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

Trial Title: Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: EARLY_PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients must have newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Grade 3B Follicular lymphoma, Burkitt Lymphoma, Peripheral T cell Lymphoma NOS, NK/T cell Lymphoma, or Transformed lymphoma.~2. Planned to receive chemotherapy for 6 cycles which the treating physician plans to utilize for pegfilgrastim to minimize risk for neutropenic fever, including but not limited to R-CHOP, R-EPOCH, and R-HyperCVAD, CHOP, and SMILE.~3. Age \>= 18 years old.~4. ECOG performance status 0-3.~5. Ability to provide informed consent for participation.~Exclusion Criteria:~1. Existing chronic bone pain prior to pegfilgrastim usage.~2. Creatinine clearance of \<50ml/minute by Cockcroft Gault equation.~3. Allergy to filgrastim, pegfilgrastim, or Loratadine.~4. Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication.~5. Inability to swallow medications.~6. Inability to complete the survey instrumentation accurately.

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

Study Arms:
- Group 1 - Loratadine (Type: EXPERIMENTAL): Pegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.~Cycle 1 and 3:~Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.~Cycle 2 and 4:~Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.~Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs.
- Group 2 - Placebo (Type: EXPERIMENTAL): Pegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.~Cycle 1 and 3:~Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.~Cycle 2 and 4:~Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.~Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs.

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: Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects having elective surgery with open unilateral Inguinal herniorraphy~Exclusion Criteria:~* Non elective surgery~* Patients currently on gabapentin therapy~* Patient hypersensitive to gabapentin surgery~* History of alcohol or drug abuse~* Patients who are pregnant or who are nursing

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

Study Arms:
- Single pre-op dose of Gabapentine (Type: ACTIVE_COMPARATOR): Active treatment with the study drug
- Placebo (Type: PLACEBO_COMPARATOR): Placebo arm for blinding the medication

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: The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles

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:~* healthy, exclusively formula-fed infants aged 1-6 months at enrollment;~* parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.~Exclusion Criteria:~* born \< 37 weeks;~* birth weight \< 2500g or \> 4000g;~* current weight \< 10th percentile for age;~* hospitalization \> 72 hours following birth or any hospital admission since birth;~* any health issue that could interfere with feeding and/or growth;~* use of complementary foods;~* inability or unwillingness to comply with study-related procedures.

- Gender: ALL
- Minimum Age: 1 Month
- Maximum Age: 6 Months
- Healthy Volunteers: t

Study Arms:
- Novel bottle (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: Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)

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

Eligibility Criteria:
Inclusion Criteria:~* Severe aortic stenosis with ejection fraction less than 40% that is schedule to undergo aortic valve replacement~Exclusion Criteria:~* Creatinine \> 2~* More than moderate mitral, tricuspid, or aortic regurgitation.~* Endocarditis~* Emergent surgery~* Prior sternotimy

- Gender: ALL
- Minimum Age: 18 Years
- 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: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Model 20105 Lead Study

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

Eligibility Criteria:
Inclusion Criteria:~* Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)~* Subject has signed and dated the study-specific informed consent form~* Subject is 18 years of age or older~* Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study~Exclusion Criteria:~* Subject is indicated for BiV pacemaker or ICD~* Subject is pacing dependent~* Subject has a previous Pacemaker System~* Subject has known coronary venous vasculature that is inadequate for lead placement~* Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month~* Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months~* Subject is not in sinus rhythm at implant~* Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)~* Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure~* Subject is contraindicated for \<1mg dexamethasone acetate~* Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study~* Subject has a terminal illness and is not expected to survive more than 6 months~* Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.~* Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.~* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study~* Subject meets exclusion criteria required by local law.~* Subject is unable to tolerate an urgent thoracotomy

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

Study Arms:
- Model 20105 (Type: EXPERIMENTAL): Receiving the model 20105 Lead

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: Microwave Coagulation in Partial Nephrectomy Protocol

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

Eligibility Criteria:
Inclusion Criteria:~1. Patient must have a solitary, polar, clinical T1 renal mass~2. Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.~3. Women of child-bearing potential must have negative serum or urine pregnancy test~4. Patient must be able to give written informed consent~5. Patient must be 18 years or older~6. No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery~Exclusion Criteria:~1. T stage greater than clinical T1~2. Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland~3. Prior surgery or radiation therapy to the region of interest~4. Patient has a single functioning kidney~5. Patient has an uncorrectable coagulopathy~6. Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition

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

Study Arms:
- Certus 140™ (Type: EXPERIMENTAL): During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.

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 to Accelerate Immune System Recovery Following Stem Cell Transplantation

