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

Trial Title: Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer

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:~* 1. Pathologically proven, measurable, unresectable, locally advanced or metastatic adenocarcinoma arising from the intra- and extrahepatic biliary ducts or gallbladder or papilla of Vater 2. No prior chemotherapy for advanced disease was allowed 3. No concurrent radiotherapy 4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 5. At least 18 years old 6. ECOG performance status of ≤ 2 7. Adequate organ function as evidenced by the following; Absolute neutophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; hemoglobin \> 10g/dL; INR ≤ 1.4; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; albumin \> 3g/dL or \> 30µmol/L; creatinine clearance ≥ 50mL/minInformed consent signed 8. Subject able to comply with the scheduled follow-up and the management of toxicities~Exclusion Criteria:~* 1. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of TS-1 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) 2. Subject with reproductive potential (male or female) not using adequate contraceptive measures 3. Pregnancy and breast-feeding 4. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics) 5. History of significant cardiac disease, arrhythmias and angina pectoris 6. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix 7. Other concomitant anticancer agent 8. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons 9. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment

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

Study Arms:
- Gemcitabine, Ts-1 (Type: EXPERIMENTAL): Gemcitabine : 1000/m2 will be administered on days 1 and 8 at every 3 weeks . TS-1 will be administered orally according to body surface area (BSA) as follows : BSA\<1.25 M2, 80 mg/day; 1.25 M2≤BSA\<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.

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: Hydroquinidine Versus Placebo in Patients With Brugada Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy adult (at least 18 years of age)~* Informed consent form signed~* Subject affiliated to French health insurance (Sécurité Sociale)~* Type 1 Brugada syndrome either symptomatic or asymptomatic~* Not pregnant, taking oral contraceptive measure if able to procreate~* If patient with asymptomatic type 1 Brugada, electrophysiological exploration must be positive at study inclusion~* No current intake of betablocking medicine used in cardiac insufficiency (bisoprolol, carvedilol, metoprolol)~* No current myasthenia~* No current treatment with halofantrine, pentamidine, moxifloxacin~* No current treatment with some neuroleptics~* Known hypersensitivity to hydroquinidine~* Intolerance to fructose, syndrome of glucose or galactose malabsorption, deficit in sucrase isomaltase- Cardiac insufficiency~* Histories of torsades de pointe~* Intake of medicine giving torsades de pointe~Exclusion Criteria:~* Subject not fulfilling inclusion criteria~* Subject being before study entry under hydroquinidine treatment but either at a dose \> 3 capsules per day or at a dose of 1, 2 or 3 capsules per day but with a plasmatic hydroquinidine concentration \>6µmol/L or \<3 µmol/L

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

Study Arms:
- hydroquinidine (Type: EXPERIMENTAL): As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.
- capsules of sugar (Type: PLACEBO_COMPARATOR): As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 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: Effect of Meal on Portal and Esophagus Variceal Pressure

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

Eligibility Criteria:
Inclusion Criteria:~* Large Esophageal varices~Exclusion Criteria:~* Treatment with beta-blocking agents~* Respiratory diseases that contradict endoscopy~* Gastric-retention~* Former gastric resection~* Resent sclerotherapy or former banding

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 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: European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)

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:
ICD Patient Population - Inclusion Criteria~* Indication for 1-/2- chamber ICD implantation, including replacement indication~* Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent~ICD Patient Population - Exclusion Criteria~* Patients with contraindication to ICD implantation~* Patients with indication for cardiac resynchronization (CRT)~* Minors and pregnant women~* Patients participating in another study~CRT-D Patient Population - Inclusion Criteria~* Patients with indication for de novo CRT-D implantation according to current guidelines~* Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent~CRT-D Patient Population - Exclusion Criteria~* Patients who had a cardiac device implanted before (upgrade, device replacement)~* Life expectancy less than 12 months~* Planned heart transplantation~* NYHA IV~* Minors \< 18 years~* Pregnant and breast-feeding women~* Participation in another clinical study

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

Study Arms:
- 1 = Home Monitoring (Type: EXPERIMENTAL): Remote monitoring of ICD and CRT-D function and patient status
- 2 = No Home Monitoring (Type: ACTIVE_COMPARATOR): Home Monitoring option is switched off

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: Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types .~* Participant must be greater than or equal to (\>=)18 years of age (or \>=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma \[MRCLS\])~* Participants with life expectancy of greater than 6 months~* Performance status: Eastern Cooperative Oncology Group 0-1.~Exclusion Criteria:~* Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)~* Prior malignancy not in complete remission.~* Clinically significant systemic illness~* Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction,~* Prior or active demyelinating disease~* Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody.~* Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Participants with solid tumors and hematological malignancies (Type: OTHER): Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this 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: Neuroprotection of Pioglitazone in Acute Ischemic Stroke

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:
Inclusion Criteria:~1. Acute ischemic stroke onset within 48 hours~2. Age≧20 years~3. Stroke severity with at least one point for limb weakness in National Institutes of Health Stroke Scale (NIHSS).~4. The patients with no known history of diabetes with admission serum glucose ≧130 mg/dl.~Exclusion Criteria:~1. The patients who have history of urinary bladder cancer or hematuira.~2. The patients who have history of congestive heart failure or myocardial infarction.~3. The patients who have known history of using pioglitazone before the onset of stroke.~4. The patients who have mRS≧3 before stroke onset.

