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

Trial Title: Tricaprilin Liquid Formulation PK Study

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.~* Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring~* Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).~* Male and female~* Agrees to comply with study procedures including blood draws, confinement to clinic, meal requirements~* Continuous non-smoker or infrequent smoker (no more than 10 cigarettes per week for at least 3 months prior to Screening)~Exclusion Criteria:~* History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement~* Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen \[up to 2 g per day\], hormone replacement therapy and hormonal contraception are permitted).~* Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products.

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

Study Arms:
- Part 1 (Formulation Optimisation) (Type: EXPERIMENTAL): Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided 30 minutes after study drug administration. There will be 4 different formulations of the study drug and participants will be randomised to one of 4 sequences. There will be a washout of 2 days between each administration.
- Part 2 (Placebo Assessment) (Type: EXPERIMENTAL): Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment.~Participants are randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods.
- Part 3 (Titration Tolerability) (Type: EXPERIMENTAL): Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment.~Participants will be randomised to either study drug or the matching placebo.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Trusted Messenger Intervention

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

Eligibility Criteria:
Inclusion Criteria:~* Able and willing to give verbal informed consent to participate in the study or able to assent with guardian consent~* Expected to remain in the hospital for the duration of the study~* Mental health diagnosis Demographics~* Male, female, or transgender (no exclusion criteria based on gender or sexual orientation)~* Ages 18 or older~* Any race or ethnicity~* English speaking~Exclusion Criteria:~* Cognitive impairment sufficient to interfere with participant's ability to provide assent~* People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to converse with the Trusted Messenger verbally~* People who have received any of the available forms of the COVID-19 vaccine, or those with a medical exemption for receiving the vaccine.

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

Study Arms:
- Trusted Messenger (Type: EXPERIMENTAL): The trusted messenger patient intervention will involve training a small number of staff trusted messengers to engage patients informally and assist with building vaccine confidence in brief one- on-one sessions, supported by trusted messengers weekly consultations with a content expert who can answer specific vaccine related questions that patients have over a 3-week period. Trusted messengers will be full time unit employees, selected with the assistance of the nursing supervisor for having excellent rapport with patients (assessed with the Nurse Coordinator Questionnaire) and for having been vaccinated. Mental health workers or nurses may serve in this role. Both inpatient units involved in this study will be grouped into the same vaccination cohort within the hospital, to provide patients in the intervention and the wait list similar opportunities to be vaccinated.
- Standard Care (Type: NO_INTERVENTION): After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Stem Cell Transplantation for Fanconi Anemia

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Patients must be less than (\<) 18 years of age with a diagnosis of Fanconi anemia.~* Patients must have an HLA-A, B, DRB1 identical unrelated donor or less than or equal to (≤)1 antigen mismatched related (non-HLA-matched sibling) or \<1 antigen mismatched unrelated UCB donor. Patients and donors will be typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing.~* Patients with FA must have aplastic anemia (AA), myelodysplastic syndrome without excess blasts, or high risk genotype as defined below.~  * Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions~ * Platelet count \<20 x 10\^9/L~ * ANC \<5 x 10\^8/L~ * Hgb \<8 g/dL~ * Myelodysplastic syndrome with multilineage dysplasia with or without chromosomal anomalies~ * High risk genotype (e.g. IVS-4 or exon 14 FANCC mutations, or BRCA1 or 2 mutations)~* Adequate major organ function including~  * Cardiac: ejection fraction greater than (\>)45%~ * Hepatic: bilirubin, AST/ALT, ALP \<2 x normal~ * Karnofsky performance status \>70% or Lansky performance status \>50%~* Women of child-bearing age must be using adequate birth control and have a negative pregnancy test~Exclusion Criteria:~* Available HLA-genotypically identical related donor~* History of gram negative sepsis or systemic fungal infection (proven or suspected based on radiographic studies)~* Refractory anemia with excess blasts, or leukemia~* Active central nervous system (CNS) leukemia at time of hematopoietic cell transplant (HCT)~* History of squamous cell carcinoma of the head/neck/cervix within 2 years of HCT~* Pregnant or lactating female~* Prior radiation therapy preventing use of total body irradiation (TBI) 450 centigray (cGy)

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

Study Arms:
- HSCT Patients (Type: EXPERIMENTAL): Patients who received total body irradiation (450 cGy \[centigray\]) with thymic shielding prior to chemotherapy regimen and Hematopoietic Stem Cell Transplant (HSCT)

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

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: None

Eligibility Criteria:
Inclusion criteria:~* Enrollment in Protocol GIPF 002 Part B or GIPF-004~* Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004~* Able to understand and sign a written informed consent form and comply with the requirements of the study~Exclusion criteria:~* pregnancy or lactation~* lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens~* if Principal Investigator deems patient is unsuitable for study

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

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock~* Mechanically ventilated~* Expected length of stay in ICU ≥ 4 days~* Written informed consent obtained from authorized surrogates~Exclusion Criteria:~* Pregnancy~* Requirement for inspired oxygen content (FIO2) \> 0.60~* High output bronchopleural fistula

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

Study Arms:
- Study group (Type: EXPERIMENTAL): Individualization of caloric administration with indirect calorimetry and 2.0 to 2.2 g/kg/day of protein. Early initiation of nutritional support (24 hours of admission)
- Control group (Type: ACTIVE_COMPARATOR): Nutritional support initiated in the first 24 hours of admission. Protein and caloric goals calculated as 25 Kcal/kg/day and 1.4 to 1.5 g/kg/day of protein.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Cerclage for Short Cervix in Twins

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

Eligibility Criteria:
Inclusion Criteria:~* at least 14 years of age, but less than 55 yrs of age~* must be able to read and write English~* must be able to give informed consent.~* Twin pregnancy~Exclusion Criteria:~* Women with a serious physical or mental illness or condition that would substantially interfere with participation in the study~* membrane prolapse beyond the external cervical os,~* major fetal anomaly in either twins will be excluded from randomization.

