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

Trial Title: Erlotinib and Surgery in Treating Patients With Head and Neck Cancer That Can Be Removed by Surgery

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx~  * SCC of the base of the tongue, pharynx, larynx, or hypopharynx are eligible provided additional biopsy tissue has been already saved in the Tumor Tissue Core Laboratory for research purposes~ * SCC of the oral cavity or tonsils are eligible only if they already have or agree to have additional biopsies of tumor with adjacent normal tissue available for molecular studies~* Candidate for surgical treatment with an established date for surgery with ≥ a 15 day window of opportunity~* Measurable disease by CT scan or MRI~* No nasopharyngeal carcinoma~PATIENT CHARACTERISTICS:~Inclusion criteria:~* ECOG performance status 0-2~* ANC \> 1,500/µL~* Platelet count \> 100,000/µL~* Total bilirubin \< 1.5 mg/dL~* AST/ALT \< 2 times upper limit of normal~* Creatinine \< 1.5 mg/dL~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~Exclusion criteria:~* Uncontrolled intercurrent illness including, but not limited to, any of the following:~  * Ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements~ * Significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, or myocardial infarction within the past 3 months)~ * Uncontrolled congestive heart failure~ * Cardiomyopathy with decreased ejection fraction~* History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on chest CT scan~* Clinically significant ophthalmologic abnormalities~* HIV positivity~PRIOR CONCURRENT THERAPY:~* More than 1 year since prior chemotherapy, biologic therapy, or hormonal therapy~* No prior radiotherapy or chemotherapy for this tumor~* No prior EGFR inhibitors~* No concurrent grapefruit or grapefruit juice~* No other concurrent investigational agents

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

Study Arms:
- Erlotinib (Type: EXPERIMENTAL): Erlotinib

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 Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

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

Eligibility Criteria:
Inclusion Criteria:~* Present with type 2 diabetes~* Patients have been treated with a stable dose of the following for at least 3 months prior to screening:~  * 100 mg/day sitagliptin and~ * ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).~* Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.~* Have a body mass index (BMI) ≥20 kg/m2 and \<45 kg/m2~Exclusion Criteria:~* Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.~* Have previously completed or withdrawn from this study or any other study investigating exenatide.~* Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.~* Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.~* Are currently treated with any of the following excluded medications:~  * Thiazolidinediones (TZD) within 3 months of screening.~ * Sulfonylurea (SU) within 3 months of screening.~ * Dipeptidyl peptidase-4 \[DPP-4\] inhibitors, with the exception of sitagliptin, within 3 months of screening.~ * Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.~ * Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.~ * Exogenous insulin within the 3 months prior to screening.~ * Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.~ * Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.~ * Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (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: Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control

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

Eligibility Criteria:
Inclusion Criteria:~1. Newly diagnosed type 2 diabetic patients.~2. Hospitalization due to hyperglycemia hyperosmolality syndrome.~3. Those who age between 30 and 80 years old and can inject insulin by themselves.~Exclusion Criteria:~1. Pregnant women.~2. Impaired liver function (ALT \> 120 U/L)~3. Impaired renal function (Serum creatinine \>3.0 mg/dL)~4. Recently suffered from MI or CVA.~5. Patients are acute intercurrent illness.~6. 2-hour C-peptide level \< 1.8 ng/mL.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Insulin (Type: EXPERIMENTAL): Insulin therapy was initiated at a 75% total daily dose in the last day hospitalization with Insulatard. Two third of daily dose was administered before breakfast and the other was administered at bedtime. Insulin doses were titrated every 3 days to achieve target FPG and pre-supper blood glucose values between 90 and 130 mg/dl. Bedtime insulin doses were titrated based on FPG values and the pre-breakfast dose was titrated base on pre-supper blood glucose.
- OAD (Type: ACTIVE_COMPARATOR): Subject in other OAD group was visited every two weeks in the two months and the every four weeks. The subjects will start with Gliclazide-MR 30mg before breakfast, The dosage was titrated based on the fasting blood glucose on the visiting day with the same target. Decreased by 30mg if blood glucose was \<70mg /dl, decreased by 15 mg if blood glucose was 70-90mg/dl, no change if blood glucose was 90-130mg/dl, increased by 15 mg if blood glucose was 131-160 mg/dl, increased by 30 mg if blood glucose \>160mg/dl. When the Gliclazide-MR dose each to the maximum dose of 60 mg twice daily, Metformin was added. The titration of Metformin was use 250mg for an adjust dosage with the same target.

