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

Trial Title: Study of GA-GCB Enzyme Replacement Therapy in Type 1 Gaucher Disease Patients Previously Treated With Imiglucerase

Study Design Characteristics:
- Allocation: None
- 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:~Includes:~* The participant has a documented diagnosis of type 1 Gaucher disease, as determined by deficient glucocerebrosidase (GCB) activity relative to normal as measured in leukocytes or by genotype analysis and the participant/legal guardian is willing and able to provide written informed consent prior to initiating any study-related procedures~* The participant has received consistent treatment with imiglucerase at a dose ≤ 60 U/kg and ≥ 15 U/kg every other week for a minimum of 30 consecutive months. Participants who are anti-imiglucerase antibody positive will be allowed to enter this study~* The participant is at least 2 years of age~* Female participants of child-bearing potential agree to use a medically acceptable method of contraception. Male participants must agree to use a medically acceptable method of birth control~* Participant must be sufficiently co-operative to participate in the study as judged by the Investigator.~Exclusion Criteria:~Includes:~* The participant has type 2 or 3 Gaucher disease or is suspected of having type 3 Gaucher disease~* The participant has received treatment with any investigational drug or device within the 30 days prior to study entry; such use during the study is not permitted~* Participant is HIV positive~* Participant is hepatitis B/C positive~* The participant presents with sustained iron, folic acid and/or vitamin B12 deficiency-related anemia during Screening~* The participant, participant's parent(s), or participant's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study~* The participant has a significant comorbidity that might affect study data or confound the study results~* The participant is unable to comply with the protocol or is otherwise unlikely to complete the study, as determined by the Investigator~* The participant has experienced an anaphylactic/anaphylactoid reaction during treatment with imiglucerase~* The participant has received miglustat during the 6 months prior to study enrollment~* The participant has an active, clinically significant spleen infarction~* The participant has active, progressive bone necrosis~* The participant is a pregnant and/or lactating female

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- GA-GCB (velaglucerase alfa) (Type: EXPERIMENTAL): 15-60 U/kg, every other week via intravenous infusion

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: Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)

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

Eligibility Criteria:
Inclusion Criteria:~* Male~* Age ≥18~* Has sex with men~* HIV-negative~* Meets PHSKC HIV/STD Program definition of high risk~* Plans to live in Seattle for the next 15 months~Exclusion Criteria:~* Unable to safely and confidentially receive or store a home testing kit

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

Study Arms:
- Home Testing (Type: EXPERIMENTAL): None
- Standard Testing (Type: NO_INTERVENTION): 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: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

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

Eligibility Criteria:
Inclusion Criteria:~* Active moderate or severe plaque psoriasis according to the judgment of the treating physician.~* The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.~Exclusion Criteria:~* Had currently participated in another prospective study with similar objectives.~* Participant could not or would not sign informed consent.~* Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

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

Study Arms:
- Topical/Traditional Systemic Agent (Type: None): Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
- Adalimumab (Type: None): Participants treated with adalimumab alone or in combination with topical agents.

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 Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with a mixed episode of bipolar I disorder.~* Have had at least one previous manic or mixed episode associated with bipolar disorder~* You must be between 18 and 60 years old.~* You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.~* If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.~Exclusion Criteria:~* You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.~* You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.~* Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).~* You are allergic to any of the medications involved in this study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): olanzapine and divalproex
- 2 (Type: PLACEBO_COMPARATOR): placebo and divalproex

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: Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Age \> 18~* Laparoscopic or non-laparoscopic elective colorectal surgery~Exclusion Criteria:~* Non elective colorectal surgery (emergent surgery and/or reintervention or revision of a previous colorectal procedure)~* Significant concomitant surgical procedure (e.g., liver resection for metastasis)~* Bacterial infection at the time of surgery or antimicrobial therapy up to 2 weeks before surgery~* Inflammatory bowel disease~* Severe obesity (defined as a BMI \>35 kg/m2)~* Known history of hypersensitivity to β-lactams and imidazoles~* Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min)~* Patients with known colonization with multidrug-resistant digestive bacteria, especially multidrug-resistant gram-negative bacteria (requiring specific infection control measures)~* Allergy to lactose, galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (rare metabolic disease)~* Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive- Refusal to participate or inability to provide informed consent

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

Study Arms:
- ornidazole (Type: EXPERIMENTAL): oral antibiotic prophylaxis using ornidazole, which has a spectrum of activity extended to most anaerobic bacteria and whose pharmacokinetic profile allows a single administration the day before surgery, in addition to intravenous antibiotic prophylaxis could be more effective than intravenous antibiotic prophylaxis alone using cephalosporin in reducing the incidence of SSI after elective colorectal surgery. Given the number of patients operated of colorectal surgery each year, the study is of significant clinical importance
- placebo (Type: PLACEBO_COMPARATOR): oral antibiotic prophylaxis using ornidazole, which has a spectrum of activity extended to most anaerobic bacteria and whose pharmacokinetic profile allows a single administration the day before surgery, in addition to intravenous antibiotic prophylaxis could be more effective than intravenous antibiotic prophylaxis alone using cephalosporin in reducing the incidence of SSI after elective colorectal surgery. Given the number of patients operated of colorectal surgery each year, the study is of significant clinical importance

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 Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

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

Eligibility Criteria:
Key Inclusion Criteria:~* be at least 18 years old~* be willing and able to avoid all disallowed medications and contact lenses~* must have a pregnancy test if of childbearing potential~* must be able to read an eye chart from 10 feet away~Key Exclusion Criteria:~* must not have any allergies to the study medications~* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters~* must not have used immunotherapy in the last 2 years~* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

