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

Trial Title: Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

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

Eligibility Criteria:
Inclusion Criteria:~* Informed Consent~* 6 to \<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient~* Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.~* Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.~* ALT \< 2xULN; alkaline phosphatase and bilirubin \<= 1.5xULN~* Average of 3TNSS is \>= 4.0 in the last consecutive 4 days prior to Visit 2.~* Completion of the patient diary on \>= 3 days of the last consecutive 4 days prior to Visit 2~Exclusion Criteria:~* Has a seasonal pollen as an allergen~* A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)~* Bacterial or viral infection of upper respiratory tract or eye~* Concurrent disease/abnormalities: Clinically significant uncontrolled disease~* Known hypersensitivity to corticosteroids or any excipients in the investigational product~* Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1~* Use of the following medication and/or its combination drug within the specified time:~Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1~* Affiliation with Investigator's Site: Relative or employee~* History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.~* Average of 3TNSS is \>= 8.0 in the last consecutive 4 days prior to Visit 2.~* Bacterial or viral infection of upper respiratory tract or eye during the screening period.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 14 Years
- Healthy Volunteers: f

Study Arms:
- GW685698X (Type: EXPERIMENTAL): GW685698X 55mcg/day
- Placebo (Type: PLACEBO_COMPARATOR): 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: Safety and Efficacy Study of Tesofensine/Metoprolol Treatment 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: DOUBLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Males and females~2. Confirmed diagnosis of T2DM~3. 18-70 years of age~4. HbA1c ≥7.0%~Exclusion Criteria:~1. Hypersensitivity to tesofensine/metoprolol~2. Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure~3. History of myocardial infarction or stroke within 12 months prior to enrolment~4. History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment~5. Patients reporting angina in the last 6 months prior to enrolment~6. Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs~7. Any clinically significant cardiac arrhythmia

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

Study Arms:
- Tesofensine/Metoprolol (Type: EXPERIMENTAL): Oral tablets Tesofensine/Metoprolol
- Placebo (Type: PLACEBO_COMPARATOR): Placebo tablets matching oral Tesofensine/Metoprolol

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: Impact of Maternal Xylitol Consumption on Mutans Sterptococci

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

Eligibility Criteria:
Inclusion Criteria:~* mothers with high salivary counts (≥ 105)~* mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth.~Exclusion Criteria:~* subjects with systemic disorders or on regular medications

- Gender: ALL
- Minimum Age: 10 Months
- Maximum Age: 36 Months
- Healthy Volunteers: t

Study Arms:
- Experimental, control (Type: EXPERIMENTAL): Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month
- fluoride varnish application (Type: ACTIVE_COMPARATOR): The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed.

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: Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease

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:~* Patient is age 40 or older~* Patient record indicates a new prescription claim for fluticasone propionate/salmeterol (FSC) or tiotropium bromide (TIO) (first pharmacy claim defines the index date)~* Patient records include at least two medical claims with a primary or non-primary diagnosis of COPD (International Classification of Disease-9 \[ICD-9\] code 490.xx - 492.xx or 496.xx)~* At least one of the patient's ICD-9 codes for COPD is observed in the 12 months prior to the first pharmacy claim for FSC or TIO (the index date)~Exclusion Criteria:~* A pharmacy claim for FSC or TIO prior to the index date~* The patient initiated FSC at a dose other than 250µg/50µg~* The patient initiated FSC and TIO at the same time~* The patient had one or more prescription with missing dosing information~* The patient had a prescription claim for the study medication other than the one they started on at the index date within 60 days after the index date

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- COPD patients - risk analysis population (Type: None): Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. Patient records for the risk analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 3 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and June 30, 2008).
- COPD patients - cost analysis population (Type: None): Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. The cost analysis population is a subset of the risk analysis population. Patient records for the cost analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 12 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and September 30, 2007).

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: Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).~2. The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).~Exclusion Criteria:~1. Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.~2. Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).

- Gender: FEMALE
- Minimum Age: 50 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Alendronate (Type: EXPERIMENTAL): Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) SC or abaloparatide-matching placebo daily for 18 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: The Impact and Detection of Driving Impairments Associated With Acute Cannabis Smoking

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

Eligibility Criteria:
Inclusion Criteria:~* Be a licensed driver.~* Need to have acuity of 20/40 or better, with or without correction on a Snellen Visual Acuity eye chart.~Exclusion Criteria:~* At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.~* Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits~* Positive pregnancy test~* A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.~* Unwilling to refrain from driving or operating heavy machinery for four hours after consuming study medication.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- Placebo Cannabis (Type: PLACEBO_COMPARATOR): Subjects will smoke cannabis with placebo THC (.02%) ad libitum
- Cannabis with 5.9% THC (Type: EXPERIMENTAL): Subjects will smoke cannabis cigarettes with 5.9% THC ad libitum
- Cannabis with 13.4% THC (Type: EXPERIMENTAL): Subjects will smoke cannabis cigarettes with 13.4% THC ad libitum

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: CPAP Effect on the Progression of Diabetic Retinopathy in Patients With Sleep Apnea

