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

Trial Title: Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Male subjects between the ages of 18-40 years.~* The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).~* Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.~* Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.~Exclusion Criteria:~* Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.~* Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.~* Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) \>10.

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

Study Arms:
- SPD489 20 mg (Type: EXPERIMENTAL): None
- SPD489 50 mg (Type: EXPERIMENTAL): None
- SPD489 70 mg (Type: EXPERIMENTAL): None
- Armodafinil (Type: ACTIVE_COMPARATOR): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection

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:~* Recurrent C. difficile infection (identified by positivity of C. difficile toxin in stools) with severe clinical picture (defined by the ESCMID Guidelines published in 2014 - Debast et al, Clin Microbiol Infect 2014)~* Possibility to undergo standard antimicrobial therapy for recurrent C. difficile infection Approval of informed consent~* Possibility to undergo protocol diagnostic and therapeutic procedures~* Stool negativity for parasites~* Stool negativity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile~* Blood negativity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL).~Exclusion Criteria:~* Subjects \<18 years old~* Prior colectomy~* Negativity of C. difficile toxin in stools~* Mild clinical picture of C. difficile infection~* High risk of post-colonoscopy complications~* Other main gastrointestinal diseases (es. Crohn's disease or ulcerative colitis)~* Stool positivity for parasites~* Stool positivity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile~* Blood positivity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL).~* Pregnancy or breastfeeding.~* Inability to follow protocol procedures

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

Study Arms:
- Multiple-infusion FMT (Type: EXPERIMENTAL): Repeated fecal infusions by colonoscopy. Before FMT, vancomycin is administered in all patients for 3 days
- Single-infusion FMT (Type: ACTIVE_COMPARATOR): Single fecal infusion by colonoscopy.Before FMT, vancomycin is administered in all patients for 3 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 DS-8201a for Participants With Advanced Solid Malignant Tumors

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Has a pathologically documented unresectable or metastatic solid malignant tumor, with HER2 expression \[immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +\], Next Generation Sequencing, or other analysis techniques as appropriate\] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, or for which no standard treatment is available~* Has a left ventricular ejection fraction (LVEF) ≥ 50%~* Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1~Exclusion Criteria:~* Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information~* Has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure

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

Study Arms:
- Cohort 1: DS-8201a + Ritonavir (Type: EXPERIMENTAL): DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3
- Cohort 2: DS-8201a + Itraconazole (Type: EXPERIMENTAL): DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Itraconazole BID on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3

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: To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)

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

Eligibility Criteria:
Inclusion Criteria:~* Actively working, either full-time or part-time~* Previous confirmed diagnosis of PsA by a rheumatologist~* Patients for whom the physician has initiated PsA treatment with an Anti-TNF in accordance with Turkish Ministry of Health regulations and reimbursement criteria~* Able to provide authorization to use and disclose their health related information~Exclusion Criteria:~* Patients with a history of an allergic reaction or significant sensitivity to anti-TNF agents~* Patients with possible follow-up problems during the planned study period or patients who may not be compliant to treatment as evaluated by the investigator/treating physician~* Patients participating in any clinical trial of an experimental drug 30 days prior to the baseline visit

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

Study Arms:
- Participants Receiving Anti-TNF for PsA (Type: None): Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.

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 a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger

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

Eligibility Criteria:
Inclusion Criteria:~1. aged 6-8 weeks at the time of inclusion~2. able to swallow and no history of vomiting within 24 hours~3. resident in Madarounfa Health District and within the catchment area of the central health facility~4. intending to remain in the study area for 2 years~5. parent/guardian providing written informed consent~Exclusion Criteria:~Any of the following will exclude an infant from randomization in the study:~1. known history of congenital abdominal disorders, intussusception, or abdominal surgery~2. receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks~3. receipt or planned administration of a blood transfusion or blood products, including immunoglobulins~4. any known immunodeficiency condition~5. any serious medical condition~6. any other condition in which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or the parent/guardian's ability to give informed consent

- Gender: ALL
- Minimum Age: 6 Weeks
- Maximum Age: 2 Years
- Healthy Volunteers: t

Study Arms:
- Rotavirus vaccine (BRV-PV) (Type: EXPERIMENTAL): Live attenuated bovine-human \[UK\] reassortant rotavirus vaccine manufactured by the Serum Institute of India, Limited (SIIL). The pentavalent vaccine (BRV-PV) contains rotavirus serotypes G1, G2, G3, G4, and G9 (≥5.6 log10 FFU/serotype/dose). The vaccine is in lyophilized form and supplied with 2.5 ml of citrate bicarbonate buffer that is added for reconstitution just before oral administration.
- Placebo (Type: PLACEBO_COMPARATOR): Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL.

