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

Trial Title: Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Diagnosis of melanoma~  * Regionally recurrent or distant metastatic disease~* Must have an established continuously proliferating cell line expanded to about 200 million cells that is free of stromal cells and contamination~* No active CNS metastases~  * Prior treatment for brain metastases or spinal cord compression allowed~ * No clear evidence of disease progression in the CNS~ * No concurrent pharmacologic doses of corticosteroids~PATIENT CHARACTERISTICS:~* Karnofsky performance status (PS) 70-100% OR ECOG PS 0-1~* Platelet count \> 100,000/mm³~* Hematocrit \> 30%~* Creatinine \< 2.0 mg/dL~* Bilirubin \< 2.0 mg/dL~* Albumin \> 3.0 mg/dL~* No significant hepatic or renal dysfunction~* No other invasive cancer within the past 5 years~* No active infection or other active medical condition that could be eminently life threatening, including any of the following:~  * Active blood clotting~ * Bleeding diathesis~* No ongoing transfusion requirement~* No underlying cardiac disease associated with known myocardial dysfunction~* No unstable angina related to atherosclerotic cardiovascular disease~* No known autoimmune disease~* Negative pregnancy test~PRIOR CONCURRENT THERAPY:~* Prior surgery, radiotherapy, chemotherapy, biological therapy (including sargramostim \[GM-CSF\]), or vaccine therapy allowed~* No concurrent anticancer therapy (e.g., hormone therapy for prostate or breast cancer)~* No concurrent digoxin or other medications for the treatment of heart failure~* No concurrent immunosuppressive therapy

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Arm I (Type: EXPERIMENTAL): Patients receive irradiated autologous tumor cells subcutaneously (SC) and sargramostim (GM-CSF) SC once weekly for 3 weeks and then once monthly for up to 5 months in the absence of disease progression or unacceptable toxicity.
- Arm II (Type: EXPERIMENTAL): Patients receive autologous dendritic cells loaded with irradiated autologous tumor cells SC and GM-CSF SC once weekly for 3 weeks and then once monthly for up to 5 months in the absence of disease progression or unacceptable toxicity.

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: LNG-IUS at 2 Weeks Postpartum

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

Eligibility Criteria:
Inclusion Criteria:~1. Desiring a LNG-IUS~2. Postpartum, ages 18-45 who deliver at a gestational age \> 32 weeks, delivery can be via cesarean or vaginal delivery~3. Following a viable, singleton pregnancy~4. Willing to return to UNC for their LNG-IUS insertion and study follow-up~5. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits~6. Fluent in English or Spanish~7. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)~Exclusion Criteria:~1. No genital bleeding of unknown etiology~2. No personal history of known or suspected breast carcinoma~3. No 4th degree vaginal laceration at time of delivery~4. No documented uterine rupture during delivery~5. No active liver disease (resolved pre-eclampsia may enroll)~6. No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion~7. No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage~8. No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4~9. Not currently incarcerated~10. No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity~11. No suspected hypersensitivity or contraindication to the LNG-IUS~12. With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- LNG-IUS placed at 2 weeks postpartum (Type: EXPERIMENTAL): Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum

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: Gene Transfer Clinical Trial for Spinal Muscular Atrophy Type 1

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Six or nine months of age and younger (depending on cohort) on day of vector infusion with Type 1 SMA as defined by the following features:~  * Diagnosis of SMA based on gene mutation analysis with bi-allelic SMN1 mutations (deletion or point mutations) and 2 copies of SMN2.~ * Onset of disease at birth up to 6 months of age.~ * Hypotonia by clinical evaluation with delay in motor skills, poor head control, round shoulder posture and hypermobility of joints.~Exclusion Criteria:~* Active viral infection (includes HIV or serology positive for hepatitis B or C)~* Use of invasive ventilatory support (tracheotomy with positive pressure)\* or pulse oximetry \<95% saturation.~* Patients may be put on non-invasive ventilator support (BiPAP) for less than 16 hours a day at the discretion of their physician or research staff.~* Concomitant illness that in the opinion of the PI creates unnecessary risks for gene transfer~* Concomitant use of any of the following drugs: drugs for treatment of myopathy or neuropathy, agents used to treat diabetes mellitus, or ongoing immunosuppressive therapy or immunosuppressive therapy within 3 months of starting the trial (e.g. corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, rituximab)~* Patients with Anti-AAV9 antibody titers \>1:50 as determined by ELISA binding immunoassay.~* Abnormal laboratory values considered clinically significant (GGT \> 3XULN, bilirubin ≥ 3.0 mg/dL , creatinine ≥ 1.8 mg/dL, Hgb \< 8 or \> 18 g/Dl; WBC \> 20,000 per cmm) Participation in a recent SMA treatment clinical trial that in the opinion of the PI creates unnecessary risks for gene transfer.~* Family does not want to disclose patient's study participation with primary care physician and other medical providers.~* Patient with signs of aspiration based on a swallowing test and unwilling to use an alternative method to oral feeding.~* Patients with a single base substitution in SMN2 (c.859G\>C in exon 7) will be excluded based on predicted mild phenotype.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 6 Months
- Healthy Volunteers: f

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): 6.7 X 10\^13 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=3)
- Cohort 2 (Type: EXPERIMENTAL): 2.0 X 10\^14 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=12)

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: Internet Treatment for Social Phobia in Romania

