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

Trial Title: Behavioral & Nutritional Treatment to Help CF Preschoolers Grow

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

Eligibility Criteria:
Inclusion Criteria:~* confirmed diagnosis of cystic fibrosis based upon 2 of the following: a. sweat chloride by quantitative pilocarpine electrophoresis ≥60 milliequivalent/Liter (mEq/L), b. two clinical features consistent with CF, or c. genetic testing demonstrating two mutations associated with CF~* confirmation of pancreatic insufficiency based upon fecal elastase of ≤ 100 micrograms per gram of stool (or an undetectable level)~* age at enrollment to the trial of 2.0 years to 6.0 years~* at least 6 months post CF diagnosis~* consuming an unrestricted fat diet~Exclusion Criteria:~* diagnosis of developmental delay (i.e., autism, cerebral palsy, or mental retardation)~* receiving supplemental enteral nutrition via nasogastric tube, gastrostomy, or total parenteral nutrition~* diagnosed with another disease/condition (e.g., insulin dependent diabetes, congenital heart disease, significant renal disease, history of bowel resection or short bowel syndrome, colonic strictures) known to affect growth~* taking a medication (e.g., insulin, growth hormone, chronic use of systemic steroids) known to affect growth~* screening assessment shows genetic potential for height as acceptable according to the 2001 Consensus Conference guidelines and diet diary indicates daily Dietary Reference Intake (DRI) of energy average of 140% or greater (DRI of 100% will be determined as the estimated energy requirement \[EER\] based upon the child's age, gender, and an active physical activity level~* weight z score (age and gender adjusted) of \> 1.0~* prior participation in the pilot intervention studies conducted by the PI during the prior period of R01 funding or current participation in an intervention trial conducted by the Cystic Fibrosis Therapeutics Development Network.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 6 Years
- Healthy Volunteers: f

Study Arms:
- Behavioral and Nutrition Treatment (Type: EXPERIMENTAL): The behavioral and nutrition treatment combines individualized nutritional counseling that targeted increasing energy and fat intake and parent training in behavioral child-management skills based on social learning theory to improve meal-time behaviors.
- Education and Attention Control (Type: ACTIVE_COMPARATOR): The education and attention control treatment provides education and served as a behavioral placebo in terms of controlling for attention and contact frequency provided. Families are provided with information including general nutrition, enzyme therapy, respiratory infection control, and typical child development anticipatory guidance and safety for preschool- aged children.

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: Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Infants less than one year of age~* Undergoing cardiac surgery with the use of cardiopulmonary bypass~Exclusion Criteria:~* Prior surgery requiring CPB within the same hospitalization~* Pre-operative need for extracorporeal membrane oxygenation or mechanical circulatory support~* Known hypersensitivity to nitric oxide~* Known hemostatic or thrombotic disorder that results in an altered transfusion/anticoagulation protocol

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

Study Arms:
- Nitric Oxide (Type: EXPERIMENTAL): 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time
- Placebo (Type: PLACEBO_COMPARATOR): INOmax device attached to the oxygenator, but no gas is delivered through the device

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: Laquinimod Phase IIa Study in Active Crohn's 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: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Subjects diagnosed with Crohn's disease for at least 3 months prior to screening.~2. Moderate to severe Crohn's disease patients as determined by the CDAI score~Exclusion Criteria:~1. Subjects who have had recent bowel surgery~2. Subjects with clinically significant GI obstructive symptoms~3. Subjects with a clinically significant or unstable medical or surgical condition~4. Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )~5. Women who are pregnant or nursing or who intend to be during the study period.~6. Women of child-bearing potential who do not practice an acceptable method of birth control

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

Study Arms:
- Laquinimod (Type: EXPERIMENTAL): Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)
- Placebo (Type: PLACEBO_COMPARATOR): Matching placebo

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 Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes

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:
Key Inclusion Criteria:~* Heterozygous for the F508del mutation (F/MF)~* Forced expiratory volume in 1 second (FEV1) value greater than equal to(≥) 70%~Key Exclusion Criteria:~* Clinically significant cirrhosis with or without portal hypertension~* Lung infection with organisms associated with a more rapid decline in pulmonary status~* Solid organ or hematological transplantation~Other protocol defined Inclusion/Exclusion criteria may apply

