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

Trial Title: Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy

Study Design Characteristics:
- Allocation: NON_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. Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible.~2. Age 5-40 years old on date of diagnostic biopsy.~3. Adequate organ function: creatinine 1.6 or lower, bilirubin \<2, Hemoglobin 8 gm/dL or greater, Absolute neutrophil count (ANC) 1000 or more, platelets 100,000 or more. Cardiac ejection fraction (EF) 50% or better, hearing threshold 40 dB at 4000 Hz or better.~4. Signed informed consent.~5. Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy.~Exclusion Criteria:~1. Diagnosis other than osteosarcoma.~2. Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 40 Years
- Healthy Volunteers: f

Study Arms:
- Outpatient Chemotherapy (Type: EXPERIMENTAL): Pre-Surgery, Regimen 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m\^2/day for 2 days, Methotrexate 12 gm/m\^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen 1: Methotrexate 12 gm/m\^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m\^2 twice daily, Leucovorin Rescue.
- Additional Risk-Adapted Outpatient Chemotherapy (Type: EXPERIMENTAL): Pre-Surgery, Regimen 2: Dexrazoxane 900 mg/m\^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m\^2 (intra-arterial); Surgery; Post-Surgery, Regimen 2: Methotrexate 12 gm/m\^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m\^2/day and Mesna 2.8 gm/m\^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

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. Age \>18 years~2. Symptomatic and severe AS defined by an effective AVA ≤1 cm² and indexed AVA ≤0.6 cm2/m2~3. LVEF ≥50%~4. MAG \<40 mm Hg (measure confirmed by the multi-window continuous-wave Doppler interrogation and use of Pedoff probe)~5. Confirmation of the presence of severe AS at DSE and MDCT aortic calcium score~6. Feasibility of AVR by surgery or TAVR according to the heart team~7. Signature of an informed consent~Exclusion Criteria:~1. Uncontrolled atrial of ventricular arrhythmias~2. Patient having a life expectancy \<1 year, independently from their aortic pathology~3. Coronary artery disease necessitating a percutaneous or surgical revascularisation~4. Presence of a concomitant valve disease needing surgical treatment~5. Patient who are included in another research protocol~6. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)

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

Study Arms:
- aortic valve replacement (Type: EXPERIMENTAL): None
- strict clinical surveillance (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: safety issues
Please assess the completion status of the following clinical trial:

Trial Title: Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Who will get surgical resection for colorectal cancer~* Who has diagnosed with diabetes~* Who met the criteria for testing of diabetes in asymptomatic adult individuals~* Criteria for testing for diabetes in asymptomatic adult individuals~  * overweight (BMI\>25 kg/m2\*) and have additional risk factors (physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander), women who delivered a baby weighing 0.9 lb or were diagnosed with GDM, hypertension (\>140/90 mmHg or on therapy for hypertension), HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level \>250 mg/dL (2.82 mmol/L), women with polycystic ovarian syndrome, HbA1C \>5.7%, IGT, or IFG on previous testing, other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans), history of CVD)~Exclusion Criteria:~* Previously exposed to surgery or chemotherapy for colorectal cancer~* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence~* Presence of CNS metastasis~* Not able or willing to give informed consent~* Any patients judged by the investigator to be unfit to participate in the study

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

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

Eligibility Criteria:
Inclusion Criteria:~* Patient ≥ 18years old~* Stable angina symptoms~* Elective treatment to coronary lesion~* Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection~Exclusion Criteria:~* Left main stem lesion~* Bifurcation lesions~* Acute coronary syndrome (UAP, NSTEMI, STEMI)~* Cardiogenic shock~* Chronic total occlusion~* Additional lesions requiring PCI~* Platelet count ≤ 50 x 109/mm3~* Left ventricular ejection fraction ≤ 30%~* Patient life expectancy less than 12 months~* Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel~* Participation in another investigational drug or device study~* Patient unable to give informed consent

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

Study Arms:
- Stent (Type: ACTIVE_COMPARATOR): drug eluting stent (Resolute)
- drug eluting balloon (Type: EXPERIMENTAL): drug eluting balloon (Elutax)

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Macular Edema Incidence/Severity Reduction With Nevanac

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:~* Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.~* History of Type 1 or Type 2 diabetes.~* History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.~* Able to understand and sign an informed consent approved by an IRB/IEC.~* Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.~* Absence of clinically significant macular edema in the study eye as detected by clinical exam.~* Other protocol-defined inclusion criteria may apply.~Exclusion Criteria:~* Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.~* Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.~* Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).~* Corneal transplant in study eye.~* Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.~* Other protocol-defined exclusion criteria may apply.

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

Study Arms:
- NEVANAC (Type: EXPERIMENTAL): One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
- Nepafenac Vehicle (Type: PLACEBO_COMPARATOR): One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

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 who voluntarily provide written informed consent prior to entering into this study~* Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically~* Patients who underwent radical resection with wide lymph node dissection~* TNM stage (6th AJCC) of IIIB or IV on post-operative staging~* Patients who can be randomized within 6 weeks after surgery~Exclusion Criteria:~* Aged \< 20 years or ≥ 76 years~* Eastern Cooperative Oncology Group (ECOG) performance status \>2~* Patients who underwent surgery for neoplasm in stomach in the past~* History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ~* Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)~* Residual cancer on post-operative staging (R1 and R2 resection)~* Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer~* Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment~* Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment~* Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•~* History of hypersensitivity to the investigational products (S1 and Oxaliplatin)

