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

Trial Title: Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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:
Select Inclusion Criteria:~1. Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration~2. Age 40 to 80 at randomization~3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening~4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening~Select Exclusion Criteria:~1. Forced expiratory volume in one second (FEV1)/FVC ratio \<0.8 after administration of bronchodilator at Screening~2. Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization~3. Known explanation for interstitial lung disease~4. History of asthma or chronic obstructive pulmonary disease~5. Active infection~6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents~7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Active Arm (Type: ACTIVE_COMPARATOR): None
- Placebo Arm (Type: PLACEBO_COMPARATOR): None

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: Canadian Biomarker Integration Network for Depression Study

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
For Depressed patients:~Inclusion Criteria:~* Outpatients who are 18-60 years of age~* Meet DSM-IV-TR criteria for Major Depressive Episode in Major Depressive Disorder by the MINI~* Episode duration ≥ 3 months~* Free of psychotropic medications for at least 5 half-lives (i.e. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1~* MADRS ≥ 24~* Fluency in English, sufficient to complete the interviews and self-report questionnaires~Exclusion Criteria:~* Any Axis I diagnosis other than MDD that is considered the primary diagnosis~* Bipolar I or Bipolar II diagnosis~* Presence of a significant Axis II diagnosis (borderline, antisocial)~* High suicidal risk, defined by clinician judgment~* Substance dependence/abuse in the past 6 months~* Presence of significant neurological disorders, head trauma or other unstable medical conditions~* Pregnant or breastfeeding~* Failure of 3 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form)~* Started psychological treatment within the past 3 months with the intent of continuing treatment~* Patients who have previously failed escitalopram or showed intolerance to escitalopram and patients at risk for hypomanic switch (i.e. with a history of antidepressant hypomania)~Inclusion criteria for Healthy Controls:~* 18 to 60 years of age~* No history of Axis I or Axis II disorders, as determined by the MINI.~* Fluency in English, sufficient to complete the interviews and self-report questionnaires.

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

Study Arms:
- escitalopram (10-20mg) (Type: ACTIVE_COMPARATOR): Patients are on escitalopram for 8 weeks. At Week 8, patients will be assessed as 'responders' or 'non-responders'. 'Responders' will continue on escitalopram until study endpoint.
- aripiprazole (2-10mg) (Type: ACTIVE_COMPARATOR): At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.

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 TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Histologically confirmed diagnosis of MDS~* Documented significant cytopenia for at least 2 months~* Adequate liver and kidney function~* Ineligible for stem cell bone marrow transplantation~* At least 18 years of age~* Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry~Exclusion Criteria:~* Prior bone marrow transplant~* Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry~* Pregnant or lactating women~* Other investigational drugs within 14 days of study entry~* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day

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: Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

Study Design Characteristics:
- Allocation: NON_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:~* Subject/legal representative is considered reliable and capable of adhering to the protocol~* Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase~* Subject is expected to benefit from participation in SP0994 in the opinion of the investigator~Exclusion Criteria:~* Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR~* Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study~* Subject is taking benzodiazepines for a non-epilepsy indication~* Subject meets a withdrawal criterion from the previous study SP0993~* Subject is experiencing an ongoing SAE from the previous study SP0993~* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the Since Last Visit version

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

Study Arms:
- Lacosamide (Type: EXPERIMENTAL): 50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
- Carbamazepine-Controlled Release (CBZ-CR) (Type: ACTIVE_COMPARATOR): 200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)

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 Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria~* Subject must be 18 or older and in good health~* Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis~* Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed~* Subject must fulfill at least one of the following three criteria:~  * Rheumatoid factor positive~ * Greater than 1 joint erosion~ * Anti-cyclic citrullinated peptide (CCP) antibody positive.~Exclusion Criteria~* Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy~* Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline~* Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.

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

Study Arms:
- ADA+MTX/PBO+MTX (Arm 1) (Type: EXPERIMENTAL): Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
- ADA+MTX/ADA+MTX (Arm2) (Type: EXPERIMENTAL): Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
- ADA+MTX/OL ADA+MTX (Arm 3) (Type: EXPERIMENTAL): Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA + MTX during Period 2
- PBO+MTX/PBO+MTX (Arm 4) (Type: EXPERIMENTAL): Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
- PBO+MTX/OL ADA+MTX (Arm 5) (Type: EXPERIMENTAL): Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2.