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 11 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Participants received placebo matched to ELX/TEZ/IVA and placebo matched to IVA in the treatment period for 24 weeks.
- ELX/TEZ/IVA (Type: EXPERIMENTAL): Participants weighing less than (\<) 30 kilograms (kg) at screening received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg every 12 hours (q12h) and participants weighing greater than equals to (\>=) 30 kg at screening received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 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: Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

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:~* Age greater than or equal to 5 years of age~* Weight greater than or equal to 30 kilograms~* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.~* Any of the following by transthoracic echocardiography:~* For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg~* For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg~Exclusion Criteria:~* Active endocarditis~* Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year~* Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements~* Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein~* Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential~* Known intravenous drug abuse

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Melody TPV Implant (Type: EXPERIMENTAL): Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

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: Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

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:~1. Diagnosis of diabetes mellitus prior to informed consent~2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)~3. Glycosylated haemoglobin A1 \>= 7.5% and \<= 10%~4. Age between 18 and less than 80~5. - Body Mass index less or equal to 45~Exclusion criteria:~1. Uncontrolled hyperglycaemia during run in period~2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent~3. Impaired hepatic function~4. Gastric by pass surgery~5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent~6. Treatment with anti-obesity drugs~7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent~8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 79 Years
- Healthy Volunteers: f

Study Arms:
- Linagliptin (Type: EXPERIMENTAL): Linagliptin tablets once daily
- Placebo (Type: PLACEBO_COMPARATOR): Placebo tablets 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: Pharmacy Home Adherence Reporting and Monitoring Outcomes Study

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Time Perspective: None
- Masking: SINGLE
- Phase: None
- Number of Arms: 11.0

Eligibility Criteria:
Physician Inclusion Criteria:~* New England Quality Care Alliance (NEQCA) primary care physicians of adult patients insured through large commercial insurer partner~Patient Inclusion Criteria:~* Adult patients of consented New England Quality Care Alliance (NEQCA) primary care physicians~* Insured through large commercial insurer partner~* Prescribed chronic medications for one or more of the three study conditions in the past six months~Patient Exclusion Criterion:~* On the insurer's do not contact list

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

Study Arms:
- Default patient default doctor (Type: EXPERIMENTAL): Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
- Information patient default doctor (Type: EXPERIMENTAL): Patient nonadherence information sent to physician
- Control patient default doctor (Type: NO_INTERVENTION): Control - no intervention
- Choice patient choice doctor (Type: EXPERIMENTAL): Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
- Information patient choice doctor (Type: EXPERIMENTAL): Patient nonadherence information sent to physician
- Control patient choice doctor (Type: NO_INTERVENTION): Control - no intervention
- Information patient information doctor (Type: EXPERIMENTAL): Patient nonadherence information sent to physician
- Control patient information doctor (Type: NO_INTERVENTION): Control - no intervention
- Information doctor (Type: EXPERIMENTAL): Physician receives nonadherence information, but there is no opportunity for pharmacist action
- Choice doctor (Type: EXPERIMENTAL): Physician receives nonadherence information, and can choose to request pharmacist action
- Default doctor (Type: EXPERIMENTAL): Physician receives nonadherence information; pharmacist action will be triggered unless physician cancels action

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 Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

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:~* Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.~* Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.~Exclusion Criteria:~* Participant has prior exposure to Janus Kinase (JAK) inhibitor.~* Participant has prior exposure to dupilumab.~* Participant is unable or unwilling to discontinue current AD treatments prior to the study.~* Participant has requirement of prohibited medications during the study.~* Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.~* Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 76 Years
- Healthy Volunteers: f

Study Arms:
- Upadacitinib 30 mg QD (Type: EXPERIMENTAL): Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
- Dupilumab 300 mg EOW (Type: EXPERIMENTAL): Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.

