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

Trial Title: Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 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 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m\^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty

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

Study Arms:
- Meal time FIAsp and insulin detemir (Type: EXPERIMENTAL): None
- Meal time insulin aspart and insulin detemir (Type: ACTIVE_COMPARATOR): None
- Post meal FIAsp and insulin detemir (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: Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion criteria:~1. Written informed consent~2. Malignant solid tumor or a hematological malignancy causing cancer-related pain~3. Background opioid treatment at a stable dose for at least a week~4. One to four episodes of breakthrough pain per day~Main exclusion criteria:~1. Hypersensitivity to fentanyl or to any of the excipients~2. Intrathecal opioids~3. Recent history of substance abuse~4. Recent or planned therapy that would alter pain~5. Moderate or severe hepatic or renal disease

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

Study Arms:
- Fentanyl / Placebo (Type: EXPERIMENTAL): After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 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: Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

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:~* Age \> 18 years old~* Diagnosed with hormone receptor positive invasive breast cancer (estrogen receptor (ER) or progesterone receptor (PR) or both \>1%) by core needle biopsy~* Clinical American Joint Committee on Cancer (AJCC) 7th edition Stage 1 or 2~* Candidate for surgical therapy~* Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2~* No chemotherapy or endocrine therapy for breast cancer in last 5 years~* Paraffin fixed core needle tissue block, or biopsy punch available for central analysis for proliferative markers~* Not pregnant or lactating and practicing adequate birth control if premenopausal~* Able and willing to provide informed consent~Exclusion Criteria:~* Prior personal history of uterine cancer~* Prior personal history of stroke or deep vein thrombosis (DVT)~* Current therapy with strong CYP2D6 inhibitors The following medications should not be administered with tamoxifen (21 day treatment period) and will need to be stopped for the designated period of time prior to starting the study tamoxifen.~No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years~Fluoxetine - should be discontinued 30 days prior to starting tamoxifen Paroxetine - should be discontinued 5 days prior to starting tamoxifen Sertraline - should be discontinued 5 days prior to starting tamoxifen Bupropion - should be discontinued 5 days prior to starting tamoxifen~* Concurrent coumarin-type anticoagulation therapy~* Any other contraindications to tamoxifen therapy

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

Study Arms:
- All patients (Type: EXPERIMENTAL): All patients enrolled in 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: Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients

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:~* From 2 up to and including 13 years of age~* Clinical and laboratory confirmed diagnosis of HAE (baseline C1INH activity \<50% of normal)~* Signed written Informed Consent Form (ICF)(parental permission) signed by the legal guardian(s)~* Clinical symptoms of an acute HAE attack~* Onset of eligible symptoms within 5 hours from the moment at which medical evaluation to determine eligibility has occurred~* Attack severity moderate or greater, as rated by the investigator~Exclusion Criteria:~* A diagnosis of acquired C1INH deficiency (AAE)~* A medical history of allergy to rabbits or rabbit-derived products or positive anti-rabbit epithelium (dander) immunoglobuline E (IgE) test

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 13 Years
- Healthy Volunteers: f

Study Arms:
- Recombinant Human C1 Inhibitor (Type: EXPERIMENTAL): Patients presented to the clinic within 5 hours of onset received rhC1INH 50 U/kg body weight up to a maximum of 4200 U.

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: Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.

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

Eligibility Criteria:
Inclusion Criteria:~* Documented HIV infection~* CD4 cell count below 300/mm3~* Plasma HIV RNA over 30,000 copies/ml~* Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)~* Written informed consent~Exclusion Criteria:~* Biological abnormalities~* Pregnancy~* Alcool abuse~* History of pancreatitis, hepatic failure~* Acute HIV related infection~* Chemotherapy

- 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: Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management

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

Eligibility Criteria:
Inclusion Criteria:~* Child with BMI greater than or equal to 85th percentile.~* English speaking~* Approval by Primary Care Doctor~Exclusion Criteria:~* Participants with medical, developmental or psychiatric diagnoses which preclude participation in both the physical activity and classroom portions of the curriculum.~* Participants who are taking medications that positively or negatively affect weight.

