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

Trial Title: A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

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

Eligibility Criteria:
Inclusion Criteria:~* Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).~* Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).~* subjects must have good or fair diabetic control (Hgb A1c \< 10%)~Exclusion Criteria:~* Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.~* Subject receives treatment for seizures.~* Subject has had any amputations other than diabetically-related toe amputations.~* Subject has major skin ulcers.~* Subject has clinically significant ECG abnormalities.~* Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.~* Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.~* At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.~* subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (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: Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* patients undergoing mechanical valve replacement surgery~Exclusion Criteria:~* combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery~* valvular replacement redo~* valvular replacement surgery secondary to infective endocarditis~* on dialysis~* ALT levels 2-3 times higher than normal range~* CHD,~* impaired gastrointestinal function~* indication for vitamin D supplementation within the prior month~* hypercalcemia defined as total calcium \>10.4 mg/dl~* hyperphosphatemia defined as serum phosphate \> 4.5 mg/dl~* pregnancy and lactation.

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

Study Arms:
- Alfacalcidol (Type: EXPERIMENTAL): Patients allocated to the alfacalcidol group received 2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay.
- Control (Type: NO_INTERVENTION): Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol.

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: GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 10.0

Eligibility Criteria:
Inclusion Criteria:~* A signed and dated written informed consent prior to study participation~* Males or females of non-childbearing potential~* 40 to 80 years of age~* COPD diagnosis~* 10 pack-years history or greater of cigarette smoking~* Post-bronchodilator FEV1/FVC ratio of 0.70 or less~* Post-bronchodilator FEV1 of 35 to 70% of predicted normal~Exclusion Criteria:~* Asthma~* Other significant respiratory disorders besides COPD, including alpha-1 deficiency~* Previous lung resection surgery~* Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening~* Hospitalization for COPD or pneumonia within 3 months of screening~* Any significant disease that would put subject at risk through study participation~* BMI greater than 35~* Pacemaker~* Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)~* Cancer~* Allergy or hypersensitivity to anticholinergics or inhaler excipients~* Diseases that would contra-indicate the use of anticholinergics~* Use of oral corticosteroids within 6 weeks of screening~* Use of long-acting beta-agonists within 48 hours of screening~* Use of tiotropium within 14 days of screening~* Use of theophyllines or anti-leukotrienes within 48 hours of screening~* Use of short-acting bronchodilators within 4 to 6 hours of screening~* Use of investigational medicines within 30 days of screening~* Use of high dose inhaled corticosteroids~* Use of long-term oxygen therapy, CPAP or NIPPV~* Previous use of GSK573719

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo
- Tiotropium (Type: ACTIVE_COMPARATOR): Tiotropium
- Arm 1 (Type: EXPERIMENTAL): GSK573719 1000mcg once daily
- Arm 2 (Type: EXPERIMENTAL): GSK573719 500mcg once daily
- Arm 3 (Type: EXPERIMENTAL): GSK573719 250mcg once daily
- Arm 4 (Type: EXPERIMENTAL): GSK573719 125mcg once daily
- Arm 5 (Type: EXPERIMENTAL): GSK573719 62.5 mcg once daily
- Arm 6 (Type: EXPERIMENTAL): GSK573719 250mcg twice daily
- Arm 7 (Type: EXPERIMENTAL): GSK573719 125mcg twice daily
- Arm 8 (Type: EXPERIMENTAL): GSK573719 62.5mcg twice daily

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: Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

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:~Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma and primary mediastinal B cell~lymphoma.~Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, NCI. Tissue blocks from patients treated in extramural sites must be forwarded to the NCI for analysis of bcl-2 by IHC and other markers within 1 month of study entry.~Patients greater than or equal to 12 years old.~Stage and Prognosis of Patients: Any stage for MGZL and PMBL.~No prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome).~HIV negative.~Not pregnant or nursing.~Adequate major organ function \[in adults: serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 ml/min; and in children serum CR less than or equal to age-adjusted normal (age 12 to 15 maximum serum creatinine 1.2 mg/dl and age greater than 15 maximum serum creatinine 1.5 mg/dl); bilirubin less than 1.5 mg/dl; ANC greater than 1,000 and platelets greater than 100,000) unless impairment is due to organ involvement by lymphoma or immune-mediated mechanism caused by lymphoma.~No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.~No other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety.~No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancer.~Ability to give informed consent.

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

Study Arms:
- Arm A (Type: EXPERIMENTAL): EPOCH + Rituximab every 3 weeks for 6 cycles.