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: Cabergoline in Nonfunctioning Pituitary Adenomas

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:~* presence of pituitary tumor rest at 6 months after neurosurgery~* absence of previous hormonal pituitary hypersecretion~* absence of previous radiotherapy and/or radiosurgery~* Histopathological exam showing pituitary adenoma~Exclusion Criteria:~* ACTH immunoexpression at histopathological exam~* presence of previous radiotherapy and/or radio surgery~* psychotic psychiatric disease~* moderate or severe alterations in cardiac valves

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

Study Arms:
- Study Group (Type: EXPERIMENTAL): This group received cabergoline, in a total week dose of 3.5 mg, starting 6 months after transphenoidal surgical approach with evidence of tumoral rest in MRI and pituitary adenoma hystopathological confirmation.
- Control Group (Type: NO_INTERVENTION): This group was followed, with clinical visits in same frequency of study group, but without intervention.

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: Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

Study Design Characteristics:
- Allocation: N/A
- Intervention Model: N/A
- Observational Model: N/A
- Primary Purpose: N/A
- Time Perspective: N/A
- Masking: N/A
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start~* Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%~Exclusion Criteria:~* Type 1 Diabetes Mellitus~* Patients with serious diabetic complications and other serious complications

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

Study Arms:
- KAD-1229/KAD-1229 (Type: EXPERIMENTAL): Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.
- Placebo/KAD-1229 (Type: OTHER): Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout 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: Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)

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

Eligibility Criteria:
Inclusion Criteria:~* Adult African-American or Black subjects with diagnosis of primary hypercholesterolemia with plasma LDL-C \>=145 mg/dL and \<=250 mg/dL, and plasma TG \<=350 mg/dL~* Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable HRT or raloxifene regimen for at least 6 weeks and throughout the study~* Female subjects of non-childbearing potential~* Willingness to give written consent, participate and complete all study-related procedures, and ability to follow a stable NCEP Step I (or stricter) diet regimen and keep a diet diary when required.~* Clinical laboratory tests (CBC, blood chemistries, and urinalysis) within normal limits (except as noted below) or clinically acceptable.~* ALT (SGPT) and AST (SGOT) concentrations \<=2 times the upper limit of normal (ULN) and creatine phosphokinase \<=2 times the ULN.~Exclusion Criteria:~* Pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study~* Secondary forms of hyperlipidemia or underlying disease likely to limit life span to less than one year~* Known hypersensitivity or any contraindication to simvastatin or ezetimibe~* Use of investigational drugs within 30 days of study entry~* Concomitant illnesses: congestive heart failure NYHA Class III or IV; obstructive cardiomyopathy; uncontrolled cardiac arrhythmias; severe aortic stenosis; MI, CABG or angioplasty within 3 months of study; unstable or severe peripheral artery disease; unstable angina pectoris; study-limiting disorders of the hematologic, digestive or central nervous systems including cerebrovascular disease and degenerative disease; uncontrolled or newly diagnosed diabetes mellitus; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for enrollment); uncontrolled hypertension; known impairment of renal function (plasma creatinine \>2.0 mg/dL), dysproteinemia, nephrotic syndrome or other renal disease (24-hour urinary protein 3+ or 1 gram); hepatobiliary or hepatic disease (AST or ALT \>2 times the upper limit of the reference range); HIV positive; known coagulopathy.

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

Study Arms:
- Ezetimibe + Simvastatin (Type: EXPERIMENTAL): None
- Simvastatin (Type: ACTIVE_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: Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

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:~* 6-12 years old~* ADHD diagnosis~* ADHD-RS-IV minimum score of 28~* CGI-S score \> or = 4~Exclusion Criteria:~* Current, controlled or uncontrolled, comorbid psychiatric diagnosis~* Condition or illness which represent inappropriate risk to subject~* Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension~* Use of prohibited medication that have CNS effects or affect cognitive performance~* History of alcohol or substance abuse within 6 months~* Current use of medication that affect BP or heart rate~* Significantly overweight~* Weight of less than 55 lbs~* Known allergy to SPD503~* Abnormal urine drug and alcohol screen

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- Extended-release Guanfacine Hydrochloride (SPD503) AM (Type: EXPERIMENTAL): None
- placebo (Type: EXPERIMENTAL): None
- SPD503 PM (Type: EXPERIMENTAL): None

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

Answer: outcome: complete