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

Trial Title: Exparel in Minimally Invasive Cardiac Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical status 2-4.~* Undergoing minimally invasive cardiac surgery.~* Subjects must be physically and mentally able to participate in the study and complete all study assessments.~* Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of thoracotomy and chest tube sites infiltration.~Exclusion Criteria:~* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics~* Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a thoracotomy and chest tube sites infiltration.~* Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.~* Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of nonsteroidal antiinflammatory drugs.~* Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Exparel infiltration (Type: EXPERIMENTAL): Exparel infiltrated into wound and chest tube sites

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: Dexmedetomidine Pharmacokinetics-pharmacodynamics in Mechanically Ventilated Children With Single-organ Respiratory Failure

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

Eligibility Criteria:
Inclusion Criteria:~* patients (m/f) admitted to the paediatric intensive care unit~* expected to require at least 24h of mechanical ventilation~* patient age : 1 month-15 years~* patients with single-organ respiratory failure~Exclusion Criteria:~* patients with neurologic conditions that prohibit an evaluation of adequate analgosedation~* no arterial catheter in place at inclusion~* patients who have received another investigational drug within 30 days~* patients on continuous infusion with neuromuscular blockers~* patients with a life expectancy \<72h~* patients with a known allergy to lorazepam, midazolam and/or morphine~* heart block~* pre-existing bradycardia~* hemodynamically unstable patients (Wernovsky index \> 16 points) after full fluid replacement with crystalloid~* patients with significant renal insufficiency (creatinine plasma level 1 month-5 year : \> 1 mg/dl ; 5-10 years : \>1.2 mg/dl; \> 10 years : \> 1.5 mg/dl)~* patients with significant hepatic insufficiency (aspartate aminase \>950 UI/L and prothrombin time \< 60 or INR \>1.4)~* previous treatment with α2-adrenoreceptor agonist clonidine within 14 days

- Gender: ALL
- Minimum Age: 1 Month
- Maximum Age: 15 Years
- Healthy Volunteers: f

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

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

Trial Title: PK/PD of Vitamin D3 in Adults With CF

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

Eligibility Criteria:
Inclusion Criteria:~* For CF, diagnosis of CF based on positive sweat chloride or known CF mutation~* For CF, Patients with pancreatic insufficiency~* Age ≥ 18 years~* Serum 25(OH)D concentrations below 30 ng/mL (75 nmol/L)~Exclusion Criteria:~* Pregnancy~* History of lung transplant,~* Severe anemia (hemoglobin concentration \< 7 g/dL),~* Liver disease (AST/ALT \> 3x ULN), kidney disease (GFR ≤ 40 mL/min), or granulomatous conditions~* Patients taking steroids, cholesterol-lowering drug (cholestyramine), weight-loss drugs (orlistat) , statins, anti-tuberculosis drugs (rifampin and isoniazid), phenobarbital, phenytoin, carbamazepine, immunosuppressants (cyclosporine, tacrolimus)

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

Study Arms:
- Adults with Cystic Fibrosis (Type: EXPERIMENTAL): CF adults with vitamin D insufficiency or deficiency will receive 300,000-600,000 IU vitamin D3 (cholecalciferol)
- Non-CF Controls with Low vitamin D (Type: EXPERIMENTAL): Non-CF controls with vitamin D insufficiency or deficiency will receive 300,000-600,000 IU vitamin D3 (cholecalciferol)

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: PASS MIS® Post-market Clinical Follow-up

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:~* Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®~* Patient \> 18years~* Patient with a mature skeleton~* Patient able to understand the protocol and the planning visit~* Patient able to complete a self-administered questionnaire~* Patient who have signed the informed consent form~Exclusion Criteria:~* Patient presenting other medical indication than thoracolumbar fracture~* Patient unable or who refuse to sign an informed consent form~* Patient unable to complete a self-administered questionnaire~* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits~* Patient who need to receive or who received an open procedure~* Patient who has been not implanted with the PASS MIS® system~* Pregnant women or intending to get pregnant within the next 2 years after the surgery~* Patient with contra-indications to do radiographies~* Local infectious state~* Allergy or intolerance to the materials, suspected or known~* Any contra-indications present in the notice of the product

- 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: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Blunt trauma~* Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)\*~* Age 15 years or older or 50 kg or more~  * Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP\>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.~Exclusion Criteria:~* Known or suspected pregnancy~* Age younger than 15 years or less than 50 kg if age unknown~* Ongoing pre-hospital cardiopulmonary resuscitation (CPR)~* Administration of more than 2L crystalloid or any colloid or blood products~* Severe hypothermia (T less than 28C)~* Drowning or asphyxia due to hanging~* Burns TBSA more than 20%~* Isolated penetrating injury to the head~* Inability to obtain pre-hospital intravenous access~* Time of call received at dispatch to study intervention more than four hours~* Known prisoners