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

Study Arms:
- Bilastine 0.2% (Type: EXPERIMENTAL): Bilastine Ophthalmic solution 0.2%~1 drop in each eye at 3 separate times during a 25 day period.
- Bilastine 0.4% (Type: EXPERIMENTAL): Bilastine Ophthalmic solution 0.4%~1 drop in each eye at 3 separate times during a 25 day period.
- Bilastine 0.6% (Type: EXPERIMENTAL): Bilastine Ophthalmic solution 0.6%~1 drop in each eye at 3 separate times during a 25 day period.
- Bilastine 0% (Type: PLACEBO_COMPARATOR): Vehicle of Bilastine Ophthalmic Solution~1 drop in each eye at 3 separate times during a 25 day period.

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

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

Trial Title: A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic 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: None

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed psoriatic arthritis for \>= 6 months~* active arthritis with \>= 5 tender and 5 swollen joints~* active psoriasis~Exclusion Criteria:~* Have other inflammatory diseases, including but not limited to, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease~* Received any systemic immunosuppressives within 4 weeks prior to enrollment in the study

- 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: A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 7.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects must have active rheumatoid arthritis~* Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)~* Subjects must not be currently taking any DMARD other than an antimalarial~Exclusion Criteria:~* Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.~* Subjects who previously received adalimumab (Humira®) therapy for any reason.~* Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): None
- 2 (Type: EXPERIMENTAL): None
- 3 (Type: EXPERIMENTAL): None
- 4 (Type: EXPERIMENTAL): None
- 5 (Type: EXPERIMENTAL): None
- 6 (Type: EXPERIMENTAL): None
- 7 (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: Mono Antiplatelet and Colchicine Therapy

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:~* Successful PCI with drug-eluting stent for NSTE-ACS or STEMI~* Provision of written informed consent~Exclusion Criteria:~* Cardiac arrest or cardiogenic shock~* Age \<19 or \>90 years old~* Severe liver impairment~* Severe renal impairment (eGFR \<30 mL/min/1.73 m2)~* Atrial fibrillation requiring anticoagulation therapy~* Intolerance of prasugrel, ticagrelor, or colchicine~* History of intracranial hemorrhage~* Active bleeding

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- Mono Antiplatelet and Colchicine Therapy (Type: EXPERIMENTAL): Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine 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: GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients with cytologically or histologically proved biliary tract cancer~2. age \>=20 years~3. Performance Status (PS) 0-2~4. No prior history of chemotherapy or radiotherapy.~5. Adequate bone marrow function (neutrophil count \>=1,500/mm3, and platelet count \>=100,000/mm3), liver function (total bilirubin \>=3 mg/dL and AST/ALT \>=150 IU/L), and renal function (creatinine clearance \>=45 mL/min)~6. Adequate oral intake~7. Provided written informed consent -~Exclusion Criteria:~1. Patients with interstitial pneumonia or pulmonary fibrosis~2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months~3. Patients with severe active infection~4. Patients with moderate or marked pleural effusion or ascites necessitating drainage~5. Patients with a history of severe drug allergy~6. Patients with other serious comorbid disease~7. Patients who are pregnant or lactating, or have an intention to get pregnant~8. Patients with mental disease~9. Patients who are judged inappropriate for the entry into the study by the principle doctor~   -

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Gemcitabine/Cisplatin group (Type: EXPERIMENTAL): Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
- Gemcitabine/Cisplatin /S-1 group (Type: EXPERIMENTAL): S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 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: Asthma Exacerbation Study

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:~* Clinical diagnosis of asthma~* Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol~* FEV1 of fifty to ninety percent of predicted~* Currently using inhaled corticosteroid therapy~* History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year~Exclusion Criteria:~* History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest~* Respiratory infection or oral candidiasis~* - Uncontrolled disease or clinical abnormality~* Allergies~* Taking another investigational medication or prohibited medication

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Fluticasone furoate/GW642444 (Type: EXPERIMENTAL): None
- fluticasone furoate (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 Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2
- Number of Arms: 8.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg~* Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements~Exclusion Criteria:~* Any meningococcal B or C vaccine administration~* Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;~* Any ascertained or suspected disease caused by N. meningitidis~* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis~* History of severe allergic reaction after previous vaccinations~* Recent significant acute or chronic infection~* Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;~* Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)~* Any impairment/alteration of the immune system resulting from (for example):~  * Receipt of any immunosuppressive therapy at any time since birth~ * Receipt of immunostimulants at any time since birth~ * Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth~* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation~* Participation in another clinical trial~* Family members and household members of research staff~* History of seizure~* Any contraindication to paracetamol

- Gender: ALL
- Minimum Age: 55 Days
- Maximum Age: 89 Days
- Healthy Volunteers: t

Study Arms:
- 1 (Type: OTHER): Vaccine candidate formulation I
- 2 (Type: OTHER): Vaccine candidate formulation II
- 3 (Type: OTHER): Vaccine candidate formulation III
- 4 (Type: OTHER): Vaccine candidate formulation IV
- 5 (Type: OTHER): Vaccine candidate formulation V
- 6 (Type: OTHER): Vaccine candidate formulation VI
- 7 (Type: OTHER): Control
- 8 (Type: OTHER): Vaccine candidate formulation I with antipyretic

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

Answer: outcome: complete