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

Trial Title: Trial of High-dose Urso in Primary Sclerosing Cholangitis

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

Eligibility Criteria:
* Chronic cholestatic disease of at least six months' duration.~* Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.~* Retrograde, operative, percutaneous, or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or narrowing consistent with PSC within one year of the study entry.~* Liver biopsy in the previous one year which is available for review and compatible with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis, ductopenia with periportal inflammation and biliary fibrosis.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet.
- Ursodeoxycholic acid (Type: EXPERIMENTAL): Ursodeoxycholic acid 28-30 mg/kg/day

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: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)

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

Eligibility Criteria:
Inclusion Criteria:~* Females Or Males Over 18 Years Old~* Patients With Systemic Arterial Hypertension Grade I And II According With The European Society Of Cardiology~* Left Ventricular hypertrophy Demonstrated By Echocardiography~* Mild To Moderated hypercholesterolemia~* Willing To Participate And Sign The Informed Consent Form (ICF)~Exclusion Criteria:~* Type 1 Or 2 Diabetes Mellitus~* Familiar hypercholesterolemia~* Low Density Lipoprotein-Cholesterol (LDL-C) \> 190 mg/dl~* History Of Myocardial Infarction Or Stable Chronic Angina~* Triglycerides \>250 mg/dl

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

Study Arms:
- Valsartan 80 mg + Paravastin 40 mg (Type: ACTIVE_COMPARATOR): Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
- Valsartan 80 mg + Simvastatin 40 mg (Type: ACTIVE_COMPARATOR): Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
- Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg (Type: EXPERIMENTAL): Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
- Valsartan 80 mg (Type: ACTIVE_COMPARATOR): Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)

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: Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients (age \> 18 years) admitted to participating ICUs with:~  1. Primary diagnosis of COPD exacerbation defined as the presence of two or more of the following clinical features: worsening dyspnea, increase in sputum purulence, increase in sputum volume~ 2. respiratory failure \[pH \< 7,35 with a PaCO2 \> 45 mm Hg and respiratory rate more than 23 breaths per minute\] requiring mechanical ventilation, invasive or non-invasive mechanical ventilation.~Exclusion Criteria:~1. Primary diagnosis of asthma exacerbation.~2. History of asthma or atopy.~3. Use of systemic corticosteroids within the preceding month.~4. Use of systemic corticosteroids for the treatment of COPD exacerbation at the time of ICU admission for more than 24 hours.~5. Clinical or radiological evidence of pneumonia.~6. Uncontrolled left-ventricular failure (patients with evidence of severe heart failure requiring inotropes or vasoactive drugs).~7. Uncontrolled hypertension arterial (systolic pressure \> 180 mm Hg or diastolic pressure \> 90 mm Hg despite antihypertensive therapy).~8. Uncontrolled diabetes mellitus.~9. Presence of a neuromuscular disease.~10. History of allergy and or adverse reaction to corticosteroids.

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

Study Arms:
- methylprednisolone (Type: EXPERIMENTAL): None
- normal saline solution (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: Serp-1 for the Treatment of Acute Coronary Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission~* Scheduled for PCI~Exclusion Criteria:~* CABG within 6 months~* Acute ST elevation, eligible for thrombolysis on initial examination~* Coronary lesions with total thrombotic occlusions~* Current immunosuppressant therapy

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 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: AnaConDa-therapy in COVID-19 Patients

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:~* Age \>18 years~* More than 24 hours of invasive mechanical ventilation needed~* Positive test (e.g. Polymerase Chain Reaction (PCR)) for SARS-CoV-2~Exclusion Criteria:~* pulmonary history~* known allergy or hypersensitivity for halogenated anesthetics~* known or suspected predisposition for malignant hyperthermia~* suspected or proven intracranial hypertension~* severe liver dysfunction and/or icterus (serum bilirubin \>42,8-51,3 μg per liter)~* neutropenia (\<0.5X10\^9 neutrophils per liter)~* chemotherapy in the month prior to ICU admission~* patients that are transported to other hospitals during admission

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

Study Arms:
- Sevoflurane (Type: None): patients admitted because of respiratory insufficiency due to COVID-19 with need for invasive mechanical ventilation that are sedated by using sevoflurane
- Control (Type: None): patients admitted because of respiratory insufficiency due to COVID-19 with need for invasive mechanical ventilation that are sedated by means of intravenous medication, such as propofol, midazolam, esketamine of fentanyl

