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

Trial Title: Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

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:~* Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.~* Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.~Exclusion Criteria:~* No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).~* Subjects with a total IgE at screening of \>2,000 kU/L~* Previous reaction to omalizumab~* Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- One (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: Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~Meningococcal C naive subjects are required to fulfill all of the following criteria:~* Age ≥ 30 years~* Good health according to the investigator~* Willingness and ability to adhere to the study regimen~* Able to give informed consent~Meningococcal C experienced subjects are required to fulfill all of the following criteria:~* Age ≥ 18 years~* Good health according to the investigator~* Willingness and ability to adhere to the study regimen~* Able to give informed consent~Exclusion Criteria:~Meningococcal C naïve subjects should not have:~* Known previous invasive meningococcal infection~* Known or suspected previous vaccination against meningococcal disease~* Known or suspected allergy against any of the vaccine components~* Close contact in the last 60 days with a person known to be Neisseria positive~* History of unusual or severe reactions to any previous vaccination~* Family history of Guillain-Barré Syndrome~* Known or suspected immune deficiency, either congenital or acquired~* Administration of plasma or blood products less than three months prior to inclusion in the study~* Pregnancy (breastfeeding is allowed)~* Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)~* Any infectious disease~* Bleeding disorders or use of anticoagulants~* Participation as a subject in another trial in the last 3 months~Meningococcal C experienced subjects should not have:~* Known or suspected allergy against any of the vaccine components~* Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide)~* Close contact in the last 60 days with a person known to be Neisseria positive~* History of unusual or severe reactions to any previous vaccination~* Family history of Guillain-Barré Syndrome~* Known or suspected immune deficiency, either congenital or acquired~* Administration of plasma or blood products less than three months prior to inclusion in the study~* Pregnancy (breastfeeding is allowed)~* Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)~* Any infectious disease~* Bleeding disorders or use of anticoagulants~* Participation as a subject in another trial in the last 3 months

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

Study Arms:
- Menveo, dose escalating (Type: EXPERIMENTAL): None
- Nimenrix, dose escalating (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 Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests). Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 50 kg (110 lbs).~* Male subjects must agree that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.~* Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.~Exclusion Criteria:~* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, or clinical findings at screening excluding untreated, asymptomatic seasonal allergies at time of dosing.~* Clinically significant abnormalities in laboratory test results.~* Previous exposure to a monoclonal antibody or current use of other biologics.~* History of allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.~* Use of prescription or non prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.~* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

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

Study Arms:
- A (Type: EXPERIMENTAL): PF-05280014
- B (Type: ACTIVE_COMPARATOR): Trastuzumab-EU
- C (Type: ACTIVE_COMPARATOR): Trastuzumab-US

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 Examining PrEP-001 in Healthy Subjects

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

Eligibility Criteria:
Inclusion Criteria:~* Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.~* Female subjects were required to provide of a history of reliable contraceptive practice.~Exclusion criteria:~* Subjects who have a significant history of any tobacco use at any time.~* Any history or evidence of any clinically significant cardiovascular, dermatological gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal disease.~* Abnormal ECG

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

Study Arms:
- Cohort A: Sentinel Group (Type: OTHER): Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
- Cohort B: PrEP-001 (Type: EXPERIMENTAL): PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
- Cohort B: Placebo (Type: EXPERIMENTAL): Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.

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: Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

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

Eligibility Criteria:
Inclusion criteria:~* Documented history of Hypereosinophilic Syndrome (HES)~* Eosinophil count greater than 1500 cells for 6 months~* Signs and symptoms of organ system involvement~* No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.~* Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.~* Not pregnant or nursing.~Exclusion criteria:~* Churg-Strauss Syndrome~* Wegener's Granulomatosis~* Lymphoma, hematological malignancy, advanced and metastatic solid tumors~* Chemotherapy, radiotherapy or interleukin 2 treatment.

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

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: PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

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:~* Patients must have an indication for allogeneic hematopoietic stem cell transplantation~* Diagnosis:~Primary myelofibrosis Secondary myelofibrosis~* Signed informed consent~* Matched related, 8-10/10 HLA-matched unrelated or haploidentical donor available. The HLA typing is performed by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.~* No second tumors~* No severe concurrent illness~Exclusion Criteria:~* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%~* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted~* Respiratory distress \>grade I~* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits~* Creatinine clearance \< 60 mL/min~* Uncontrolled bacterial or fungal infection at the time of enrollment~* Requirement for vasopressor support at the time of enrollment~* Karnofsky index \<30%~* Pregnancy~* Somatic or psychiatric disorder making the patient unable to sign informed consent