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:~* To be treated on this study, patients must have recently undergone a T-cell depleted allogeneic bone marrow or peripheral blood stem cell transplant from an HLA-matched sibling donor, an HLA matched unrelated donor, or an HLA partially matched (single antigen mismatched, two antigen mismatched, or haplodisparate) donor. Patients will be counseled and will sign informed consent for this study prior to their transplant. Our intention is to analyze the effectiveness of LLME treated DLI (Donor Lymphocyte Infusion) on an intent to treat basis. To proceed with this therapy after HSCT, patients must meet the other selection criteria below at the time of first DLI. Additionally, discussion prior to transplant helps present the patient (and donor) a picture of the proposed therapy in its entirety, rather than in piecemeal fashion. A patient or donor's unwillingness to participate in this study will in no way affect their eligibility for transplant therapy at our center.~* At the time of initial DLI therapy, patients must be between 28 and 42 days post allogeneic HSCT or between 28 and 42 days after the last dose of ATG if that agent was used after the transplant as part of their graft rejection prophylaxis. They must also meet the following criteria during the week prior to first infusion:~* Patients must have achieved primary engraftment with an absolute neutrophil count of at least 1000 per l for 3 consecutive days.~* Patients must have a CD4+ lymphocyte count of less than 200 per l. An absolute lymphocyte count of less than 200 per l will be taken as prime facie evidence that the CD4+ lymphocyte count meets this criteria.~* Patients may not exhibit overt hematologic manifestations of relapse or persistent disease. Evidence of recurrent/persistent disease based primarily on flow cytometry, cytogenetics, chimerism analysis, or other molecular studies does not by itself represent grounds for exclusion.~* Patients must be 16 years of age or older. There is no upper age limit for this study.~* Patients must not be pregnant.~* Patients must not have any documented graft-versus-host disease.

- Gender: ALL
- Minimum Age: 16 Years
- 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: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants

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:~1. The participant had a diagnosis of PKAN as indicated by confirmed mutations in the pantothenate kinase 2 gene.~2. The participant was male or female aged 6 to 65 years, inclusive.~3. The participant had a score of ≥ 6 on the PKAN-specific activities of daily living measure.~Exclusion Criteria:~1. The participant had required regular or intermittent invasive ventilatory support to maintain vital signs within 24 weeks prior to randomization.~2. The participant had a deep brain stimulation device implanted within 6 months prior to screening.~3. The participant had taken deferiprone within 30 days prior to screening.~4. The participant was unable to maintain stable doses of allowed concomitant medications for the first 24 weeks of the study.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Fosmetpantotenate (Type: EXPERIMENTAL): Administered as powder for reconstitution.
- Placebo (Type: PLACEBO_COMPARATOR): Administered as powder for reconstitution.

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: Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

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:~* Able to understand and have the ability to provide written consent~* Between 18 and 70 years of age~* Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy~* ECOG Performance Status of 0-2~* Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion.~* Patients must have left ventricular ejection fraction (LVEF) ≥50%~* Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception.~Exclusion Criteria:~* Patients with acute promyelocytic leukemia~* Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin~* Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML~* History of thromboembolic event within the past 12 months~* Hepatitis B or C or HIV positive serology~* Symptomatic central nervous system (CNS) involvement~* History of congestive heart failure~* Myocardial infarction in the past 6 months~* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy~* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent~* Patient may not be receiving any other anti neoplastic investigational agents~* INR\> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin)~* Patient undergone autologous or allogeneic stem cell transplantation~* Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia~* Women who are pregnant or breastfeeding.

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

Study Arms:
- Gemtuzumab ozogamicin/Mitoxantrone/Etoposide (Type: EXPERIMENTAL): 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: AGIR Study: Angio-Seal in Interventional Radiology

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:~* Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)~* Patient available for follow-up at 2 weeks~* Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.~Exclusion Criteria:~* Access unsuitable for use of Angio-Sea~* Presence of calcification at the puncture site~* Presence of visible hematoma at the end of the procedure~* Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.~* Patients who are pregnant.~* Patients currently participating in a clinical investigation that includes an active treatment arm.~* Contraindication for ambulation at 2 hours after the end of the procedure~* Patients with a life expectancy of less then 1 month.

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

Study Arms:
- Angio-Seal (Type: ACTIVE_COMPARATOR): Closure procedure by Angio-Seal
- Manual compression (Type: ACTIVE_COMPARATOR): Closure procedure by manual compression

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: Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya

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:~A. Infants newly initiating HAART~* Less than 13 months of age~* HIV-1 DNA detection with confirmation (positive on two HIV-1 DNA filter paper tests)~* Caregiver of infant plans to reside in Nairobi for at least 3 years (reported by caregiver)~* Caregiver is able to provide sufficient location information~B. Infants already receiving HAART~* Initiated HAART at \<13 months of age~* Records confirming HIV positive status~* Documentation of CD4% and weight prior to HAART initiation~* Must be on 1st line drug regimen~Eligibility for randomization:~* Completed 24 months of treatment with HAART~* Normalized growth: weight for height z-score (WHZ) \> -0.5; Child's weight must be above the 5th weight-for-age percentile and the weight curve must not be flat or falling (i.e. cross 2 major percentile lines or more over the past 3 months)~* CD4% \> 25~* Children who recently initiated or who require anti-tuberculosis treatment at the time of randomization will be ineligible for randomization.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 54 Months
- Healthy Volunteers: f

Study Arms:
- Interrupted HAART (Type: NO_INTERVENTION): After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
- Continued HAART (Type: ACTIVE_COMPARATOR): After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.

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

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

Trial Title: Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Allergic rhinitis to house dust mite (Df, Dp), cat or dog~* More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST)~Exclusion Criteria:~* Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline~* FEV1 less than 50% of predicted value if there is comorbid asthma.~* Subject rejects the enrollment into study~* Low compliance~* Pregnancy or lactation~* Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases~* Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immnosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks~* Prior history of allergen-specific immunotherapy~* Allergic rhinitis caused by other perennial or seasonal allergen~* Vulnerable volunteer

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Allergen extract (Type: ACTIVE_COMPARATOR): 0.1 ml of allergen extracts
- Placebo (Type: PLACEBO_COMPARATOR): Normal saline, 0.1 ml

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

Answer: outcome: terminate
termination_type: enrollment issues