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

Trial Title: Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain

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:~1. Presumptive diagnosis of high grade or low grade glioma based on imaging studies, or will have recurrent high-grade or low grade gliomas that have previously undergone diagnosis (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme). Both of these groups will be undergoing craniotomy for tumor resection.~2. Patient age 18 to 72 years.~3. Karnofsky performance of 60% or greater~4. Patients must have normal organ and marrow function as defined below:~   Leukocytes \>3,000/μL Absolute neutrophil count \>1,500/μL Platelets \>100,000/μL Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT) \<2.5 X institutional upper limit of normal Creatinine within normal institutional limits or Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.~5. The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.~6. Patient must have the ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign the written informed consent.~Exclusion Criteria:~1. Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA).~2. Subjects with a history or family history of Porphyrias~3. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.~4. Pregnancy.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 72 Years
- Healthy Volunteers: f

Study Arms:
- ALA for glioma (WHO G1-IV) subjects (Type: EXPERIMENTAL): Up to 300 patients with diagnosed glioma (WHO G1-IV) eligible for surgery will be entered into the trial and will be given 5-Aminolevulinic Acid (ALA) orally at a dose of 20mg/kg body weight preoperatively

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: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

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:
This study collects safety data on patient treatments performed commercially under the FDA approved labeling.~* Eligibility is as per approved device indication.~* All registry-consented patients who undergo commercial ExAblate procedure for bone mets palliation after device approval.

- 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: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: 68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)

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

Eligibility Criteria:
Inclusion Criteria:~* Known or suspected somatostatin receptor positive NETs (e.g. carcinoid, pancreatic neuroendocrine tumors, and pheochromocytoma). Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.~* Karnofsky performance status of ≥50 (or ECOG/WHO equivalent)~* Off Sandostatin (octreotide acetate)-long acting release (LAR) \> 4 weeks and off immediate release (subcutaneous) for at least 12 hrs prior to 68Ga-DOTATOC PET-CT imaging~* Able to provide informed consent~* At least 18 years of age~Exclusion Criteria:~* Pregnancy or breast feeding. A negative serum pregnancy test is required for all female subjects with child- bearing potential~* Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed~* Medical condition uncontrolled by treatment making completion of study unlikely~* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to Body Mass Index (BMI)~* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)~* Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation

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

Study Arms:
- 68Ga-DOTATOC PET (Type: EXPERIMENTAL): patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)

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: High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

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:~* Age less than 18 years~* Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.~* Harvey Bradshaw Index of at least 7~* The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.~* Written informed consent~Exclusion Criteria:~* Concomitant corticosteroids, budesonide~* Corticosteroids within 2 months~* Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months~* Maintenance infliximab, or infliximab or other biologics in the preceding 3 months~* If the severity of the flare has started to decrease spontaneously~* Coexisting diagnosis of primary sclerosing cholangitis~* Infectious diarrhea~* Signs of intestinal obstruction or perforation~* New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare~* Hypersensitivity to 4-ASA or any components of PASER®~* Pregnancy or breast-feeding~* Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active~* Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC \< 3,000 during the preceding three months

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Active (Type: EXPERIMENTAL): 4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks

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: Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects

