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

Trial Title: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy~* For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations positive by FISH or IHC~* Eastern Cooperative Group ECOG) Performance Status score of 0 or 1~* Adequate organ system function~* Male patients willing to use adequate contraceptive measures; female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures~* Measurable disease per RECIST~* Willingness and ability to comply with the trial and follow-up procedures~* Written informed consents are required to indicate that the patients are aware of the investigational nature of the study~Exclusion Criteria:~* Current use of anticancer therapy.~* Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib~* Any major surgery, radiotherapy, or immunotherapy within the last 21 days.~* Chemotherapy regimens with delayed toxicity within the last 4 weeks.~* Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.~* Prior stem cell transplant~* Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib or to the active ingredient of ensartinib~* Prior use of ALK TKIs with the exception of crizotinib~* Primary CNS tumors or meningeal metastasis~* Pregnant or breastfeeding female~* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib~* Clinically significant cardiovascular disease.~* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol~* Concurrent condition evaluated by investigator would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled~* Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol

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

Study Arms:
- Ensartinib (Type: EXPERIMENTAL): Escalating dose of ensartinib was orally given once er 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: This is a Study to Determine the Antidepressant Effects of AZD6765

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features~* Females must be of non-childbearing potential.~Exclusion Criteria:~* Treatment with Clozapine or ECT within 3 months prior to study~* Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV

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

Study Arms:
- AZD6765 (150 mg) / Placebo (Type: EXPERIMENTAL): Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
- Placebo / AZD6765 (150 mg) (Type: PLACEBO_COMPARATOR): Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second 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: First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy, non-smoking male subjects~* BMI (body mass index) between 18.0 and 28.0 kg/m\^2, both incl.~* Body weight 50 to 100 kg, both incl.~Exclusion Criteria:~* Strenuous exercise within 4 days prior to dosing~* Receipt of any investigational medicinal product within 3 months prior to randomisation

- Gender: MALE
- Minimum Age: 20 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- Single dose (SD) (Type: EXPERIMENTAL): Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation
- Multiple dose (MD) (Type: EXPERIMENTAL): Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation

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: Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse

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:~* English-speaking~* Age ≥18~* Currently on methadone~* Experiencing non-malignant pain for a duration of 3 months or longer.~Exclusion Criteria:~* Severe cognitive impairment or active psychosis~* Suicide risk~* Inability to attend the MORE group, if randomized to that arm.

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

Study Arms:
- Mindfulness Oriented Recovery Enhancement (Type: EXPERIMENTAL): The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
- Methadone Treatment as Usual (Type: OTHER): In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.

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 Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys

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

Eligibility Criteria:
Inclusion Criteria:~* adult patient, \>/= 18 years of age~* chronic hepatitis B~* treatment with peginterferon alfa-2A~Exclusion Criteria:~* coinfection with HAV, HCV and HIV

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

Study Arms:
- Cohort (Type: None): 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: Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

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

Eligibility Criteria:
Inclusion Criteria:~* \>18yr~Exclusion Criteria:~* Lack of informed consent~* Age \< 18 years,~* Current involvement in other research studies,~* Systolic blood pressure \>190 mmHg or \<100 mmHg~* Malignant arrhythmias~* Renal or hepatic failure~* Haemodynamically significant aortic stenosis~* Severe or significant co morbidity~* Women of childbearing potential.~* Any regular medication~* Previous history of any cardiovascular disease

- Gender: ALL
- Minimum Age: 18 Months
- Maximum Age: 85 Years
- Healthy Volunteers: t

Study Arms:
- Sodium depletion (Type: EXPERIMENTAL): Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing \>2000 kcal of energy, \>60 g of protein, \<12 mmol of sodium and \<70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.
- Normal diet (Type: PLACEBO_COMPARATOR): Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.

