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

Trial Title: Evaluating Wound Healing With Next Science Gel & Wash.

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female 18 years or older~2. Presence of full-thickness chronic wound for more than one month (i.e. chronic)~3. Ulcer must be greater than 1 cm2 to enable biofilm sampling~4. He/she is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period~5. Willing to comply with all study procedures and be available for the duration of the study~6. Provide signed and dated informed consent~Exclusion Criteria:~1. Subjects unable to provide signed and dated informed consent~2. Male or female less than 18 years old~3. Presence of a full-thickness chronic wound for less than one month~4. Subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely~5. Subjects whose wound is less than 1 cm2~6. He/she requires endovascular or surgical arterial intervention during the study period~7. Subject with known allergic reaction to the study products ingredients~8. Wound, in the investigator's clinical judgment, is not amenable to management solely with the techniques described in this study (i.e., should be managed in addition with hyperbaric oxygen, vacuum suction, or other adjunctive methods)

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

Study Arms:
- Control Group (Type: ACTIVE_COMPARATOR): After standard of care debridement and irrigation (using normal saline), Mepilex foam dressing will be used. Foam dressing will be used throughout the study, including for mid-week dressing changes.
- Antibacterial Control (Type: ACTIVE_COMPARATOR): After standard of care debridement and irrigation (using normal saline), Mepilex AG foam dressing will be used. This dressing will be used throughout the study, including for mid-week dressing changes.
- Next Science Group (Type: EXPERIMENTAL): Standard of care debridement will be performed as well as irrigation using TorrentX Wound Wash,then BlastX Wound gel will be applied to the wound before covering treatment site with Mepilex foam dressing (no AG component). BlastX will re-applied again mid-week during mid-week dressing change.

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: Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~1. Over 60 years old.~2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.~3. MMSE score of 10\~24, CDR of 1\~2.~4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.~5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.~Exclusion criteria:~1. Uncontrolled by donepezil because of adverse events.~2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.~3. If they have taken concomitant medication which were not allowed.

- Gender: ALL
- Minimum Age: 60 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: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Key Inclusion Criteria:~* Diagnosis of large duct PSC~* Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader~* Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:~  * Platelet count ≥ 150,000/mm\^3~ * Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation~ * Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)~ * Total bilirubin \< 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia~ * International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation~ * Negative anti-mitochondrial antibody~Key Exclusion Criteria:~* Current or prior history of any of the following:~  * Cirrhosis~ * Liver transplantation~ * Cholangiocarcinoma or hepatocellular carcinoma (HCC)~ * Ascending cholangitis within 30 days of screening~* Presence of a percutaneous drain or biliary stent~* Other causes of liver disease~* Current or prior history of unstable cardiovascular disease~* Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)~Note: Other protocol defined Inclusion/Exclusion criteria may apply

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

Study Arms:
- Cilofexor 100 mg (Blinded Phase) (Type: EXPERIMENTAL): Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
- Placebo (Blinded Phase) (Type: PLACEBO_COMPARATOR): Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
- Cilofexor From Cilofexor 100 mg (OLE Phase) (Type: EXPERIMENTAL): Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
- Cilofexor From Placebo (OLE Phase) (Type: EXPERIMENTAL): Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.

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: Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children

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

Eligibility Criteria:
Inclusion Criteria:~* age ≤4 months or 4-18 years~* ability to report VAS for patients 4-18 years~* require lumbar puncture as part of their clinical care~Exclusion Criteria:~* ages 5-47 months~* developmental delay or inability to complete VAS in older patients~* allergy to lidocaine~* requirement of sedation for procedure~* pre-procedural analgesia treatment except for nonsteroidal anti-inflammatory drugs and acetaminophen.

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

Study Arms:
- Lidocaine Injection (Type: EXPERIMENTAL): 0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
- lidocaine 2.5% and prilocaine 2.5% (EMLA) Cream (Type: ACTIVE_COMPARATOR): Patients in this arm will receive 1g EMLA cream if they are in the younger age group and 10g EMLA cream if they are in the older age group. This will be placed for a minimum of 30 minutes.

