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

Trial Title: Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

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. Children under the age of 18 years.~2. IBD Diagnosis~3. Initiating Vedolizumab therapy~Exclusion Criteria:~1. Starting Vedolizumab to prevent post operative recurrence

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

Study Arms:
- Vedolizumab (Type: EXPERIMENTAL): IV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks

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: Effect of Vitamin D Treatment on Fatigue

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:~* BMI 18-25 kg/m2~* Serum 25-Hydroxy-Vitamin D level \< 20 mkg/l~* Adequate contraception during the study period~* Informed consent~Exclusion Criteria:~* Anemia with Hb level \< 120 g/l~* Known hypersensitivity to vitamin D~* Intake of vitamin D preparations (including) during the last 8 weeks before the start of the trial protocol~* Pregnancy or lactation or intention to become pregnant during the course of the study~* Any cardiovascular, pulmonary, renal or hepatic disease~* Presence of muscle disease, CK\>167 U/L~* Presence of known bone disease, alkaline phosphatase \> 104 U/l~* Severe infection/inflammation or malignancy~* Known mental disorders (e.g. depression), sleep disorders~* Chronic intake of concurrent medication, except oral contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed.~* CRP \> 10 mg/l~* TSH out of normal range~* Ferritin \<15 µg/L~* Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the participants.~* Participation in any other therapeutic trial within the previous month~* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia etc.~* Enrollment of the investigator, his/her family members, employees and other dependent persons

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- Cholecalciferol (Type: ACTIVE_COMPARATOR): 100 000 units vitamin D3 single dose
- Placebo (Type: PLACEBO_COMPARATOR): similar appearance

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: Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors

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: None

Eligibility Criteria:
Inclusion Criteria:~* Must have pathologically or cytologically confirmed advanced solid malignancy for which there is no standard treatment exists.~* Solid malignancy that has persisted or recurred following prior therapy or advanced solid malignancy for which docetaxel is considered an acceptable first line treatment option:~  * Non-Small Cell Lung~ * Breast~ * Head and Neck~ * Esophageal~ * Stomach~ * Ovarian carcinomas~* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2~* Life expectancy of at least 12 weeks.~* Must have adequate organ function~* Peripheral Neuropathy must be less than Grade 2

- 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: Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Over 40 years of age~* Kellgren \& Lawrence grade I-III~* If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS~* Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study~Exclusion Criteria:~* Body mass index \> 32~* Have rheumarthritis~* Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS~* Have Sudek's atrophy, Paget's disease, Spinal disc herniation~* Kellgren \& Lawrence Grade IV

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo and then LBSA0103 (Type: EXPERIMENTAL): The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee.
- Hyruan Plus (Type: ACTIVE_COMPARATOR): The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.

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: D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement

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:~1. age\>18years,male or female without pregnancy;~2. Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;~3. The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).~Exclusion Criteria: Patients with following diseases within 3 months.~1. deep venous thromboembolism~2. Pulmonary embolism~3. Aortic dissection~4. stroke~5. Cerebral hemorrhage~6. Myocardial infarction

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

Study Arms:
- Standard intensity of anticoagulation (Type: None): After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
- Low intensity and adjusted by elevated D-dimer (Type: None): The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
- Low intensity without adjustment (Type: None): The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

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: A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder

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:~* Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)~Exclusion Criteria:~* Participant has a history of suicide attempt~* Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time~* Participant has active psychosis~* Participant has a medical history of seizures~* Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder

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

Study Arms:
- Part A: SAGE-217 (Type: EXPERIMENTAL): Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated.
- Part B: Placebo (Type: PLACEBO_COMPARATOR): Eligible participants received matching placebo capsules once daily for 14 days.
- Part B: SAGE-217 (Type: EXPERIMENTAL): Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.

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: Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

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:~Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin.~Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.~Exclusion Criteria:~* Breastfeeding female.~* Pregnant female.~* Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2.~* Patients with type 1 diabetes mellitus.~* Patients with diabetic ketoacidosis.~* Patients with urinary tract infections.~* Dehydrated patients till normalized.~* Lower limb amputation patients.~* SGLT2 inhibitors hypersensitivity.~* Severe hepatic patients.~* Patients on neuroprotective drugs.

