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

Trial Title: Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling

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

Eligibility Criteria:
Inclusion Criteria:~* Adults \> 18 years of age~* Planning for outpatient surgical treatment of SUI with placement of a transobturator suburethral sling under general anesthesia~Exclusion Criteria:~* Pregnant or nursing~* Allergy to bupivacaine~* History of drug/alcohol abuse~* Severe cardiovascular, hepatic, renal disease, or neurological impairment°~* Long-acting opioid within 3 days or any opioid use within 24 hours before surgery~* Contraindication to:~* acetaminophen~* oxycodone~* non-steroidal anti-inflammatory drugs (NSAID)~* Administration of an investigational drug within 30 days before study~* Chronic pain syndromes~* Daily NSAID/opioid use~* Patients having concomitant procedures or not undergoing general anesthesia~* Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.

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

Study Arms:
- Liposomal bupivacaine (Type: ACTIVE_COMPARATOR): Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.
- Placebo (Type: PLACEBO_COMPARATOR): Subjects in this arm will received the placebo - normal saline 30 mL.

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 Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening~* Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)~Exclusion Criteria:~* Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)~* Requiring hospitalisation for current episode of severe UC~* Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)~* Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)~* Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)~* Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)~* Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)~* Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)~* Currently receiving total parenteral nutrition

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- rFXIII (Type: EXPERIMENTAL): None
- Placebo (Type: ACTIVE_COMPARATOR): None

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: An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma

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:~* Participants with histologically confirmed relapsed or refractory follicular Stage III or IV, Grade 1 and 2, cluster of differentiation 20 plus (CD20+) lymphoma (WHO - World Health Organization) that requires therapy~* Participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies~* Women must be either postmenopausal or sterilized; negative pregnancy test at Screening~* Participants with total bilirubin below 1.5-fold upper limit of normal (ULN) and creatinine below 2-fold ULN~* Participants with Karnofsky Status greater than or equal to 60 percent~Exclusion Criteria:~* Participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib~* Participants with previous known allergic reaction to bortezomib, boron or mannitol~* Participants with life-expectancy of less than 3 months~* Participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years~* Participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (CTCAE) grade greater than or equal to 2

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

Study Arms:
- Bortezomib plus rituximab (Type: EXPERIMENTAL): Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m\^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3. Rituximab will be administered as intravenous infusion as 375 mg per m\^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.

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 Room Air Versus 60% Oxygen for Resuscitation of Premature Infants

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

Eligibility Criteria:
Inclusion Criteria:~Infants with a gestational age of 23 0/7 to 28 6/7 weeks by best obstetrical estimate.~Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation Infants whose parents/legal guardians have provided consent for enrollment, or for whom a waiver of consent is in place Infants without known major congenital malformations prior to delivery~Exclusion Criteria:~Any infant transported to the center after delivery Infants whose parents/legal guardians refuse consent Infants born when the research apparatus/study personnel are not available Infants \< 23 weeks 0 days or \> 28 weeks 6 days, completed weeks of gestation

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

Study Arms:
- Room Air (Type: ACTIVE_COMPARATOR): Neonatal Resuscitation using continuous positive airway pressure(CPAP) or positive pressure ventilation (PPV) will be provided with 21% oxygen. Infants will remain on 21% oxygen until they have a functioning oximeter when SpO2 will be managed as below. FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range.
- 60% Group (Type: ACTIVE_COMPARATOR): Neonatal Resuscitation using CPAP or PPV will be provided with 60% oxygen. Infants will remain on 60% oxygen until they have a functioning oximeter at which time their SpO2 will be managed as described below FiO2 will be increased by 10% increments when the infant's SpO2 is below the lower sat limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 seconds as often as is necessary to bring the SpO2 within the pre-specified range. The FiO2 will be decreased by 10% increments when the SpO2 is above the upper limit for 30 seconds and repeated if the SpO2 remains outside the limit for a subsequent interval of 30 second as often as is necessary to bring the SpO2 within the pre-specified range.

