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

Trial Title: Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female 5 years to 65 years of age.~* Clinical diagnosis of MPS II (based on evidence of hepatosplenomegaly, dysostosis multiplex by X-ray, valvular heart disease, or obstructive airway disease) IDS deficiency confirmed by gene sequencing.~Exclusion Criteria:~* Known to be unresponsive to ERT~* Neutralizing antibodies to AAV 2/6~* Serious intercurrent illness or clinically significant organic disease (unless secondary to MPS II)~* Receiving antiviral therapy for hepatitis B or C, or with active hepatitis B or hepatitis C or HIV 1/2~* Lack of tolerance to idursulfase treatment with significant IARs or occurrence of anaphylaxis~* Markers of hepatic dysfunction~* Creatinine ≥ 1.5 mg/dL~* Contraindication to the use of corticosteroids for immunosuppression~* Current treatment with systemic (IV or oral) immunomodulatory agent or steroid use (topical treatment allowed)~* Participation in prior investigational drug or medical device study within the previous 3 months~* Prior treatment with a gene therapy product~* Elevated or abnormal circulating α-fetoprotein (AFP)~* Weight \< 20 kg at Screening Visit

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg (Type: EXPERIMENTAL): A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
- Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg (Type: EXPERIMENTAL): A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
- Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg (Type: EXPERIMENTAL): A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.

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: DECT Ventilation Imaging

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

Eligibility Criteria:
Inclusion criteria:~For oncologic patients :~* Potentially operable lung tumor~* With a recent (less than 1 month) V/Q scan~For lung transplant recipients :~* Single of bilateral lung transplant~* From 5 months onwards~* With recent (less than 1 month) respiratory functional explorations~Exclusion criteria:~* Impossibility to follow simple orders or control one's respiration~* Known Krypton hypersensitivity~* History of malignant hyperthermia~* Increased intracranial pressure~* Minors~* Pregnant Women

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- oncologic patients (Type: EXPERIMENTAL): Prediction of postoperative pulmonary function.~Patients with an operable lung cancer: dual energy computed tomography with Krypton will be tested to estimate the postoperative FEV1
- lung transplant recipients (Type: EXPERIMENTAL): Detection of BOS~6 months+ lung transplant recipients will be tested using dual energy computed tomography with Krypton, with acquisition in the end-inspiratory and end-expiratory phase, in search of regional air trapping.

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: Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

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:
Inclusion Criteria:~* Signed written informed consent~* Age ≥ 18 years~* Histologically-confirmed adenocarcinoma of the prostate~* Hormone-refractory prostate cancer~* Failed 1st-line docetaxel-containing regimen~* No prior immunotherapy including:~  * Vaccines~ * GM-CSF~* Minimum prostate-specific antigen (PSA) \> 5 mg/dL and rising according to the PSA Consensus Criteria~* Karnofsky Performance Status (KPS) \> 60%~* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3~* Life expectancy \> 6 months~Exclusion Criteria:~* Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist~* Use of herbal products known to decrease PSA levels~* Use of supplements or complementary medicines, except for:~  * Conventional multivitamin supplements~ * Selenium~ * Lycopene~ * Soy supplements~ * Vitamin E~* Initiation of bisphosphonates within one month prior to enrollment or throughout the study~* Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment~* Major surgery or radiation therapy completed \< 4 weeks prior to enrollment~* Any concomitant second malignancy other than non-melanoma skin cancer~* Any concomitant serious infection~* Any nonmalignant medical illness~* Absolute neutrophil count (ANC) \< 1,500/µL~* Platelet count \< 100,000 µL~* Hemoglobin \< 8 mg/dL~* Total bilirubin greater than 1.5 x upper limit of normal (ULN)~* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases~* Ejection fraction \< 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan~* Noncompliance with study procedures

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

Study Arms:
- GM-CSF Plus Mitoxantrone (Type: EXPERIMENTAL): GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.

