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

Trial Title: Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)

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

Eligibility Criteria:
Inclusion Criteria:~* Participant is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines.~* Males or females ≥ 18 years of age.~* Premenopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug.~* Participant who has received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study.~* One hemoglobin value of ≥ 10.0 grams per deciliter (g/dL) in the 4 weeks prior to study drug administration.~Exclusion Criteria:~* Known intolerance to peginesatide or pegylated products.~* History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA).~* High likelihood of early withdrawal or interruption of the study (e.g., participant suffers from any clinically significant medical disease or condition that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)~* Anticipated life expectancy \< 18 months~* Receipt of any ESA other than peginesatide at any time after participant enrollment in the previous Affymax-sponsored study

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

Study Arms:
- Maintenance Switch in Dialysis Participants (Type: EXPERIMENTAL): Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study.
- Treatment Initiation in Non-Dialysis Participants (Type: EXPERIMENTAL): Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during 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: Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~DISEASE CHARACTERISTICS:~* Histologically confirmed primary infiltrating adenocarcinoma of the breast~  * Confirmed by core needle biopsy or incisional biopsy or surgery~ * Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy~ * At least 2 cycles same anthracycline based chemotherapy are needed~Exclusion Criteria:~* Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2~* With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart~* Pregnant or nursing~* Other currently active malignancy except nonmelanoma skin cancer~* Uncontrolled or severe bleeding,diarrhea,intestinal obstruction~* Grade 2 or more Cardiac Toxicity (CTC AE3.0)

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- control arm (Type: NO_INTERVENTION): anthracycline chemotherapy only
- low dose dexrazoxane group (Type: EXPERIMENTAL): anthracycline chemotherapy plus low dose dexrazoxane(10:1)
- middle dose dexrazoxane group (Type: EXPERIMENTAL): anthracycline chemotherapy plus middle dose dexrazoxane(15:1)

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: Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19

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

Eligibility Criteria:
Inclusion Criteria:~* Age greater than or equal to 18 years~* Gestational age greater than or equal to 22 weeks of gestation~* Pregnant women suspected of COVID-19 :~* already having a nasopharyngeal RT-PCR for the SARS-CoV-2~* AND having a chest CT-scan or waiting for this exam~* Women giving a writing consent to participate~Exclusion Criteria:~* Women giving an opposition to participate~* Women not enough fluent in French to benefit from clear and intelligible information

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

Study Arms:
- Pregnant women (Type: EXPERIMENTAL): Pregnant women suspected of COVID-19

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 Study of LY3405105 in Participants With Advanced Cancer

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

Eligibility Criteria:
Inclusion Criteria:~Phase 1 a:~* Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic~* Have available archived tissue for exploratory biomarker analysis~* Have adequate organ function~* Have discontinued all previous treatments for cancer and recovered from their side effects~* Are able to swallow capsules/tablets~Phase 1 b:~* Cohort 1: Triple-negative breast cancer (TNBC).~* Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).~* Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3. Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also eligible.~* Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 4.~* Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).~Exclusion Criteria:~* Have symptomatic central nervous system (CNS) malignancy or metastasis~* Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C~* Have congestive heart failure~* Are breastfeeding

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

Study Arms:
- LY3405105 (Type: EXPERIMENTAL): LY3405105 administered orally.

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: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

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

Eligibility Criteria:
Inclusion Criteria:~* Acute-care inpatients;~* Aged 18 years or older;~* At least one dose of echinocandin therapy during the hospitalization;~* Primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia.~Exclusion Criteria:~* \< 18 years of age;~* No recorded echinocandin therapy during hospitalization;~* Acetaminophen hepatotoxicity;~* Pre-existing autoimmune hepatitis;~* Autoimmune/metabolic liver disease;~* Primary biliary cirrhosis;~* Primary sclerosing cholangitis and orthotopic liver transplantation.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: t

Study Arms:
- Cases (Type: None): Potential cases were defined as patients with a diagnosis of severe hepatic injury identified in the acute-care inpatient cohort using ICD-9 codes associated with the case definition of severe liver injury. Case status was validated by a Consultant Gastroenterologist blinded to study drug exposure via medical record review using an apriori algorithm. Only validated cases were included in the analysis (N=69)
- Controls (Type: None): Controls were defined as patients without a diagnosis of severe hepatic injury (i.e. with no ICD-9 codes associated with the case definition of severe liver injury) selected at random from the same acute-care inpatient cohort as cases (N=467)

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: Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19

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:~* Willing to provide informed consent and able to comply with protocol requirements~* 18 years or older~* Has a COVID-19 diagnosis confirmed by PCR~* Hospitalized within 5 days and meets the following criteria at screening:~Peripheral capillary oxygen saturation (SpO2) ≤ 93% on room air or SpO2 ≥93% on ≤10 liters per minute of supplemental oxygen via nasal cannula~* Radiographic (chest X-ray, computed tomography scan, or ultrasound) evidence of bilateral pulmonary infiltrates consistent with SARS-CoV-2/COVID-19~* Clinical symptoms consistent with COVID-19 per Investigator judgement~* Body mass index between 18 to 40 kg/m2~* If of reproductive potential, willing to abstain or agree to the use of highly effective contraception~Exclusion Criteria:~* Respiratory failure at screening~* History of heart failure~* History of COPD or bronchial asthma~* Active TB or history of TB of the following types~* Uncontrolled arrhythmia within 3 months prior to randomization~* Heart disease of the following types~* Moderate to severe renal insufficiency~* Abnormal white cell and platelet counts~* History of transplantation of vital organs (e.g., heart, lung, liver, and/or kidney);~* Malignant tumor~* Uncontrolled systemic or local autoimmune or inflammatory disease besides SARS-CoV-2~* Unhealed wounds, active gastric ulcer, had surgery~* Received other investigational therapeutic products~* Used interferon therapies~* History of HIV infection, hepatitis B, and/or hepatitis C~* Known serious allergic reaction or hypersensitivity to components of F-652~* Pregnant or breastfeeding~* History of drug abuse or use of narcotics~* Treated with immunomodulators or immunosuppressants~* Other conditions resulting in increased risk

