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

Trial Title: Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

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

Eligibility Criteria:
Inclusion criteria:~* Signed and dated written informed consent~* Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) \> 1 year~* C-peptide value of \< 0.7 ng/mL~* Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin \>= 0.3 and \<= 1.5 U/kg~* Glycated haemoglobin (HbA1c) \>= 7.5% and \<= 10.0%~* Good understanding of T1DM~* Age \>= 18 years~* Body Mass Index (BMI) \>= 18.5 kg/m2~* Estimated glomerular filtration rate \>= 30 mL/min/1.73 m2~* Women of child-bearing potential must use highly effective methods of birth control~* Compliance with trial medication administration between 80% and 120% during placebo run-in period Further inclusion criteria apply~Exclusion criteria:~* History of type 2 diabetes mellitus, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis~* Pancreas, pancreatic islet cells or renal transplant recipient~* T1DM treatment with any other antihyperglycaemic drug except subcutaneous basal and bolus insulin within last 3 months~* Occurrence of severe hypoglycaemia within last 3 months and until randomisation~* Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6~* Irregular sleep/wake cycle~* Acute coronary syndrome, stroke or Transient Ischaemic Attack (TIA) within last 3 months~* Severe gastroparesis~* Brittle diabetes~* Liver disease~* Eating disorders~* Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen~* Treatment with systemic corticosteroids~* Change in dose of thyroid hormones within last 6 weeks and until randomisation~* Cancer or treatment for cancer in the last five years~* Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells~* Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial~* Alcohol or drug abuse~* Intake of an investigational drug in another trial within last 30 days Further exclusion criteria apply

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

Study Arms:
- Empagliflozin low dose (Type: EXPERIMENTAL): None
- Empagliflozin high dose (Type: EXPERIMENTAL): None
- Empagliflozin medium dose (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 Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression

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:~* Female and male subjects must be 18 to 65 years of age;~* Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;~* Meet criteria for major depression~* Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;~* Able to comply with all required study procedures and schedule;~* Able to speak and read English;~* Willing and able to give written informed consent~Exclusion Criteria:~* Obesity of known endocrine origin~* Serious medical condition~* History of drug or alcohol abuse or dependence~* Use of excluded concomitant medications~* History of surgical or device (e.g. gastric banding) intervention for obesity;~* History or predisposition to seizures~* Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;~* Planned surgical procedure that can impact the conduct of the study;~* Use of investigational drug, device or procedure within 30 days prior to Screening;~* Participation in any previous clinical trial conducted by Orexigen Therapeutics;~* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.

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

Study Arms:
- NB32 (Type: EXPERIMENTAL): Naltrexone SR 32 mg/Bupropion SR 360 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: Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

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

Eligibility Criteria:
Inclusion criteria:~* Provided written informed consent.~* Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.~* Have history of RLS symptoms at least 15 nights/month.~* Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).~Exclusion criteria:~* Secondary RLS~* Primary sleep disorder~* Sleep apnea~* Have any medical conditions that may impact efficacy assessments or that may present a safety concern.~* Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.~* Use of any prohibited medication.

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

Study Arms:
- GSK1838262:placebo (Type: OTHER): GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2
- Placebo:GSK1838262 (Type: OTHER): Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2

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 Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome

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:~1. Treatment naive PCOS women having age from 14-45 years with scanty or no menstruation, hirsutism and elevated serum androgen levels, will be diagnosed on the basis of AES (Androgen access society) guidelines 2006 according to which when two of the following criteria are present patient will be said to have the syndrome~2. Hirsutism or hyperandrogenism~3. Oligo or an-ovulation and or polycystic ovaries -~Exclusion Criteria:~1. Women with previous history of Cushing syndrome~2. Thyroid disorders~3. Hyperprolactinemia~4. Ovarian tumors~5. Congenital adrenal hyperplasia androgen-producing tumors,~6. History of seizures~7. Patients on warfarin, Coumadin and Sintrom because of drug interaction with acetyl-L-Carnitine,~8. Pregnancy or using contraceptive medications,~9. Patients on hormonal therapy that alters the biochemical or hormonal profile

- Gender: FEMALE
- Minimum Age: 15 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- Combination therapy group (Type: ACTIVE_COMPARATOR): Arm 1: Metformin (1000 mg daily), Pioglitazone (30 mg daily), Acetyl-L-carnitine (3 gm daily)
- Standard therapy group (Type: PLACEBO_COMPARATOR): Arm 2: Metformin (1000 mg daily), Pioglitazone (30 mg daily), Placebo

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

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

Trial Title: Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

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

Eligibility Criteria:
Inclusion Criteria:~* Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.~Exclusion Criteria:~* Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.

