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

Trial Title: A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic 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:~* Female between 18 and 70 years old;~* Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;~* ECOG (Eastern Cooperative Oncology Group) 0\~1;~* Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;~* Got ICF (Informed Consent Form) before enrollment;~* Life expectancy more than 12 weeks~Exclusion Criteria:~* Pregnant or breast-feeding women or positive serum pregnancy test;~* Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;~* Participation in any investigational drug study within 4 weeks preceding treatment start;~* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;~* Serious uncontrolled intercurrent infections;~* Poor compliance

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

Study Arms:
- Abraxane and Gemcitabine (Type: EXPERIMENTAL): Abraxane and Gemcitabine

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 PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

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 rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.~* At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.~* Hs-CRP equal or greater than 8 mg/L.~* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.~Exclusion Criteria:~* Evidence of untreated or inadequately treated latent or active TB.~* Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.~* History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.~* May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).~* Any second DMARD must be washed out prior to the first study dose.

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

Study Arms:
- PF-06410293 (Type: EXPERIMENTAL): None
- Adalimumab (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: To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients with diagnosis of MPS II based on both clinical and biochemical criteria~2. Male, ages 6 to 35 years old~3. Patients who are able to comply with the study requirements~4. Patients who have given voluntary written consent to participate in the study~5. Patients who is acceptable for using an appropriate method of contraception~Exclusion Criteria:~1. History of a tracheostomy or a bone marrow transplant~2. Known hypersensitivity to idursulfase~3. Known shock to idursulfase~4. History of receiving treatment with another investigational therapy within the past 30 days~5. History of a stem cell transplant~6. Known hypersensitivity to any of the components of idursulfase~7. Female

- Gender: MALE
- Minimum Age: 6 Years
- Maximum Age: 35 Years
- Healthy Volunteers: f

Study Arms:
- GC1111_0.5mg/kg (Type: EXPERIMENTAL): None
- GC1111_1.0mg/kg (Type: EXPERIMENTAL): None
- Elaprase_0.5mg/kg (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 Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck 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:~* Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.~* No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.~* Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.~* Life Expectancy of greater than 6 months~Exclusion Criteria:~* Stage IVB Squamous Cell Carcinoma~* Use of any investigational agent within the previous 30 days~* Uncontrolled cardiovascular disease~* Myocardial infarction within the last 3 months~* Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts~* Positive for hepatitis B or C or HIV~* Evidence of distant metastases~* Clinical gastritis or peptic ulcer within the last 6 months~* Stroke within the last six months

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- IRX-2 Regimen (Type: EXPERIMENTAL): The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin, zinc supplementation, and omeprazole.

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 CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

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:~* Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.~* Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections~* Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.~* Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature \>=100.4 degree F, increased white blood cell count, or bandemia.~* Must not have received treatment with another systemic antibiotic for the current ABSSI.~Exclusion Criteria:~* Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis.~* Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.~* Suspected polymicrobial infection involving Pseudomonas aeruginosa~* Anticipated need for \>14 days of antibiotic therapy.~* Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.~* Known significant renal, hepatic, or hematologic impairment.~* Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.

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

Study Arms:
- Linezolid (Type: ACTIVE_COMPARATOR): 600 mg BID
- CEM-102 Regimen A (Type: EXPERIMENTAL): None
- CEM-102 Regimen B (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: Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Mantel cell lymphoma~* CD 20+~* At diagnosis or without anterior chemotherapy~* Age \>18 and \< 66 years~* Ann Arbor ii, III or IV~* ECOG \<3~* contraindication for rituximab treatment~* Informed consent signed~* No cancer anteriory~* Renal and hepatic function compatible with the treatment~* Ventricular Fraction \> 50 % with echographic method and \> 40% with isotopic method~Exclusion Criteria:~* Other type of lymphoma~* age\<18 ou \> 66 years~* Informed consent not signed~* anterior cancer~* Contraindication to rituximab~* Cardiac insufficiency

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

Study Arms:
- VAD Clorambucil Rituximab (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 Remission Induction Therapy and Risk-oriented Postremission Strategy for Adult Acute Myelogenous Leukemia (AML)

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 (Random 1):~* Age 16+ years~* Diagnosis of untreated (or only hydroxyurea/cyclophosphamide) acute myelogenous leukemia (AML, including myeloid sarcoma) or high-risk myelodysplasia (RAEB-2), either de novo or following an antecedent hematological disorder, or secondary to chemo-radiotherapy for other cancer~* Signed informed consent~* Adequate sampling for full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria~* ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.~Exclusion criteria:~* Diagnosis of acute promyelocytic leukemia~* Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin \>3 mg/dL and/or ALT \>3 x upper normal limit (unless attributable to AML), kidney function impairment with serum creatinine \>2 mg/dL (unless attributable to AML), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan~* Known HIV positive serology~* Other active hematological or non-hematological cancers with life expectancy \<1 year~* Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods)

