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

Trial Title: The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)

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:~* age over 18 years old~* low back pain for more than 3 months~* Modic type I or II change in lumbar magnetic resonance imaging~* Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at least 30%~Exclusion Criteria:~* premenopausal female patients with possibility of pregnancy~* patients with calculated creatinine clearance of less than 40 ml/min~* patients with hypocalcemia~* patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product~* patients with red flags symptoms~* patients with nerve root impingement~* patients with willingness for early retirement

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

Study Arms:
- Zoledronic acid (Type: ACTIVE_COMPARATOR): Single infusion of 5 mg zoledronic acid I.V.
- Placebo (Type: PLACEBO_COMPARATOR): Single infusion of 100 ml isotonic NaCl-solution I.V.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent signed prior to the performance of any study procedures~* Male or female volunteers, age 18 to 65 years, inclusive~* Overweight to obese (greater than or equal to BMI 28.0~* Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%~* If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy~Exclusion Criteria:~* Women who are pregnant or breastfeeding~* Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%~* History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

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

Study Arms:
- ALT-801 Dose Level 1 (Type: EXPERIMENTAL): Administered once a week for 12 weeks
- ALT-801 Dose Level 2 (Type: EXPERIMENTAL): Administered once a week for 12 weeks
- ALT-801 Dose Level 3 (Type: EXPERIMENTAL): Administered once a week for 12 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Administered once a week for 12 weeks

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles

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: The target population includes couples undergoing IVF. All eligible couples will be asked to join the study. Study participants will be recruited from the Reproductive Endocrinology Clinic at University of California at San Francisco Center for Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be offered participation in the study.~Exclusion Criteria:~* Age \>41 years old~* Antral Follicle Count (AFC; 2-10 mm) \< 8~* Body Mass Index \> 30 kg/m2~* History of ≥ 2 prior canceled IVF cycles secondary to poor response~* Diagnosis of cancer~* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results~* Undergoing embryo co-culture~* Use of any of the following medications: Growth Hormone, Sildenafil, or Aspirin (except if being used for hypercoagulable state)~* Severe male factor infertility diagnosis. Male factor infertility diagnosis should be cleared for eligibility by the PI based on previous patient history of fertilization outcomes and/or expected fertilization outcomes of the cause of male factor infertility based on known scientific data.~* Ovulation trigger less than or greater than 36 hours to oocyte retrieval~* Serum estradiol level \>5,000 pg/ml on the day of expected trigger due to high risk of OHSS

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 41 Years
- Healthy Volunteers: t

Study Arms:
- Low dose hCG plus FSH co-trigger (Type: EXPERIMENTAL): On the day of ovulation trigger the patient will receive hCG 1,500 IU SQ plus FSH 450 IU SQ
- Standard dose of hCG alone (Type: ACTIVE_COMPARATOR): On the day of ovulation trigger the patient will receive standard dose of hCG (10,000 or 5,000 IU SQ)

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Study Design Characteristics:
- Allocation: None
- 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:~* Male, aged 2-16yrs~* Severe hemophilia A (\<1% FVIII:C \[Blood Clotting Factor VIII:C\] )~* Minimum of at least 50 documented ED (exposure day) prior to enrolment~* No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation~* Parents or legal guardians document, sign, and date informed consent~Exclusion Criteria:~* Another bleeding disease that is different from hemophilia A~* Known hypersensitivity to the active substance, mouse or hamster protein~* Thrombocytopenia (platelet count \<100 000/mm3) based on previous medical records

- Gender: MALE
- Minimum Age: 2 Years
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- Recombinant Factor VIII (Type: EXPERIMENTAL): None

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

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:~1. Confirmed diagnosis of ITP ≥6 months;Platelets \<30×109/L.~2. No evidence of other causes of thrombocytopenia.~3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.~4. Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.~5. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.~6. PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.~7. Signed informed consent.~Exclusion Criteria:~1. Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.~2. Subjects diagnosed with tumor.~3. Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block.~4. Female subjects who are nursing or pregnant at screening or pre-dose on baseline.~5. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .~6. Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for \>3 consecutive days within 2 weeks of the study start and until the end of the study.~7. Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.~8. ALT\> 1.5 x upper limit of normal (ULN), AST\> 3 x upper limit of normal (ULN)) DBLI\> 1.2 x upper limit of normal (ULN),Scr\> 1.2 x upper limit of normal (ULN)~9. The subject has participated in other clinical trial within the 3 months prior to randomization.