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

Study Arms:
- PTCy and ruxolitinib (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: Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histological confirmation of invasive, early stage breast cancer~* Prior complete excision of tumor required (wide local excision or mastectomy)~* Hormone receptor status:~  * Not specified~PATIENT CHARACTERISTICS:~Age:~* Not specified~Sex:~* Female~Menopausal status:~* Pre-, peri-, or post-menopausal~Performance status:~* Not specified~Hematopoietic:~* Adequate bone marrow function~Hepatic:~* Adequate hepatic function~Renal:~* Adequate renal function~Other:~* No prior cancer except for basal cell carcinoma or carcinoma in situ~* Not pregnant or nursing~* Fertile patients must use effective contraception~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* Not specified~Chemotherapy:~* No prior chemotherapy~Endocrine therapy:~* Concurrent hormone therapy allowed~Radiotherapy:~* No prior radiotherapy~* Concurrent radiotherapy allowed~Surgery:~* See Disease Characteristics~* No more than 6 weeks since prior surgery to the breast

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

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: Analgesic Efficacy of Orally Administered VTS-K for Pain Management

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:~* 18 years+~* presenting to Maimonides Medical Center ED~* acute musculoskeletal painful conditions (traumatic and non-traumatic) with an initial pain score of 5 on a standard 11- point (0 to 10) numeric rating scale~* be awake, alert, and oriented to person, place, and time,~* demonstrate understanding of the informed consent process and content.~* have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS.~Exclusion Criteria:~* Patients with altered mental status~* allergy to aspirin and ketamine~* pregnant patients~* unstable vital signs (systolic blood pressure \<90 or\>180 mm Hg~* pulse rate \<50 or \>150 beats/min~* respiration rate \<10 or \>30 breaths/min)~* inability to provide consent~* consumption of Aspirin or NSAID's within 6 hours of arrival to the ED~* active PUD~* history of GI Hemorrhage~* history of renal and hepatic insufficiency~* past medical history of alcohol or drug abuse~* schizophrenia.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 110 Years
- Healthy Volunteers: f

Study Arms:
- Vitalis Pharmaceuticals (VTS)-Aspirin and Ketamine (Type: None): An oral combination drug of VTS-Aspirin and ketamine (VTS-K) would facilitate the shift from IV opioids to a non-IV therapy for patients presenting to the ED with acute MSK pain. This formulation has a potential to provide effective analgesia in the ED with reduced side effects. VTS-K's proprietary oral formulation of established, safe, and well-understood APIs, makes it uniquely appropriate for use in the ED. VTS-K is administered orally, which is suitable for resource-poor environments in which the healthcare setting may be inadequate as well as suitable to improve the throughput of ED Patients by reducing their length of stay. This is especially pertinent given the alternative of IV opioids for pain management of acute MSK pain, which requires both clinical monitoring and equipment, whereas VTS-K promotes weaning off opioids, alleviating the resource consumption.

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 Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

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

Eligibility Criteria:
Inclusion Criteria:~* Hospitalized male or female subjects, at least 18 year of age.~* Complicated intra-abdominal infection is present at most under two weeks duration.~* Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.~Exclusion Criteria:~* Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.~* Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.~* Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.

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

Study Arms:
- Group A (Type: EXPERIMENTAL): None
- Group B (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: A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Patient has a cholesterol level of 130 mg/dL or greater~* Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study~* Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines~Exclusion Criteria:~* Patient weighs less than 100 lbs~* Patient has an allergy to ezetimibe, simvastatin or atorvastatin

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
- 2 (Type: EXPERIMENTAL): Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
- 3 (Type: EXPERIMENTAL): Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
- 4 (Type: EXPERIMENTAL): Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
- 5 (Type: EXPERIMENTAL): Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 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: Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female inpatients 18 to 65 years of age~* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode~* Having a total Young Mania Rating Scale (YMRS) score \>= 20 and a score of at least 4 on two of the following YMRS items:~  * Irritability,~ * Speech,~ * Content, and~ * Disruptive/Aggressive Behavior~Exclusion Criteria:~* Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values \[such as thyroid-stimulating hormone (TSH)\].~* Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score \>= 18 at Visit 2.~* Patients experiencing first manic episode.~* Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.

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

Study Arms:
- Cariprazine (Type: EXPERIMENTAL): Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo dose-matching cariprazine capsules oral administration, once per day for 3 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: Walk With Me for Perinatal Grief

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:
Inclusions Criteria~Focus Groups and Usability Testing (Bereaved Parents)~* Experienced a perinatal loss~* Have had at least 6 months pass since experiencing the most recent loss~* Age 15 and older~Efficacy Study (Bereaved Parents)~* Bereaved parent who has experienced a perinatal loss within the last two weeks \* Age 15 and older~* Have access to technology to view WWM content~Exclusion Criteria~\* Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- PeriGrief (Type: EXPERIMENTAL): A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss.

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

Answer: outcome: complete