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

Trial Title: Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria~2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia~3. Subjects experiencing an acute exacerbation of psychotic symptoms~4. Other protocol specific inclusion criteria may apply~Exclusion Criteria:~1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug~2. Subjects with a current DSM-IV-TR Axis I diagnosis of:~   * Schizoaffective disorder~  * Major depressive disorder (MDD)~  * Bipolar disorder~  * Delirium, dementia, amnestic or other cognitive disorder~  * Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder~3. Subjects presenting with a first episode of schizophrenia~4. Other protocol specific exclusion criteria may apply

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

Study Arms:
- OPC-34712 [Brexpiprazole] High Dose (Type: EXPERIMENTAL): Higher Dose, tablet, once daily, for six weeks
- OPC-34712 [Brexpiprazole] Middle Dose (Type: EXPERIMENTAL): Middle Dose, tablet, once daily, for six weeks
- OPC-34712 [Brexpiprazole] Low Dose (Type: EXPERIMENTAL): Lower Dose, tablet, once daily, for six weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo, once daily, for six 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: A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

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:~* Have a diagnosis of migraine or chronic migraine.~* History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.~* History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.~* Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.~Exclusion Criteria:~* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.~* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.~* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine).~* Pregnant or nursing.

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

Study Arms:
- Galcanezumab (Type: EXPERIMENTAL): Galcanezumab administered subcutaneously (SC).
- Placebo (Type: PLACEBO_COMPARATOR): Placebo administered SC.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

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:~* 8 years of age and older~* Received at least 7 out of 8 scheduled doses in Study PKU 001~* Responsive to Phenoptin™ in Study PKU-001, defined as a reduction in blood Phenylalanine level of \>/=30% compared with baseline~* Blood Phenylalanine level \>/=450 μmol/L at screening~* Willing and able to provide written informed consent or, in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained~* Negative urine pregnancy test at screening (females of child-bearing potential)~* Male and Female subjects of childbearing potential (if sexually active) must be using acceptable birth control measures, as determined by the investigator, and willing to continue to use acceptable birth control measures while participating in the study~* Willing and able to comply with study procedures~* Willing to continue current diet unchanged while participating in the study~Exclusion Criteria:~* Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable~* Use of any investigational agent other than Phenoptin™ within 30 days prior to screening, or requirement for any investigational agent or investigational vaccine prior to completion of all scheduled study assessments~* Pregnant or breastfeeding, or considering pregnancy~* ALT \>5 times the upper limit of normal (i.e., Grade 3 or higher based on World Health Organization Toxicity Criteria) at screening~* Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes, or organ transplantation recipient)~* Serious neuropsychiatric illness (e.g., major depression) not currently under medical management~* Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)~* Concurrent use of levodopa~* Clinical diagnosis of primary BH4 deficiency

- Gender: ALL
- Minimum Age: 8 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: Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia

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

Eligibility Criteria:
Inclusion Criteria:~* 6 months to 8 years undergoing general anesthesia for elective MRI of brain, spine and extremities. Patients who were ASA physical status 1-3 only were included.~exclusion criteria: Patients who were ASA 4-5 were excluded from the study. Patients not NPO for solids for 8 hours and liquids for 2 hours were excluded.

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 8 Years
- Healthy Volunteers: f

Study Arms:
- Children undergoing MRI (Type: None): 120 children ages of 6 months and 8 years for MRI and axillary temperature before MRI and after the MRI with MRI compatible 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: A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)

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:~* Patients with involvement of at least 2 anatomical areas at screening and baseline~* Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline~* Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s)~* Patients meet the diagnosis criteria for atopic dermatitis (AD)~* Provide informed consent/assent signed by study patient or legally acceptable representative~* Patients need to have been compliant with the skin protection measures through the entire duration of the screening period~Key Exclusion Criteria:~* Treatment with dupilumab in the past~* Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis~* Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis~* Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline~* Known history of HIV/HBV/HCV infection~* Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study~* Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study~NOTE: Other protocol defined inclusion / exclusion criteria apply

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

Study Arms:
- dupilumab (Type: EXPERIMENTAL): Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
- Matching Placebo (Type: EXPERIMENTAL): Administered SC Q2W, following a loading dose on Day 1

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: IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* ASA I, II,III;~* BMI \> 35 kg/m2,~* Age between 18-70,~* Fluent in English,~* Patients undergoing laparoscopic gastric bypass,~* EKG within 3 months.~Exclusion Criteria:~* History of allergy to local anesthetics,~* History of chronic opioid use,~* Pregnant patients,~* History of EKG abnormalities.~Dropout: Conversion to open, patient or surgeon request.