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

Study Arms:
- Control group (Type: NO_INTERVENTION): include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
- Empagliflozin group (Type: EXPERIMENTAL): include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)

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: A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months~* On stable dose of methotrexate for at least 6 weeks prior to screening~* Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL~* Not currently receiving steroid medication~Exclusion Criteria:~* Pregnant or nursing women~* Patients that have active infections, TB, HIV and/or Hepatitis B or C~* Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids

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

Study Arms:
- PF-04171327 10 mg (Type: EXPERIMENTAL): None
- PF-04171327 25 mg (Type: EXPERIMENTAL): None
- Prednisone (Type: ACTIVE_COMPARATOR): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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: PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin

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. Subject who received the enough study information and signed informed consent form.~2. Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.~3. Subject is male or female patient ≥18 years old.~4. Subject who has complained low back pain for 3 months or more before Visit 1.~5. Subject who is refractory to prior analgesics for 3 months and more.~6. Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.~7. Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)~Exclusion Criteria:~1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.~2. Subject who has been already treated by pregabalin

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

Study Arms:
- Pregabalin (Type: None): Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
- Usual care (Type: None): Patients will be treated for 8 weeks with other analgesics in usual care: no intervention

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: Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Meets protocol-specified criteria for qualification and contraception~* Is willing and able to comply with any restrictions related food, drink and medications~* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures~Exclusion Criteria:~* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters~* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:~  1. the safety or well-being of the participant or study staff~ 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)~ 3. the analysis of results

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

Study Arms:
- Edoxaban-based Regimen (Type: EXPERIMENTAL): Edoxaban-based regimen 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing must follow the locally approved label.
- VKA-based Regimen (Type: ACTIVE_COMPARATOR): VKA-based regimen oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator will monitor the patient and adjust the VKA dose to maintain the dose within target.

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: Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds

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:~* Presence of a dermatological wound caused by superficial second-degree burn with up to 20% of the body surface or deep second degree with area of 5 to 15% of the body surface;~* Absence of previous treatment for the current burn~* Without other significant diseases that could impact their participation in the study~Exclusion Criteria:~* Hypersensitivity to materials used in the study or to related compounds;~* History of serious adverse reactions;~* Addiction to drugs, including alcohol;~* Pregnancy~* Labor or miscarriage in the 12 weeks prior to the scheduled start of treatment.

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

Study Arms:
- Sulfadiazine, Silver (Type: ACTIVE_COMPARATOR): Intervention: Treatment with silver sulfadiazine ointment. Procedures: wound washing, application of silver sulfadiazine ointment, bandage covered with gauze and bandage. These patients undergone the change of dressings on alternate days.
- Skin of Nile tilapia (Type: EXPERIMENTAL): Intervention: treatment with skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.~Procedures: wound washing, application of tilapia skin and dressing with gauze and bandage. These dressings were changed if the skin of the tilapia was loose (not adhered).

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: Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Males and non-pregnant females who are 12 years of age and older.~* Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)~* A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).~Exclusion Criteria:~* Pregnant or lactating women.~* History of anaphylaxis and/or other severe local reaction(s) to skin testing.~* History of positive test for HIV, Hepatitis B or Hepatitis C infection.~* Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.~* Subjects with an active pulmonary disorder or infection.~* Subjects with posterior subcapsular cataracts or glaucoma~* Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- GSP 301 NS (Type: EXPERIMENTAL): None
- GOM-NS (Type: ACTIVE_COMPARATOR): None
- GMM-2 NS (Type: ACTIVE_COMPARATOR): None
- GSP 301 placebo NS (Type: PLACEBO_COMPARATOR): None

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: Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia

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

Eligibility Criteria:
Inclusion Criteria:~* Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year~* experiencing an acute episode, with a total PANSS score at screening between 70 and 120~* agree to voluntary hospitalization for a minimum of 14 days~* willing and able to fill out self-administered questionnaires~* must be able to be compliant with self-administration of medication, or have consistent help/support available.~Open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy~* patient and investigator must agree that open-label treatment is in the best interest of the patient.~Exclusion Criteria:~* Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia~* DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)~* history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)~* history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)~* previous history of a lack of response (2 adequate trials) to any antipsychotic~* significant risk of suicidal or violent behavior. Open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior~* received an injection of a depot antipsychotic since entry into the preceding double-blind phase.

- 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: Brexpiprazole in Patients With Schizophrenia

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* The patient has completed the lead-in study 14644A.~* The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.~* The patient agrees to protocol-defined use of effective contraception.~Exclusion Criteria:~* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.~* The patient has a clinically significant unstable illness diagnosed during Study 14644A.~* The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.~* The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.~* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply.

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

Study Arms:
- Brexpiprazole (Type: EXPERIMENTAL): None

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

Answer: outcome: complete