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

Trial Title: Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant

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:
Key Inclusion Criteria:~1. Participant is an adult ≥18 years old at the time of consent~2. Participant with ABC (loco regionally recurrent or metastatic) not amenable to curative therapy.~3. Participant with a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory.~4. Participant with a confirmed HER2-negative ABC.~5. Participant with a pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood).~6. Participant was willing to operate a smartphone compatible with the software of the medical device and willing to manage applications~7. Participant was willing to use the telemedicine platform and to follow the remote participant monitoring procedure.~Key Exclusion Criteria:~1. Participant had received prior treatment with any PI3K, mTOR or AKT inhibitor.~2. Participant with known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.~3. Participant participated in a prior investigational study within 30 days prior to the start of trial treatment or within 5 half-lives of the trial treatment, whichever was longer.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Alpelisib + fulvestrant (Type: EXPERIMENTAL): Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each 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: IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

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

Eligibility Criteria:
Inclusion Criteria:~* Provision of signed written informed consent~* Age of 18 years or older~* Diagnosis of Type 2 Diabetes Mellitus (T2DM)~Exclusion Criteria:~Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.

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

Study Arms:
- Type 2 Diabetes Mellitus (Type: None): Patients with antidiabetic treatment for Type 2 Diabetes Mellitus

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: Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study

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:~* Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)~* Anticipated \>=50% daily ventricular pacing~* LVEF \>=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography~* Minimum age of 18 years, and at least 1 year life expectancy~Exclusion Criteria:~* Prior tricuspid valve replacement (annuloplasty is permitted)~* Intrinsic rhythm \< 30bpm~* Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.~* Echocardiographic window of insufficient quality for measuring LVEF~* Life expectancy of \< 1year~* Pregnancy (women of childbearing potential will undergo pregnancy testing)~* Unable of unwilling to sign a patient informed consent form

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

Study Arms:
- Right ventricular apex pacing (Type: ACTIVE_COMPARATOR): None
- Left ventricular apex pacing (Type: EXPERIMENTAL): 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: Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method

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 hospitalized into the dermatology unit~* patient with an evolutive leg ulcer since more than 1 month~* signed informed consent~Exclusion Criteria:~* known allergy to one of dressings used in this study~* patient with a non-treated osteomyelitis~* patient with tumoral tissues into the wound~* patient with raw organ or raw blood vessels~* patient with an anticoagulation treatment with a potentially hemorrhagic curative dose~* patient having hemostasis problems that can lead to hemorrhagic exudates

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

Study Arms:
- V.A.C.® Therapy (Type: EXPERIMENTAL): In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.
- usual dressing method (compresses) (Type: ACTIVE_COMPARATOR): In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.

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: Collaborative Problem Solving vs. Positive Solutions for Families in Preschool Parent Groups

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:~* Guardian of a child between the ages of three and five currently enrolled at participating Head Start center~* Speaking and writing English at level necessary to complete study requirements~Exclusion Criteria:~* A diagnosis of significant Autism that currently impacts day to day functioning~* A diagnosis of a psychotic disorder including schizophrenia, schizoaffective disorder, schizophreniform disorder~* An intellectual disability that impairs day to day functioning~* Participation in a similar parenting group at the Head Start site within the last year

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

Study Arms:
- Collaborative Problem Solving (Type: EXPERIMENTAL): Participants will attend parent group sessions led by trained group leaders and learn the Collaborative Problem Solving approach.
- Positive Solutions For Families (Type: ACTIVE_COMPARATOR): Participants will attend parent group sessions and learn the Positive Solutions for Families approach, a group that is usually offered by Head Start.

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: Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

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

Eligibility Criteria:
INCLUSION CRITERIA:~* Men or women age 18 years or older~* Histologically or cytologically confirmed NSCLC~  * Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)~ * Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion~* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC~* Measurable disease on computerized tomography (CT) scan~* ECOG Performance Status of 0 or 1~* Expected survival ≥12 weeks~* Provide written informed consent~EXCLUSION CRITERIA:~* More than 2 prior chemotherapy regimens~* Clinically significant laboratory abnormalities, specifically:~  * Total bilirubin ≥ institutional upper limit of normal (ULN)~ * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN~ * Serum creatinine ≥2.0mg/dL~ * Absolute neutrophil count \<1500/μL or platelets \<100,000/μL~* Untreated or symptomatic brain metastases~* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix~* A history of severe hypersensitivity to drugs formulated with polysorbate 80~* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol~* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.~* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

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

Trial Title: Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

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

Eligibility Criteria:
Inclusion Criteria - Patients must meet all of the following criteria:~* \> 18 and \< 85 years of age~* ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes~* Coronary artery disease (CAD) with prior myocardial infarction (MI)~* ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy \[antitachycardia pacing (ATP) \& shocks\].~Exclusion Criteria - Patients should not have any of the following criteria:~* Contraindication or allergy to contrast media, routine procedural medications or catheter materials~* Contraindication to an interventional procedure~* Current or previous (within 3 months) amiodarone therapy~* Atrial Fibrillation requiring antiarrhythmic drug therapy~* Contraindication to amiodarone therapy~* New York Heart Association (NYHA) functional class IV~* Myocardial infarction within the past 60 days~* Stroke within the past 90 days~* Unstable angina~* Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome~* Patients with active ischemia that are eligible for revascularization~* Life expectancy less than 6 months~* Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation~* Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.~* Current enrollment in another investigational drug or device study.~* Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.~* Absolute contra-indication to the use of heparin and or warfarin.~* Documented intra-atrial thrombus, ventricular thrombus (\< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.~* Females of childbearing potential who are not practicing protocol acceptable method of birth control.