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 Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response

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

Eligibility Criteria:
Inclusion Criteria:~* Aged 18 years or older.~* Scheduled for elective total hip arthroplasty or hemicolectomy.~Exclusion Criteria:~* Lack of informed consent or inability to give informed consent.~* Urgent surgery, such as hip fracture.~* Contra-indications for spinal or epidural analgesia, including but not limited to:~  * Infection at the site of puncture.~ * Coagulopathy.~ * Severe hypovolemia.~ * Severe aortic valve stenosis (cross sectional area \< 1,3 cm2).~ * Severe mitralis valve stenosis (cross sectional area \< 1,0 cm2).~ * Increased intracranial pressure.~ * Pre-existing neurological condition.~ * Severe spine deformity.~ * Sepsis.~ * Body mass index (BMI) \> 35 kg/m2~* Hypersensitivity or known allergic reactions to any products used for anesthesia.~* History of chronic opioid analgesics use.~* Preoperative use of steroids:~  * Including, but not limited to: injection of hydrocortisone \< 3 months before surgery.~* Preexisting muscle disease~  * Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.

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

Study Arms:
- Hip surgery: spinal anesthesia (Type: EXPERIMENTAL): Patients scheduled to undergo elective total hip arthroplasty will receive spinal anesthesia in combination with monitored anesthesia care (MAC).
- Hip surgery: general anesthesia (Type: EXPERIMENTAL): Patients scheduled to undergo elective total hip arthroplasty will receive general anesthesia
- Colectomy: general anesthesia and epidural analgesia (Type: EXPERIMENTAL): Patients scheduled to undergo elective laparoscopic hemicolectomy will receive general anesthesia combined with epidural analgesia (EA).
- Colectomy: general anesthesia (Type: EXPERIMENTAL): Patients will receive general anesthesia.

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 Advanced Pancreatic Cancer

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 or cytologically confirmed advanced pancreatic adenocarcinoma~  * Distant metastases OR~ * Locoregional disease that has failed or is not amenable to locoregional therapy~* No de novo locoregional disease~* No known brain metastases~PATIENT CHARACTERISTICS:~Age:~* Adult~Performance status:~* Zubrod 0-1~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 1.5 times upper limit of normal (ULN)~* SGOT or SGPT no greater than 2.5 times ULN~* Alkaline phosphatase less than 2.5 times ULN~Renal:~* Creatinine no greater than 1.5 mg/dL~Cardiovascular:~* No recent myocardial infarction, unstable angina, or life-threatening arrhythmia~Other:~* Not pregnant or nursing~* Fertile patients must use effective contraception~* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission~* No prior severe hypersensitivity reaction to drugs containing Cremophor EL~* No active or uncontrolled infection~* No severe psychiatric disorders~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* No prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer~* No concurrent anticancer immunotherapy~Chemotherapy:~* No prior neoadjuvant, adjuvant, or primary chemotherapy for advanced pancreatic cancer~* No other concurrent anticancer chemotherapy~Endocrine therapy:~* No prior neoadjuvant, adjuvant, or primary hormonal therapy for advanced pancreatic cancer~* No concurrent anticancer hormonal therapy~Radiotherapy:~* No prior neoadjuvant, adjuvant, or primary radiotherapy or chemoradiotherapy for advanced pancreatic cancer~* Prior palliative radiotherapy allowed if at least 1 lesion remains outside of radiation field or at least 1 lesion has progressed since radiotherapy~* No concurrent anticancer radiotherapy except palliative radiotherapy to non-target metastatic sites~Surgery:~* At least 2 weeks since prior surgery for pancreatic cancer and recovered~Other:~* No other concurrent anticancer therapy~* No concurrent herbal or unconventional therapy (e.g., St. John's Wort)

- 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: A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