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: Ascorbic Acid (Vitamin C) Infusion in Human Sepsis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. systemic inflammatory response: fever (38°C or greater) or hypothermia (36°C or lower), tachypnea (20 breaths/min) or need for mechanical ventilation for an acute process, tachycardia (rate 90/min or more), white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 or more than 10% band forms.~2. Presumed or Known Site of Infection: Purulent sputum, chest radiograph with new infiltrate, spillage of bowel contents, radiographic or physical examination evidence of an infected collection, white blood cells in a normally sterile body fluid, positive blood culture, evidence of infected mechanical hardware by physical, radiographic, or ultrasonographic evidence.~3. Evidence of Dysfunction of One or More End Organs: cardiovascular dysfunction: mean arterial pressure 60 mm Hg or less, the need for vasopressors to maintain this pressure in the presence of adequate intravascular volume (central venous pressure 12 mmHg); respiratory failure: (arterial PO2-to-FiO2 ratio of less than 250 or less than 200 in the presence of pneumonia; renal dysfunction: Urine output ≤ 0.5 ml/kg/hr for 2 hours in the presence of adequate intravascular volume or doubling of the serum creatinine; hematologic dysfunction: thrombocytopenia ≤ 80,000 platelets/mm3 or 50% decrease from baseline during the acute illness; Unexplained metabolic acidosis: arterial pH ≤ 7.3 and a plasma lactate level higher than 2.5. Hepatic Dysfunction: Acute Serum transaminase elevation greater than five times normal.~4. Informed Consent: Ability to obtain informed consent within 48 hours.~Exclusion Criteria:~1. Demographic Characteristics: Children (age \< 18 years), pregnant women, prisoners, and other wards of the state are excluded from participation in this study.~2. Informed Consent: Inability to obtain informed consent within 48 hours.~3. Cognitive Impairment: In the absence of family or next of kin, if the investigators feel the patient is cognitively impaired, and unable to provide informed consent, the patient will not be accessed to the study.~4. Non-English Speaking Patients: Patients who are non english speaking will not be accessed to this study.

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

Study Arms:
- High Dose Ascorbic Acid (Type: ACTIVE_COMPARATOR): Subject receives a high dose of infused Vitamin C
- Low Dose Ascorbic Acid (Type: ACTIVE_COMPARATOR): Subject receives a low dose of infused Vitamin C
- Placebo (Type: PLACEBO_COMPARATOR): Subject receives an infusion of saline

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 Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

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:~* adult patients, \>= 18 years of age;~* chronic renal anemia;~* continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;~* regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.~Exclusion Criteria:~* transfusion of red blood cells during previous 2 months;~* poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;~* significant acute or chronic bleeding.

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

Study Arms:
- C.E.R.A. 120, 200, or 360 mcg (Type: EXPERIMENTAL): Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).

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: High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2/PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria: Gestational age \<29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support.~-~Exclusion Criteria: Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of \>1.5 mg/dL (129 μmol per liter); a platelet count of \<50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites.~-

- Gender: ALL
- Minimum Age: 12 Hours
- Maximum Age: 24 Hours
- Healthy Volunteers: f

Study Arms:
- Infant treated with high dose ibuprofen (Type: EXPERIMENTAL): 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: Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in 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:
Key Inclusion Criteria:~1. Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC~2. Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting~3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease~4. Greater than or equal to 18 years of age~5. Patients must be post-menopausal~6. Life expectancy \>3 months~Key Exclusion Criteria:~1. Greater than 3 lines of endocrine therapy for metastatic disease.~2. Prior anti-cancer treatment or investigational drug therapy within the following windows:~   1. Tamoxifen or fulvestrant therapy \< 42 days before 1st 18FES-PET scan~  2. Any other anti-cancer endocrine therapy \< 14 days before 1st dose of study drug~  3. Any chemotherapy \< 28 days before 1st dose of study drug~  4. Any investigational drug therapy \< 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug 2. Patients with untreated or symptomatic central nervous system (brain) metastases 3. Patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts

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

Study Arms:
- Elacestrant (formerly RAD1901) (Type: EXPERIMENTAL): To receive daily oral elacestrant

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 Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Type 2 diabetes~* Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months~* HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)~* BMI (Body Mass Index) maximum 40 kg/m2~Exclusion Criteria:~* Metformin contraindications according to local practice~* Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

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

Study Arms:
- BIAsp 30-30 (Type: EXPERIMENTAL): Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

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: NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female patients~* Age ≥ 18 and ≤ 50 years~* Moderately severe / severe persistent allergic rhinitis~* Positive skin prick test for perennial aero-allergens~* Active symptoms with prominent congestion at the time of inclusion~Exclusion Criteria:~* Subjects with pollen sensitization during the respective pollen season~* Subjects with arterial hypertension, arrhythmia or evidence of heart ischemia~* Subjects with other serious chronic comorbidities and bad therapeutic control~* Subjects with nasal polyposis~* Flu-like episode during the past 30 days~* Subjects unable to give informed consent~* Subjects with any of the contra-indications of oxymetazoline or NoAL~* Pregnant or lactating women

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

Study Arms:
- Group A (Type: ACTIVE_COMPARATOR): One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning \& evening, for 8 days.
- Group B (Type: PLACEBO_COMPARATOR): One puff of oxymetazoline immediately followed by one puff of placebo, morning \& evening, for 8 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: Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

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

Eligibility Criteria:
Inclusion Criteria:~* Age above 18 years;~* Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor \[C1-INH\] deficiency);~* Current edema be in the cutaneous, abdominal and/or laryngeal areas;~* Current edema be moderate to severe according to the investigator's Symptom Score.~Exclusion Criteria:~* Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);~* Participation in a clinical trial of another investigational medicinal product (IMP) within the past month;~* Treatment with any pain medication since onset of the current edema attack;~* Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack;~* Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);~* Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;~* Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;~* Pregnancy and/or breast-feeding.

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

Study Arms:
- Icatibant- Randomized (Type: EXPERIMENTAL): Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
- Placebo-Randomized (Type: PLACEBO_COMPARATOR): Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
- Controlled Open-label / laryngeal attack (Type: EXPERIMENTAL): Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
- Untreated Patients at the baseline (Type: EXPERIMENTAL): Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )

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

Answer: outcome: complete