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

Trial Title: Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk

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:~* Type 2 diabetes duration between 2 and 20 years~* Two or more components of metabolic syndrome:~  * HDL-cholesterol \< 1.0 mmol/L (in males) or \< 1.3 mmol/L (in females)~ * Elevated triglycerides (\> 1.7 mmol/L)~ * Elevated blood pressure (\> 130 mmHg systolic and/or \>85 mmHg diastolic or antihypertensive treatment)~ * Elevated waist circumference (\> 102 cm in males, \> 85 cm in females)~* Or at least one of the following~  * Carotid ultrasound showing an IMT \> 1 mm and plaque of carotid artery or~ * Left ventricular hypertrophy or~ * Increased UACR in the absence of other renal diseases than diabetic nephropathy~* Increased hsCRP (\> 2 mg/l but \< 10 mg/l) at or within 6 months prior to screening and/or increased PAI 1 (\> 15 ng/ml) at or within 6 months prior to screening (the historical hsCRP or PAI 1 value can be used only if the patient was in stable conditions regarding the concomitant diseases and statin therapy since the time point of measurement)~* Stable treatment with statins (if tolerated/clinically indicated)~* Age 40 - 75 years~Exclusion Criteria:~* Major cardiovascular (CV) event with need for oral anticoagulation or platelet inhibitor therapy or acute coronary syndrome \< 12 month before study entry~* Sustained uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg~* Hypersensitivity to the active substance or to any of the excipients~* Active clinically significant bleeding~* Lesion or condition, if considered to be a significant risk for major bleeding~* Concomitant treatment of acute coronary syndrome (ACS) with antiplatelet therapy in patients with a prior stroke or a transient ischemic attack (TIA)~* Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C~* Chronic renal failure with eGFR \< 15 ml/min (MDRD formula)~* Pregnant or breast-feeding woman and woman without adequate method of contraception.

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Rivaroxaban (Type: EXPERIMENTAL): 5mg b.i.d. for 20 weeks (primary phase) + additional 32 weeks (extension phase)
- Aspirin (Type: ACTIVE_COMPARATOR): 100mg once daily for 20 weeks (primary phase) + additional 32 weeks (extension phase)

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 Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

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:~Both of following symptoms should be observed.~* Lower abdominal pain and/or lower abdominal tenderness.~* Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).~Exclusion Criteria:~Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.~Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).

- Gender: FEMALE
- Minimum Age: 16 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Azithromycin switch therapy (switch from intravenous to oral). (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: Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Provision of written informed consent.~* Over 18 years of age.~* Two consecutive i STAT potassium values, measured 60 (+/- 15) minutes apart, both \>/= 5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.~* Ability to have repeated blood draws or effective venous catheterization.~* Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test at Acute Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.~* Controlled diabetic subjects.~Exclusion Criteria:~* Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.~* Subjects treated with lactulose, rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.~* Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium polystyrene sulfonate (eg, Resonium®) within 3 days prior to first dose of ZS on Acute Phase Study Day 1.~* Subjects with a life expectancy of less than 12 months.~* Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.~* Women who are pregnant, lactating, or planning to become pregnant.~* Subjects with diabetic ketoacidosis.~* Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.~* Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.~* Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.~* Subjects with cardiac arrhythmias that require immediate treatment.~* Subjects on dialysis.~* Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.~* Documented GFR \<15 mL/min within 90 days prior to study entry.

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

Study Arms:
- Sodium Zirconium Cyclosilicate (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: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

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

Eligibility Criteria:
Inclusion Criteria:~Eligible participants will include women who:~* Were diagnosed with a childhood cancer prior to the age of 21 years;~* Were treated with ≥ 10 Gy of chest RT (recent revision with a lower dose threshold);1~* Do not have a history of breast cancer;~* Have not had both a breast MRI and mammogram in the previous 24 months;~* Do not have a contraindication to MRI (i.e., pacemaker);~* Are 25 years of age or older at time of enrollment;~* Have an interval from their chest RT to the time of enrollment of at least 8 years;~* Have a smartphone;~* Are English-speaking.~Participants will be selected from women in the Childhood cancer Survivor Study (CCSS) cohort.

- Gender: FEMALE
- Minimum Age: 25 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Control (C) (Type: EXPERIMENTAL): Targeted mailed educational materials (C).
- Patient activation (PA) (Type: EXPERIMENTAL): C + patient activation (PA) consisting of (1) smartphone app with HIPAA compliant survivorship care plan that can be viewed, printed, or emailed to their primary care provider; and (2) two-way (interactive) tailored text messages with links to video vignettes discussing the primary barriers to breast MRI and mammography.
- Patient activation + primary care provider activation (PA+PCP) (Type: ACTIVE_COMPARATOR): C + PA + PCP activation (PA+PCP) with physician materials about breast cancer risk in this population along with national and international guidelines for breast cancer surveillance.

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: Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated PAH due to congenital heart disease (Group I / Dana Point Classification of PH) demonstrating insufficient response to treatment with PDE-5i for at least 3 months~* Patients with and without endothelin receptor antagonist (ERA) therapy~* World Health Organization Functional Class (WHO FC) III at screening~* 6-minute walking distance (6MWD) of 165-440 m~* Cardiac index \<3.0 L/min/m\*2.~Exclusion Criteria:~* All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria~* Evidence of clinically significant restrictive or obstructive parenchymal lung diseases~* Diffusing capacity of the lung for carbon monoxide (DLCO) \<30% predicted~* History or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization~* Patients unable to perform a valid 6MWD test~* Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study.