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- Exergaming and Didactic health teaching (Type: EXPERIMENTAL): Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
- Didactic health teaching (Type: ACTIVE_COMPARATOR): Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.

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: Role of Endorphins in Perception of Dyspnea With Resistive Loading in Chronic Obstructive Pulmonary Disease (COPD)

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female patient 50 years of age or older;~* A diagnosis of COPD defined by American Thoracic Society-European Respiratory Society criteria~* Current or former smoker with a smoking history of greater than or equal to 10 pack-years;~* A post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted; AND~* A post-bronchodilator FEV1/forced vital capacity ratio less than 70%; and clinically stable COPD.~Exclusion Criteria:~* Any patient who has a concomitant disease that might interfere with study procedures or evaluation;~* Inability to perform resistive breathing maneuvers; OR~* Any current use of a narcotic medication.

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- naloxone (Type: EXPERIMENTAL): None
- normal saline (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: Effect of Olopatadine on Allergic Tear Mediators

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

Eligibility Criteria:
Inclusion Criteria:~* Skin test positive~* Able to put drops in eyes~* Able to have tears collected

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

Study Arms:
- Olopatadine (Type: EXPERIMENTAL): one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week

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: Effect of Dexmedetomidine on Propofol Requirement During Anesthesia

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

Eligibility Criteria:
Inclusion Criteria:~1. ASA physical status I/II~2. Undergoing elective laparoscopic / robotic surgery of more than 60-minutes duration~Exclusion Criteria:~1. Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)~2. Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks)~3. Any hepato-renal insufficiency~4. Uncontrolled diabetes mellitus~5. Known allergy/hypersensitivity to study drug~6. Pulmonary dysfunction (restrictive /obstructive lung disease)~7. Acute/chronic drug dependence/substance abuse

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Dexmedetomidine group (Type: ACTIVE_COMPARATOR): Patients will receive a pre-induction loading dose of dexmedetomidine 1-µ/kg over 10 minutes followed by an intraoperative infusion of 0.5-µ/kg/hour . Over and above the use of study drug dexmedetomidine propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients
- Non-Dexmedetomidine group (Type: PLACEBO_COMPARATOR): Patients will receive a pre-induction loading dose of 0.9% saline solution over 10 minutes followed by an intraoperative infusion.Over and above the use of 0.9% saline solution propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients

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: Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B

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:
Key Inclusion Criteria:~* Participated in the previous study Efficacy and safety of factor IX (FIX) contained in Alphananine in patients with severe hereditary haemophilia B:~* Congenital deficiency in Factor IX (FIX)~* FIX residual activity of ≤2% of normal~* Had required FIX-containing products in the past and in clinical records that were collected data to assess a reliable estimation of at least 150 treatment exposure days to previous products~* Was able to receive treatment for more than 10 days for a 6-month period~Key Exclusion Criteria:~* Received a dose of FIX in the 7 days prior to the infusion~* FIX inhibitor level of \>0.5 Bethesda units (BU) or clinically relevant presence in the past (≥5 BU)~* Active bleeding at the moment of infusion~* Had a known allergic reaction to any BeneFIX component~* Exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the time of the first infusion~* Had any disease that might affect the distribution or metabolism of FIX and which could affect interpretation of the study (such as non-controlled diabetes mellitus)~* Had non-controlled arterial hypertension~* Had abnormal renal function (creatinine \>1.5 mg/dL)~* Had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase (ALT) levels 2.5x upper limit of normal (ULN )~* Prevision to be concomitantly treated with other FIX-containing products~* Had conditions that might affect subject compliance (survival-limiting \[in 2 year time\] diseases, alcohol or other drug abuse, etc.)~* Unable to provide a storage plasma sample before the first dose of BeneFIX

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

Study Arms:
- BeneFIX (Type: EXPERIMENTAL): BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.