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: Pharmacological Cognitive Enhancement

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: DOUBLE
- Phase: EARLY_PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* subjects do not meet the criteria for exclusion~Exclusion Criteria:~* current signs of psychiatric, neurological or medical (hypertension, cardiac disorders, epilepsy) conditions as determined by the Millon test and by clinical examination;subjects showing visual or motor impairments. All subjects taking any psychoactive drug or having a history of alcohol abuse.

- Gender: MALE
- Minimum Age: 25 Years
- Maximum Age: 35 Years
- Healthy Volunteers: t

Study Arms:
- Placebo (Type: EXPERIMENTAL): Study subjects received, in a double blind fashion, a placebo pill identical to the drug.
- Modafinil (Type: EXPERIMENTAL): Modafinil (Provigil), a drug on the market since 1997, is employed for the treatment of narcolepsy and other sleep disorders. In recent years, modafinil has also been used off-label to treat cognitive dysfunction in psychiatric disorders such as schizophrenia and Attention Deficit/Hyperactivity Disorder (ADHD).~Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil.

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 to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion criteria:~1. Healthy male subjects~2. overweight or obese~Exclusion criteria:~1. Any relevant deviation from healthy conditions

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

Study Arms:
- BI 187004 CL (Type: EXPERIMENTAL): 1 single dose per subject as oral solution
- Placebo to BI 187004 CL (Type: PLACEBO_COMPARATOR): 1 single dose per subject as oral solution

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: Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

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:~* Have confirmed mantle cell lymphoma diagnosis.~* Have measurable disease.~* Have received at least 2 prior treatment, which may include stem cell transplant.~* Have adequate organ and bone marrow function.~* There are other criteria--please discuss with your doctor.~Exclusion Criteria:~* Had any prior treatment with temsirolimus or mTOR inhibitor.~* Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.~* Has active or untreated brain or central nervous system metastases.~* There are other criteria--please discuss with your doctor.

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

Study Arms:
- temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly (Type: ACTIVE_COMPARATOR): None
- temsirolimus (Torisel) 75mg weekly (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: The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria~1. Subjects, ages 18-70, inclusive.~2. Availability for the six-month duration of the clinical research study.~3. Good General health.~4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).~5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.~6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).~7. Signed Informed Consent Form.~Exclusion Criteria~1. Presence of orthodontic bands.~2. Presence of partial removable dentures.~3. Tumor(s) of the soft or hard tissues of the oral cavity.~4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).~5. Five or more carious lesions requiring immediate restorative treatment.~6. Antibiotic use any time during the one-month period prior to entry into the study.~7. Participation in any other clinical study or test panel within the one month prior to entry into the study.~8. Dental prophylaxis during the past two weeks prior to baseline examinations.~9. History of allergies to oral care/personal care consumer products or their ingredients.~10. On any prescription medicines that might interfere with the study outcome.~11. An existing medical condition that prohibits eating or drinking for periods up to 4 hours.~12. History of alcohol or drug abuse.~13. Pregnant or lactating subjects.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- Control toothpaste (Type: PLACEBO_COMPARATOR): 1450 ppm Fluoride toothpaste
- Experimental toothpaste (Type: EXPERIMENTAL): 1450 ppm sodium fluoride toothpaste with a zinc base
- Active comparator (Type: ACTIVE_COMPARATOR): 1450 ppm sodium fluoride/triclosan toothpaste

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: Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)

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

Eligibility Criteria:
Inclusion Criteria:~* The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.~* Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study

- Gender: ALL
- Minimum Age: 26 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Reduce Elevated Blood Pressure Errors First (Type: EXPERIMENTAL): Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values.~Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.
- Reduce Depression Errors First (Type: EXPERIMENTAL): Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis.~Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.
- Reduce Lab Related Errors First (Type: EXPERIMENTAL): Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis.~Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.

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: Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

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:~* Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.~Exclusion Criteria:~* Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- home intravenous ertapenem and PICC (Type: ACTIVE_COMPARATOR): Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)
- home oral amoxicillin-clavulanate (Type: EXPERIMENTAL): Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate(Drug Class:beta lactam antibiotic)(15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).

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: Nucleus Hybrid L24 Extended Duration Post Approval Study

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:~- Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study~Exclusion Criteria:~* Recipients who withdrew or were terminated from the L24 pivotal IDE study~* Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant

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

Study Arms:
- Hybrid L24 pivotal study subjects (Type: EXPERIMENTAL): Subjects implanted with the Nucleus Hybrid L24 Implant as part of the pivotal IDE study and who still have the device implanted will continue to be followed for 5 years post activation

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

Answer: outcome: complete