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

Trial Title: Veterans Individual Placement and Support Towards Advancing Recovery

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:~* Veteran~* Age greater than or equal to 18\* (\*18 or 19 depending on state legal definition of a minor) to age 65~* Eligible for VA TWP services~* Diagnosis of PTSD, as confirmed by Clinician Administered PTSD Scale (CAPS)~* Currently unemployed (and not participating in TWP - Impact Statement #3 10/4/13)~* Expression of interest in competitive employment (part-time or full-time - Impact Statement #3 10/4/13)~* Willing and able to give informed consent~Exclusion Criteria:~* Lifetime diagnosis if (i) schizophrenia, (ii) schizoaffective or (iii) bipolar I disorder~* Diagnosis of dementia or severe cognitive disorder (evidenced in the medical record)~* Unlikely that participant can complete the study; reasons may include: expected deployment, expected incarceration, expected long-term hospitalization, or expected relocation from the vicinity of the participating medical center (PMC) during the study period~* Active suicidal or homicidal ideation~* Current participation in another interventional trial

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

Study Arms:
- Individual Placement and Support (IPS) (Type: EXPERIMENTAL): The IPS intervention must achieve a rating of \>66 of a possible 75 points on the Supported Employment Fidelity Scale. The fidelity ratings are conducted by the National IPS Fidelity Monitor at biannual on-site monitoring visits.
- VA Transitional Work Program (TWP) (Type: ACTIVE_COMPARATOR): TWP will adhere to a lower rating (less than or equal to 55 of a possible 75 points) on the Supported Employment Fidelity Scale rated by the National Fidelity Monitor. The TWP specialist participates in face-to-face supervision with the local Compensated Work Therapy (CWT) team according to the CWT manager's schedule.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* healthy male and female subjects between 18 and 40 years of age (inclusive).~* female subjects of child bearing potential with negative pregnancy test at screening and willing to use 2 effective methods of contraception (i.e. established method of contraception plus condom, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.~* male subjects willing to use 2 effective methods of contraception unless anatomically sterile, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject, from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.~* subjects with a Body Mass Index (BMI) of \<30 kg/m2.~* subjects with a negative urinary drugs of abuse screen determined within 28 days of the first dose.~* subjects with negative HIV and Hepatitis B and C results.~* subjects must be willing and able to comply with the requirements of the protocol and must be available to complete the trial, including all follow up visits.~* subject must provide written informed consent to participate in the trial.~Exclusion Criteria:~* any relevant abnormality in medical history examination, vital signs laboratory tests or ECG.~* any reason that would make the assessment of any injection site reaction difficult (e.g. tattoos at injections site, black skin).~* history of migraine or asthma (no inhaler use for 5 years).~* proven diagnosis of pneumonia within last 5 years.~* current smokers.~* history of anaphylaxis or hypersensitivity to previous vaccinations.~* known impairment of the immune system or chronic diseases, e.g. autoimmune diseases, diabetes, cancer.~* anticipation that the subject may require any other vaccination during the trial period.~* subjects who are antinuclear antibody (ANA) positive (above a titre of 1:80).~* subjects with haemoglobin level \< 8.4 mmol/ L (males) and \<7.8 mmol/L (females).~* palpable cervical or axillary lymph nodes.~* receipt of regular prescribed medication within 28 days of the first trial day and / or receipt of vitamins, minerals, herbal remedies and nutritional supplements within 7 days of the first trial day.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): 50 µg of PnuBioVax
- Cohort 2 (Type: EXPERIMENTAL): 200 µg of PnuBioVax
- Cohort 3 (Type: EXPERIMENTAL): 500 µg of PnuBioVax
- Placebo (Type: PLACEBO_COMPARATOR): Placebo

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.~* Meet qualifying IOP entry criteria.~* Able to understand and sign an informed consent form.~* Other protocol-specified inclusion criteria may apply.~Exclusion Criteria:~* Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.~* Severe central visual field loss.~* Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.~* Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).~* Chronic, recurrent or severe inflammatory eye disease.~* Ocular trauma within the preceding 6 months.~* Ocular infection or inflammation within the preceding 3 months.~* Clinically significant or progressive retinal disease.~* Other ocular pathology.~* Intraocular surgery within the 6 months prior to entry.~* Ocular laser surgery within the 3 months prior to entry.~* Any abnormality preventing reliable applanation tonometry.~* Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.~* Recent use of high-dose (\>1 gram daily) salicylate therapy.~* Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.~* Other protocol-specified exclusion criteria may apply.

