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

Trial Title: A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder)

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:~* Provision of a parent/guardian signed and dated informed consent form.~* Stated willingness of parent/guardian to comply with all study procedures and availability for the duration of the study.~* Child is between 36 months and \<132 months of age at baseline.~* Child has a confirmed DSM-5 diagnosis of both ASD and ADHD, informed by results of assessments including: an ASD diagnostic assessment (Brief Observation of Symptoms of Autism \[BOSA\], Autism Diagnostic Observation Schedule, 2nd Edition \[ADOS-2\], or TELE-ASD-PEDS, and if applicable the Autism Diagnostic Interview - Revised \[ADI-R\]) and an ADHD diagnostic (a standardized ADHD Diagnostic Interview and the MINI psychiatric diagnostic interview).~Exclusion Criteria:~* If continuing psychotropic (CNS-active) medications, must not have been changed within 4 weeks prior to baseline.~* Significant visual, auditory or motor impairments that would preclude participation in ESDM-informed caregiver coaching or completion of key assessments.~* Inability of the caregiver participating in ESDM-informed caregiver coaching and responding to questionnaires to fluently speak English.~* Study clinician judgment that it is not in the best interests of the participant and/or the study for the child to participate (including presence of psychiatric conditions or psychiatric symptoms in addition to ASD and ADHD that in the opinion of the PI or based on senior clinical review, would confound assessments and/or affect participation in the study).

- Gender: ALL
- Minimum Age: 36 Months
- Maximum Age: 131 Months
- Healthy Volunteers: f

Study Arms:
- A+ Treatment/Feasibility participants (Type: OTHER): Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. ESDM-informed parent coaching (\~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline.

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 Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients with overactive bladder who completed a previous darifenacin short-term trial.~* Patients capable of independent toileting and able of independently completing the patient diary.~Exclusion Criteria:~* Patients in whom the use of anticholinergic drugs was contraindicated~* Evidence of severe liver disease~* Patients with other clinically significant urinary or gynecological conditions~Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Darifenacin

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: Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

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

Eligibility Criteria:
Inclusion Criteria:~* Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).~Exclusion Criteria:~* Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.~* History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 19 Years
- Healthy Volunteers: f

Study Arms:
- MenABCWY Group (Type: EXPERIMENTAL): Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
- MenACWY Group (Type: ACTIVE_COMPARATOR): Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current 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: Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

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:~* Competent and willing to voluntarily provide informed consent~* 18 years of age or older~* In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia~Exclusion Criteria:~* No allergies to the medications and/or the active ingredients of any of the study medications~* No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery~* No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication

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

Study Arms:
- OMS302 (Type: EXPERIMENTAL): OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

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 Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.~* History of disabling migraine for at least 1 year.~* Migraine Disability Assessment Test (MIDAS) score ≥11.~* Migraine onset before the age of 50 years.~* History of 3-8 migraine attacks per month and \<15 headache days per month during the past 3 months.~Exclusion Criteria:~* Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.~* History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures.~* History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.~* History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy).~* History of orthostatic hypotension with syncope.

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

Study Arms:
- 50 milligram (mg) Lasmiditan (Type: EXPERIMENTAL): 50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
- 100 mg Lasmiditan (Type: EXPERIMENTAL): 100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
- 200 mg Lasmiditan (Type: EXPERIMENTAL): 200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.

