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

Trial Title: Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: EARLY_PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Adults 18-65~* Diagnosis of SRED~* Must be able to swallow capsules and follow instructions~Exclusion Criteria:~* Women who are pregnant or lactating~* Other sleep disorders~* Kidney or Liver disease~* Night shift workers~* Previous history of Topiramate or Topamax use for any condition

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

Study Arms:
- Topiramate (Type: ACTIVE_COMPARATOR): Study medication arm, 25-300mg of Topiramate
- Placebo (Type: PLACEBO_COMPARATOR): Placebo arm of study, 25-300mg of sugar pill

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: Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania~* patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration~* minimum score of 18 on the 17-item HAM-D at screen and baseline~Exclusion Criteria:~* patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia~* patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture~* Suicidal ideation or history that makes participation in a clinical trial unduly risky~* unstable medical conditions or any abnormality in thyroid function~* patients with a QTc of 450msec or greater on the initial ECG~* patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics~* the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment~* patients with dementia or substance abuse in the last 6 months~* pregnant or lactating women will be excluded, as will those not using adequate forms of contraception

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

Study Arms:
- Ziprasidone (Type: EXPERIMENTAL): Ziprasidone monotherapy, 20-60 mg BID.

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 Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 14.0

Eligibility Criteria:
Inclusion Criteria:~* Baseline health is stable.~* Has a clinical diagnosis of chronic HCV infection.~Exclusion Criteria:~* Has a history of stroke or chronic seizures.~* Has a history of cancer.~* Has a history of human immunodeficiency virus (HIV) infection.~* Has had major surgery, donated blood or participated in another investigational study within the past 3 months.

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

Study Arms:
- 400 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
- 600 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
- 800 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
- 400 mg Grazoprevir - GT3 (Type: EXPERIMENTAL): GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
- 600 mg Grazoprevir - GT3 (Type: EXPERIMENTAL): GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
- 800 mg Grazoprevir - GT3 (Type: EXPERIMENTAL): GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
- 200 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
- 100 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
- 50 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
- 200 mg Grazoprevir - GT3 (Type: EXPERIMENTAL): GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
- 100 mg Grazoprevir - GT3 (Type: EXPERIMENTAL): GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
- 50 mg Grazoprevir - GT3 (Type: EXPERIMENTAL): GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
- 30 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
- 10 mg Grazoprevir - GT1 (Type: EXPERIMENTAL): GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo

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 Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

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. Women, 50 to 80 years of age, both inclusive.~2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.~3. Postmenopausal~4. Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.~5. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.~6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.~Exclusion Criteria:~1. Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis~2. Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening~3. Patient with history and/or presence of one severe or \> 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray~4. Patient with history and/or presence of hip fracture~5. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status~6. Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)~7. Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)~8. Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results

- Gender: FEMALE
- Minimum Age: 50 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- CT-P41 (Type: EXPERIMENTAL): 60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS)
- US-licensed Prolia (Type: ACTIVE_COMPARATOR): 60 mg/mL single dose administration, Solution for injection in PFS

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: Sirolimus for Autoimmune Disease of Blood Cells

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age \> 12 months and \< 30 years at the time of study entry~* Diagnosis of autoimmune cytopenias requiring treatment with medications~* At least one of the following: Autoimmune Neutropenia, Autoimmune Hemolytic Anemia, and/or Autoimmune Thrombocytopenia~* Must be proven autoimmune by either a documented autoantibody (positive direct anti globulin test, positive anti-neutrophil, and/or anti-platelet antibody) and/or a documented clinical response to immunosuppression~* Autoimmune Cytopenias can be idiopathic (Idiopathic Thrombocytopenic Purpura (ITP), Autoimmune Hemolytic Anemia (AIHA), Autoimmune Neutropenia (AIN), or Evans syndrome) or secondary to one of following conditions: Lupus, Rheumatoid Arthritis (RA), ALPS (Autoimmune Lymphoproliferative Syndrome), or Inflammatory bowel disease (IBD)~* Patients must have chronic disease diagnosed by either a documented cytopenia syndrome (Lupus, ALPS, RA, or IBD), or by having Evans syndrome defined as idiopathic destruction of multiple blood cell types, and/or by having disease \>6 months~* Patients must be refractory to or unable to tolerate standard front-line therapies for autoimmune cytopenias (corticosteroids and/or IVIG)~* Patients may be taking second-line agents for autoimmune cytopenias (mycophenolate mofetil, cyclosporine, tacrolimus, mercaptopurine, and/or methotrexate) at time of study entry; however, attempts should be made to wean these agents. Patients may not stay on a combination of sirolimus and a calcineurin inhibitor for greater than 4 weeks~* Informed consent/assent must be obtained prior to initiating treatment~* Patient must be able to consume oral medication in the form of tablets or solution~Exclusion Criteria:~* Pregnancy or breast feeding~* Uncontrolled infection~* Known allergy to Sirolimus or its components~* Patients with a documented malignancy on therapy or not in remission~* Patients who do not meet organ function requirements listed in protocol~* Patients with a documented history of severe combined immunodeficiency or human immunodeficiency virus infection (HIV)

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 30 Years
- Healthy Volunteers: f

Study Arms:
- Sirolimus treatment (Type: EXPERIMENTAL): Sirolimus treatment

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: Pregnenolone in the Management of Schizophrenia Patients

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

Eligibility Criteria:
Inclusion Criteria:~* DSM-IV criteria for schizophrenia or schizoaffective disorder~* Ability and willingness to sign informed consent for participation in the study~Exclusion Criteria:~* Evidence of organic brain damage, mental retardation, alcohol or drug abuse~* Prostate nodules or cancer.~* Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding.~* History of ischemic cardiac disease.~* Renal disease.~* Hepatic dysfunction.~* Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.~* Women with a history of uterine cancer.~* Patients with a known hypersensitivity to androgens.~* Pregnant women.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 55 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: Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.

