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

Trial Title: Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness

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

Eligibility Criteria:
Inclusion Criteria:~* African American~* Age 18 or older~* Serious mental illness (as indicated by disability)~* Identifies as either male or female~* Concerned about weight and health goals~* Willing to attend~* BMI of greater than or equal to 28~Exclusion Criteria:~* Currently receiving services from a peer support specialist or community health worker to work on weight-related goals~* Weigh more than 440 pounds~* Lifetime diagnosis of eating disorder~* Pregnant or plan to become pregnant~* Lifetime bariatric surgery~* No doctor permission for exercise~* Taking medication for weight loss

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

Study Arms:
- Behavioral Weight Loss Intervention (Type: ACTIVE_COMPARATOR): Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:~* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)~* 45 minute, physical activity led by facilitator (one-two times per week);~* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and~* weigh-in during weight management group and individual visits (once each week).
- BWLI & Peer Navigator (Type: EXPERIMENTAL): Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:~* partnering with participant on BWLI homework;~* meeting with participant and BWLI facilitator individually;~* attending all other health care appointments; and~* partnering on tasks that arise out of those appointments.
- Integrated Care (Treatment as Usual) (Type: ACTIVE_COMPARATOR): Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.

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: Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

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:~* underwent macroscopically curative resection;~* immunohistochemically confirmed KIT (CD117)-positive tumors;~* judged as being high-risk according to the criteria for risk classification~Exclusion Criteria:~* synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;~* received therapy with Imatinib Mesylate prior to study entry;~* cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)~Other protocol-defined inclusion / exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- Imatinib Mesylate (Type: EXPERIMENTAL): 400 mg once per day

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: Intracerebral Gene Therapy in Children With Sanfilippo Type B Syndrome

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion criteria:~* Age: 18 months up to 60 months (5th birthday);~* Onset of clinical manifestations related to mucopolysaccharidosis type IIIB (MPSIIIB);~* NAGLU activity in peripheral blood cell and/or cultured fibroblast extracts of less than 10% of controls;~* Patient affiliated to, or covered by a French social security regimen, or European patients with European Health Insurance Card;~* Family understanding the procedure and the informed consent;~* Signed informed consent by both parents or legal representative;~* Vital laboratory parameters within normal range.~Exclusion Criteria:~* Presence of brain atrophy on baseline MRI judged on a cortico-dural distance of more than 0.6 cm;~* Any condition that would contraindicate general anesthesia;~* Any other permanent medical condition not related to MPSIIIB that could contraindicate the study participation;~* No independent walking (ability to walk without help);~* Any medication aiming at modifying the natural course of MPSIIIB given during the 6 months before vector injection (sleep and mood regulators are accepted);~* Any condition that would contraindicate treatment with Modigraf®, Cellcept® and prednisolone (Solupred® and Solumedrol®).

- Gender: ALL
- Minimum Age: 18 Months
- Maximum Age: 60 Months
- Healthy Volunteers: f

Study Arms:
- rAAV2/5-hNAGLU (Type: EXPERIMENTAL): Each patient will receive 960 µL of vector suspension. The vector suspension will be deposited simultaneously at 16 sites, each deposit containing 2.4x 1011 vg (4x1012 vg 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: Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas

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

Eligibility Criteria:
Inclusion Criteria:~1. Informed consent OF PATIENT OR PARENTS~2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.~3. Age 1 - 18 years~4. Negative pregnant blood test in case of fertile women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.~5. Patient newly diagnosed of DIPG in MRI~6. Lansky Performance Status ≥ 70 before inclusion~7. Lesion considered by the investigator to be accessible for stereotactic biopsy. Lesion location will allow injection without entrance of virus in the ventricular system.~8. No previous treatment for DIPG~Exclusion Criteria:~1. Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline \[i.e., \< 38 degrees (Cº)\].~2. Investigational medication in the previous 30 days.~3. Subjects with immunodeficiency, autoimmune conditions or active hepatitis.~4. Any medical or psychological condition that might interfere with the subject's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.~5. Tumor with multiple locations or doubt in MRI of a DIPG.~6. Pregnant or breast-feeding females will be excluded, due to the risk for the fetal development of a recombinant virus containing genes related to cellular growth and differentiation.~7. Severe bone marrow hypoplasia.~8. AST (aspartate transaminase) and/or ALT (alanine transaminase)\> 3 times over upper normal laboratory level~9. Neutrophils \< 1 x 109/L~10. Thrombocytes ≤ 100 x 109/L~11. Hemoglobin \< 9g/dl~13. Patients with Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.~14. Vaccinations of any kind within 30 days prior to DNX-2401 administration. 15. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions within 28 days of baseline.

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- single arm treatment DNX-2401 (Type: EXPERIMENTAL): Single arm receiving virus DNX-2401 infusion after tumor biopsy

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: IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma

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

Eligibility Criteria:
Inclusion Criteria:~* Recently diagnosed MM according to the criteria of the South West Oncology Group (SWOG)~* Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency~* Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion~* \< 65 years of age~* Ability to give signed informed consent~* Secretion of a measurable monoclonal spike (\> 10 g/l in the serum or 0.2 g/24h in the urine)~* Negative pregnancy test at inclusion (if necessary)~* Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone~Exclusion Criteria:~* ECOG performance status \> 2~* History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ)~* Life expectancy \< 2 months~* Confirmed amyloidosis~* Positive HIV serology~* Serious psychiatric item in the history~* Renal failure requiring dialysis~* Uncontrolled diabetes, contra-indicating the use of corticosteroids~* Peripheral neuropathy National Cancer Institute (NCI) grade \> 2 (Annex 5)~* Clinical signs of heart failure or coronary heart disease~* Bilirubin \> 3 x normal~* Transaminases or gamma-glutamyl transpeptidase (GT) \> 4 x normal~* Platelets \< 50 x 10\^9/l during the 15 days prior to inclusion~* Neutrophils \< 0.75 x 10\^9/l during the 15 days prior to inclusion~* Use of an investigational medicinal product during the 30 days prior to inclusion~* Known hypersensitivity to bortezomib, boron or mannitol

