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

Trial Title: A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.~* Subjects must have adequate vital organ function and functional status for HDM + ASCT~* Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.~* At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.~* Subjects must have measurable disease according to one of the following criteria:~  1. Serum M-spike ≥0.1 g/dl~ 2. Urine M-spike \>200 mg in a 24-hour urine collection~ 3. Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.~* At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy~Exclusion Criteria:~* Prior allogeneic or autologous hematopoietic stem cell transplant~* Current active infections, including HIV and hepatitis C and B~* Autoimmune disease requiring ongoing immunosuppressive therapy.~* History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.~* History of transient ischemic attack or stroke.~* At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.

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

Study Arms:
- HDM+ASCT (Type: ACTIVE_COMPARATOR): Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation
- BI-505 (Type: EXPERIMENTAL): Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation

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: Whey Protein Concentrate 40% Made of Milk of Immunized Cows to Aid in the Prevention of Relapse of Clostridium Difficile-Diarrhea

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

Eligibility Criteria:
Inclusion Criteria:~Eligible subjects must meet all of the following inclusion criteria:~* Willingness and ability to comply with all study requirements, to fully understand all elements of informed consent, and to provide written informed consent.~* Confirmed CDAD by ELISA toxin assay or cell test.~* Are currently receiving or have received standard antibiotic treatment for CDAD with oral/intravenous metronidazole and/or vancomycin for a minimum of 10 days per standard of care at the discretion of the study physician.~* Resolution of diarrhea to a maximum of 3 stools per day following completion of antibiotic therapy.~* Ability to tolerate fluids by mouth or by feeding tube.~* Have passage of stools.~Exclusion Criteria:~Subjects will not be eligible to participate in this study if any of the following exclusion criteria apply:~* Unable to provide informed consent.~* History of lactose intolerance.~* Cannot tolerate fluids by mouth or by feeding tube, or are judged by the attending physician unfit to receive fluids by mouth or by feeding tube.~* Have received an investigational drug within 4 weeks prior to study entry.~* Have underlying gastrointestinal tract disease characterized by diarrhea or unformed stools.~* Are currently receiving any antidiarrheal medications.~* Current use of an ileostomy or colostomy.~* History of milk allergy.~* Current use of Saccharomyces boulardii, Lactinex, or Culturelle preparations at start of study. (S. boulardii is a non-colonizing yeast species purported to support gastrointestinal tract function. It has been widely studied and used to help prevent post-antibiotic diarrhea.)~* Reside outside of the United States.~* Cannot speak or read English.

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

Trial Title: Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

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

Eligibility Criteria:
Inclusion Criteria:~* Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.~Exclusion Criteria:~* Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.

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

Study Arms:
- A (Type: EXPERIMENTAL): Lactulose Group
- B (Type: ACTIVE_COMPARATOR): Plantago Group

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: Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

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. Both type 1 and type 2 diabetes~2. HbA1c 7-11%~3. Treated with MDI for at least 3 months~4. Ability to use the system at home, mobile phone~Exclusion Criteria:~1. Active CAD, CVA during last 6 months~2. Treatment with steroids or other glucose modifying drugs~3. Chronic infection/cancer/other severe disease

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- GlucoMe App (Type: EXPERIMENTAL): Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App

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: Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome

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:~1. Subjects will be selected if they have Prader Willi Syndrome previously confirmed by standard genetic testing (the DNA methylation test) or meet the clinical diagnostic criteria as follows :the presence of at least four of the six principal characteristics of PWS syndrome including 1) infantile hypotonia, 2) abnormal pubertal development, 3) obesity after early infancy, 4) dysfunctional central nervous system performance, 5) dysmorphic facial features, and 6) short stature. In addition, they must have one or more of the following characteristics commonly associated with PWS: 1) small hands and feet, 2) skin problems, 3) behavioral problems related to food, and 4) decreased pain sensitivity.~2. Subjects must be 18 to 35 years of age and fairly cooperative with the study protocol.~3. Subjects must have a BMI of at least 30 or more.~Exclusion Criteria:~1. Presence of pulmonary disease.~2. Presence of any other abnormal endocrine findings, including abnormal thyroid function.~3. Presence of significant behavioral problems or psychiatric illness including anxiety disorder and depression, interfering with the follow up of protocol. Any degree of depression and moderate to severe anxiety will be exclusion criteria for this study.~4. Subjects with Prader Willi Syndrome who are on other medications including growth hormone therapy, anti epileptic medications, or antipsychotic medications.~5. The presence of moderate to severe renal or liver disease. Mild elevations of liver enzymes are not exclusive.~6. Subjects who are on any other research or weight loss medication

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

Study Arms:
- I (Type: EXPERIMENTAL): Subjects receive rimonabant 20 mg per day PO
- II (Type: PLACEBO_COMPARATOR): Subjects take placebo capsule one a day PO

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

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

Trial Title: Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression

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

Eligibility Criteria:
Inclusion Criteria:~* Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive).~* Patients with a moderate-severe level of emotional distress who meet the diagnostic criteria for major depression for at least two weeks or adjustment disorder with depressive mood for at least two months, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (DSM-V), during the twelve months following the diagnose of breast cancer.~* Informed Consent Form Signature~Exclusion Criteria:~* Women who are pregnant or breastfeeding.~* Suicide risk.~* Metastatic brain disease.~* Personal History of oncological disease.~* Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).~* Personal History of organic brain disorder, substance abuse/dependence.~* Personal History of psychotic disorder, bipolar disorder and/or mental retardation.~* Contraindications of citalopram treatment.~* Taking antidepressants after the breast cancer diagnosis.~* Psychotherapy treatment after breast cancer diagnosis .

