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

Trial Title: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

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:~1. Female aged ≥18 and ≤45 years with a viable pregnancy.~2. Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements.~3. Diagnosis of ICP.~4. (Part 2 only) Qualified level of pruritus associated with ICP, during screening.~Exclusion Criteria:~1. At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication.~2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG or BPP) at or within 7 days before the baseline visit.~3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.~4. Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- Part 1 Arm 1 - Volixibat 20mg (Type: EXPERIMENTAL): Participants randomized to this arm will receive volixibat 20mg twice daily.
- Part 1 Arm 2 - Volixibat 80mg (Type: EXPERIMENTAL): Participants randomized to this arm will receive volixibat 80mg twice daily.
- Part 2 Arm 1 - Volixibat Selected Dose mg (Type: EXPERIMENTAL): Participants randomized to this arm will receive volixibat selected dose (mg) twice daily.
- Part 2 Arm 2 - Placebo (Placebo Comparator) (Type: PLACEBO_COMPARATOR): Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.

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

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

Trial Title: Analysis of Aldehyde Biomarkers of Exposure and Host Response

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:~* Smokers of at least 5 pack years;~* Stable smoking habit for 3 months;~* Willing to make a serious quit attempt;~* Able to use nicotine replacement therapy~Exclusion Criteria:~* Regular use of anti-inflammatory medication~* Inflammatory lung disease~* Unstable medical condition

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

Study Arms:
- Nicotine replacement therapy (NRT) (Type: EXPERIMENTAL): open label NRT self comparator design

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

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

Trial Title: Vesair Clinical Trial

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

Eligibility Criteria:
Inclusion Criteria:~* Post-menopausal women with SUI for at least 12 months~* Average of at least one leak per day~* Failed non-invasive treatment~* Willing to undergo cystoscopy and a minimum of 5 visits over one year~Exclusion Criteria:~* BMI \> 40.0~* Last menstrual period within 12 months of enrollment~* On birth control and/or oral hormone replacement therapy~* Urge-predominant mixed incontinence~* SUI due to intrinsic sphincter deficiency~* Prior treatment with the Vesair Balloon~* Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment~* Recurrent or recent (within the past 5 years) kidney stones~* Recurrent or recent (within the past 3 months) Urinary Tract Infection~* Stage 3 or higher cystocele (POP-Q)~* Interstitial or follicular cystitis / painful bladder syndrome~* Local genital infection~* Artificial sphincter~* Anatomic abnormalities which would interfere with device placement.~* Visible blood in the urine~* Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc~* History of cancer of the urinary tract~* History of any cancer within the past two years (excluding non-melanoma skin cancers)~* History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)~* Immunologically suppressed or immunocompromised~* Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation~* Non ambulatory / unable to do simple pad weight testing exercises~* On anticoagulation therapy with the exception of aspirin~* History of mental illness requiring inpatient treatment~* Neurological disease such as Parkinson's or multiple sclerosis~* Uncontrolled diabetes (A1C \> 9%)~* Recent alcohol or drug abuse requiring treatment in the past year~* Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis~* Allergy to polyurethane or perfluorocarbons

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

Study Arms:
- Vesair (Type: EXPERIMENTAL): Subjects are treated with Vesair Balloon at enrollment (day 0)
- Sham (Type: SHAM_COMPARATOR): Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.

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 Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

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

Study Arms:
- SprayShield Adhesion Barrier (Type: EXPERIMENTAL): SprayShield Adhesion Barrier
- Control (Type: SHAM_COMPARATOR): Good Surgical Technique Alone

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: Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old

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

Eligibility Criteria:
Inclusion Criteria:~* FAP (Functional Abdominal Pain) according to Rome III criteria for~* Child/Adolescent (Rasquin, 2006);~* 1 or more abdominal pain episodes per week over the past 8 weeks;~* Informed consent by study participant and at least one parent / legal guardian;~* Age 8-14 years;~* Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;~* Ability to understand and comply with the requirements of the trial;~* Stated availability throughout the study period.~Exclusion Criteria:~* Chronic illness;~* Surgery of Gastrointestinal tract;~* Any organic symptoms and/or clinical signs of disorder or disease other than FAP;~* Weight loss of 5% or more in body weight over the preceding 3 months;~* Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;~* Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;~* Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.~* Participation in other clinical trials in the past 3 months;~* Subjects with anemia;~* Subjects with special dietary needs