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: Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge

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

Eligibility Criteria:
Parent/Caregiver Group-~Inclusion Criteria:~• Parents of a child with congenital heart disease and planned discharge from the Nemours Cardiac Center.~Exclusion Criteria:~• Non-English and Non-Spanish speaking families.~The Healthcare providers group is pre-identified and they will be invited to provide feedback through semi-structured qualitative interviews only. They will not receive any intervention. Their participation will be voluntary.

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

Study Arms:
- Parent/Caregiver of high-risk children with heart disease (Type: OTHER): The parent/caregivers of high-risk children with heart disease coming to the Nemours Cardiac Center for care will be offered a support tool and will be asked for it's acceptance and feasibility through their experience.

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: Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care

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

Eligibility Criteria:
Inclusion Criteria:~* Any neonatal intensive care patient who is requiring oxygen therapy as part of their respiratory treatment course will be eligible for this study.~* Parental consent~Exclusion Criteria:~* Infant on room air

- Gender: ALL
- Minimum Age: None
- Maximum Age: 3 Months
- Healthy Volunteers: f

Study Arms:
- Part 1 group (Type: None): Observational study with a convenience sample of ten (10) patients. PART 1 will end when at least 3 of 4 consecutive patients achieve the goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations from study guidelines, or at ten (10) patients.
- Part 2 group (Type: None): (After successful completion of PART 1) Within patient cross-over study with a randomized cross-over sequence. Sequential data analysis methods will be used to help minimize the patient sample size which will be no more than twenty (20) patients plus up to a maximum of seven (7) who might be eligible from PART 1.
- Part 3 Group (Type: None): (After successful completion of PART 2) Within patient cross-over study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes.

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: Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy

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:~* Age over 75 years old~* Suffering from digestive cancer : colorectal, pancreatic, biliary, oesophageal, gastric~* Palliative cancer : not resectable, multimetastatic~* Decision in multi-disciplinary liaising meeting (CPR) to perform a first course of palliative chemotherapy~* Having received an informed consent form~* Understanding french language~Exclusion Criteria:~* Cognitive disorders~* Patient benefiting from a legal protection measure~* Life expectancy below 1 year~* Not understanding french language

- Gender: ALL
- Minimum Age: 75 Years
- Maximum Age: None
- Healthy Volunteers: 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: Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

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

Eligibility Criteria:
Inclusion Criteria:~Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old~Exclusion Criteria:~Hypoglycemia hypoxemia patients with known dementia blood pressure \<90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- loxapine (Type: ACTIVE_COMPARATOR): agitated patients were randomly assigned either to loxapine, either to midazolam group
- midazolam (Type: ACTIVE_COMPARATOR): midazolam is compared to loxapine in terms of efficacy and tolerance

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: An Open Label Extension Study of STX209 in Subjects With Fragile X 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:~* Have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator~Exclusion Criteria:~* Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.~* The occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 40 Years
- Healthy Volunteers: f

Study Arms:
- STX209 (Type: ACTIVE_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: Sildenafil and Stroke Recovery

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

Eligibility Criteria:
Inclusion Criteria:~1. between 4 and 9 days post-ischemic stroke;~2. admitted to inpatient rehabilitation;~3. cognitively able to provide consent or assent;~4. were living independently in the community prior to their stroke.~Exclusion Criteria:~1. hemorrhagic stroke or subarachnoid hemorrhage;~2. other neurological or psychiatric conditions deemed by the investigator to impair participation;~3. no previous stroke on same side of brain unless that stroke was cerebellar~4. moribound or not expected to live 6 months;~5. contraindications to taking sildenafil in pill or syrup form;~6. other medical conditions that would limit ability to participate in the study, specifically a) currently taking the P450 enzyme inhibitors (erythromycin, ketoconazole, itraconazole, saquinavir), b) currently taking the protease inhibitor ritonavir, c) currently taking nitrates or have a history of requiring nitrates treatment, d) have left ventricular outflow obstruction (i.e., aortic stenosis, idiopathic hypertrophic subaortic stenosis as confirmed by review of standard of care echo received before admission to rehabilitation), e) have severely impaired autonomic control of blood pressure, f) have previous history of symptomatic hypotension, g) have severely impaired hepatic function, h) is pregnant or become pregnant during the course of the study, i) Any medical condition which, in the opinion of the investigator, may compromise compliance with the objectives and/or procedures of the protocol.~7. scores \> 50 on the upper extremity section of the Fugl-Meyer or no walking/gait impairment~   For the MRI portion of the study only:~8. contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker~9. allergic to or had previous reaction to gadolinium

