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

Trial Title: Tolerability and Safety Study of Recombinant Human Acid Sphingomyelinase in Acid Sphingomyelinase Deficiency Patients

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with documented non-neuronopathic acid sphingomyelinase deficiency~* The patient has a diffusing capacity of carbon monoxide (DLco) \>20% and ≤80% of the predicted normal value.~* The patient has a spleen volume ≥6 multiples of normal(MN). A partial splenectomy will be permitted if performed ≥1 year prior to Screening/Baseline and residual spleen volume is ≥6 MN.~* The patient who is receiving lipid lowering therapy should be on a stable dose and regimen of lipid-lowering therapy(ies) for at least 12 weeks prior to Screening/Baseline, with the patient expected to remain on the same dose and regimen throughout the 26-week treatment period.~* The patient who is female and of childbearing potential must have a negative serum pregnancy test for β-HCG.~Exclusion Criteria:~* The patient is female and pregnant or lactating.~* The patient has a Body Mass Index(BMI)\>30.~* The patient has received an investigational drug within 30 days prior to study enrollment~* The patient has a medical condition or any extenuating circumstance that may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities.~* The patient has had a major organ transplant~* ALT or AST \>250 IU/L or total bilirubin \>1.5 mg/dL.~* The patient is unwilling or unable to abstain from the use of alcohol for 1 day prior to and 3 days after each rhASM infusion for the duration of the study.~* The patient requires medications that may decrease rhASM~* The patient is unwilling or unable to avoid the use of medications or herbal supplements that may cause or prolong bleeding, or have potential hepatotoxicity within 10 days prior to and 3 days after liver biopsy

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

Study Arms:
- Recombinant human acid sphingomyelinase (Type: EXPERIMENTAL): Participants will receive rhASM of an initial dose of 0.1 mg/kg, followed by several dose escalations, as tolerated, up to 3.0 mg/kg. All doses are given 2 weeks apart.

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: Perimenopausal Estrogen Replacement Therapy Study

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

Eligibility Criteria:
Inclusion Criteria:~* must be between 45 and 60 years of age~* must be in the menopause transition (irregular/ absent menstrual cycles or hot flashes)~* must be are medically healthy~Exclusion Criteria:~- currently taking antidepressant medication

- Gender: FEMALE
- Minimum Age: 45 Years
- Maximum Age: 60 Years
- Healthy Volunteers: t

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo patches for 12 months and placebo pills for 12 days every 2 months.
- Estradiol (Type: EXPERIMENTAL): Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two 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 Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012~* No previous craniofacial surgery~* Patients agreed to attend this study and willing to sign the agreement~* Patients who are elder than 18 years old and after growth completion~Exclusion Criteria:~* Craniofacial anomalies~* cleft lip and /or palate patients~* patients without all the documents~* patients do not receive combined correcting nasolabial shape and orthognathic surgery.

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

Study Arms:
- modified alar base cinch suture (Type: ACTIVE_COMPARATOR): Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The modified alar cinch suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine.
- conventional alar base cinch suture (Type: PLACEBO_COMPARATOR): Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The conventional alar base cinch suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.

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

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

Trial Title: A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder

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:~* Patients who have successfully completed the ALZA screening protocol C-98-011 within the past six months~* taking or have taken in the past 5 - 20 mg of immediate-release methylphenidate (Ritalin®) at least twice a day, 20 - 60 mg of sustained-release methylphenidate (Ritalin-SR®) per day, or a combination of immediate-release and sustained-release methylphenidate up to a daily dose not exceeding 60 mg, or have successfully completed ALZA Protocol C-98-007~* agreeing to take only the supplied study drug as treatment for ADHD during the four-week treatment phase of the study~* who are able to comply with the study visit schedule and whose parent(s) and teacher are willing and able to complete the protocol-specified assessments~* having normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined to be not clinically significant by the investigator~Exclusion Criteria:~* Patients who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract~* having glaucoma, an ongoing seizure disorder, a psychotic disorder, clinical depression (and are suicidal or require immediate treatment for depression), or a diagnosis of Tourette's syndrome~* having a known allergy to methylphenidate or currently having significant adverse experiences from methylphenidate~* having a mean of two blood pressure measurements (systolic or diastolic) equal to or greater than the 95th percentile for age, sex, and height at screening~* if female, have begun menstruation

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- 001 (Type: EXPERIMENTAL): OROS methylphenidate HCl
- 002 (Type: ACTIVE_COMPARATOR): Ritalin
- 003 (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: Early Use of Botulinum Toxin in Spasticity Post Stroke.

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:~1. Over 18 years of age.~2. Patients with stroke due to a primary cerebral haemorrhage/infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemiplegia~3. Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative~4. No useful arm function (i.e. less than or equal to 2 on the grasp subsection of the Action Research Arm Test) at onset of spasticity~Exclusion Criteria:~1. Significant musculoskeletal conditions that affected upper limb function prior to the stroke~2. Unconscious or moribund during the screening period~3. Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections~4. Patients with contraindications to electrical stimulation including active implants (e.g. cardiac assist devices), metal implants at site of stimulation, scar tissue/cancerous tissue at site of stimulation, uncontrolled epilepsy, deep vein thrombosis in limb / muscle being stimulated and pregnancy (or planned pregnancy)~5. Previous upper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder~6. Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)~7. Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder~8. Patients with infection at the proposed injection site(s)~9. Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study~10. Current treatment with any antispasticity agent or previous injection with BOTOX

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

Study Arms:
- Botulinum Toxin - Type A (onabotulinumtoxinA) (Type: EXPERIMENTAL): Botulinum Toxin - Type A. One set of injections of up to 200 Units of Botox (Allergan). Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
- 0.9% NaCl Saline Injection (Type: PLACEBO_COMPARATOR): Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.

