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

Trial Title: Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* BMI within the range of 19 to 30 kilograms/meters\^2~* Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up~Exclusion Criteria:~* Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids~* Treatment with known hepatic enzyme altering agents

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- Test nicotine gum (2 mg) (Type: EXPERIMENTAL): A single dose of Nicotine Mint Gum (2 mg) to be chewed.
- Test nicotine gum (4 mg) (Type: EXPERIMENTAL): A single dose of Nicotine Mint Gum (4 mg) to be chewed.
- Reference nicotine gum (2 mg) (Type: ACTIVE_COMPARATOR): A single dose of reference nicotine gum (2 mg) to be chewed.
- Reference nicotine gum (4 mg) (Type: ACTIVE_COMPARATOR): A single dose of reference nicotine gum (4 mg) to be chewed.

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 an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers

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:~* Patients must have histologically documented invasive epithelial ovarian, extraovarian, fallopian tube or endometrial carcinoma.~* Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional therapy.~* Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable.~* Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months.~* Patients must have adequate hematologic, renal, and hepatic function defined as:~  * WBC \> 3,000 ul~ * Granulocytes \> 1,500 ul~ * Platelets \> 100,000~ * Creatinine clearance \> 80 mg/dl or serum creatinine \> 2.0~ * Serum transaminases \< 2.5 x upper limits of normal~ * Normal serum bilirubin~ * PT/PTT/INR \< 1.5 x institutional ULN~ * O2 saturation \> or = 92 %~* Patients must be 19 years or older and must have signed informed consent~Exclusion Criteria:~* Patients with epithelial tumors of low malignant potential, stromal tumors and germ cell tumors of the ovary are ineligible to participate in the study.~* Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study.~* Patients who are pregnant or lactating are ineligible to participate in the study.~* Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study.~* Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF \< 55%, pulmonary hyper- tension, active or chronic debilitating pulmonary disease(i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation \< 92%), or coagulation disorders (i.e. bleeding disorders, or on therapeutic anti- coagulants)

- Gender: FEMALE
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Gene therapy (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 of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female subjects between 18 and 70 years of age, inclusive.~2. Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or DSM-5 criteria, and currently untreated or treated with or without anticataplectics.~3. If applicable, treated with a stimulant or alerting agent at unchanged doses for at least 2 months prior to dosing or not treated with a stimulant or alerting agent.~4. Willing and able to comply with the study design schedule and other requirements.~5. Willing and able to provide written informed consent.~Exclusion Criteria:~1. Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)~2. History or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological disorder or surgical history that might affect the subject's safety and/or interfere with the conduct of the study in the opinion of the Investigator.~3. Treatment with any central nervous system sedating agents, including but not limited to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac, valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the purpose of study enrollment is permitted only if considered safe by the Investigator and approved by the Medical Monitor).~4. Treatment with an antidepressant for cataplexy, if the withdrawal of the antidepressant during cross-titration with JZP-258 might be unsafe due to prior history of depression.~5. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the Investigator.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo
- JZP-258 (Type: EXPERIMENTAL): JZP-258

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 to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support Program

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) (CIS indication only applicable for interferon beta-1a)~* Exposure to either SC Peginterferon beta-1a therapy or an IM Interferon beta-1a therapy before or during pregnancy~* Registered in the PSP of the multiple sclerosis service- center (MSSC) and agreed in writing to the privacy policy of the registration form~* Reported pregnancy data (pregnancy report and pregnancy outcome report) available at MSSC. Note: only pregnancy data (i.e. obtained until 15 October 2020) will be considered.~* Pregnancy outcome in the retrospectively collected data was a live birth~Exclusion Criteria: Any criteria that does not fulfil the above-mentioned inclusion criteria.~NOTE: Other protocol defined Inclusion criteria may apply

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

Study Arms:
- All Participants (Type: None): Pregnant Multiple Sclerosis (MS) participants treated with SC interferon beta therapy or an IM interferon beta therapy in the German PSP of the MSSC.

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: Pharmacogenomics of Thiazolidinediones

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

Eligibility Criteria:
Inclusion Criteria:~* Age 35-64~* BMI: ≥ 25 and ≤ 40~Exclusion Criteria:~* Pregnancy as determined by urine pregnancy test Breast-feeding, or planning to become pregnant during the study~* Physical dimensions exceeding the limits of any equipment used~* Stage III or greater congestive heart failure~* Symptomatic peripheral vascular disease~* Stroke~* Severe hypertension (\>170/100 mmHg)~* Anemia (Hgb and Hct \< normal reference range)~* Receiving treatment for thyroid, pituitary, kidney or liver disease (except controlled thyroid hormone replacement)~* History of diabetes (as told by doctor, or taking diabetic medications Fasting glucose value diagnostic for diabetes 2-h oral glucose tolerance test diagnostic for diabetes~* Rheumatoid arthritis~* History of wrist, hip or leg fracture after the age of 45~* History of kidney stones~* Medications that the investigator judges will make interpretation of the results difficult or increase the risk of participation (e.g. anticoagulants)~* Any disease or condition that the investigator judges will affect bone metabolism or make interpretation of the results difficult or increase the risk of participation (e.g. anemia, cardiac decompensation, intolerance to pioglitazone, lidocaine, or other agents used)

