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

Trial Title: A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age 18 years and older experiencing ADRs related to IVIG infusions~* Stable dose of IVIG for 3 months~* Willing to comply with all aspects of the protocol, including blood draws~* Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate \< 1% when properly applied and include: a combination oral pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire study period.~Exclusion Criteria:~* Receiving treatment for HAE, either prophylactic or acute therapy~* Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)~* Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant.~* Patients who, in the investigator's opinion, might not be suitable for the trial

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

Study Arms:
- C1-esterase inhibitor [recombinant] (C1-INH-R) (Type: EXPERIMENTAL): Single-site, open-label arm to evaluate the benefit of C1-INH-R in subjects on IVIG therapy who experience ADRs. The study will have 2 periods:~* 6 - 8 weeks - subjects will receive 2 infusions of IVIG~* 9 - 12 weeks - subjects will receive 3 infusions of C1-INH-R prior to IVIG infusion

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: Extension in AS: Sustainability of Benefits, Safety and Tolerability

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria: patients having completed the core study CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the core study CAIN457F2305.

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

Study Arms:
- Secukinumab (AIN457) 75mg Grp1 (Type: EXPERIMENTAL): Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
- Secukinumab (AIN457) 75 to 150mg Grp1 (Type: EXPERIMENTAL): Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
- Secukinumab (AIN457) 150mg Grp2 (Type: EXPERIMENTAL): Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
- Pbo in Core then AIN457 75mg Grp1 (Type: EXPERIMENTAL): Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W
- Pbo in Core then AIN457 75 to 150mg Grp1 (Type: EXPERIMENTAL): Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
- Pbo in Core then AIN457 150mg Grp2 (Type: EXPERIMENTAL): Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

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: Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department

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:~* Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are:~  1. 18 years or older,~ 2. meet criteria for opioid dependence as measured by the Mini-SCID, and~ 3. have a positive urine toxicology for opiates.~Exclusion Criteria:~* Inability to read or understand English~* Currently receiving formal substance abuse treatment~* Current suicide or homicidal risk~* Current psychotic disorder~* Life-threatening or unstable medical or psychiatric condition requiring hospital admission~* Unable to provide 2 phone contact numbers~* Unwilling to be randomized and/or follow up as per study protocol, including release of information to assess treatment engagement at 30-days~* Requiring opioid agonist medication for a pain-related diagnosis (contraindication to buprenorphine)

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

Study Arms:
- SC (Type: NO_INTERVENTION): Standard Care
- SBIRT (Type: EXPERIMENTAL): Screening, Brief Intervention and Facilitated Referral to Treatment
- SBI+Bup (Type: EXPERIMENTAL): Screening, Brief Intervention and Buprenorphine initiation

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 Safety and Efficacy of Infliximab in Patients With Psoriasis

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

Eligibility Criteria:
Inclusion Criteria:~* Patients who have had a diagnosis of plaque-type psoriasis for at least 6 months~* Patients who have plaque-type psoriasis covering at least 10% of the body~Exclusion Criteria:~* Patients must not have nonplaque forms of psoriasis~* Patients must not have current drug-induced psoriasis~* Patients must not be pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment~* Patients must not have had any previous treatment with infliximab or any therapeutic agent targeted at reducing TNF

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

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: Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer

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

Eligibility Criteria:
Inclusion Criteria:~* The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with biochemical recurrence (BCR) on the basis of:~  1. Post radical radiotherapy (RRT) / brachytherapy: Increase in PSA level ≥2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) \[53\], or~ 2. Post radical prostatectomy (RP): EITHER two consecutive rises in PSA and final PSA \>0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).~  i. In addition, the subject post RP, should have a PSA doubling time of ≤15 months OR PSA level ≥1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening.~* The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.~* The subject is being considered for radical salvage therapy.~* The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed.~* The subject's Eastern Cooperative Oncology Group \[ECOG\] performance status 0-2.~* The subject should not have received androgen-deprivation therapy within 3 months of screening.~* The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug).~Exclusion Criteria:~* The subject has been previously included in this study.~* The subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of fluciclovine (18F) injection.~* The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.~* The subject has had a choline PET/CT scan within 3 months of the screening visit.~* The subject has bilateral hip prostheses.

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

Study Arms:
- Single arm (Type: EXPERIMENTAL): Single intravenous administration of 18F-Fluciclovine for PET Scan

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: An Open Label Study of Severe Sepsis in Adults

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:~  1. Must be 18 years.~ 2. Suspected or proven infection~ 3. Have or have had two or more sepsis-induced organ failures sepsis~Exclusion Criteria:~* Patients will be excluded from entry in this study for any of the following reasons:~  1. Documented first organ dysfunction greater than 48-hours prior to start of study drug.~ 2. Patients greater than 135 kg in weight.~ 3. Patients with a platelet count less than 30,000/mm3~ 4. Active internal bleeding or at increased risk for bleeding

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

Study Arms:
- 1 (Type: EXPERIMENTAL): 24 microgram/kg/hr for 96 hours (+ or - 1 hour)

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 Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

