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

Trial Title: A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Patient is a healthy postmenopausal woman less than or equal to 65 years of age with onset of menopause less than or equal to 10 years prior to prestudy visit 1~* Patient has a uterus and no history of uterine bleeding in the past 3 months~* Patient has not had a previous endometrial biopsy within the last 4 weeks~* Patient has had a normal mammogram within the last 11 months~* Patient has had a normal pap-smear within the past 3 years prior to screening~* Patient has had a normal transvaginal ultrasound of the endometrium~* Patient is willing to avoid strenuous physical activity such as strenuous or unaccustomed weight lifting, running, bicycling, etc for the duration of the study~* Patient agrees to not consume grapefruit products beginning approximately 2 weeks prior to the first dose of study drug and throughout the study~* Patient agrees to limit daily consumption of alcohol. During the study, daily alcohol consumption should not be more than 2 glasses~* Patient agrees to limit daily consumption of caffeine. During the study, daily caffeine consumption should not exceed 3 cups of coffee~* Patient is a non-smoker~Exclusion Criteria:~* Patient is mentally or legally incapacitated~* Patient has a history of any first degree relatives with breast or endometrial cancer~* Patient has a history of multiple and/or severe allergies to prescription or non-prescription drugs or food~* Patient has used any type of estrogen or progesterone preparation unless followed by appropriate wash-out periods~* Patient has had surgery, donated approximately 500 mL of blood or has participated in another investigational study within the last 4 weeks~* Patient has a history of deep vein thromboses, coronary artery disease, heart attack or stroke~* Patient is a current user of illegal drugs~* Patient has a history of hypersensitivity to estrogen products~* Patient is unable to refrain from using anti-coagulants

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- 17β-estradiol 2.0 milligrams (Type: ACTIVE_COMPARATOR): Estrace 2.0 mg tablet
- 17β-estradiol 0.5 milligrams (Type: ACTIVE_COMPARATOR): Estrace 0.5 mg tablet
- 3 (Type: PLACEBO_COMPARATOR): 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: Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

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

Eligibility Criteria:
Inclusion Criteria:~* Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.~* Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.~* Eye tests in both eyes: Corneal fluorescein staining (Oxford scale \> 0), Tear break-up time \< 10 seconds and Schirmer's test with anaesthesia \< 10 mm/5min.~Exclusion criteria:~* Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.~* Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.~* Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.~* Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.~* Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.~* Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.~* Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.~* History of hypersensitivity to drugs.~* Use of contact lenses during the treatment and previous 15 days.~* History of drug abuse or drug or alcohol dependence.~* Laboratory abnormalities which, in the investigator's opinion, are clinically significant.~* Previous refractive surgery.~* Having participated in another clinical trial within the 2 months prior to inclusion.~* Another eye disease that is significant in the investigator's opinion.

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

Study Arms:
- SYL1001 eye drops dose C (Type: EXPERIMENTAL): SYL1001 eye drops dose C administration via the ophthalmic route
- SYL1001 eye drops dose D (Type: EXPERIMENTAL): SYL1001 eye drops dose D administration via the ophthalmic route
- Placebo (Type: PLACEBO_COMPARATOR): Placebo eye drops administration via the ophthalmic route

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: Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination

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

Eligibility Criteria:
Inclusion Criteria:~* Advanced CLL, defined as no response or progressive disease during standard nucleoside analogue based regimen; or, evidence of progressive disease within 24 months of completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure to achieve complete remission following salvage regimen.~* no sites of adenopathy \> 5cm~* (8/8) HLA matched related or unrelated donor available.~* Must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone marrow biopsy or by lymph node dissection, per DF/HCC protocol 06-200~* ECOG performance status 0-2~Exclusion Criteria:~* Serum creatinine greater than or equal to 2.0mg/dl~* ALT or AST greater than or equal to 3x ULN~* Total bilirubin greater than or equal to 2.0mg/dl (except for patients with Gilbert's syndrome)~* Cardiac ejection fraction greater than or equal to 30%~* HIV infection~* Pregnancy

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

Study Arms:
- GM-K562 Vaccine (Type: EXPERIMENTAL): Biological/Vaccine: GM-K562 vaccine The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines.~Procedure/Surgery: stem cell transplantation Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation

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 Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

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:~* Untreated Hypertensive Patients: An systolic blood pressure of \>=160 mmHg or diastolic blood pressure \>=100mmHg.~* Treated Hypertensive Patients: An systolic blood pressure of \>=140 mmHg or diastolic blood pressure of \>= 90 mmHg.~* Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) \>=140 mmHg~* Patients with a screening treatment compliance rate \>= 80%~Exclusion Criteria:~* Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 79 Years
- Healthy Volunteers: f

Study Arms:
- Amlodipine 5mg (Type: ACTIVE_COMPARATOR): None
- Amlodipine 10mg (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: Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_ONLY
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Patients who received Nexavar for unresectable or advanced renal cell carcinoma~Exclusion Criteria:~* Patients who are contraindicated based on the product label

