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

Trial Title: Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

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

Eligibility Criteria:
Inclusion Criteria:~* Adult male subject aged 18 to 65 years inclusive~* BMI \> 30 kg/m2 and \< 50 kg/m2~* Serum total testosterone concentration below the normal range~* LH levels below the upper limit of normal~* Oestradiol levels within or above the normal range of approved assay~* At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction~Exclusion Criteria:~* Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments~* Other types of hypogonadotropic hypogonadism or primary hypogonadism~* Any other pituitary or hypothalamic disease

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

Study Arms:
- BGS649 0.1 mg (Type: EXPERIMENTAL): BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
- BGS649 0.3 mg (Type: EXPERIMENTAL): BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
- BGS649 1.0 mg (Type: EXPERIMENTAL): BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
- Placebo (Type: PLACEBO_COMPARATOR): Placebo weekly (3 indistinguishable placebo capsules)

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: Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

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:~* 18 years of age or older~* Active, stable plaque psoriasis defined by the following criteria:~  * Body surface area (BSA) ≥ 10 % at screening and baseline~ * Or, PASI \>10 at screening and baseline~ * Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline~ * Or, DLQI \> 10 at baseline~* Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI \> 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.~* Failure of at least one systemic psoriasis therapy for nail psoriasis~* Eligible to receive biologic therapy for psoriasis in accordance to local guidelines~Exclusion Criteria:~* Evidence of Skin conditions other than psoriasis~* Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation~* Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
- 2 (Type: ACTIVE_COMPARATOR): etanercept 50 mg SC once weekly for the complete 24 week treatment 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: Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1~* Agreement to maintain the same dose of metformin from randomization to the end of the study~* Age in the range of 18-78 years inclusive~* Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1~* HbA1c in the range of \> 7.0 to ≤10% at Visit 1~* Agreement to maintain prior diet and exercise habits during the full course of the study~* Ability to comply with all study requirements~Exclusion Criteria:~* Fasting Plasma Glucose (FPG) \> 270 mg/dl (15 mmol/L) at Visit 1~* Pregnant or nursing (lactating) women~Other protocol-defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 78 Years
- Healthy Volunteers: f

Study Arms:
- Vildagliptin Dose 1 (Type: EXPERIMENTAL): None
- Vildagliptin Dose 2 (Type: EXPERIMENTAL): 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: A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy.

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

Eligibility Criteria:
Inclusion Criteria:~* History of simple or complex partial epilepsy that has been documented or witnessed~* an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy~* during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks~* and no seizure-free interval longer than 3 weeks~* good physical health.~Exclusion Criteria:~* Patients having solely generalized seizures or lacking documentation of partial epilepsy~* patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy~* generalized seizures, which are defined by the EEG wave pattern~* seizures that lack an abnormal pulsation pattern on EEG~* females who are pregnant, nursing, or those not using adequate birth control if capable of having children

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

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Drug-drug Interaction Study Between GLPG1205 and a Cocktail of CYP450 Substrates in Healthy Male Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* healthy male, age 18-50 years~* BMI between 18-30 kg/m2~Exclusion Criteria:~* Poor or moderate metabolizer for CYP2C9 or CYP2C19 as determined by genotyping~* Having a contraindication as indicated in the respective Summary of Product Characteristics (or Package Leaflets) for warfarin, omeprazole or caffeine~* Intake of nutraceuticals within 3 weeks prior to dosing or within 6 times the elimination half life~* Intake of enzyme inducing or enzyme inhibiting drugs within 3 months prior to dosing~* Intake of vitamin K within 3 weeks prior to dosing~* Any condition that might interfere with the procedures or tests in this study~* Drug or alcohol abuse~* Smoking

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

Study Arms:
- GLPG1205 and single CYP450 substrate cocktail dose (Type: EXPERIMENTAL): Daily GLPG1205 administration from Day 1 to Day 12 Single GLPG1205 co-administration on Day 13 with CYP450 substrate cocktail
- Placebo and single CYP450 substrate cocktail dose (Type: PLACEBO_COMPARATOR): Daily Placebo administration from Day 1 to Day 12 Single Placebo co-administration on Day 13 with CYP450 substrate cocktail

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: Using Imaging to Assess Effects of THC on Brain Activity

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

Eligibility Criteria:
Inclusion Criteria General~1. Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive)~2. Competent and willing to provide written informed consent;~3. Able to communicate in English language.~4. Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC~   Additional Inclusion Criteria For Phase 2B:~5. Past consumption of at least two alcoholic beverages in one occasion.~6. Past co-consumption of alcohol and THC at least once in lifetime with no serious adverse effects.~7. Weigh more than 100 lbs.~Exclusion Criteria:~General (Phase 2A, 2B 3)~1. Any unstable, serious medical illness, or cardiovascular disease or events.~2. New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder,~3. Diabetes, cirrhosis, renal failure, Hepatitis C, HIV,~4. History of syncope without an identified situational stressor, migraines \>1x/month, head injury with prolonged unconsciousness (\> 24 hours);~5. Allergy to sesame oil (contained in Marinol pills) or Marinol capsules~6. Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents;~7. Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)~8. In the opinion of the investigator, not able to safely participate in this study.~   Additional Exclusion Criteria For Phase 2B:~9. Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- Phase 2A (Type: EXPERIMENTAL): In a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order.
- Phase 2B (Type: EXPERIMENTAL): In a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 4 sequences and received each of the following treatments: placebo dronabinol + placebo ethanol, placebo dronabinol + ethanol, dronabinol + placebo ethanol, \& dronabinol + ethanol.

