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

Trial Title: Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~AML confirmed subjects aged ≥ 60 years who have achieved complete remission (CR or CRi) after induction/consolidation Ara-C based therapy, that have MRD positive status and are not planned for stem cell transplantation.~Exclusion Criteria:~Subjects diagnosed with acute promyelocytic leukemia or with extramedullary AML or subjects who have achieved CR or CRi following treatment for AML. Subjects who have received treatment with hypomethylating agents.

- Gender: ALL
- Minimum Age: 60 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Combination Treatment Single Arm (Type: EXPERIMENTAL): Combination Treatment of BL-8040 with Atezolizumab

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: AssessMent and Counseling to Get the Best Efficiency and Effectiveness of the Assistive TeCHnology

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

Eligibility Criteria:
Inclusion Criteria:~* People with recognized disability, derived by a disease or a permanent health status.~* Age between 2 and 21 years old.~* To form part of any of the collaborators' centers with the three universities.~* To have an independent functional level moderate - low (assessed by the Functional Independence Measure.~* To have functional skills - mobility domain level moderate - low (assessed by the Spanish version of Pediatric of Disability Inventory - PEDI)~Exclusion Criteria:~* To have any health status that is incompatible with the use of assistive technology designed and prototyped in the project.~* To have cognitive skills very limited, that limits to follow the instructions to good use of AT.~* Not to have adequate human supports to make use of AT.~* To have functional skills - mobility domain level low (assessed by the Spanish version of Pediatric of Disability Inventory - PEDI), with the need for maximum assistance from caregivers.

- Gender: ALL
- Minimum Age: 24 Months
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- Person with disability (Type: EXPERIMENTAL): * Initial assessment.~* Implementation of AT in the daily life of participants~* Application of outcome measures and analysis of the data

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: Glucocorticoids Promote Osteoclast Survival

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:~1. 18 years old or greater~2. agree to at least one bone biopsy~3. agree to BMD, blood and urine tests~4. receiving at least 10 mg/day of prednisone for at least three months~5. either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months)~Exclusion Criteria:~1. any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia~2. obesity enough to make a biopsy difficult~3. concurrent use of any tetracycline~4. hypercalcemia~5. kidney stones in the last two years~6. home O2~7. gastric surgery, stapling or bypass~8. inflammatory bowel disease~9. untreated thyroid disease~10. organ transplants~11. malabsorption~12. anticoagulation~13. current infection~14. serious illness~15. allergy to Demerol, Valium, iodine, tetracycline, tape~16. use of anticonvulsant drugs, heparin, Forteo, calcitonin or high-dose fluoride within the past six months

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: t

Study Arms:
- glucocorticoids (Type: None): patients receiving glucocorticoid treatment
- glucocorticoids and bisphosphonates (Type: None): patients receiving both glucocorticoids and bisphosphonates

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: Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws

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

Eligibility Criteria:
Inclusion Criteria:~* Spinal stenosis~* Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)~* Fracture (including dislocation or subluxation)~* Spine tumor~* Scoliosis~* Lordotic deformities of the spine~Exclusion Criteria:~* An active systemic or local infection~* Previous fusion attempt at index level~* A local inflammation with or without fever or leukocytosis~* Pregnancy~* Obesity (BMI \>40 kg/m2)~* Drug or alcohol abuse~* Uncooperativeness or neurological or mental illness rendering the individual unwilling or unable to follow instructions~* Inability to restrict high activity level~* A suspected or documented metal allergy or intolerance~* A poor prognosis for good wound healing (e.g., decubitus ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition)~* Any medical or surgical condition that would preclude the potential benefit of spinal implant surgery, prevent secure component fixation, or seriously increase the risk of tolerating any surgical procedure,~* Any other contraindications as enumerated in the device's Instructions for Use.

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

Study Arms:
- Group 1 (Type: EXPERIMENTAL): Trinica Anterior Lumbar Plate System with fixed screws only
- Group 2 (Type: EXPERIMENTAL): Trinica Anterior Lumbar Plate System with variable screws only
- Group 3 (Type: EXPERIMENTAL): Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).

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: The Nuvigil and Provigil Pregnancy Registry

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

Eligibility Criteria:
Inclusion Criteria:~* Reported exposure to brand or generic formulations of Nuvigil (armodafinil) and/or Provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy~* Patients who provide oral or written informed consent.~* Infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.~* Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff.~Exclusion Criteria:~* Patients who refuse to provide oral or written informed consent.~* Patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.~* Infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.

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

Study Arms:
- Prospective Cohort (Type: None): Prospective is defined per protocol: prospective data of pregnancy exposure are data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination (e.g. fetal ultrasound, serum markers).
- Retrospective Cohort (Type: None): Retrospective is defined per protocol: retrospective data of pregnancy exposure are data acquired after the outcome of the pregnancy is known or after the detection of a congenital malformation on prenatal examination.

