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

Trial Title: MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin

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:~* Diagnosis of type 2 diabetes mellitus~* Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive)~* Current therapy with ACEi or ARB at stable dose for 10 weeks~* Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening.~* Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min.~* Age between 18 and 80 years.~Exclusion criteria:~* Dual or triple blockade of the Renin Angiotensin System (RAS)~* Uncontrolled hyperglycaemia~* Mean arterial blood pressure \> 110 mmHg~* Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).~* Treatment with a glitazone within 6 months prior to informed consent.~* Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent.~* Treatment with anti-obesity drugs 10 weeks prior to informed consent.~* Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.~* Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.~* Participation in another trial with an investigational drug within 2 months prior to informed consent.

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

Study Arms:
- linagliptin 5mg (Type: EXPERIMENTAL): linagliptin 5 mg once daily
- placebo (Type: PLACEBO_COMPARATOR): matching placebo for linagliptin dose 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: Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Currently undergoing cervical, thoracic, or lumbar discectomy; corpectomy, laminectomy, lateral or interbody fusion, including both anterior and posterior approaches (not including minimally invasive procedures; arterial reconstruction; peripheral artery bypass (PAB) grafting; or arteriovenous (AV) vascular access procedures~* History of surgery with high likelihood of exposure to bovine thrombin within the past 3 years. Prior surgery must have been 1 of the following open procedures: open procedures involving the spine or cranium, PAB grafting, AV vascular access procedures, autologous skin grafting, or other surgical procedure accompanied by documented treatment with bovine thrombin~* Age of 18 years or younger at time of informed consent~* If female and of child-bearing potential: Negative pregnancy test result within 14 days prior to treatment~* Use of a medically accepted form of contraception from the time of informed consent to completion of all follow-up study visits, if sexually active male or a sexually active female of childbearing potential~* Signed IRB/independent ethics committee-approved informed consent document~Exclusion Criteria:~* Currently undergoing procedures requiring cardiopulmonary bypass or involving the aortic arch~* Known hypersensitivity to rThrombin or any of its components~* Presence of medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures~* Breastfeeding~* Receipt of treatment with any experimental agent within 30 days of study enrollment or treatment

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

Study Arms:
- 1 (Type: EXPERIMENTAL): rThrombin

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 Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Key Inclusion Criteria:~* Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening.~* Female participants of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.~Key Exclusion Criteria:~* Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or hepatitis B virus (test for hepatitis B surface antigen \[HBsAg\] and hepatitis B core antibody \[HBcAb\])~* Known history of chronic fatigue syndrome or fibromyalgia~* Within one month, flu-like illnesses (e.g., gastroenteritis, upper respiratory infection, common cold)~* History of severe allergic reactions to any drug or anaphylactic reactions~* Known allergy to Avonex or any of its components~* Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to Screening or active bacterial or viral infection~* History of alcohol or substance abuse (as defined by the Investigator)~* Female participants who are pregnant or currently breastfeeding~* Any previous treatment with any interferon product.10. Vaccinations within 2 weeks or 5 half-lives, whichever is longer, prior to Day 1~* Blood donation within 30 days prior to Screening~* Use of any tobacco product more than 5 times within 30 days prior to Screening~NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Arms:
- Group 1 (Type: EXPERIMENTAL): No dose titration
- Group 2 (Type: EXPERIMENTAL): Fast dose titration
- Group 3 (Type: EXPERIMENTAL): Slow dose titration

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: Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

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:~* Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)~  * Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD~ * Partial Mayo score of 2 - 7 for participants with UC~* Patient should be appropriate candidate for biologic therapy per guidelines~* Up-to-date on cancer screening~* No severe systemic disease~* Patients with evidence of abscess~* Agree to comply with study procedures including contraception~Exclusion Criteria:~* Low lymphocyte counts~* History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other neurological illness~* Active or recent serious infections~* Recent treatment with biologic (i.e., Remicade) or investigational drug~* Impending surgery~* Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion

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

Study Arms:
- Vedolizumab 2 mg/kg (Type: EXPERIMENTAL): Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.
- Vedolizumab 6 mg/kg (Type: EXPERIMENTAL): Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 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: suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19

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:~1. Age equal to or above 18 years~2. Male or female gender~3. In case of women, unwillingness to remain pregnant during the study period.~4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member State where the trial is planned.~5. Confirmed infection by SARS-CoV-2 virus~6. Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection~7. Need for hospitalization for COVID-19. The need for hospitalization is defined by the attending physician taking into consideration clinical presentation, requirement for supportive care, potential risk factors for severe disease, and conditions at home, including the presence of vulnerable persons in the household.~8. Plasma suPAR ≥6ng/ml~Exclusion Criteria:~* Age below 18 years~* Denial for written informed consent~* Any stage IV malignancy~* Any do not resuscitate decision~* Αny pO2/FiO2 (partial oxygen pressure to fraction of inspired oxygen) ratio less than 150 mmHg irrespective if the patient is under mechanical ventilation (MV) / non-invasive ventilation (NIV) / extracorporeal membrane oxygenation (ECMO) or not~* Patient under MV or NIV or ECMO~* Any primary immunodeficiency~* Less than 1,500 neutrophils/mm3~* Plasma suPAR less than 6 ng/ml~* Known hypersensitivity to anakinra~* Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days.~* Any anti-cytokine biological treatment the last one month~* Severe hepatic failure defined as Child-Pugh stage of 3~* End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis~* Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study~* Participation in any other interventional trial

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Patients receiving standard-of-care (SOC) and placebo. Placebo is injected subcutaneously once daily for 10 days
- Anakinra (Type: EXPERIMENTAL): Patients receiving SOC and anakinra. Anakinra is injected subcutaneously as 100 mg once daily for 10 days