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:~* over 18 years~* social anxiety disorder is the primary diagnostic (according to the DSM-IV)~* access to an Internet connected computer~* be fluent in Romanian language~Exclusion Criteria:~* suicidal ideation~* ongoing psychological treatment for social anxiety disorder~* recent change in psychiatric medication (i.e., during the last 6 weeks)~* psychoses or borderline personality disorder

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

Study Arms:
- iSOFIE (Type: EXPERIMENTAL): Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
- Waitlist control group (Type: NO_INTERVENTION): Waitlist control group

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: Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

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

Eligibility Criteria:
Inclusion Criteria: patients who are postmenopausal women or men who aged older than 50 years and meet the indications for osteoporosis treatment according to the Thai Osteoporosis Foundation's 2010 treatment guidelines.~* History of spinal or hip fractures with low energy trauma.~* BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral neck, total hip, or L1-L4 spine.~* BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool (FRAX)~Exclusion Criteria:~* Patients who have contraindications to use bisphosphonates e.g. gastroesophageal reflux disease or drug allergy to bisphosphonates~* Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less than 8.7 mg/dl)~* Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2~* Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism, etc.~* Patients who were received anti-osteoporotic drugs during the past 1 year.~* Patients who currently taking steroids, hormone replacement therapy, or selective estrogen receptor modulators (SERMs) within 1 year.

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- Original alendronate (Fosamax) (Type: NO_INTERVENTION): The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
- Generic alendronate (Bonmax) (Type: ACTIVE_COMPARATOR): The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

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

Eligibility Criteria:
Inclusion Criteria:~* Impaired glucose tolerance~* On diet/exercise therapy~* Unlikely to conceive~* Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) \<6.1%, Fasting Plasma Glucose \<126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and \<200 mg/dL~Exclusion Criteria:~* History of diabetes mellitus~* Disease or condition of clear or likely glucose tolerance disorder~* Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
- Sitagliptin 25 mg (Type: EXPERIMENTAL): Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
- Sitagliptin 50 mg (Type: EXPERIMENTAL): Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 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: Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

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:~* Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.~* Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.~* Willing and able to comply with study requirements and visit schedule.~* Provide signed and dated informed consent.~Exclusion Criteria:~* Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures~* Have an ACC count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit~* Have a Grade \> 0 on the Ocular Pain Assessment in either eye at the Screening visit~Note: Other inclusion/exclusion criteria apply.

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

Study Arms:
- APP13007 0.05% BID (Type: EXPERIMENTAL): 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
- Matching Vehicle Placebo (Type: PLACEBO_COMPARATOR): 1 drop matching vehicle place twice daily for 14 days to study (operated) eye

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 to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

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:~Healthy females~* 17(in states where the legal age of consent to receive contraceptives is 17)-40 years~* Regular, consistent menstrual cycles between 25 and 35 days~* Sexually active women requesting birth control~* In good general health, confirmed by medical history, physical (including gynecologic) examination and screening laboratory values~Exclusion Criteria:~* Known or suspected pregnancy;~* Lactating women~* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape~* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)~* Use of other contraceptive methods than study medication

- Gender: FEMALE
- Minimum Age: 17 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- AG200-15 (cycles 1-13) (Type: EXPERIMENTAL): AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
- Lessina crossover to AG200-15 (Type: ACTIVE_COMPARATOR): Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.

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: Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

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

Eligibility Criteria:
Inclusion Criteria:~* Patients undergoing median sternotomy;~* Patients eighteen (18) years of age or older;~* Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI \> 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation,~* Off mid-line sternotomy~* bilateral IMA use~* Long cardio-pulmonary bypass runs~* Transverse fractures of the sternum~Exclusion Criteria:~* Patients with a non-standard sternotomy;~* Patients with an off-midline sternotomy that reduced the bony margin to \<2mm~* Patients under eighteen (18) years of age;~* Patients that are pregnant or currently lactating;~* Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation,~* Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure,~* Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia;~* Patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debridement or other treatment to the osteotomy);~* Patients unwilling or unable to return for follow-up;~* Lacking the ability to follow instructions;~* Intraoperative death.

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

Study Arms:
- wire (control) (Type: ACTIVE_COMPARATOR): patients will have their sternum closed using wire (stainless steel surgical wire).
- SternaLock Rigid Fixation Plates (Type: EXPERIMENTAL): patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.

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: The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT

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

Eligibility Criteria:
Inclusion Criteria:~1. Aged 50 years and older~2. Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy.~3. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2.~4. HbA1c values below 65 mmol/L.~5. Patients with stable diabetes mellitus, i.e. no changes in type of glucose lowering therapy and / or dosage of oral glucose lowering therapy in the past three months. No more than 20% change in dosage of insulin therapy (short and long acting) in the last three months.~Exclusion Criteria:~1. History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome).~2. History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \< 45 ml/min/1,73m2~3. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.~4. Chronic or recent (\< 1 month) infections and/or clinical signs of acute infection.~5. History of auto-immune diseases.~6. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.~7. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.~8. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.~9. Elevated liver enzymes (\> 2 ULN of liver transaminases), acute liver failure or known liver disease.~10. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e.~    (severe) muscle pains with and/or without myopathy .~11. The concomitant use of statin contra-indicated drugs, including the use of CYP3A4 inhibitors (i.e. erytromycin, dilthiazem, amiodaron, verapamil, fluconazole, ciclosporin, stiripentol, itraconazol, ketoconazol, voriconazol, posaconazol, clarithromycin, ..), systemic use of fusidic acid and ciclosporin.~12. Any contra-indications to the use of statins.

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Intervention arm (Type: EXPERIMENTAL): Atorvastatin 40mg once daily.

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

Answer: outcome: complete