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

Eligibility Criteria:
Inclusion Criteria:~1. Healthy male and female volunteers a minimum of 18 years to 75 years of age~2. Female must be non-lactating and either be of non-child-bearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation) or if of child-bearing potential, must have a negative human chorionic gonadotropin (hCG) pregnancy test and be practicing effective dual barrier contraceptive method from consent to 42 days after initiation of study drug administration.~3. Negative test for hepatitis B surface antigen, Hepatitis C antibody and HIV 1 and 2 antibody within 14 days prior to admission to this study~4. The subject has provided written informed consent prior to admission into this study.~Exclusion Criteria:~1. History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically-mediated disorders~2. History of drug or alcohol abuse, (\* 10 drinks weekly)~3. Blood donation within 30 days prior to dosing~4. History of drug allergies, anaphylaxis or laryngeal edema~5. Use of any medication within 7 days before dosing with study medication or anticipated need for any medication during the study conduct~6. Use of any investigational medication within 6 weeks prior to dosing with study medication or scheduled to receive an investigational drug other than pafuramidine maleate during the course of this study~7. Clinically significant abnormal laboratory value at screening including CBC, blood chemistry or urinalysis~8. Clinically significant anomalies noted on physical examination or ECG~9. Resting pulse rate of \> 100 beats per minute or \< 45 beats per minute during the screening period, either supine or standing.~10. Any condition, which compromises ability to give informed consent or to communicate with the Investigator as required for the completion of this study~11. The subject has been previously enrolled in this study. -

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

Study Arms:
- 1 (Type: PLACEBO_COMPARATOR): Placebo tablets resembling 100 mg tablet of active drug BID X 14 days
- 2 (Type: ACTIVE_COMPARATOR): Pafuramidine maleate, 100 mg tablet, BID X 14 days

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: Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Adult with age equal or above to 18.~* Subject affiliated to French health insurance (Sécurité Sociale)~* Sciatic pain evolving since more than 1 month and less than 3 months~* Leg irradiation (pain above the knee)- True Lasègue- Mean leg pain during the latest 24 hours above 40 on an analogic visual scale (from 0 to 100)~* Pain induced by palpation in regards to the neo-articulation~* Pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics No sign of seriousness : no motor deficiency (muscular testing above or equal to 4 on an international scale (from 0 to 5), no sphincter deficiency, mean leg pain during the latest 24 hours below 80 on an analogic visual scale (from 0 to 100).~* Scanner of MRI since less than 3 months confirming discal hernia L4L5 or L5S1 in accordance with the clinic.~* Informed consent form signed~Exclusion Criteria:~* Age below 18~* Clinical arguments in favour of a non discal origin- Pregnant women~* Diabetic patient- Past history of diverticulosis complicated with severe arterial hypertension- Patient unable to understand the protocol~* No autonomy for coming to the hospital (no budget allocated for patient transportation)~* Hypersensitivity to local anesthetics with liaison amide-Hypersensitivity to one of the components-Porphyria~* Local or generalized infection, suspicion of infection~* Severe troubles of coagulation, anti-coagulant treatment taken- Imaging non concording~* Past history of infiltration via the sacro-coccygien hiatus~* Past history of lombar rachis surgery- Body mass index above 40.~* Intake of b-bloquants- Intake of antiarrythmics possibly giving torsades de pointe (amiodarone, disopyramide, quinidiniques, sotalol,...)-Cimétidine used at doses above or equal to 800mg/day.

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

Study Arms:
- corticoïd (Type: EXPERIMENTAL): anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
- physiological solution (Type: PLACEBO_COMPARATOR): anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
- feigning of peridural infiltration (Type: SHAM_COMPARATOR): feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
- no intervention (Type: NO_INTERVENTION): natural evolution of discal sciatica

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

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

Trial Title: A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice

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:~* Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months~* Started on tocilizumab, with or without previous history of biological treatment~Exclusion Criteria:~* Pregnant or lactating women~* Treated with an investigational drug within 30 days prior to initiation of study drug~* Having a condition that, in the opinion of the investigator, could compromise the participant's safety or interfere with the study results

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

Study Arms:
- Participants with confirmed rheumatoid arthritis (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 Maternal Feedback to Shorten Pushing Efforts During Labor

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

Eligibility Criteria:
Inclusion Criteria:~1. Laboring nulliparous women who are \> 36 0/7 weeks estimated gestational age undergoing epidural or combined spinal epidural (CSE) placement for labor pain management.~Exclusion Criteria:~1. Women with multiple gestations.~2. Women with contraindications to pushing during second stage labor.~3. Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.~4. Women who do not plan to initiate pushing immediately (those who plan to rest and descend prior to initiation of pushing).

