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

Trial Title: A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers

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

Eligibility Criteria:
Inclusion Criteria:~* Caucasian~* No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder~* Normal 12-lead Electrocardiogram (ECG)~* Systolic blood pressure \<140 mm Hg and diastolic blood pressure \<90 mm Hg~* Non-smoker within 3 months prior to screening~* Willing to abstain from alcohol during the study~Exclusion Criteria:~* Positive screen for illicit drug or alcohol consumption~* Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)~* Positive tuberculin skin test or known history of tuberculosis infection~* Known history of serious head injuries, seizures or eating disorders~* Body Mass Index \<18.0 or \>30.0~* History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin \<130 g/L~* Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.~* Drug or alcohol abuse within 1 year prior to study entry~* Steroid injections within 12 weeks prior to first dose of study drug~* Live vaccine within 7 days prior to first dose of study drug

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Advagraf followed by Prograf (Type: EXPERIMENTAL): None
- Prograf followed by Advagraf (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: A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

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:~* Subject is a male or female subject 40 years of age or older~Exclusion Criteria:~* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- TD-4208-1 (Type: EXPERIMENTAL): 88 mcg
- TD-4208-2 (Type: EXPERIMENTAL): 175 mcg
- Tiotropium (Type: ACTIVE_COMPARATOR): 18 mcg

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: Prevention of Lung Edema After Thoracic Surgery

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

Eligibility Criteria:
Inclusion Criteria:~Patients with at least 3 risk factors for postoperative lung edema~* age \> 60 yrs~* history of chronic alcohol consumption (\>60g/day)~* prior radiation or chemotherapy~* cardiac insufficiency (left ventricular ejection fraction \< 40%, or a history of past acute heart failure)~* coronary artery disease (history of myocardial infarct, Q wave on the ECG, positive stress test or coronary angiogram)~* recent pneumonia (within 6 weeks of hospital admission)~* reduced diffusion capacity for carbon monoxide (DLCO \< 60% of predicted values)~* predicted postoperative lung perfusion of \< 55% of total lung perfusion~Exclusion Criteria:~* pneumonectomy~* intracardiac shunts~* valvular diseases~* aortic abdominal aneurysm~* chronic treatment with inhaled bronchodilators~* a history of any adverse reaction to bronchodilators~* liver or kidney insufficiencies

- Gender: ALL
- 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: Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

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:~* has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease~* has cirrhosis or is non-cirrhotic~* is human immunodeficiency virus (HIV) coinfected or not infected with HIV~* is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception~Exclusion Criteria:~* has evidence of decompensated liver disease~* is coinfected with hepatitis B~* has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer~* has hepatocellular carcinoma (HCC) or is under evaluation for HCC~* has clinically-relevant drug or alcohol abuse within 12 months of screening

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

Study Arms:
- Immediate Treatment (Type: EXPERIMENTAL): Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.
- Deferred Treatment (Type: PLACEBO_COMPARATOR): Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.

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: Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Diagnosis of localized breast cancer~  * Stage I or II (T1-3, N0-2, M0)~* Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration~* Hormone receptor status:~  * Estrogen receptor and progesterone receptor status known~PATIENT CHARACTERISTICS:~Age~* 18 to 50~Sex~* Female~Menopausal status~* Premenopausal or perimenopausal~Performance status~* Not specified~Life expectancy~* Not specified~Hematopoietic~* Not specified~Hepatic~* Not specified~Renal~* Creatinine less than 2 mg/dL~Other~* No T score of less than 2.0 on bone mineral density (BMD)~* No fragility fracture~* No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of 3 lumbar vertebrae~* Not pregnant~PRIOR CONCURRENT THERAPY:~Biologic therapy~* Not specified~Chemotherapy~* See Disease Characteristics~Endocrine therapy~* Not specified~Radiotherapy~* No concurrent radiotherapy~Surgery~* See Disease Characteristics~Other~* At least 1 month since prior calcitonin~* At least 12 months since prior bisphosphonates given for more than 1 month duration~* No concurrent fluoride therapy (10 mg/day or more)~* No concurrent enrollment in another experimental drug study

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 50 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: Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines