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Citalopram 20-40 mg (Type: EXPERIMENTAL): Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.
- Psychotherapy (Type: EXPERIMENTAL): Participants received one psychotherapy session weekly for 12 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: UVA1 Light for Scleroderma and Similar Conditions

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:~* Age: 10-80 years~* Clinical diagnosis of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and other related conditions associated with altered dermal matrix.~* No disease states or physical conditions which would impair evaluation of the test site.~* Willing and able to receive UVA1 as directed in the protocol, make evaluation visits, and follow protocol restrictions.~* Signed, written, witnessed, informed consent form.~* Must live within driving distance of Ann Arbor, Michigan.~Exclusion Criteria:~* History of photosensitivity.~* Pregnant or nursing women.~* Systemic therapy for the fibrosing skin condition within 30 days prior to study enrollment.~* Involved in an investigational study within the previous 4 weeks.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- UVA1 Irradiation (Type: EXPERIMENTAL): UVA1 irradiaton up to 5 times per week, for up to 16 weeks using German manufactured UVA1 emitting light system. UVA1 dose will be applied with up to 130 J/cm2.

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: The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

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

Eligibility Criteria:
Inclusion Criteria:~1. 18-89 years old on the day of enrollment.~2. Currently admitted to study designated medical or surgical ward~3. Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.~4. Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.~5. Completed SBAR handover (Situation, Background, Assessment, Recommendation)~6. SIRS present as defined by the presence of two or more of the following:~   * Temperature \> 38°C or \< 36°C~  * Heart Rate \> 90 beat/min~  * Tachypnea \> 20/min or PaCO2 \< 32 mmHg~  * WBC count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)~Exclusion Criteria:~1. Consent not provided~2. Patients less than 18 years of age, or 90 years of age or older.~3. Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.~4. Patients that are not located in the designated medical or surgical ward associated with the study.~5. Patients listed for Comfort Measures Only.~6. Less than 2 SIRS criteria~7. Commencement of narrow spectrum directed antibiotics prior to screening.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 89 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: Fycompa in Catamenial Epilepsy

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

Eligibility Criteria:
Inclusion Criteria:~* Female~* Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history~* Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses~* ≥18-50 years old~* ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED)~* Seizures must show a C1 catamenial pattern in 2 of 3 documented cycles i. C1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. The menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (Herzog et al, 1997). Of note, in the NIH Progesterone Trial, the level of catameniality was 1.69 based on Herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation.~* Willingness and ability to comply with scheduled visits and study procedures~Exclusion Criteria:~* Progressive neurologic or systemic disorder~* Use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing IUD who still have monthly periods may be enrolled)~  a. Women on system hormonal contraception will be excluded as these women are not ovulatory~* Subject is pregnant or breastfeeding~* Active suicidal or homicidal ideation~* Comatose individuals.

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

Study Arms:
- Fycompa 4 mg daily (Type: EXPERIMENTAL): None
- Fycompa 4 mg daily with a boost to 6 mg daily (Type: ACTIVE_COMPARATOR): None

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: Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?

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:~* Elective colon and rectal cancer surgery with primary anastomosis~* Or elective colorectal surgery for suspected carcinoma~* No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CTthorax)~* Procedure either with or without diverting stoma~* Both laparoscopic and open surgery~* Informed consent~* Aged 18 years or older~Exclusion Criteria:~* Previous colorectal malignancy~* Current malignancy which is now undergoing treatment~* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)~* Previous surgery for diverticular disease~* Performance status ASA 4 or higher (American Society for Anaesthesiologists)~* Expected adverse reactions/allergies for study medication~* Prednisone use \> 5 mg per day~* Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)~* Mental disorder/unable to give informed consent~* Pregnancy

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

Study Arms:
- Standard treatment (Type: NO_INTERVENTION): Standard treatment for colorectal cancer
- Selective decontamination of the digestive tract (SDD) (Type: EXPERIMENTAL): Standard treatment + SDD perioperatively 4 times daily 10 ml of SDD suspension, consisting of 100mg colistin sulfate, 80mg tobramycin and 500mg of amphotericin B.~SDD treatment starts 3 days before surgery and is continued until at least 3 days postoperatively.

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: Maintenance Dosing of Vitamin D in Crohn's Disease

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: EARLY_PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Diagnosis of Crohn's disease~2. In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4~3. 25(OH)D level \<30 ng/ml within three months of study enrollment~4. Prior 25(OH)D level \<30 ng/ml currently on repletion therapy~5. Provided written informed consent~6. 18 years of age or older~7. All maintenance therapies required to be on stable doses for 3 months.~Exclusion Criteria:~1. Unwilling to provide consent or lack capacity~2. Clinical disease activity (Harvey Bradshaw index \>4)~3. Current pregnancy or attempting to conceive~4. Hypercalcemia (must have calcium level within 6 months of enrollment)~5. Known coexisting hyperparathyroidism~6. BMI \>30 kg/m²~7. History of kidney stones~8. Subjects \<18 years of age - pediatric population with different recommended dosing than adults~9. Non-english speakers~10. Has an ileo-anal pouch or ileostomy~11. C-reactive protein greater than 2x the upper limit of normal~12. Lactose intolerant~13. Short gut syndrome~14. Renal insufficiency (CrCl \<60 ml/min)~15. Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental products containing vitamin D~16. Vitamin D levels \<30ng/ml at completion of lead in

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- Vitamin D 1000 IU D3 daily (Type: ACTIVE_COMPARATOR): None
- Vitamin D 5000 IU D3 daily (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: enrollment issues