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

Study Arms:
- Patients receiving PushCoach feedback (Type: EXPERIMENTAL): Patients will receive continuous maternal feedback from the PushCoach device, which includes both audio and visual feedback of fetal head movement during the second stage of labor
- Patients blinded to PushCoach feedback (Type: ACTIVE_COMPARATOR): Patients will not receive continuous maternal feedback from the PushCoach device (it will be in place and collect data), but will receive normal feedback from the clinician during the second stage of labor.

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: NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

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

Eligibility Criteria:
Inclusion Criteria:~* isolated supracondylar humerus fracture~* undergoing closed reduction with percutaneous pinning (CRPP)~Exclusion Criteria:~* Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone~* Liver or renal disease~* history of bleeding disorder~* medical diagnosis of juvenile arthritis~* on chronic NSAIDs or Opioids PRIOR to the procedure~* medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)~* vascular compromise and/or compartment syndrome upon admission

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 13 Years
- Healthy Volunteers: f

Study Arms:
- Control (Type: OTHER): Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
- Treatment (Type: EXPERIMENTAL): Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.

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: Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer

Study Design Characteristics:
- Allocation: 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:~* Patients scheduled for operation for rectal cancer~Exclusion Criteria:~* Inflammatory bowel disease (IBD)~* Pacemaker~* Metal in the investigated areas~* Claustrophobia~* Age \< 18 years~* Pregnancy~* Kidney disease~* Arrhythmia

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

Study Arms:
- Total preoperative MR evaluation (Type: OTHER): Total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session combined with CT thorax
- Standard diagnostic evaluation (Type: OTHER): Standard preoperative diagnostic evaluation for patients with rectal cancer, incl. CT thorax, abdomen and MRI of the rectum and colonoscopy

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: Safety and Efficacy of Rasagiline in Restless Legs Syndrome

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:~* Men and women at least 18 years of age, capable of providing informed consent~* Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group diagnostic criteria without evidence for secondary causes of RLS~* Moderate or severe symptoms, defined as a score of 15 or greater on the International RLS Study Group Rating Scale (IRLS)~* Not currently receiving treatment for RLS. A 30-day washout period will be required for participants on dopamine agonists or other therapies. Stable doses of iron supplementation will be allowed~* On a stable dose of the following antidepressants, for at least 30 days prior to baseline visit:~  * Amitriptyline, up to 50mg/day~ * Trazodone, up to 100mg/day~ * Citalopram, up to 20mg/day~ * Escitalopram, up to 10mg/day~ * Paroxetine, up to 30mg/day~ * Sertraline, up to 100mg/day~* Female subjects must not be of childbearing potential or must agree to use of contraception for duration of study~Exclusion Criteria:~* Signs consistent with a secondary cause of RLS:~* History of initial unresponsiveness to dopaminergic RLS treatment despite adequate dose of initial therapy~* Use of another MAO inhibitor within 30 days of baseline visit~* Allergy or adverse reaction to rasagiline~* Prior adverse reaction to tyramine-containing foods~* Use of meperidine or other opiates within 30 days of the baseline visit~* Use of benzodiazepines within 30 days of the baseline visit~* Use of antidepressants, including TCAs, SSRIs, and SNRIs, except for those permitted as listed above~* Use of other drugs or supplements contraindicated with rasagiline, including St. John's wort, mirtazapine, cyclobenzaprine, dextromethorphan, cold products that contain ephedrine, pseudoephedrine~* Scheduled to undergo elective surgery during the course of the study~* Active medical or psychiatric illness that requires changes to treatment during the course of the study or jeopardize the subject's ability to remain in the study

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

Study Arms:
- rasagiline (Type: ACTIVE_COMPARATOR): None
- placebo (sugar pill) (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: enrollment issues