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

Trial Title: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Signed informed consent prior to any study-mandated procedure;~* Male or female aged ≥ 18 years;~* Insomnia disorder according to DSM-5 criteria;~* Insomnia Severity Index score ≥ 15;~* Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;~* Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.~Exclusion Criteria:~* Body mass index below 18.5 or above 40.0 kg/m2;~* Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;~* Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;~* Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;~* Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;~* Mini Mental State Examination (MMSE) score \< 25 in subjects ≥ 50 years;~* For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;~* History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.~* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

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

Study Arms:
- Daridorexant 10 mg (Type: EXPERIMENTAL): None
- Daridorexant 25 mg (Type: EXPERIMENTAL): None
- Placebo (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: Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

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:~* Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma~* Subjects who have been positive for CCR4~* Subjects who received one or more chemotherapy regimens~* Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy~* Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment~* Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions~* Subjects who have a performance status of 0 to 2~* Subjects who are negative for HBs antigen and reported as not detected for HBV-DNA~* Subjects who are negative for anti-HCV antibody~* Subjects who have normal function of the major organs~* Subjects who have given written voluntary informed consent to participate in the study~Exclusion Criteria:~* Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)~* Subjects who are known carriers of HIV~* Subjects who have active multiple cancer~* Subjects who have a history of allergic reactions to therapeutic antibodies~* Subjects requiring continuous systemic treatment with steroid~* Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment or who may require such radiotherapy after the start of the study~* Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children

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

Study Arms:
- KW-0761 (Type: EXPERIMENTAL): 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: A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.~* Signed informed consent (assent) form.~* Documented positive allergic skin test to local pollen.~* An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for nasal congestion and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).~Exclusion Criteria:~* History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).~* Some other past and concomitant medical conditions, prohibited medications.~* Upper respiratory tract infection or any untreated infections.~* Patient has started immunotherapy/changed the dose.~* Any known allergy to any of the components of the study nasal spray.

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

Study Arms:
- Test (Type: EXPERIMENTAL): Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
- Reference (Type: ACTIVE_COMPARATOR): Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo nasal spray administered once daily for 14 days.

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 Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with type 2 diabetes~* If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days~* The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)~* The metformin dose has been stable for at least 90 days~* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.~* Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2.~Exclusion Criteria:~* Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs~* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.~* Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening~* Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.~* Are currently treated with any of the following excluded medications:~  * Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening~ * Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening~ * Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening~ * Pramlintide acetate injection within 3 months prior to screening~ * Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics~ * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

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

Study Arms:
- Exenatide twice daily (BID) (Type: EXPERIMENTAL): None
- Placebo (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: Montelukast in the Treatment of Duodenal Eosinophilia

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

Eligibility Criteria:
Inclusion Criteria:~A subject will be eligible for inclusion in this study if all of the following criteria are met:~* Patients with dyspepsia defined as upper abdominal pain or discomfort of at least two months duration.~* Male and female subjects 6 - 17 years of age~* Endoscopic mucosal biopsies revealing at least 20 eosinophils in a high power field on specimens from the duodenum in the absence of other defined duodenal pathology.~* Written informed consent signed by the subject's legal guardian and by the investigator and patient assent.~Exclusion Criteria:~Subjects will not be eligible for inclusion in this study if any of the following criteria apply:~* A subject who has previously been treated with montelukast.~* Treatment with steroids or oral cromolyn in the four weeks prior to endoscopy or during the study.~* Any history, clinical, and/or biochemical evidence of clinically significant renal or liver disease.~* Treatment with any inducers or inhibitors of CYP3A4.~* Intake of grapefruit juice or oral vitamin E supplementation

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 17 Years
- Healthy Volunteers: t

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 Study of Albiglutide in Type 2 Diabetes

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* type 2 diabetes~* BMI 20-45kg/m2 inclusive~Exclusion Criteria:~* females who are pregnant, lactating, or \<6 weeks post-partum~* CHF NYHA class III-IV