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

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

Trial Title: The Influence of Sedation for Endoscopy on Cognitive Function

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. The scores of MMSE are more than 26.~2. The AHA grade I and II.~Exclusion Criteria:~1. The AHA grade III, IV or V.~2. binge drinking.~3. Take sedatives, sleeping agents and some drug which may affect the study in a month.~4. Psychiatric disorders.~5. The dysfunction of heart, lung, liver and kidney.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- sedation group (Type: None): Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus
- control group (Type: None): patients undergo conventional EGD

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: Recall by Genotype: Neuropeptide Stimulation

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* No prescription medications that could interfere with hypothalamic reproductive function~* No illicit drug use~* No excessive alcohol consumption (more than 10 drinks/week)~* No history of an allergic medication reaction requiring emergency medical care~* Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg)~* White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range~* Normal hemoglobin~* Blood urea nitrogen (BUN), creatinine not elevated~* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal~* Enrolled in the Partners HealthCare Biobank and genotypically characterized~* For women~  * No oral contraceptives for at least 1 month~ * No contraceptive implants for at least 3 months~ * Not breastfeeding and not pregnant~ * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- kisspeptin, GnRH (Type: EXPERIMENTAL): IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.

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: Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer

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:~* Histologically/biopsy confirmed adenocarcinoma of prostate within 1 year of registration~* Disease confined to the prostate. Prostate volume must be \<150cc confirmed by pelvic CT (with or without contrast) or pelvic/prostate MRI (with or without contrast) +/- ultrasound, within 8 months of signing research consent~* Age \>18~* Patients deemed medically suitable to undergo rectal spacer placement, external beam radiotherapy and brachytherapy at the discretion of the radiation oncologist, urologist, medical oncologist and/or internist.~* ECOG score of 0-2.~* One or more of the following risk factors for intermediate risk prostate cancer; T2b or T2c clinical stage, GS 7 (either 3+4 or 4+3), PSA 10-20.~* Ability to understand and the willingness to sign a written informed consent.~* PSA result within 6 months of simulation~Exclusion Criteria:~* Patients with disease not confined to the prostate based on imaging, biopsy, or clinical exam~* Patients with a prostate size \> 100 cc based on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound measurements~* Patients who have undergone previous rectal, bowel, bladder, or prostate surgeries in the past~* Patients with previous treatments for their prostate cancer or that are currently receiving any other experimental therapies~* Patients who have undergone prior pelvic radiotherapy~* Patients with high risk prostate cancer that have any of the following risk factors; GS \>= 8, PSA \> 20, clinical or imaging stage T3a or higher~* Patients receiving antiandrogen therapy (ADT)~* Patients with any prior active or treated genitourinary malignancy

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

Study Arms:
- Patients with prostate cancer (Type: EXPERIMENTAL): Patients undergo hydrogel rectal spacer placement on day 1. Within 2 weeks (+/-1 week) after Rectal Spacer placement, patients will be scheduled for CT simulation for external beam treatment planning. Patients will begin the SBRT of 24Gy in 5 fractions within 2 weeks (+/-1 week) from the simulation date. Within 4 weeks (+/-1 week) of last day of SBRT, patients undergo brachytherapy. Patient will return for post-implant CT-based dosimetry analysis 4 weeks (+/- 1 week) post brachytherapy,

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: Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

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:~* Diagnosis of Down syndrome (established during study E2020-A001-220).~* Completion of study E2020-A001-219 (NCT00570128 \[also known as A2501059\]) with no ongoing seroius adverse events and no severe drug reactions.~Exclusion Criteria:~* Weight less than 20 kg.~* Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.~* No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.~* Females of childbearing potential who are not practicing an effective means of birth control.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Prior Donepezil-DB (Type: EXPERIMENTAL): All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant's weight at clinic visits during the study duration.

