERIMENTAL): Singe dose of orally administered VXA-G1.1-NN (high dose) Oral Vaccine Tablet. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk.
- H1N1 (low dose) Oral Vaccine Tablet (Type: EXPERIMENTAL): Singe dose of orally administered VXA-G1.1-NN (low dose) Oral Vaccine Tablet. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk.
- Placebo Tablets (Type: PLACEBO_COMPARATOR): Singe dose of VXA Placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.

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: Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

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:~* IUGR defined as birth length and/or weight below the lower limit (\< P10) of the Lubchenco curves for the gestational age.~* Chronological age = 2-5 years~* HV below average for CA~* Insufficient catch-up growth (Height \< P3 for chronological age, according to Hernández)~* Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother~* Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)~* Bone age (measured through Greulich and Pyle method) less than or equal to CA~Exclusion Criteria:~* Children born from multiple pregnancy~* Children with post-ischemic encephalopathy~* Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)~* Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)~* Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)~* Nutritional disorders (celiac disease) or osteodystrophies~* Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects~* Abnormal karyotype~* Neoplasms~* Previous or ongoing chemotherapy and/or irradiation~* Renal dysfunction, defined as serum creatinine \> 1 mg/dL

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 5 Years
- 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: Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm

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

Eligibility Criteria:
Inclusion Criteria:~* provide written informed consent,~* male or female 18 years of age or greater; women of child bearing potential must use adequate contraception~* symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms~* AF/AFL documented by ECG at the start of study drug administration~Exclusion Criteria:~* Systolic blood pressure \<100 mmHg.~* Average heart rate \<50 bpm.~* Average QTcF (Fridericia correction) \>440 ms.~* Average QRS interval \>140 ms.~* Paced atrial or ventricular rhythm on ECG.~* Serum potassium \<3.5 meq/L (may be corrected prior to randomization).~* Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.~* received amiodarone (oral or IV) in prior 3 months.~* Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.~* Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.~* Rheumatic mitral stenosis with valve area of \<1.5 cm2.~* Untreated hyperthyroidism.~* Acute pericarditis.~* AF/AFL as a result of surgery within the last 7 days~* History of failed electrical cardioversion~* History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).~* History or family history of long QT syndrome.~* History of ventricular tachycardia requiring drug or device therapy.~* History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.~* Ejection fraction (EF) of 35% or less.

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

Study Arms:
- vanoxerine 200mg (Type: EXPERIMENTAL): vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)
- placebo (Type: PLACEBO_COMPARATOR): placebo to match vanoxerine oral capsule
- vanoxerine 300mg (Type: EXPERIMENTAL): vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
- vanoxerine 400mg (Type: EXPERIMENTAL): vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)

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 Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 7.0

Eligibility Criteria:
Inclusion Criteria:~* • HCV infection~  * Adult patients, 18years and older.~Exclusion Criteria:~* • Child score \> 12~  * Severe Renal impairment~ * Pregnant and lactating women~ * HCC or other malignant neoplasms~ * Co-infection with human immunodeficiency virus (HIV)~ * Co-infection with hepatitis B virus (HBV)

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

Study Arms:
- Sof-Riba (Type: ACTIVE_COMPARATOR): Sofosbuvir ribavirin 6 months.
- Sof- Riba- Pegylated interferon (Type: ACTIVE_COMPARATOR): Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
- Sof- Olysio (Type: ACTIVE_COMPARATOR): Sofosbuvir and simeprevir for 3 months.
- Sof- Dacla (Type: ACTIVE_COMPARATOR): Sofosbuvir and Daclatasvir for 3 months.
- Harvony (Type: ACTIVE_COMPARATOR): Sofosbuvir and ledipasvir for 3 months
- Ritaprevir, paritaprevir, ombetasvir (Type: ACTIVE_COMPARATOR): Querevo for 3 months
- Salvage therapy (Type: ACTIVE_COMPARATOR): sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo

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: Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

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

Eligibility Criteria:
Inclusion Criteria:~* At least 18 years of age or older and at a minimum have a recent history (more than 3 days worth) of shoulder pain with moderate to severe tenderness to palpation over the subacromial bursa.~Exclusion Criteria:~* Allergies to lidocaine, marcaine, or kenalog.~* Allergies to rilonacept~* Flare of active inflammatory arthritis (such as a flare of Rheumatoid Arthritis)~* Gout or Pseudogout attack of the shoulder with subacromial tenderness~* Active infection~* Actively receiving chemotherapy, radiation therapy, or anticipating surgery for neoplasia~* Active myocardial infarction~* Clinical and/or radiographic evidence of a fracture (clavicular, humeral, or other).