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 64 Years
- Healthy Volunteers: t

Study Arms:
- Pioglitazone (Actos) (Type: EXPERIMENTAL): Participants will have metabolism studies to consist of outpatient X-ray and MR measurements of bone density and body composition, metabolic testing (intravenous glucose tolerance test), and muscle and adipose tissue biopsies. Blood will also be drawn for genetic testing and for microarray studies of leukocytes. Upon completion of the above studies, the participant will begin pioglitazone therapy. Every 4 weeks throughout the drug intervention, glycemic control, lipoprotein profile, and weight will be monitored. After 12 weeks of pioglitazone therapy, the X-ray and MR measurements of body composition, the biopsies, microarray studies for leukocytes and the metabolic tests will be repeated.

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 the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

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:~* Moderate to severe PsA~* Inadequate response to DMARD therapy~* Corticosteroid stable dose \<= 10 mg QD~* DMARDs must have been taken for 3 months and stable dose for 4 weeks~* MTX maximum dose = \<= 30 mg/week~* Active chronic plaque PS or documented history of chronic plaque PS~Exclusion Criteria:~* No other active skin disease

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

Study Arms:
- A (Type: ACTIVE_COMPARATOR): None
- B (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: DE-111 Against Timolol Ophthalmic Solution 0.5%

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with primary open angle glaucoma or ocular hypertension~* Provided signed, written informed consent~* 20 years of age and older~* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study~Exclusion Criteria:~* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception~* Presence of any abnormality or significant illness that could be expected to interfere with the study

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

Study Arms:
- DE-111 ophthalmic solution (Type: EXPERIMENTAL): DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
- Timolol ophthalmic solution 0.5% (Type: ACTIVE_COMPARATOR): Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.

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: Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion criteria:~- Healthy male or female subjects~Exclusion criteria:~- Any relevant deviation from healthy condition

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- FDC first, fasted (Type: EXPERIMENTAL): Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition
- Single tablets first, fasted (Type: EXPERIMENTAL): single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition
- FDC first, fed (Type: EXPERIMENTAL): Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition
- Single tablets first, fed (Type: EXPERIMENTAL): single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition

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: Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer

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:~* Patients with advanced stage refractory breast cancer~* Progressive or relapsed disease following standard therapy with chemotherapy and/or surgery, and/or radiation~* Patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous metastatic lesions~* Patients must be at least 7 days from last chemotherapy and 30 days from local radiotherapy and/or systemic steroids~* Patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are eligible~* White blood cell count \>= 1000/ul~* Absolute neutrophil count (ANC) \>= 1200/ul~* Platelets \> 75,000/ul~* Serum creatinine =\< 2.0 mg/dL, a creatinine clearance \> 60 ml/min~* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2 X upper limit normal (ULN)~* Total bilirubin \< 2 X ULN~* Patients must have a Performance Status Score (Eastern Cooperative Oncology Group \[ECOG\] Scale) =\< 2~* Patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment~* Men and women of reproductive ability must agree to contraceptive use during the study and for 1 month after imiquimod/Abraxane treatment is discontinued~Exclusion Criteria:~* Patients with prior allergic reaction to taxanes~* Patients with any clinically significant active autoimmune disease requiring active treatment with systemic steroids or other immunomodulators~* Pregnant or breast-feeding women~* Patients with peripheral neuropathy \>= Grade 2

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

Study Arms:
- Treatment (biological therapy, chemo) (Type: EXPERIMENTAL): Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

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: Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

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 includes:~1. Men and women, ≥ 18 years~2. Hb ≤ 11 g/dL~3. Chronic renal impairment, as defined by either (i) eGFR \< 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) \< 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model~4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %~5. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation~6. Willingness to participate and signing the informed consent form~Exclusion Criteria includes:~1. Anaemia predominantly caused by factors other than IDA~2. Hemochromatosis or other iron storage disorders~3. Previous serious hypersensitivity reactions to any IV iron compounds~4. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy~5. Undergoing dialysis for treatment of CKD~6. Planned surgical procedure within the trial period~7. Decompensated liver cirrhosis or active hepatitis~8. Alcohol or drug abuse within the past 6 month.~9. Pregnant or nursing women.

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

Study Arms:
- Iron isomaltoside/ferric derisomaltose (Type: EXPERIMENTAL): Administered IV
- Iron sucrose (Type: ACTIVE_COMPARATOR): Administered IV

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 Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

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:~* Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.~* Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.~Exclusion Criteria:~* Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.~* Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.~* Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.~* Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.

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

Study Arms:
- Mirikizumab (Type: EXPERIMENTAL): Period 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W).~Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1.~Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.
- Placebo (Type: PLACEBO_COMPARATOR): Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.

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

Answer: outcome: complete