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

Trial Title: NSAIDs in Sciatica NSAIDS IN SCIATICA

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:~* Age ≥ 18 years~* Radiating pain below the knee with a severity score of ≥4 on a 0-10 (NRS) in the previous 24 hours~* Signs of nerve root/spinal nerve involvement as indicated by at least one of the following features; myotomal weakness, dermatomal sensory disturbances (e.g. sensory loss, self-reported tingling/numbness), diminished reflexes, radiating pain exacerbation by SLR~Exclusion criteria:~* Not able to read or speak Norwegian.~* Unlikely to adhere to treatment and/ or complete follow-up (e.g ongoing serious psychiatric disease, drug abuse, plans to move)~* Sciatica of known cause other than disc herniation or degenerative stenosis.~* Neurogenic claudication, i.e. pain in the legs on walking or standing that resolves with sitting down or lumbar flexion.~* Symptoms indicating immediate surgery: cauda equina syndrome or a progressive large paresis.~* Women who attempt to conceive, are pregnant or breastfeeding.~* Previous episodes of asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs.~* Active or history of peptic ulceration, gastrointestinal bleeding, or perforation.~* Use of drugs known to increase upper gastrointestinal adverse events in combination with Naproxen: anticoagulants, aspirin (acetyl salicylic acid), serotonin reuptake inhibitors and systemic corticosteroids.~* Hepatic enzyme (ASAT/ALAT) values above 1,5 x upper limit of normal (ULN)~* Renal function tests (creatinin/eGFR) outside normal range~* Congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.~* Known hypersensitivity to Naproxen or any of the excipients (lactose, maize starch, povidone, sodium starch glycolate, talcum, magnesium stearate, polysorbate 80)~* Ongoing treatment with aspirin, systemic corticosteroids, diuretics, ACE-inhibitors, lithium and anticoagulants~* Scheduled for spinal surgery prior to end of study~* Reservation against intake of gelatine (the capsules contains gelatine, which among other things is produced by ingredients from pigs)

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

Study Arms:
- Naproxen (Type: EXPERIMENTAL): Naproxen 500 mg twice daily
- Placebo (Type: PLACEBO_COMPARATOR): Placebo 1 tablet twice 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 of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

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:~* patients with moderate to severe plaque type psoriasis for at least 6 months before randomization~* patients eligible for systemic therapy with inadequately controlled psoriasis~Exclusion Criteria:~* forms of sporiasis other than plaque type psoriasis~* previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- AIN457 300 mg (Type: EXPERIMENTAL): patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
- Ustekinumab (Type: ACTIVE_COMPARATOR): patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive

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: Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

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

Eligibility Criteria:
Inclusion Criteria:~1. Must have provided written informed consent~2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:~   * History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)~  * Positive Anti-Mitochondrial Antibodies (AMA) titers (\> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies~  * Liver biopsy consistent with PBC~3. ALP \>= 1.67x upper limit of normal (ULN)~4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit~5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.~Exclusion Criteria:~1. History or presence of other concomitant liver diseases~2. Screening creatine phosphokinase (CPK) \> upper limits of normal (ULN)~3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) \> 5 ULN~4. Screening total bilirubin \> 2 ULN~5. Screening serum creatinine \> 1.5 mg/dl~6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate \[eGFR\] of less than 60 mL/min/1.73 m\^2).~7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)~8. Platelet count \<150 X 10\^3/microliter~9. Albumin \<3.5 g/dL~10. Presence of clinical complications of PBC or clinically significant hepatic decompensation~11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating~12. Known history of human immunodeficiency virus (HIV) infection~13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
- Elafibranor 80 mg (Type: ACTIVE_COMPARATOR): Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
- Elafibranor 120 mg (Type: ACTIVE_COMPARATOR): Study subjects will take two tablets per day orally before breakfast with a glass of water each morning

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: Study of FYU-981 in Hyperuricemia With or Without Gout

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Hyperuricemic or gout patients~* Serum urate level:~\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL~Exclusion Criteria:~* Gouty arthritis within two weeks before start of study treatment~* Secondary hyperuricemia~* HbA1c: \>= 8.4%~* Uric acid-overproduction type in the classification of hyperuricemia~* History of, clinically significant cardiac, hematologic and hepatic disease~* Kidney calculi or clinically significant urinary calculi~* eGFR: \< 30mL/min/1.73m\^2~* Systolic blood pressure: \>= 180 mmHg~* Diastolic blood pressure: \>= 110 mmHg

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

Study Arms:
- FYU-981 High dose (Type: ACTIVE_COMPARATOR): Drug: FYU-981 High dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
- FYU-981 High middle dose (Type: ACTIVE_COMPARATOR): Drug: FYU-981 High middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High middle dose arm receive active drug, FYU-981 High middle dose.
- FYU-981 Middle dose (Type: ACTIVE_COMPARATOR): FYU-981 Middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
- FYU-981 Low dose (Type: ACTIVE_COMPARATOR): Drug: FYU-981 Low dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
- Placebo (Type: PLACEBO_COMPARATOR): Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.