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 7.5% hypertonic saline/6% dextran (HSD) (Type: EXPERIMENTAL): 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70
- 7.5% hypertonic saline (HS) (Type: EXPERIMENTAL): 250 ml intravenous bolus administration of 7.5% hypertonic saline
- 0.9% normal saline (NS) (Type: PLACEBO_COMPARATOR): 250 ml intravenous bolus administration of 0.9% saline

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: A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

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: 1.0

Eligibility Criteria:
Inclusion Criteria:~* adult patients, \>=18 years of age;~* documented squamous non-small cell lung cancer;~* stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;~* suitable for platinum-based treatment as first line chemotherapy.~Exclusion Criteria:~* prior systemic anti-tumor therapy;~* prior radiotherapy for treatment of patient's current stage of disease;~* other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;~* major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None

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: Steroid Withdrawal in Pediatric Kidney Transplant Recipients

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

Eligibility Criteria:
Inclusion Criteria:~Patients may be eligible for this study if they:~* Are between the ages of 0 and 20 years (prior to their 21st birthday)~* Are receiving their first living related (e.g.,kidney from a relative or unrelated donor) or cadaver donor transplant~* Are willing to practice an acceptable method of birth control during the study, if women able to have children~Exclusion Criteria:~Patients will not be eligible for this study if they:~* Have received multiple organs~* Have received 2 or more transplants~* Have an active infection (including tuberculosis), or cancer~* Have used an experimental agent within 4 weeks of transplantation

- Gender: ALL
- Minimum Age: 1 Day
- Maximum Age: 20 Years
- Healthy Volunteers: f

Study Arms:
- Corticosteroid (steroid) withdrawal (Type: EXPERIMENTAL): All enrolled subjects who have not experienced an episode of acute rejection or other event resulting in removal from the study in the first 6 months after transplantation will undergo a protocol-driven biopsy at 6 months. Subjects with no clinical or histologic evidence of rejection will be eligible to be randomized and treated in a double-blinded (e.g., masked-neither subject nor health care providers will know treatment being received) fashion while continuing other immunosuppressive medications. Subjects in this arm will undergo complete steroid withdrawal by the end of 12 months post-transplant.
- Control Treatment (Type: ACTIVE_COMPARATOR): All enrolled subjects who have not experienced an episode of acute rejection or other event resulting in removal from the study in the first 6 months after transplantation will undergo a protocol-driven biopsy at 6 months. Subjects with no clinical or histologic evidence of rejection will be eligible to be randomized and treated in a double-blinded (e.g., masked-neither subject nor health care providers will know treatment being received) fashion while continuing other immunosuppressive medications. Subjects in this arm will be maintained on low-dose (0.15 mg/kg/day) daily steroids.

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: Evaluation of Molecular Markers in Adrenal Tumors

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:~  1. An individual with a primary localized adrenal neoplasm greater than 2 cm in size~ 2. Age greater than or equal to 18 years~ 3. Adults must be able to understand and sign the informed consent document~ 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.~ 5. Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery Note: patients with suspected but unconfirmed adrenal neoplasm may be enrolled.~EXCLUSION CRITERIA:~1. Biochemically proven Pheochromocytoma~2. Women who are pregnant because of the possible side effects of radiation from computed tomography (CT)-guided biopsies to the unborn child.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- Adrenal Gland Neoplasm (Type: None): To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells. Participants who have a large tumor or one that secretes hormones will have standard surgery to remove 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: Study of Fish Oil to Reduce ALT Levels in Adolescents

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

Eligibility Criteria:
Inclusion Criteria:~* BMI (kg/m2) at or above the 95th percentile for age and gender~* Weight below 400 pounds (less than 182 kilograms)~* Persistent elevation of ALT (41-90 UI/L at study screening)~* Presence of hepatic steatosis on abdominal CT-scan~* Able to give informed consent/assent~Exclusion Criteria:~* Type 2 diabetes mellitus~* Prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening~* Use of prescription strength glucocorticoids within three months before screening~* History of syndrome or medical disorder associated with significant obesity~* Participation in a weight loss program within six months of screening resulting in 5% or more weight loss~* History of weight loss surgery~* Alcohol use more than twice weekly or more than 3 alcohol containing beverages within a 24-hour period in the past six months~* Known or suspected bleeding condition~* History of liver disease including prior liver biopsy with NASH type 2 or cirrhosis~* Former or present positive blood tests for Infectious hepatitis B or C, autoimmune hepatitis, Wilson disease, Alpha-1 anti-trypsin deficiency, Iron storage disease, or high TSH~* History of past or current pregnancy~* Use of illegal/illicit drugs~* Other conditions contraindicated or cause for caution in the use of fish oil~* Unable to comply with the protocol~* Any other serious disease determined by the study gastroenterologists and physician nutrition specialist as potential study risk for the patient