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

Study Arms:
- Brinz/Brim (Type: EXPERIMENTAL): Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
- Brinz+Brim (Type: ACTIVE_COMPARATOR): Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: High Resolution MRI Study for Prostate Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Age over 18 years~* Patients diagnosed with clinically localized prostate cancer~* Low or Low-intermediate Risk Prostate cancer1 defined as:~* Pre-operative prostate specific antigen (PSA) ≤ 20.0 ng/ml~* Clinical stage cT1 or cT2~* Gleason score 3+3 or 3+4~* Patients choosing AS or already on AS as primary management strategy~* No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy~* No contraindications for gadolinium enhanced MRI~Exclusion Criteria:~* No exclusion criteria

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

Study Arms:
- Paired imaging (Type: OTHER): Single arm, paired imaging of high resolution MRI (hrMRI) and stand MRI (sMRI)

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Phase 4 IOP Signals Associated With ILUVIEN®

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.~Exclusion Criteria:~* Patients who are unable to understand and sign the Informed Consent Form.

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

Study Arms:
- ILUVIEN 0.19 MG (Type: EXPERIMENTAL): All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

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

Eligibility Criteria:
Inclusion Criteria:~* Medical diagnosis of COPD~* Current or prior history of cigarette smoking~Exclusion Criteria:~* Medical diagnosis of asthma~* Significant condition or disease other than COPD

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

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients

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:~* Male or Female~* Self-identifies as being Hispanic or Latino~* 50 to 75 years of age~Exclusion Criteria:~* Previous diagnosis of CRC~* Up to date with CRC screening guidelines.~* Personal history of inflammatory bowel disease~* Personal history of polyps~* Family history of CRC diagnosed before the age of 60 years

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 75 Years
- Healthy Volunteers: t

Study Arms:
- Standard (Type: ACTIVE_COMPARATOR): SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
- Decision Support & Navigation (Type: EXPERIMENTAL): DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

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

Eligibility Criteria:
Inclusion Criteria:~* Major depression (according to DSM-IV criteria)~* MADRS scores superior to 21~* Subjects meeting the International Headache Society criteria for chronic primary headache (IHSC-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ICHS, 2003)~Exclusion Criteria:~* Over 50% reduction on MADRS scores during wash-out period~* Illicit drug or alcohol dependence~* History of multiple allergies or hypersensitivity to duloxetine~* History of epilepsy or significant neurological disorder~* Significant suicide risk~* Pregnancy or lactation~* Sexually active female subjects not using an efficient contraceptive method~* Significant laboratory abnormalities at baseline~* Significant clinical disease~* Subjects meeting DSM-IV criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Subject is willing and able to comply with all trial requirements~* Subject is male or female and over 13 years of age~* Subject has a diagnosis of either TSC or NF1 and has visible fibromatous lesions (angiofibromas or neurofibromas)~* Female subjects of child-bearing potential must not be pregnant and must agree to use appropriate contraceptive methods for the duration of the trial~Exclusion Criteria:~* Subject is currently receiving therapy with rapamycin or sirolimus~* Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction~* Subject is currently participating in or has participated within the last 30 days in any clinical trial involving an investigational drug~* Subject has a known hypersensitivity to either the PVDF coating (Skincerity®) or rapamycin~* Subject is a pregnant or nursing female

