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

Trial Title: A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumors

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Men and women ≥ 18 years old~* Must have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy~* Measurable disease by RECIST criteria~* Must be able to undergo MRI evaluation~* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2~* Competent to sign and date an Institutional Review Board approved informed consent form~Exclusion Criteria:~* Presence of untreated or symptomatic primary central nervous system tumors or metastases~* Presence of leukemia or myelodysplastic syndrome~* Subjects with head and neck cancer~* Previous hematopoietic stem cell transplant (allogeneic)~* Unresolved hematological toxicities \> grade 1 with the exception of grade 2 lymphopenia and non-hematological toxicities \> grade 1, excluding alopecia and grade 2 neuropathy, from prior anti-cancer therapy~* Myocardial infarction within 1 year before study day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function~* History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study~* Active peripheral vascular disease~* History of bleeding diathesis~* History of pulmonary hemorrhage or gross hemoptysis within 6 months before study~* Known history of adrenal hemorrhage~* Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C~* Major surgery within 1 month before study~* Prior treatment with any agent targeting the angiopoietin-Tie2 signaling pathway~* Concurrent antitumor treatment, except Lupron for subjects with prostate cancer and selective estrogen receptor modulators (SERMS) for subjects with breast cancer, within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1~* Known sensitivity to mammalian-derived products, bacterially-produced proteins, or any of the products to be administered during dosing~* Investigational agent within 30 days before study~* Pregnant (eg, positive urine test) or breastfeeding~* Subjects of childbearing potential, or subject who has a partner of childbearing potential, and is not using highly effective contraceptive precautions

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

Study Arms:
- A (Type: EXPERIMENTAL): Dose Escalation
- B (Type: EXPERIMENTAL): Dose Expansion

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal).~* Patients must be between the ages of birth and 18 years at the time of screening.~* Patients must have a life expectancy of at least 3 months.~Exclusion Criteria:~* Patients with primary neuroblastoma in central nervous system.~* Patients must not have an uncontrolled life-threatening infection.~* Patients must not have received cranial or spinal irradiation less than 3 weeks prior to first dose of 131I-omburtamab in this trial.~* Patients must not have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to enrollment in this trial.~* Patients must not have severe major non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity must fall below Grade 3 prior to enrollment in this trial. Patients with stable neurological deficits (due to brain tumor) are not excluded. Patients with Grade 3 or lower hearing loss are not excluded.

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

Study Arms:
- 131I-omburtamab (Type: EXPERIMENTAL): One treatment cycle of 131I-omburtamab consists of one dosimetry dose (2 mCi ) (for subjects enrolled on Version 1-7 of Protocol 101) and one treatment dose (50 mCi) for up to 2 cycles of length 5 weeks (for subjects enrolled on Version 1-7 of Protocol 101) or 4 weeks (for subject enrolled after Version 7 of Protocol 101). For Japan only, the first cycle consisted of one dosimetry dose (2 mCi ) week 1 one treatment dose (50 mCi) week 2. If eligible a second cycle of 50 mCi 131I-omburtamab was given at week 6. For subjects below 3 and 1 years of age, the treatment dose was reduced by 33% and 50%, respectively.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

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

Eligibility Criteria:
Inclusion Criteria:~* Has given written informed consent.~* Is at least 18 years of age.~* Has advanced or metastatic gastrointestinal tract adenocarcinoma.~* No previous cancer chemotherapy for cancer.~* Measurable or evaluable lesions according to RECIST v1.1 criteria.~* Is able to take medications orally.~* Has ECOG performance status 0 or 1.~* Has a life expectancy of at least 3 months.~* Has adequate organ function.~Exclusion Criteria:~* Cancer considered operable without prior chemotherapy.~* Prior chemotherapy to cancer.~* Previous therapy with fluoropyrimidines or anthracyclines for any indication.~* Inability to swallow tablets.~* Known brain metastasis or leptomeningeal metastasis.~* History of myocardial infarction, coronary stenting/graft.~* History of unstable angina, coronary/peripheral artery bypass graft.~* History of cerebrovascular accident or transient ischemic attack.~* History of pulmonary embolism or deep vein thrombosis.~* Symptomatic congestive heart failure.~* Ongoing cardiac dysrhythmias.~* Patients with any cardiac disease that requires regular medication.~* Hypertensive crisis or severe hypertension that is not controlled.~* Is a pregnant or lactating female.~* The cardiac arterial flow tests cannot be done.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- S-1 plus oxaliplatin (SOX) (Type: EXPERIMENTAL): Oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14.
- Oxaliplatin plus capecitabine (XELOX) (Type: ACTIVE_COMPARATOR): Intravenous oxaliplatin 130 mg/m2 d.1 followed by oral capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study to Investigate Cystic Fibrosis Pulmonary Exacerbations and the Lung Microbiome

