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

Trial Title: Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

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:
Key Inclusion Criteria:~* Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.~* Males and females ages 9 years and older at the time of consent.~* Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.~* Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.~* An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.~* Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.~* Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).~* Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.~* Subjects in good health as judged by the Investigator.~* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.~Key Exclusion Criteria:~* Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.~* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.~* Previous treatment with ARQ-154 or ARQ-151.~* Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.~* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.~* Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.~* Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).~* Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.

- Gender: ALL
- Minimum Age: 9 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Roflumilast Foam 0.3% (Type: EXPERIMENTAL): Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.
- Vehicle Foam (Type: PLACEBO_COMPARATOR): Participants with seborrheic dermatitis apply vehicle foam QD for 8 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: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

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

Eligibility Criteria:
Inclusion Criteria:~* Males, age 18 to 65 years~  * Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1%~ * ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records~Exclusion Criteria:~* Evidence of current or past inhibitor antibody~  * History of any congenital or acquired coagulation disorders other than hemophilia A~ * Platelet count \<75,000/mm3~ * Abnormal renal function (serum creatinine \>2 times the upper limit of the normal \[ULN\] range)~ * Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

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

Study Arms:
- BAY81-8973 (Type: EXPERIMENTAL): BAY81-8973 infusion to analyze pharmacokinetics
- Advate (Type: OTHER): Advate infusion to analyze pharmacokinetics.

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: Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Cystic Fibrosis~* Hospitalized with acute pulmonary exacerbation~* Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an appropriate antibiotic treatment~Exclusion Criteria:~* Known allergy to meropenem~* Require less than 3 days of meropenem in the hospital~* Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen~* Known fungal or viral infection~* Females in their 2nd or 3rd trimester of pregnancy~* Moderate to severe renal dysfunction, as defined by a creatinine clearance less than 50 ml/min/1.73m2 (by use of Schwartz method)~* History of solid organ transplantation within previous 6 months~* Active or recent (within 30 days) participation in another antibiotic clinical trial

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Meropenem 3 hour prolonged infusion (Type: EXPERIMENTAL): All 30 participants will receive meropenem as a 3 hour 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: An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Chronic creatinine clearance \</= 40cc/h~* Pre-operative cardiac surgery~Exclusion Criteria:~* Pre-operative ongoing dialysis~* Nausea and vomiting~* Uncontrolled glaucoma~* Allergy to metabisulfite~* Enrollment in another clinical study within 30 days~* Pregnancy~* Acute renal failure

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

Study Arms:
- NAC (Type: EXPERIMENTAL): N-acetylcysteine started day prior to surgery, continued through night of surgery
- fenoldopam (Type: EXPERIMENTAL): fenoldopam started at surgery continued for 24 hours
- NAC and fenoldopam (Type: EXPERIMENTAL): Both N-acetylcysteine and fenoldopam as above
- Control (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: Pharmacokinetics of Levobupivacaine After Cesarean Section

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Term pregnant patients~* American Society of Anesthesiologists physical status I or II, scheduled for elective cesarean section.~Exclusion Criteria:~* Allergy/sensitivity to the local anaesthetic~* Significant renal or liver dysfunction.

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

Study Arms:
- Pharmacokinetics (Type: EXPERIMENTAL): A bilateral TAP block will be performed with 20 ml levobupivacaine 0,25% and epinephrine (5ug/ml). After the blockade, venous blood samples will be taken on predefined times.

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: Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

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:~- Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.~Exclusion Criteria:~* Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.~* Has participated in a previous crisaborole clinical study.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Crisaborole ointment (Type: EXPERIMENTAL): Crisaborole ointment application twice daily for 28 days
- Crisaborole Placebo Vehicle (Type: PLACEBO_COMPARATOR): Vehicle Ointment application twice daily for 28 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: A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy~* Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of \>= 220 and \<= 450, with confirmation of active inflammation~* Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria~* Have screening laboratory test results within protocol-specified parameters~Exclusion Criteria:~* Patients who have had any kind of bowel resection within 6 months~* Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent~* Patients who have received infliximab, adalimumab or certolizumab pegol \< = 8 weeks before the first administration of study drug~* Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug~* Patients with a history of or ongoing chronic or recurrent infectious disease~* Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Placebo IV (Type: PLACEBO_COMPARATOR): Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
- Ustekinumab 130 milligram (mg) (Type: EXPERIMENTAL): Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
- Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg) (Type: EXPERIMENTAL): Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg).

