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

Trial Title: Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* diagnosis of acute myeloid leukemia~* patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed~* expected to be neutropenic for \>9 and \<28 days after enrollment~* women of childbearing potential must have a negative pregnancy test~Exclusion Criteria:~* patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study~* patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months~* patients with fever defined as central body temperature of \> 38°C~* known hypersensitivity to azoles or any component of the study medication~* concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine~* hepatic or severe renal dysfunction~* patients with a medical history of oliguria unresponsive to fluid challenge~* patients with a concomitant medical condition that may be an unacceptable additional risk to the patient should he/she participate in the study~* treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols~* suspected other or additional cause for neutropenia or immunosuppression

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

Study Arms:
- Low dose isavuconazole intravenous solution (Type: EXPERIMENTAL): None
- High dose isavuconazole intravenous solution or oral capsules (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 of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination~* Non pregnant/ non lactating females~Exclusion Criteria:~* Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines~* Vaccination against influenza in the previous 6 months~* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality~* Known history of Guillain-Barré Syndrome;~* Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.~* History of neurological disorders or seizures~* Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder~* Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids~* Administration of immunoglobulins and/or any blood products;~* Participation in a clinical trial or use of an investigational compound;~* Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;~* Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: t

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (Type: OTHER): 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 Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura

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

Eligibility Criteria:
Inclusion Criteria:~* Subject or subject's legally acceptable representative has provided informed consent.~* Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP.~Exclusion Criteria:~* Subject has or previously had any bone marrow stem cell disorder (any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study).~* Subject has any new active malignancy diagnosed since enrollment in the previous romiplostim ITP study.~* Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study.~* Other investigational medications are excluded.~* Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) (with the exception of romiplostim in a previous clinical study).~* Female subject of child bearing potential (defined as having first menses) is not willing to use highly effective contraception during treatment and for 4 weeks after the end of treatment.~* Female subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment.~* Subject has known sensitivity to any of the products to be administered during dosing.~* Subject previously has entered this study (this will depend on the type of study).~* Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.~* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Romiplostim (Type: EXPERIMENTAL): Participants received romiplostim administered by subcutaneous injection once a week. The starting dose of romiplostim was 1 μg/kg; weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of between 50 x 10\^9/L and 200 x 10\^9/L.

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: Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

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

Eligibility Criteria:
Inclusion Criteria:~* Provide written informed consent prior to participation in the study.~* Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff.~* If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care~* Be at least 18, but not more than 80 years of age~* Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA).~* Have the ability to read and understand the study procedures and the use of the pain scales. Must have the ability to communicate meaningfully with the Study Investigator and staff.~* Be free of other physical, mental, or medical conditions, which in the opinion of the Investigator, makes study participation inadvisable.~Exclusion Criteria:~* Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study.~* Has significant preexisting pulmonary (respiratory/breathing) disease, diaphragmatic paralysis or history of phrenic nerve injury (problems with the diaphragm causing breathing difficulties).~* Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.~* Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications.~* Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years.~* Has clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) based on medical history and examination.~* Has participated in another clinical Study (investigational or marketed product within 30 days of surgery.

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

Study Arms:
- A (Type: ACTIVE_COMPARATOR): Initial Bolus 5 ml Ropivacaine
- B (Type: ACTIVE_COMPARATOR): Initial Bolus 10 ml Ropivacaine
- C (Type: ACTIVE_COMPARATOR): Initial Bolus 20 ml Ropivacaine

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: Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)

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

Eligibility Criteria:
Eligibility criteria apply to two subject groups: 1) seriously ill adult patients; 2) hospital clinicians.~Inclusion Criteria:~* PATIENTS. Eligible patients will be those who are: 1) older than 80 years of age; or 2) 55 years of age or older who meet criteria for serious illness. Serious illness encompasses acute illness (e.g. COVID-19) and chronic illnesses (e.g. those included in the Dartmouth Atlas to study end-of-life care: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease).~* CLINICIANS (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial.~Exclusion Criteria:~* Reasons for exclusion for any patient include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation).

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

Study Arms:
- EHR-based Clinician Jumpstart (Type: EXPERIMENTAL): The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status.
- Usual Care (Type: NO_INTERVENTION): The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.

