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

Trial Title: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)

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

Eligibility Criteria:
Inclusion Criteria:~* Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.~* Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.~* The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.~Exclusion Criteria:~* Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.~* Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).~* Has a known hypersensitivity to any component of the study vaccine.~* Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.~* Has a bleeding disorder contraindicating intramuscular vaccinations.~* Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.~* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 10 Years
- Healthy Volunteers: t

Study Arms:
- HBVAXPRO™ (Type: EXPERIMENTAL): Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

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 Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria :~* Aged over 18 years on the day of inclusion~* Informed consent form signed~* Able to attend all scheduled visits and to comply with all trial procedures~* For a woman, inability to bear a child or negative urine pregnancy test~* For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.~Exclusion Criteria :~* Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances~* Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion~* Breast-feeding~* Previous vaccination with an avian flu vaccine~* Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination~* Planned participation in another clinical trial during the present trial period~* Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy~* Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)~* Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures~* Receipt of blood or blood-derived products within the past 3 months~* Any vaccination within 4 weeks prior to the first trial vaccination~* Vaccination planned within 4 weeks after any trial vaccination~* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination~* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

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

Study Arms:
- Study Group 1 (Type: EXPERIMENTAL): Vaccine with adjuvant
- Study Group 2 (Type: EXPERIMENTAL): Vaccine without adjuvant

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 Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)

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

Eligibility Criteria:
Inclusion Criteria:~1. Aged 12 years and older inclusive of either sex.~2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)~3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).~Exclusion Criteria:~1. Pregnant or lactating women.~2. Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period.~3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.~4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.~5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.~6. Subjects with an active pulmonary disorder or infection.~7. Subjects with posterior subcapsular cataracts or glaucoma

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

Study Arms:
- GSP 301 NS (Type: EXPERIMENTAL): None
- Olopatadine HCl NS (Type: ACTIVE_COMPARATOR): None
- Mometasone furoate NS (Type: ACTIVE_COMPARATOR): None
- GSP 301 Placebo NS (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: ADV-TK Improves Outcome of Recurrent High-Grade Glioma

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically confirmed WHO grades 3 to 4 malignant glioma~* Diagnosed recurrence or progression by clinical or radiological evidence~* Fit for intraarterial infusion and intravenous chemotherapy~* Adequate hepatic, renal, and hematologic function.~* Legal age ≥18 years~* Life expectancy ≥12 weeks~* Eastern Cooperative Oncology Group performance (ECOG) ≥2~* Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities.~Exclusion Criteria:~* Active pregnancy~* Prior gene therapy~* Second primary tumor~* Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections~* Requiring treatment with warfarin or any other anticoagulants

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

Study Arms:
- ADV-TK/GCV (Type: EXPERIMENTAL): ADV-TK was administered via intraarterial cerebral infusion. Systemic GCV therapy was delivered at a dose of 5mg/kg intravenous, every 12 h at 36 hours after ADV-TK therapy.
- Control group (Type: ACTIVE_COMPARATOR): Patients received surgery or systemic chemotherapy or palliative care.

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: Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

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:~1. Age 18 to 65~2. Patient deemed by the ED attending physician to require IV opioid analgesia for pain and for whom the ED Attending Physician would consider using PCA~Exclusion Criteria:~1. Patients requiring initial resuscitation that would preclude the use of PCA~2. Long-term use of prescription or non-prescription opioids now or within the past year~3. Recent opioid use within the past 24 hours~4. Chronic pain syndromes~5. Clinician suspicion of current or past opioid dependence/abuse~6. Altered mental status/Clinical suspicion of intoxication~7. Patients expected to require conscious sedation while in the ED~8. Pregnancy or breast-feeding~9. History of chronic obstructive pulmonary disease, history of sleep apnea syndrome, baseline oxygen saturation (room air) \< 97%~10. Systolic blood pressure \< 100 mm Hg~11. Use of sedative medications e.g. benzodiazepines, monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants.~12. History of renal insufficiency/renal failure~13. Prior allergic reaction to morphine~14. Inability to provide informed consent or inability to understand or operate PCA device~15. Previous entry of patient into study

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

Study Arms:
- Patient Controlled Analgesia (Type: EXPERIMENTAL): PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
- Usual Care (Type: ACTIVE_COMPARATOR): Usual opioid analgesia determined by the provider

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: Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

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:
Primary Inclusion criteria:~* diagnosis of idiopathic pulmonary fibrosis~* 40 to 80 years of age~* Forced Vital Capacity greater than or equal to 50% predicted value~* Carbon monoxide diffusing capacity greater than or equal to 35% predicted value~* either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal to 90% predicted value~* no improvement in past year~* able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (L/min) supplemental oxygen~Primary Exclusion criteria:~* unable to undergo pulmonary function testing~* evidence of significant obstructive lung disease or airway hyper-responsiveness~* in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization~* active infection~* liver disease~* cancer or other medical condition likely to result in death within 2 years~* diabetes~* pregnancy or lactation~* substance abuse~* personal or family history of long QT (Q wave,T wave) syndrome~* other IPF treatment~* unable to take study medication~* withdrawal from other IPF trials