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

Study Arms:
- albiglutide (Type: EXPERIMENTAL): albiglutide weekly injection
- placebo (Type: PLACEBO_COMPARATOR): albiglutide matching placebo
- albiglutide up-titration (Type: EXPERIMENTAL): albiglutide weekly injection uptitration at week 12

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: Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

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:~Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study~Exclusion Criteria:~* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)~* Female patients of childbearing potential who are not using effective contraception~* Use of any psychoactive medication~* The patient, in the investigator's clinical judgment, has a significant risk of suicide.~Other protocol-defined inclusion and exclusion criteria applied.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Vortioxetine (Type: EXPERIMENTAL): 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: Afatinib Osimertinib Sequencing NIS

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)~* The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment~* Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line~* Patients treated with osimertinib within an EAP/CUP or regular clinical practice~* Age ≥ 18 years~* Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)~Exclusion Criteria:~* Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment~* Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)

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

Study Arms:
- patients with EGFR mutation-positive NSCLC (Type: None): (Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)

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 of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis

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:~* Patients must meet the American College of Rheumatology criteria for rheumatoid arthritis (RA) or osteoarthritis (OA) of the hip or knee and have moderate or severe pain that is not adequately controlled by other medications (paracetamol (acetaminophen), NSAIDs, COX-2 inhibitors, weak opioids)~* OA patients must be in need of and waiting for hip or knee replacement~* RA patients using disease modifying antirheumatic drugs (DMARDs) must have been on stable dose of medication for \>=3 months.~Exclusion Criteria:~* Patients who have received regular treatment with strong opioids during the month prior to study~* another continuous pain that stands out compared to RA or OA pain~* skin disease or known allergy or hypersensitivity to fentanyl or to the adhesives~* history of liver disease~* new physical therapy or change in that therapy within one month of study~* pregnant or nursing females, or those without adequate contraception.

- 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: Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

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

Eligibility Criteria:
Inclusion Criteria:~* Provision of informed consent prior to any study specific procedures~* Male and female patients, aged 18 to 65 years, inclusive.~* Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).~* Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.~* Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator~Exclusion Criteria:~* Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder~* Patients whose Young Mania Rating Scale (YMRS) total score \>12 at enrolment and randomisation.~* Patients with \>8 mood episodes during the past 12 months at enrolment.~* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.~* Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.~* Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.~* Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (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: Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist

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

Eligibility Criteria:
Inclusion Criteria:~* Age \>20~* Diabetes mellitus Type 2 (American Diabetes Association criteria) of at least 3 months duration~* HbA1c \>7.5%~* Body-mass index (BMI) \> 27~Exclusion Criteria:~* Positive GAD 65 or IA-2 antibodies at inclusion.~* HbA1c \>12%, polyuria and thirst (exclusion of severely decompensated patients)~* C-peptide \< 400pmol/l (basal )~* Established anti-inflammatory therapy (includiung cortisone, NSAID, Cox-2-inhibitor). Low dose aspirin (£ 100mg) will be tolerated.~* CRP \>30 mg/dl, fever, current treatment with antibiotics, or chronic granulomatous infections (e.g. tuberculosis) in the history or on a screening chest X-ray.~* Neutropenia or anemia (leucocyte count \< 2.0x109 /l, hemoglobin \<11g/dl for ma les or \<10g/dl for females)~* Pregnancy or breast-feeding. When appropriate (fertile women),anticonception for at last 3 month prior inclusion will be required.~* Severe liver or renal disease ( AST or ALT\>3 times the upper limit of normal laboratory range, serum creatinine \>130mM)~* Ongoing malignant neoplasm~* Use of any investigational drug within 30 days of enrollment into the study or within 5 half-lives of the investigational drug (whichever is longer)~* Immunosuppressive treatment or immunodeficient diseases.

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

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

Answer: outcome: complete