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

Trial Title: Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion criteria INCLUSION CRITERIA~1. Patients scheduled to undergo a primary, unilateral elective total knee repla cement.~2. Male or female 18 years of age or older.~3. Patients weighing at least 40 kg.~4. Written informed consent prior to the start of study participation.~Exclusion criteria EXCLUSION CRITERIA~1. History of bleeding diathesis.~2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.~3. Major surgery or trauma (e.g. hip fracture) within the last 3 months.~4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months.~5. Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic.~   Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery.~6. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.~7. History of VTE or pre-existing condition requiring anticoagulant therapy.~8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.~9. Gastric or duodenal ulcer within the last 6 months.~10. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete recovery).~11. Elevated AST or ALT \>2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.~12. Known severe renal insufficiency (CrCl \< 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.

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

Study Arms:
- Dabigatran Dose 1 (Type: EXPERIMENTAL): low dose regimen taken once daily
- Dabigatran Dose 2 (Type: EXPERIMENTAL): high dose regimen taken once daily
- Enoxaparin (Type: ACTIVE_COMPARATOR): 30 mg subcutaneously 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: HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~1. Tumor cell phenotype consistent with B-CLL~2. Patients with active B-CLL and with an indication for treatment~3. Failing at least one fludarabine-containing treatment regimen~4. Failing at least one alemtuzumab-containing treatment regimen~5. ECOG Performance Status of 0, 1, or 2~6. Life expectancy of at least 4 months~Exclusion Criteria:~1. Previous treatment with alemtuzumab within 6 weeks prior to Visit 2~2. Previous autologous stem cell transplantation within 6 months prior to Visit 2~3. Allogeneic stem cell transplantation~4. Radioimmunotherapy

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

Study Arms:
- ofatumumab (Type: EXPERIMENTAL): Anti-CD20 antibody therapy

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 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

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

Eligibility Criteria:
Inclusion Criteria:~* Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.~* Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception~* Documented HIV infection.~Exclusion Criteria:~* Homozygous familial hypercholesterolemia~* Any conditions that may cause secondary dyslipidemia~* History of coronary artery disease (CAD) or CAD equivalent

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

Study Arms:
- Pitavastatin 4 mg QD (Type: EXPERIMENTAL): None
- Pravastatin 40 mg QD (Type: ACTIVE_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: Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female at least 18 years of age at time of screening.~2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection.~3. Treatment must have been completed at least 1 month prior to Screening Visit.~4. Screening laboratory result indicating chronic HCV GT1 infection. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements and must voluntarily sign and date an informed consent.~Exclusion Criteria:~1. History of severe, life-threatening or other significant sensitivity to any drug.~2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.~3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.~4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) in patient without known history of HIV infection.~5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.~6. History or presence of liver decompensation.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- Arm A: G/P 300 mg/120 mg QD for 12 Wks (Type: EXPERIMENTAL): Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.
- Arm B: G/P 300 mg/120 mg QD for 16 Wks (Type: EXPERIMENTAL): Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)
- Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks (Type: EXPERIMENTAL): Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)
- Arm D: G/P 300 mg/120 mg QD for 16 Wks (Type: EXPERIMENTAL): Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)

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: The Effect of Milnacipran in Patients With Fibromyalgia

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:~* Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.~* 18 through 68 years of age~Exclusion Criteria:~* Pregnant or trying to become pregnant~* Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran~* Patients who do not indicate their pain levels as less than substantial despite their best care~* History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview~* Presence of current depression as determined by psychiatric diagnostic interview~* Presence of brain lesion on MRI anatomical study

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 68 Years
- Healthy Volunteers: f

Study Arms:
- Patients taking the drug Milnacipran (Type: ACTIVE_COMPARATOR): Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.
- Patients taking the placebo (Type: PLACEBO_COMPARATOR): Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.

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: Medications for Obstructive Sleep Apnea In Children With Down Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. Enrollment will be stratified to ensure equal representation of children age 6-12 and age 13-17. No more than 14 subjects will be randomized for each age group.~2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)~Exclusion Criteria:~1. Hypoxemia independent of respiratory events on polysomnography (≥5 minutes with oxygen saturation \<90%)~2. Presence of central sleep apnea on polysomnography (central AHI ≥ 5)~3. Currently using and adherent to PAP therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report)~4. MAO inhibitor use~5. Urinary retention~6. Prematurity \< 37 weeks estimated gestational age~7. Seizure disorder~8. Untreated or inadequately treated hypothyroidism~9. Significant traumatic brain injury~10. Congenital heart disease and not cleared to participate by the patient's cardiologist~11. History of current, untreated depression~12. History of liver disease~13. 3+ or greater tonsillar hypertrophy.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- High dose ato-oxy (Type: ACTIVE_COMPARATOR): None
- Low dose ato-oxy (Type: ACTIVE_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: Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

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

Eligibility Criteria:
Inclusion criteria:~* Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.~Exclusion criteria:~* Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,~* deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,~* anticoagulant medication for more than 48 hours prior to inclusion,~* need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,~* major surgery within last 3 months, low platelet count (below 100×109/L),~* kidney disease (Calculated creatinine clearance \< 30 mL/min), woman of child-bearing potential not using reliable contraceptive method