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 14 Years
- Healthy Volunteers: f

Study Arms:
- L. reuteri protectis tablets (Type: EXPERIMENTAL): one tablet a day for 4 weeks
- Placebo tablet (Type: PLACEBO_COMPARATOR): one tablet a day for 4 weeks

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: ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects with confirmed diagnosis of Parkinson's disease or Dementia with Lewy Bodies~* MoCA score 11 to 23, inclusive, at screening~* Probable Parkinson's Disease Dementia or Lewy Body Dementia~* BMI between ≥ 16and ≤ 35 kg/m2 for females and between≥ 18 and ≤ 35 kg/m2 for males at Screening~* Reliable and capable support person/caregiver, who is willing to accept responsibility for supervising the treatment or, if required, administering study drug, and assessing the condition of the subject throughout the study in accordance with all protocol requirements~Exclusion Criteria:~* Hoehn-Yahr stage 5~* History of significant neurological disease other than PDD or DLB that may affect cognition at onset of dementia~* Subjects on deep brain stimulation~* History of brain MRI scan indicative of any other significant abnormality~* History of unexplained loss of consciousness, and epileptic fits~* Hearing test result considered unacceptable for auditory ERP P300 assessment~* Diagnosis of severe major depressive disorder even without psychotic features (GDS score \[15-item scale\] \>7 at Screening)~* Significant suicide risk based on C-SSRS~* Significant psychosis (according to Diagnostic and Statistical Manual of Mental Disorders)~* Moderate or severe substance abuse disorder (according to DSM-5)~* Myocardial infarction or unstable angina within the last 6 months~* Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)~* Clinically significant ECG abnormality at Screening~* Chronic kidney disease (eGFR \< 45 mL/min using Cockcroft-Gault formula)~* Hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or Child-Pugh class B and C~* Malignant tumor within 3 years before Screening~* Memantine at any dose or combination~* Donepezil at 23 mg

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- 40mg Dose (Type: EXPERIMENTAL): Daily subcutaneous injection of 40mg ATH-1017
- 70mg Dose (Type: EXPERIMENTAL): Daily subcutaneous injection of 70mg ATH-1017
- Placebo (Type: PLACEBO_COMPARATOR): Daily subcutaneous injection of 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: Manual Wheelchair Skills Training for Long-term-care Residents

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

Eligibility Criteria:
Inclusion Criteria (wheelchair user):~* be seventeen (17) or older~* be a manual wheelchair user, living in a long-term-care facility;~* be expected to require the long-term use of a wheelchair (at least four \[4\] hours/week for at least eight \[8\] weeks), as reported by a clinical therapist;~* be competent to give informed consent (as indicated by a Mini Mental State Examination score of 20 or higher) or have a proxy with power of attorney willing to provide consent,~* have the verbal endorsement of the clinical therapist (if any) to participate;~* have the written permission of the attending physician to participate;~* be willing to take part in the study, including signing the consent after carefully reading it.~Exclusion Criteria (wheelchair user):~* have an unstable medical condition (e.g. angina, seizures), as determined by the attending physician, house staff or ERN;~* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending physician, house staff or ERN.~Inclusion Criteria (caregiver):~* be seventeen (17) or older;~* provide at least part-time \[at least one (1) hour/week\] wheelchair-handling care for a wheelchair user in a long-term-care facility;~* be willing to take part in the study, including signing the consent form after carefully reading it.~Exclusion Criteria (caregiver):~* have an unstable medical condition (e.g. angina, seizures), as indicated by self-report;~* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by self-report.

- Gender: ALL
- Minimum Age: 17 Years
- Maximum Age: None
- Healthy Volunteers: t

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: Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy

