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

Trial Title: Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Diagnosis of cancer~* Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses)~PATIENT CHARACTERISTICS:~* Life expectancy \> 12 weeks~* No preexisting neuropathy~* No known allergy to pyridoxine hydrochloride and its incipients~* No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment~PRIOR CONCURRENT THERAPY:~* See Disease Characteristics~* No prior capecitabine~* Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab \[Herceptin®\] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS)~* No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS~* No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy~* No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex)~* No concurrent over-the-counter products that contain urea or lactic acid~* No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)

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

Study Arms:
- Pyridoxine hydrochloride (Type: ACTIVE_COMPARATOR): Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
- Placebo (Type: PLACEBO_COMPARATOR): Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

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: Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients

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

Eligibility Criteria:
Inclusion Criteria:~* Be age ≥ 18 years old.~* Have Karnofsky performance status score ≥ 70.~* Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in population) followed by allogeneic SCT for hematological malignancy.~* Have anticipated in-patient status for 14 to 20 days from the time of transplant.~* Be willing and capable of swishing/gargling oral gel/solution as required per protocol.~* Be willing and capable of completing the assessments and adhering to protocol requirements.~* Be willing and able to provide written informed consent.~To be randomized to begin treatment, subjects randomized to Arms 2 or 3 must also meet the following criterion:~-Be diagnosed with G1 or G2 OM via WHO OM scale during observation period from conditioning to Day +14.~Exclusion Criteria:~* Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than those defined, herein.~* Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.~* Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day 1.~* Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.~* Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.~For subjects randomized to Treatment Arms 2 or 3 during observation period:~-OM ≥ G3 diagnosed prior to initiating randomized treatment during observation period (conditioning through Day +14; i.e., missed treatment window).

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

Study Arms:
- Arm 1 (Gelclair at time of conditioning) (Type: EXPERIMENTAL): All subjects in study Arm 1 will receive GEL starting on the first day of conditioning.
- Arm 2 (Gelclair when OM diagnosed) (Type: ACTIVE_COMPARATOR): Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive GEL.
- Arm 3 (MMW when OM diagnosed) (Type: ACTIVE_COMPARATOR): Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive MMW.

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: Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

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

Eligibility Criteria:
Inclusion Criteria:~* Ages 10-19 years old~* Fasting Triglyceride levels of 150-1000 mg/dl at the screening and baseline visit~* Ability to swallow pills~* Informed consent from a parent or legal guardian of minors or adult subject~* Written assent from the adolescent to participate in the study~* English or Spanish speaking~Exclusion Criteria:~* Food Allergy to Fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or corn oil, and iron oxide or iron oxide containing food color additives.~* Pregnancy or positive urine pregnancy test for those females who have begun menstruating~* Breast feeding~* Alcohol Use: Patient is unable to abstain from alcohol use during the study. This will be assessed by asking the following questions: During the past 30 days, on how many days did you have at least one drink of alcohol?; During the past 30 days, on how many days did you have 5 or more drinks of alcohol in a row, that is, within a couple of hours?; This study requires that you abstain from alcohol use during the course of the study. Do you think you can do this?~* Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.~* Significant cognitive or psychosocial disorder or medical illness that would limit participation in the trial.~* Type 1 or 2 Diabetes or fasting glucose that is \>=126 mg/dl~* Liver disease or an ALT greater than 2 times upper limit of normal~* Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.~* Be currently taking the same oral contraceptive pills for less than the past three months or intend to change or discontinue prescription oral contraceptive pills used in the next seven months~* Be currently taking any over-the-counter supplements that affect triglycerides or lipid metabolism including over the counter fish oil supplements.~* Treatment for or diagnosis of a thyroid disorder or an elevated TSH level at baseline

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 19 Years
- Healthy Volunteers: f

Study Arms:
- A , Experimental (Type: EXPERIMENTAL): Lovaza, 4 grams/day orally for 6 months
- Corn Oil Pill (Type: PLACEBO_COMPARATOR): Corn Oil Pill, 4 pills/day orally 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: Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

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:~* Presenting with at least two comparable, discrete, and separate partial thickness thermal burns, as determined by the Investigator, measuring 50 - 1,000 cm2 each~* Study wounds identified are partial thickness depth~* KeraStat Gel and SSD can be applied to randomized study burn wounds as definitive care treatment within 24 hours from time of injury\]~* Overall total body surface area burned \< 20%~Exclusion Criteria:~* Pregnant or nursing~* Prisoner~* Presence of inhalation injury, as determined by the Investigator~* Injury requiring formal intravenous fluid resuscitation~* Concomitant non-thermal traumatic injuries~* Chronic medical conditions including, but not limited to, documented renal impairment (Cr \> 2.5 mg/dL), hepatic impairment (Total bilirubin \> 2.5 mg/dL), thromboembolic disorders, active infection in study wound areas, uncontrolled diabetes (HbA1C \> 7%), HIV infection, history of melanoma or systemic malignancy within the last 10 years~* Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, or any other medication the Investigator feels will affect wound healing~* Not expected to live at least 13 months post-burn~* Received an investigational drug or biologic within 3 months prior to injury~* Previously treated with a skin graft at either of the treatment sites~* Chemical or electrical burn~* Known or documented allergy to sulfonamides~* Proposed study wounds are full thickness~* Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- KeraStat Gel (Type: EXPERIMENTAL): Each enrolled subject will have at least one eligible burn randomized to the KeraStat Gel arm. This burn will be dressed with KeraStat Gel and covered by a secondary dressing. Subjects will be instructed to change the dressing and re-apply the KeraStat Gel per the instructions for use (at least every 3 days).
- Silver Sulfadiazine (Type: ACTIVE_COMPARATOR): Each enrolled subject will have at least one eligible burn randomized to the Silver Sulfadiazine arm. This burn will be dressed with the Silver Sulfadiazine and covered by a secondary dressing. Subjects will be instructed to change the dressing and re-apply the Silver Sulfadiazine per the institution's Standard of Care instructions.

