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

Trial Title: IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics

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:~1. Subject is between the ages of 18 and 65.~2. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.~3. Subject is willing and able to provide informed consent.~4. Subject is considered capable of complying with study procedures.~5. Subject has no medical history of liver or kidney disease.~6. Subject has no evidence of NYHA Class II-IV cardiac disease.~7. Subject has recent (\< 3 months) clinical hematology (CBC) values within the acceptable values reference range.~8. Subject has recent (\< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.~Exclusion Criteria:~1. Subject is pregnant or nursing.~2. Subject has a history of alcoholism.~3. Subject has a history of drug abuse.~4. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.~5. Subject has known human immunodeficiency virus (HIV) infection.~6. Subject has been diagnosed with or treated for cancer in the last 2 years.~7. Subject has a total body weight \< 32 kg.~8. Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.~9. Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.~10. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.

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

Study Arms:
- IV IS-001 drug (Type: EXPERIMENTAL): IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System

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: Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

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

Eligibility Criteria:
Inclusion Criteria:~* Must be healthy based on by medical history, laboratory work, and physical exam~* Be at least 18 years of age to 65 years of age~* If childbearing potential, use of acceptable form of birth control~* In the case of females of childbearing potential, have a negative serum pregnancy test~Exclusion Criteria:~* Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication~* Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation~* Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization

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

Study Arms:
- Lidocaine Patch (Sequence AB) (Type: EXPERIMENTAL): Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.
- Lidocaine Patch (Sequence BA) (Type: EXPERIMENTAL): Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.

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: Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

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: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.~* Subjects must have active RA disease as defined by:~  * At least 9 tender joints and 9 swollen joints~ * ESR of 30 mm/hour or CRP of 1.5 mg/dL~* Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.~Exclusion Criteria:~* Patients who have a diagnosis of any other inflammatory arthritis~* Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)~* Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)~* Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure~* Patients who currently have, or who have a history of, tuberculosis~* Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)~* Patients who currently have, or who have a history of, malignancy~* Female patients who are breastfeeding or pregnant, who are of childbearing potential~* Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- CDP870 100mg (Type: EXPERIMENTAL): 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
- CDP870 200mg (Type: EXPERIMENTAL): 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
- CDP870 400mg (Type: EXPERIMENTAL): 400mg CDP870 given every 2 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo given every 2 weeks

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: Rifampin Versus Isoniazid for the Treatment of Latent Tuberculosis Infection in Children (P4v9)

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:~* Children (age \<18) with documented positive TST (or in the absence of TST, a positive QFT or T-Spot) and prescribed 9INH for LTBI for the following indications:~  1. HIV positive (TST \>5 mm or QFT+)~ 2. Age 5 or less (TST \>5 mm or QFT+)~ 3. Other reason for immuno-compromised state - such as therapy for malignancy or post-transplant (TST \>5 mm or QFT+)~ 4. Contact: with adult or adolescent with active contagious pulmonary TB. (TST \>5 mm or QFT +)~ 5. Have both of the following factors if TST = 10-14mm or QFT + or one factor if TST \>15mm :~     1. Arrival in Canada, Australia, or Saudi Arabia in the past 2 years from countries with estimated annual incidence of active TB greater than 100 per 100,000~    2. Body mass index (BMI) less than 10th percentile for their age~Exclusion Criteria:~* Patients who were contacts of TB cases known to be resistant to Isoniazid, Rifampin, or both.~* Known HIV-infected individuals on anti-retroviral agents whose efficacy would be substantially reduced by Rifampin, unless therapy can safely be changed to agents not affected by Rifampin.~* Pregnant women - Rifampin and Isoniazid are considered safe in pregnancy but therapy is usually deferred until 2-3 months post-partum to avoid fetal risk and the potential for increased hepato-toxicity immediately post partum.~* Patients on any medication with clinically important drug interactions with Isoniazid or Rifampin, which their physician believes would make either arm contra-indicated.~* Patients with a history of allergy/hypersensitivity to Isoniazid or to Rifampin, Rifabutin, or Rifapentine.~* Patients with active TB. Patients initially suspected to have active TB can be randomized once this has been excluded.~* Prior complete LTBI therapy or if children have taken \>1 week and are still taking the treatment. Children will be eligible if they took an incomplete LTBI therapy (less than 80% of recommended total dose) but \> 6 months ago.

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

Study Arms:
- Isoniazid (Type: ACTIVE_COMPARATOR): The standard therapy will be daily self-administered INH, 10-15 mg/kg/day (max=300mg/day) for 9 months (9INH).
- Rifampin (Type: ACTIVE_COMPARATOR): The experimental arm will be daily self-administered RIF 10-20 mg/kg/day for 4 months (4RIF).