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

Eligibility Criteria:
Inclusion Criteria:~1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest~2. Age ≥ 18 years~3. Able and willing to give written informed consent~4. WHO performance status of 0, 1 or 2~5. Life expectancy of at least 12 weeks~6. Able to swallow and retain oral medication~7. Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis~8. Minimal acceptable safety laboratory values (ANC, platelet count, hepatic function, renal function)~Additional inclusion criteria for patients in subgroup of study:~1. Able and willing to undergo blood sampling and breath sampling at several time points~2. Able and willing to receive uracil for the test dose assay~3. Able and willing to receive \[2-13C\] -labeled uracil for the breath test~Exclusion Criteria:~1. Prior treatment with fluoropyrimidines~2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety~3. Women who are pregnant or breast feeding~4. Both men and women who refuse to use reliable contraceptive methods throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)~5. Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD

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

Study Arms:
- heterozygous carrier of DPYD variant (Type: EXPERIMENTAL): Patients screened for four single nucleotide polymorphisms (SNPs) in DPYD (DPYD\*2A, c.2846A\>T, c.1236G\>A/HapB3 and DPYD\*13) that are found to be heterozygous for one of these SNPs
- wild type for DPYD (Type: EXPERIMENTAL): Patients screened for four single nucleotide polymorphisms (SNPs) in DPYD (DPYD\*2A, c.2846A\>T, c.1236G\>A/HapB3 and DPYD\*13) that are found to be wild type for these SNPs

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: Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro

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

Eligibility Criteria:
MAJOR INCLUSION CRITERIA:~1. Must experience sleep disturbances at least 3 nights/week, based on historical data~2. Must meet the diagnostic requirements for Major Depressive Disorder~3. Must have QIDS-SR16 score between 6 and 15~4. Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication~5. Age 21-64, inclusive~6. Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization.~7. Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.~MAJOR EXCLUSION CRITERIA:~1. Severity of depressive episode had been rated as severe or severe with psychotic features.~2. History of a suicide attempt or suicidal ideation.~3. History of mania, manic episode or bipolar disease.~4. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.~5. Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag~6. Any abnormal pre-study laboratory values that require clinical intervention~7. Prior failure to respond to escitalopram therapy for depression~8. Current depressive episode requiring inpatient hospitalization.~9. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.~10. History of drug addiction, alcoholism, or drug abuse.~11. A positive urine drug screen for medication that would interfere with the assessment of the study medication.~12. Known allergy to zolpidem, escitalopram or any of their excipients~13. History of sleep apnea~14. History of myasthenia gravis~15. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.~16. Pregnant or breastfeeding~17. Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 64 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: ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer

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:~-~Aim 1:~Inclusion Criteria:~* Patients are 30-90 years of age~* Patients have breast masses with BIRADS 4a, 4b, 4c, or 5 rating~* Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup~* Informed consent obtained and signed~Aim 2:~Inclusion Criteria:~* Patients are 30-90 years~* Patients who are or will be undergoing neoadjuvant chemotherapy (NAC) for stage 2 or 3 malignant breast lesions~* Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup~* Informed consent is obtained and signed~Exclusion Criteria: Subjects who meet any of the exclusion criteria will be excluded from study participation for both Aim 1 and Aim 2.~* Inability to provide informed consent~* Inability to communicate in English~* Inability to remain motionless for 15 minutes~* Suspicious or malignant breast mass deeper than 3 cm from skin surface~* Previous biopsy or surgery to the site of the suspicious or malignant mass~* Patients who are pregnant~* Patients who are lactating~* Patients with a history of masectomy~* Patients with breast implants

- Gender: FEMALE
- Minimum Age: 30 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- Women scheduled for biopsy (Type: None): 40 participants with diagnosed BIRADS-4a, 4b, 4c, or -5 masses will be recruited. The investigators aim to have approximately 10 in each of the BIRADS categories (4a, 4b, 4c, 5), resulting in 40 total subjects for Aim #1.
- Women scheduled for neoadjuvant chemo (Type: None): 40 participants with malignant masses undergoing neoadjuvant chemotherapy (NAC) will be recruited.

