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

Trial Title: A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

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:~* Currently participating in study VX17-659-105 (NCT03447262)~Exclusion Criteria:~* History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator~* Current participation in an investigational drug trial (other than study VX17-659-105)~Other protocol defined Inclusion/Exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- ELX/TEZ/IVA (Type: EXPERIMENTAL): Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.~Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 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: Emotion Regulation and Emotion Perception

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: None
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. ages 18-55;~2. have a smartphone and agree to receive text-messages;~3. have difficulty with their relationships or social interactions;~4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz \& Roemer, 2004) with scores over 90.~Exclusion Criteria:~1. Current mania;~2. Meets full criteria for any current psychotic disorder;~3. Currently/chronically homeless;~4. Current suicidal ideation;~5. Psychiatric hospitalization within past 6 months;~6. Unable to read, blind or deaf. Our previous study recruited only participants who were currently in treatment, but this study will include both participants who are currently in treatment, as well as those who are not in treatment.~7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung \& Baron-Cohen, 2012).

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

Study Arms:
- Mindful Breathing (Type: EXPERIMENTAL): Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.
- Habituation (Type: ACTIVE_COMPARATOR): Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.
- Control (Type: PLACEBO_COMPARATOR): Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.

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: First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement

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

Eligibility Criteria:
Key Inclusion Criteria:~* Male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening~* Patients diagnosed with primary osteoarthritis of the knee assessed locally for whom a total knee replacement is planned~* General health status acceptable for total knee replacement surgery in the opinion of the investigator~* Stable medications within 3 months prior to enrollment (such as appropriate pain medication, antibiotics prophylaxis) and standard of care~Key Exclusion Criteria:~* Presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder~* Prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (ACI) or else, at the same knee~* Any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 2 months prior to enrollment~* BMI \> 40; presence of uncontrolled diabetes or hyperthyroidism~* Large effusion in the knee to be replaced, more than (\>)1 cm fluid in the suprapatellar space at the midline~* Corticosteroid use by any route except topical and nasal in the 3 months prior to enrollment~* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases~* Pregnant or nursing (lactating) women~* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant

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

Study Arms:
- LNA043 (Type: EXPERIMENTAL): LNA043 given intra-articularly
- Placebo (Type: PLACEBO_COMPARATOR): Placebo given intra-articularly

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 Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

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:
Key Inclusion Criteria:~* Willing and able to provide written informed consent~* HCV RNA ≥ 10\^4 IU/mL at screening~* Chronic HCV infection (≥ 6 months)~* Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV~* Use of protocol specified methods of contraception~Key Exclusion Criteria:~* Current or prior history of clinically significant illness that may interfere with participation in the study~* Screening ECG with clinically significant abnormalities~* Laboratory results outside of acceptable ranges at screening~* Pregnant or nursing female~* Chronic liver disease not caused by HCV~* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)~Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Arms:
- SOF/VEL/VOX (Type: EXPERIMENTAL): SOF/VEL/VOX for 12 weeks
- SOF/VEL (Type: EXPERIMENTAL): SOF/VEL for 12 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: The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine

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

Eligibility Criteria:
Inclusion Criteria:~* adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season~Exclusion Criteria:~* a sensitivity to pneumococcal and influenza vaccine~* received other inactivated vaccine within 14 days~* received other live vaccine within 28 days~* the presence of conditions known to impair pneumococcal vaccine response~* having malignant disease~* taking oral corticosteroids or immunosuppressive agent~* history of splenectomy~* history of an acute febrile illness or signs of severe acute illness at the time of vaccination~* other inappropriate condition to receive vaccination~* suffering an acute illness requiring antibiotics or steroids within the past month~* not expected to survive 12 months were also excluded

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Simultaneous administration group (Type: ACTIVE_COMPARATOR): The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
- Sequential administration group (Type: ACTIVE_COMPARATOR): The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.

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 Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

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

Eligibility Criteria:
Inclusion Criteria:~* Adult participants who had inadequate response to \>= 2 non-steroidal anti-inflammatories (NSAIDs)~* Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria~* Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative~* Ability to administer subcutaneous injections~* General good health~Exclusion Criteria:~* Prior anti-tumor necrosis factor (TNF) therapy~* Psoriasis or Psoriatic Arthritis~* Fulfillment of modified New York criteria for Ankylosing Spondylitis~* Recent infection requiring treatment~* Significant medical events or conditions that had put patients at risk for participation~* Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study~* History of cancer, except successfully treated skin cancer~* Recent history of drug or alcohol abuse

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

Study Arms:
- Double-blind (DB) Adalimumab (Type: EXPERIMENTAL): Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
- Double-blind Placebo (Type: PLACEBO_COMPARATOR): Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
- Double-blind Adalimumab / Open-label Adalimumab (Type: EXPERIMENTAL): Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
- Double-blind Placebo / Open-label Adalimumab (Type: PLACEBO_COMPARATOR): Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.