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: Metabolic Effects of Switching Kaletra to Boosted Reyataz

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

Eligibility Criteria:
Inclusion Criteria:~1. Previously diagnosed HIV infection~2. Age between 18-65 years~3. Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos~4. CD4 count \> 400 cell/mm3~5. Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin \>= 15 mIU/ml), hypercholesteremia (fasting total cholesterol \>= 200 mg/dL), hypertriglyceridemia (fasting triglycerides \>= 150 mg/dL), or treatment with a lipid lowering medication.~Exclusion Criteria:~1. Hemoglobin \< 11.0 g/dL~2. History of Diabetes Mellitus~3. Currently on medication for Diabetes~4. Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months~5. Current substance abuse, including alcohol, cocaine and/or heroin~6. Any contraindication to ATV/r or known allergy to ATV~7. Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam~8. New or serious opportunistic infection in the past 3 months~9. Pregnancy

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
- 2 (Type: ACTIVE_COMPARATOR): Kaletra (pre-study dose)

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: Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

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

Eligibility Criteria:
Inclusion Criteria:~* STEMI within 12 hours of randomization~* Planned treatment with a fibrinolytic agent and aspirin~Exclusion Criteria:~* Intention of performing coronary angiography within 48 hours of fibrinolysis~* Treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, or planned treatment with clopidogrel or ticlopidine.~* Contraindication to fibrinolysis~* Planned use of a glycoprotein IIb/IIIa inhibitor~* Prior CABG~* Evidence of cardiogenic shock or acute pulmonary edema requiring intubation or an intraaortic balloon pump~* Known renal or hepatic insufficiency

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (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: A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Bilateral sensorineural hearing loss with an active decline in hearing in one ear~* No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days~* Enrollment within 14 days of completion of corticosteroid therapy~* Age 13 years and older~* No evidence of neutropenia (low white blood cell count)~* No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)~* May have concurrent, systemic autoimmune disease~Exclusion Criteria:~* Age over 75, or less than 13~* Neutropenia~* Renal insufficiency~* Pregnant females~* Unilateral hearing loss~* Patients with any immunodeficiency syndrome~* Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy~* Patients with chronic infections~* Patients treated for a malignancy within the past 3 years~* Patients with a latex allergy~* Patients with an inner ear anomaly~* Patients with retrocochlear pathology

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Single Arm-Open Label (Type: EXPERIMENTAL): Single Arm-Open Label use of Anakinra

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: Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets

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:~* Diagnosis of XLH rickets~* Fasting serum calcium of 10.7 mg/dl or less~* Fasting PTH greater than 40 nleq/ml and less than 120 nleq/ml in the mid-molecule PTH assay at screening (upper limit of normal is 25 nleq/ml)~* Willing and able to participate in the trial~* Taking stable dose of standard therapy for XLH rickets for at least 2 months prior to study entry~* Concomitant therapy for XLH rickets will not be an exclusion criteria~* Parent or guardian willing to provide informed consent, if applicable~Exclusion Criteria:~* Concomitant kidney failure (estimated creatinine clearance less than 60 cc/min or serum creatinine greater than 1.5 mg/dl)~* Serum 25-hydroxy vitamin D less than 20 ng/ml. Participants meeting this criterion will receive vitamin D3 supplementation for 3 months and then be rescreened.~* Unable to comply with protocol and appropriate follow-up visits~* Treatment with agents that may affect skeletal metabolism, such as glucocorticoids and anticonvulsants

- Gender: ALL
- Minimum Age: 9 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
- 2 (Type: PLACEBO_COMPARATOR): Participants given placebo capsule to match for comparison

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: Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female~* At least 18 years of age~* Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation~* Subject had a baseline ATIII level of less than 100% and equal to or above 60%~* Subject signed the informed consent form~* Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study~Exclusion Criteria:~* Documented congenital ATIII deficiency or ATIII levels below 60%~* Subject had a baseline ATIII level of 100% or higher~* Subject needed emergency (non-elective) surgery~* Subject needed heart transplantation~* History of anaphylactic reaction(s) to blood or blood components~* Allergies to excipients~* Subject was pregnant~* Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected~* Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment~* Subject had participated in any another investigational study within the last 30 days previous to the inclusion

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

Study Arms:
- Antithrombin III treatment group (Type: EXPERIMENTAL): Preoperative ATIII supplementation administered immediately after anesthesia induction
- Control group (Type: NO_INTERVENTION): No preoperative ATIII supplementation administered

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

Answer: outcome: complete