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: Sirolimus/Tacrolimus Combination After HLA Matched Related Peripheral Blood Stem Cell Transplants

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

Eligibility Criteria:
Inclusion Criteria:~* Ability to provide written informed consent prior to participating to the study~* Patients with acute leukemia in remission, MDS, and CML in chronic \& accelerated phase~* Patients with HLA identical donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched.~* Patients with an ECOG performance status score \< 2~* Adequate end organ functions as defined by: Total bilirubin \< 1.5 × ULN, AST and ALT \< 2.5 × ULN, Creatinine \< 1.5 × ULN.~* Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug.~Exclusion Criteria:~* Acute promyelocytic leukemia (M3)~* Patients with another primary malignancy other than hematologic disease~* Patients with a severe or uncontrolled medical condition (i.e. uncontrolled diabetes, chronic renal disease)~* Patients who are ① pregnancy, ② breast feeding, ③ of childbearing potential without a negative pregnancy test prior to baseline and ④ male or female of childbearing potential unwilling to use barrier contraceptive precautious throughout the trial (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)~* Patients with an ECOG performance status score ≥ 2~* Patients with known positivity for HIV; baseline testing for HIV is not required

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- acute GVHD prevention by sirolimus based regimen (Type: EXPERIMENTAL): The investigators will evaluated the primary endpoint and secondary endpoints comparing with historical control, that is used tacrolimus/methotrexate as a GVHD prophylaxis after HLA-matched, related PBSCT.

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: GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Ability to provide written informed consent~2. Age over 18 years~3. Relapsed/refractory lymphoma after at least 1 prior chemotherapy treatment:~   1. Hodgkin's lymphoma~  2. Aggressive non-Hodgkin's lymphoma~  3. Follicular lymphoma~4. Chemosensitive disease at time of transplantation (i.e. partial response or better to salvage chemotherapy)~5. ECOG (Eastern Cooperative Oncology Group) performance 0-2~6. Adequate organ function:~   1. Cardiac: LVEF (left ventricular ejection fraction)\>40%~  2. Pulmonary: FEV1 (forced expiratory volume at one second) and DLCO (diffusing capacity of lung for carbon monoxide)\>60% predicted~  3. Renal: creatinine \<150 µmol/L unless caused by ureteric obstruction from lymphoma~  4. Liver: No evidence of cirrhosis. ALT (Alanine Aminotransferase) and bilirubin \<2x upper limit of normal unless caused by biliary tract obstruction from lymphoma~Exclusion Criteria:~1. Clinically significant active infection~2. Active secondary central nervous system disease~3. Other serious co-morbid illness that would compromise study participation.~4. Pregnant or lactating females~5. Prior HDCT/ASCT

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

Study Arms:
- Gemcitabine/Melphalan Condition + ASCT (Type: EXPERIMENTAL): Day -1 -~* IV gemcitabine 1.5-2.5 g/m2 (depending on dose level assigned) administered as a loading bolus of 75 mg/m2, followed by a continuous infusion of 10 mg/m2/min.~* immediately following gemcitabine - IV melphalan 200 mg/m2 over 5 minutes.~Day 0~•Stem cell infusion~Patients will be assigned a dose level using the continual reassessment method based on the toxicity data available at the time of their enrollment. The dosing will start at 1.5 g/m2 and will increase by 0.5 mg/m2 at each level to a maximum of 2.5 g/m2. Dose-limiting toxicity is defined as grade 3 mucositis or skin toxicity lasting more than 3 days before downgrading, or any grade 4 non-hematological toxicity.

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: Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients

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:~* Main diagnosis: aplastic anemia~* Absence of severe and/or uncontrolled comorbidities~* Confirmed iron overload (serum ferritin ≥ 1000 mkg/L)~* Serum creatinine is not higher than the upper limit of normal for the given age~* Absence of severe proteinuria. Protein/Creatinine ratio should be \< 0.5 mg/mg~* Liver enzymes are \< 5 ULN~* Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications~* WHO (ECOG) performance status ≤ 2~Exclusion Criteria:~* No signed informed consent form~* Patient is under 18 years old~* Severe concomitant condition~* Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment.~* History of increased sensitivity to active substance and any other ingredient of the medicinal product.~* Creatinine clearance (CC) \< 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2.~* Severe liver disorders (class C by Child-Pugh scale).~* Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease.~* Significant proteinuria basing on protein creatinine ratio \> 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening);~* Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption;~* Pregnancy, lactation;~* Level of liver enzymes higher than 5 upper limits of age normal at Visits 1 and 2.

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

Study Arms:
- Serum ferritin level ≥ 1,000 μg/l (Type: EXPERIMENTAL): Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study
- Serum ferritin level < 1,000 μg/l (Type: EXPERIMENTAL): Transfusion-dependent adult patients with AA and serum ferritin \< 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product

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

Answer: outcome: terminate
termination_type: enrollment issues