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

Trial Title: Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients

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. Admission to MD Anderson Cancer Center Surgical Intensive Care Unit (SICU) under the Thoracic Surgery physician group~2. Intravenous vancomycin therapy deemed necessary~Exclusion Criteria:~1. Age less than 18 years~2. History of hypersensitivity to vancomycin~3. Patient weight greater than 150 kg~4. Receival of 1 or more doses of the following agents within 72 hours prior to screening: amphotericin B (lipid, liposomal, or conventional formulation), aminoglycosides, foscarnet and/or intravenous contrast dye.~5. Prior exposure (within 7 days) to intravenous vancomycin~6. Current renal insufficiency defined as baseline Scr \>/= 1.5 mg/dL, or increase in baseline serum creatinine (SCr) by \>/= 0.5 mg/dL within the last 2 days, or estimated creatinine clearance (CrCl) \</= 30 mL/min by Cockcroft-Gault equation.~7. Current need for hemodialysis or continuous renal replacement therapy

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

Study Arms:
- Vancomycin Loading (Type: EXPERIMENTAL): Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.

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 Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

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

Eligibility Criteria:
Inclusion Criteria:~Disease Characteristics~* The patient must be 18 years of age or older.~* The patient must have squamous cell carcinoma of the head and neck.~* The squamous cell carcinoma must be Ep-CAM positive.~* ECOG performance status of 0, 1, 2 or 3.~* 12 week life expectancy~Prior/Concurrent Therapy~* The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).~* The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.~* The patient's disease must be refractory.~* There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.~Patient Characteristics~* The patient must have adequate hepatic function \[alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN\].~* The patient must have adequate renal function (serum creatinine \< 1.5 × ULN).~* The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin \>8 g/dL.~* The patient must have prothrombin time and partial thromboplastin time within normal limits.~Other~• Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.~Exclusion Criteria:~* The patient has clinically significant distant metastases.~* The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.~* The patient has a nasopharyngeal tumour.~* The patient has AIDS, hepatitis C or hepatitis B.~* The patient has clinically significant renal or hepatic disease.~* Tumors are prone to bleeding.~* The patient is pregnant or lactating.~* The patient requires 'blood thinning' medications and can not safely discontinue the medication.~* The patient is currently enrolled in another clinical trial.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Proxinium plus Best Supportive Care
- 2 (Type: NO_INTERVENTION): Best Supportive Care

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: Exercise Program for Maintaining Physical Function and Frailty on Dwelling Older Adults

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

Eligibility Criteria:
Inclusion Criteria:~* 60 years or older.~* Home care users managed by the municipal social network.~* In a stable situation (no worsening, no convalescence, no hospital discharge).~* Frail or pre-frail individuals.~Exclusion Criteria:~* At the end of life.~* \<60 on the Barthel Index.~* Cognitive impairment that affects their decision-making ability (Mini Mental State Examination, MMSE \<24).~* Subjects that, on Home Care Service's assistant's criteria, do not meet the conditions to be included in the study.

- Gender: ALL
- Minimum Age: 60 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- Control Group (Type: OTHER): The control group received general recommendations for maintaining physically active and reducing sedentary behaviors. This was done verbally and through written material.
- Intervention Group (Type: EXPERIMENTAL): The intervention group received the same recommendations as the control group. In addition, they participated in a multicomponent physical exercise program consisting of a) 1 face-to-face weekly multicomponent session (Rodriguez-Larrad et al. BMC Geriatrics (2017)), and b) 2 autonomous sessions at home following the Vivifrail program. Our targeted duration of 24 weeks was missed due to the lack of predisposition expressed by some participants, once the recruitment was completed, to continue during summer vacation. Therefore, the intervention was restructured to be carried out in 16 weeks.~Face-to-face supervised sessions lasted 1 hour and included strength, balance, and flexibility exercises (50%-75% of the 1 repetition maximum for strength exercises). The volume, intensity and difficulty of the exercises were individualized based on the initial performance of each participant, and progressed as the participants' physical capacity evolved.

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: PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease

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:~* New diagnosis of symptomatic Crohn's disease or an established diagnosis of Crohn's disease with a suspected flare.~* Appropriate clinical candidate for infliximab induction therapy, as determined by the patient's gastroenterologist~Exclusion Criteria:~* Anti-TNF medications in the previous 6 months~* Pregnancy or plan to become pregnant~* Severe claustrophobia, sufficient to preclude PET/CT scanning

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

Study Arms:
- Infliximab responders (Type: None): Gastroenterologist's overall assessment (response) Decrease in Harvey-Bradshaw index score of 2 or more points (clinical response) Harvey-Bradshaw index score less than 5 (clinical remission) Maintenance of steroid-free remission No Crohn's-related hospitalizations or surgeries
- Infliximab non-responders (Type: None): Gastroenterologist's overall assessment (no response) Decrease in Harvey-Bradshaw index score of 1 or 0 points, or increase in HBI (no response) Harvey-Bradshaw index score greater than or equal to 5 (no remission) Resumption of steroid treatment Crohn's-related hospitalization or surgery

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: Catechin Mouth-washing for Removal of Intraoral Bacteria

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

Eligibility Criteria:
Inclusion Criteria:~* aged over 65 years~* detected oral pathogenic bacterium and revalidated during the wash-out period~* without antibacterial medicine, other mouth-washing remedies during the study~* Obtained written informed consent before participation~Exclusion Criteria:~* possessing some infectious diseases in need of therapy~* possessing tea or catechin allergy~* diagnosed as inadequate for other reasons to participate the study by principal investigator

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: 95 Years
- Healthy Volunteers: f

Study Arms:
- catechin (Type: EXPERIMENTAL): mask containing catechins

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 of Intravenous Phenobarbital in Neonatal Seizures

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:~* Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection)~* Parental informed consent (in-person or remote consent)~* Undergoing continuous video electroencephalogram (cvEEG) monitoring~* Has evidence of electrographic seizure burden of at least 30 seconds/h~Exclusion Criteria:~* Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation \> 24 hours before enrollment)~* Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization~* Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder~* Death appears to be imminent as assessed by the NICU attending physician~* Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.

