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

Trial Title: Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

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:~* Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery~Exclusion Criteria:~* Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.~* Inability to follow directions or comprehend the English language.~* Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.~* Prisoners.~* Patient refusal to provide informed consent.~* Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).

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

Study Arms:
- Intravenous opioids (Type: EXPERIMENTAL): This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
- Epidural Catheter (Type: EXPERIMENTAL): The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.

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: Intravenous Bisphosphonate in Stress Fracture Treatment -A Randomised Controlled Double Blinded Multicenter Trial

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-70 years~* Stress fractures in the foot. A stress fracture is defined as a fracture occured after repetitive trauma, with characteristic MRI findings (ref) and distinctive pain over the fracture site at weight bearing.~* at least 6 months of pain history~* compliant patient~* non-aided ambulatory patient prior to the injury~Exclusion Criteria:~* Ongoing use of bisphosphonates, PTH/PTH-analogues or use within 12 months prior to the injury~* Use of bisphophonates for more than 6 months within the last 5 years~* Intolerance to zoledronic acid~* Renal failure (GFR\<30)~* S-25(OH)vitD \> 25~* pregnancy~* breast feeding~* hypocalcemia~* MRI contraindications

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

Study Arms:
- Zoledronic Acid Injectable Product (Type: ACTIVE_COMPARATOR): Patients randomized to treatment with Zoledronic Acid 5mg infusion, repeated after 3 months
- Placebo (Type: PLACEBO_COMPARATOR): Patients randomized to Placebo infusion (saline), repeated after 3 months

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: Multifactorial Pre-operative Intervention in Diabetes Mellitus

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of diabetes mellitus~* A1c 7.5%,~* Scheduled elective vascular surgery that may be safely deferred for 6 weeks~* Surgeon's approval to participate~Exclusion Criteria:~* Hemoglobin A1c \>14% (This criterion was included since, once identified, such a patient warrants improved glucose control and can not be ethically entered into a trial where there is a 50% chance of being assigned to usual care)~* Myocardial infarction in prior 6 months~* Cerebrovascular disease in prior 6 months~* Active cancer requiring ongoing treatment~* Severe psychiatric disease limiting ability to comply with protocol~* Unable to attend follow up appointments

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

Study Arms:
- Multifactorial Intervention (Type: EXPERIMENTAL): Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
- Usual care (Type: NO_INTERVENTION): Control group

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: ROSA® Hip System THA PMCF

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:~1. Age 18 - 80 years~2. Body mass index ≤40 (BMI = kg/m2)~3. Patient is willing and able to provide informed consent~4. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment~5. Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System~Exclusion:~1. Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months~2. Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other~3. Active infection, sepsis, osteomyelitis~4. Patient is at a high risk for dislocation including those with long-segment spinal fusions (\>3 levels) and neuromuscular disorders~5. Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis~6. Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule~7. Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.)~8. Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure

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

Study Arms:
- Robotic-Assisted THA (Type: EXPERIMENTAL): Consecutive participants will receive THA via the ROSA Hip System.

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease

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:~* Deterioration of Crohn's disease~* CDAI\>150~* Treated with systemic steroids or TNF alfa inhibitors~* Lesion found on ultrasound~Exclusion Criteria:~* Disease location not reachable with ileocolonoscopy~* Pregnancy~* Acute coronary disease~* Unstable coronary disease~* Previous allergic reaction to SonoVue or its components

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

Study Arms:
- Deterioration, Crohn's disease (Type: None): Patients \> 18 years old with a deterioration of Crohn's disease defined by CDAI \>150 and requiring treatment with systemic steroids or TNF alfa inhibitors

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: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

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:~1. Modified Braden Scale score of 14 or less. The Modified Braden Scale score is calculated as follows:~   Braden Scale score (Ranges from 6 to 23)~  * 1 for Low Serum Albumin~  * 1 for Type II Diabetes~2. Anticipated length of stay of at least 4 days~3. BMI \< 35~4. Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf.~Exclusion Criteria:~1. Existing pressure injuries above Stage II and injuries classified as DTI or unstageable~2. Neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction~3. Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction~4. Rhabdomyolysis~5. Use of a Pacemaker~6. Skin breakdown over the gluteal regions that would preclude the use of surface electrodes.

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

Study Arms:
- IES Device + Standard of Care (Type: EXPERIMENTAL): Intermittent electrical stimulation system. Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10s every 10 minutes. The intervention is administered 24/7 and added to the standard of care management. Standard of care is defined as turning the patient every two hours.
- Standard of Care (Type: ACTIVE_COMPARATOR): Standard of care treatment for pressure injuries is turning the patient every two hours.

