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

Trial Title: A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

Study Design Characteristics:
- Allocation: None
- 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 years~* Current treatment for RA on an outpatient basis~* Active disease~* Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.~* Considered by Investigator to be a primary non-responder to their first anti-TNFÎ± treatment for efficacy reasons~Exclusion Criteria:~* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA~* History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)~* Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab~* Treatment with more than one prior anti-TNFÎ± therapy

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

Study Arms:
- Ocrelizumab 200mg (Type: EXPERIMENTAL): Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
- Infliximab 5mg/kg (Type: ACTIVE_COMPARATOR): Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.

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: Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

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:~* 18 to 80 years of age inclusive~* Type 1 or type 2 diabetes mellitus~* History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit~* Documented delayed gastric emptying~* Upper gastrointestinal obstruction ruled out by endoscopy or barium scan~* Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.~* Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception~Exclusion Criteria:~* Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty~* Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study~* NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit~* Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit~* Active gastric pacemaker within 3 months prior to the Screening Visit

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

Study Arms:
- TZP-102 three times a day (Type: EXPERIMENTAL): 10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
- Placebo three times a day (Type: PLACEBO_COMPARATOR): Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.

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: Cough Assist in Bronchiolitis

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:~* Children between 3 and 18 months admitted to our hospital with a clinical diagnosis of bronchiolitis in the RSV season or with a positive nasopharyngeal aspirate for RSV.~Exclusion Criteria:~* Children with congenital cardiac disease.~* Children with cystic fibrosis.~* Children with reactive airways disease.~* Children with neurological impairment including cerebral palsy.~* Children with neuromuscular disease.~* Children with upper GI surgery.~* Children with emphysema.~* Children with a known susceptibility to pneumothorax or with a pneumothorax in the past.

- Gender: ALL
- Minimum Age: 3 Months
- Maximum Age: 18 Months
- Healthy Volunteers: f

Study Arms:
- Cough Assist (Type: EXPERIMENTAL): These children will receive 2 Cough Assist sessions daily.
- Control group (Type: NO_INTERVENTION): These children receive standard care but no physiotherapy.

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: Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

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

Eligibility Criteria:
Inclusion Criteria:~* Skeletally mature patients with minimum age of 18 years and maximum age of 65.~* Patients deemed appropriate for operative intervention by the treating physician.~* Distal humerus intra-articular fractures (types 13-C1, C2, and C3), with or without proximal radius/ulna fractures - open or closed.~* Fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed.~Exclusion Criteria:~* Head injury, quantified by Glasgow Coma Score (GCS) \< 13 at time of consent for operative intervention.~* Burns \> 20% Total Body Area (TBA) or involving the operative site.~* Patients with spinal cord injury affecting the upper extremities will be excluded.~* Open fractures which cannot be closed primarily within 72 hours of initial operative intervention.~* Patients with estimated life expectancy of less than one year due to preexisting condition.

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

Study Arms:
- No Radiation Therapy (XRT) (Type: NO_INTERVENTION): This group will not receive radiation therapy after surgery.
- Radiation Therapy (XRT) (Type: ACTIVE_COMPARATOR): Radiotherapy will be administered no later than 72 hours postoperatively.

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: A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria

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

Eligibility Criteria:
Inclusion Criteria:~* severe unremitting chronic idiopathic urticaria~* disease resistant to treatment with antihistamines~* aged 18 years or more~Exclusion Criteria:~* predominant physical urticaria~* urticarial vasculitis~* any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions~* use of immunosuppressant within 4 weeks of entry

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

Study Arms:
- 1 methotrexate (Type: ACTIVE_COMPARATOR): patient to receive methotrexate
- 2 Placebo (Type: PLACEBO_COMPARATOR): given placebo capsules

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: 20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

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:~* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia~* Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥ 20~* Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30~* Receiving stable antipsychotic therapy for at least 8 weeks prior to screening~* Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening~* Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study~* The subject or subject's legally acceptable representative has provided informed consent.~Exclusion Criteria:~* Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70~* Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam~* Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening~* Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening~* Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study~* Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).~* Other criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- AMG 747 - Dose 1 (Type: EXPERIMENTAL): None
- AMG 747 - Dose 2 (Type: EXPERIMENTAL): None
- AMG 747 - Dose 3 (Type: EXPERIMENTAL): None
- Placebo Comparator (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: Robotic Seed Implantation for Prostate Cancer Brachytherapy

