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

Trial Title: Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Participant's parent or legal guardian provided written informed consent/permission prior to any study procedures.~* Male or female child with documented decreased LAL activity relative to the normal range of the laboratory performing the assay or documented result of molecular genetic testing (2 mutations) confirming a diagnosis.~* Growth failure with onset before 6 months of age.~Exclusion Criteria:~* Clinically important concurrent disease or comorbidities.~* Had received an investigational product other than sebelipase alfa within 14 days prior to the first dose.~* Participant was older than 24 months of age.~* Myeloablative preparation, or other systemic pre-transplant conditioning, for hematopoietic stem cell or liver transplant.~* Previous hematopoietic stem cell or liver transplant.~* Known hypersensitivity to eggs.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 24 Months
- Healthy Volunteers: f

Study Arms:
- Open-Label Sebelipase Alfa (Type: EXPERIMENTAL): Participants received intravenous (IV) infusions of sebelipase alfa during the open-label treatment. Participants initially received 0.35 milligrams (mg)/kilogram (kg) qw and escalated to 1 mg/kg qw after demonstrating acceptable safety and tolerability during at least 2 infusions. One participant initiated treatment under a Temporary Use Authorization prior to enrollment, wherein the participant's dose was gradually escalated from 0.2 to 1 mg/kg over 4 weeks; the participant started the study at this dose. Participants on treatment for 96 weeks and on stable qw dosing for 24 weeks could be switched to an every other week (qow) dosing schedule. In the event of protocol-defined disease progression at any time during treatment, a participant could receive a dose increase from 1 to 3 mg/kg qw and, if necessary, a dose increase to 5 mg/kg qw with Safety Committee approval. Participants dosed qow who met dose-escalation criteria were reverted to qw dosing or escalated to 1 or 3 mg/kg qow.

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: Thyroid Hormone Dose Adjustment in Pregnancy

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

Eligibility Criteria:
Inclusion Criteria:~* women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy~* less than 8 weeks pregnant~Exclusion Criteria:~* cardiac disease, renal failure~* not euthyroid biochemically within 6 months pre-pregnancy

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

Study Arms:
- 2 tablet increase (Type: ACTIVE_COMPARATOR): Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)
- 3 tablet increase (Type: ACTIVE_COMPARATOR): Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).

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: Hepcidine and Iron Deficiency in Critically Ill Patients

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

Eligibility Criteria:
Inclusion Criteria:~1. Hospitalized man/woman in reanimation unit for at least 5 days.~2. Age ≥ 18 years old.~3. Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin \< 13 g/dl, for woman: Hemoglobin \< 12 g/dl).~4. Signed inform consent by the patient or a close person.~5. Subject affiliated to a national health insurance~Exclusion Criteria:~1. Known iron metabolism pathology (such as primitive or secondary hemochromatosis, ...).~2. Chronic anaemia (Hemoglobin ≤ 10 g/dl for more than 3 months).~3. Current chemotherapy.~4. Patient having an organ transplant~5. Expected survival \< 28 days post Intensive Care Unit discharge.~6. Pregnancy~7. Patient deprived of freedom, by judicial or administrative order.~8. Major protected by the law.~9. Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy \< 48 hours) untreated).~10. Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma....).

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

Study Arms:
- Dosage of hepcidin (Type: EXPERIMENTAL): In order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry
- Usual biomarker dosage (Type: ACTIVE_COMPARATOR): In order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation)

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: LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

Study Design Characteristics:
- Allocation: 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:~1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.~2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.~3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1~4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.~5. Age \>= 18 years.~6. Adequate organ function as defined by the following criteria:~Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =\< 3 x upper limit of normal (ULN), or AST and ALT =\<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =\<1.5 x ULN Absolute neutrophil count (ANC) \>=1.5 x 109/L Creatinine clearance \> 45ml / min Platelets \>= 75 x 109/L~Exclusion criteria:~1. Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.~2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.~3. Major surgery within 4 weeks of study randomisation.~4. Active brain metastases~5. Meningeal carcinomatosis.~6. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.~7. Known pre-existing interstitial lung disease.~8. Clinically relevant cardiovascular abnormalities as judged by the investigator.~9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.~10. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.~11. Pregnancy or breast-feeding.~12. Active hepatitis and/or known HIV carrier~13. Any prohibited concomitant medications for therapy with afatinib or gefitinib

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- afatinib (Type: EXPERIMENTAL): afatinib once daily.
- gefitinib (Type: ACTIVE_COMPARATOR): gefitinib 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: A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

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 or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia~* experiencing an acute exacerbation of psychosis~Exclusion Criteria:~* any subject unable to provide informed consent~* any female subject who is pregnant or breast-feeding~* any subject judged to be medically inappropriate for study participation

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

Study Arms:
- 20 mg ITI-007 (Type: EXPERIMENTAL): 20 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
- 60 mg ITI-007 (Type: EXPERIMENTAL): 60 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo administered orally as visually-matched capsules once daily for 6 weeks
- Risperidone (Type: ACTIVE_COMPARATOR): Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 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: Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Metastatic nonseminomatous germ cell tumor of the testis~  * In first relapse following first line treatment with bleomycin, etoposide, and cisplatin~ * Biopsy proven germ cell tumor OR~ * Rising tumor markers (alpha fetoprotein and/or human chorionic gonadotropin)~* No brain metastases~PATIENT CHARACTERISTICS:~Age:~* 16 to 64~Performance status:~* 0-2~Life expectancy:~* Not specified~Hematopoietic:~* Not specified~Hepatic:~* Not specified~Renal:~* Glomerular filtration rate greater than 50 mL/min~Other:~* No other prior malignancy except curatively treated nonmelanomatous skin cancer or superficial bladder cancer~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* Not specified~Chemotherapy:~* See Disease Characteristics~Endocrine therapy:~* Not specified~Radiotherapy:~* Not specified~Surgery:~* Not specified~Other:~* No prior experimental drugs