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: Repeated Application of Gene Therapy in CF Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Cystic fibrosis confirmed by sweat testing or genetic analysis~2. Males and females aged 12 years and above~3. Forced expiratory volume in the 1st second (FEV1) between 50 \& 90% predicted inclusive (Stanojevic reference equations).~4. Clinical stability at screening defined by:~   1. Not on any additional antibiotics (excluding routine, long-term treatments) for the previous 2 weeks~  2. No increase in symptoms such as change in sputum production/colour, increased wheeze or breathlessness over the previous 2 weeks~  3. No change in regular respiratory treatments over the previous 4 weeks~  4. If any of these apply, entry into the study can be deferred~5. Prepared to take effective contraceptive precautions for the duration of their participation in the study and for 3 months thereafter (as stated in GTAC guidelines)~6. If taking regular rhDNase (pulmozyme) is willing, and considered able by independent medical carers, to withhold treatment for 24 hours before and 24 hours after the gene therapy dose (nebulised doses only)~7. Written informed consent obtained~8. Permission to inform their general practitioner of participation in study~Exclusion Criteria:~1. Infection with Burkholderia cepacia complex organisms, MRSA or M. abscessus~2. Significant nasal pathology including polyps, clinically-significant rhinosinusitis, or recurrent severe epistaxis (nose bleeds) (nasal cohort only)~3. Chloride secretory response on nasal PD of \> 5 mV (nasal cohort only; will only be known after first measurement)~4. Acute upper respiratory tract infection within the last 2 weeks (entry can be deferred)~5. Previous spontaneous pneumothorax without pleurodesis (bronchoscopic subgroup only)~6. Recurrent severe haemoptysis (bronchoscopic subgroup only)~7. Current smoker~8. Significant comorbidity including:~   1. Moderate/severe CF liver disease (varices or significant, sustained elevation of transaminases: ALT/ AST\>100 IU/l)~  2. Significant renal impairment (serum creatinine \> 150 mmol/l)~  3. Significant coagulopathy (bronchoscopic group only)~9. Receiving 2nd line immunosuppressant drugs such as methotrexate, cyclosporine, intravenous immunoglobulin preparations~10. Pregnant or breastfeeding

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- pGM169/GL67A (CFTR Gene/Lipid Vector) (Type: ACTIVE_COMPARATOR): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis

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:~* Adults ( male or female) 18-60 years of age~* Acute, symptomatic, non-severe (minimum Hb.5 gm/dL) VL proven by parasitological examination of splenic or bone marrow aspirate.~* History of fever.~* Living within reachable distance of the trial site to enable attendance for follow-up visits~* Written informed consent to participate~* Proven HIV negative status~* Women of child-bearing potential who are using an assured method of contraception~Exclusion Criteria:~* Signs/symptoms indicative of severe VL ( Hb.\< 5gm/dl, evidence of cardiac failure, etc)~* Patients who have received anti-leishmanial or anti-fungal treatment within the last 45 days~* Patients who have received any investigational (unlicensed) drugs within the last 6 months~* Severe malnutrition BMI\<15 in adults, weight for height less than 60% in children.~* Chronic underlying disease such as severe cardiac, renal, or hepatic impairment.~* Renal function tests (serum creatinine) outside the normal range~* Liver function tests (transaminases) more than three times the upper limit of the normal range at study entry~* Jaundice (bilirubin \>2.0mg/dL)~* Known hepatitis B or C positive~* Platelet count less than 40,000/mm3~* Prothrombin time 5 seconds or greater than normal range~* TotalWBC \< 1,000/mm3~* Known alcohol or other drug abuse~* HIV positive status~* Pregnancy and/or lactation~* Females having unprotected sexual intercourse, or using a non-assured method of contraception (e.g. condom)~* Concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc~* Concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days~* Any other condition which may invalidate the trial~* Known hypersensitivity to AmBisome, Paromomycin, amphotericin B and/or Miltefosine

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): None
- 2 (Type: EXPERIMENTAL): None
- 3 (Type: EXPERIMENTAL): None
- 4 (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: A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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:~* Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening~* Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL~* Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening~* Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product~Exclusion Criteria:~* Have been treated previously with any biological agents including any tumour necrosis factor inhibitor~* Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4~* Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus~* Have a current diagnosis of active tuberculosis~* Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.~* Have any of the following conditions~  1. Other inflammatory or rheumatic diseases.~ 2. History of any malignancy within the previous 5 years prior to Screening~ 3. History of lymphoproliferative disease including lymphoma.~ 4. History of congestive heart failure~ 5. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).~ 6. History of demyelinating disorders.

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

Study Arms:
- SB4 (proposed biosimilar to etanercept) (Type: EXPERIMENTAL): SB4 50 mg/week via subcutaneous injection
- Enbrel (etanercept) (Type: ACTIVE_COMPARATOR): Enbrel 50 mg/week via subcutaneous injection

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 Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

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:~* Histologically or cytologically proven adenocarcinoma of the colon or rectum.~* Metastatic disease that was not amenable to potentially curative treatment.~* Participants with measurable disease.~* One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.~* Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were also eligible.~Exclusion criteria:~* Prior therapy with irinotecan.~* Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration.~* Unresolved toxicity (grade \>1) from prior anticancer therapy.~* Eastern Cooperative Oncology Group (ECOG) performance status \>1.~* Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.~* Other prior malignancy.~* Pregnant or breast-feeding women.~* Uncontrolled hypertension.~* Inadequate bone marrow function, liver function, or renal function.~The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Study Arms:
- Aflibercept + FOLFIRI (Type: EXPERIMENTAL): Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m\^2 (2 hours) and irinotecan 180 mg/m\^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m\^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m\^2.

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

Answer: outcome: complete