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

Trial Title: Antimicrobial Therapy for Ulcerative Colitis (UC)

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

Eligibility Criteria:
Inclusion Criteria:~1. Established diagnosis of UC, disease confined to the large intestine, involving the rectosigmoid for at least 3 months.~2. Weight \>30 kg~3. Mild to Moderate active disease, SCCAI of ≥5 and ≤ 10, 10 ≤ PUCAI ≤4.~4. Refractory to mesalamine 6 weeks, or steroids \> 14 days, or immunomodulator 12 weeks or biologics at least 12 weeks therapy.~Exclusion Criteria:~1. Start of a new biologic in the previous 12 weeks.~2. Proctitis~3. Evidence for Clostridium difficile infection.~4. Any proven current infection such as CMV, positive stool culture or parasite.~5. Current Extra intestinal manifestation of UC such as active arthritis or PSC.~6. Immune deficiency (other than drug induced).~7. Current use of a calcineurin inhibitor~8. Pregnancy.~9. Suspected toxic megacolon, guarding on palpation, or signs of peritoneal inflammation~10. Patients with other IBD unrelated disease such as autoimmune disorders, renal failure, fever or current infection (UTI, strep throat, pneumonia, etc), prior or current neoplasia~11. Fever \>38~12. Participation in another clinical interventional trial~13. An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC).~14. Anticipation for antibiotic use within the study period (such as for elective surgery or dental treatment).~15. Acute severe UC in the past 3 months.~16. Presence of a pouch or pouchitis.

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Group 1 -Amoxycillin Doxycyclin and metronidazole (Type: ACTIVE_COMPARATOR): triple therapy with amoxicillin, metronidazole and tetracycline twice daily, for 2 weeks.
- Group 2 -Amoxycillin and Doxycyclin (Type: EXPERIMENTAL): double therapy with Amoxycillin and Doxycyclin twice daily, for 2 weeks.

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: Dialysate Sodium Individualization in Hemodialysis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* ESKD on hemodialysis~* Hypertension, defined as average pre-HD BP \>150/85 mmHg or use of antihypertensive drugs~* Average pre-HD serum sodium \<139 mmol/L~Exclusion Criteria:~* Intradialytic hypotension~* Atrial fibrillation or other chronic tachyarrhythmia (due to effects on measuring equipment)~* Uncontrolled hypertension (average pre-HD BP \>200/105 mmHg)~* Uncontrolled diabetes mellitus (due to problems on interpretation of serum sodium values)~* Debilitating illness~* Inability to provide written informed consent

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- standard dialysate sodium (Type: ACTIVE_COMPARATOR): In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L
- dialysate sodium individualization (Type: EXPERIMENTAL): .Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium (individualized).

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: A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

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

Eligibility Criteria:
Inclusion Criteria:~* Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient~* Diagnosis of junctional or dystrophic EB.~* Patients who present with Hallopeau-Siemens subtype may be enrolled.~* At least one active, unroofed EB erosion on the limb or on the trunk.~* Lesion size 5 to 50 cm2, inclusive.~* Stable lesion present for 14-60 days before enrollment.~* More that one member in a family can be enrolled as long as that member is treated to a different cohort with an assurance that the study medication will not be shared.~* No clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher.~Exclusion Criteria:~* Clinical evidence of local infection of the index (targeted) lesion.~* Use of any investigational drug within the 30 days before enrollment.~* Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.~* Use of systemic or topical steroidal therapy within the 30 days before enrollment.Inhaled steroids are allowed.~* Use of systemic antibiotics within the 7 days before enrollment.~* Current or former malignancy.~* Arterial or venous disorder resulting in ulcerated wounds.~* Diabetes mellitus.~* Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: PLACEBO_COMPARATOR): Placebo comparator gel does not contain any active drug. Topical administration of 0.0% Thymosin Beta 4 gel, once a day (qd) up to 56 days
- 2 (Type: ACTIVE_COMPARATOR): Topical Administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel once a day (qd) up to 56 days

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: Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes