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 84 Years
- Healthy Volunteers: f

Study Arms:
- Ablation (Type: ACTIVE_COMPARATOR): Catheter based radiofrequency ablation for ischemic ventricular tachycardia
- Amiodarone (Type: ACTIVE_COMPARATOR): amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.

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: Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* Type II diabetes~Exclusion Criteria:~-

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Diabetes type 2 patients (Type: OTHER): diabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training
- Healthy volunteers (Type: OTHER): healthy volunteers whose cardiac function is tested after 4x4 high intensity interval training

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: Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy.~* Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy.~* Zubrod performance status of 0 or 1.~* Patients have measurable disease according to RECIST version (v)1.1.~* Ability to understand and willing to sign a written informed consent.~Exclusion Criteria:~* Severe anemia (hemoglobin \[Hb\] \< 8 g/dL).

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

Study Arms:
- Ancillary-correlative (Specimen collection) (Type: None): Participants undergo collection of blood samples in addition to the usual amount collected when they come in for their regular cancer treatments or doctor?s appointment every 6-8 weeks until disease progression or stopping at 9 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: Microvascular Flow Assessment Repeatability Study: The MARS Study

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

Eligibility Criteria:
Inclusion Criteria:~1. Men and non-pregnant/lactating women between the ages of 18 and 45;~2. Lean (BMI ≥18 and ≤25) or Obese grade I-II(BMI\>30 and ≤35)~3. Provide written informed consent and sign HIPAA Waiver of Authorization~4. Be able and willing to follow all instructions and attend all study visits~Exclusion Criteria:~Subjects must not have been diagnosed with:~1. Coronary artery disease~2. Congestive heart failure~3. Congenital heart disease (Right-to-left, bi-directional, or transient right-to-left cardiac shunts)~4. Hypersensitivity to perflutren~5. Renal disease~6. Chronic obstructive pulmonary disease or Asthma~7. Primary or secondary pulmonary hypertension~8. Obstructive sleep apnea~9. Thyroid disease~10. Vasculitis~11. Peripheral arterial disease.~12. Cancer~13. Any type of immunosuppression~14. Any active infection (systemic or of the underlying skin or subcutaneous tissue).~15. Taking any prescribed medication for hypertension, dyslipidemia or diabetes.~16. Current or past smoking in the last 12 months.~17. Positive urine pregnancy test~18. Creatinine (Cr) above 1.4 mg/dl on screening evaluation~19. Hemoglobin (Hb) less than 10 mg/dl on screening evaluation~20. Aspartate Transaminase (AST) or Alanine Transaminase (ALT) two fold above upper limit of normal on screening evaluation

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

Study Arms:
- Lean Healthy Subjects (Type: OTHER): Lean defined as (BMI ≥18 and ≤25)
- Obese Healthy Subjects (Type: OTHER): Obese grade I-II defined as (BMI\>30 and ≤35)

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: 1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain

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

Eligibility Criteria:
Inclusion Criteria:~* age 13-18 years~* English-speaking~* DSM diagnoses that have an FDA indication for SGA use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of early-onset schizophrenia spectrum disorders; bipolar I disorder mania (and BP-NOS); irritability associated with autism spectrum disorder, as well as severe mood dysregulation (SMD) according to Leibenluft et al. (2011) with an ABC-irritability score of \>/=18 Sexually active girls must agree to use two effective forms of birth control or be abstinent~* Participant has a primary caretaker who has known the child well for at least 6 months before study entry Primary caretaker is able to participate in study appointments~* Ability of child to participate in all aspects of the protocol per investigator clinical judgment.~Exclusion Criteria:~* Major neurological or medical illnesses that affect weight (e.g., unstable thyroid disease), require a prohibited systemic medication (e.g., diabetes mellitus \[insulin\], chronic renal failure \[steroids); Fasting glucose \> 125 mg/dL on 2 occasions during screening~* Any medication (other than currently prescribed psychotropic medications) that would significantly alter weight~* Antidepressants not allowed for at least 2 weeks in BP-I or BP-NOS patients~* DSM-IV diagnosis of anorexia or bulimia nervosa~* DSM-IV diagnosis of Substance Dependence disorder (other than tobacco dependence) within the past month~* Initial urine toxicology screen and follow-up screen indicate ongoing use of illicit substance~* Hypersensitivity to ZIP or UC antipsychotics~* Pregnant, breast feeding or unwilling to comply with contraceptive requirements~* Screening or baseline QTc \> 450 msec~* IQ \< 55~* Significant risk for dangerousness to self or to others~* Ongoing or previously undisclosed child abuse requiring new department of social service intervention.

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Ziprasidone (Type: ACTIVE_COMPARATOR): (20-160mg/d, bid) for 12 weeks
- Aripiprazole, quetiapine, risperidone (Type: ACTIVE_COMPARATOR): Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 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: Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy

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

Eligibility Criteria:
Inclusion Criteria:~* Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study~Exclusion Criteria:~• Not Applicable

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

Study Arms:
- Genetically engineered NK Cell - treated (Type: None): Long term follow-up of subjects who have received lentivirus-mediated genetically engineered NK Cells.

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 Reproductive Microbiome & Perinatal Health Outcomes

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:~* Able to read and understand English, full decision making capabilities, African American (self-identified), Pregnant, At 20 weeks or less of gestation, Singleton pregnancy, 18-45 years of age~Exclusion Criteria:~* Race other than African American, Advanced gestational age (\>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.

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

Study Arms:
- Preterm Delivery (Type: None): African american women who present for prenatal care who experience spontaneous preterm birth
- Term delivery (Type: None): African american women who present for prenatal care who experience term birth

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

Answer: outcome: terminate
termination_type: feasibility