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

Trial Title: A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

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

Eligibility Criteria:
Inclusion Criteria:~* Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype~* Minimum PANSS total score of 70 at Screening and Baseline~* Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS~* Confirmed to be experiencing an acute exacerbation of schizophrenia~* CGI-S scale score of at least 4 (moderately ill) at Baseline~* Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode~Exclusion Criteria:~* Body mass index (BMI) \<18.5 or \>40.0 kg/m\^2~* Laboratory and/or clinical evidence of clinically significant hepatic conditions~* Known history of, or undergoing treatment for, narrow angle glaucoma~* Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures~* Known serological evidence of human immunodeficiency virus (HIV) antibody~* History of neuroleptic malignant syndrome or tardive dyskinesias~* Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder

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

Study Arms:
- Asenapine 2.5 mg BID (Type: EXPERIMENTAL): None
- Asenapine 5 mg BID (Type: EXPERIMENTAL): None
- Olanzapine 15 mg QD (Type: ACTIVE_COMPARATOR): None
- Placebo BID (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: A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

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

Eligibility Criteria:
Inclusion Criteria:~* Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to have residual function~* Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening~* Sweat chloride value ≥60 millimole per liter (mmol/L) during screening OR as documented in the participant's medical record~* Stable CF disease as judged by the investigator~Exclusion Criteria:~* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant~* An acute upper or lower respiratory infection, pulmonary exacerbation~* History of solid organ or hematological transplantation~* Ongoing or prior participation in an investigational drug study (including studies investigating VX-661, lumacaftor \[VX-809\], and/or ivacaftor) within 30 days of screening~* Pregnant and nursing females~* Sexually active participants of reproductive potential who are not willing to follow the contraception requirements

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

Study Arms:
- VX-661/Ivacaftor combination (Type: EXPERIMENTAL): None
- Ivacaftor monotherapy (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability

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:~* Adults aged 18-70 years with a BMI of 25-45 kg/m2 and weight \<160 kg~* Access to a smartphone~* Satisfactory completion of all enrollment procedures~* Ability to engage in physical activity (i.e. can walk at least 2 blocks without stopping for rest)~Exclusion Criteria:~* Medical condition (i.e. acute coronary syndrome, type 1 diabetes, renal failure) or psychiatric condition (i.e. active substance abuse, eating disorder) that may:~  * Pose a risk to the participant during the intervention~ * Cause a change in weight~ * Limit ability to comply with the behavioral recommendations of the program~* Pregnant or planning pregnancy in the next 1 year~* Planned move out of the Philadelphia area during the data collection period~* Use of a pacemaker (incompatible with wireless scale technology)~* Recently began or changed the dosage of a medication that can cause significant change in weight~* History of bariatric surgery~* Weight loss of \> 10% in the previous 3 months

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

Study Arms:
- Lifestyle Modification (Type: ACTIVE_COMPARATOR): Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.
- Lifestyle Modification + Share (Type: EXPERIMENTAL): Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.

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: BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically confirmed adenocarcinoma of the prostate~  * Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)~* Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:~  * Progression of unidimensionally measurable lesion outside of a prior radiation port~ * Progression of non-measurable disease (e.g., bone scan)~* Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart~* PSA at least 5 ng/mL~* No brain metastases~PATIENT CHARACTERISTICS:~Age:~* Not specified~Performance status:~* Zubrod 0-2~Life expectancy:~* Not specified~Hematopoietic:~* Absolute granulocyte count at least 1,500/mm\^3~* Platelet count at least 100,000/mm\^3~Hepatic:~* Bilirubin no greater than upper limit of normal (ULN)~* SGOT or SGPT no greater than 2.5 times ULN~Renal:~* Creatinine no greater than 2.0 mg/dL OR~* Creatinine clearance at least 40 mL/min~Other:~* No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission~* No other concurrent significant active illness that would preclude study participation~* Recovered from major infections~* Fertile patients must use effective contraception~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* At least 28 days since prior biologic therapy and recovered~* No more than 1 prior biologic (non-cytotoxic) therapy~* No concurrent biological response modifiers~Chemotherapy:~* No prior chemotherapy for this disease~* No other concurrent chemotherapy~Endocrine therapy:~* See Disease Characteristics~* At least 28 days since prior flutamide or ketoconazole~* At least 42 days since prior bicalutamide or nilutamide~* No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy~* No concurrent corticosteroids~Radiotherapy:~* See Disease Characteristics~* Prior radiotherapy to less than 30% of bone marrow allowed~* No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium~* At least 28 days since prior radiotherapy and recovered~* No concurrent radiotherapy~Surgery:~* Recovered from prior surgery~* Prior orchiectomy allowed~Other:~* No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)~* Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)

- Gender: MALE
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: f

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

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

Trial Title: A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

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:~* Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.~* Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.~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 CGRP antibody.~* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.~* 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) defined by IHS ICHD-3 beta.

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

Study Arms:
- Galcanezumab 120 mg (Type: EXPERIMENTAL): Galcanezumab 240mg given as loading dose at first dosing visit followed by 120 mg given by subcutaneous (SC) injection once a month for up to 11 months by auto injector or pre-filled syringe.
- Galcanezumab 240 mg (Type: EXPERIMENTAL): Galcanezumab 240 mg given by SC injection once a month for up to 12 months by auto injector or pre-filled syringe.