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- S-1/Oxaliplatin (Type: EXPERIMENTAL): S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of MDS according to protocol-specified criteria via bone marrow studies performed within 12 weeks before randomization~Exclusion Criteria:~* No prior or concurrent treatment with epoetin alfa or any other approved or experimental erythropoietin stimulating agents (ESAs) within the previous 12 months before randomization~* No prior use of approved or experimental agents for the treatment of MDS or recent treatment with granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) for the treatment of neutropenia~* Patients must not have secondary MDS or anemia caused by factors other than MDS (including iron deficiency, vitamin B12 or folate deficiencies, hemolysis, chronic renal failure, or gastrointestinal bleeding)~* No history (within 12 months) of deep venous thrombosis~* or history (within 6 months) of stroke, acute coronary syndrome or other arterial thrombosis~* Not currently receiving therapeutic anticoagulants or have uncontrolled hypertension~* No uncontrolled disease or dysfunction deemed clinically significant by the Investigator not attributable to MDS

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

Study Arms:
- 001 (Type: EXPERIMENTAL): Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks
- 002 (Type: EXPERIMENTAL): Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks
- 003 (Type: PLACEBO_COMPARATOR): Placebo Matching volume 1 mL for 48 weeks
- 004 (Type: PLACEBO_COMPARATOR): Placebo Matching volume 2 mLfor 48 weeks

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

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:children~* Age 2-17 with a diagnosis of perforated appendicitis~Exclusion Criteria:~* Age \<2 and \>18~* Pregnancy~* Immunocompromise

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Initial appendectomy (Type: OTHER): children with complicated appendicitis will undergo initial appendectomy
- Interval appendectomy (Type: OTHER): children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

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:~* Age ≥ 18 (or as required by local regulation).~* Histological or cytological confirmation of unresectable or metastatic solid tumor malignancy harboring a KRAS mutation.~* No more than 3 prior standard treatments appropriate for tumor type and stage of disease.~* ECOG performance status ≤ 1.~* Existence of measurable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria).~* Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.~* Adequate organ function.~Exclusion Criteria:~* Major surgery within four weeks of the start of treatment.~* Previous other cancer requiring treatment within the previous two years.~* Clinically significant cardiovascular disease.~* Any of the following cardiac criteria:~* Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events~* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG~* Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).~* Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.~* Subjects being treated with or anticipating the need for treatment with strong CYP3A inhibitors or inducers.

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

Study Arms:
- TPX-0005 + Trametinib (Type: EXPERIMENTAL): TPX-0005 + Trametinib Dose Escalation and Dose Expansion~Dose escalation: KRAS G12D mutant advanced solid tumors. Dose expansion: KRAS G12D locally advanced or metastatic NSCLC

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

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

Eligibility Criteria:
Inclusion Criteria:~* Infant \<1 year suffering from cholestasis~Exclusion Criteria:~* Rejection or inability for parent to give their informed consent

- Gender: ALL
- Minimum Age: None
- Maximum Age: 1 Year
- Healthy Volunteers: f

Study Arms:
- cholestasis (Type: None): infant suffering from cholestasis proteomic urine analysis

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Vitamin Therapy in Concussion Management: A Randomized Control Trial

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects ages 11-22~* Concussion within 7 days of enrollment~* Presenting for treatment at Rothman Institute or Jefferson Concussion Center~Exclusion Criteria:~* Subjects with recent prior concussion within the past 30 days~* Subjects with a history of moderate to severe TBI requiring hospitalization or resulting in prolonged symptoms (\>3weeks).~* Subjects with known neurologic diagnosis associated with impaired cognitive function other that Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.~* Subjects with know allergy to algae, omega-3 fatty acid, or any component of the formulation.~* Subjects currently requiring anticoagulants (ie- Warfarin), anti-platelets (ie- Aspirin, Plavix), or any non-steroidal anti-inflammatory drugs (ie- Ibuprofen, Naprosyn).~* Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 X normal).~* Subjects with a current lower extremity injury that will affect postural stability testing.~* Subjects who are pregnant and/or breast feeding.

- Gender: ALL
- Minimum Age: 11 Years
- Maximum Age: 22 Years
- Healthy Volunteers: t

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
- Experimental: Vitamin Mixture (Type: EXPERIMENTAL): Vitamin coenzyme Q10, magnesium, riboflavin and omega-3-fatty acid combination.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study

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

Eligibility Criteria:
Inclusion Criteria:~* Patients who have been mechanically ventilated for at least fourteen days.~* Clinically stable: oxygen saturation \> 90% with a fractional inspired oxygen ≤ 0.40, external positive end expiratory pressure ≤ 5 centimeters water, temperature ranging from 35.5 to 38.5 degrees celsius, no intravenous administration of vasoactive agents.~Exclusion Criteria:~* Patients in whom Neuromuscular Electrical Stimulation (NMES) does not elicit a palpable contraction of the abdominal muscles.~* Patients with broken or irritated skin on the abdominal wall~* Patients with a history of neuromuscular disease~* Body Mass Index (BMI) \> 35 kg/m2~* Patients who are not medically stable~* Patients with a pacemaker~* Female patients who are pregnant~* Patients under the age of 18~* Patients who are expected to die within four weeks~* Patients who are unable to follow verbal instructions~* Patients with epilepsy~* Patients with an abdominal wall hernia~* Patients with anoxic encephalopathy~* Patients with history of, or active, substance abuse

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

Study Arms:
- VentFree Stimulation (Type: EXPERIMENTAL): Breath synchronized abdominal NMES
- Sham Stimulation (Type: SHAM_COMPARATOR): Sham breath synchronized abdominal NMES

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

Answer: outcome: terminate
termination_type: enrollment issues