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

Eligibility Criteria:
Inclusion Criteria:~* Participants are willing and able to give written informed consent and to comply with all of the study visits and procedures~* Age \>= 55 years, or with a Sorror co-morbidity index of \>= 3~* Post allogenic hematopoietic stem cell transplantation using bone marrow, peripheral blood or cord blood; or after pre planned donor lymphocyte infusion~* Presumptive diagnosis of acute GVHD necessitating high-dose corticosteroid treatment (with an approximate starting dose of methylprednisolone equivalent of 2 mg/kg/day)~* Within 5 days of receiving corticosteroid treatment~* ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 or equivalent Karnofsky score of 60 or higher~* The patient is referred to the study by their stem cell transplant attending physician~Exclusion Criteria:~* Non-English speaking~* Underlying unstable cardiac or pulmonary disease in the opinion of the investigator that limits participant involvement in exercise~* Has a pre-transplant echocardiogram with ejection fraction \< 45%~* Requires supplemental oxygen to maintain oxygen (O2) saturation \> 92%~* Musculoskeletal injury that precludes participation in an exercise program~* Inability to participate in a structured exercise program~* Patients for whom the physician feels is unsafe for an exercise program~* Platelets equal to or less than 10,000 or evidence of active bleeding~* Patients who are unable to understand or follow through with the exercise program

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

Study Arms:
- Supportive care (exercise intervention) (Type: EXPERIMENTAL): Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.

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: Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

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

Eligibility Criteria:
INCLUSION CRITERIA:~* Patient and family must agree to return to the clinic up to 8 times within 2 months~* Children ≥ 8 and \<18 years of age at the time of study entry who were previously treated for:~* a hypothalamic tumor~* mid-line brain tumor~* a tumor involving one or both thalami~* craniopharyngioma~* diagnosis of hydrocephalus secondary to a brain tumor or treatment of a brain tumor that required placement of a permanent shunt.~* Off cancer treatment for at least six months~* Proficient in English~* Able to swallow capsules~* Experiencing symptoms of excessive daytime sleepiness (EDS) for at least three months prior to study entry that is not a result of inadequate sleep hygiene or other known medical disorder.~* Negative pregnancy test~EXCLUSION CRITERIA:~* Patients treated with doxorubicin or high dose cyclophosphamide~* History of a clinically significant drug sensitivity to methylphenidate, modafinil, armodafinil or any of their components~* Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease~* Have taken methylphenidate or modafinil within the last 14 days~* Current/concurrent use of antihistamines, benzodiazepine, anticonvulsants or alcohol~* Clinical diagnosis of major depression, subclinical depression, or anxiety disorder~* History of psychosis or mania~* Patients with suicidal ideation~* Diagnosis with anemia, untreated hypothyroidism, mononucleosis or narcolepsy~* History of substance abuse~* Pregnant or breast feeding~* A total dietary intake of more than 500 mg of caffeine per day (e.g., approximately ten 330 mL cans of soft drinks, five cups of coffee or tea, or 750 g chocolate per day).

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Arm I - methylphenidate hydrochloride (Type: EXPERIMENTAL): Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
- Arm II -modafinil (Type: EXPERIMENTAL): Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
- Arm III placebo (Type: PLACEBO_COMPARATOR): Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.

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

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

Trial Title: Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically confirmed hormone-refractory metastatic prostate cancer~  * Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease~* Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL~PATIENT CHARACTERISTICS:~* ECOG performance status 0-2~* Estimated life expectancy ≥ 6 months~* Absolute neutrophil count ≥ 1,500/mm³~* Hemoglobin ≥ 8 g/dL~* Platelet count ≥ 100,000/mm³~* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min~* Bilirubin normal~* AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria:~  * AP normal and AST and ALT ≤ 2.5 times upper limit of normal (ULN)~ * AP elevated and AST and ALT normal~* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80~* No peripheral neuropathy \> grade 1~* No concurrent active infections~* No concurrent major depression or suicidal ideation~* No concurrent medical condition that would preclude study participation~* No known HIV positivity~* Fertile patients must use effective contraception during and for 10 weeks after completion of study therapy~PRIOR CONCURRENT THERAPY:~* Recovered from prior surgery or radiotherapy~* No prior chemotherapy, retinoids, or interferon therapy~* More than 4 weeks since prior flutamide~* More than 6 weeks since prior bicalutamide

- Gender: MALE
- 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: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Diagnostic Yield of Deep Learning Based Denoising MRI in Cushing's Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Patients suspected of Cushing disease undergoing MRI~* Signed informed consent~Exclusion Criteria:~* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction~* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential~* Poor MRI image quality due to artifacts

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

Study Arms:
- Denoising MRI group (Type: None): Patients suspected of Cushing disease undergoing deep learning based denoising MRI

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

Answer: outcome: terminate
termination_type: enrollment issues