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

Study Arms:
- Lidocaine (Type: ACTIVE_COMPARATOR): Lidocaine infusion
- Placebo (Type: PLACEBO_COMPARATOR): Placebo Normal Saline Infusion

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: Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders

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

Eligibility Criteria:
Inclusion Criteria:~* For the intervention trial: infant must meet risk criteria on the First Years Inventory (Calculated based on data collected in another study where risk status on the FYI was confirmed with follow up at 3 years. We empirically determined combinations of the two FYI domain scores that would sort respondents into at-risk and not-at-risk. The resulting cut-points enabled us to sort children such that we capture about 1/3 of those who would go on to be confirmed as having a autism spectrum diagnosis while misclassifying less than 5% of the typically developing (TD) sample as at-risk). Infants also must score at least one s.d. below the mean on either the Receptive or Expressive subscale t scores AND meet the following SPA inclusion criteria on hyporeactivity (HYPO) or hyperreactivity (HYPER):~  * HYPO: Cut-point (equal or greater than) of 1.69 for Mean of the raw orienting score across 7 items, each with the range of 1 to 4 possible points)~ * HYPER: Cut-point (equal or greater than) of .333 for Mean of the raw approach/avoid novel toys score across 9 items, each with the range of 0 to 2 possible points) OR Any clear defensive response on orienting items or Yes to covering ears to sound (in stereotypies checklist)~Exclusion Criteria:~* families who speak English \< 50% of the time at home~* infants with previously identified genetic disorders (e.g., Down syndrome)~* infants with identified vision/hearing/physical impairments.

- Gender: ALL
- Minimum Age: 11 Months
- Maximum Age: 16 Months
- Healthy Volunteers: t

Study Arms:
- PC followed by SR (Type: EXPERIMENTAL): Parents will be coached for 6 weekly sessions in the Parents and Infants Engaged (PIE) intervention pre-linguistic (PC) domain to identify their child's pre-linguistic communication bids during daily routines and respond to those bids in ways that optimize parent-child engagement. After posttest 1, they will be coached for 6 weekly sessions on sensory reactivity bids.
- SR followed by PC (Type: EXPERIMENTAL): Parents will be coached for 6 weekly sessions in the Parents and Infants Engaged (PIE) intervention sensory reactions (SR) domain to identify their child's sensory reactions to daily activities and respond to those reactions or modify the environment in ways that optimize parent-child engagement. After posttest 1, they will be coached for 6 weekly sessions on pre-linguistic communication bids.

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 Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

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:~* Upper and lower limb spasticity of the same body side due to cerebral causes~* Time since event leading to spasticity in the target body side greater than 12 weeks~* Need for 800 units Botulinum toxin type A~Exclusion Criteria:~* Body weight below 50kg~* Fixed contractures of the target joint~* Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A~* Infection at the injection site

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

Study Arms:
- IncobotulinumtoxinA (Xeomin) (up to 800 Units) (Type: EXPERIMENTAL): IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for 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: Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial

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:~1. 18 years of age and older~2. Implantation with HeartMate II® or HeartWare®, LVAD at Barnes Jewish Hospital~Exclusion Criteria:~1. Unable to receive heparin-based therapy~2. Hypercoagulable disorders \[factor V Leiden, Antithrombin deficiency, Protein C deficiency, Antiphospholipid antibodies or other thrombophilia\]~3. Incarceration~4. Pregnancy or breastfeeding

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

Study Arms:
- aPTT nomogram (Type: ACTIVE_COMPARATOR): aPTT guided heparin management
- Anti-factor Xa nomogram (Type: EXPERIMENTAL): Anti-factor Xa guided heparin management

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 INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Men and women, aged 18 years or older.~* Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.~* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.~* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.~Exclusion Criteria:~* History of central nervous system lymphoma (either primary or metastatic).~* Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan PI3K inhibitor.~* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.~* Active graft-versus-host disease.~* Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

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

Study Arms:
- Cohort 1: Treatment A (Exposed to Ibrutinib) (Type: EXPERIMENTAL): Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks.~Participants who were exposed to ibrutinib before enrollment were included in this group.
- Cohort 1: Treatment B (Exposed to Ibrutinib) (Type: EXPERIMENTAL): Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks.~Participants who were exposed to ibrutinib before enrollment were included in this group.
- Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) (Type: EXPERIMENTAL): Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks.~Participants who had not received a BTK inhibitor previously were included in this group.
- Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) (Type: EXPERIMENTAL): Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks.~Participants who had not received a BTK inhibitor previously were included in this group.

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: Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

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

Eligibility Criteria:
Patients with New York Heart Association class II or class III heart failure and ejection fraction less than or equal to 35%.

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 90 Years
- 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: Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

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:~* Signed written informed consent,~* 20 to 75 years old,~* Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)~Exclusion Criteria:~* Acute myocardial infarction within 72 hours after the onset,~* Heart failure of New York Heart Association (NYHA) Class III or above,~* Serious arrhythmia,~* Being treated with LDL-apheresis~* History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

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

Answer: outcome: complete