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- 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: Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia

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:~* Schizophrenia~* age 18-65 years~* necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects~* written informed consent~Exclusion Criteria (amongst others):~* Known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol~* Acute suicidal tendency~* Einwilligungsvorbehalt (BGB) or Unterbringung (PsychKG)~* Epilepsy~* Organic psychosis~* Parkinson Disease~* Dementia~* History of malignant neuroleptic syndrome~* QTc interval ≥ 0.5s / history of congenital QTc prolongation

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- atypical antipsychotics (Type: EXPERIMENTAL): Olanzapine, Quetiapine, or Aripiprazole
- typical antipsychotics (Type: ACTIVE_COMPARATOR): Haloperidol or Flupentixol

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: Virtual Reality Hypnosis in Total Knee Arthroplasty Under Spinal Anesthesia

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

Eligibility Criteria:
Inclusion Criteria:~* Patients \>18 yo and scheduled for elective knee arthroplasty under spinal anesthesia~Exclusion Criteria:~1. Low auditory and/or visual acuity that precludes the use of the device.~2. ASA status \> 3~3. Head or face wounds precluding use of the device.~4. Schizophrenia or dissociative disorder.~5. Pregnancy.~6. Chronic renal insufficiency or severe hepatic insufficiency.~7. Non-proficiency in French (Research language).~8. Phobia of deep water.~9. Chronic pain and/or chronic analgesics consumption.~10. Medication affecting the autonomic nervous system.~11. Revision surgery.~12. Dizziness.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Control Group (Type: ACTIVE_COMPARATOR): During the procedure, the patient in the control group receives pharmacological sedation, which is the standard of care currently practiced. Such sedation allows intraoperative anxiolysis, which is constantly required by patients in order to dissociate from their surroundings. Recall that total knee replacement surgery is extremely noisy, and the surrounding environment is itself an anxiety-provoking factor for the patient. Light to moderate, intraoperative sedation is carried out by intermittent boluses of midazolam 1 mg IV. Boluses are given every 5 minutes until a sedation level of -2 or -3 on the RASS (Richmond Agitation-Sedation Scale) scale is reached.~Patients randomized to the control group will undergo perioperative anesthesia according to the current standards of care, without the addition of the VR headset or headphones.
- VRH Group (Type: EXPERIMENTAL): They will experience an underwater experience while listening to hypnotic script designed to induce a change in state of consciousness, increasing parasympathetic system tone and relaxation response, and reducing the perception of painful stimuli.~During the whole procedure, an anesthesiologist will perform the usual cares, including closely monitoring, and will administrate intravenous sedation (midazolam) when necessary (see sedation protocol in the previous section).

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 Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).~Exclusion Criteria:~* Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities~* Requirement for a medication during the study that is on the list of prohibited medications.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 76 Years
- Healthy Volunteers: f

Study Arms:
- Usual Care (Type: ACTIVE_COMPARATOR): Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
- Ubrogepant 50 mg (Type: EXPERIMENTAL): Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
- Ubrogepant 100 mg (Type: EXPERIMENTAL): Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

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: Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study

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

Eligibility Criteria:
Inclusion Criteria:~* Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.~Exclusion Criteria:~* 1. previous gastrectomy or colectomy 2. inadequate bowel preparation, 3. obstructive lesions of the colon 4. severe colitis, gastrointestinal bleeding 5. allergy to fentanyl or midazolam 6. American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, 7. mental retardation 8. regular use of narcotics 9. pregnancy 10. refusal to provide a written informed consent.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- EGD-colonoscopy group (Type: ACTIVE_COMPARATOR): In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to EGD and colonoscopy examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded.
- Colonoscopy-EGD group (Type: ACTIVE_COMPARATOR): In this study group, patients receive a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to colonoscopy and EGD examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded.

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: Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients with proven HIV-1 infection~* Naïve or antiretroviral experienced~* CD4 cell count between 200 and 500/mm3~* Plasma HIV RNA load lower than 4 log10 copies/mL~* Signed written informed consent~Exclusion Criteria:~* Immunotherapy~* Immunization with the PPV within the past 5 years~* Splenectomy~* Use of intravenous immunoglobulin within the past 2 months~* Chemotherapy or radiation~* Any other vaccination within the past 2 months~* Severe renal failure~* End-stage liver disease~* Pregnancy

- 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: Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~Healthy volunteers:~1. Must be 18 years of age or older.~2. Must have no known medical problems and have had a full medical exam within 6 months of the study.~3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.~4. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization).~5. Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.~Cancer subjects:~1. Greater than 18 years-old at the time of radiotracer administration~2. Provides written informed consent~3. Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy~4. Able to remain still for duration of each imaging procedure (about one hour)~Exclusion Criteria~1. Less than 18 years-old at the time of radiotracer administration~2. Pregnant or nursing

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

Study Arms:
- Healty Volunteers (Type: OTHER): Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.
- Breast Cancer (Type: EXPERIMENTAL): Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection.
- Glioblastoma Multiform (brain) (Type: EXPERIMENTAL): Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection.
- Lung Cancer (Type: EXPERIMENTAL): Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection.

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

Answer: outcome: complete