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: Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18 years or over.~* Meeting the Center for Disease Control (CDC) criteria for TBI.~* Mild, Moderate, or Severe TBI as categorized by initial Glasgow Coma Scale (GCS) scores 13 to 15, 9 to 12, or 3 to 8, respectively.~* Complete recovery from Post Traumatic Amnesia (PTA) within 4 weeks of the traumatic episode.~Exclusion Criteria:~* Penetrating head injuries.~* Clinical or neuro-radiological evidence of associate spinal cord injury.~* Patients with severe comprehension deficits (i.e., those who are not able to complete part II of the Token Test) that precludes a thorough neuropsychiatric evaluation.~* Presence of Diagnostic and Statistical Manual IV defined mood, anxiety or psychotic disorder at the time of enrollment to the study. However, patients with a history of alcohol abuse or alcohol dependence during the year preceding TBI will be included in the study.~* Patients who were taking antidepressants at the time of TBI or during a six month period prior to the traumatic event.~* Patients who have failed an adequate previous trial with sertraline or had side effects that prompted the discontinuation of this medication.~* Pregnant women or women that plan to become pregnant during the period of the study.~* Severe complicating illness such as neoplastic disease or uncompensated heart, renal or liver failure.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo will be given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
- Sertraline (Type: EXPERIMENTAL): Sertraline will be given in a double blind fashion via tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention.

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 Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta

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

Eligibility Criteria:
Inclusion Criteria:~* Previous established diagnosis of Osteogenesis Imperfecta AND~* \> 2 previous adult fractures, AND/OR~* BMD at lumbar spine, femoral neck or total hip T score \< -2.0~Exclusion Criteria:~* Open epiphyses.~* History of external beam radiation to the skeleton.~* Pagets disease.~* Bone metastases or skeletal malignancies.~* Total lifetime exposure to any antiresorptive medication \< 90 days (Primary Inclusion).~* Treatment with any antiresorptive medication 12 months proceeding enrollment - (Secondary Inclusion).~* Women with OI who are pregnant or unwilling to use 1 form of contraception.~* Vitamin D insufficiency (25-hydroxyvitamin D \<15ng/ml)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Teriparatide (FORTEO) (Type: ACTIVE_COMPARATOR): Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months
- Placebo (Type: PLACEBO_COMPARATOR): Daily SQ placebo for 18 months

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: Literacy-Adapted Psychosocial Treatments for Chronic Pain --- Learning About Mastering/My Pain

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

Eligibility Criteria:
Inclusion Criteria:~1. Must be at least 19 yrs-old in order to consent to treatment.~2. Must have received at least one diagnosis consistent with chronic pain by a physician at one of the participating primary care clinics.~3. Must have experienced pain most days of the month for 3 months, and although pain may have more than one pain source, all pain must be non-malignant (e.g., not cancer- or HIV-related).~4. Must be able to speak and understand English.~5. Must have a telephone or other avenue of communication for contact regarding the study.~Exclusion Criteria:~1. Must not demonstrate significant cognitive impairment (based on results of a cognitive screener).~2. Must not have current, uncontrolled serious psychological disturbance (e.g., schizophrenia, bipolar disorder) or active substance abuse (based on responses to a structured diagnostic interview).~3. Must have minimal literacy skills (i.e., read at the 1st grade level).~4. Must have been stabilized for at least 4 weeks on current pain and psychotropic medication regimen to reduce potential confounds to treatment results.~5. Must not have a surgery scheduled for the intervention period (\~3 months).~6. Must neither be currently receiving a psychosocial treatment for pain (though they may be receiving psychotherapy for non-pain difficulties) nor be a participant in our previous treatment studies.

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Pain Ed (Type: EXPERIMENTAL): Pain Education: A psychosocial treatment group focusing on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. This condition also included medical treatment as usual.
- CBT for Pain (Type: EXPERIMENTAL): Cognitive-Behavioral Therapy for Pain: A psychosocial treatment group focusing on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. This condition also included medical treatment as usual.
- Usual Care (Type: ACTIVE_COMPARATOR): Usual Care (Medical Treatment-as-Usual: A control/comparison condition in which patients receive on-going standard care at the federally qualified health center partnering in this research. Facets of care may include medication, surgery, chiropractic, and physical therapy, among others, which are available to all patients in all 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: Early Short Course Corticosteroids in COVID-19