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: Transdermal Insulin Response In Healthy Volunteers

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

Eligibility Criteria:
Inclusion Criteria:~1. The subject has a serum protein HbA1c of less than 6.~2. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.~3. The subject has a body mass index (BMI) within 18-50 kg/m2.~4. The subject is in otherwise good health as determined by medical history and physical examination.~5. The subject is a non-smoker.~6. The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose for the pharmacokinetic assessments.~7. The subject is willing and able to comply with all testing and requirements defined in the protocol.~8. The subject is willing and able to return to the study site for all visits.~Exclusion Criteria:~1. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.~2. The subject has had a clinically significant illness within 30 days preceding entry into this study.~3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.~4. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.~5. The subject has used any prescription medication that may interfere with the evaluation of study medication.~6. The subject has donated or lost a significant volume of blood (\>450 mL) within four (4) weeks of the study, and their Haemoglobin concentration and haematocrit have not returned to within 5% of normal.~7. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.~8. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).~9. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry

- Gender: MALE
- Minimum Age: 20 Years
- Maximum Age: 60 Years
- Healthy Volunteers: t

Study Arms:
- Main Experimental (Type: EXPERIMENTAL): Each subject will receive doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight

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: VQI DELTA Paclitaxel Device Safety Analysis

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:~* All patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic Peripheral Artery Disease.~Exclusion Criteria:~* In an effort to focus this safety evaluation on those patients being treated in accordance with accepted 'best practice' endovascular intervention strategies and 'on-label' use of devices, patients will be excluded from either exposure cases or controls if they received a balloon expandable stent or a balloon expandable stent graft in the treatment of femoral or popliteal disease. Balloon expandable stents were excluded because these stents have historically shown inferior patency and current best practice favors placement of self-expanding nitinol stents which were engineered for the femoral popliteal segment and tested in multiple trials for this indication 12-14.~Additionally, patients will be excluded (as either potential cases or controls) if their index procedure was performed for acute limb ischemia due to the different etiologies (embolism, in-situ thrombosis) as compared with chronic conditions as they have different treatment paradigms and higher major amputation and mortality rates.~In addition, patients with prior angioplasty or stenting of the superficial femoral artery (SFA)-popliteal segment will be excluded in order to avoid the possibility of improperly assigning paclitaxel exposure to the control group.

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

Study Arms:
- Uncoated Balloon Treatment (Type: None): Patients treated for PAD with balloon angioplasty, without use of stent.
- Bare Metal Stent Treatment (Type: None): Patients treated for PAD with implantation of bare metal stent.
- Paclitaxel Coated Balloon (Type: None): Patients treated for PAD with drug coated balloon angioplasty, without use of stent.
- Paclitaxel Eluting Stent (Type: None): Patients treated for PAD with implantation of Paclitaxel DES.

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: Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy

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

Eligibility Criteria:
Inclusion Criteria:~1. congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) \<= 50%;~2. moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;~3. patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.~Exclusion Criteria:~1. hemodialysis-dependent patients;~2. complicated with severe short-term progressive disease;~3. Patients \< 18 years;~4. pregnancy;~5. emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);~6. exposure to radiographic contrast media within the previous 7 days;~7. acute decompensated heart failure.

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

Study Arms:
- CVP guided hydration (Type: EXPERIMENTAL): The fluid rate was adjusted according to the CVP dynamically
- Control (Type: ACTIVE_COMPARATOR): The control group was hydrated at 1 mL/kg per h.