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 Case Management Intervention to Prevent ER Visits in HIV-infected Persons

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

Eligibility Criteria:
Inclusion Criteria:~* Patient in our clinic as of 4-1-04~Exclusion Criteria:~* \<18 years old

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

Study Arms:
- Intervention (Type: EXPERIMENTAL): Phone call after an ER visit.
- Control (Type: NO_INTERVENTION): No phone call after an ER visit.

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: Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

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:~* Surgery scheduled under laparotomy~* Extended ileal resection~* Total proctocolectomy~* Colectomy left/right/total~* Rectosigmoidal resection~* Anterior resection of rectum~* Abdomino-perineal amputation~* Adult patient~* Written consent obtained~* Planned hospitalization in the intensive care unit~* Patient affiliated to social security~Exclusion Criteria:~* Patients inapt to give consent~* Emergency surgery~* Contraindication to epidural analgesia~* Contraindication to levobupivacaïne, morphine or sufentanil~* Dementia~* Participation in another research protocol~* Pregnancy or breastfeeding

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

Study Arms:
- APD (Type: EXPERIMENTAL): patient with epidural analgesia
- PCA (Type: ACTIVE_COMPARATOR): Patient with morphine analgesia

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: Demographics and Findings of Upper Endoscopy Patients

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:~* Patients who present to the KCVA GI endoscopy unit with symptoms of reflux,upper abdominal pain, anemia (patients referred by their primary care physicians with a diagnosis of low hemoglobin (\< 10 G/DL, and or dyspepsia~Exclusion Criteria:~* Weight loss (Weight loss of \> 10% of their mean body weight over last 6 months)~* Dysphagia~* Gastrointestinal bleeding~* Gastrointestinal malignancy~* Recent EGD (in the past 5 years)

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

Study Arms:
- GI observation (Type: None): Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.

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: Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

Study Design Characteristics:
- Allocation: None
- 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 for de novo AIH~* Age 18 or older~* Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and a different pre-transplant etiology of liver disease will be eligible.~* Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible.~* Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure.~* Women of child bearing potential agree to have pregnancy test at screening~* Males agree use of appropriate contraceptives during the active Orenia dosing period~Inclusion Criteria for recurrent AIH~* Age 18 or older~* Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and whose original etiology of liver disease was AIH will be eligible.~* Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible.~* Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure.~* Women of child bearing potential agree to have pregnancy test at screening~* Males agree use of appropriate contraceptives during the active Orenia dosing period~Exclusion Criteria:~* Active systemic infection~* Allergy to abatacept~* Known malignancy in the previous 2 years except for non-melanoma skin cancer~* Pregnancy or breast feeding~* Inability to commit to complete treatment protocol at Duke, as all procedures must be completed at Duke~* Prisoners or those who are compulsory detained~* Inability to read and understand English~* EBV seronegative (if not tested within 2 years prior to study enrollment, then testing will be done prior to study enrollment, results must be positive for study participation)

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

Study Arms:
- Orencia® (Abatacept) (Type: EXPERIMENTAL): Abatacept 125 mg, subcutaneous once a week for 6 months or up to one year if subject has a favorable response

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: Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia

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

Eligibility Criteria:
DISEASE CHARACTERISTICS: Cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy FAB L1 or L2 Bone marrow relapse either isolated or associated with CNS or testicular relapse Bone marrow blast cells greater than 10% No isolated CNS relapse~PATIENT CHARACTERISTICS: Age: Under 18 Performance status: WHO 0-2 Play-performance scale at least 60% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times normal Renal: Creatinine less than 2.5 times normal Cardiovascular: No symptoms of cardiac failure No decline of ejection fraction by more than 20% of the lower limit of normal Shortening fraction at least 25% Other: No psychological, familial, sociological or geographical condition that would hamper compliance No uncontrolled infection~PRIOR CONCURRENT THERAPY: At least 6 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No concurrent treatment with other experimental drug

- Gender: ALL
- Minimum Age: None
- 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: Symptom Burden in Patients With Cancer- and Treatment-Related Skin Problems

