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

Trial Title: Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female between, and including, +- 36-46 months of age at the time of vaccination.~* For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).~* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.~* Written informed consent obtained from the parent(s)/guardian(s) of the subject.~* Free of obvious health problems as established by medical history and clinical examination before entering into the study~Exclusion Criteria:~* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.~* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.~* For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).~* For unprimed subjects: previous vaccination with any pneumococcal vaccine.~* Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.~* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.~* History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.~* Acute disease at the time of enrolment.

- Gender: ALL
- Minimum Age: 36 Months
- Maximum Age: 46 Months
- Healthy Volunteers: t

Study Arms:
- Synflorix™ Group 1 (Type: EXPERIMENTAL): Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
- Synflorix™ Group 2 (Type: EXPERIMENTAL): Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
- Unprimed Group (Type: ACTIVE_COMPARATOR): Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.

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 Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)

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:~* Patient has confirmed ENS by physician diagnosis~* Patient has confirmed FGF23 elevations in the context of low serum phosphorous \< 4.1 mg/dL~* Patient able to tolerate KRN23 treatment~* Have a corrected serum calcium level \< 10.8mg/dL~* Have an eGFR \>60 ml/min~* Must be willing in the opinion of the investigator, to comply with study procedures and schedule~* Provide written informed consent by a parent after~Exclusion Criteria:~* Patient should not use CRYSVITA with Oral phosphate or active Vitamin D analogs.~* Patient and investigator should not initiate CRYSVITA if Phosphorus level is within or above normal.~* CRYSVITA is contraindicated in patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.~* The use or enrollment in studies using other investigational therapies including other monoclonal antibodies~* Subject and their Parent not willing or not able to give written informed consent~* In the Investigators opinion, the subject may not be able to meet all the requirements for study participation~* Subject has a history of hypersensitivity to KRN23 excipients that in the opinion of the investigator, places the subject at an increased risk of adverse effects~* Subject has a condition that in the opinion of the investigator could present a concern for subject safety or data interpretation.

- Gender: MALE
- Minimum Age: 6 Months
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Crysvita (burosumab-twza) Treatment (Type: EXPERIMENTAL): The starting dose will be 0.3 mg/kg to be given every 2 weeks. If required dose may be titrated with increments of 0.1 mg/kg/dose every 4 weeks up to a maximum of dose of 2.0mg/kg (not to exceed 90mg per dose) until phosphorus level is WNL.~Patient will receive study drug via SC injection to the abdomen, upper arms, thighs, or buttocks; the injection site will be rotated with each injection. If the dose level exceeds 1.5 mL in volume, the dose should be administered at two injection sites.~Duration of treatment is 52 weeks. Subjects that complete treatment through week 52 may have the option to continue KRN23 treatment. If this is warranted based on preliminary efficacy, the current protocol will be amended to allow for an extension.

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: Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

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

Eligibility Criteria:
Inclusion Criteria:~* Unresectable malignancy of the extrahepatic bile duct~Exclusion Criteria:~* Age below 21 years~* Pregnancy~* Active alcohol or drug abuse~* Simultaneously participating in another investigational drug or device study.~* Allergy to stainless steel or nitinol~* Active cholangitis~* Brachytherapy~* Unable or unwilling to comply with follow up

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

Study Arms:
- 6 mm Zilver (Type: EXPERIMENTAL): 6 mm Nitinol Zilver Stent
- 10 mm Zilver (Type: EXPERIMENTAL): 10 mm Nitinol Zilver Stent
- 10 mm Wallstent (Type: ACTIVE_COMPARATOR): 10 mm Stainless Steel Wallstent

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 Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

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

Eligibility Criteria:
Inclusion Criteria:~* is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent~* has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent~Exclusion Criteria:~* has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease~* has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine~* has had a recent febrile illness (rectal temperature ≥38.1°C \[≥100.5°F\] or axillary temperature ≥37.8°C \[≥100.0°F\]) within 72 hours prior to receipt of study vaccine~* has known or suspected impairment of immunological function~* has or his/her mother has human immunodeficiency virus (HIV) infection~* has or his/her mother has hepatitis B surface antigen-positive test~* has known or history of functional or anatomic asplenia~* has a history of autoimmune disease~* has a history or suspected history of neurological disorder~* has received a pneumococcal vaccine prior to study entry~* has received, or is anticipated to need, corticosteroid therapy~* has received a blood transfusion of immunoglobulin products~* has participated in another clinical study of an investigational product

- Gender: ALL
- Minimum Age: 42 Days
- Maximum Age: 90 Days
- Healthy Volunteers: t

Study Arms:
- V114 (Type: EXPERIMENTAL): Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.

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: Long-Term Safety Study of Tafenoquine

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

Eligibility Criteria:
Main Inclusion Criteria:~1. Completion of the written informed consent process (signed).~2. Male or female age 18 to 55 years inclusive, in good health as assessed by the Investigator.~3. Normal G6PD enzyme activity levels as defined by the parameters of the specific G6PD test employed at the local laboratory.~4. Negative HBsAg and HCV, HIV-1, HIV-2 antibody screen at the screening visit.~5. Negative serum pregnancy test.~6. Use acceptable method of birth control.~7. Hematology, biochemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator in accordance with approved clinically acceptable laboratory ranges, documented prior to study start.~8. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.~Main Exclusion Criteria:~1. History of allergy or intolerance to tafenoquine, primaquine or any excipients.~2. History of thalassemia or current or past history of methemoglobinemia or methemoglobin \>2% at screening.~3. History of eye disease or surgery~4. Having previously received hydroxychloroquine for skin conditions or rheumatological diseases, chloroquine for malaria, tamoxifen, amiodarone or other drugs that may affect the optic nerve/retina/cornea within 30 days or 5 half-lives (whichever is longer) of study start. There are no travel restrictions, but the choice of concurrent anti-malarial must be atovaquone-proguanil if the participant chooses to take a registered antimalarial drug while travelling.~5. Any current diagnosis of Axis I psychiatric disorders