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:~* Subjects aged 35 to 75 years old.~* Previous diagnosis of type 2 diabetes, fulfilling at least one of the following criteria: 1) current treatment with oral antidiabetic drugs and/or insulin; 2) a fasting glucose value above 126 mg/dl on at least 2 occasions; 3) blood glucose level at 2 hours after an oral glucose tolerance test is equal to or more than 200 mg/dl; or 4) a glycated hemoglobin (HbA1c) level \> 6.5 %~* Clinical diagnosis of mild non-proliferative diabetic retinopathy, with or without macular edema.~* Best corrected visual acuity according to ETDRS optotype from 20/40 to 20/320 letters from 4 meters (score 73-25 letters) in the studied eye.~* Spherical equivalent refraction less than ± 5 dioptre.~Exclusion Criteria:~* Prior systemic treatment for diabetic retinopathy, with the exception of nutritional supplements or vitamins.~* Pre-treatment with anti-vascular endothelial growth factor (VEGF) drugs in the studied eye. It is allowed a pre-treatment with anti-VEGF approved in the other eye more than 3 months ago.~* Prior systemic anti-VEGF, experimental or approved treatment, three months before the inclusion.~* Evidence of inflammation or infection in or around the studied eye.~* Treatment with troglitazone in the last three months.~* Eye surgery (including cataract surgery) in the studied eye three months before the inclusion.~* Late macular degeneration (geographical with foveal or neovascular involvement).~* Vascular retinal diseases, such as vascular occlusions.~* Previous diagnosis of other eye diseases that could lead to a decrease in visual acuity.~* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mm Hg at the baseline visit.~* Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization for heart failure worsening, within the previous 30 days.~* Professional drivers, risk profession or respiratory failure.~* Severe daytime sleepiness (Epworth sleepiness scale \>18)~* Concomitant treatment with high doses of acetylsalicylic acid (\> 500 mg/day) or continuous treatment with non-steroidal anti-inflammatory drugs~* Previous treatment with CPAP~* Participation in another clinical trial within the 30 days prior to randomization.

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- CPAP treatment (Type: EXPERIMENTAL): Diet and conventional pharmacological treatment with oral antidiabetic drugs or insulin plus continuous positive airway pressure (CPAP)
- Control treatment (Type: ACTIVE_COMPARATOR): Diet and conventional pharmacological treatment with oral antidiabetic drugs or insulin

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: Early Use of Norepinephrine in Septic Shock Resuscitation

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

Eligibility Criteria:
Inclusion Criteria:~* Age \> or = 18 years old~* Diagnosed severe sepsis or septic shock according to survival sepsis campaign 2013~* Mean arterial pressure \< 65 mmHg~Exclusion Criteria:~* Pregnancy~* Severe underlying condition that unexpected to survive more than 48 hours~* Severe peripheral vascular disease~* Patient who required major surgery within 24 hours

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

Study Arms:
- Early norepinephrine (Type: ACTIVE_COMPARATOR): Norepinephrine 4 mg in 5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour, adjusted according to patient's body weight to achieve norepinephrine 0.05microgram/kg/min Continuous drip for 48 hours.
- Placebo (Type: PLACEBO_COMPARATOR): 5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour. Adjust rate of infusion according to patient's body weight to achieve dosage of norepinephrine comparable to 0.05 microgram/kg/min Continuous drip for 48 hours.

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: Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

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

Eligibility Criteria:
Inclusion Criteria:~* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).~* Number of lesions: 1 to 5 ulcerative lesions.~* Lesion´s diameter: 1 to 5 cm.~* Disease duration: up to three months.~Exclusion Criteria:~Safety concerns:~* Thrombocyte count \<30 x 109/l~* Leukocyte count \<1 x 109/l~* Hemoglobin \<5 g/100 ml~* ASAT, ALAT, AP \>3 times upper limit of normal range~* Bilirubin \>2 times upper limit of normal range~* Serum creatinine or BUN \>1.5 times upper limit of normal range~* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)~* Immunodeficiency or antibody to HIV~* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases~* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months~Lack of suitability for the trial:~* Negative parasitology (aspirate/smear)or negative Montenegro test~* Any history of prior anti-leishmania therapy~* Any condition which compromises ability to comply with the study procedures~* Concomitant serious infection other than cutaneous~Administrative reasons:~* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)~* Anticipated non-availability for study visits/procedures

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- 1.1 (Type: EXPERIMENTAL): Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
- 1.2 (Type: ACTIVE_COMPARATOR): Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
- 2.1 (Type: EXPERIMENTAL): Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
- 2.2 (Type: ACTIVE_COMPARATOR): Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).

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: RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

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

Eligibility Criteria:
Inclusion criteria:~Participation in RE-LY, requires long term anticoagulation, provides written informed consent~Exclusion criteria:~Permanent discontinuation of dabigatran during RE-LY

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

Study Arms:
- dabigatran dose 1 (Type: EXPERIMENTAL): dabigatran high dose twice daily
- dabigatran dose 2 (Type: EXPERIMENTAL): dabigatran low dose 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: Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration

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

Eligibility Criteria:
Inclusion Criteria:~* Age greater than or equal to 55 years;~* Subfoveal CNV secondary to AMD and with best corrected visual acuity of 3/60 - 6/9 with 6/60 or better in the other eye;~* Fluorescein angiogram of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion, or CNV currently under active management with anti-VEGF therapy;~* Must be a candidate for anti-VEGF intravitreal injections;~* No previous retinal treatment of photodynamic therapy or laser;~* Able to provide informed consent;~* Able to comply with protocol requirements, including follow-up visits.~Exclusion Criteria:~* Liver enzymes \> 2 X upper limit of normal;~* Any prior treatment for AMD in the study / control eye, excluding anti-VEGF injections;~* Extensive sub-foveal scarring, extensive geographic atrophy, or thick subretinal blood in the study eye as determined by the investigator;~* Significant retinal disease other than sub-foveal CNV AMD;

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Low Dose rAAV.sFlt-1 (Type: EXPERIMENTAL): None
- High Dose rAAV.sFlt-1 (Type: EXPERIMENTAL): None
- Control - ranibizumab only (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: complete