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: Explore Efficacy of FMT Treating Childhood ASD Patients

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R);~2. Patients with moderate to severe gastrointestinal symptoms which are not life-threatening and do not require immediate surgery;~3. Patients aged 3-17 years, male or female;~4. Patients who are suitable for receiving oral FMT capsules, and able to swallow the capsules without chewing;~5. Patients who are able to complete the study as required by the trial protocol;~6. Patients without known immunodeficiency diseases;~7. Subjects and/or their guardians are able to fully understand the informed consent of the trial, and voluntarily sign the informed consent form.~Exclusion Criteria：~1. Patients diagnosed with severe malnutrition;~2. Patients depend on tube feeding (liquid food);~3. Patients with a serious gastrointestinal disease requiring immediate treatment (or life-threatening);~4. Patients with primary immunodeficiency disease during screening;~5. Patients with a single-gene disorder;~6. Patients with a history of severe allergies;~7. Patients with severe fever and/or serious infection within 7 days prior to enrollment;~8. Patients with renal insufficiency and liver dysfunction (or creatinine \> 2 mg/dl, direct bilirubin \> 2 mg/dl);~9. Subjects with congenital or acquired immunodeficiency or immunosuppression (e.g., neoplastic disease or organ transplant) who have received or are undergoing chemotherapy, or have been diagnosed with HIV;~10. Patients with inflammatory bowel disease, celiac disease, large intestine irritation or eosinophilia, esophagitis, eosinophilic gastroenteritis or similar diseases;~11. Subjects with severe sensory or motor disorders (e.g., blindness, deafness, seizures, cerebral palsy);~12. Patients who are participating in other clinical studies, or have received interventions in other interventional clinical studies within 4 weeks prior to enrollment.

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- FMT (Type: EXPERIMENTAL): 20 subjects will be enrolled in this arm to receive FMT treatment.

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: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation

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:~* 18 years old~* Undergoing evaluation for hand transplantation~Exclusion Criteria:~* unable to complete surveys

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

Study Arms:
- hand transplant candidates (Type: None): Participants enrolled will be asked to complete behavioral questionnaires.

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: Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria~* Man or woman 18 years of age or older~* Scheduled for corneal transplant surgery~* Patients must be healthy enough to undergo surgery~* Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy~* Women must be abstinent at the discretion of the investigator~* Women practicing an effective method of birth control~* Women agree before entry to continue to use the same method of contraception throughout the study~* Women of childbearing potential must have a negative urine pregnancy test at screening~Exclusion Criteria~* Presence of an active ocular infection or positive history of ocular herpetic infection~* History of severe dry eye syndrome~* Use of contact lenses in the 2 weeks prior to the study and for the duration of the study~* Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment~* Pregnant or breast feeding~* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center as well as family members of the employees or the investigator

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (Type: ACTIVE_COMPARATOR): 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: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

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

Eligibility Criteria:
Inclusion Criteria:~* Age 30+ years~* Hypertriglyceridemia (150-400 mg/dl)~* Statin use for at least six months at the time of screening~* Type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year~* Ability to provide informed consent and provide blood samples~* Willingness to abstain from fish oil, EPA, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks)~* Ability to travel to the study site at Brigham and Women's Hospital for 3 study visits~* Reactive hyperemia index (RHI) of ≤ 2.0~Exclusion Criteria:~* Eating disorder or heavy drinkers~* Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification~* Pregnant or lactating women~* Statin use \<6 months at the time of screening~* Allergy to EPA, fish oil, or other omega-3 fatty acids~* Current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids.~* Inability to provide informed consent or blood samples~* History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure~* Diagnosis of diabetes \< 1 year prior to enrollment~* Intention to move out of greater Boston area within one year~* Current use of omega-3 supplements, fish oil, or \>2 servings of fish per week~* Bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders~* Treatment with blood thinning drugs (i.e. warfarin and clopidogrel)~* Major surgical operation 3 months before or after screening~* Organ transplantation~* Current participation in another trial or plan to do so during the study~* Inability to give informed consent or to travel to the study center at Brigham and Women's Hospital~* RHI of \>2.0~* Triglycerides \<150 mg/dl or \>400 mg/dl~* Body mass index of 40+ kg/m2

