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

Trial Title: Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

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:~* Age of newborn through 17 years at time of enrollment~* At least 1 skin graft recipient site measuring at least 1% of total body surface area (TBSA)~* Total initial burn wounds estimated to measure less than 40% of TBSA~* Bleeding indicating treatment with rThrombin during the surgical procedure~* Females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment~* informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (IRB/IEC)~* Participant has signed an IRB/IEC-approved pediatric assent document, if applicable~Exclusion Criteria:~* Gestational age younger than 36 weeks at birth (for infants younger than 2 years)~* Documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded)~* Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury~* Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies~* Presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors~* Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed)~* History of HIV infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications~* Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures~* Breastfeeding or being breastfed~* Treatment with any experimental agent within 30 days of study enrollment or treatment

- Gender: ALL
- Minimum Age: None
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Recombinant thrombin (rThrombin), 1000 IU/mL (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: Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female between 18 and 65 years of age~* Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure~* Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes~* Could breathe through both nostrils~* Had normal lip, nose, eyelid, and cheek sensations~* Could understand and sign the informed consent document~* Could communicate with the investigator~* Could understand and comply with the requirements of the protocol~Exclusion Criteria:~* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma~* Clinically relevant sinus/nasal surgical history~* Baseline Visual Analog Scale value of \> 36 (or greater than weak) at the treatment site~* Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours~* Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)~* Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens~* Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions~* Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications~* History of alcoholism and/or drug abuse~* Had taken a monamine oxidase inhibitor within the past 3 weeks~* Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy)~* Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline

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

Study Arms:
- Kovacaine Nasal Spray (Type: EXPERIMENTAL): 3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
- Lidocaine Injection (Type: ACTIVE_COMPARATOR): .5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine

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 Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

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

Eligibility Criteria:
* Male and female subjects =/\> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;~* HBeAg negative, anti-HBeAb positive;~* Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);~* Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;~* Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)

- Gender: ALL
- Minimum Age: 16 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: Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

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

Eligibility Criteria:
Inclusion Criteria:~A participant was to meet all of the following criteria to be eligible for this study:~* The participant and/or the participant's parent/legal guardian was willing and able to provide signed informed consent.~* The participant had a confirmed acid alpha-glucosidase (GAA) enzyme deficiency from skin, blood, or muscle tissue and/or 2 confirmed GAA gene mutations.~* Infant and toddler Pompe disease participants could be included in the study only under condition (minimal body weight) that the trial-related blood loss (including any losses in the maneuver) would not exceed 3 percent (%) of the total blood volume during a period of 4 weeks and would not exceed 1 % at any single time.~* The participant, if female and of childbearing potential, must have had a negative pregnancy test (urine beta-human chorionic gonadotropin) at screening. Note: All female participants of childbearing potential and sexually mature males must have agreed to use a medically accepted method of contraception throughout the study.~* For participants previously treated with alglucosidase alfa the participant had received alglucosidase alfa for at least 6 months.~Exclusion Criteria:~A participant who met any of the following criteria was excluded from this study:~* The participant was participating in another clinical study using an investigational product.~* The participant, in the opinion of the Investigator, was unable to adhere to the requirements of the study.~The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Study Arms:
- Alglucosidase alfa (Type: EXPERIMENTAL): Participants received intravenous (IV) infusion of Alglucosidase alfa 20 milligrams per kilogram (mg/kg) body weight on Day 1. Infusion was administered at an initial rate of approximately 1 milligram per kilogram per hour (mg/kg/hr) with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of infusion-associated reactions (IARs), until a maximum rate of approximately 7 mg/kg/hr was reached.

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 Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

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:~* Male or female patients aged 18 to 55 years at Screening~* Diagnosis of multiple sclerosis (MS)~* Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity~* Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization~* Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5~* Neurologically stable within 1 month prior to randomization~Exclusion Criteria:~* Patients with primary progressive MS or SPMS without disease activity~* Disease duration of more than 10 years in patients with an EDSS score of 2 or less~* Patients with an active chronic disease of the immune system other than MS~* Patients at risk of developing or having reactivation of hepatitis~* Patients with active systemic infections or with neurological findings consistent with PML

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

Study Arms:
- OMG 20 mg (Type: EXPERIMENTAL): Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1~,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide-matching placebo, taken orally once daily
- TER 14 mg (Type: ACTIVE_COMPARATOR): Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter

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

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

Trial Title: ComparisoN of ticAgrelor vs. Clopidogrel in endoTHeliAl Function of COPD patieNts