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

Study Arms:
- Arm 1 (Type: EXPERIMENTAL): oral hetrombopag at an initial dose of 2.5 mg once daily
- Arm 2 (Type: EXPERIMENTAL): oral hetrombopag at an initial dose of 5 mg once daily
- Arm 3 (Type: PLACEBO_COMPARATOR): oral placebo at an initial dose of 2.5 mg once daily
- Arm 4 (Type: PLACEBO_COMPARATOR): oral placebo at an initial dose of 5 mg once daily

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

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:~* Aged 12 to \<18 years~* Parent or legal guardian must provide written informed consent~* Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen~* Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy~* Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy~* Screening laboratory values within defined thresholds~* No History of solid organ or bone marrow transplantation~* No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)~NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- LDV/SOF (Type: EXPERIMENTAL): Participants will receive LDV/SOF 90/400 mg fixed dose combination (FDC) (1x 90/400 mg tablet or 4 x 22.5/100 mg tablets based on swallowability assessment during screening) for 12 weeks.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Pharmacokinetic Boosting of Osimertinib

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with EGFR-mutated NSCLC receiving standard treatment with osimertinib for at least 2 months (steady state), without any signs of disease progression, or during treatment beyond progression, if treatment continuation is expected for multiple months. After anticipated EMA approval of osimertinib adjuvant therapy, patients on adjuvant osimertinib treatment may also participate on the following conditions; If they are receiving standard treatment with osimertinib for at least 2 months (steady state), and if treatment will be continued for a longer period than necessary for participation in the OSIBOOST trial.~* Age ≥ 18 years~* WHO performance status ≤ 2.~* Able and willing to give written informed consent.~* Able and willing to undergo blood sampling for pharmacokinetic analysis.~* Patients with osimertinib plasma trough concentration below 195 ng/mL. Plasma trough concentration of osimertinib will be determined in another study (METC MUMC: 2018-0800).~Exclusion Criteria:~* Any concurrent medication that is known to strongly inhibit or induce CYP3A4.~* Any concurrent medication that is primarily metabolized by CYP3A4 with a narrow therapeutic window.~* Impairment of gastrointestinal function that may alter the absorption of osimertinib or cobicistat (e.g. ulcerative disease, uncontrolled nausea or vomiting, malabsorption syndrome, small bowel resection).~* Refusing to refrain from consuming CYP3A4 influencing products, e.g. grapefruit(juice), St. John's wort.~* Pregnancy or breast feeding~* Child-Pugh score class C, chronic liver disease.

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

Study Arms:
- Cobicistat (Type: EXPERIMENTAL): Cobicistat will serve as experimental drugs, and will be added to the regular treatment with osimertinib. Combination-treatment will be started at 150 milligram cobicistat, and can be increased to a maximum daily dose of 600 milligram cobicistat (four times 150 milligram).

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone

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

Eligibility Criteria:
Inclusion Criteria:~* Brain injured patients with a Glasgow scale score ≤ 12 who require ventilation more than 48 hours~Exclusion Criteria:~* Patient with a high risk of death within the 48 first hours after admission,~* Patient intubated for more than12 hours~* Intubation after the 48th hours after admission~* Coverage to cardiopulmonary arrest~* Coma due to a tumor, an infectious disease or a cardiac arrest~* Previous hospitalisation within the last month before admission for coma~* béta-lactamines allergy~* Patient who receive already antibiotics at the admission for a previous infection~* Prophylactic antibiotic due to be done within 24 hours following the randomisation~* Patient Intubated through a tracheal tube with subglottic secretion aspiration~* Patient with a tracheotomy~* Patient or family refuse to be involved in the study~* Use of Ceftriaxone within 2 days before enrolment~* Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection~* Patients not affiliated to a social security scheme, Pregnant woman or breast-feeding mother, Patients deprived of their liberty by judicial or administrative decision

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

Study Arms:
- Ceftriaxone (Type: EXPERIMENTAL): None
- Sodium Chloride (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Nonsense Mutation Patients

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~(i) RDEB patients with a nonsense mutation in COL7A1 in either one or two alleles (ii) An absence or decrease in C7 expression at their DEJ when compared to that of normal human skin.~Exclusion Criteria:~(i) Pre-existing renal or auditory impairment (ii) Allergies to aminoglycosides or sulfate compounds (iii) Pregnancy (iv) Exposure to gentamicin within the past 6 weeks.