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

Eligibility Criteria:
Pulmonary Exacerbation Cohort~Inclusion Criteria:~1. Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride \> 60 mEq/L; c. Two known CF mutations)~2. 3 or more admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment.~Clinically Stable Disease Cohort~Inclusion Criteria:~1. Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride \> 60 mEq/L; c. Two known CF mutations)~2. Age and gender matched to Pulmonary Exacerbation Cohort~3. No hospitalizations with an admitting diagnosis of pulmonary exacerbation, within the 12 month period prior to study enrollment.~Exclusion criteria for both groups includes:~1. History of intolerance or inability to tolerate the induced sputum protocol.~2. History of organ transplantation.~3. Any patient that in discretion of the investigators is not suitable.~4. Any clinically unstable participants.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 22 Years
- Healthy Volunteers: f

Study Arms:
- Stable Disease (Type: None): 15 control stable disease participants
- Frequent Exacerbation Cohort (Type: None): 15 experimental frequent exacerbation cohort

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

Answer: outcome: terminate
termination_type: feasibility
Please assess the completion status of the following clinical trial:

Trial Title: FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG

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

Eligibility Criteria:
Inclusion Criteria:~* Subject must be 4 - 17 years of age.~* Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.~* Subject is currently using SMBG for managing their diabetes.~* Subject and/or caregiver must be able to read and understand English.~* In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.~* Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.~Exclusion Criteria:~* Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.~* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.~* Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.~* Subject is on dialysis at the time of enrollment.~* Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.~* Subject currently is participating in another clinical trial.~* Subject is unsuitable for participation due to any other cause as determined by the Investigator.

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Social Cognition Training and Cognitive Remediation

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

Eligibility Criteria:
Inclusion Criteria:~* Children with diagnosis of 22q11.2 deletion syndrome (CGH-Array and FISH)~* Native French speaker~* Clinically stable~* Parental and children consent~Exclusion Criteria:~* history of neurological illness or trauma~* Taking of medicine with somatic aim having a cerebral or psychic impact~* Simultaneous participation on another program of cognitive remediation~* child or parents unlikely to cooperate

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 13 Years
- Healthy Volunteers: f

Study Arms:
- Cognitive remediation program (Type: EXPERIMENTAL): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Teens Coping With Parental Military Deployment

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

Eligibility Criteria:
Inclusion Criteria:~Adolescents must: 1) be 13-17 years old; 2) be English speaking; 3) provide adolescent assent; 4) have parental consent and a parent/legal guardian available to participate in the intervention protocol; 5) have a parent who is deployed or returned from a deployment within the last year; and 6) report current sub-clinical or clinical levels of depression, anxiety, or oppositional behavior. In order to meet the symptom criterion, adolescents must receive a T score of ≥ 65 on the affective problems, anxiety problems, and/or oppositional defiant problems on the Youth Self-Report or the Child Behavior Checklist.~Exclusion Criteria:~Adolescents who : 1) are developmentally delayed such that the intervention materials will not be appropriate; 2) are actively suicidal or psychotic at intake; 3) are receiving pharmacotherapy or psychotherapy in the community for depression, anxiety, or disruptive behavior which are the primary targets of this intervention; or 4) meet current criteria for a DSM-IV diagnosis of bipolar disorder, conduct disorder, substance dependence, or obsessive-compulsive disorder.~-