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:~1. 18 years of age or older~2. Ability to read and speak English~3. Receiving treatment and/or follow up at M. D. Anderson Cancer Center~4. Residing where IVR service is available (Validation part of study only)~5. Rating of skin problem at its worse in the last 24-hours of at least 1 on a 0 to 10 scale where 0 is no skin problem and 10 is the skin problem as bad as can be imagined~6. Written consent to participate~Exclusion Criteria:~1. Medical condition (impaired speech that would preclude taking part in a 30 minute interview, deafness that would impair the ability to use the IVR system) or impaired performance status that would preclude participation in the study~2. Diagnosis of active psychosis or severe cognitive impairment as determined by physician~3. Active treatment (systemic drug therapy or radiation therapy) for a second malignancy

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

Study Arms:
- Interview (Type: None): None
- Symptom Inventory Assessment (Type: None): 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: Evaluation of Mirus™ for Sedation in Resuscitation

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:~* Patients aged over 18 years~* In mechanical ventilation for more than 48 hours~* No intracranial hypertension~* In severe state of agitation measured by a sedation scale score greater than 2 RASS~* Agitation observed in two circumstances: receiving maximal doses of propofol (≥ 5 mg / kg / h) and / or midazolam (≥ 0.2 mg / kg / h), or weaning failure to stop the sedation agitation.~Exclusion Criteria:~* Presence of a severe head injury (Glasgow initial score between 3 and 8) requiring monitoring intracranial pressure and / or treatment of intracranial hypertension~* Sedation with dexmedetomidine~* Personal or family antecedent of anesthetic malignant hyperthermia~* Pregnant woman

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

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: Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease~* Serum calcium =\< 1.2 x upper normal limit (UNL)~* Serum magnesium =\< UNL~* Serum creatinine =\< 1.5 x UNL~* Ability to sign informed consent and understand the nature of a placebo-controlled trial~* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2~* Ability to complete questionnaire(s) by themselves or with assistance~* Life expectancy \>= 4 months~* Presence of a central line~Exclusion Criteria:~* Pre-existing history of peripheral neuropathy \>= grade 2 (National Cancer Institute \[NCI\] CTCAE Active Version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)~* Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy~* Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient~* Any of the following:~  * Pregnant women~ * Nursing women~ * Women of childbearing potential (per physician judgment)~* Diagnosed diabetes requiring insulin or oral hypoglycemic medications~* Receiving digoxin or digitoxin~* History of heart block (any degree)~* Current treatment for arrhythmias~* Concurrent treatment with other neuropathic chemotherapy agents

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

Study Arms:
- Arm I (calcium gluconate, magnesium sulfate) (Type: EXPERIMENTAL): Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
- Arm II (placebo) (Type: PLACEBO_COMPARATOR): Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

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: ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma

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 Criteria:~* Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).~* Age from 18 to 65 years.~* Patient not previously treated.~* Ann Arbor stage I or II.~* ECOG performance status \< 2.~* Normal LDH.~* Negative HIV, HBV and HCV serologies 4 weeks (except after vaccination).~* Having previously signed a written informed consent.~Exclusion Criteria:~* Any other histological type of lymphoma. vAny history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in lymph node may be included.~* Central nervous system or meningeal involvement by lymphoma.~* Contra-indication to any drug contained in the chemotherapy regimens.~* Poor renal function (creatinin level \>150 mmol/l), poor hepatic function (total bilirubin level \>30 mmol/l, transaminases \>2.5 maximum normal level).~* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l.~* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.~* Any serious active disease (according to the investigator's decision).~* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.~* Pregnant or lactating women~* Adult patient under tutelage.

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

Study Arms:
- R-ACVBP (Type: EXPERIMENTAL): addition of rituximab to standard ACVBP chemotherapy
- ACVBP (Type: NO_INTERVENTION): standard ACVBP chemotherapy

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

Answer: outcome: terminate
termination_type: enrollment issues