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- A (Type: ACTIVE_COMPARATOR): Remission induction arm A is with conventional chemotherapy cycle (ICE: idarubicin, standard-dose cytarabine, etoposide)
- B (Type: EXPERIMENTAL): Remission induction therapy with high-dose cytarabine sequential regimen (HD-Ara-C, idarubicin)

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: Short Term, High Dose Vitamin D Supplementation for COVID-19

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

Eligibility Criteria:
Inclusion Criteria:~* SARS-CoV-2 RNA positive Asymptomatic individuals~Exclusion Criteria:~* Uncontrolled Diabetes Uncontrolled Hypertension Chronic Liver Disease Chronic obstructive Pulmonary disease Requiring Invasive Ventilation

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

Study Arms:
- Intervention (Type: EXPERIMENTAL): Vitamin D high dose
- Control arm (Type: NO_INTERVENTION): No Vitamin D supplementation

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 Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)

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

Eligibility Criteria:
Inclusion Criteria:~* Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler~* Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator~Exclusion Criteria:~* Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components~* Has required an oral corticosteroid rescue for worsening asthma during the screening period

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): mometasone
- 2 (Type: PLACEBO_COMPARATOR): montelukast followed by placebo; or placebo followed by montelukast.

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: Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Males and females, age 18 to 80 years~* Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention~* Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris~* Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count \> 1.2 × 10\^3 per μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function (glomerular filtration rate \> 29 mL/minute/1.73 m2)~* Adequate birth control if of child-bearing potential~* Must be willing and able to provide informed consent~Exclusion Criteria:~* ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days~* New York Heart Association Function Class III or IV or left ventricular ejection fraction \< 25% within the 6 weeks prior to the screening visit~* HbA1c ≥ 8.5%, SBP \<90 or \>180 mmHg, DBP \>100 mmHg~* Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- AdVEGFXC1 at 1x10^9 vp (Type: EXPERIMENTAL): None
- AdVEGFXC1 at 1x10^10 vp (Type: EXPERIMENTAL): None
- AdVEGFXC1 at 4x10^10 vp (Type: EXPERIMENTAL): None
- AdVEGFXC1 at 1x10^11 vp (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 Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

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

Eligibility Criteria:
Inclusion Criteria:~* primary or secondary renal allograft within preceding 14 days;~* IgG seropositive for CMV;~* receiving immunosuppressive therapy.~Exclusion Criteria:~* active CMV infection;~* current/history of malignancy;~* acute steroid resistant rejection episode since transplantation.

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

Study Arms:
- Valganciclovir Cytomegalovirus (CMV) Prophylaxis (Type: EXPERIMENTAL): None
- Pre-emptive CMV Therapy (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 Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder

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

Eligibility Criteria:
Inclusion Criteria:~1. Diagnosis of bipolar II disorder currently in a depressive episode (without psychotic features)~2. Pretreatment HRSD score of \>/= 13 and \<28 and a CGI less than or equal to 5.~3. Between 18 and 85 years old~4. Willing to provide informed consent -~Exclusion Criteria:~1. Subject has a history of bipolar II disorder previously untreated with medication, or bipolar I disorder, or is in a manic or mixed episode; unipolar depression, schizophrenia, schizo-affective disorder, other (non mood disorder) psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or MMS (mini mental exam) less than or equal to 24, delirium. HRSD score \> 28 and CGI \> 5.~2. Significant current history of autoimmune, endocrine, disorder affecting the brain. No unstable cardiac disease, uncontrolled hypertension or sleep apnea.~3. Changes in psychotropic medications for 2 weeks prior to study entry amd unable to maintain stable doses throughout the trial.~4. Subject has active suicide plan, or history of suicide attempt within the past 12 months.~5. Pregnancy or positive serum pregnancy test.~6. Having a pacemaker~7. History of: skull fracture, craniotomy, deep brain stimulation, cochlear implants, dorsal column pacemaker, cardiac pacemaker, seizures or epilepsy.~   -

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Active CES (Type: EXPERIMENTAL): The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
- Sham CES (Type: SHAM_COMPARATOR): The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two 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: Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Facial synkinesis~Exclusion Criteria:~* Previous complication from botulinum toxin neuromodulator injection~* Inability to understand or complete the SAQ survey~* Inability to participate in follow-up~* Pregnancy

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

Study Arms:
- OnabotulinumtoxinA Injectable Product (Type: ACTIVE_COMPARATOR): onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
- AbobotulinumtoxinA Injectable Product (Type: ACTIVE_COMPARATOR): abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
- Incobotulinumtoxin A Injectable Product (Type: ACTIVE_COMPARATOR): incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.

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

Answer: outcome: complete