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Fish oil (Type: EXPERIMENTAL): Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g)
- Placebo (Type: PLACEBO_COMPARATOR): Placebo

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: Modulation of the Surgical Inflammatory Response by Etoricoxib

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

Eligibility Criteria:
Inclusion Criteria:~* Subject undergoing elective primary single hip arthroplasty~* Subject diagnosed with Osteoarthritis / arthrosis~* Subject has not taken non-steroidal anti-inflammatory drugs within 4 of their terminal half life times prior to enrollment~* Subject capable of understanding and cooperating with the requirements of the study~Exclusion Criteria:~* Patients with renal insufficiency (serum creatinine \>1.5 mg/dl)~* Recent major trauma or systemic infection (within 3 months)~* Use of corticosteroid medication or chronic opioids (within 3 months)~* Any other condition likely to affect prostaglandin and cytokine levels~* Participation in another clinical study or receipt of an investigational drug within 30 days~* Hypersensitivity to any component of the etoricoxib and/or placebo tablets~* Uncontrolled hypertension defined as systolic blood pressure \>140 mm Hg and diastolic pressure \>90 mm Hg at rest after two repeated measurements~* Congestive heart failure (NYHA II-IV)~* Cerebrovascular disease~* Established ischemic heart disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty)~* Patients with any kind or severity of cirrhosis of the liver or cholestasis or elevated liver function enzymes (ALT or AST 3 fold) as a sign of clinical significant liver malfunction (corresponds to any Child-Pugh-Score ≥5)~* Patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)~* Pregnancy and lactation~* Patients with active peptic ulcerations or active gastro-intestinal (GI) bleeding~* Inflammatory bowel disease~* Recent history (within the last year) of alcohol or other substance abuse~* An employee of the sponsor or study site~* Any neurological syndrome or any other condition leading to contra-indication to spinal anesthesia

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- A, 1 (Type: EXPERIMENTAL): Study part 1 (n = 8)
- A, 2 (Type: PLACEBO_COMPARATOR): Study part 1 (n = 4)
- B, 1 (Type: EXPERIMENTAL): Study part 2 (n = 20)
- B, 2 (Type: PLACEBO_COMPARATOR): Study part 2 (n = 20)

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: Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction

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:~* over age 18~* suspected history and clinical features suggestive of sphincter of oddi dysfunction~Exclusion Criteria:~* prior history of endoscopic therapy for sphincter of oddi dysfunction~* no proven sphincter of oddi dysfunction on manometry

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

Study Arms:
- sphincter of oddi dysfunction (Type: None): endoscopic therapy vs conservative care

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: Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria (phase lb):~* Females with Breast cancer that is histologically or cytologically confirmed, HER2 negative and locally advanced or metastatic as confirmed by radiology~* ECOG performance status 0 and 1~* Adequate bone marrow and organ function~Exclusion Criteria (Phase lb):~* Previous treatment with PI3K and/or mTOR inhibitors~* Symptomatic Central Nervous System (CNS) metastases~* Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment~* Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug~* Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF \> 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)~* Inadequately controlled hypertension~* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 and/or paclitaxel~* Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists~* Sensitivity to paclitaxel treatment~* Uncontrolled diabetes mellitus~* Pregnant or nursing (lactating) woman~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- BEZ235 100 mg bid + paclitaxel 80 mg (phase lb) (Type: EXPERIMENTAL): Increasing doses of oral BEZ235 100 mg administered on a continuous twice daily (BID) schedule + weekly paclitaxel infusion at a fixed dose of 80 mg/m2. Treatment was organized into cycles of 28 days.
- BEZ235 200 mg bid + paclitaxel 80 mg (phase lb) (Type: EXPERIMENTAL): Increasing doses of oral BEZ235 200 mg administered on a continuous twice daily (BID) schedule + weekly paclitaxel infusion at a fixed dose of 80 mg/m2. Treatment was organized into cycles of 28 days

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

Answer: outcome: terminate
termination_type: lack of efficacy