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

Eligibility Criteria:
Inclusion Criteria:~1. The patient has a complaint of sore throat.~2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.~3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.~4. The patient has provided written informed consent prior to any study-related procedures.~Exclusion Criteria:~1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).~2. The patient has a history of any hepatic disease or renal dysfunction.~3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)

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

Study Arms:
- flurbiprofen 8.75 mg lozenge (Type: EXPERIMENTAL): Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another study medication lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use study medication lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.
- placebo lozenge (Type: PLACEBO_COMPARATOR): Participants were instructed to suck one study (placebo) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use a lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day 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: Asacol Acute Diverticulitis(DIVA)Study

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* A clinical diagnosis of acute diverticulitis~* Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception \[at least 3 months prior to enrollment\]; 2-barrier methods \[e.g., condom, diaphragm, or spermicide\]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)~* Willing and able to participate in the study and provide a signed informed consent~Exclusion Criteria:~* Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);~* Active or recent history (within 6 months) of a peptic ulcer;~* Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;~* History of major abdominal surgery (as determined by the Investigator);~* History of GI surgery within 3 months of diagnosis of acute diverticulitis;~* History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);~* If female patient, active or recent history of endometriosis or dysmenorrhea;~* Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
- Mesalamine (Type: ACTIVE_COMPARATOR): Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
- Mesalamine & Probiotic (Type: ACTIVE_COMPARATOR): Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily

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

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

Trial Title: Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. HER2/neu expressing tumor~2. HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2- and/or HLA-A3- patients will be eligible to be included in the control group.~3. Immunologically intact with a good performance status~4. Identified as being high or intermediate risk for recurrence~5. Without evidence of disease~6. Completion of all standard first-line therapies (but may still be on hormonal therapy)~Exclusion Criteria:~1. Tumor does not express HER2/neu~2. Not HLA-A2+ and/or HLA-A3+~3. Anergic~4. Receiving immunosuppressive therapy~5. In poor health (Karnofsky \<60%, ECOG \>2 and Tbili \>1.5 and creatinine\>2)~6. Pregnant (beta HCG+)~7. Metastatic disease or have refused standard therapies~8. Patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study PI.

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

Study Arms:
- E75 + GM-CSF vaccine (Type: EXPERIMENTAL): The dose escalation scheme is for three patients to receive each of the doses, 100, 500, and 1,000 mcg of peptide + 250 mcg GM-CSF each month for 6 months until the maximum tolerated dose is determined. Patients who receive the vaccine are HLA-A2+ and/or HLA-A3+. Responses to the vaccine are measured via immunologic assays.
- Control/observation (Type: NO_INTERVENTION): HLA-A2- and HLA-A3- patients do not receive the E37 + GM-CSF vaccine, but are instead enrolled to the control arm for observation.

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 and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of statin intolerance~* Diagnosis of Coronary Artery Disease (CAD)~* Diagnosis of hypercholesterolemia~* Stable weight for \> 6 weeks~Exclusion Criteria:~* Significant health problems in the recent past (≤24 weeks) including heart attack, heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive problems, disease of central nervous system, cancer, liver or renal disease

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): 1 mL placebo saline, weekly subcutaneous injections for 26 weeks
- Mipomersen (Type: EXPERIMENTAL): 200 mg (1 mL), weekly subcutaneous injections for 26 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: High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion

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

Eligibility Criteria:
Inclusion Criteria:~* Older than 18 years old~* Scheduled for 5 or 6 Fr diagnostic coronary angiography~* The interventional cardiologist is willing to proceed with radial access~* Written informed consent~Exclusion Criteria:~Before randomization~* chronic hemodialysis~* oral anticoagulation~* hemodynamic instability~* severe dermo-myoskeletal forearm deformities~* history of CABG and bilateral use of either the internal mammary or radial artery~* history of CABG and ipsilateral use of both the internal mammary and radial artery~* admission for elective PCI After randomization~* crossover to another arterial access site is required~* ad hoc PCI

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

Study Arms:
- Standard dose of Heparin (Type: ACTIVE_COMPARATOR): 50IU/Kg heparin intravenously
- High dose of Heparin (Type: EXPERIMENTAL): 100IU/Kg heparin intravenously

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

Answer: outcome: complete