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

Trial Title: Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Willing and able to provide written informed consent~* History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology~* Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan.~* Prior docetaxel-based chemotherapy is permitted~* Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases)~* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2~Exclusion Criteria:~* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection~* Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT~* Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT~* Administered oral contrast medium ≤120 hours prior to the date of study PET/CT~* Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

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

Study Arms:
- 18F-DCFPyL Injection (Type: EXPERIMENTAL): 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

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

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

Trial Title: Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Patients have given written informed consent~* Body mass index (BMI) ≤ 50 kg/m²~* For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug~* Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m²~* Liver fat content ≥ 8% on MRI-PDFF~* Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3~* Effective contraception for women of child bearing potential~Exclusion Criteria:~* Evidence of another form of liver disease~* Evidence of liver cirrhosis~* Evidence of hepatic impairment~* Positive serologic evidence of current infectious liver disease~* History of excessive alcohol intake~* Acute cardiovascular disease within 6 months prior to Randomization~* Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study~* Use of non-permitted concomitant medication~* Pregnancy or lactation

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

Study Arms:
- Group 1 (Type: EXPERIMENTAL): PXL065 Dose 1
- Group 2 (Type: EXPERIMENTAL): PXL065 Dose 2
- Group 3 (Type: EXPERIMENTAL): PXL065 Dose 3
- Group 4 (Type: PLACEBO_COMPARATOR): Placebo oral tablet

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 of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

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:~* male or female between 18 and 75 years of age;~* have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;~* currently demonstrating moderately active disease~Exclusion Criteria:~Patients will be excluded from admission to the study if they have/are:~* a history of allergy or hypersensitivity to salicylates or aminosalicylates;~* a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;~* current renal or hepatic disease;~* participated in any drug or device clinical study within 30 days of entry;~* currently enrolled in any other clinical study;~* received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;~* received any other topical rectal therapy during the week prior to the Screening Visit;~* received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;~* received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);~* received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;~* received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;~* if female, positive pregnancy test, or lactating.

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

Study Arms:
- Asacol 2.4 g/day (Type: ACTIVE_COMPARATOR): Asacol (2.4 g/day)
- Asacol 4.8 g/day (Type: EXPERIMENTAL): Asacol (4.8 g/day)

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, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

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:~* Male and female, 18 - 70 years of age~* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)~* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)~Exclusion Criteria:~* Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control~* History of meeting DSM-IV-TR criteria for any of the following:~  * Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode~ * Any depressive episode with psychotic or catatonic features~ * Panic disorder with or without agoraphobia~ * Obsessive-compulsive disorder~ * Schizophrenia, schizoaffective, or other psychotic disorder~ * Bulimia or anorexia nervosa~ * Presence of borderline personality disorder or antisocial personality disorder~ * Mental retardation, dementia, amnesia, or other significant cognitive disorders~* Patients who are considered a suicide risk

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Dose-matched placebo one per day, oral administration
- Vilazadone 20mg (Type: EXPERIMENTAL): Vilazodone 20mg once per day, oral administration.
- Vilazodone 40mg (Type: EXPERIMENTAL): Vilazodone 40mg once per day, 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: Fertility Decision-Making in Youth and Young Adults

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

Eligibility Criteria:
Inclusion Criteria:~* (1) youth is between the ages of 8-14 years~* (2) youth self-asserts a transgender identity~* (3) youth has expressed interest in GnRHa or is currently on GnRHa treatment; or~* (1) AYA is between the ages of 13-24 years,~* (2) AYA self-asserts a transgender identity, and~* (3) AYA has expressed interest in gender-affirming hormone (GAH) or is currently on GAH treatment.~* Parents of eligible youth will be eligible to participate.~Exclusion Criteria:~* (1) youth/parents are unable to read, speak or understand English~* (2) youth/parents are unable or unwilling to provide consent/assent/parental permission for study participation.

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 24 Years
- Healthy Volunteers: t

Study Arms:
- Decision-aid (Type: EXPERIMENTAL): Participants will spend up to one hour freely navigating the web-based decision aid. They will complete pre- and post-test measures to determine if using the decision-aid website increased knowledge and impacted decision self-efficacy regarding fertility and fertility preservation.

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 of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.

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:~* Confirmed diagnosis of type 2 diabetes mellitus.~* Contraindicated or intolerant to take metformin.~* HbA1c of ≥ 7.0% and ≤ 8.5%~* Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled~* Other protocol-defined inclusion/exclusion criteria may apply~Exclusion Criteria:~* Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.~* Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month~* Patients taking sulfonylurea for longer than 5 years~* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures~* pregnancy~* Other protocol-defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Vildagliptin (Type: EXPERIMENTAL): Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.
- Protaphane (Type: ACTIVE_COMPARATOR): Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.