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

Study Arms:
- Group 1 (Type: None): 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: Drug-Drug Interaction Between Colchicine and Verapamil ER

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.~Exclusion Criteria:~* Recent participation (within 28 days) in other research studies~* Recent significant blood donation or plasma donation~* Pregnant or lactating~* Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)~* Recent (2-year) history or evidence of alcoholism or drug abuse~* History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease~* Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study~* Drug allergies to colchicine or verapamil

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

Study Arms:
- Colchicine alone (Type: ACTIVE_COMPARATOR): baseline colchicine pharmacokinetics
- Colchicine with Verapamil HCl ER (Type: EXPERIMENTAL): colchicine pharmacokinetics in presence of steady-state verapamil

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 Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment.~* Negative urine pregnancy test for all female subjects.~* Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.~Exclusion Criteria:~* History of any invasive meningococcal disease.~* A previous anaphylactic or severe vaccine-associated adverse reaction.~* Any clinically significant chronic disease.~* A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.~* Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

- Gender: ALL
- Minimum Age: 11 Years
- Maximum Age: 18 Years
- Healthy Volunteers: t

Study Arms:
- 1 (Type: EXPERIMENTAL): dose level 1 rLP2086 vaccine
- 2 (Type: EXPERIMENTAL): dose level 2 rLP2086 vaccine
- 3 (Type: EXPERIMENTAL): dose level 3 rLP2086 vaccine
- 4 (Type: PLACEBO_COMPARATOR): normal saline (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: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months

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

Eligibility Criteria:
Inclusion Criteria:~1. Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination~2. Healthy assessed from medical history and physical examination~3. Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine~4. Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form~5. Parent(s)/guardian(s) granting access to the infant's trial related medical records~6. Parent(s)/guardian(s) likely to comply with the trial procedures~Exclusion Criteria:~1. Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial~2. OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 months prior to inclusion or planned during the trial~3. Low birth weight (\< 2,500 g)~4. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria~5. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease~6. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)~7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling~8. Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial~9. Participating in another clinical trial~10. Not suitable for inclusion in the opinion of the investigator

- Gender: ALL
- Minimum Age: 6 Weeks
- Maximum Age: 9 Months
- Healthy Volunteers: t

Study Arms:
- IPV-Al SSI (Type: EXPERIMENTAL): IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
- IPV SSI (Type: ACTIVE_COMPARATOR): IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age

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 & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

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:~* Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.~* Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.~* At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.~* Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.~Exclusion Criteria:~* Previous treatment with darifenacin~* Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.~* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.~* Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.~* Clinically significant outflow obstruction as determined by the Investigator~* Uncontrolled narrow angle glaucoma, urinary or gastric retention.~* All patients with severe renal or hepatic impairment will be excluded~* Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

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

Study Arms:
- 1 (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: Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients positive for COVID-19 by polymerase chain reaction (PCR) assay or alternative accepted methodology~2. PENN class 2,3,4 CRS~3. Respiratory insufficiency with supplemental oxygen to maintain O2 sat greater than 89%~4. Clinically positive imaging by chest x-ray (CXR) or CT scan with evidence of bilateral pulmonary infiltrates, ground glass opacification or other pattern of consolidation felt likely to be linked to COVID infection or complication thereof~5. Age 12-80 years of age~Exclusion Criteria:~1. Pregnancy~2. Breast feeding~3. Class 3-4 New York Heart Association (NYHA) heart failure~4. Current use of synthetic disease modifying anti-rheumatic drugs (DMARDS) or IL-6 inhibitors or other immunosuppressive therapies outside of number five below~5. Current use of chronic corticosteroids if in excess of prednisone 10mg per day or equivalent~6. Suspected or confirmed clinically significant bacterial infection~7. History of tuberculosis (TB)~8. History of HIV~9. History of irritable bowel disease (IBD)~10. JAK inhibitor use within last 30 days~11. Creatinine clearance less than 15 ml / min~12. Absolute neutrophil count \< 1000~13. Platelet count \< 50,000~14. Clinical assessment that the trial could pose unacceptable risk by study participation~15. Current enrollment on another investigational protocol for COVID-19 induced CRS~16. Stage 4 obstructive lung disease with chronic hypoxic respiratory failure requiring supplemental O2 at baseline, or interstitial lung disease (ILD) with chronic hypoxic respiratory failure requiring supplemental O2 at baseline

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- 1 - TPE Alone (Type: EXPERIMENTAL): TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy
- 2 - TPE Plus Ruxolitinib (Type: EXPERIMENTAL): TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy combined with ruxolitinib 5mg po twice daily (BID) beginning day prior to first TPE and continuing BID for total of 14 days.

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: Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement

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:~* Patients scheduled to undergo elective~  * TAVI~ * SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))~* Patient able to read and understand the research materials~Exclusion Criteria:~* Inability to give informed consent~* Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)~* Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)

- Gender: ALL
- Minimum Age: 70 Years
- Maximum Age: None
- Healthy Volunteers: f

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

Answer: outcome: complete