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

Eligibility Criteria:
Type of Patients Subjects either male or female eligible for PCI and undergoing drug eluting stent implantation who have meet all inclusion criteria and did not meet any of the exclusion criteria.~Inclusion Criteria:~For inclusion in the study subjects should fulfill the following criteria:~1. Age ≥18 years;~2. Ability to provide informed written consent and to participate in the 6-months follow-up period;~3. Diagnosis of SCAD requiring coronary artery angiography~4. COPD diagnosis confirmed by spirometry in stable phase and after medical treatment from at least 3 months.~Exclusion Criteria:~Subjects should not enter the study if any of the following exclusion criteria are fulfilled:~1. Patients hospitalized with diagnosis of acute coronary syndrome~2. Previous chronic use of P2Y12 inhibitors~3. Known intolerance to aspirin and/or P2Y12 inhibitors~4. Absence of significant variation in guideline driven medical treatment in the last 15 days~5. History of intracranial haemorrhage~6. Known intake of a strong CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir),~7. Known pregnancy, breast-feeding, or intend to become pregnant during the study period~8. Planned surgery, including CABG as a staged procedure (hybrid) within 6 months;~9. Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);~10. Need for chronic oral anti-coagulation therapy;~11. Active major bleeding or major surgery within the last 30 days;~12. Known stroke (any type) within the last 30 days;~13. Currently participating in another trial before reaching primary endpoint;~14. Thrombocytopenia;~15. Increased risk of bradycardia;~16. Known other inflammatory chronic disorders;~17. Known or suspected malignancy~18. Other concomitant pulmonary diseases

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

Study Arms:
- Aspirin 100 mg + Clopidogrel 75 mg (Type: ACTIVE_COMPARATOR): dual antiplatelet therapy as suggested by guidelines with aspirin 100 mg and clopidogrel 75 mg daily
- Aspirin 100 mg + Ticagrelor 90 mg x2 (Type: EXPERIMENTAL): dual antiplatelet therapy with aspirin 100 mg and ticagrelor 90 mg x 2 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: SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

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

Eligibility Criteria:
Key Inclusion Criteria:~* Male or female, age greater than or equal to 18 years.~* Confirmed chronic HCV infection.~* Subjects will have cirrhosis status assessment; liver biopsy may be required.~* Genotype 2 subjects must have cirrhosis of the liver to be eligible.~* Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event~* Infection with HCV genotype 2 or 3 as determined at Screening~* Body mass index (BMI) greater than or equal to 18 kg/m\^2~* Screening laboratory values within predefined thresholds.~* Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.~* Subject must be of generally good health as determined by the Investigator.~Key Exclusion Criteria:~* Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase~* Pregnant or nursing female or male with pregnant female partner~* History of any other clinically significant chronic liver disease.~* HIV or chronic hepatitis B virus (HBV) infection.~* Malignancy with the exception of certain resolved skin cancers.~* Chronic use of systemically administered immunosuppressive agents.~* Clinically-relevant drug or alcohol abuse.~* History of solid organ transplantation.~* Current or prior history of clinical hepatic decompensation.~* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.~* Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.~Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Arms:
- SOF+RBV 16 weeks (Type: EXPERIMENTAL): SOF+RBV for 16 weeks
- SOF+RBV 24 weeks (Type: EXPERIMENTAL): SOF+RBV for 24 weeks
- SOF+RBV+Peg-IFN 12 weeks (Type: EXPERIMENTAL): SOF+RBV+Peg-IFN for 12 weeks
- Retreatment Substudy (Type: EXPERIMENTAL): Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 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: Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

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

Eligibility Criteria:
Inclusion Criteria:~* Age. 12-80~* Documented physician-diagnosed asthma for at least 12 months~* Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.~* Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.~* At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.~* Morning pre-BD FEV1 \<80% predicted normal (\<90% for subjects 12-17 yrs)~* Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.~* Documented history of at least 2 asthma exacerbation events within 12 months.~* ACQ-6 score ≥1.5 at screening and on day of randomization~Exclusion Criteria:~* Pulmonary disease other than asthma.~* History of cancer.~* History of a clinically significant infection.~* Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.~* History of chronic alcohol or drug abuse within 12 months.~* Hepatitis B, C or HIV.~* Pregnant or breastfeeding.~* History of anaphylaxis following any biologic therapy.~* Subject randomized in the current study or previous tezepelumab studies.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Tezepelumab (Type: EXPERIMENTAL): Tezepelumab: Tezepelumab subcutaneous injection
- Placebo (Type: PLACEBO_COMPARATOR): Placebo: Placebo subcutaneous injection

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: Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

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:~* Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.~Exclusion Criteria:~* Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.~* Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

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

Study Arms:
- Ceftaroline fosamil for Injection (Type: EXPERIMENTAL): Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
- IV Vancomycin plus IV Aztreonam (Type: ACTIVE_COMPARATOR): Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 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: Study of Glycopyrronium in Axillary Hyperhydrosis

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:~* Male or female ≥ 9 years of age.~* Primary, axillary hyperhidrosis of at least 6 months duration~* Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline~* Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline~* Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically~Exclusion Criteria:~* Prior surgical procedure for hyperhidrosis.~* Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).~* Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.~* Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.~* Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.~* Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.~* Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.~* Other treatment with glycopyrrolate within 4 weeks prior to Baseline.~* Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.~* History of Sjögren's syndrome or Sicca syndrome.~* History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.~* Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.~* History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.~* Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.

- Gender: ALL
- Minimum Age: 9 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- glycopyrronium (Type: EXPERIMENTAL): glycopyrronium Topical Wipes
- Vehicle (Type: PLACEBO_COMPARATOR): glycopyrronium Topical Wipes, Vehicle

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

Answer: outcome: complete