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

Eligibility Criteria:
Inclusion Criteria:~* All patients (men, women) who are African American or Hispanic over the age of 21 who have been diagnosed with type 2 diabetes and have a HbA1c of greater than 8.0%. Subjects with neuropathic pain will be included in the study. Their pain will be assessed via a validated pain scale. Their primary care providers will treat their pain as necessary.~Exclusion Criteria:~* Pregnant women, patients on dialysis, patients with liver disease or liver enzymes elevated three times above normal, patients with blood pressure greater than 160 systolic or 95 diastolic on two consecutive visits, patients with history of severe depression (as determined by hospitalization or the HAM-D survey) or suicide attempts, patients on therapy for depression, patients already taking SSRI's, and patients with psychotic features or bipolar disease.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo 50 mg up to 100 mg daily for 6 months
- Sertraline (Zoloft) (Type: ACTIVE_COMPARATOR): Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months

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: Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age 18 years or older, at the time of acquisition of informed consent~* Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene~* Patients with metastatic and/or advanced (unresectable or recurrent) GISTs, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations~* imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2

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

Study Arms:
- prednisone (Type: EXPERIMENTAL): prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -\> 10mg/day-\>7.5mg/day-\>5mg/day-\>stop

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: Incretin and CRTd.

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

Eligibility Criteria:
Inclusion Criteria:~* aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.~Exclusion Criteria:~* T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.

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

Study Arms:
- incretin arm (Type: ACTIVE_COMPARATOR): T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
- conventional hypoglycemic drug arm (Type: PLACEBO_COMPARATOR): T2DM with HF treated by CRTd participants will be assigned prospectively to placebo comparator (placebo plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

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: Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

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

Eligibility Criteria:
Inclusion Criteria:~To be included in this study, you must meet the following criteria:~* Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.~* Must be surgical candidates~* No previous treatment for esophageal cancer~* Must have measurable or evaluable disease~* Able to perform activities of daily living with minimal to no assistance~* Adequate bone marrow, liver and kidney function~* Provide written informed consent~Exclusion Criteria:~You cannot participate in this study if any of the following apply to you:~* Tumor location in the proximal esophagus~* Metastatic disease or locally advanced cancer~* Moderate to severe peripheral neuropathy~* Serious pre-existing medical illnesses~* Significant heart disease~* Treated for an invasive cancer within the previous 5 years~* Women who are pregnant or breast-feeding~* Age \< 18 years~Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
- Cohort 2 (Type: EXPERIMENTAL): Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.

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: Oral Nutrition After Regular Radical Cystectomy

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

Eligibility Criteria:
Inclusion Criteria:~* regular radical cystectomy~Exclusion Criteria:~* preoperative contra-indications for enteral nutrition (EN): intestinal obstruction, malabsorption, multiple high-output fistula and intestinal ischemia

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

Study Arms:
- Control group (Type: ACTIVE_COMPARATOR): Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
- Oral Nutrition Protocol (ONP) group (Type: EXPERIMENTAL): Oral intake was increased progressively with oral fluids and easily digestible food, independent of bowel movements. The corresponding energy content from the meals and oral fluids were calculated. Fortimel Jucy®, 200 ml containing 300 kcal, was used as the formulary energy sip. Extra fluids, up to two liter per day, were given intravenously, at the discretion of the treating physician. If the patient tolerated the ONP well, the oral intake was considered equal in terms of calories as the corresponding oral meal in the ONP. From the sixth day, the patient was allowed to eat at will. Only if oral intake remained insufficient after 5 days, which was left to the opinion of the treating physician, PN could be initiated in this group.

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: Paracervical Block in First Trimester Surgical Abortions

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* age greater than or equal to 18 years~* English-speaking~* ability and willingness to sign the informed consent~* ability and willingness to comply with the terms of the study~* voluntary request for pregnancy termination~* ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle~Exclusion Criteria:~* women who require or request sedation~* untreated acute cervicitis or pelvic inflammatory disease~* contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria~* allergic reaction or sensitivity to lorazepam or NSAIDs~* chronic NSAID use~* history of gastritis or gastric ulcer~* acute renal failure or chronic renal disease~* chronic liver disease~* history of bleeding diathesis~* chronic narcotic use~* current or past history of illegal drug use (excluding marijuana)

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

Study Arms:
- paracervical block with lidocaine (Type: ACTIVE_COMPARATOR): Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
- paracervical block with ketorolac and lidocaine (Type: EXPERIMENTAL): Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion

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

Answer: outcome: complete