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 Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection

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:~* Age 18 to 45 years, inclusive~* In good health with no history of major medical conditions~* A total body weight ≥ 50 kg and a body mass index (BMI) of \>/=18kg/m2 and \</=30kg/m2~Exclusion Criteria:~* Evidence of any clinically significant or currently active major medical condition~* Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test~* Significant nose or nasopharynx abnormalities~* Abnormal lung function~* History or currently active symptoms suggestive of upper or lower respiratory tract infection

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- RV521 (Type: EXPERIMENTAL): RV521 drug substance in capsule for oral administration
- Placebo (Type: PLACEBO_COMPARATOR): Micro-crystalline cellulose in capsule for oral administration

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: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

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

Eligibility Criteria:
Inclusion Criteria:~* Term neonates, gestational age 37-42 weeks~* Apgar \>= 7~* Not fed in the last 30 minutes~* Informant consent~Exclusion Criteria:~* Congenital malformation~* Born in Caesarian Section in General Anaesthesia~* Maternal use of opioids~* Administration of Naloxone, Phenobarbital in the previous 48 hours~* Impossibility of breastfeeding

- Gender: ALL
- Minimum Age: 2 Days
- Maximum Age: 5 Days
- 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: Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172

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

Eligibility Criteria:
Inclusion Criteria:~* Current Washington Heights-Inwood Community Aging Project (WHICAP) participant Age 65 or older Residing in the community of Washington-Heights/Inwood/Hamilton Heights~* Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the Positron Emission Tomography (PET) scanner~* Possesses a general health that permits adequate compliance with all study procedures.~* Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable Alzheimer's Disease (AD) patients)~Exclusion Criteria:~* Has any contraindication to PET, such as claustrophobia, or inability to lie flat for half an hour as determined by the onsite radiologist performing the scan~* Current, past, or anticipated exposure to radiation, which may include being badged for radiation exposure in the workplace or participation in nuclear medicine procedures, including research protocols in the last year~* Significant active physical illness particularly those that may affect the brain including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, low hemoglobin and malignancy~* Scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following scan~* Allergic to the tracer or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients with allergic asthma)~* Critically ill and/or medically unstable and whose clinical course within the observation period is unpredictable, e.g. participants with 14 days of myocardial infarction or stroke, unstable participants with previous surgery (within 7 days), participants with advanced heart insufficiency (New York Heart Association (NYHA) stage IV), or participants with acute renal failure.~* Has received any contrast material (X-ray, Magnetic Resonance Imaging (MRI)), or radiopharmaceuticals within 48 hours prior to the application of the Investigational Medicinal Product (IMP) or for whom application of such a substance is planned for 24 hours following IMP administration

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- BAY 94-9172 (Type: EXPERIMENTAL): BAY 94-9172 PET/CT

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: ESP Catheter Vs Single Shot ESP for Open Heart Surgery in Infants

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

Eligibility Criteria:
Inclusion Criteria:~* Elective open heart surgery~Exclusion Criteria:~* Consent refusal~* Urgent surgery~* unstable hemodynamic patient after anesthesia induction

- Gender: ALL
- Minimum Age: 2 Months
- Maximum Age: 10 Years
- Healthy Volunteers: f

Study Arms:
- Control Group (Type: PLACEBO_COMPARATOR): Erector spinae bilateral catheters with continuous infusion iso saline during 48h after surgery Day 0 to day 2
- Regional analgesia group (Type: EXPERIMENTAL): Erector spinae bilateral catheters with continuous infusion Ropivacaine 0.1 or 0.2%, depending on age, infusion during 48h after surgeryDay 0 to day 2

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: Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Males or non-pregnant/non-breast feeding females~* At least 30 years of age~* Diagnosis of idiopathic Parkinson''s disease (Hoehn \& Yahr criteria)~* Completed either Study 167 or Study 164~Exclusion Criteria:~* Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy~* Dizziness or fainting due to orthostatic hypotension on standing~* Significant sleep disorder~* Drug abuse or alcoholism

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Active (Type: ACTIVE_COMPARATOR): Open label medication - Ropinirole CR

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

Answer: outcome: complete