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

Study Arms:
- Fondaparinux 2.5mg (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: Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female, ≥18 y of age~* Judged to be in generally good health~* Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening~* Body mass index of ≥20.0 kg/m2~* No clinically significant findings in a 12-lead ECG or physical examination~* Willing and able to undergo the scheduled study procedures~* Understands study procedures and signs forms documenting informed consent to participate in the study~Exclusion Criteria:~* Laboratory test result of clinical significance~* Uncontrolled hypertension~* Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder~* History of human immunodeficiency virus, hepatitis B or hepatitis C infection~* Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit~* Active systemic infection~* A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol

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

Study Arms:
- Omega-3 pentaenoic acid (MAT9001) (Type: EXPERIMENTAL): 2g MAT9001 capsules twice daily with meals
- Icosapent ethyl (Vascepa) (Type: ACTIVE_COMPARATOR): 2g Vascepa capsules twice daily with meals

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 Licorice and Hydrochlorothiazide on Plasma Potassium

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy volunteer~* Age 18-40 years~Exclusion Criteria:~* Any continuous medication~* Any significant disease~* Hypotension or hypertension~* Allergy to licorice or hydrochlorothiazide~* Pregnancy and breast feeding~* Fear of needles and previous difficult blood samplings~* Substance abuse~* Participation in another clinical drug trial within 1 month of enrollment

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Licorice (Type: ACTIVE_COMPARATOR): None
- Licorice and HCTZ (Type: ACTIVE_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: Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy male subjects~* 20 to 45 years old~* Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2~* Others~Exclusion Criteria:~* Known history of hypersensitivity to human growth hormone (hGH)~* Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies~* Others

- Gender: MALE
- Minimum Age: 20 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- ACP-001, dose-level 1 (Type: EXPERIMENTAL): None
- ACP-001, dose-level 2 (Type: EXPERIMENTAL): None
- ACP-001, dose-level 3 (Type: EXPERIMENTAL): None
- ACP-001, dose-level 4 (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: Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Female or male subject of 2 to 17 years of age (inclusive).~* Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL injections with BoNT for the treatment of spasticity.~* Ashworth Scale \[AS\] score ≥2 in plantar flexors (at least unilaterally).~* Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the treatment of LL spasticity according to the clinical judgment of the investigator.~Exclusion Criteria:~* Fixed contracture defined as severe restriction of the range of joint movement on passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).~* Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this study within 12 months prior to Screening Visit (V1), in the screening period or planned for the time of participation in this study.~* Hip flexion requiring BoNT injection.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- 16 Units per kg body weight incobotulinumtoxinA (Xeomin) (Type: EXPERIMENTAL): None
- 12 Units per kg body weight incobotulinumtoxinA (Xeomin) (Type: EXPERIMENTAL): None
- 4 Units per kg body weight incobotulinumtoxinA (Xeomin) (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: TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

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:~* Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.~* Able to utilize the HM system throughout the study~* Ability to give informed consent~* Geographically stable and able to return for regular follow-ups for fifteen (15) months~* At least 18 years old~Exclusion Criteria:~* Patients who do not fulfill all inclusion criteria~* Pacemaker dependent~* Currently enrolled in any other cardiac clinical investigation

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

Study Arms:
- Home Monitoring (Type: ACTIVE_COMPARATOR): Home Monitoring programmed on.
- In-Office Conventional Follow-up (Type: OTHER): Home Monitoring programmed off.

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: GLP-1/Basal Insulin Combination Therapy

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

Eligibility Criteria:
Inclusion Criteria:~* T2DM, age 18-85 years, documentation of basal insulin therapy for minimum of one year prior to GLP-1 initiation, and addition of weekly exenatide or daily liraglutide added to basal insulin therapy~Exclusion Criteria:~* Type 1 diabetes, patients receiving prescription medications for weight loss, and initiation of additional diabetes, hypertension or cholesterol drugs during the follow-up period

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Weekly GLP-1 therapy: exenatide (Type: None): Patients receiving weekly exenatide
- Daily GLP-1 therapy liraglutide (Type: None): Patients receiving daily liraglutide

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: Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children

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

Eligibility Criteria:
Inclusion Criteria:~* Admission to the PICU with RSV infection~* Need for positive pressure ventilation (invasive and non-invasive)~* Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit~Exclusion Criteria:~* Azithromycin use within 7 days of PICU admission~* Contraindication to azithromycin use including:~  * Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450 ms~ * Patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL)~ * Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug~ * Cardiac arrhythmia~* History of pyloric stenosis~* Immunocompromised children (any cause)~* Current use of any medication known to cause QT prolongation

- Gender: ALL
- Minimum Age: None
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- Control (Type: PLACEBO_COMPARATOR): Placebo controlled (normal saline) daily for 3 days
- Azithromycin (10 mg/kg) (Type: ACTIVE_COMPARATOR): 10 mg/kg IV Azithromycin daily for 3 days
- Azithromycin (20 mg/kg) (Type: ACTIVE_COMPARATOR): 20 mg/kg IV Azithromycin daily for 3 days

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

Answer: outcome: complete