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:~* Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer~* Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)~* Body Mass Index (BMI) equal to 40 kg/m\^2 or below~* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis~* Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation~Exclusion Criteria:~* Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening~* Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors~* Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)

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

Study Arms:
- Insulin detemir / IAsp (Type: EXPERIMENTAL): None
- insulin NPH (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: A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer

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:~* Pathologically confirmed HR+ metastatic breast cancer, currently stable or minimally progressive on current endocrine-based therapy.~* Continuing on current endocrine-based therapy with an aromatase inhibitor, selective estrogen receptor degrader, or selective estrogen receptor modulator; and must be medically eligible to remain on this therapy during the treatment period.~Exclusion Criteria:~* Uncontrolled acute life-threatening bacterial, viral, or fungal infection.~* Subjects who are pregnant or breastfeeding~* Concurrent treatment with any cytotoxic chemotherapy agent or other targeted therapies including HER2 targeting therapies~* Currently receiving, or less than 28 days since ending treatment on another investigational drug.~* Clinically significant cardiovascular disease.~* Abnormal liver function.~* Any medical, psychiatric, or other condition which, in the opinion of the investigator, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.

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

Study Arms:
- Single Ascending Dose followed by Multiple Doses (Type: EXPERIMENTAL): Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.

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: Feeding Intervention for Infants With Crying

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

Eligibility Criteria:
Inclusion Criteria:~* full term infants greater than or equal to 37 wks gestation~* 3 weeks to less than or equal to 4 months of age upon enrollment~* experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment~* otherwise healthy as reported by parent/caregiver~* is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit~* taking no more than one feeding of breast milk per day~* having not initiated weaning foods or beverages other than infant formula or breast milk~* study explained and written information provided with Parent/caregiver demonstrating understanding of the given information~* informed consent signed(parent/legal representative)~Exclusion Criteria:~* Chromosomal or major congenital anomalies~* known cow's milk allergy~* receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)~* receiving an antibiotic or probiotic in the week prior to enrollment~* complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications~* infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol~* infant currently participating in another conflicting clinical study

- Gender: ALL
- Minimum Age: 3 Weeks
- Maximum Age: 4 Months
- Healthy Volunteers: t

Study Arms:
- Infant formula with probiotic (Type: EXPERIMENTAL): Infant formula with probiotic for 0 to 12 months of age
- Standard infant formula (Type: PLACEBO_COMPARATOR): Infant formula for 0 to 12 months of age

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: A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~1. Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.~2. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.~3. Patient able to understand the study designed and cooperate with instructions of use.~4. Patient able to sign informed consent~Exclusion Criteria:~1. Woman with lactose allergy (lactose intolerance are eligible)~2. Woman with known connective tissue disorder~3. Woman with uncontrolled diabetes~4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx~5. Woman who is unable to sign an informed consent

- Gender: FEMALE
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- Breast cancer patient receiving RT (Type: None): Total dose:2Gy/Fx

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: AT1001 for the Treatment of COVID-19 Related MIS-C

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

Eligibility Criteria:
Inclusion Criteria:~1. Pediatric patients with or without comorbidity~2. Age ≥ 1 month to \< 21 years~3. Confirmed MIS-C by signs and symptoms as detailed by the CDC Health Advisory (https://www.cdc.gov/mis-c/hcp/; May 14, 2020)~   1. Persistent fever/chills (\>38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours); AND~  2. One or more laboratory parameters (evidence of inflammation); AND,~   i) elevated C-reactive protein (CRP) ii) elevated erythrocyte sedimentation rate (ESR) iii) elevated ferritin iv) elevated lactic acid dehydrogenase (LDH) v) elevated d-dimer vi) elevated fibrinogen vii) elevated procalcitonin viii) elevated interleukin 6 (IL-6) ix) increased neutrophils x) reduced lymphocytes xi) low albumin c) Evidence of clinically severe illness requiring hospitalization, with multisystem (\>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic, or neurological)-MUST include GI symptoms, such as nausea, vomiting, diarrhea and/or abdominal pain; AND, d) No alternative plausible diagnoses; AND e) Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test~4. Subject (or legal authorized representative) capable of understanding and signing an informed consent form and assent form, when appropriate.~Exclusion Criteria:~1. Female participants pregnant and/or lactating.~2. Female participant has childbearing potential and is unwilling to use an acceptable method of birth control for the duration of the study.~3. Participant has a significant co-morbid disease that by the Investigator's determination would make the participant unsuitable for enrollment, including unstable medical conditions.~4. Participation in any other clinical investigation using an experimental drug within 30 days prior to screening or intends to participate in another clinical study while participating in AT1001 MIS-C 101 study.~5. Have participated in a blood/plasma donation or blood loss greater than 400 mL within 90 days, or greater than 200 mL within 30 days prior to Screening.~6. Known hypersensitivity to any of the formulation components of AT1001.