- Gender: FEMALE
- Minimum Age: None
- Maximum Age: 85 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: Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy

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:~* Patients aged over 18~* ASA I, II and III~* Non allergic to lidocaine or any of the drugs used in the study~* Consent form signed by the patient~Exclusion Criteria:~* Stomach or esophagus diagnosed cancer~* Giant hiatal hernia diagnosed~* Zenker's diverticulum diagnosed~* Achalasia diagnosed~* Patients aged over 70~* Medical history of moderate to severe liver disease~* Medical history of moderate to severe renal insufficiency~* Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).~* Severe respiratory insufficiency(asmtha or COPD) diagnosed~* Patients with encephalopaty active~* Patients with medical history of methemoglobinemia~* Patients with history of drug abuse~* Patients with mental impairment~* Patients with BMI≥ 35~* Use of pediatric tube

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

Study Arms:
- Lidocaine (Type: EXPERIMENTAL): Five lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy.
- Control (Type: PLACEBO_COMPARATOR): Five placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy

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 the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia

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

Eligibility Criteria:
Inclusion Criteria:~1. Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;~2. Be able and willing to follow all instructions and attend study visits;~3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;~4. Have +1.00 to -4.00 diopter(D) of sphere (so that spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;~5. Have ≤ 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;~6. Be presbyopic as determined at Visit 1~Exclusion Criteria:~1. Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;~2. Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;~3. Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;~4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;~5. Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: 75 Years
- Healthy Volunteers: t

Study Arms:
- Combination ophthalmic solution (LNZ101) dosed bilaterally (Type: EXPERIMENTAL): LNZ 101: Aceclidine/Brimonidine combination ophthalmic solution
- Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally (Type: EXPERIMENTAL): LNZ 100: Aceclidine ophthalmic solution
- Vehicle Ophthalmic Solution dosed bilaterally (Type: EXPERIMENTAL): Proprietary vehicle ophthalmic solution

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 Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i 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: 2.0

Eligibility Criteria:
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% \[53-97 mmol/mol\] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m\^2 and below 40 kg/m\^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products

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

Study Arms:
- IDegLira (Type: EXPERIMENTAL): None
- IGlar (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: New Haven MOMS Partnership

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

Eligibility Criteria:
Inclusion Criteria:~* CES-D score \>=16~* Child under the age of 18 (participant must be a mother)~* Resident of public housing authority complex in New Haven, CT or an affiliated Section 8 recipient~Exclusion Criteria:~* Positive for psychosis~* Active suicidal ideation~* Non-English or Spanish speakers~* Unable to provide informed consent~* Unwilling to accept randomization~* Moving within the intervention \& follow-up period

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

Study Arms:
- Cognitive-Behavioral Group Therapy (Type: EXPERIMENTAL): 8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer).
- Standard of care - Cognitive-Behavioral Group Therapy (Type: ACTIVE_COMPARATOR): 8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention administered by mental health clinician.

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 and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Aged between 19 and 75 years~* Signed informed consent~Exclusion Criteria:~* At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL~* Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug~* Has a history of multi-drug allergy

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Irbesartan/Atorvastatin A (Type: EXPERIMENTAL): None
- Irbesartan (Type: ACTIVE_COMPARATOR): None
- Atorvastatin A (Type: ACTIVE_COMPARATOR): None
- Placebo (Type: PLACEBO_COMPARATOR): None
- Irbesartan/Atorvastatin B (Type: EXPERIMENTAL): None
- Atorvastatin B (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: A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)

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

Eligibility Criteria:
Inclusion criteria:~* Participant has an LDL-C ranging from ≥100 mg/dL to \<160 mg/dL.~* Patient has a triglyceride (TG) level of ≤500 mg/dL.~Exclusion Criteria:~* Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).~* Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal \[ULN\])~* Participant has increased creatine kinase (CK) (≥2 x ULN).~* Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.~* Participant has a history of alcohol and/or drug abuse.

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

Study Arms:
- Diabetic participants (Type: EXPERIMENTAL): Diabetic participants with normal to moderately high LDL-C
- Nondiabetic participants (Type: EXPERIMENTAL): Non-diabetic participants with normal to moderately high LDL-C

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: Creatine as a Treatment Option for Depression in Methamphetamine Using Females

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:~1. Female gender, ages 18-64 years inclusive~2. Diagnosis of MA dependence or abuse within the past 12 months, with MA preferred drug of abuse, identified by the SCID-I-RV~3. Current diagnosis of Major Depressive Disorder identified by the SCID-I-RV~4. Current HAM-D17 score of \> 15~Exclusion Criteria:~1. Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-I-RV~2. History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease~3. Diabetes type I or II~4. Colitis or diverticulitis~5. Seizure disorder~6. Current serious suicide risk identified by the Columbia Severity Suicide Rating Severity~7. Current treatment with an antipsychotic, mood stabilizer, or antidepressant~8. Positive HIV test~9. Active Hepatitis C~10. Contraindication to magnetic resonance scan

- Gender: FEMALE
- Minimum Age: 13 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- Creatine monohydrate (Type: EXPERIMENTAL): 14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks.

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

Answer: outcome: complete