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 of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses

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

Eligibility Criteria:
Inclusion Criteria:~* Willing and able to consent for participation;~* Willing and able to attend postoperative examinations per protocol schedule;~* Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;~* Other protocol-specified inclusion criteria may apply.~Exclusion Criteria:~* Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;~* Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;~* Untreated or uncontrolled Glaucoma;~* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;~* Poorly dilating pupil or other pupil defect;~* Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®);~* Severe retinal disorders;~* Corneal disease or retinal detachment;~* Other protocol-specified exclusion criteria may apply.

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

Study Arms:
- CVS with 45° Balanced Tip (Type: EXPERIMENTAL): Centurion® Vision System, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
- CVS with 45° MFK Tip (Type: ACTIVE_COMPARATOR): Centurion® Vision System, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
- IVS with 45° MFK Tip (Type: ACTIVE_COMPARATOR): lnfiniti® Vision System, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up

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 Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

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:~* Thoracic esophageal squamous cell carcinoma~Exclusion Criteria:~* Preoperative chemoradiotherapy~* Cardiovascular disease with NYHA grade III or IV~* Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo~* Liver cirrhosis~* Renal failure

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: 77 Years
- Healthy Volunteers: f

Study Arms:
- Control group (Type: PLACEBO_COMPARATOR): Patients in the control group received saline for 7 days starting at the beginning of surgery
- S group (Type: ACTIVE_COMPARATOR): Patients in the S group received sivelestat sodium hydrate at a dosage 4.8mg/kg/day for 7 days starting at the beginning of surgery

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: An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* The following inclusion criteria are consistent with information in the SYMLIN package insert and apply to insulin using patients with type 2 or type 1 diabetes who:~  * Have failed to achieve the desired or optimal level of glycemic control despite utilizing appropriate, individualized insulin regimens~ * Have A1C \<=9.0% within 3 months of study enrollment~ * Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN~Exclusion Criteria:~* The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:~  * Are poorly compliant with their current insulin regimen, as defined by their HCP~ * Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP~ * Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months~ * Have hypoglycemia unawareness~ * Have a confirmed diagnosis of gastroparesis~ * Require the use of drugs that stimulate gastrointestinal motility~ * Are female and pregnant or lactating and for whom the HCP determines the potential benefit does not justify the potential risk to the fetus or infant~ * Have been treated with SYMLIN within 3 months prior to study start

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

Study Arms:
- Type 1 (Type: None): Patients with type 1 diabetes
- Type 2 (Type: None): Patients with type 2 diabetes

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: Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)

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

Eligibility Criteria:
Inclusion Criteria:~* persistently elevated serum aminotransferase levels~* diffusely echogenic liver on imaging studies suggestive of fatty liver~* biopsy consistent with the diagnosis of NAFLD~Exclusion Criteria:~* hepatic virus infections (HCV RNA-PCR negative)~* Hepatitis A, B, C, D, E and G~* cytomegalovirus and Epstein-Barr virus~* alcohol consumption~* history of parenteral nutrition~* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism~* autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- DHA250 (Type: EXPERIMENTAL): DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
- DHA500 (Type: EXPERIMENTAL): DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
- PLA (Type: PLACEBO_COMPARATOR): placebo and lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

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: Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV

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:~* Willingness to take CBD and to participate in follow up for two months~* Older than 21 and younger than 60~* Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count \<350cells/ml)~Exclusion Criteria:~* Conditions/medications that may impair the immune response, e.g., rheumatoid arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease), cellulitis, autoimmune diseases such as lupus, sarcoidosis~* All medications that may affect inflammation such as aspirin, steroids, statins; CD4 count \<350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)~* UF(University of Florida)/Shands staff and students will not be considered for enrollment

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- CBD Intervention (Type: EXPERIMENTAL): Participants will self-administer CBD daily for 2 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: A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with a major depressive episode (MDE)~* Body mass index less than or equal to 40 kg/m2~* Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study~* History of inadequate response during the entire current MDE to 1 or 2 adequate antidepressant treatments, including current treatment~* Be otherwise physically healthy~Exclusion Criteria:~* Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder~* Have a clinically significant current axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder~* Are experiencing hallucinations, delusions, or any psychotic symptomatology in the current MDE~* Receive new onset psychotherapy within 6 weeks of screening~* Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening~* Have received electroconvulsive therapy during the current MDE~* Have attempted suicide within the past 2 years~* Have a thyroid pathology~* Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome~* Have a positive test for human immunodeficiency virus (HIV)~Additional inclusion/exclusion criteria may apply

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

Study Arms:
- ALKS 5461 (Type: EXPERIMENTAL): 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: PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases

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:~* histologically or cytologically proven SCLC~* measurable disease defined by RECIST criteria~Exclusion Criteria:

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

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

Answer: outcome: complete