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

Trial Title: A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

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

Eligibility Criteria:
Key Inclusion Criteria:~* Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit.~* Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments.~* Onset of seizures at 11 years of age or younger.~* Abnormal cognitive development.~* Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments.~Key Exclusion Criteria:~* Etiology of seizures is a degenerative neurological disease.~* History of hemiclonic seizures in the first year of life.~* Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.~* Pulmonary arterial hypertension.~* Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.~* Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine.~* Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.~* Currently receiving an investigational product.~* Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care).~* A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 35 Years
- Healthy Volunteers: f

Study Arms:
- ZX008 0.2 or 0.8 mg/kg/day (Type: EXPERIMENTAL): Part 1: ZX008 is supplied as an oral solution. Subjects will be randomized to receive 1 of 2 doses of ZX008 0.2 mg/kg/day or 0.8 mg/kg/day.
- Matching Placebo (Type: PLACEBO_COMPARATOR): Part 1: Matching ZX008 placebo is supplied as an oral solution.
- Open-Label (Type: EXPERIMENTAL): Part 2: ZX008 is supplied as an oral solution. Study medication will be administered twice a day (BID) in equally divided doses.

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: Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

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

Eligibility Criteria:
Inclusion Criteria:~* healthy women aged 18 years or above;~* requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle;~* having menstrual cycles between 24 and 42 days~* willing to abstain from further acts of unprotected intercourse and;~* available for follow-up over the next 6 weeks.~Exclusion Criteria:~* post-abortion or postpartum and period have not yet returned,~* being on prescription drugs currently~* having unprotected intercourse in this cycle more than 72 hours or more than once before attending the clinic,~* being found pregnant at the time of presentation,~* breastfeeding,~* having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,~* uncertain about the date of the last menstrual period,~* having used hormonal contraceptive (including EC pill) or NSAID in the current or past one cycle,~* having history of asthma, urticarial or other allergic reactions to piroxicam, aspirin or other NSAIDs,~* having history of ischaemic heart disease in the past one year~* having history of pelvic ulcer disease and/or gastrointestinal bleeding

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

Study Arms:
- Piroxicam (Type: ACTIVE_COMPARATOR): Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose

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: Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Severe hypertriglyceridemia~Exclusion Criteria:~* HbA1c \>/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year~* Body mass index (BMI) \>40 kg/m2~* History of bariatric surgery or currently on weight loss drugs~* Use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing~* Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. Group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period.~* Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with potential lipid-altering effects unless dose is stable and well controlled for 30 days prior to dosing~* Any Screening laboratory values that are out of allowed reference ranges~* Inability to comply with protocol or study procedures~* Any other significant illness or condition that may adversely affect the subjects participation in the study

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

Study Arms:
- Group 1 (Type: EXPERIMENTAL): Non-extensive PK/non post-prandial
- Group 2a (Type: EXPERIMENTAL): Extensive PK
- Group 2b (Type: EXPERIMENTAL): Post-prandial assessment
- Group 3 (Type: EXPERIMENTAL): Stable dose of fibrate
- Group 4 (Type: EXPERIMENTAL): Fredrickson Type 1 dyslipidemia

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: STepped Exercise Program for Knee OsteoArthritis

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

Eligibility Criteria:
Inclusion Criteria:~* Veteran enrolled at the Durham VA Medical Center (VAMC)~* Physician diagnosis of knee osteoarthritis~* Current knee joint symptoms~Exclusion Criteria:~* Currently meeting physical activity guidelines~* Currently completing Physical Therapy (PT) visits for knee OA~* Gout (in knee)~* Rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease~* Dementia~* Psychosis~* Active substance abuse disorder~* Meniscus or anterior cruciate ligament (ACL) tear in the past 6 months~* Total joint replacement, other major lower extremity surgery in the past 6 months or planned in the next 9 months~* Severe hearing impairment~* Serious/terminal illness~* Other health problem that would prohibit participation in the study and/or warrant immediate PT~* Current participation in another OA intervention study~* Unstable angina~* History of ventricular tachycardia~* Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)~* Uncontrolled hypertension (diastolic blood pressure \>110 mm/Hg or systolic \> 200mm/Hg)~* Stroke with moderate to severe aphasia

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

Study Arms:
- STEP-KOA (Type: EXPERIMENTAL): This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.
- Arthritis Education (AE) (Type: ACTIVE_COMPARATOR): Participants in the AE control group will receive low literacy educational materials via mail every two weeks. Because STEP-KOA is a multi-component intervention, with participants receiving different numbers of Steps, it is not possible to implement a control condition that will mirror the exact intervention dose received by all participants in the STEP-KOA group. However, AE will achieve the goal of providing an active, OA-related control condition.