- Gender: FEMALE
- Minimum Age: 14 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- Cerclage (Type: ACTIVE_COMPARATOR): - Macdonald cerclage placed in standard fashion
- Expectant management (Type: ACTIVE_COMPARATOR): - Patient is placed on activity restrictions

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: Obstructive Sleep Apnea Syndrome in Glaucoma

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

Eligibility Criteria:
Inclusion Criteria:~* OSAS planned begin of a nCPAP treatment~Exclusion Criteria:~* Current malignancy~* Oral steroids

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 95 Years
- Healthy Volunteers: f

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Evaluation of Hysterotomy Site After Open Fetal Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* SSM Cardinal Glennon Fetal Care Institute evaluation~* Received Open Fetal Surgery~* Open fetal surgery of myelomeningocele: maternal age of \>= 18 yrs. and \<=50 yrs.~* If a woman \< 18 years old presented with a fetal tumor requiring open fetal repair, this would be done if deemed ethically sound by both CG and St. Mary's Health Center (SMHC) ethics committees. Given this, then the patient may qualify for this study. This is a RARE event.~* Agree to travel to SSM St. Mary's in St. Louis for sonohysterogram 6 or more months after delivery.~Exclusion Criteria:~* Presently pregnant~* Hysterectomy after delivery~* Menopause~* Using IUD (Intrauterine Device) for birth control~* There is no exclusion criteria for infants

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: f

Study Arms:
- single-arm study (Type: EXPERIMENTAL): This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery. These women will undergo sonohysterogram.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

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:~1. Subject has provided informed consent.~2. Subject is ≥ 18 years of age at the time of consent.~3. Subject will be undergoing an elective midline laparotomy.~4. Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:~   1. High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism~  2. Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI \< 35; ii.Age \> 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery~Exclusion Criteria:~1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.~2. Subject for which the device is used outside the product IFU, including;~   1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period~  2. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics~  3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).~3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.~4. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.~5. Subject has participated in an investigational drug or device research study within 30 days of enrollment.~6. Subject has a life expectancy of \<2 years.~7. Subject has an ASA Physical Status Classification System score \>3.~8. Subject has \>5 total risk factors or \>2 high-risk factors

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

Study Arms:
- Hernia prevention cohort (Type: OTHER): single arm safety study, no control arm

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation

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:~* Richter's Transformation, arising in the setting of prior CLL, documented by histologically confirmed lymphoma, including large B-cell and immunoblastic variants.~* All patients must have received at least one prior regimen for CLL, including cytotoxic chemotherapy, anti-CD20 monoclonal antibodies, a BTK inhibitor, or a PI3K inhibitor. Patients may have received high dose chemotherapy/autologous stem cell transplant (HDT/ASCT) or allogeneic hematopoietic stem cell transplant (allo SCT).~* One or more measurable (\> 1.5 cm in longest dimension) disease sites on CT (preferably PET/CT) or, if CT is contraindicated, MRI (preferably PET/MRI) scans.~* Objective documented evidence of disease progression at study entry~* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2~Exclusion Criteria:~* Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1, except ibrutinib which may be continued until one day prior to initiation of selinexor; radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Patients must have recovered to Grade ≤ 1 from clinically significant adverse effects.~* Prolymphocytic transformation~* Less than 1 month since completion of autologous stem cell transplantation or less than 3 months since completion of allogeneic stem cell transplantation~* Major surgery within 4 weeks of C1D1~* Impairment of GI function or GI disease that could interfere with the absorption of selinexor, including obstructed GI tract and uncontrolled vomiting or diarrhea.~* Inability or unwillingness to take supportive medications including a centrally acting appetite stimulant (e.g., mirtazapine or olanzapine) and a peripherally acting appetite stimulant (e.g., low dose glucocorticoids or megesterol acetate).

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

Study Arms:
- selinexor (Type: EXPERIMENTAL): oral tablets~* 10 mg \& 25 mg (bottled); or~* 20 mg (blister pack)

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Transfer and Ultrafiltration In Peritoneal Dialysis

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

Eligibility Criteria:
Inclusion Criteria:~* Patients hospitalized in the Nephrology department of the Besançon University Hospital~* Patients treated by continuous ambulatory peritoneal dialysis or ambulatory peritoneal dialysis for at least 6 months~* Absence of hospitalization caused by an infection in the month prior to inclusion~* Patients with a ratio (D / P) of the concentration of creatinine in the blood and dialysate between 0.5 and 0.8 on a checkup of less than 1 year.~* No contraindication to the use of hypertonic bag~* Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study~* Affiliation to a French social security system or beneficiary~Exclusion Criteria:~* Legal incapacity or limited legal capacity~* Patients unlikely to cooperate in the study and/or low cooperation anticipated by the investigator~* Patients without health insurance~* Pregnant women~* Patient being in the exclusion period from another study or planned by the national register of volunteers~* Hospitalization caused by an infection in the month prior to inclusion~* Patients with a peritoneal dialysis catheter dysfunction

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

Study Arms:
- conventional scheme followed by alternate schem (Type: EXPERIMENTAL): The first day of the study, patients receive an adapted conventional peritoneal dialysis scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²).~The second day, patients receive an adapted and alternate scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once.
- alternate scheme followed by conventional scheme (Type: EXPERIMENTAL): The first day of the study, patients receive an adapted and alternate peritoneal dialysis scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once.~The second day, patients receive an adapted conventional scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²).

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

Answer: outcome: terminate
termination_type: enrollment issues