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

Study Arms:
- Gentamicin (Type: EXPERIMENTAL): Gentamicin antibiotic
- Placebo (Type: PLACEBO_COMPARATOR): Vehicle control

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

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:~* Male and female patients that have signed informed consent and are \>/= 40 years of age.~* Patients with stable COPD according to GOLD 2011.~* Patients with a post-bronchodilator FEV1 of \>/= 30% and \< 80% predicted and a post-bronchodilator FEV1/FVC \<0.70.~* Current or ex-smokers who have a smoking history of at least 10 pack years.~* Patients with an mMRC grade 2 or greater.~Exclusion Criteria:~* Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)~* Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)~* Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.~* Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.~* Patients who had a COPD exacerbation within 6 weeks prior to screening.~* Patients who have a respiratory tract infection within 4 weeks prior to screening.~* Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.~* Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.~* Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.~* Patients with concomitant pulmonary disease.~* Patients with a diagnosis of alpha-1 anti-trypsin deficiency.~* Patients with active pulmonary tuberculosis.~* Patients in the active phase of a pulmonary rehabilitation programme.~* Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- QVA149 (Type: EXPERIMENTAL): 27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
- QAB149 (Type: ACTIVE_COMPARATOR): 27.5 ug b.i.d.
- NVA237 (Type: ACTIVE_COMPARATOR): 12.5 ug b.i.d.
- Placebo (Type: PLACEBO_COMPARATOR): b.i.d

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Fish Oil-derived N-3 Polyunsaturated Fatty Acids and Extracellular Vesicles

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

Eligibility Criteria:
Inclusion Criteria:~* Aged 40-70 years~* Non-smoker~* At moderate risk of cardiovascular diseases~  * The risk will be evaluated by an online calculator called QRISK2. This online calculator (https://qrisk.org/2016/), which use traditional risk factors (age, systolic blood pressure, smoking status and ratio of total serum cholesterol to high-density lipoprotein cholesterol) together with body mass index, ethnicity, measures of deprivation, family history, will provide a percentage of risk of having a heart attack or stroke within the next 10 years.~ * Subjects with 10%-20% will be regarded as being at moderate risk~Exclusion Criteria:~* BMI: \<18.5 kg/m2~* Anaemia (haemoglobin concentration \<12.5 g/L in men and\<11.5 g/L in women)~* Hyperlipidaemia (total cholesterol concentration \>8 mmol/L)~* Diabetes (diagnosed or fasting glucose concentration \>7 mmol/L) or other endocrine disorders~* Angina, stroke, or any vascular disease in the past 12 months~* Renal, gastrointestinal, respiratory, liver or bowel disease~* Inflammatory disease~* Take drug treatment for hypertension, hyperlipidaemia, inflammation, depression or thyropathy.~* Take aspirin, ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) \> 4 times per month, or once in the week preceding the study~* Take any other anti-platelet or anti-coagulant drugs, like triflusal, clopidogrel and warfarin.~* Have allergies~* Smoking (including e-cigarettes and nicotine products)~* Alcohol misuse or intakes \>21 units/wk for men and \>15 units/wk for women or have a history of alcohol misuse~* Regularly consume oily fish and/or dietary supplements~* Planning to start or on a weight reducing regimen~* Intense aerobic exercise (\>20 min, three times a week)~* Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)~* Have participated in another clinical trial within the last three months

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- Intervention (Type: ACTIVE_COMPARATOR): Fish oil capsules
- Placebo (Type: PLACEBO_COMPARATOR): High-oleic safflower oil capsules

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel

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

Eligibility Criteria:
* INCLUSION CRITERIA:~Volunteers who are healthy 1-4 year old children whose parents/guardians have read the Information Sheet provided by the Principal Investigator and signed the consent form, and who will be available for follow up.~EXCLUSION CRITERIA: Children with~* chronic diseases receiving medication;~* who have received systemic steroids during the month preceding Shigella vaccination;~* who had severe side effects following vaccinations; and~* those not available for follow up.

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 4 Years
- Healthy Volunteers: f

Study Arms:
- S. sonnei conjugate vaccine (Type: EXPERIMENTAL): Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa
- S. flexneri 2a conjugate vaccine (Type: EXPERIMENTAL): Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of pseudomonas aeruginosa

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

Answer: outcome: complete