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

Study Arms:
- F-652 (Type: EXPERIMENTAL): Patient receives standard care plus F-652
- Placebo (Type: PLACEBO_COMPARATOR): Patient receives standard care plus placebo

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: Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

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

Eligibility Criteria:
Inclusion Criteria:~* Patient is \>= 18 years of age.~* Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.~* Patient has clinical diagnosis of cirrhosis.~* Patient has undergone variceal banding.~Exclusion Criteria:~* Patient has a Child-Pugh score \>12.~* Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.~* Variceal banding procedure was performed within 1 month of the screening visit.~* Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.~* Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.~* Patient has hepatocellular carcinoma that is being medically treated or is advanced.~* Patient has impaired renal function (i.e., serum creatinine concentration \>1.8 mg/dl)~* Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.~* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.

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

Study Arms:
- Placebo TID (Type: PLACEBO_COMPARATOR): Participants receive matching placebo capsules three times daily (TID)
- 12 mcg TID (Type: EXPERIMENTAL): Participants receive 12 mcg Cobiprostone TID
- 18 mcg TID (Type: EXPERIMENTAL): Participants receive 18 mcg Cobiprostone TID

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 Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia

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:~* Rest pain, gangrene or ulcers located below the patella for a duration of at least two weeks (either one of these criteria are sufficient).~* One measurement of: Ankle blood pressure(ABP) \<70 mm Hg, an toe blood pressure(TBP) \<50, or a TcPO2\<45 mm Hg, or an ankle/brachial pressure index \<0.7 (either one of these criteria are sufficient).~* Informed consent obtained~Exclusion Criteria:~* Age \< 55 years~* Women of childbearing potential~* Patients already medicating with Pregabalin or Gabapentin~* Creatinine clearance \<30ml/min~* Amputation necessary within two weeks~* Revascularization necessary within two weeks (open vascular surgery or endovascular)~* A medical history of clear dizziness~* NYHA class IV heart failure~* Known hypotension, or having a systolic arm blood pressure \<120 mm Hg (two consecutive measurements with the patient lying supine)~* Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices~* Mental condition making the subject unable to understand the concepts and risk of the study~* Known allergies against pregabalin

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

Study Arms:
- A (Type: ACTIVE_COMPARATOR): Active intervention with pregabalin
- B (Type: PLACEBO_COMPARATOR): placebo arm with capsule Lyrica Placebo

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

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

Trial Title: Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population

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

Eligibility Criteria:
Inclusion Criteria:~* Infants born with gestational age ≥37 weeks~* Birth weight ≥2000g and ≤4500g~* Age 1 - 14 days~* Infants requiring a blood sample (newborn screening / clinically suspected jaundice)~Exclusion Criteria:~* Infants transferred to the paediatric ward for advanced treatment.~* Infants with a skin rash or other disease that affects the skin where measurements are performed.~* Infants that receive or have received phototherapy in the last 24 hours.~* Infants with an inborn disease

- Gender: ALL
- Minimum Age: 24 Hours
- Maximum Age: 14 Days
- Healthy Volunteers: t

Study Arms:
- Enable high qualitative estimation of bilirubin levels in the blood of new-borns (Type: OTHER): In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors. .

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: A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

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:~* Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive~* Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)~* Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)~* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2~Exclusion Criteria:~* Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC~* UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment~* UC and/or CIS in the prostatic urethra within 12 months of enrollment~Other protocol-defined inclusion/exclusion criteria apply

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

Study Arms:
- Arm A: nivolumab + Bacillus Calmette-Guérin (BCG) (Type: EXPERIMENTAL): None
- Arm B: placebo +BCG (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: A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

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

Eligibility Criteria:
Inclusion Criteria:~* Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection)~* Baseline pain intensity \>= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization~* Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study~Exclusion Criteria:~* Patients will be excluded from the study if they have a history of seizure disorder or epilepsy~* history of malignancy within the past 2 years before starting the study~* history of alcohol or drug abuse~* evidence of active infections that may spread to other areas of the body~* clinical laboratory values reflecting moderate or severe kidney insufficiency~* currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor \[SSRI\] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose)

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

Study Arms:
- 003 (Type: PLACEBO_COMPARATOR): Placebo Fixed Dose Matching placebo for 3 days
- 002 (Type: ACTIVE_COMPARATOR): Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days
- 001 (Type: EXPERIMENTAL): Tapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days
- 004 (Type: OTHER): Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days

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

Answer: outcome: terminate
termination_type: enrollment issues