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

Eligibility Criteria:
Inclusion Criteria:~* 18 years of age or older~* Confirmed COVID-19 infection~* Radiographic evidence of bilateral pulmonary infiltrates~* Oxygen requirement by nasal cannula, high-flow nasal cannula (HFNC), or mechanical ventilation~Exclusion Criteria:~* Transfer from an out-of-system hospital~* Death within 24 hours of presentation to the ED~* Admitted for less than 24 hours

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

Study Arms:
- Pre-Corticosteroid protocol (Type: None): Patients with moderate or severe disease who presented to HFHS within the first week of the COVID epidemic in Detroit were initially treated with supportive care with or without a combination of lopinavir-ritonavir and ribavirin or hydroxychloroquine according an institutional guideline developed by Infectious Diseases Physicians and Pharmacists. The institutional guidelines were developed by consensus, and based on the available literature, experience from Wuhan, China and other centers around the world affected by COVID-19 before Michigan. Intravenous (IV) remdesivir compassionate use was requested for eligible mechanically ventilated patients. On March 17, 2020 lopinavir-ritonavir with ribavirin was removed from the COVID-19 institutional protocol.
- Corticosteroid Protocol (Type: None): As a result of observed poor outcomes, clinical rationale based upon immunology, clinical course of COVID-19, and more recently best available evidence, the HFHS corticosteroid protocol was developed. We hypothesized that early corticosteroids would combat the inflammatory cascade leading to respiratory failure, ICU escalation of care, and mechanical ventilation. The corticosteroid protocol became the institutional standard on March 20, 2020. Patients with confirmed influenza infection were not recommended to receive corticosteroids.~Patients with moderate COVID-19 who required 4 liters or more of oxygen per minute on admission, or who had escalating oxygen requirements from baseline, were recommended to receive IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 days. Patients who required ICU admission were recommended to receive the above regimen of hydroxychloroquine and IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 to 7 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: P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Female or male adult subjects, with known or highly suspected focal areas of disrupted Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm (long axis). This lesion had been detected on a previous imaging procedure (computerized Tomography \[CT\] or MRI).~* Subject scheduled for a routine contrast-enhanced MRI examination of Central Nervous System for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the study.~Exclusion Criteria:~* Subject presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m² based on one eGFR assessment performed the day of the MRI prior to the first contrast agent injection.

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

Study Arms:
- Subset 1 Arm 1 (Type: EXPERIMENTAL): One of the two doses of P03277 (0.05 or 0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
- Subset 1 Arm 2 (Type: EXPERIMENTAL): Gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI then one of the two doses of P03277 (0.05 or 0.1 mmol/kg)-enhanced MRI
- Subset 2 Arm 1 (Type: EXPERIMENTAL): One of the four doses of P03277 (0.025, 0.05, 0.1 or 0.2 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
- Subset 2 Arm 2 (Type: EXPERIMENTAL): Gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI then one of the four doses of P03277 (0.025, 0.05, 0.1 or 0.2 mmol/kg)-enhanced MRI

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

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

Trial Title: Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy with no chronic illness~* Age 18-35~* Normal BMI (18-25)~* Normal screening labs or no clinically significant values~Exclusion Criteria:~* First degree relative with Type 2 Diabetes~* Smoking presently or in the past 6 months~* Medications that affect the vasculature~* Overweight or other indications of insulin resistance~* Elevated LDL cholesterol \> 160~* Elevated BP \> 140/90~* History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease, bleeding disorders~* Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease~* Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).~* Pregnant or breastfeeding.~* Known hypersensitivity to perflutren (contained in Definity)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 35 Years
- Healthy Volunteers: t

Study Arms:
- Octreotide- Euglycemia (Type: ACTIVE_COMPARATOR): octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
- Octreotide - Euglycemia- insulin clamp (Type: ACTIVE_COMPARATOR): octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
- Octreotide- hyperglycemia (Type: ACTIVE_COMPARATOR): octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
- Octreotide- hyperglycemia - insulin clamp (Type: ACTIVE_COMPARATOR): octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min

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

Answer: outcome: complete