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 Hepatic Impairment Study for PF-04965842.

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

Eligibility Criteria:
Inclusion Criteria:~* Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 pounds).~* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.~Additional Inclusion Criteria for subjects with hepatic impairment:~* Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild: Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points), within 14 days of investigational product administration.~* A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging (MRI).~Exclusion Criteria:~* Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days, history of disseminated herpes simplex infection or recurrent (\>1 episode) or disseminated herpes zoster.~* Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.~Additional exclusion criteria for subjects with hepatic impairment:~* Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).~* Subjects who have previously had a transplanted kidney, liver, or heart.~* At Screening, persistent severe, uncontrolled hypertension.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- PF-04965842 (Type: EXPERIMENTAL): PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.

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: Mobile Mental Health Apps for Suicide Prevention

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

Eligibility Criteria:
Inclusion Criteria:~Phase 1~* 19 years old and older~* Identify as an essential worker or unemployed due to COVID-19~* English-speaking~* Access to a mobile device (e.g. smartphone or tablet)~* Based in the United States~Phase 2~* 19 years old and older~* Scored at or above validated cut off scores in Phase 1 (PHQ-2\>3; GAD-2\>3; SBQ-R\>7) or reported history of past suicide attempt~* Identify as an essential worker or unemployed due to COVID-19~* English-speaking~* Access to a mobile device (e.g. smartphone or tablet)~* Based in the United States~Exclusion Criteria:~Phase 1~* Under the age of 19~* Neither an essential worker nor unemployed due to COVID-19~* Non-English speaking~* No access to a mobile device (e.g. smartphone or tablet)~* Not based in the United States~Phase 2~* Under the age of 19~* Did not score at or above validated cut off scores in Phase 1 (PHQ-2\>3; GAD-2\>3; SBQ-R\>7) nor reported history of past suicide attempt~* Neither an essential worker nor unemployed due to COVID-19~* Non-English speaking~* No access to a mobile device (e.g. smartphone or tablet)~* Not based in the United States

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Phase 2: Mobile Mental Health App - 1 (Type: ACTIVE_COMPARATOR): Participants randomized to a free mobile mental health application that focuses on meditation.
- Phase 2: Mobile Mental Health App - 2 (Type: ACTIVE_COMPARATOR): Participants randomized to a free mobile mental health application that assists with coping with COVID-19.
- Phase 2: Mobile Mental Health App - 3 (Type: ACTIVE_COMPARATOR): Participants randomized to a free mobile mental health application that focuses on positive psychology.
- Phase 2: Mobile Mental Health App - 4 (Type: ACTIVE_COMPARATOR): Participants randomized to a free mobile application that addresses mental health issues through mood tracking.

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: V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

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:~* Healthy infant per investigator, 6 through 12 weeks of age~Exclusion Criteria:~* History of congenital abdominal disorders, intussusception, or abdominal surgery~* Known or suspected impairment of immunological function~* Known hypersensitivity to any component of the rotavirus vaccine~* Prior administration of any rotavirus vaccine~* Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa~* Any infant born from a known HBsAg-positive mother~* Prior administration of any oral polio vaccine~* Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study~* Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization~* History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive~* Clinical evidence of active gastrointestinal illness~* Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination~* Infants residing in a household with an immunocompromised person~* Prior receipt of a blood transfusion or blood products~* Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study~* Any infant who cannot be adequately followed for safety by a contact visit~* History of seizure disorders or prior history followed for safety by a contact visit~* Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives

- Gender: ALL
- Minimum Age: 6 Weeks
- Maximum Age: 12 Weeks
- Healthy Volunteers: t

Study Arms:
- 1 (Type: EXPERIMENTAL): RotaTeq/Infanrix Hexa
- 2 (Type: PLACEBO_COMPARATOR): Placebo/Infanrix Hexa

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

Answer: outcome: complete