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 to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

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:~* Provision of signed informed consent prior to any study specific procedures~* Male or female, aged ≥18 years~* Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months~* LVEF≤40%~* Elevated NT-proBNP levels~* Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines~* eGFR ≥30 mL/min/1.73 m\^2 (CKD-EPI formula) at enrolment (visit 1)~Exclusion Criteria:~* Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor~* Type 1 diabetes mellitus~* Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2~* Current acute decompensated HF or hospitalization due to decompensated HF \<4 weeks prior to enrolment~* MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment~* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization~* Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device~* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization~* HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease~* Symptomatic bradycardia or second or third degree heart block without a pacemaker~* Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 130 Years
- Healthy Volunteers: f

Study Arms:
- Dapagliflozin (Type: EXPERIMENTAL): Patients will be randomized 1:1 to either dapagliflozin or placebo.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo matching dapagliflozin.

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 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Age \>=18 years, either sex, any race.~* Eastern Cooperative Oncology Group performance status of 0, 1, or 2.~* There must be no known standard therapy, or disease must be refractory to standard therapy~* Adequate hematologic, renal, and hepatic organ function and laboratory parameters~* For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:~  * Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.~ * Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH 727965.~* Subjects with multiple myeloma must have measurable disease defined as:~  * Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.~ * Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:~    * serum free light chain ratio greater than 5 times the normal ratio limit; and/or~   * measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or~   * bone marrow involvement greater than 30%.~* For B-cell chronic lymphocytic leukemia (B-CLL):~  * Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.~ * Disease must be evaluable according to NCI-WG response criteria.~Exclusion Criteria:~* Symptomatic brain metastases or primary central nervous system malignancy.~* Previous radiation therapy to \>25% of the total bone marrow.~* Previous treatment with SCH 727965.~* Known HIV infection.

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

Study Arms:
- Advanced solid tumors (Type: EXPERIMENTAL): Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts
- Non-Hodgkin's lymphoma and multiple myeloma (Type: EXPERIMENTAL): Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965
- B cell chronic lymphocytic leukemia (Type: EXPERIMENTAL): Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts

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: CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

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:~* Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document~* Patient-reported history of dry eye in both eyes~* Current use of over-the-counter and/or prescription eye drops for dry eye symptoms~* Ability and willingness to follow instructions, including participation in all study assessments and visits~Exclusion Criteria:~* Women who are pregnant, nursing or planning a pregnancy~* Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control~* Clinically significant slit-lamp findings or abnormal lid anatomy at screening~* DED secondary to scarring or ocular or periocular malignancy~* History of herpetic keratitis~* Active ocular allergies or ocular allergies that are expected to be active during the study period~* Ongoing ocular or systemic infection at screening or baseline~* Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study~* History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening~* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period~* Presence of an uncontrolled systemic disease~* Presence of a known allergy and/or sensitivity to the study drug or its components

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- CyclASol Ophthalmic Solution 1 (Type: EXPERIMENTAL): Cyclosporine A solution (dose-level 1) in vehicle
- CyclASol Ophthalmic Solution 2 (Type: EXPERIMENTAL): Cyclosporine A solution (dose-level 2) in vehicle
- Placebo Ophthalmic Solution (Type: PLACEBO_COMPARATOR): Vehicle only
- Restasis (Type: ACTIVE_COMPARATOR): Cyclosporine A 0.05% ophthalmic emulsion

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 Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.

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:~* Patients must undergo primary unilateral first metatarsal bunionectomy~* pain intensity must be moderate to severe following stoppage of a continuous popliteal sciatic block (a nerve block with local anesthetic that numbs the foot)~* female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.~Exclusion Criteria:~* Patients will be excluded from the study if they have a history of seizure disorder or epilepsy~* history of malignancy within the past 2 years before starting the study~* history of alcohol or drug abuse~* evidence of active infections that may spread to other areas of the body~* clinical laboratory values reflecting moderate or severe renal insufficiency~* currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).

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

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

Answer: outcome: complete