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

Trial Title: Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

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

Eligibility Criteria:
Inclusion Criteria:~* Inborn infants with a gestational age of less than 30 weeks~* Who required parenteral nutrition for at least 7 days~Exclusion Criteria:~* Evidence of congenital infection~* Perinatal asphyxia~* Congenital anomalies~* Severe IVH~* Thrombocytopenia~* Shock or circulation failure~* Renal or hepatic disorders.

- Gender: ALL
- Minimum Age: 24 Weeks
- Maximum Age: 30 Weeks
- Healthy Volunteers: f

Study Arms:
- study group (Type: EXPERIMENTAL): multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
- control group (Type: ACTIVE_COMPARATOR): pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.

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: Effects of Somatostatin on Liver in ADPKD

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* diagnosis of autosomal dominant polycystic kidney and liver disease~* glomerular filtration rate greater than 40 ml/min~Exclusion Criteria:~* diabetes mellitus~* proteinuria greater than 1 g/24 hours~* significant glomerular disease~* urinary tract lithiasis and infections~* symptomatic gallstones~* biliary sludge~* cancer~* pregnant women~* lactanting women

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

Study Arms:
- OCTEOTRIDE (Type: EXPERIMENTAL): octeotride 20 mg, intramuscular injection monthly for 3 years
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (saline soluction), intramuscular injection monthly for 3 years

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

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

Trial Title: Database Surveillance Safety Study of PENTACEL® Vaccine

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

Eligibility Criteria:
Inclusion Criteria:~* Receipt of DTaP vaccine during the study period by a previously unvaccinated child~Exclusion Criteria:~* None

- Gender: MALE
- Minimum Age: 6 Weeks
- Maximum Age: 24 Months
- Healthy Volunteers: t

Study Arms:
- Pentacel Group (Type: None): Infants initiated on PENTACEL® vaccine
- Other DTap vaccines Group (Type: None): Infants initiated on other DTaP vaccines

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 Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta

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

Eligibility Criteria:
Inclusion Criteria:~1. Adult male or female of ages 18 to 45 inclusive~2. Body weight \> 50 kg (110 lb.) and body mass index between 18 and 28 kg/m2 inclusive~3. Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination~4. Negative urine pregnancy test in women of childbearing potential~Exclusion Criteria:~1. Previous exposure to pegfilgrastim or filgrastim~2. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder~3. History of chronic or acute respiratory illness within the past 3 months~4. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation~5. No prescription or nonprescription drugs during the study~6. Participation in an investigational clinical study within 30 days prior to screening~7. History of known clinically significant drug and/or food allergies, including allergic reaction to latex

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Sequence A (Type: EXPERIMENTAL): 3 doses of CHS-1701 or Neulasta, random order
- Sequence B (Type: EXPERIMENTAL): 3 doses of CHS-1701 or Neulasta, random order
- Sequence C (Type: EXPERIMENTAL): 3 doses of CHS-1701 or Neulasta, random order

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 Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

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:~* Signed and dated informed consent~* Men or women patients ≥40 years of age~* Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2~* Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator~* Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period~Exclusion Criteria:~* A history of asthma and seasonal allergic rhinitis before 40 years of age~* Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period~* Patients with relevant cardiovascular disorder judged by the investigator~* Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator~* Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator

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

Study Arms:
- 1 (Type: OTHER): Add-on treatment
- 2 (Type: OTHER): Add-on treatment

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

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

Trial Title: An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

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

Eligibility Criteria:
Inclusion Criteria:~1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)~2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol~Exclusion Criteria:~1. Development of any new, unstable, or uncontrolled disease