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 Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;~* type 2 diabetes mellitus, with stable metformin treatment for \>=3 months;~* HbA1c \>=7.0% and \<=9.5% at screening;~* stable weight +/-10% for \>=3 months before screening.~Exclusion Criteria:~* type 1 diabetes mellitus;~* clinically significant gastrointestinal disease;~* treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;~* use of weight-lowering medications in the last 3 months;~* uncontrolled hypertension;~* previous exposure to GLP-1 or GLP-1 analogues.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): sc weekly
- Taspoglutide 20mg (Type: EXPERIMENTAL): sc weekly
- Taspoglutide 20mg-30mg (Type: EXPERIMENTAL): sc weekly
- Taspoglutide 20mg-40mg (Type: EXPERIMENTAL): sc weekly

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: Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

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

Eligibility Criteria:
Inclusion Criteria:~All subjects:~* In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values (except for values related to hepatic insufficiency).~Hepatic impaired subjects:~* A Child-Pugh Classification score clinically determined as Class A, Class B, or Class C.~* Absolute neutrophil count (ANC) \> 1000 cells/mm3~* Hemoglobin \> 9 mg/mL~* Platelet count \> 50,000/mm3 at screening and baseline~* Serum creatinine ≤ 2.0 x ULN~* Free of significant medical disorders unrelated to the subject's hepatic disorder~Exclusion Criteria:~All subjects:~* Significant illness, including infections, or hospitalization within 4 weeks prior to dosing (hospitalization is allowed for hepatic impaired subjects if related to liver disease). Invasive systemic fungal infections need to be fully resolved prior to study entry.~* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).~* History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug (everolimus) or drugs similar to the study drug (other mTOR inhibitors, e.g., rapamycin or temsirolimus).~* Active bleeding during the last 28 days prior to dosing, including variceal bleeding.~* Except for hepatic impairment, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study.~* Use of tobacco within 7 days prior to dosing or during the study.~* Consumption of alcohol within 3 days prior to dosing or during the study.~* Consumption of grapefruits, grapefruit juice, Sevilla oranges, starfruit or related foods within 7 days prior to dosing or during the study period.~* Use of any drugs known to affect CYP3A4 or PgP, including both inhibitors and inducers, within 7 days prior to dosing or during the study.~Hepatic impaired subjects:~* Symptoms or history of Grade 3 or 4 hepatic encephalopathy within 4 weeks of study entry.~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- RAD001 (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 Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

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:~* Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, as confirmed by genetic testing~* One or more fractures in the past 5 years~* Capable of giving signed consent~Exclusion Criteria:~* History of skeletal malignancies or other bone diseases (other than OI)~* History of neural foraminal stenosis (except if due to scoliosis)~* History of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack~* History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism~* Treatment with bisphosphonates within 3 months of randomisation~* Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation

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

Study Arms:
- Setrusumab 20 mg/kg (Blinded) (Type: EXPERIMENTAL): Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
- Setrusumab 8 mg/kg (Blinded) (Type: EXPERIMENTAL): Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
- Setrusumab 2 mg/kg (Blinded) (Type: EXPERIMENTAL): Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
- Setrusumab 20 mg/kg (Open-Label) (Type: EXPERIMENTAL): Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.

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: Mylan Insulin Aspart Study

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~1. Written and signed informed consent.~2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.~3. Subject is able and willing to comply with the requirements of the study protocol.~Exclusion Criteria~1. History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.~2. History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.~3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.~4. Any elective surgery requiring hospitalization planned during the study period.~5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.~6. Subjects with major depressive illness in the last 3 years.~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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

Study Arms:
- MYL-1601D Product (100 U/mL) (Type: ACTIVE_COMPARATOR): None
- FlexPen NovoLog® (100 U/mL) (Type: ACTIVE_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: Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects with stable asthma.~* Tidal breathing PC20≤16 mg/mL.~* Baseline FEV1 more than 65% of predicted normal.~* Able to complete 3 methacholine challenges on 3 separate days at the same time of day, at least 24-hours apart and within a 2-week period. (1 during screening and the other 2 during the study)~Exclusion Criteria:~* Airway infection or allergen exposure during the last 4 weeks.~* Exacerbation during the last 4 weeks.~* Change in dosage of inhaled or oral steroids during the last 4 weeks.~* Inhaled salbutamol less than 8 hours prior to testing.~* Inhaled formoterol or salmeterol less than 36 hours prior to testing.~* Antihistamines during the last 48 hours.~* Chronic health conditions that are determined by the principal investigator to be significant (eg cystic fibrosis).~* Smokers~* Pregnant women.

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

Study Arms:
- 'The English-Wright nebulizer' (Type: ACTIVE_COMPARATOR): The English-Wright nebulizer will be used to perform a methacholine challenge.
- Trudell AeroEclipse*II BAN nebulizer (Type: ACTIVE_COMPARATOR): The Trudell AeroEclipse\*II BAN nebulizer will be used to perform a methacholine challenge

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: 24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination

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

Eligibility Criteria:
Inclusion Criteria:~* The patient is suffering from XFG (if the patient has bilateral XFG, both eyes will be treated, but the worse eye will be selected for the statistical analysis)~* Patient is older than 39 years and younger than 85 years~* Patient is able and willing to participate in the study for the whole duration of the follow up. Will sign the consent form.~* At screening the untreated IOP at 10:00 (± 1 hr) is greater than 25 mm Hg and lower than 40 mm Hg~* After bimatoprost run-in therapy the treated IOP at 10:00 (± 1 hr) is greater than 19 mm Hg

- Gender: ALL
- Minimum Age: 39 Years
- Maximum Age: 81 Years
- Healthy Volunteers: f

Study Arms:
- Bimatoprost/Timolol AM therapy (Type: ACTIVE_COMPARATOR): None
- Bimatoprost/Timolol PM therapy (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: complete