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: Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 7.0

Eligibility Criteria:
Inclusion Criteria:~* Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms~* Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time~Exclusion Criteria:~* Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate

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

Study Arms:
- Period I: 1 (Type: EXPERIMENTAL): etoricoxib
- Period I: 2 (Type: EXPERIMENTAL): etoricoxib
- Period I: 3 (Type: EXPERIMENTAL): etoricoxib
- Period I: 4 (Type: EXPERIMENTAL): etoricoxib
- Period I: 5 (Type: PLACEBO_COMPARATOR): Placebo
- Period II: 1 (Type: EXPERIMENTAL): etoricoxib
- Period II: 2 (Type: ACTIVE_COMPARATOR): diclofenac

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 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

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:~* Patients with HL who have received ASCT in the previous 30-45 days~* Patients at high risk of residual HL post ASCT~* Histologically-confirmed HL~* ECOG of 0 or 1~* Adequate organ function~Exclusion Criteria:~* Previous treatment with brentuximab vedotin~* Previously received an allogeneic transplant~* Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT~* History of another primary malignancy that has not been in remission for at least 3 years~* Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents

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

Study Arms:
- Brentuximab vedotin (Type: EXPERIMENTAL): brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
- Placebo (Type: PLACEBO_COMPARATOR): placebo every 3 weeks by IV infusion

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: Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis~Exclusion Criteria:~* Pregnant females~* Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk

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

Study Arms:
- 10 mg Methotrexate (MTX) (Type: EXPERIMENTAL): MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
- 15 mg MTX (Type: EXPERIMENTAL): MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
- 20 mg MTX (Type: EXPERIMENTAL): MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
- 25 mg MTX (Type: EXPERIMENTAL): MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

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 Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy~* Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy~Exclusion Criteria:~* Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)~* Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)~* Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures~* Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)~* Ascites~* Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)~* Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)~* Severely reduced renal function (Glomerular filtration rate (GFR) \<30 (mL/min/1.73 m2))~* The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:~  1. Transdermal patch~ 2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive)~ 3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)~ 4. Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy~ 5. Sexual abstinence~* The subject is a breast-feeding or lactating woman

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

Study Arms:
- PICOPREP day-before dosing schedule (Type: ACTIVE_COMPARATOR): Both doses administered the day before colonoscopy.
- PICOPREP tailored dosing schedule (Type: EXPERIMENTAL): First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.

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: Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-40~* Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria~Exclusion Criteria:~* Age \<18, \>40~* Women of child-bearing potential not on adequate contraception~* Serum creatinine of \>0.11~* A history of intolerance to ACEI~* Patients on angiotensin receptor blockers~* Blood pressure \>140/90mmHg~* History of previous aortic surgery

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 40 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: Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs

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:~* Written informed consent.~* Men or women, 18-65 years of age.~* MDD, current, according to DSM-IV criteria and as diagnosed by the SCID- I/P during the screen and baseline visit of phase 1.~* A HAM-D-17 score \> 14 during the screen and baseline visit of phase 1.~Exclusion Criteria:~* Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine~* Device, tubal ligation, or partner with vasectomy).~* Serious suicide or homicide risk, as assessed by evaluating clinician.~* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.~* History of multiple adverse drug reactions or allergy to the study drug.~* The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).~* Patients requiring excluded medications (see appendix 1 for details).~* Psychotic features in the current episode or a history of psychotic features.~* Prior course of ziprasidone, or intolerance to ziprasidone at any dose.~* Any investigational psychotropic drug within the last 3 months.~* Have failed more than 3 adequate antidepressant trials during the current MDE. Some examples of adequate dosage of an antidepressant trial include either \> 150 mg of imipramine (or its tricyclic equivalent), \> 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), \> 20 mg of fluoxetine (or its SSRI-equivalent), \> 150mg of bupropion, \> 300mg of trazodone (or nefazodone), \>75 mg of venlafaxine, \>60mg of duloxetine, or \> 15mg of mirtazapine. A trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2. If they are in remission following phase two, and decide to enter phase three, they will continue on Ziprasidone for 12 months.
- 2 (Type: PLACEBO_COMPARATOR): Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2. If they are in remission following phase two, and decide to enter phase three, they will continue on Placebo for 12 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: Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)

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

Eligibility Criteria:
Inclusion Criteria:~* is ≥20 years of age.~* has an established diagnosis of MM based on the myeloma diagnostic criteria~* has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen~* has adequate organ function~Exclusion Criteria:~* has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study~* has known hypersensitivity to any components of vorinostat or bortezomib~* has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive~* has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Vorinostat + Bortezomib (Type: EXPERIMENTAL): Participants undergo up to 3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg once daily \[QD\] on Days 1 through 14) + bortezomib (1.3 mg/m\^2 intravenous \[IV\] on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).

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

Answer: outcome: complete