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

Study Arms:
- Vedolizumab 300 mg (Type: EXPERIMENTAL): Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for approximately up to 510 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: Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients aged 4 to 75 years (inclusive)~* Body weight ≥ 12 kg and \< 100 kg.~* Females of child-bearing potential must have a negative pregnancy test. Additional birth control details to be provided at screening.~* Documented molecular diagnosis of NALP3 mutations and clinical symptoms that are either untreated or insufficiently treated and require medical intervention.~* Patients under anakinra therapy or any other IL-1 blocking therapy, whose clinical symptoms improved under treatment and are willing to discontinue that therapy until a relapse becomes evident.~* Patients with a very severe characteristics requiring oral prednisone are eligible if the dose is stable (≤ 0.4 mg/kg/day or ≤ 20 mg/day, whichever is lower) for at least 1 week prior to the screening visit. Steroid therapy may be tapered during treatment with ACZ885 at the discretion of the investigator.~* Parents' or legal guardian's written informed consent (patient's informed consent for ≥ 18 years of age) and child's assent, if appropriate, are required prior to study participation.~Exclusion Criteria:~* Participation in any clinical trial investigation (except trials with anakinra) within 4 weeks prior to dosing or longer per local regulation~* Antiinflammatory therapy with colchicine, chlorambucil, dapsone, azathioprine, mycophenolate mofetil, within 3 weeks prior to dosing. Therapeutic antibodies (e.g. anti-TNF-alpha antibodies) must be discontinued at least 60 days before dosing.~* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.~* A past personal or close family medical history of clinically significant ECG abnormalities or prolonged QT-interval syndrome.~* History of~  * Immunocompromise, including a positive HIV result.~ * Positive Hepatitis B surface antigen or Hepatitis C test result.~ * Drug or alcohol abuse within the 12 months prior to dosing.~ * Tuberculosis.~ * Renal transplant.~ * Evidence of lymphoma.~* Active medical condition preventing participation in the study such as infection, poorly controlled diabetes etc.~* No live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): ACZ885

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 Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Relapsed, refractory CNS lymphoma, ocular lymphoma, lymphomatous meningitis~2. Tumors must be CD20 + on pathologic analysis.~3. Patients must have an Ommaya reservoir (ventricular access device.~4. Patients may have had prior intrathecal methotrexate, ara-C or thiotepa but must have recovered from any reversible toxicity caused by prior treatment.~5. Concurrent systemic chemotherapy is allowed for treatment of disease outside the meninges with the exception of high-dose methotrexate (\>500 mg/m2/d, high-dose ara-C (\> 2 gm/m2/d), high-dose thiotepa (\>300 mg/m2/d) or investigational agents.~6. Patients must have sufficient baseline hematologic function: \>1,500 granulocytes and \>50,000 platelets/ul.~7. Patients must have had a nuclear medicine CSF flow study performed within 30 days of treatment which shows no significant obstruction within the ventricles.~Exclusion Criteria:~1. History of whole brain or craniospinal irradiation or intrathecal chemotherapy \< 4 days before initiation of intra-CSF administration of rituximab.~2. Anticipated survival of less than one month.~3. HIV infection. -

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

Study Arms:
- Rituximab Plus MTX (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: Evaluate Misoprostol for the Healing of Small Bowel Ulcers in Low-dose Aspirin Users Complicated by Small Bowel Bleeding

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion criteria:~1. Suspected small bowel overt bleeding - melena or hematochezia with normal upper endoscopy and colonoscopy~2. Suspected small bowel occult blood loss - defined as a significant decrease in hemoglobin (≥ 2g/dL), with normal upper endoscopy and colonoscopy, confirmed iron deficiency anemia, and absence of other identifiable causes for hemoglobin decrease (e.g. fluid overload, progressive renal failure, malnutrition, or other hematological disorders such as hemolysis or malignancies)~3. Continuous use of ASA for the duration of the trial~4. Age ≥ 18~5. Written informed consent obtained~Exclusion criteria:~Patients are excluded if they have one or more of the following conditions~1. Increased risk of capsule retention (e.g. Gastric outlet obstruction, bypass surgery, Crohn's disease or suspected small bowel stricture)~2. Abnormal findings on upper endoscopy (e.g. Esophageal varices, grade C or D erosive esophagitis, vascular malformations, ulcer, ≥5 erosions, neoplasms) or colonoscopy (e.g. cancer, polyps \> 1cm, inflammatory bowel disease, vascular malformations, bleeding hemorrhoids or diverticular disease)~3. Unable to swallow the video capsule~4. Terminal illness~5. Concomitant use of NSAIDs, sucralfate, rebamepide, anticoagulants, corticosteroids (prednisolone \> 7.5mg daily or equivalent), and iron supplement~6. Pregnancy or women of child-bearing age without regular use of contraception

