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

Trial Title: Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide

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

Eligibility Criteria:
Inclusion Criteria:~* Age: 0-21 years at the time of diagnosis.~* Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma.~* Disease Status: Refractory or relapsed neuroblastoma~* Measurable disease, including at least one of the following:~Measurable tumor \>10mm by CT or MRI A positive MIBG and abnormal urinary catecholamine levels Positive bone marrow biopsy/aspirate.~* Current disease state must be one for which there is currently no known curative therapy.~* A negative urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).~* Patients without bone marrow metastases must have an ANC \> 500/μl and platelet count \>50,000/μl~* Organ Function Requirements Subjects must have adequate liver function as defined by AST or ALT \<10x normal Serum bilirubin must be ≤ 2.0 mg/dl Serum creatinine must be ≥ 1.5 mg/dl~* Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines~Exclusion Criteria:~* Life expectancy \<2 months or Lansky score \<30%~* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.~* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects)~* Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.~* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.

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

Study Arms:
- DFMO and Etoposide (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: Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

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:~* Chronic stroke (\>6 months after initial stroke)~* Age 40-80~* Stable neurologic deficits~* Able to walk with an assistive device~* Language skills to understand the training program safely~Exclusion Criteria:~* No anticoagulation or medical conditions that preclude exercise.~* No dementias or depression

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Velocity based treadmill training (Type: EXPERIMENTAL): 6 month of progressive treadmill walking with treadmill speed gradually progressed to meet the training heart rate goals for moderate intensity aerobic exercise, when hemiparetic gait velocity can no longer be safely progressed, incline is added to achieve the heart rate training goals.
- Duration based treadmill training (Type: EXPERIMENTAL): 6 month of progressive treadmill walking with duration is gradually progressed to meet the endurance goals for low aerobic intensity exercise, gait velocity and incline do not progress.

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 Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

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

Eligibility Criteria:
Inclusion Criteria:~* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria).~* Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.~Exclusion Criteria:~* Evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.~* Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).~Other protocol-defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: 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: The Fibrin Pad CV Phase III Study

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and \<20 years of age will require consent by the subject's legal representative~* Subjects must be willing to participate in the study and provide written informed consent.~* Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;~Exclusion Criteria:~* Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;~* Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.~* Female subjects who are pregnant or nursing.~* TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;~* TBS with major arterial bleeding requiring suture or mechanical ligation;~* TBS involves an expanded polytetrafluoroethylene (ePTFE) graft~* TBS within an actively infected field;~* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;~* Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

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

Study Arms:
- EVARREST™ Fibrin Sealant Patch (Type: EXPERIMENTAL): EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
- Topical hemostat (Type: ACTIVE_COMPARATOR): Equine collagen with Human Fibrinogen and Human Thrombin

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: Learn to Quit-HIV Pilot Study

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:~* HIV-positive~* Currently engaged with an HIV care provider~* Self-report smoking 5 cigarettes or more per day during the past 30 days~* Age 18 years or older~* Current interest in quitting smoking~* Currently own a functioning Android or Apple smartphone~Exclusion Criteria:~* No desire to quit smoking~* Inability to attend study sessions~* Inability to provide informed consent~* Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigators and/or Study Physician~* Presence of contraindications for nicotine patch~* Previous allergic reaction or hypersensitivity to nicotine patch (lifetime)~* Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion, varenicline)~* Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study~* Current untreated and unstable diagnosis of alcohol/substance abuse or dependence (eligible if past abuse/dependence and if receiving treatment and stable for \>30 days)

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

Study Arms:
- Learn to Quit-HIV (Type: EXPERIMENTAL): A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
- QuitGuide (Type: ACTIVE_COMPARATOR): A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.