- Gender: MALE
- Minimum Age: 16 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

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 Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

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:~* Written informed consent/assent~* General good health~* Persistent asthma, with an FEV1 50-80% predicted.~* Ability to perform spirometry in an acceptable manner as per protocol guidelines.~* Ability to perform PEFR with a handheld peak flow meter.~* Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.~* Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.~* Non-smokers.~* Capable of understanding the requirements, risks, and benefits of study participation.~* Other inclusion criteria apply.~Exclusion Criteria:~* Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).~* A known hypersensitivity to albuterol or any of the excipients in the formulations.~* History of severe milk protein allergy.~* History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).~* Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.~* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.~* Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).~* Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.~* Other exclusion criteria apply.

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

Study Arms:
- Placebo MDPI (Type: PLACEBO_COMPARATOR): Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
- Albuterol MDPI (Type: EXPERIMENTAL): Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day 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: Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia

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

Eligibility Criteria:
Inclusion Criteria:~* Child age: less than 17 years old.~* Taking oral methotrexate in maintenance therapy.~* Patients are at cycle one day zero.~Exclusion Criteria:~* Child infected by hepatitis B or C viruses.~* Child taking medications or having a condition causing elevation in liver enzymes level other than methotrexate.(eg:thrombosis ,antibiotic therapy, infiltrating malignancy ,auto immune manifestations or having TPN)~* Child remission.~* Child death~* Child drop out due to non compliance

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

Study Arms:
- Intervention arm with Omega 3 FA (Type: ACTIVE_COMPARATOR): included standard risk ALL pediatric patients who were supplemented with oral omega-3 capsule (one capsule / day) .~Omega-3 was supplied as soft gelatin capsules in a dose of 1000 mg of omega-3 fatty acids/day .
- control group (Type: ACTIVE_COMPARATOR): control group, included pediatric patients with standard risk acute lymphoblastic leukemia in maintenance phase day 0 and receiving oral Methotrexate (20 mg / m2) weekly without any supplementation .

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: Phase I-II Study of Vorinostat, Paclitaxel, and Bevacizumab in Metastatic Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* histologically or cytologically confirmed adenocarcinoma of the breast; effective with version 2.2 (1/26/09), only patients with disease that is accessible to biopsy and consent to serial biopsy are eligible~* stage IV disease, locally recurrent inoperable chest wall disease; at least one bidimensional and/or unidimensional, measurable indicator lesion must be present (patients with only non-measurable disease are eligible for the phase I trial only); all sites of disease should be noted and followed~* ECOG performance status =\< 1 (Karnofsky \>= 70%)~* Absolute neutrophil count \>= 1,500/ul~* Platelets \>= 100,000/ul~* Total bilirubin within normal institutional limits~* AST(SGOT)/ALT(SGPT) =\< 2.5 x institutional upper limit of normal~* PTT and either INR or PT \< 1.5 x normal~* Creatinine within normal institutional limits OR creatinine clearance \>= mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal~* Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein should be obtained and the level should be \< 1000 mg for patient enrollment;~* LVEF must be at or above the lower institutional limit of the normal range (on MUGA or Echo obtained within 12 weeks of registration, or within 4 weeks of prior Herceptin)~* Not pregnant/lactating~Exclusion criteria:~* chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study~* may not be receiving any other investigational agents.~* history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in the study (e.g., paclitaxel, bevacizumab, quinolones)~* uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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

Study Arms:
- vorinostat, paclitaxel, bevacizumab (Type: EXPERIMENTAL): Vorinostat BID on days 1-3, 8-10, and 15-17, paclitaxel IV over 1 hour on days 2, 9, and 16, bevacizumab IV over 30-90 minutes on days 2 and 16, repeat every 28 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: Study of AK156 in Primary Osteoporosis Patients

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 diagnosed with primary osteoporosis~* Patients who have vertebral fractures at the time of screening~Exclusion Criteria:~* Patients diagnosed with secondary osteoporosis~* Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: 89 Years
- Healthy Volunteers: f

Study Arms:
- 1. (Type: EXPERIMENTAL): None
- 2. (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: Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

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:~* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months~* Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day~* Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)~* Body Mass Index (BMI) below 45.0 kg/m\^2~Exclusion Criteria:~* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors~* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months~* Known proliferative retinopathy or maculopathy requiring treatment according to the investigator~* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening~* Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

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

Study Arms:
- Lira+Insulin (Type: EXPERIMENTAL): None
- Placebo+Insulin (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: Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Euvolemic or hypervolemic (edematous) based on clinical presentation~* Serum sodium between 115 and 130mEq/L at baseline~Exclusion Criteria:~* Clinical presentation of volume depletion or dehydration

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

Study Arms:
- Regimen 1 Conivaptan QD (Type: EXPERIMENTAL): 20 mg conivaptan once a day
- Regimen 2 Conivaptan BID (Type: EXPERIMENTAL): 20 mg conivaptan two times a day
- Regimen 3 Placebo (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: complete