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Drug (Type: EXPERIMENTAL): Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
- control (Type: PLACEBO_COMPARATOR): placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation

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: Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet

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:~* Diagnosis of epilepsy; suffering from recurrent seizures (\> or equal to 2 seizures per month) despite at least two anticonvulsant medication trials.~* Aged 18 years and above.~* Not on the ketogenic diet.~* Absence of any metabolic or mitochondrial disorder that precludes the use of MCT and the ketogenic diet.~* Willingly given, written, informed consent from the patient or caregiver.~* Ability to comply with study protocol and keep written records.~Exclusion Criteria:~* Non-compliant with previously recommended treatments.~* Significantly underweight (BMI \<18.5), untreated dysphagia, or severe gastroesophageal reflux.~* Kidney disease, including history of nephrolithiasis.~* Uncontrolled or untreated hypercholesterolemia (\>300mg/dL) or hypertriglyceridemia (\>200mg/dL) within the last two years.~* Prior use of Betaquik at any time for any duration.~* Any serious medical, psychological, or social condition precluding the study intervention.~* Use of additional macro/micronutrient supplement during the study period, unless clinical indicated and prescribed by the investigator (must be recorded electronic medical records).~* Women who are pregnant/breastfeeding at the start of the study or planning to become pregnant during the study period.~* N.B.: Women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.

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

Study Arms:
- Betaquik (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: UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder

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:~* Signed informed consent and willing to comply with protocol-specified procedures.~* Has any confirmed UCD other than N-acetyl glutamatesynthase (NAGS) deficiency.~* Is male or female, 12 to 70 years of age (inclusive)~* If ≥ 18 years old, has a BMI ≥20.0 and \< 40.0 kg/m2. If \< 18 years old, has a BMI between 5th percentile and 95th percentile and weight greater than 5th percentile according to age, sex and regionally appropriate growth chart~* Has evidence of poorly controlled disease on the current standard of care (SOC)~* If NBT is part of SOC, is on a stable dose and regimen for at least 4 weeks before Screening and the dose is expected to remain stable during the study~* Is willing to maintain a stable diet throughout the course of study and is willing to continue usual exercise routine.~* If taking probiotics or prebiotics, is on a stable dose regimen for at least 4 weeks before Screening and the dose and regimen are expected to remain stable during the study~* Has a negative urine screen for drugs of abuse at Screening~* If male or female of child bearing potential, agree with use effective method of contraception for the duration of the study and 90 days after last dose of study product~Key Exclusion Criteria:~* Is at a high risk for metabolic decomposition.~* Has had a substantive change in diet or any other aspect of UCD management within 4 weeks before the Screening Visit~* Has used a systemic anti-infective within 4 weeks before the Screening Visit, or use is anticipated during the study~* Has been diagnosed with Citrullinemia Type II~* Is receiving any systemically administered immunosuppressant medication on a chronic basis~* Has changed the use of or dose of any drug or other compound to modulate GI motility within 4 weeks before the Screening Visit, or the use or dose is expected change during the course of the study~* Has a history of or active GI or liver disease~* Has a prior solid organ transplantation including liver transplantation, or is anticipated to receive a liver transplant during study participation~* Has used an investigational drug, product, or device within 30 days before the Screening Visit~* Has a contraindication, sensitivity, or known allergy to the study drug~* Is considered, in the opinion of the PI, to likely be a poor attendee or unlikely for any reason to be able to comply with the study drug procedures

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- KB195 (Type: EXPERIMENTAL): KB195 is a novel glycan

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

Answer: outcome: terminate
termination_type: lack of efficacy