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: Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Hospitalization for MI or high risk unstable angina within the last 10 days.~* Total cholesterol 240 mg/dl or greater.~* Stabilized post ACS~Exclusion Criteria:~* Co-morbidity with life expectations no more than 2 years.~* Current lipid lowering therapy~* Corrected QT interval~* Need for Class IA or III antiarrhythmic agent

- 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: complete
Please assess the completion status of the following clinical trial:

Trial Title: Pain and Suction Curettage

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: None
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.~Exclusion Criteria:~incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets... etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.

- Gender: FEMALE
- Minimum Age: 16 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- paracetamol (Type: ACTIVE_COMPARATOR): Duration
- without drug (Type: ACTIVE_COMPARATOR): Control group
- dexketoprofen trometamol (Type: ACTIVE_COMPARATOR): Study group
- two puff xylocain administration on cervical surface (Type: ACTIVE_COMPARATOR): Study group
- paracervical block with ultracaine (Type: ACTIVE_COMPARATOR): study group

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 Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)~* Signed informed consent or assent form~* Body weight between 33 kg and 136 kg, inclusive~* Negative urine pregnancy test for females of childbearing potential~* Agrees to use effective method of contraception throughout study, if applicable.~* Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)~Exclusion Criteria:~* Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.~* Discontinued participation in a Phase 3 study with sarecycline for any reason~* Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline~* Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)~* Is pregnant, lactating or planning a pregnancy during the study period~* Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study~* Is judged by the Investigator to be unsuitable for any reason

- Gender: ALL
- Minimum Age: 9 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo/Sarecycline (Type: EXPERIMENTAL): Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
- Sarecycline/Sarecycline (Type: EXPERIMENTAL): Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 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: Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1~Exclusion Criteria:~* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1~* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.~* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)~* Have a known hypersensitivity to any of the procedural agents or study drug components~* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

- Gender: ALL
- Minimum Age: 22 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- OC-01 Low Dose, 0.12 mg/mL (Type: ACTIVE_COMPARATOR): OC-01 (varenicline) nasal spray, Low Dose, 0.12 mg/mL
- OC-01 Mid Dose, 0.6 mg/mL (Type: ACTIVE_COMPARATOR): OC-01 (varenicline) nasal spray Mid dose, 0.6 mg/mL
- OC-01 High Dose, 1.2 mg/mL (Type: ACTIVE_COMPARATOR): OC-01 (varenicline) nasal spray High dose, 1.2 mg/mL
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (vehicle) nasal spray

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: RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

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. ≥ 18 years old.~2. Patients with metastatic papillary renal cell carcinoma, type I or II.~3. Patients with at least one measurable lesion.~4. Patients with an ECOG Performance Status ≤1.~5. Adequate bone marrow function.~6. Adequate liver function.~7. Adequate renal function.~8. Adequate lipid profile.~Exclusion criteria:~1. Patients who had radiation therapy within 28 days prior to start of study.~2. Patients who have received prior systemic treatment for their metastatic RCC.~3. Patients who received prior therapy with VEGF pathway inhibitor.~4. Patients who have previously received systemic mTOR inhibitors.~5. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.~6. Patients with uncontrolled central nervous system (CNS) metastases.~7. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.~8. Patients with a known history of HIV seropositivity.~9. Patients with autoimmune hepatitis.~10. Patients with an active, bleeding diathesis.~11. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.~12. Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.~13. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.~14. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.~15. Patients unwilling to or unable to comply with the protocol.

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

Study Arms:
- RAD001 (Type: EXPERIMENTAL): two 5 mg tablets of everolimus orally, once daily

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: Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

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

Eligibility Criteria:
Inclusion Criteria:~* Male and female participants 18 years and older.~* Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations.~* Severe renal impairment (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m\^2) based on medical history and previous laboratory examinations, at least once, within the last 3 months prior to the Baseline Visit, or participants with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days prior to the Baseline Visit.~Exclusion Criteria:~* Participants with simple liver cysts only.~* Any investigational drug or device within 6 weeks prior to the Baseline Visit.~* Any magnetic resonance imaging (MRI) contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.~* Participants with severe hepatic impairment (according to Child-Pugh score C).~* Participants scheduled for surgery before last study visit.~* Participants with encephalopathy / neurodegenerative or acute neurological disorders.~* Participants with hemochromatosis.

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

Study Arms:
- Mangoral (Type: EXPERIMENTAL): All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate \[MnCl2 4H2O\]).

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

Answer: outcome: complete