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 Between Symbicort® and Prednisolone in 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:~* Patients with chronic obstructive pulmonary disease and an acute exacerbation~* After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value.~* Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease~Exclusion Criteria:~* Diagnosis/history of asthma~* Oxygen uptake (saturation) is \<92% after the initial acute treatment~* A requirement for regular use of oxygen therapy~* Regular treatment with any inhaled steroid \>1 000 µg/day at study entry~Additional inclusion and exclusion criteria will be evaluated by the investigator

- 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: A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

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:~* Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria~* Have positive antinuclear antibodies (ANA)~* Agree not to become pregnant throughout the course of the trial~* Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)~Exclusion Criteria:~* Have active severe Lupus kidney disease~* Have active Central Nervous System or peripheral neurologic disease~* Have received intravenous immunoglobulin (IVIg) within 180 days of randomization~* Have active or recent infection within 30 days of screening~* Have had a serious infection within 90 days of randomization~* Have evidence or test positive for Hepatitis B~* Have Hepatitis C~* Are human immunodeficiency virus (HIV) positive~* Have evidence of active or latent tuberculosis (TB)~* Presence of significant laboratory abnormalities at screening~* Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization~* Have received greater than 40 mgs of prednisone or equivalent in the past 30 days~* Have changed your dose of antimalarial drug in the past 30 days~* Have changed your dose of immunosuppressive drug in the past 90 days~* Have previously received rituximab

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

Study Arms:
- LY2127399 every 2 weeks (Type: EXPERIMENTAL): None
- LY2127399 every 4 weeks (Type: EXPERIMENTAL): During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
- 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: Zenith® p-Branch® Endovascular Graft Pivotal Study

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

Eligibility Criteria:
Inclusion Criteria:~* Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter~* Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year~* Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation~Exclusion Criteria:~* Age \<18 years~* Life expectancy \<2 years~* Pregnant, breast-feeding, or planning on becoming pregnant within 60 months~* Inability or refusal to give informed consent by the patient or a legally authorized representative~* Unwilling or unable to comply with the follow-up schedule~* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)~* Additional medical restrictions as specified in the Clinical Investigation Plan~* Additional anatomical restrictions as specified in the Clinical Investigation Plan

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

Study Arms:
- Endovascular (Type: EXPERIMENTAL): Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

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 Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay

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

Eligibility Criteria:
Inclusion Criteria:~* Parent has a child ages 3 to 5 years with an agency-identified DD in one or more functional areas who is receiving early intervention or early childhood/ preschool special education through an individualized family service plan (IFSP) or individualized education plan (IEP);~* Parent reports elevated child behavior problems, as indicated by a T-score of 60 or above on the Total Problems scale of the Child Behavior Checklist;~* Parent reports elevated parenting stress, as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4.~Exclusion Criteria:~* Parent screens positive for active psychosis, substance abuse, or suicidality;~* Parent is currently receiving any form of psychological or behavioral treatment at the time of referral; or~* The child has sensory impairments or nonambulatory conditions that would necessitate the need for significant modifications to the lab and home visit protocols.

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

Study Arms:
- BPT-E (Type: EXPERIMENTAL): Behavioral parent training (BPT) plus a psychoeducation program.~Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT.
- BPT-M (Type: EXPERIMENTAL): Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR).~Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT.

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: Pediatric Teduglutide Registry

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

Eligibility Criteria:
Cohort A:~Inclusion Criteria:~1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days~2. Received teduglutide after FDA approval~3. Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation~4. Weight ≥ 10 kg at start of teduglutide initiation~5. Dependent on PS at the time of teduglutide initiation~6. Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit.~7. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry.~Exclusion Criteria:~1. Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304).~2. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.~Cohort B:~Inclusion Criteria:~1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days~2. Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304)~3. Currently receiving teduglutide~4. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry.~Exclusion Criteria:~1. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Cohort A (Type: None): Participants with SBS who started Teduglutide after FDA approval (May 2019)
- Cohort B (Type: None): Subjects who participated in any of the teduglutide pediatric clinical trial studies (TED-C13-003, TED-C14-006, SHP633-303, or SHP633-304) and subsequently started therapy with teduglutide

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 Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* adult patients, \>=18 years of age;~* histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;~* measurable disease according to RECIST;~* failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;~* ECOG performance status of 0-2.~Exclusion Criteria:~* local or locally advanced-resectable pancreatic cancer;~* any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;~* major surgery within 2 weeks prior to randomization.

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

Study Arms:
- Erlotinib (Type: EXPERIMENTAL): Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
- Placebo (Type: PLACEBO_COMPARATOR): Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.

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

Answer: outcome: complete