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

Trial Title: A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

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:~* treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection~* liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening~* liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)~Exclusion Criteria:~-Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study

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

Study Arms:
- TMC435 + PegIFNα-2a + RBV (Type: EXPERIMENTAL): TMC435 will be administered as triple therapy with pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV).

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: Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate

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

Eligibility Criteria:
Inclusion Criteria:~1. Adult 18 or over~2. Meets definition of acute sinusitis by Infectious Disease Society of America (2012)~3. Clinician and participant chose to start antibiotic treatment~Exclusion Criteria:~1. Previously enrolled in the study~2. Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate~3. Specific medication concerns: lactating (since safety of clavulanate unknown); taking allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash with amoxicillin); chronic kidney disease with glomerular filtration rate \< 30; significant hepatic impairment; history of antibiotic-associated colitis~4. Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement~5. Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin within the past month (risk of penicillin-resistant pneumococci), very ill patient (though not ill enough to send to hospital); immunocompromise~6. Need to hospitalize the patient

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

Study Arms:
- standard dose (Type: ACTIVE_COMPARATOR): amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
- high dose (Type: EXPERIMENTAL): Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days

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

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

Trial Title: The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy

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

Eligibility Criteria:
Inclusion Criteria:~1. being classified at Gross Motor Function Classification System (GMFCS) level III-IV~2. being classified at Manual Ability Classification System (MACS) level III-IV~3. being able to understand and execute given instructions for evaluations~4. parental acceptance of using the lycra based compression garment.~Exclusion Criteria:~1. serious respiratory restriction~2. having refractory cyanosis or circulatory disorder~3. having undergone lycra compression orthosis treatment programme previously~4. having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year~5. severe scoliosis (Cobb angle (CA) \>40°)~6. uncontrolled epilepsy~7. having intrathecal baclofen pump~8. having undergone selective dorsal rhizotomy~9. having reflux more than 3 times a week.

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- SPIO 2 hours (Type: EXPERIMENTAL): All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.~SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.
- SPIO 6 hours (Type: EXPERIMENTAL): SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.
- Control(conventional exercises) (Type: ACTIVE_COMPARATOR): Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 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: Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening.~* Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.~* Subjects who are currently being treated with oral or depot antipsychotics other than clozapine.~* Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.~Exclusion Criteria:~* Subjects with a current DSM-IV-TR diagnosis other than schizophrenia.~* Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).~* Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or subjects who were on a stimulant treatment for any period of time over the last one year prior to screening.~* Subjects with any neurodevelopmental disorder, except Tourette's syndrome.~* Subjects experiencing acute depressive symptoms within the past 30 days prior to screening.~* Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.~* Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.~* Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism or hyperthyroidism (unless the condition has been stabilized with medication for at least 90 days prior to entry into Phase 1 or Phase 2).~* Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels.

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Phase 1 (Type: EXPERIMENTAL): Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
- Phase 2 (Type: EXPERIMENTAL): Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
- Phase 3 (Type: PLACEBO_COMPARATOR): Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or 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 Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice

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:~* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)~* Diagnosed with type 2 diabetes mellitus~* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study~* Male or female, age above or equal to 18 years at the time of signing informed consent~* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice~* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days~Exclusion Criteria:~* Previous participation in this study. Participation is defined as having given informed consent in this study~* Treatment with any investigational drug within 30 days prior to enrolment into the study~* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

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

Study Arms:
- Patients with type 2 diabetes (Type: None): Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

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: Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