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

Study Arms:
- Tafenoquine 200 mg (2 x 100 mg tablets) (Type: ACTIVE_COMPARATOR): Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks

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: BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy~* Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated~* Known kidney damage for \>/= 3 months, as defined by structural or functional abnormalities of the kidney, and~  * Part A: 60 mL/min/1.73 m\*2 \</= eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m\*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit~ * Part B: 30 mL/min/1.73 m\*2 \</= eGFR \<= 60 mL/min/1.73 m\*2 (MDRD) at the screening visit~* Serum potassium \</= 4.8 mmol/L at the screening visit~* Systolic blood pressure \>/= 90 mmHg without signs or symptoms of hypotension at the screening visit~Exclusion Criteria:~* Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)~* Subjects with anuria, acute renal failure, or Addison's disease~* Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization~* Valvular heart disease requiring surgical intervention during the course of the study~* History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment

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

Study Arms:
- Arm 1 (Type: EXPERIMENTAL): None
- Arm 2 (Type: EXPERIMENTAL): None
- Arm 3 (Type: EXPERIMENTAL): None
- Arm 4 (Type: EXPERIMENTAL): None
- Arm 5 (Type: PLACEBO_COMPARATOR): None
- Arm 6 (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: Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage

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

Eligibility Criteria:
Inclusion Criteria:~* \> 18 years old~* Cognitively sound and able to provide informed consent~* Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.~Exclusion Criteria:~* Contraindicated for Optison administration~* Known right-to-left or bi-directional cardiac shunts~* Hypersensitivity to perflutren, blood, blood products or albumen~* Women who are pregnant~* Removal of Left Atrial Appendage~* Not able to provide informed consent

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

Study Arms:
- Echo arm (Type: EXPERIMENTAL): Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent

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: Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)

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: None

Eligibility Criteria:
Inclusion Criteria:~* Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation.~* best corrected visual acuity in the affected eye(s) 6/9 or worse~Exclusion Criteria:~* Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects~* Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)~* Significant macular ischemia (FFA)~* No useful vision in fellow eye~* Known allergies to triamcinolone acetate or steroids~* Patient is already under systemic treatment with \> 5mg prednisolone (or equivalent) daily.~* Intercurrent severe disease such as septicaemia~* Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- 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: Case Managers for CVD Risk Reduction in HIV Clinic

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

Eligibility Criteria:
Inclusion Criteria:~* In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months~* On antiretroviral therapy~* 2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia~* English literate (able to speak and read at a 6th grade level)~* Subjects must have the capacity to give legally effective consent.~Exclusion Criteria:~* Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Educational pamphlets + telephone (Type: EXPERIMENTAL): None
- Educational pamphlets (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: Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Neonates / infants~* Body weight \< 5 kg~* In cohort 1, infants aged \> 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days~* Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of \> 1,000 and \< 100,000 parasites/µL~Exclusion Criteria:~* Presence of severe malaria (according to World Health Organization definition)~* Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)~* Presence of any clinically significant neurological condition~* Presence of clinically significant abnormality of the hepatic and renal systems~* Patients who sustained a significant blood volume loss (\> 3% of calculated blood volume) in the past 30 days~* Patients unable to swallow or whose drinking is impaired~* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease~* Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)~* Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities~* Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age \>28 days.

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 Dysport In The Treatment Of Upper Limb Spasticity In Children

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

Eligibility Criteria:
Inclusion Criteria:~* Upper limb spasticity due to cerebral palsy~* Body weight 10 kg or over~* MAS score of 2 or more in affected elbow or wrist flexors~Exclusion Criteria:~* Fixed myocontracture~* Previous phenol or alcohol injection within 1 year~* Severe athetoid or dystonic movements~* Previous or planned surgery for spasticity in elbow or wrist flexors~* Neuromuscular disorders~* Previous Rhizotomy within 6 months~* Intrathecal baclofen within 30 days

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

Study Arms:
- Group A (Type: EXPERIMENTAL): Group A - Treatments 1, 2, 3 and 4: Dysport 16 Units (U)/kg in one upper extremity (the study limb).
- Group B (Type: EXPERIMENTAL): Group B - Treatments 1, 2, 3 and 4: Dysport 8 U/kg in one upper extremity (the study limb).
- Group C (Type: EXPERIMENTAL): Group C - Treatment 1: Dysport 2 U/kg in one upper extremity (the study limb).~Group C - Treatments 2, 3 and 4: Dysport 8 or 16 U/kg in one upper extremity (the study limb).

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 Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

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:~* Diagnosis of UC for at least 3 months prior to baseline.~* Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).~* Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.~* If female, must meet the contraception requirements.~Exclusion Criteria:~* Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).~* Participants with a previous colectomy.~* Participants with current evidence of toxic megacolon.~* Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Placebo Intravenous (IV) Every 4 Weeks (Q4W) (Type: PLACEBO_COMPARATOR): Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
- 300 Milligram (mg) Mirikizumab IV Q4W (Type: EXPERIMENTAL): 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
- Placebo IV Q4W Maximum Extended Enrollment (ME2) (Type: PLACEBO_COMPARATOR): Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
- 300 mg Mirikizumab IV Q4W ME2 (Type: EXPERIMENTAL): 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

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

Answer: outcome: complete