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: Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia

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

Eligibility Criteria:
Inclusion Criteria:~* Fetal gestational age 23 0/7 to 31 6/7 weeks~* Treated with expectant management~* Meets modified ACOG criteria for severe preeclampsia~* Willing and able to provide written, informed consent~Exclusion Criteria:~* Decision to deliver within 24 hours has been made~* Weight \> 150 kg~* Eclampsia~* Significant antecedent obstetrical problems~* Clinically significant fetal anomaly or chromosomal abnormalities~* Chronic renal disease~* Active hepatic disease, antiphospholipid antibody syndrome, or lupus~* Unstable medical or psychiatric disorder~* Need for use of digitalis like products~* History of anaphylactic allergic reactions~* Prior use of antibodies/fab fragments from sheep~* Serum creatinine ≥ 2.0 mg/dL~* Platelet count \< 50,000~* Pulmonary edema~* Estimated fetal weight \< 5th percentile

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

Study Arms:
- AMAG-423 (digoxin immune fab) (Type: ACTIVE_COMPARATOR): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
- Placebo (Type: PLACEBO_COMPARATOR): Normal saline, 30 minute IV infusion, every 6 hours x 4 days

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: Artificial Valve Endocarditis Reduction Trial

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:~* The patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement~* The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series valve(s) with either the conventional cuff or the cuff with Silzone coating~* The patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements~Exclusion Criteria:~* The patient has a medical condition which contraindicates implantation of the SJM Masters Series with Silzone coating~* The patient already has a prosthetic valve other than the valve being replaced at this time~* The patient requires a tricuspid valve replacement

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

Study Arms:
- St. Jude Medical (SJM) Conventional (Type: OTHER): St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff
- St. Jude Medical (SJM) Silzone (Type: OTHER): St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating

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: Pediatric Chronic Kidney Disease Safety and Efficacy

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

Eligibility Criteria:
Inclusion Criteria:~* Age 6 to less than 18 years at screening~* Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization~* Dry weight ≥ 12.5 kg at screening~* iPTH obtained from the central laboratory must be \> 300 pg/mL (31.8 pmol/L)~* Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)~* Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old~* Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization~* Subjects taking growth hormone, a stable dose defined as no change \> than 20% in the last 2 months prior to randomization~* Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization~* Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization~Exclusion Criteria:~* Underwent parathyroidectomy in the last 6 months~* Anticipated parathyroidectomy within 6 months after randomization~* Received therapy with cinacalcet (sensipar/mimpara) within the last month~* A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months~* Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
- Cinacalcet (Type: EXPERIMENTAL): Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: TOM: Testosterone in Older Men With Sarcopenia

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

Eligibility Criteria:
Inclusion Criteria:~* Community dwelling, ages 65 and older~* Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground~* A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)~* Total serum testosterone level (TT) \< 350 ng/dL and \> 100 ng/dL~* Without dementia (Mini-Mental State Examination \[MMSE\] score \> 24)~Exclusion Criteria:~* Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year~* Alcohol or drug abuse~* Use of anti-convulsants or glucocorticoids (equivalent to prednisone \> 20 mg/day)~* Prostate cancer, breast cancer or other cancers with life expectancy \< 5 years~* Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems~* Any neurological condition that would impact cognitive functioning including:~  * epilepsy~ * multiple sclerosis~ * HIV~ * Parkinson's disease~ * stroke~ * other focal lesion~* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months~* Abnormal prostate examination; PSA \> 4 ng/mL; or BPH symptom score \> 21~* Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry~* Abnormal laboratory values (at discretion of principal investigator)~* Untreated thyroid disease; systolic blood pressure \> 160 or diastolic \> 100 mm Hg~* Body mass index \> 40 kg/m2~* Untreated severe obstructive sleep apnea

- Gender: MALE
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Treatment (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: 3-Dimensional Form and Soft Tissue Biomechanics of the Breast

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:~1. Female~2. Greater than 18 years old.~3. Presenting complaint requires breast physical examination.~4. Free of connective tissue disorders and cutaneous malignancy on the breast.~5. Free of medical conditions that contraindicate MRI or CT scanning.~6. Willing to participate in the study and able to complete informed consent.~Exclusion Criteria:~1) Patients who do not meet inclusion criteria.

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

Study Arms:
- 1 (Type: None): Patients with Breast Cancer.

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: Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents

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

Eligibility Criteria:
Inclusion Criteria:~* Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:~  1. Waist circumference \> or equal to percentile 90 according the age.~ 2. Presence of 2 or more of following factors: systolic blood pressure \> or equal 130 mmHg or diastolic \> or equal to 85 mmHg, or treated hypertension~ 3. Cholesterol HDL \< 1.03 mmol/l or treatment with drugs to increase cHDL~ 4. Glucose blood levels \> 5.6 mmol/l or type II diabetes diagnosed treated or no.~Exclusion Criteria:~* Loss of body weight \> 3kg in the last 2 months~* Waist circumference 10 cm higher of 90 percentile according to the age~* Intake of fiber, aven supplements or phytosterols in the last 2 months~* Glycosylate haemoglobin \>7% in the time of inclusion~* Systolic blood pressure \> 145 mmHg or Diastolic blood pressure \>95 mmHg.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: feasibility