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: ELITE: Early Versus Late Intervention Trial With Estradiol

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

Eligibility Criteria:
Inclusion Criteria:~* Women with a serum estradiol level 25 pg/ml or less~* No period for 6 months or more~* Postmenopausal less than 6 years, OR 10 years or longer~Exclusion Criteria:~* Clinical signs, symptoms, or personal history of cardiovascular disease~* Women who have had a hysterectomy only and no oophorectomy (since time from menopause cannot be determined)~* Diabetes mellitus or fasting serum glucose 140 mg/dL or greater~* Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater)~* Thyroid disease (untreated)~* Serum creatinine greater than 2.0 mg/dL~* Plasma triglyceride levels greater than 500 mg/dL~* Life threatening disease with prognosis less than 5 years~* Cirrhosis or liver disease~* History of deep vein thrombosis or pulmonary embolism~* History of breast cancer~* Current hormone replacement therapy (HRT)

- Gender: FEMALE
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- 17B-estradiol (Type: ACTIVE_COMPARATOR): Oral 17B-estradiol 1 mg daily
- Placebo (Type: PLACEBO_COMPARATOR): Matching oral 17B-estradiol placebo 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: Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* BMI of 18 - 29.9 kg/m2~* have not used tobacco or nicotine containing products for at least 3 months prior to dosing~* be able to remain abstinent throughout the study.~Exclusion Criteria:~* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.~* positive urine drug/alcohol testing~* Positive for HIV, HBsAg, HCV ab~* History of anaphylactic reaction to medicine or environmental exposure

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): 1.1 mcg/kg of HM10460A, placebo, or Neulasta
- Cohort 2 (Type: EXPERIMENTAL): 3.3 mcg/kg HM10460A, placebo or Neulasta
- Cohort 3 (Type: EXPERIMENTAL): 10 mcg/kg of HM10460A, placebo, or Neulasta
- Cohort 4 (Type: EXPERIMENTAL): 30 mcg/kg of HM10460A, placebo, or Neulasta
- Cohort 5 (Type: EXPERIMENTAL): 90 mcg/kg or HM10460A, placebo, or Neulasta
- Cohort 6 (Type: EXPERIMENTAL): 270 mcg/kg of HM10460A, placebo, or Neulasta

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 and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy

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 for Step 1 Participants:~* HIV infected~* Continuous treatment with a three-drug, NNRTI-containing regimen for at least 6 months prior to study entry~* Viral load of 1,000 copies/ml or greater and less or equal to 200,000 copies/ml obtained within 30 days of study entry~* Negative pregnancy test within 48 hours of study entry~* Willing to use acceptable forms of contraception for the duration of the study~* Laboratory values obtained within 30 days of study entry:~  * Hemoglobin greater or equal to 8.0 g/dL~ * Platelet count greater or equal to 50,000/mm3~ * Estimated Creatinine Clearance greater or equal to 60 mL/min x ULN~ * AST (SGOT), ALT (SGPT) and alkaline phosphatase \< 3 x ULN~ * Total bilirubin less or equal to 2.5 x ULN~* Ability and willingness of participant or legal guardian/representative to give informed consent~Inclusion Criteria for Step 2 Participants:~* Virologic failure on LPV/r monotherapy defined as viral load of 400 copies/ml or greater after 24 consecutive weeks on LPV/r monotherapy OR virologic failure after initial viral suppression on LPV/r monotherapy~* Estimated creatinine clearance of 60 ml/min or greater~* Negative pregnancy test within 48 hours of entry into Step 2~* Willing to use acceptable forms of contraception for the duration of the study~Exclusion Criteria for All Participants:~* Breastfeeding~* Known allergy or sensitivity to study drugs~* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence to study requirements~* History of chronic hepatitis B infection~Exclusion Criteria for Step I Participants:~* Prior use of any protease inhibitor treatment~* Acute therapy for any serious medical condition within 14 days of study entry. For ongoing or chronic therapy, the participant must be on the treatment regimen for at least 14 days, and clinically stable prior to entry. If a potential participant has TB and has received treatment for more than 2 weeks, the TB treatment would have to be modified to include a rifabutin-containing regimen. TB compatible syndromes will also be carefully evaluated prior to entry.~Exclusion Criteria for Step 2 Participants:~- Active opportunistic infection, including tuberculosis (TB)

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

Study Arms:
- LPV/r monotherapy (Type: EXPERIMENTAL): Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.

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: Innovation in Pulmonary Rehabilitation

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

Eligibility Criteria:
Inclusion Criteria:~* 40 years of age~* FEV1 70%~* FEV1/FVC \<70%~* RV/TLC \> 120%~Exclusion Criteria:~* Respiratory infection/exacerbation within last 4 weeks~* Exercise limiting heart disease~* Primary asthma~* Congestive heart failure New York Heart Association (NYHA) Class III-IV~* Exercise limiting peripheral arterial disease or arthritis~* Inability to walk on a treadmill

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

Study Arms:
- Breathing retraining (Type: EXPERIMENTAL): Exercise training with computerized training program
- Heliox (Type: EXPERIMENTAL): Exercise training with helium oxygen combination
- Exercise (Type: ACTIVE_COMPARATOR): Exercise training

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

Answer: outcome: complete