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

Study Arms:
- Riociguat (Type: EXPERIMENTAL): Subjects received riociguat film coated immediate-release (IR) tablet 3 times a day (tid) with or without food at a starting dose of 1.0 milligram (mg) and increased by 0.5 mg increments at 2-weekly intervals to a maximum of 2.5 mg tid, until Week 8 (titration phase). An optimal dose was determined based on systolic blood pressure (SBP) and well-being. Thereafter, riociguat continued at the optimal individual dose until Week 24 (Main phase). Dose reductions or stop of study medication for safety reasons were allowed at any time. Increases or re-increases in 0.5 mg steps (maximum dose 2.5 mg) were possible at the investigator's discretion weighing the benefit with potential risks implied. Subjects were offered participation in EDSP and received riociguat 2.5 mg film coated IR tablet 3 tid with or without food for 18 months or until reimbursement.

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 Fentanyl Citrate in Children

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

Eligibility Criteria:
Inclusion Criteria:~* children mechanically ventilated~* age : from 2 months to 18 years~Exclusion Criteria:~* children with neurologic disease~* children with drugs which can affect the level of consciousness~* children with renal disease~* children with hypotension (systolic blood pressure \< 70 + (2 x age in year) mmHg)

- Gender: ALL
- Minimum Age: 2 Months
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Fentanyl (Type: EXPERIMENTAL): midazolam and fentanyl citrate infusion
- Control (Type: PLACEBO_COMPARATOR): midazolam and normal saline infusion

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

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

Trial Title: Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

Study Design Characteristics:
- Allocation: None
- 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:~* Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.~* HbA1c in the range of 7.0-10.0%~* Body mass index in the range 20-35 kg/m2~Exclusion Criteria:~* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes~* Significant heart diseases~Other protocol-defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Vildagliptin (Type: EXPERIMENTAL): In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.
- Placebo (Type: PLACEBO_COMPARATOR): In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.

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

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

Trial Title: A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

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. Age of at least 18 years.~2. Life expectancy of at least 6 months.~3. Diagnosis of Chronic Kidney Disease (CKD).~4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible.~5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.~6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB).~7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device.~Exclusion Criteria:~1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ.~2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.~3. Previous treatment with PRT 201.~4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- PRT-201 (Type: ACTIVE_COMPARATOR): PRT-201 administered at the time of radiocephalic fistula creation
- Placebo (Type: PLACEBO_COMPARATOR): Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.

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: Low Dose Cyclosporin A in Primary Sjögren Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of a primary Sjögren´s Syndrome~* Liver values above 1,5 ULN~* uncontrolled arterial hypertension~* intraarticular or systemic use of Glucocorticoids in the last 4 weeks before~* begin with Study medication~Exclusion Criteria:~* pre-treatment with Cyclosporine A~* Infection~* Neoplasia~* relevant cardiac, pulmonary, neurologic or psychiatric disease~* life-Vaccination within 4 weeks before begin with study medication~* pregnant or breast-feeding~* weight under 45kg or more than 110kg

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

Study Arms:
- Cyclosporine A (Type: OTHER): All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 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: Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.~Exclusion Criteria:~* Positive for H1 influenza by HAI.~* Has had an influenza vaccine in the past 2 years.~* Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.~* History of any confirmed or suspected immunodeficient or immunosuppressive condition~* Positive serology for HIV, HCV, or HBV~* Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.~* History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine~* Use of proton pump inhibitors(Nexium, Prilosec).~* Stool sample with occult blood at baseline exam

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 49 Years
- Healthy Volunteers: t

Study Arms:
- Low Dose VXA-A1.1 Oral Vaccine (Type: EXPERIMENTAL): Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.
- VXA Placebo Tablet (Type: PLACEBO_COMPARATOR): Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.
- Medium Dose VXA-A1.1 Oral Vaccine (Type: EXPERIMENTAL): Two doses of replication incompetent adenovirus vaccine given in an oral tablet
- High Dose VXA-A1.1 Oral Vaccine (Type: EXPERIMENTAL): One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.

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: Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* preterm infants less than 32 weeks of gestational age~* intubated more than 48 hours after birth~* subjected to extubation with minimal ventilator setting (mean airway pressure \< 7cmH2O + peak inspiratory pressure \< 13 cmH2O + FiO2 \< 0.4 + respiratory rate \< 35/min)~* with informed consent from parents~Exclusion Criteria:~* with major congenital anomalies~* use of sedative or anesthetic drugs~* hemodynamic instability~* grade 3 or higher intraventricular hemorrhage~* phrenic nerve palsy

- Gender: ALL
- Minimum Age: 3 Days
- Maximum Age: 3 Months
- Healthy Volunteers: f

Study Arms:
- NAVA-PS (Type: EXPERIMENTAL): noninvasive NAVA first for 15 minutes and then PSV for 15 minutes
- PS-NAVA (Type: EXPERIMENTAL): noninvasive PSV first for 15 minutes and then NAVA for 15 minutes

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

Answer: outcome: complete