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- 2403 mg/day pirfenidone (Type: ACTIVE_COMPARATOR): Active arm 1, 2403 mg/day pirfenidone dose group.
- 1197 mg/day pirfenidone (Type: ACTIVE_COMPARATOR): Active arm 2, 1197 mg/day pirfenidone.
- placebo (Type: PLACEBO_COMPARATOR): Placebo equivalent.

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 All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

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:~* Male or female participants with symptomatic anemia associated with CKD~* Participants with renal anemia who are not treated with an ESA:~* Anemia was defined as hemoglobin (Hb) concentration less than (\<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment~* Participants with renal anemia who are on maintenance ESA therapy:~* If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening~* Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)~* Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent~Exclusion Criteria:~* Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy~* Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:~* History of hemoglobinopathy~* Anemia due to hemolysis~* Pure red cell aplasia~* High likelihood of early withdrawal (for example, within 1 year) or interruption of the study~* Pregnancy or breast-feeding~* Women of childbearing potential without effective contraception~* Administration of another investigational drug within 1 month before screening or planned during the study period

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

Study Arms:
- Erythropoiesis Stimulating Agents (Type: ACTIVE_COMPARATOR): Participants will receive reference ESA according to approved label. The approved reference ESA compounds in the study will be darbepoetin alfa, epoetin alfa and epoetin beta.
- Methoxy Polyethylene Glycol-Epoetin Beta (Type: EXPERIMENTAL): Participants not currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta iv or sc once every 2 weeks for correction of renal anemia (target Hb 10-12 g/dL). Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta will be administered once monthly.

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: Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

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

Eligibility Criteria:
Inclusion Criteria:~* Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.~Exclusion Criteria:~* Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.

- Gender: ALL
- Minimum Age: 2 Months
- Maximum Age: 3 Years
- Healthy Volunteers: t

Study Arms:
- 1 (Type: None): None

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

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

Trial Title: Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female adults aged ≥40 years~* Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of \<0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.~* Current or ex-smokers who have a smoking history of at least 10 pack years.~Exclusion Criteria:~* Pregnant or nursing (lactating) women~* Patients who have a clinically significant laboratory abnormality at run-in~* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR \<50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).~* Patients with any history of asthma~* Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation~* Patients receiving medications in the classes listed in the protocol as prohibited.~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- NVA237 followed by tiotropium (Type: EXPERIMENTAL): Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
- Tiotropium followed by NVA237 (Type: EXPERIMENTAL): Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.

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: Brown Adipose Tissue Activity in Pre- and Postmenopausal Women

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

Eligibility Criteria:
Inclusion Criteria:~* Premenopausal volunteers will be healthy, eumenorrheic women, aged 18-45 yrs. Eumenorrheic status will be verified by regular menses (no missed cycles in previous year; cycle length 25-35 d).~* Postmenopausal volunteers will be healthy women who have no menses for at least 12 months~Exclusion Criteria:~- Body mass index (BMI) \> 35 kg/m2~Additional exclusion criteria for premenopausal women~* Hormonal contraceptive use (past 6 mo.)~* Pregnant, lactating or intention to become pregnant during the period of study~Additional exclusion criteria for postmenopausal women~* History or current use of hormonal replacement therapy (HRT)~* Women who have undergone surgical menopause.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: t

Study Arms:
- Pre-menopausal women (Type: EXPERIMENTAL): To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
- Post-menopausal women (Type: NO_INTERVENTION): To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.

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 Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.~2. Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse~3. Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)~Exclusion Criteria:~1. History of severe, life-threatening or other significant sensitivity to any drug~2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study~3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol~4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)~5. Co-infection with more than one HCV genotype

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

Study Arms:
- Arm A (Type: EXPERIMENTAL): ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
- Arm B (Type: EXPERIMENTAL): ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
- Arm C (Type: EXPERIMENTAL): ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
- Arm D (Type: EXPERIMENTAL): ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
- Arm E (Type: EXPERIMENTAL): ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

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: Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department

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

Eligibility Criteria:
Inclusion Criteria:~* Patient in the St. Louis Children's Hospital Emergency Department~* 15-21 years old~Exclusion Criteria:~* Evaluation of abuse or sexual assault~* Activation of the trauma system,~* Level 1 or 2 triage scores (highest severity)~* Disabilities preventing independent computer use~* Psychiatric chief complaints~* Inability to speak English

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- ACASI (Type: OTHER): The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)

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

Answer: outcome: complete