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 and female patients ≥ 18 years of age~* An acute onset of at least 3 of the following signs and symptoms (new or worsening):~  1. Cough~ 2. Production of purulent sputum~ 3. Shortness of breath (dyspnea)~ 4. Chest pain due to pneumonia~* At least 1 of the following:~  1. Fever~ 2. Hypothermia~ 3. Presence of pulmonary rales and/or evidence of pulmonary consolidation~* PORT Risk Class II, III, or IV~* Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study~* Not received any systemic antibiotics during the prior 7 days~Exclusion Criteria:~* Ventilator-associated pneumonia~* Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease~* Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms~* Presence of known:~  1. Viral or fungal pneumonia~ 2. Pneumocystis jiroveci pneumonia~ 3. Aspiration pneumonia~ 4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)~ 5. Primary or metastatic lung cancer~ 6. Cystic fibrosis~ 7. Active or suspected tuberculosis~* Known HIV or myasthesia gravis

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

Study Arms:
- Solithromycin (Type: EXPERIMENTAL): Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7
- Moxifloxacin (Type: ACTIVE_COMPARATOR): Moxifloxacin 400 mg PO daily on Day 1 through Day 7

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: Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

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:~1. Age \>18 years~2. Both genders~3. Diagnosis of non-m3 AML by the WHO 2016 diagnostic criteria~4. Patients eligible and not eligible for transplant~5. AML secondary to treatment or associated to myelodisplasia~Exclusion Criteria:~1. AML with PML/RAR-alfa translocation t(15;17)~2. Central nervous system involvement~3. Poor functional status (ECOG\>2)~4. Organic dysfunction (Marshall score ≥2)~5. Active infection~6. Use of other CYP3A4 inhibitors~7. Pregnancy~8. GFR \<30 ml/min/1.72m2

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

Study Arms:
- Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine (Type: EXPERIMENTAL): Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.

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: Expanded Access Protocol (EAP) to Provide Bortezomib to Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with previous diagnosis of multiple myeloma based on standard criteria~* patient has received at least 2 previous lines of therapy for multiple myeloma and, currently requires therapy because of relapsed or progressive disease~* If female, the patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit~* If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit~* patient has a Karnofsky performance status \>= 60~* patient meets defined pretreatment laboratory criteria~Exclusion Criteria:~* If patient received bortezomib in a previous clinical trial, the patient's best response to bortezomib was progressive disease~* Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment, corticosteroids (\>10 mg/day prednisone or equivalent) within 3 weeks before enrollment, immunotherapy or antibody therapy within 4 weeks before enrollment~* Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI CTC~* Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities~* Patient has cardiac amyloidosis

- Gender: ALL
- 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
Please assess the completion status of the following clinical trial:

Trial Title: Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

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

Eligibility Criteria:
Inclusion Criteria:~* Male and female subjects ≥ 18 years of ag.~* Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated~* The presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°C/100.4°F, axillary temperature \>38.1°C/100.6°F, tympanic temperature \>38.5°C/ 101.2°F, or a rectal/core temperature \>39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature \<35°C/95°~Exclusion Criteria:~* Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days)~* Hospitalization within 14 days prior to the onset of symptoms~* Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms

- Gender: ALL
- 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
Please assess the completion status of the following clinical trial:

Trial Title: IRAD2 : Patients With Respiratory Failure at Home

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:~* well informed and consenting person~* woman is old enough to procreate~* Assisted respiratory treatment at home for 3 months : oxygenotherapy \> 8 hours per day and/or assisted ventilation \> 6 hours per day.~* PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning of assisted respiratory treatment.~* Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, non neuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion) obstructive and restrictive syndrome.~* malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weight loss (10% of the previous weight) or non-fatty mass measured by 50 Hz impedancemetry ≤25th percentiles or ≤ 63% of ideal weight for women, ≤ 67% of ideal weight for men.~Exclusion Criteria:~* Sleep apnea with daytime drowsiness (drowsiness scale of Epworth \> 9/24)~* Known pathology that reduce the vital prognosis at 6 months (AIDS, cancer...).~* History of hormone dependent cancer ( breast cancer, prostate cancer), pathologic Prostate Specific Antigen.~* Inability to follow a rehabilitation program

- Gender: ALL
- 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
Please assess the completion status of the following clinical trial:

Trial Title: Norepinephrine Consumption After Prophylactic Ondansetron

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

Eligibility Criteria:
Inclusion Criteria:~* ASA physical status I-II patients~* Between the ages of 18 and 40 years~* Scheduled for elective caesarean section with spinal anesthesia~Exclusion Criteria:~* History of hypertension~* History of severe hepato-renal disease,~* sensitivity or contraindication to ondansetron,~* Drug or alcohol abuse~* Contraindication to regional anesthesia.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Ondansetron (Type: EXPERIMENTAL): None
- Saline (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: A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.

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:~* Positive dipstick test for leukocyte esterase AND/OR at least 5 white blood cells per centrifuged urine sediment AND/OR at least 10 white blood cells per microliter of uncentrifuged urine~* outpatient or inpatient (in hospital, nursing home, or other extended-care facility)~* clinical diagnosis of either complicated urinary tract infection or acute pyelonephritis.~Exclusion Criteria:~* Allergy or serious adverse reaction to levofloxacin, ciprofloxacin, or other fluoroquinolone~* urinary tract surgery or lithotripsy (treatment for kidney stones) within 7 days before study entry~* a second coexisting bacterial infection that requires systemic antibiotics~* need for a second antibiotic to treat the urinary tract infection~* obstruction of the urinary tract~* prostate infection.

- Gender: ALL
- 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