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:~* Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T2b, NX, N0, M0.~* Zubrod status 0-1.~* Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration~* No prior pelvic radiation or chemotherapy for any reason; induction hormonal therapy beginning \< or = 6 months prior to registration is acceptable.~* Prostate volume \< or = 65 cc prior to registration, or planned use of LHRH agonist therapy for reduction of prostate volume. If LHRH agonist therapy is used to reduce prostate volume, then prostate volume must be \< or = 65 cc on the routine pre-implant volume study to be eligible for the study.~* Gleason score 6, or Gleason Score 7 if both , or = 33% of biopsy cores contain cancer and PSA level is \< or = 10 ng/mL.~* AUA voiding symptoms score \< or = 15.~* Prostate specific antigen (PSA) prior to study entry (and prior to any hormone treatment if given); must be \< or = 20 ng/ml.~* Patients must sign a study-specific consent form prior to registration (Standard of care: only the standard consent form must be signed).~* Patient must be \> or = 40 years old.~Exclusion Criteria:~* Stage T2c, T3 or T4 disease.~* Lymph node involvement (pathological N1)~* Evidence of distant metastases (M1)~* Gleason score 8-10.~* Prostate specific antigen (PSA) prior to study entry \> 20 ng/mL.~* AUA voiding symptoms score \> 15.~* Radical surgery for carcinoma of the prostate.~* Previous hormonal therapy beginning \> 6 months prior to registration~* Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease- free for \> or = 5 years.~* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up and/or completion of HRQoL questionnaires (not a condition for ineligibility in Standard of care).~* Prior TURP~* Hip prosthesis

- Gender: MALE
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Implant (Type: EXPERIMENTAL): Robotic implantation of brachytherapy seeds to treat prostate cancer

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: Blood-brain Barrier Permeability Study in Adults With Meningitis

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: NONE
- Phase: None
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* patients over 18 years old~* diagnosed with meningitis in the examination of cerebrospinal fluid~Exclusion Criteria:~* allergic to any of the contrast agents~* a lack of consent to the test~* liver failure and kidney failure

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

Study Arms:
- ICG washout kinetics assessment (Type: EXPERIMENTAL): Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject
- Pulse oximeter monitor (Type: OTHER): Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation
- Gadolinium washout kinetics assessment (Type: EXPERIMENTAL): 20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject

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: Skills Training Within a Family-based Obesity Treatment Intervention

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:~* caregiver of child is ≥18 years of age;~* the caregiver has a child between the ages of 4 and 8 years-old who is classified as overweight (body mass index for age ≥ 85th percentile);~* the caregiver and child are able to read, speak and understand English due to delivery of the program in English;~* has transportation to the University of Delaware; and~* is willing and able to commit to the 3-month study.~Exclusion Criteria:~* the child has a medical condition impacting physical activity or eating (e.g. Type~  1 or Type 2 diabetes);~* the child have a medical condition that affects growth (e.g. Prader Willi Syndrome);~* the child is currently participating in a weight management program, and/or taking weight loss medication; or~* the caregiver or child has an inability to participate in regular physical activity.

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 8 Years
- Healthy Volunteers: t

Study Arms:
- Child Health Education (Type: ACTIVE_COMPARATOR): The child health education condition will participate in a family-based obesity treatment program for the first 40 minutes of each session, followed by 20 minutes designated to education about a child health topic. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time.
- Skills Training (Type: EXPERIMENTAL): The skills training condition will participate in a family-based obesity treatment program for the first 40 minutes of each session followed by 20 minutes of experiential learning about meal stimulus control strategies. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time. In addition they will self-monitor the use the following stimulus control strategies: portion control, energy density and variety.

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 the Impact of a Pain Diary in Pediatric Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.~Exclusion Criteria:~* Admitted to the Pediatric Intensive Care Unit~* Surgical patients, defined as patients having surgery since admission other than minor procedures~* Patients anticipated to receive pain medication for less than 24 hours~* Patients unable to verbally communicate their pain

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 19 Years
- Healthy Volunteers: f

Study Arms:
- Pediatric Pain Diary (Type: None): Patients will be give a pain diary to complete.

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 to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. who completed the full study period in the main ADORE study (FAB122-CT-2001);~2. whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view;~3. a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria:~   * female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating.~  * female subject who is not of reproductive potential is eligible without requiring the use of contraception~4. a male patient must:~   * agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential~Exclusion Criteria:~1. Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view.~2. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.~3. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study

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

Study Arms:
- Open Label (Type: EXPERIMENTAL): Drug: FAB122 Daily dose 100 mg

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: NEOBREADS: Neoadjuvant Breast Diet Study

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:~* Histologically confirmed breast cancer; clinical T2-T4c, any N, M0 invasive breast cancer by AJCC 7th edition clinical staging, with goal being surgery to complete excision of tumor in the breast and lymph node. Primary tumor must be palpable, largest diameter \>2.0 cm by physical examination or by radiological assessment.~* ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells~* HER2 Negative; HER2 negative is defined by the following criteria:~  1. 0 or 1+ by IHC and ISH not done~ 2. 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) \< 2~ 3. 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) \< 2~* Ability to read, write, and understand English~* BMI \>24 kg/m2~* ECOG performance status 0-2~* Planning to receive neoadjuvant aromatase inhibitor therapy~* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.~* Age \> 18 years~Exclusion Criteria:~* Already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet~* Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study~* Candidate for chemotherapy or HER2 directed therapy~* Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy, or investigational agent prior to study entry (initiation of AI within 30 days of diet initiation acceptable)~* Loss of \>10% of body weight within the previous 6 months~* Clinical or radiographic evidence of metastatic disease.~* Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program

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

Study Arms:
- Dietary intervention (Type: EXPERIMENTAL): Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors

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

Answer: outcome: terminate
termination_type: enrollment issues