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:~* Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years~  * If histologic proof of malignancy is from \> 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis)~ * Patients with metastasis of unknown primary tumor are permitted~* Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days~* Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection~  * These treatment options are allowed only at relapse~* Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans~* At least 1 week since open biopsy~* Karnofsky performance status 70-100%~* Fertile patients must use effective contraception~* Negative pregnancy test 2 weeks or less prior to study entry~* Patients must be English proficient, with patients who speak English as a second language eligible~EXCLUSION CRITERIA:~* Small cell lung cancer or germ cell malignancy~* Leptomeningeal metastases~* Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases~* Radiologic evidence of hydrocephalus~* Serum creatinine \> 1.4 mg/dL within 30 days prior to study entry~* Pregnant or nursing~* Contraindication to MRI imaging such as implanted metal devices or foreign bodies or severe claustrophobia~* Severe, active co-morbidity including any of the following:~  * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months~ * Transmural myocardial infarction within the past 6 months~ * Acute bacterial or fungal infection requiring intravenous antibiotics~ * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects~ * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy~ * Uncontrolled, clinically significant cardiac arrhythmias~* Prior radiotherapy to the brain~* Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 120 Years
- Healthy Volunteers: f

Study Arms:
- WBRT with Hippocampal Avoidance (Type: OTHER): Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)

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: Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies

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 18-89~* Diagnosis of indolent or intermediate grade B-cell malignancy~* Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight~* First dose given within 3 months of the second dose~* Infusion scheduled for outpatient administration at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute~Exclusion Criteria:~* Diagnosis of aggressive lymphoma~* Absolute lymphocyte count \> 10 x 103 cells/µL~* New York Heart Association (NYHA) classification Grade II or greater congestive heart failure~* Enrolled on another clinical trial~* Allergy to murine-containing medications~* Grade III or IV hypersensitivity reaction during the initial infusion of rituximab~* Prisoners~* Pregnant women~* Mentally or physically unable to give consent

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 89 Years
- Healthy Volunteers: f

Study Arms:
- Rituximab (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: Plegridy Observational Program

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:
Key Inclusion Criteria:~* Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).~* Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance.~Key Exclusion Criteria:~* Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol.~NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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

Study Arms:
- peginterferon beta-1a (Type: None): Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.

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 Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years.~* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.~Exclusion Criteria:~* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).~* History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.~* History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.~* History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.~* Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- PF-04447943 low dose (Type: EXPERIMENTAL): 25 mg of PF-04447943
- PF-04447943 high dose (Type: EXPERIMENTAL): 100 mg of PF-04447943
- Placebo (Type: PLACEBO_COMPARATOR): Matching placebo for PF-04447943
- Moxifloxacin (Type: ACTIVE_COMPARATOR): 400 mg of moxifloxacin

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: Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic for preoperative evaluation.~* Above referral must be in anticipation of a non-cardiac, non-vascular surgery.~* Must have been on ACE-Inhibitor therapy for at least six weeks.~Exclusion Criteria:~* Hypotension (systolic blood pressure \< 90 or diastolic blood pressure \<60) at the time of preoperative evaluation~* Uncontrolled Hypertension (systolic blood pressure \> 150 or diastolic blood pressure \> 95) at the time of preoperative evaluation~* Surgery during which vasopressor use is anticipated (carotid endarterectomy, major abdominal operations, orthopedic oncology)~* Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma)~* Left Ventricular ejection fraction less than 40%~* Clinical evidence of decompensated heart failure at the time of preoperative evaluation~* End-stage renal disease~* Organ transplant surgeries

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- ACEI continuation (Type: EXPERIMENTAL): Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively
- ACEI omission (Type: EXPERIMENTAL): Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.

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 Comparison of Once a Day Dose Compared to 2 Doses/Day

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

Eligibility Criteria:
Inclusion Criteria:~* Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry~* At least one flare in the past 18 months~* Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)~* Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception~Exclusion Criteria:~* History of or current renal disease~* History of hepatic disease~* History of allergy or hypersensitivity to salicylates, aminosalicylates~* Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening~* Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening

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

Study Arms:
- Mesalamine (Asacol) Once-Daily (Type: ACTIVE_COMPARATOR): an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
- Mesalamine (Asacol) Twice-Daily (Type: ACTIVE_COMPARATOR): an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

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

Answer: outcome: complete