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

Study Arms:
- Misoprostol (Type: ACTIVE_COMPARATOR): ASA 100 mg daily + misoprostol 200 four times daily (misoprostol group)
- Placebo misoprostol (Type: PLACEBO_COMPARATOR): ASA 100 mg daily + placebo misoprostol four times daily (placebo group)

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: First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

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:~* Age ≥18 years to ≤ 75 years.~* Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone~* Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm~* Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.~* ECOG performance 0-2.~* No more than 3 cycles of chemotherapy prior to surgery.~* Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin \< 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min.~* Comply with intraperitoneal chemotherapy and follow-up.~* Written informed consent.~Exclusion Criteria:~* Low-malignant potential ovarian tumor.~* Laboratory testing insufficiency. Hemoglobin \< 10 g/dL. Renal insufficiency with serum creatinine \> 1.6.~* Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3.~* Active infection.~* Clinically significant gastrointestinal abnormalities.~* Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure.~* Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.~* Prior invasive malignancies within the last 5 years showing activity of disease.

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

Study Arms:
- Regimen B, PEip and TCiv therapy (Type: EXPERIMENTAL): Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
- Regimen A: Standard TCiv therapy (Type: ACTIVE_COMPARATOR): IV paclitaxel plus carboplatin or docetaxel plus carboplatin

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: Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

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

Eligibility Criteria:
Inclusion Criteria:~* 18 years old or over~* Currently using smokeless tobacco products as primary tobacco product~* Use smokeless tobacco for the last 6 months~* Currently want to quit~* Able to read and write English; and~* Willing to share phone number, e-mail, and mailing address with the research project~* complete informed consent process~Exclusion Criteria:~* have used behavioral or pharmacologic tobacco treatment in last 30 days~* medical history of unstable angina, myocardial infarction within the past 6 months, cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT or medically treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic~* have phenylketonuria (PKU)~* have another member of their household already participating in this study~* currently pregnant or nursing~* score of ≥ 15 on the Patient Health Questionnaire (PHQ-8)

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

Study Arms:
- Lozenge Self Help: self help materials & lozenge NRT. (Type: ACTIVE_COMPARATOR): Self-help materials + Commit® nicotine lozenges (4 mg)
- Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials (Type: EXPERIMENTAL): Self-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling
- Assisted Self-Help: self-help materials & phone counseling without lozenges (Type: EXPERIMENTAL): Self-help materials + Phone counseling

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

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

Trial Title: An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

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

Eligibility Criteria:
Inclusion Criteria:~* Ability to comply with the study protocol, in the investigator's judgment~* Participation in Study GA39688 or GA39855, including completion of endoscopy and other assessments at Week 24, without discontinuation of study drug~* Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior to the Week 24 visit of Study GA39688 or GA39855~* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug~Exclusion Criteria:~* Anaphylaxis/hypersensitivity related to study drug in Study GA39688 or GA39855~* Serious adverse events related to study drug in Study GA39688 or GA39855 that the investigator or Sponsor determines may jeopardize the patient's safety if he or she continues in the study~* Uncontrolled epistaxis within Study GA39688 or GA39855~* Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab~* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

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

Study Arms:
- Cohort A: Study GA39688 Omalizumab (Type: EXPERIMENTAL): Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.
- Cohort A: Study GA39688 Placebo (Type: EXPERIMENTAL): Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
- Cohort B: Study GA39855 Omalizumab (Type: EXPERIMENTAL): Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.
- Cohort B: Study GA39855 Placebo (Type: EXPERIMENTAL): Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

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

Answer: outcome: complete