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 Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.~* Fever plus other symptoms such as nausea, vomiting, abdominal pain.~Exclusion Criteria:~* Cancer~* Medicines that suppress the immune system~* Dialysis

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

Study Arms:
- A (Type: ACTIVE_COMPARATOR): None
- B (Type: ACTIVE_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: Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced adenocarcinoma of the prostate, including: Bulky primary tumors confined to the prostate (clinical Stage T2c) Primary tumors extending beyond the capsule (clinical Stage T3-4) No common iliac or para-aortic nodal involvement Regional lymph node involvement below the common iliac level allowed Positive nodes on imaging studies must be biopsied by FNA or surgical sampling PSA no more than 150 (mandatory) No distant metastases~PATIENT CHARACTERISTICS: Age: At least 50 Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or concurrent second cancer except basal cell skin cancer No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up~PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior radiotherapy Surgery: No prior radical surgery for carcinoma of the prostate

- Gender: MALE
- Minimum Age: 50 Years
- Maximum Age: None
- 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: Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma

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 confirmed diagnosis of extranodal extra-gastric marginal zone cell B lymphoma or gastric Helicobacter pylori positive lymphoma refractory to conventional antibiotic therapy, or H. pylori negative~* at least one measurable lesion~* relapsed or refractory lymphoma after systemic (chemotherapy, immunotherapy, antibiotic) or local (surgery or radiation) therapy~* ECOG PS \</= 3~* no prior antibiotic therapy within 3 months before enrollment~Exclusion Criteria:~* HIV 1-2 infection~* concomitant conventional or experimental antitumor therapy (chemotherapy, radiotherapy, immunotherapy, corticosteroids)~* severe inadequate liver (AST \</=3 ULN, ALT \</= 3 ULN, bilirubin \</=3 ULN) or renal (creatinine \</= 1.5 ULN) function~* allergy to macrolides~* concomitant malignant neoplasms within prior 5 years (with the exclusion of basal cell carcinoma, in situ spinocellular carcinoma of skin and cervix)

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

Study Arms:
- clarithromycin, oral, high dose (Type: EXPERIMENTAL): 2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total

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: Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)

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:~* • Capacity and willingness to sign informed consent~  * ≥ 21 years of age~ * Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI ≤ 30) within 12 months of the screening visit with the 3% hypopnea criteria~ * Able to tolerate using the device during a day time trial/acclimation~ * Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)~Exclusion Criteria:~* • Nasal deformities~  * Severe nasal allergies~ * Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum~ * Co-morbid sleep disorders~ * Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)~ * Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.~ * Full Face Mask user~ * Mouth breather~ * Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- BONGO DEVICE (Type: EXPERIMENTAL): All participants that qualify will receive the intervention of the Bongo device

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: Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Age ≥18 years (male or female)~2. Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)~3. Currently admitted to an intensive care unit (ICU)~Key Exclusion Criteria:~1. Ongoing (\>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication~2. Ongoing or planned treatment with dual antiplatelet therapy~3. Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:~   1. History of intracranial hemorrhage, known central nervous system (CNS) tumor or CNS vascular abnormality~  2. Active or recent major bleeding within the past 30 days with untreated source~  3. Platelet count \<70,000 or known functional platelet disorder~  4. Fibrinogen \<200 mg/dL~  5. International normalized ratio (INR) \>1.9~4. History of heparin-induced thrombocytopenia~5. Ischemic stroke within the past 2 weeks~Patients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy):~1. Ongoing or planned antiplatelet therapy, including aspirin monotherapy

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

Study Arms:
- Full-dose anticoagulation (FDAC) (Type: EXPERIMENTAL): * Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an activated partial thromboplastin time (aPTT) of 1.5-2.5 times the control as per institutional therapeutic target for treatment of venous thrombotic events (VTE)~* Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours~* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days
- Standard-dose prophylactic anticoagulation (SDPAC) (Type: ACTIVE_COMPARATOR): * Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if creatinine clearance CrCl \<30 ml/min)~* Heparin 5,000 units administered subcutaneous three times daily~* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent 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: GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

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

Eligibility Criteria:
Inclusion Criteria:~* Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.~* Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.~* Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.~Exclusion Criteria:~* Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.~* Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).~MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY~* Calcitonin~* Bisphosphonates~* Fluoride at pharmacologic dose~* Strontium at pharmacologic dose~* Estrogenic steroids (except oral contraceptives)~* Selective Estrogen Receptor Modulator (raloxifene)~* Parathyroid hormone~* Any androgens, including prescription or nutritional supplement DHEA, other than study drug~* Additional Calcium supplements other than those prescribed as part of this study

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

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

Answer: outcome: complete