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Cognitive behavioral group therapy (Type: EXPERIMENTAL): Cognitive behavioral group therapy for adolescents and a parallel group for parents
- Nondirective supportive group therapy (Type: ACTIVE_COMPARATOR): Nondirective supportive group therapy for adolescents and a parallel group for parents

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial

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

Eligibility Criteria:
Inclusion Criteria:~* Chronic liver failure (cirrhosis or chronic graft dysfunction) from any cause and medical indication of central venous line placement~Exclusion Criteria:~* Acute liver failure or~* Use of therapeutic doses of oral or parenteral anticoagulants (unfractionated heparin or low molecular weight heparin or oral anticoagulants) or~* Use of oral or parenteral platelet aggregation inhibitors or~* Patients with von Willebrand syndrome or~* Over-the-guidewire central venous catheter changing~* Patients previously included in this study protocol during the same hospital stay

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

Study Arms:
- Coagulogram-based protocol (Type: ACTIVE_COMPARATOR): Arm based on standard coagulation tests protocol to guide blood transfusion before central venous catheterization. The possible components to be used include fresh frozen plasma, platelets (random or aphaeresis) and or cryoprecipitate.
- Thromboelastometry-based protocol (Type: EXPERIMENTAL): Arm based on rotational thromboelastometry (ROTEM(R)) protocol to guide blood transfusion before central venous catheterization. The possible components to be used include fresh frozen plasma, platelets (random or aphaeresis) and or cryoprecipitate.
- Restrictive strategy (Type: EXPERIMENTAL): Arm based on a restrictive protocol strategy based on INR/PT and platelets count. The possible components to be used include fresh frozen plasma and/or platelets (random or aphaeresis).

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

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

Eligibility Criteria:
Inclusion Criteria:~* pregnant women 18 years of age or older~* infants born to these women from this pregnancy~* hepatitis C virus antibody and RNA positive (for study group)~* hepatitis C virus antibody and RNA negative (for control group)~Exclusion Criteria:~* HIV infection~* hepatitis B infection~* plan to use cord blood for another purpose

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

Study Arms:
- hepatitis C (Type: None): pregnant women with hepatitis C virus infection and their infants
- controls (Type: None): pregnant women without hepatitis C infection and their infants

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor

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:~* Adult patients, \>/= 18 years of age~* Rheumatoid arthritis of \>/= 6 months duration (according to American College of Rheumatology (ACR) criteria)(according to ACR criteria)~* Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study~* On methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks~* Disease Activity Score (DAS28) \>3.2 at baseline~* Oral corticosteroids (\</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for \>/=6 weeks prior to baseline.~Exclusion Criteria:~* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization~* Rheumatic autoimmune disease other than rheumatoid arthritis~* Prior history of or current inflammatory joint disease other than rheumatoid arthritis~* Functional class IV (ACR criteria)~* History of severe allergic reaction to human, humanized or murine monoclonal antibodies~* Known active current or history of recurrent infection (including tuberculosis)~* Primary or secondary immunodeficiency (history of or currently active)~* Body weight \>150 kg~* Previous treatment with any cell-depleting therapies~* Previous treatment with tocilizumab~* Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.

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

Study Arms:
- Tocilizumab + Methotrexate (Type: EXPERIMENTAL): Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
- Adalimumab + Methotrexate (Type: ACTIVE_COMPARATOR): Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SCREENING
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com~Inclusion Criteria:~* Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug~* Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis)~Exclusion Criteria:~* Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C~* Subjects with history of cancer, lymphoproliferative disease, class III or IV congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease~Other protocol defined inclusion/exclusion criteria could apply

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

Study Arms:
- Single Ascending Dose (SAD) - IV Panel (Type: EXPERIMENTAL): Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
- Single Ascending Dose (SAD) - SC Panel (Type: EXPERIMENTAL): Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
- Multiple Ascending Dose (MAD) - IV Panel (Type: EXPERIMENTAL): Multiple IV doses of BMS-986184 or placebo matching BMS-986184
- Proof of Mechanism (POM) - IV Panel (Type: EXPERIMENTAL): Multiple IV doses of BMS-986184 or placebo matching BMS-986184

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

Answer: outcome: terminate
termination_type: safety issues