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- TSC Placebo Arm (Type: PLACEBO_COMPARATOR): TSC subjects will apply a study product containing polyvinylidene fluoride coating alone to facial angiofibromas
- TSC 1% Arm (Type: EXPERIMENTAL): TSC subjects will apply a study product containing polyvinylidene fluoride coating plus 1 mg of sirolimus/rapamycin to facial angiofibromas
- TSC 5% Arm (Type: EXPERIMENTAL): TSC subjects will apply a study product containing polyvinylidene fluoride coating plus 5 mg of sirolimus/rapamycin to facial angiofibromas
- NF1 Placebo Arm (Type: PLACEBO_COMPARATOR): NF1 subjects will apply a study product containing polyvinylidene fluoride coating alone to cutaneous neurofibromas
- NF1 1% Arm (Type: EXPERIMENTAL): NF1 subjects will apply a study product containing polyvinylidene fluoride coating plus 1 mg of sirolimus/rapamycin to cutaneous neurofibromas
- NF1 5% Arm (Type: EXPERIMENTAL): NF1 subjects will apply a study product containing polyvinylidene fluoride coating plus 5 mg of sirolimus/rapamycin to cutaneous neurofibromas

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

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

Eligibility Criteria:
Inclusion Criteria:~* histologically proven breast cancer~* eligible for six cycles of neoadjuvant or adjuvant chemotherapy~Exclusion Criteria:~* concurrent or prior chemotherapy for breast cancer~* concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy~* concurrent prophylactic antibiotics~* previous therapy with any G-CSF (granulocyte-colony stimulating factor) product~Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- Neulasta® (Type: ACTIVE_COMPARATOR): During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
- LA-EP2006 (Type: EXPERIMENTAL): During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Has stable schizophrenia or schizoaffective disorder~* Has demonstrated ability to tolerate aripiprazole~* Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening~* Has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive~* Additional criteria may apply~Exclusion Criteria:~* Is pregnant, breastfeeding, or is planning to become pregnant during the study period~* Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months~* Is a danger to himself/herself at screening or upon admission~* Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C~* Has a positive urine drug screen at screening or Day 1~* Additional criteria may apply

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

Study Arms:
- Aripiprazole Lauroxil - A (Type: EXPERIMENTAL): Intramuscular (IM) injection Dose and Dosing Sequence A
- Aripiprazole Lauroxil - B (Type: EXPERIMENTAL): Intramuscular (IM) injection Dose and Dosing Sequence B
- Aripiprazole Lauroxil - C (Type: EXPERIMENTAL): Intramuscular (IM) injection Dose and Dosing Sequence C
- Aripiprazole Lauroxil - D (Type: EXPERIMENTAL): Intramuscular (IM) injection Dose and Dosing Sequence D

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)

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:~* Male and female subjects 29 days to \< 6 years old. If the subject is born prematurely, calculation of the lower age limit begins at the corrected gestational age of 40 weeks.~* Signed informed consent by the subject's legally acceptable representative~* Suspected or confirmed UCD diagnosis of any subtype, except NAGS deficiency~* On stable dose of NaPBA powder for at least 5 days before Day 1~* Not receiving sodium benzoate for at least 5 days before Day 1~* No concomitant illness which would preclude safe participation as judged by the investigator~* Able to receive medication orally~* Has not undergone liver transplantation, including hepatocellular transplantation~* Judged sufficiently stable and compliant with diet and treatment to be suitable for enrollment~Exclusion Criteria:~* Screening ammonia level \> 100 μmol/L and signs and symptoms indicative of hyperammonemia; subjects may be rescreened after their ammonia is controlled and they are clinically stable, at the discretion of the investigator~* Use of any investigational drug within 30 days of Day 1~* Active infection (viral or bacterial) or any other condition that may increase ammonia levels~* Any clinical or laboratory abnormality of Grade 3 or greater severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, except Grade 3 elevations in ammonia and liver enzymes, defined as levels 5-20 times ULN (upper limit of normal)in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyl transpeptidase (GGT) in a clinically stable subject~* Any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may put the subject at increased risk by participating in this study~* Known hypersensitivity to PAA or PBA~* Liver transplant, including hepatocellular transplant~* Currently treated with Carbaglu® (carglumic acid)

- Gender: ALL
- Minimum Age: 29 Days
- Maximum Age: 6 Years
- Healthy Volunteers: f

Study Arms:
- HPN-100 (Type: EXPERIMENTAL): Switch over from sodium phenylbutyrate to open label HPN-100 oral liquid over 10 days then open label, long term treatment for 12 months

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

Answer: outcome: complete