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: Triggering of Follicular Maturation

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

Eligibility Criteria:
Inclusion Criteria:~1. Infertile couples wishing to do intracytoplasmic injection trial .~2. first intracytoplasmic injection trial~3. Body mass index:18-30.~5-Antral follicular count: more than 5 follicles in one ovary 6-normal, mild or moderate male factor infertility. 7- Antimullerian hormone \>1 ng/ml~Exclusion Criteria:~1. Azoospermic male.~2. Body mass index more than 29.~3. Patients with endometriosis .~4. Antimullerian hormone \< 1 ng/ml

- Gender: FEMALE
- Minimum Age: 20 Years
- Maximum Age: 40 Years
- Healthy Volunteers: f

Study Arms:
- Human chorionic gonadotrophin group (Type: EXPERIMENTAL): Patients will receive Human chorionic gonadotrohpin injection 5000 unit
- Human chorionic gonadotrophin + agonist group (Type: ACTIVE_COMPARATOR): patients will receive both Human chorionic gonadotrophin (2500 unit) and gonadotrophin releasing hormone agonist 1mg leuprolide acetate

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: Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent/assent~* General good health~* Diagnosis of asthma as defined by the National Institutes of Health (NIH)~* A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV)~* Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the SV.~* Other inclusion criteria apply~Exclusion Criteria:~* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.~* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the SV.~* Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.~* Taking long-acting β-agonists within 2 weeks of the SV~* Other exclusion criteria apply.

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

Study Arms:
- FS MDPI 100/6.25 mcg (Type: EXPERIMENTAL): Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
- FS MDPI 100/12.5mcg (Type: EXPERIMENTAL): Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
- FS MDPI 100/25 (Type: EXPERIMENTAL): Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
- FS MDPI 100/50 (Type: EXPERIMENTAL): Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
- Fp MDPI 100 mcg (Type: ACTIVE_COMPARATOR): Subjects inhaled a single dose of 100 mcg fluticasone propionate.
- Advair Diskus 100/50 mcg (Type: ACTIVE_COMPARATOR): Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.

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 Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

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:~* Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.~* Each participant must be willing and able to provide written informed consent.~* Each participant must have an identified external contact person or an identified responsible person.~* Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\^TM\] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview \[MINI\]) at Screening.~* Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.~Exclusion criteria:~* Uncontrolled, unstable clinically significant medical condition.~* Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.~* Current primary Axis I disorder other than bipolar 1 disorder.~* Meets the current DSM-IV-TR\^TM criteria for substance abuse or dependence (excluding nicotine).~* Imminent risk of self-harm or harm to others.

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

Study Arms:
- Asenapine (Type: EXPERIMENTAL): All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks.
- Placebo (Type: PLACEBO_COMPARATOR): All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 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: Lay Health Worker Engage, Educate, and Encourage Patients to Share

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

Eligibility Criteria:
Inclusion Criteria:~1. Newly diagnosed patients with a cancer diagnosis.~2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.~3. The patients must be 18 years or older.~4. Patients must have the capacity to verbally consent.~Exclusion Criteria:~1. Inability to consent to the study due to lack of capacity as documented by the referring physician.~2. Patients without a newly diagnosed malignancy or patients without relapse of disease.~3. Patients not eligible for Fund benefits.~Patients without a newly diagnosed malignancy or patients without relapse of disease.

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

Study Arms:
- Intervention Group Arm (Type: EXPERIMENTAL): Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice).~The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.
- Control Group Arm (Type: ACTIVE_COMPARATOR): The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.

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: Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair~* Refractory to or relapsed after at least 1 prior treatment regimen~* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2~Exclusion Criteria:~* Any major surgery, chemotherapy or immunotherapy within the last 21 days~* Known hepatitis B virus, hepatitis C virus or HIV infection~* Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months~* Primary central nervous system lymphoma or known intracranial involvement

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

Study Arms:
- Ublituximab + TGR-1202 (Type: EXPERIMENTAL): Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
- Ublituximab + TGR-1202 + ibrutinib (Type: EXPERIMENTAL): Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
- Ublituximab + TGR-1202 + bendamustine (Type: EXPERIMENTAL): Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 \& 2

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: The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18 years or over~* Diagnosis = ITP + platelet count above or equal to 25 Mia/l or platelet count above or equal to 50 Mia/l and bleeding from the mucous membranes.~* Adequate contraceptive measures within the last 3 months for women of childbearing potential.~Exclusion Criteria:~* Performance status above or equal to 2~* Previous treatment with rituximab~* Immunosuppressive treatment within the last month except for not previously treated patients~* Other serious disease~* Pregnant women and nursing mothers~* Contraindication for rituximab treatment.~* Active infection requiring antibiotic treatment.

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Combination therapy with Dexamethasone and Rituximab
- 2 (Type: ACTIVE_COMPARATOR): Dexamethasone as monotherapy

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

Answer: outcome: complete