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 Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance

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

Eligibility Criteria:
Inclusion Criteria:~* Adults age 18 and above able to provide informed consent to participate~* Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention~Exclusion Criteria:~* Adults unable to consent~* Individuals less than 18 years of age~* Prisoners~* Pregnant women.~* Known contradictions or sensitivities to study medication (oxymetazoline)~* Ocular surgery within the past 3 months or refractive surgery within the past six months~* Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery~* Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)~* Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters~* Presence of an active ocular infection~* Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents~* Inability to sit comfortably for 15 - 30 minutes

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

Study Arms:
- Upneeq Group (Type: EXPERIMENTAL): Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group)
- Control Group (Type: SHAM_COMPARATOR): Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group)

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: Symptomatic Treatment of Acute Uncomplicated Diverticulitis

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

Eligibility Criteria:
Inclusion Criteria:~* Computed tomography-diagnosed acute uncomplicated\* diverticulitis~  * No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.~Exclusion Criteria:~* Already commenced antimicrobial medication~* Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)~* Suspicion of generalized peritonitis~* Organ dysfunction~* Another infection requiring antimicrobial medication~* Pregnancy~* Age \< 18 years or \> 90 years~* Missing written consent

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- Symptomatic treatment (Type: EXPERIMENTAL): 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 Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

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:~- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1~Exclusion Criteria:~- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

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

Study Arms:
- CZP 200 mg Q2W + Methotrexate (Type: EXPERIMENTAL): None
- CZP 200 mg Q4W + Methotrexate (Type: EXPERIMENTAL): None
- Placebo + Methotrexate (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: XprESS Maxillary Balloon Dilation Study

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

Eligibility Criteria:
Inclusion Criteria:~1. Be at least 18 years of age.~2. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.~3. Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.~4. Have a CT scan within 6 months prior to enrollment.~5. Be mentally and physically capable (as per physician discretion) to participate in the investigation.~6. Be willing and able to sign the study-specific informed consent prior to any study-related procedures.~7. Be willing and able to undergo balloon dilation in the clinic setting.~Exclusion Criteria:~1. Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.~2. Have presence of features consistent with sinus fungal disease.~3. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.~4. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).~5. Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).~6. Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.~7. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.~8. Have a history of primary ciliary dysfunction.~9. Have hemophilia.~10. Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.~11. Have a history of cystic fibrosis.~12. Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).~13. Have known sinonasal tumors or obstructive lesions.~14. Be pregnant at the time of enrollment.~15. Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.~16. Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.~17. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

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

Study Arms:
- Balloon sinus dilation (Type: EXPERIMENTAL): Balloon dilation of the maxillary sinus using a transnasal approach.

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 Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients

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

Eligibility Criteria:
Inclusion Criteria:~* A clinical diagnosis of COPD with symptoms for more than 2 years~* Smoking history of 10 or more pack years~* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.~Exclusion Criteria:~* A history of asthma~* Patients taking oral steroids.~* Any significant disease or disorder that may jeopardize the safety of the patient

- Gender: ALL
- Minimum Age: 40 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: Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

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:~* Previous participation in qualifying PsA study involving tofacitinib~Exclusion Criteria:~* Time from End of Study visit of qualifying study is \>3 months.~* Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.~Sub-study Inclusion Criteria:~* Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study~* Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)~Sub-study Exclusion Criteria:~-Subjects who are receiving methotrexate by a route other than oral

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

Study Arms:
- Tofacitinib (Type: EXPERIMENTAL): 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: Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2

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

Eligibility Criteria:
Inclusion Criteria:~1. Men and women at least 18 years of age~2. Subjects with type-2 diabetes history \>=5 years~3. HbA1C 7-10% with glucose control medications including insulin, metformin or sulfonylurea~4. Medically stable~5. Willing to participate and sign informed consent.~Exclusion Criteria:~1. Contraindication to MRI~2. Currently or within last three months treatment with a SGLT2 inhibitor~3. Currently taking glucagon-like peptide (GLP)-1 receptor antagonist~4. Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2~5. Unstable or rapidly progressive renal disease~6. Hypotension with systolic blood pressure (SBP) \<100 mmHg~7. Hypersensitivity to dapagliflozin or any excipients~8. Patients with severe hepatic impairment (Child-Pugh class C)~9. Patients with active hepatitis B or C infection~10. Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrollment, as assessed by the investigator:~    1. Myocardial infarction~   2. Cardiac surgery or revascularization (CABG/PTCA)~   3. Unstable angina~   4. Heart Failure - New York Heart Association (NYHA) Class IV~   5. Transient ischemic attack (TIA) or significant cerebrovascular disease~   6. Unstable or previously undiagnosed arrhythmia~   7. Established peripheral artery disease (PAD)~(18) Active bladder cancer (19) Recent episode of Diabetic ketoacidosis (DKA), frequent episodes of DKA (20) High risk of fractures, amputations and fibrosis (21) Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or randomization, OR women who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent until two weeks after the last dose of study drug, OR women who are breast-feeding.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): 10mg tabs placebo matching dapagliflozin.
- Active (Type: ACTIVE_COMPARATOR): 10mg tabs of dapagliflozin

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

Answer: outcome: complete