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- EPA arm (Type: EXPERIMENTAL): EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
- Control (Type: NO_INTERVENTION): Control group will not receive EPA

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: Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma

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:
* Documented leptomeningeal metastases~* Carcinomatous meningitis that is previously untreated or failed prior therapy OR~* Lymphomatous meningitis~* Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious~* Age 18 and over~* Karnofsky Performance Status 60-100%~* Life expectancy of at least 6 weeks~* Absolute neutrophil count greater than 1,500/μL~* Platelet count greater than 100,000/μL~* Creatinine no greater than 2.0 mg/dL~* No congestive heart failure~* No unstable angina~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir~* No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting)~* No uncontrolled infection~* Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed~* No other concurrent chemotherapy for other sites of disease~* No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas~* No prior radiotherapy to greater than 30% of bone marrow~* Prior radiotherapy to the neuroaxis allowed~* No concurrent radiotherapy for other sites of disease or for progressive disease~* Recovered from any prior recent therapy

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

Study Arms:
- Temozolomide (Type: EXPERIMENTAL): Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until:~* disease progression~* intolerable toxicity~* complete response - 2 full additional cycles~* if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response.

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: Coronary Artery Revascularization in Diabetes

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:~Patients with diabetes with severe coronary artery disease General Inclusion Criteria~1. Age at least 18 years old~2. Patients with either Type I or Type II diabetes with a documented HbA1c greater than site ULN (If not on diabetic medication must be confirmed by a blood glucose of \>126 mg/dL fasting, or \>200mg/dL non-fasting); OR on diabetic medication with a documented physician diagnosis of diabetes mellitus.~3. No child bearing potential (if female)~4. Patient competent to provide consent~   Exclusion Criteria:~   General Exclusion Criteria~5. Congenital heart disease~6. Coronary bypass surgery within the preceding one year~7. Need for concomitant cardiac surgery~8. AHA Class III decompensated heart failure or AHA Class IV heart failure~9. Undergoing PCI for hemodynamic instability related to acute STEMI~10. History of a hemorrhagic stroke~11. Severe bleeding diathesis~12. History of chronic pancreatitis~13. A severe co-morbid condition that is expected to limit life to less than two years~14. Embolic stroke in the past six months~15. Significant GI bleed within the last one month~16. Lack of adequate surgical conduit~17. Sensitivity to clopidogrel (Plavix)~18. Sensitivity to glycoprotein IIb/IIIa inhibitors~19. Chronic systemic steroid use~20. Participation in another trial with active intervention~21. Patient unable to be adequately followed

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

Study Arms:
- PCI (Type: ACTIVE_COMPARATOR): Percutaneous coronary intervention
- CABG (Type: ACTIVE_COMPARATOR): Coronary artery bypass graft (CABG)

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: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

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

Eligibility Criteria:
Inclusion Criteria:~* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury~* Inadequate response to anticholinergic medication used to treat overactive bladder~Exclusion Criteria:~* History or evidence of pelvic or urologic abnormality~* Previous or current diagnosis of bladder or prostate cancer~* Urinary tract infection at time of enrollment

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): botulinum toxin Type A (50U); botulinum toxin Type A (200U)
- 2 (Type: EXPERIMENTAL): botulinum toxin Type A (100U); botulinum toxin Type A (200U)
- 3 (Type: EXPERIMENTAL): botulinum toxin Type A (200U)
- 4 (Type: OTHER): placebo; botulinum toxin Type A (200U)

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

Answer: outcome: terminate
termination_type: enrollment issues