- Gender: ALL
- Minimum Age: 1 Month
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
- Larazotide Acetate (Type: EXPERIMENTAL): AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) will be administered orally four times a day (QID) to the standard of care for MIS-C.

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: Phase IIB Pilot of Atazanavir + Raltegravir

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:~* Human Immunodeficiency Virus (HIV)-1 positive status~* HIV ribonucleic acid (RNA) level \>=5000 copies/mL~* Antiretroviral treatment-naive~* Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:~* \<350 cells/mm\^3~* Screening CD4 \>=350 and \<=500 cells/mm\^3 ONLY if at least 1 of the following conditions apply:~  * Screening HIV RNA level \>100,000 copies/mL, or~ * CD4 decline \>50-100 cells/mm\^3/year, or~ * Age \>=55 years~* Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness~* Medically stable~Exclusion Criteria:~* Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)~* Hepatitis B or hepatitis C coinfection~* History of or current cardiac disease~* Electrocardiogram findings:~* PR Interval \>260 msec (severe 1st degree atrioventricular block)~* QRS Interval \>120 msec

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

Study Arms:
- Atazanavir + Raltegravir (Type: EXPERIMENTAL): Atazanavir 300 mg twice daily + Raltegravir 400 mg twice daily
- Atazanavir + Ritonavir + Tenofovir /Emtricitabine (Type: ACTIVE_COMPARATOR): Atazanavir, 300 mg once daily, + Ritonavir, 100 mg once daily, + Tenofovir 300 mg/Emtricitabine, 200 mg once daily

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: Zuni Health Initiative - Chronic Disease Education

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:~* Diabetes with HbA1c greater than 6.6%~* Zuni Native only~* Age 21-75 yrs~* on diabetes medication~Exclusion Criteria:~* Non-Zuni Native~* Non-diabetic~* Not able to consent

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 75 Years
- 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: Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with symptomatic grade 3 and 4 haemorrhoidal disease~* Age 18-80~* Patients who are fitted for local and general anaesthesia~* Patients who are able to understand the information given and are willing to give a written consent~Exclusion Criteria:~* Previous operated for piles~* Previous operated in the anal canal~* Faecal incontinence~* Inflammatory bowel disease with affection of the anal canal~* Chronic diarrhea~* Fissura ani~* Fistula in ano~* Chronic anal pain~* Neurological illness with affection of anal sensation~* Patients not able to follow the study protocol~* Patients taking immunosuppressant medication~* Pregnancy~* Disability~* Anal polyps~* Medication affecting the coagulation system~* Circular anal prolapse

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

Study Arms:
- Milligan Morgan (Type: ACTIVE_COMPARATOR): None
- Recto Anal Repair (Type: ACTIVE_COMPARATOR): None

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 Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck~* Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck~* At least 18 years of age~* Patient must be able to understand and willing to sign a written informed consent document.~Exclusion Criteria:~* Contraindications to MRI, including:~  * MRI-incompatible implantable devices~ * severe claustrophobia; and~* Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test

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

Study Arms:
- DWI MRI + Standard of care FDG PET/CT (Type: EXPERIMENTAL): -The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.

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

Answer: outcome: terminate
termination_type: enrollment issues