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 to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis

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. Age 18 and older, male and female~2. Patients must consent in writing to participate in the study by signing and dating an informed consent document~3. Diagnosis of osteoarthritis by ACR osteoarthritis of the knee~4. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4~5. More than Grade 4 (0\~10 point numeric scale) pain at least for 12 weeks~6. Diagnosis of osteoarthritis of class Ⅰ\~Ⅲ by ACR(American College of Rheumatology Criteria) Global functional criteria~7. Patient who agree with contraception~Exclusion Criteria:~1. Preparing for Pregnancy or Pregnant women or lactating mothers.~2. Patients with Body Mass Index (BMI) \> 35.~3. Patients with other disease including~   : Septic arthritis, Rheumatoid or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder~4. Patients with serious condition internal medicine disease~5. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection.~6. Patient with behavioral disorders, cognitive disorders and chronic mental symptoms~7. Patient with significant neurologic or psychiatric disorders~8. Patients who alcohol, drug abuse history~9. Patients who had participated in other clinical trials within 12 weeks prior to this study.~10. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.~11. Patients who experienced as the knee joint cartilage and stem cell therapy~12. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above~13. Patients who penicillin hypersensitivity reactions -

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

Study Arms:
- Jointstem (Type: EXPERIMENTAL): Autologous Adipose Tissue derived MSCs
- Saline solution (Type: PLACEBO_COMPARATOR): Sodium chloride

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 IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~1. Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea~2. History of at least one unsuccessful dietary effort to lose body weight~Exclusion Criteria:~1. Diabetes mellitus~2. Weight change \> 5.0% after diet and exercise control for at least 12 weeks before screening~3. Have used or are currently using weight loss drugs within 3 months before screening~4. History of pancreatitis~5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)~6. History of moderate to severe depression，or have a history of serious mental illness~7. Any lifetime history of a suicide attempt

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

Study Arms:
- IBI362 high dose (Type: EXPERIMENTAL): high dose IBI362 administered subcutaneously (SC) once a week.
- IBI362 low dose (Type: EXPERIMENTAL): Low dose IBI362 administered subcutaneously (SC) once a week.
- placebo (Type: PLACEBO_COMPARATOR): placebo administered subcutaneously (SC) once a week.
- IBI362 moderate dose (Type: EXPERIMENTAL): moderate dose IBI362 administered subcutaneously (SC) once a week.
- IBI362 extra high dose (Type: EXPERIMENTAL): extra high dose IBI362 administered subcutaneously (SC) once a 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: Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

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:~1. Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms;~2. 18 years of age or older;~3. Be willing and able to give informed consent;~4. Patients with a Patient rated Pruritus Severity Score ≥ 1~Exclusion Criteria:~1. Receipt of an investigational drug or device, within the past 30 days;~2. Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);~3. Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;~4. Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;~5. Receipt of an H2 antagonist within the past 2 hours;~6. Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties;~7. Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction;~8. Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;~9. Anaphylaxis prior to the acute anaphylactic symptoms having been treated.~10. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;~11. Pregnancy or breastfeeding;~12. Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;~13. Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;~14. Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;~15. History of HIV or other known immunodeficiency;~16. Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;~17. Inability to provide informed consent.~18. Patients on concomitant p-glycoprotein inhibitors

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

Study Arms:
- Test Drug (Type: EXPERIMENTAL): JDP-205 Injection, 10 mg/mL, 1 mL
- Control (Type: ACTIVE_COMPARATOR): Diphenhydramine Injection, 50 mg/mL, 1 mL

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: Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery

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

Eligibility Criteria:
Inclusion Criteria:~1. Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG~2. Females of child-bearing age must have a negative pregnancy test at enrollment~Exclusion Criteria:~1. Patients undergoing combined valve or aortic surgeries~2. Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)~3. Known allergy or intolerance to aspirin, clopidogrel or ticagrelor~4. Patients with active bleeding or history of bleeding diathesis~5. Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days~6. Patients with severe liver disease (e.g. ascites or signs of coagulopathy)~7. Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker~8. Patients with end-stage renal failure requiring dialysis~9. For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR \< 50 ml/min is an exclusion criteria

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo twice daily. Study drug will be started within 48 hours of CABG.
- ticagrelor 90 mg (Type: ACTIVE_COMPARATOR): Taken twice daily. Study drug will be started within 48 hours of CABG.

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: Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Newborns admitted to the UCSD, Children's Hospital or Sharp Mary Birch NICUs with seizures.~* Term infants (gestational age greater than or equal to 37 weeks.~* \> 2500 grams (max blood for study 6mL =3%).~* Postnatal age 14 days or less.~* Serum creatinine less than 1.2 at time of enrollment.~* Received loading dose of phenobarbital 20mg/kg.~* Are still experiencing either clinical or electroencephalographic seizures despite this therapy.~* For whom parental consent to participate in the study is obtained.~Exclusion Criteria:~* Biochemical abnormality - hypoglycemia, hypocalcemia-that when treated result in seizure cessation.~* Severe hypoxic ischemic injury likely to result in imminent death~* The only significant exclusions that will be made in recruitment and enrollment will be the exclusion of infants who are judged by the attending neonatologist to be so critically ill that death is imminent and benefit from neonatal intensive care is very unlikely.~* No rule-based criteria, (using lab or clinical parameters) adequately capture the complete nature of this clinical assessment.~* In general any child receiving active treatment with head cooling will not be excluded.~* Mechanical ventilation and/or the use of inotropic agents to support blood pressure will not be exclusion criteria.

- Gender: ALL
- Minimum Age: 1 Minute
- Maximum Age: 14 Days
- Healthy Volunteers: f

Study Arms:
- levetiracetam dose escalation (Type: EXPERIMENTAL): 6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day

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

Answer: outcome: complete