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

Study Arms:
- Pioglitazone (Type: ACTIVE_COMPARATOR): 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: SonoVue Guided Prostate Biopsy

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Male patient, age ≥ 40 years old~* Optimization part only: Diagnosis of prostate cancer~* Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.~* Written Informed Consent and willing to comply with protocol requirements~Exclusion Criteria:~* Documented acute prostatitis or urinary tract infections~* Known allergy to sulphur hexafluoride micro bubbles~* Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:~* evolving or ongoing myocardial infarction~* typical angina at rest within the previous 7 days~* significant worsening of cardiac symptoms within the previous 7 days~* recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)~* acute cardiac failure, class III/IV cardiac failure~* severe cardiac rhythm disorders~* right-to-left shunts~* Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome~* Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)~* Determined by the Investigator that the patient is clinically unsuitable for the study~* Participation in a concurrent clinical trial or in another trial within the past 30 days~* Repeated participation in this trial (the patient should not be enrolled twice in the present study)

- Gender: MALE
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- SonoVue guided biopsy (Type: EXPERIMENTAL): None
- Systematic biopsy (Type: OTHER): 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: Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria

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:~* Men and women with classical PKU~* Age ≥ 18 years~* Good metabolic control during childhood (at least until 12 years of age)~* Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year~* Written informed consent prior to study participation~Exclusion Criteria:~* Reduced cognitive function (unability to perform test battery)~* Drug and or alcohol abuse~* Treatment with BH4~* Treatment with drugs known to affect cognitive function

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 59 Years
- Healthy Volunteers: f

Study Arms:
- Diet (Type: EXPERIMENTAL): None
- Control (Type: NO_INTERVENTION): 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: A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement

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

Eligibility Criteria:
Inclusion Criteria:~i) Male or female subjects, aged between 18 and 75 years inclusive.~ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.~iii) Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.~iv) Subjects with a primary diagnosis of osteoarthritis.~v) Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.~Exclusion Criteria:~i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, or extend their time to discharge beyond that required for their hip replacement surgery.~ii) Women who are pregnant.~iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.~iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).~v) Subjects who are currently involved in any injury litigation claims.~vi) Subjects with a Body Mass Index (BMI) \> 30.~vii) Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.~viii) Subjects requiring a simultaneous bilateral total hip arthroplasty.~ix) Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): DePuy MI System
- 2 (Type: ACTIVE_COMPARATOR): Conventional surgical technique

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: Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy

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:~* Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC~* Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway~* Measurable disease, as defined by RECIST criteria~* Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable~* Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable~* ECOG Performance Status 0-2~* 18 years of age or older~* Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential~* Bone marrow function, renal function, hepatic function as outlined in protocol~Exclusion Criteria:~* Women who are pregnant of breastfeeding~* Active concurrent malignancy~* Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab~* Significant history of uncontrolled cardiac disease~* Uncontrolled seizure disorder, or active neurological disease~* Prior severe infusion reactions to a monoclonal antibody~* Prior chemotherapy regimen within 21 days prior to study entry~* Any EGFR tyrosine kinase inhibitor within 14 days of study entry~* Radiation therapy within 14 days prior to the first infusion of cetuximab~* Acute hepatitis or known HIV~* Active or uncontrolled infection~* Any concurrent chemotherapy or any other investigational agent(s)

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

Study Arms:
- Cetuximab (Type: EXPERIMENTAL): 400mg/m2 IV x 1 and then 250mg/m2 IV weekly

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 Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain

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

Eligibility Criteria:
Inclusion Criteria:~* age greater than 18~* admission with abdominal pain for up to one week prior to admission deemed to be non-specific pain by senior surgical team member~* patient willing to give full informed consent for participation~Exclusion Criteria:~* patients less than 18 years of age~* pain of greater than 7 days duration~* admission with abdominal pain in previous 6 months~* history of inflammatory bowel disease~* previous history of appendicectomy~* previous surgery rendering laparoscopy unsafe eg. multiple laparotomies~* history of intra-abdominal transplant including retroperitoneal renal allografting~* clinical picture necessitating immediate surgical procedure~* cases involving trauma~* patients who are unable or unwilling to give full informed consent

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

Study Arms:
- early laparoscopy (Type: ACTIVE_COMPARATOR): early laparoscopy, aiming to achieve this within 12 hours
- active observation (Type: PLACEBO_COMPARATOR): standard management - the wait and see approach with serial examinations and investigations as deemed necessary

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: Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).

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:~* 18 years or more~* macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under \<13%~* indication for a treatment with intra-vitreal injections of ranibizumab~Exclusion Criteria:~* treatment with anti-VEGF during the previous 2 months~* treatment by intra-vitreous implant of dexamethasone during the previous six months~* previous history of vitrectomy or glaucoma~* photocoagulation during the previous 3 months~* patient's opposition to participate to the study

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

Study Arms:
- Micropulsed laser photocoagulation (Type: EXPERIMENTAL): None
- Sham micropulsed laser photocoagulation (Type: SHAM_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: enrollment issues