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: Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis

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:~* age 18 and above~* have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month~* able and willing to attend subsequent follow-up visits~Exclusion Criteria:~* Associated retinitis~* patients who are allergic to gancyclovir~* patients who will require systemic or intra-vitreal gancyclovir therapy~* patients who are pregnant or breastfeeding

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 95 Years
- Healthy Volunteers: t

Study Arms:
- Gancyclovir gel (Type: EXPERIMENTAL): 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.
- hypromellose gel (Type: PLACEBO_COMPARATOR): 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 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: Antiepileptic Drugs and Vascular Risk Markers

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

Eligibility Criteria:
Inclusion Criteria:~* Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV~* Within 48 hours of admission~Exclusion Criteria:~* Grade V subarachnoid hemorrhage~* Being treated with a lipid-lowering agent~* Contraindication to phenytoin, valproate, or levetiracetam (e.g. history of allergy to one of these agents)~* Contraindication to receiving no antiepileptic drug treatment (e.g. history of pre-existing epilepsy, seizure activity on admission EEG)

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
- 2 (Type: ACTIVE_COMPARATOR): Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
- 3 (Type: ACTIVE_COMPARATOR): Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
- 4 (Type: NO_INTERVENTION): Participants randomized to Group 4 will receive no drug intervention.

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: Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO grade I-IV) or brain metastasis scheduled for neurosurgical procedure (gross-total resection, sub-total resection or biopsy) at Duke University Medical Center (DUMC);~2. Safe for surgery per treating neurosurgeon;~3. Due to the potential implications of the treatment on the developing central nervous system (CNS), all patients must be ≥ 18 years of age at the time of entry into the study;~4. Laboratory Studies:~   1. Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)~  2. Creatinine ≤ 1.5~5. A signed informed consent form approved by the Duke University Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.~6. Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men.~Exclusion Criteria:~1. Pregnant or need to breast feed during the study period (Negative urine β-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED;~2. Patients already on AED(s);~3. Known history of epilepsy/seizure disorder;~4. Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or narcotics;~5. Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate therapy, per the discretion of the treating investigator;~6. Known allergy to LCM or LEV.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Lacosamide (Type: ACTIVE_COMPARATOR): Enrolled subjects will be randomized to receive Lacosamide.
- Levetiracetam (Type: ACTIVE_COMPARATOR): Enrolled subjects will be randomized to receive Levetiracetam.
- No anti-epileptic (Type: NO_INTERVENTION): Enrolled subjects will be randomized to not receive anti-epileptic drugs.

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: Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

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

Eligibility Criteria:
Inclusion Criteria:~* Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.~Exclusion Criteria:~* Women with predominantly symptoms of urge urinary incontinence~* Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery~* Detrusor overactivity on cystometrogram at urodynamic testing~* Previous surgery for incontinence~* Intrinsic sphincter deficiency (MUCP\<20 cm H2O or Q -tip \<30o)~* Voiding dysfunction with postvoid residual \>100 cc

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

Study Arms:
- TVT SECURE (Type: ACTIVE_COMPARATOR): sling
- TVT O (Type: ACTIVE_COMPARATOR): sling

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: Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Newly diagnosed breast cancer patients~* Breast cancer patients identified as conservation candidates by their surgeons~Exclusion Criteria:~* Patients with a history of prior breast cancer treatment (recurrence)~* Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study)~* Patients with documented sensitivity to gadolinium (contrast agent used during MRI)~* Patients who weigh more than 350 pounds (weight limit on MRI machine)~* Patients who receive neoadjuvant chemotherapy~* Patients with renal insufficiency (serum Cr \> 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of Gadolinium

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

Study Arms:
- MRI (Type: EXPERIMENTAL): Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)
- Non-MRI (Type: NO_INTERVENTION): Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)

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: Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

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:~* Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease~* Locally advanced HN SCC, stages III, IV, and bulky (\> 27 cm\^3 volume) stage II, excluding larynx and nasopharynx, of no more than 150 cm\^3 volume base on CT scan~* All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines~* Candidate for chemotherapy~* Zubrod performance score of 0 or 1~* Absolute granulocyte count (AGC) \>= 2000 cells/mm\^3~* Platelet count \>= 100,000 cells/mm\^3~* Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study~* Serum creatinine =\< 1.5 mg/dl or measured or calculated creatinine clearance \>= 50 ml/min~* Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential~Exclusion Criteria:~* Prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years~* Prior cancer treatment for this cancer, including gross total tumor excision~* Prior radiation treatment to the HN region~* Patients with known syndromes that alter radiosensitivity~* Any medical contraindications for chemotherapy~* Pregnant or lactating women~* Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Arm I (Type: EXPERIMENTAL): Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.

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 Dual Trigger Ovulation in Oocyte Donors

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~Donors~* Young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements for donation.~Recipients~* Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs.~Exclusion Criteria:~Donors~* Less than 2 ovaries or any other significant ovarian abnormality~* Does not meet current FDA or program requirements for donation.~* A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)~* A contraindication for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)~* Known gene defects, genetic abnormalities or abnormal karyotype~* Contraindication or hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol~* Inability to give informed consent~* Donors who, because of their place of residence or personal situation, would not be able to commit to all required time points including the one extra visit required by study participation.~* The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease

- Gender: FEMALE
- Minimum Age: 21 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- hCG (Type: ACTIVE_COMPARATOR): standard dose of hCG for ovulation trigger
- Lupron Trigger (Type: ACTIVE_COMPARATOR): Leuprolide acetate 2 mg ovulation trigger
- Dual Trigger (Type: EXPERIMENTAL): Lupron and hCG combined ovulation trigger

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

Answer: outcome: terminate
termination_type: enrollment issues