- Gender: ALL
- Minimum Age: 34 Weeks
- Maximum Age: 44 Weeks
- Healthy Volunteers: f

Study Arms:
- Phenobarbital Sodium Injection 20mg (Type: ACTIVE_COMPARATOR): Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).
- Phenobarbital Sodium Injection 40mg (Type: ACTIVE_COMPARATOR): Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).

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: N/A

Study Design Characteristics:
- Allocation: N/A
- Intervention Model: N/A
- Observational Model: N/A
- Primary Purpose: N/A
- Time Perspective: N/A
- Masking: N/A
- Phase: N/A
- Number of Arms: N/A

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: Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills

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:~Subjects will be recruited in several sites:~* The principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses~* Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).~* American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).~Exclusion Criteria:~Not applicable

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

Study Arms:
- Surgeons (Type: None): Surgeons and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience. .
- Trainee Surgeons (Type: None): Surgeon and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience.

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: Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

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~* Male or female between 35-70 years of age.~* Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.~* Patients with at least 5 years since the disease.~* Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.~* PD of Stage 2.5, 3 \& 4 of HOEHN \& YAHR staging.~* Stable Parkinsonian medications for the 60 days prior to the surgical therapy.~* MRI not showing gross atrophy or any other pathology of brain.~* Patients with score less than 19 for the Montgomery-Asberg Rating Scale (MADRS) for Depression.~* NO Significant cognitive impairment.MMSE \> 24.~* The participant is able to comply with and understand the required visit schedule and all required tests and procedures.~* The participant (and/or LAR) must sign an informed consent.~Exclusion Criteria:~* History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.~* History of psychiatric disorders like schizophrenia or psychotic disorders.~* History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.~* Contraindication for MRI~* General medical contraindications for surgery like coagulopathy~* Subjects with abnormal hematology and chemistry values, unless the out of range values are clinically significant with respect to general surgery.~* Severe skin infection or osteomyelitis at the site of bone marrow aspiration potentially limiting the procedure.~* Positive test results for HIV.~* History of drug or alcohol abuse~* Pregnant or nursing women

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Therapy for Parkinson's disease (Type: EXPERIMENTAL): Stem cell derived from the bone marrow of the patient will be stereotactically transplanted in the striatum.These stem cell are the expected to grow up into dopamine secreting neural cells.

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: Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome

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

Eligibility Criteria:
Key Inclusion Criteria:~1. Females of childbearing potential cannot be at risk of pregnancy during the study.~2. Genetically confirmed diagnosis of VCFS at the time of screening.~3. Must have one of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise specified (NOS), bipolar disorder, or mood disorder with psychotic features.~4. A total PANSS composite score \>65.~5. Willing to discontinue psychotropic medications. -~Key Exclusion Criteria:~1. Evidence of acute suicidality.~2. Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or gastrointestinal disorders; other clinically significant psychiatric/neurological and sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic diseases.~3. Full scale IQ of less than 50.~4. Pregnancy.~5. Not using a reliable means of contraception.~6. Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60 mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.~7. QTcF \> 450 msec, or PR \> 250 msec, or QRS \> 110 msec on ECG.~8. History of seizure disorder. -

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Metyrosine (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): 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: Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

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

Eligibility Criteria:
Inclusion Criteria:~* Women age 18 and over~* Diagnosed with Interstitial Cystitis as defined by protocol~* Able and willing to complete questionnaires and diary~* Able to comply with visit schedule including Day 14 Removal visit~* Completion of blinded study prior to enrolling in unblinded part of study~Exclusion Criteria:~* Pregnant or lactating women~* Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product~* History or presence of any condition that would make it difficult to evaluate symptoms~* Did not complete blinded study (unblinded part of study only)

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

Study Arms:
- Lidocaine Releasing Intravesical System (Type: EXPERIMENTAL): Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
- LiRIS containing inactive substance only (Type: PLACEBO_COMPARATOR): LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
- Cystoscopy Procedure (Type: SHAM_COMPARATOR): No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.

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: Phase 2 Study of EPI-743 in Children With Pearson Syndrome

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:
Inclusion Criteria:~* Genetically confirmed diagnosis of Pearson syndrome~* Age less than 18~* Availability of medical history for 12 months prior to enrollment~* Abstention from use of CoQ10, vitamin E, lipoic acid and Idebenone 14 days prior to treatment with EPI-743~Exclusion Criteria:~* Allergy to EPI-743, sesame oil or vitamin E~* Clinical history of bleeding/ abnormal PT/PTT~* Concurrent inborn errors of metabolism~* Use of anticoagulant medications~* Participation in any interventional study within 30 days of treatment~* Use of erythropoietin 30 days prior to trial enrollment

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

Study Arms:
- EPI-743 (Type: EXPERIMENTAL): 15 mg/kg EPI-743 to be administered three times per day for 1 year

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 Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution

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

Eligibility Criteria:
Inclusion Criteria:~* adults (18 years and older) undergoing colonoscopy~Exclusion Criteria:~* age less than 18 years old~* not willing to participate~* cardiac pacemaker~* internal cardiac defibrillator~* previous colonic surgery

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

Study Arms:
- Staff Gastroenterologists. (Type: None): Staff Gastroenterologists ability to recognize loops will be assessed using an magnetic endoscopic imager.

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

Answer: outcome: terminate
termination_type: lack of efficacy