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: Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

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

Eligibility Criteria:
Inclusion Criteria:~* At least 18 years old~* Diagnosed with type 2 diabetes mellitus~* HbA1c of 7.1% to 11.0%, inclusive, at screening~* Has stable body weight, i.e., not varying by \>3% for at least 3 months prior to screening~* Fasting plasma glucose concentration \<280 mg/dL (15.5 mmol/L) at screening~* Body mass index of \<45 kg/m2 at screening~* Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)~Exclusion Criteria:~* History of pancreatitis or triglycerides \>=500 mg/dL~* Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either~* History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance \<50 mL/min~* Active cardiovascular disease~* Presence or history of severe congestive heart failure~* Central nervous system disease, including epilepsy~* Liver disease~* History of severe gastrointestinal diseases~* Clinically significant malignant disease~* Repeated severe hypoglycemia within the last 6 months~* Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog~* Any DPP-4 inhibitor within 3 months prior screening

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

Study Arms:
- Exenatide once weekly suspension (Type: EXPERIMENTAL): Exenatide once weekly suspension 2mg subcutaneous injection
- Sitagliptin 100mg (Type: ACTIVE_COMPARATOR): Overencapsulated Sitagliptin 100mg oral tablet once daily
- Placebo (Type: PLACEBO_COMPARATOR): Placebo oral capsule once 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: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

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

Eligibility Criteria:
Inclusion Criteria:~* term (≥ 37+0 weeks) singleton pregnancy~* a vertex presentation~* ruptured membranes for less than 12 hours~* negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks~Exclusion Criteria:~* active labor~* absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)~* contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery

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

Study Arms:
- Antibiotic group (Type: ACTIVE_COMPARATOR): women submitted to antibiotic prophylaxis
- Control group (Type: NO_INTERVENTION): 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: High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

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:~1. Clinical diagnosis of ALS~2. Male or female subjects aged 18 years or older~3. Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or PEG) or jejunostomy tube (J-tube)~4. Must require non-invasive ventilation (BIPAP) for less than 10 hours/day~5. Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.~Exclusion Criteria:~1. History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy, prior biliary disease such as gallstones~2. History of diabetes~3. History of prior myocardial infarction or stroke~4. Laboratory values: Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal~5. Allergy to soy, fish, or milk products

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

Study Arms:
- High fat/high calorie (Type: EXPERIMENTAL): High fat/high calorie diet: Oxepa
- High calorie (Type: ACTIVE_COMPARATOR): High calorie diet: Jevity 1.5
- Control (Type: PLACEBO_COMPARATOR): Control diet: Jevity 1.0

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: Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with primary or secondary hip osteoarthritis who are scheduled for cemented total hip replacement at the Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.~* Written informed consent is obtained from the patient or the legally accepted representative.~Exclusion Criteria:~* Patients with rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures~* Patients with previous allergic reaction on non-steroidal anti-inflammatory drugs~* Patients with gastrointestinal complaints at admission, a history of gastrointestinal ulcers or perforations, inflammatory bowel-disease, hepatic dysfunction, renal dysfunction with a clearance below 30 ml/min and cardiac insufficiency.~* Patients with blood pressure consistently \> 140/90 mmHg and who have not been adequately controlled.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 95 Years
- Healthy Volunteers: f

Study Arms:
- Drug: Etoricoxib (Arcoxia, MSD), 90 mg. (Type: EXPERIMENTAL): Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.

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: Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Male and Female outpatients 18-65 years of age~Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:~* Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or~* Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial~Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:~• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.~Exclusion Criteria:~* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.~* Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase

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

Study Arms:
- OPC-34712 (Brexpiprazole) and Escitalopram (Type: EXPERIMENTAL): OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
- OPC-34712 and Fluoxetine (Type: EXPERIMENTAL): OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
- OPC-34712 and Paroxetine CR (Type: EXPERIMENTAL): OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
- OPC-34712 and Sertraline (Type: EXPERIMENTAL): OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
- OPC-34712 and Duloxetine (Type: EXPERIMENTAL): OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
- OPC-34712 and Venlafaxine XR (Type: EXPERIMENTAL): OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day

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 Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.~2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.~Exclusion Criteria:~1. Two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation.~2. Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- Soticlestat Dup 15q (Type: EXPERIMENTAL): Soticlestat tablets twice daily (BID) orally or via gastrostomy tube (G-tube)/ percutaneous endoscopic gastrostomy (PEG) tube, BID. Participants with Dup 15q weighing \<60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
- Soticlestat CDD (Type: EXPERIMENTAL): Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing \<60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.

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: Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~Systemically healthy patients with sites showing PPD ≥ 5 mm, CAL ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months.~-~Exclusion Criteria:~* Subjects allergic to MF or AV Those on systemic MF or AV therapy Subjects with aggressive periodontitis Immunocompromised subjects Use of tobacco in any form, alcoholics Lactating, and pregnant females

- Gender: ALL
- Minimum Age: 25 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- Group 1 (Type: PLACEBO_COMPARATOR): Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
- Group 2 (Type: ACTIVE_COMPARATOR): Aloe vera gel to be delivered at baseline, 6 and 12 months.
- Group 3 (Type: ACTIVE_COMPARATOR): 1% metformin gel to be delivered at baseline, 6 and 12 months.

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

Answer: outcome: complete