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: Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers

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: None

Eligibility Criteria:
Inclusion Criteria:~1. Subjects must demonstrate their willingness to participate in the study (reliable and compliant for repeated treatments) and comply with its procedures by signing a written informed consent.~2. Subjects must be 18 years of age or older.~3. Subjects must have received a platinum regimen, with or without paclitaxel or cyclophosphamide, and have maintained a disease-free status for at least 6 months following the completion of first line therapy.~4. Documented measurable or evaluable ovarian, tubal or primary peritoneal cancer by appropriate radiologic imaging (x-ray, or CT scan). Radiation therapy is allowed as long as not at the site of measurable disease. Recurrent disease based on elevated CA-125 alone is allowed, provided it meets the CA-125 progression definition.~5. Subjects must have adequate hepatic, renal and marrow function (AST/ALT\< 3UNL, creatinine\<2UNL, ANC\>2, HGB\>90)~6. Histologic diagnosis of ovarian, tubal or primary peritoneal cancer.~7. Performance status: ECOG Score greater than or equal to 2.~8. Subjects must have life expectancy of at least 6 months.~9. Women of childbearing potential must have a negative pregnancy test at time of enrollment and must be using an acceptable method of birth- control during the study.~Exclusion Criteria:~1. Female subjects who are pregnant, breast-feeding, or unwilling to use adequate contraception.~2. Any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix;~3. Two or more prior chemotherapy regimens for ovarian cancer~4. Serious infection within one month of commencement of treatment.~5. Patients with known brain metastasis. However baseline CT of the head is not a must.~6. Patients with severe gastro-intestinal symptoms- e.g.- partial obstruction, bleeding or diarrhea.~7. Patients with Grade 2 or higher neuropathy \[NCI Common toxicity criteria\].

- 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: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients

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:~* Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease~* Mini-Mental Status Examination (MMSE) \>=10 at screening~* Caregiver able to attend all clinic visits with subject~Exclusion Criteria:~* Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.~* Any significant brain MRI abnormality.~* Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening

- Gender: ALL
- Minimum Age: 51 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Bapineuzumab 0.5 mg/kg (Type: EXPERIMENTAL): bapineuzumab
- Bapineuzumab 1.0 m/kg (Type: EXPERIMENTAL): bapineuzumab

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: Anesthetic Techniques in EP Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Patients scheduled for cardiac electrophysiology procedures~* Patients ≥18 years of age~Exclusion Criteria:~* Gastroesophageal reflux disease (GERD),~* pulmonary hypertension,~* severe pulmonary disease,~* obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)

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

Study Arms:
- Sedation - Group 1 (Type: EXPERIMENTAL): Sedation - monitored anesthesia with propofol.
- Sedation - Group 2 (Type: EXPERIMENTAL): Sedation - monitored anesthesia with ketamine + propofol
- Sedation - Group 3 (Type: EXPERIMENTAL): Sedation - monitored anesthesia with remifentanil + propofol
- General Anesthesia - Group 1 (Type: EXPERIMENTAL): General anesthesia (GA) with Sevoflurane + O2

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 Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis~2. Patients with a ratio of affected to unaffected free light chains \>5 or free light chain difference of \>50~Exclusion Criteria:~1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm~2. Contraindication to florbetapir or its components~3. Refusal to participate in the study

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 95 Years
- Healthy Volunteers: f

Study Arms:
- AL or TTR type amyloidosis (Type: EXPERIMENTAL): The participants will undergo F-18 florbetapir PET scan.

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: Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation~* Requires hospitalization for intravenous (IV) empiric antibiotic therapy~Exclusion Criteria:~* Fungal or viral infection requiring additional therapy~* Known acute viral hepatitis~* Known to be human immunodeficiency virus (HIV) positive~* Expected requirement for hemodialysis while on study therapy~* Received \>24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug~* Past or current history of epilepsy or seizure disorder~* Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.

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

Study Arms:
- CAZ-AVI + Vancomycin or Linezolid (Type: EXPERIMENTAL): Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care \[SOC\]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
- Standard of Care+Vancomycin or Linezolid (Type: ACTIVE_COMPARATOR): Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.

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: Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

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:~* Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy~* Patient who have given their written consent~Exclusion criteria:~* Current participation in a clinical trial for the second-line treatment of prostate cancer~* Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity~* Patients having already started a second line treatment~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Study Arms:
- CRPC patients (Type: None): None

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: Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

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

Eligibility Criteria:
Inclusion criteria:~* in good general health.~* not pregnant and using effective birth control~* agreed to participate in entire study and comply with protocol requirements.~Exclusion criteria:~* military service prior to 1989.~* no previous smallpox vaccination.~* no contact with with children 1 year of age or younger~* immunodeficiency individuals or close contacts who are immunodeficient~* past history or current renal disease~* diagnosis or past history of eczema~* known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).~* known allergy or past allergic to blood products.~* known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.~* transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.~* serology positive for HIV, hepatitis B or hepatitis C.~* current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.~* inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 29 Years
- Healthy Volunteers: t

Study Arms:
- Group 1 (Type: EXPERIMENTAL): ACAM1000
- Group 2 (Type: EXPERIMENTAL): ACAM1000
- Group 3 (Type: EXPERIMENTAL): ACAM1000
- Group 4 (Type: ACTIVE_COMPARATOR): Dryvax

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

Answer: outcome: terminate
termination_type: feasibility