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

Study Arms:
- Rilonacept (Type: ACTIVE_COMPARATOR): 160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
- Corticosteroid (Type: PLACEBO_COMPARATOR): 80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once

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: Prospective OCT Study With Lucentis for Neovascular AMD (PrONTO Study)

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: None

Eligibility Criteria:
Inclusion Criteria:~* • All subjects must meet the following criteria to be eligible for study entry: Signed informed consent~  * Age greater than 50 years~ * Active primary or recurrent subfoveal lesions with CNV secondary to AMD in the study eye, as defined in Table 1~ * Lesions with occult CNV or with some classic CNV component are permissible. However, if predominantly classic CNV (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) is present, the patient must have had prior PDT (up to 3 previous photodynamic therapy treatments).~ * The OCT features that will permit participation will include retinal thickness (macular edema) ≥300 microns, subretinal fluid ≥100 microns in thickness, or a detachment of the retinal pigment epithelium ≥100 microns in thickness~ * The total area of CNV (including both classic and occult components) encompassed within the lesion must be ≥ 50% of the total lesion area~ * The total lesion area must be \<12 disc areas (DA) in size.~ * Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye~ * Only one eye will be assessed in the study. If both eyes are eligible, the one with the better acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study.~Exclusion Criteria:~* • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)~  * Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0~ * Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)~ * Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye~ * Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0~ * History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye~ * Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) Lesion Characteristics~ * Subfoveal fibrosis or atrophy in the study eye~ * CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia

- Gender: ALL
- Minimum Age: 50 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: Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition \[beta version\] criteria) or clinical judgment suggests a migraine diagnosis~* Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period~* Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.~* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.~Exclusion Criteria:~* Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses~* Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days.~* Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- TEV-48125 (675/225/225 mg) group (Type: EXPERIMENTAL): TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).
- TEV-48125 (675 mg/placebo/placebo) group (Type: EXPERIMENTAL): TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).
- Placebo group (Type: PLACEBO_COMPARATOR): Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/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: Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection

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

Eligibility Criteria:
Inclusion Criteria:~* HIV infection~* Chronic hepatitis C infection~* Did not attend a hepatitis C specialty appointment in the past year~* Able to speak English~* Current patient at the John G. Bartlett Specialty Practice at Johns Hopkins Hospital (at least 1 visit in the past year)~Exclusion Criteria:~* Pregnancy~* Emergency medical care needed~* Unable to provide informed consent

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

Study Arms:
- Enhanced Usual Care (Type: NO_INTERVENTION): Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
- Nurse Case Management (Type: EXPERIMENTAL): Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention

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 II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma

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:
Criteria:~Inclusion Criteria:~* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)~* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.~* diagnosed with major or main portal vein invasion (Vp3 or Vp4)~* KPS≥70；~* with no previous treatment~* No Cirrhosis or cirrhotic status of Child-Pugh class A only~* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.~* The following laboratory parameters:~  * Platelet count ≥ 75,000/µL~ * Hemoglobin ≥ 8.5 g/dL~ * Total bilirubin ≤ 30mmol/L~ * Serum albumin ≥ 30 g/L~ * ASL and AST ≤ 5 x upper limit of normal~ * Serum creatinine ≤ 1.5 x upper limit of normal~ * INR ≤ 1.5 or PT/APTT within normal limits~ * Absolute neutrophil count (ANC) \>1,500/mm3~* Ability to understand the protocol and to agree to and sign a written informed consent document~Exclusion Criteria:~* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy~* Known history of HIV~* History of organ allograft~* Known or suspected allergy to the investigational agents or any agent given in association with this trial.~* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy~* Evidence of bleeding diathesis.~* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.~* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug~* Serious non-healing wound, ulcer, or bone fracture~* Known central nervous system tumors including metastatic brain disease

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

Study Arms:
- Sorafenib combined with HAIC (Type: EXPERIMENTAL): Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox 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: Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Design Characteristics:
- Allocation: N/A
- Intervention Model: N/A
- Observational Model: N/A
- Primary Purpose: N/A
- Time Perspective: N/A
- Masking: N/A
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity \[FVC\] ratio \< 70% and FEV1 ≥ 30% to \<80% of the predicted value.~* Current or former cigarette smokers with a smoking history of at least 10 pack-years.~Exclusion Criteria:~* History or current diagnosis of asthma~* Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1~* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1.~* Patients with any clinically significant respiratory conditions other than COPD

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

Study Arms:
- aclidinium bromide (Type: ACTIVE_COMPARATOR): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: complete