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

Trial Title: Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol~* A male or female of 4 to 5 years of age at the time of enrolment.~* With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ in Germany.~* Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.~* Healthy subjects as established by medical history and clinical examination before entering into the study.~Exclusion Criteria:~* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .~* Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.~* History of or intercurrent hepatitis B disease.~* Hepatitis B vaccination at birth.~* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.~* Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.~* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 5 Years
- Healthy Volunteers: t

Study Arms:
- Group A (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: The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial

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:~* Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire;~* Participation \>12 months in the UMBRELLA cohort;~* Previous treatment with radiotherapy for breast cancer;~* Completed surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.~Exclusion Criteria:~* Poor responder to questionnaires (i.e. return of ≤ 2 UMBRELLA questionnaires);~* Previous HBOT;~* Contra-indications for HBOT (e.g. (severe) chronic obstructive pulmonary disease (COPD) or asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure);~* Current metastatic disease or recurrent breast cancer.~Additional exclusions criteria based on screening visit:~* Inability to follow schedule of all consecutive HBO treatments (e.g. due to scheduled holidays \> 2 days);~* Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).

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

Study Arms:
- Hyperbaric oxygen therapy (Type: EXPERIMENTAL): Hyperbaric oxygen therapy consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions the pressure will be raised to 2.4 atmospheres absolute in a hyperbaric chamber and patients breath in 100% oxygen during 4 times 20 minutes.
- Usual care (Type: NO_INTERVENTION): Usual care may consist of physiotherapy, analgetics, edema therapy

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

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

Trial Title: Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta 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: 2.0

Eligibility Criteria:
Inclusion Criteria:~* OI diagnosis~* increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.~Exclusion Criteria:~* Any bisphosphonate use within one year of enrollment

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 15 Years
- Healthy Volunteers: f

Study Arms:
- Placebo Daily (Type: PLACEBO_COMPARATOR): placebo tablet, once a day for one year then for two years open label risedronate
- Risedronate Daily (Type: EXPERIMENTAL): risedronate tablet, once a day for one year then for two years open label risedronate once a day

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: Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)

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

Eligibility Criteria:
Inclusion Criteria:~* The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment.~* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation.~Exclusion Criteria:~* Patients who have secondary constipation caused by systemic disorder.~* Patients who have organic constipation.~* Patients who received intestinal resection.

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

Study Arms:
- KWA-0711 High dose (Type: EXPERIMENTAL): None
- KWA-0711 Low dose (Type: EXPERIMENTAL): None
- Placebo (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: PMS of Trazenta on the Long-term Use as Add-on Therapy

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:~Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.~Exclusion criteria:~None

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

Study Arms:
- Trazenta (Type: None): 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 and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.~2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification~3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.~4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is 30% FEV1 \<80% of the predicted normal value (i.e., 100 x Post-salbutamol \< FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).~5. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is \< 70% (i.e., 100 x Post-salbutamol FEV1 /FVC \< 70%).~6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.~7. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment~Exclusion Criteria:~1. History or current diagnosis of asthma or exercise-induced bronchospasm.~2. Clinically significant respiratory conditions at the time of Inform Consent signature~3. Hospitalisation due to COPD exacerbation within the previous 3 months.~4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.~5. Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.~6. Clinically significant cardiovascular conditions~7. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.~8. Presence of narrow-angle glaucoma.~9. QTc \[calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,~10. Patient who does not maintain regular day/night, waking/sleeping cycles

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Formoterol 12 μg (Type: ACTIVE_COMPARATOR): Formoterol fumarate 12 μg twice daily
- Placebo (Type: PLACEBO_COMPARATOR): Placebo twice daily
- Aclidinium 200 μg / formoterol 12 μg (Type: EXPERIMENTAL): Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
- Aclidinium 200 μg / formoterol 6 μg (Type: EXPERIMENTAL): Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
- Aclidinium 200 μg (Type: EXPERIMENTAL): Aclidinium bromide 200 μg twice daily

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

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

Trial Title: Local Phase 4 Pan-European SMART Study

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

Eligibility Criteria:
Inclusion Criteria:~* Patients at out-patient clinics~* \>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief~Exclusion Criteria:~* Asthma exacerbation within the last 14 days prior to study start~* subject aged \>40 years with a smoking history of \>10pack-years~* subjects with chronic obstructive lung disease or other significant respiratory disease

- 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: Islet Allotransplantation With Steroid Free Immunosuppression

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

Eligibility Criteria:
Inclusion Criteria:~* type 1 diabetes documented for more than 5 years~* arginine stimulated C-peptide lower than 0.2 ng/mL~* one of the following:hypoglycemia unawareness OR metabolic lability documented by one or more severe hypoglycemias or two or more hospital admissions for ketoacidosis within the previous year.~Exclusion Criteria:~* body mass index greater than 28 kg/m2~* non stable arteriopathy or heart disease~* active infection~* previous transplantation~* hyperimmunization~* insulin daily needs above 1.2 U/Kg~* creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d~* malignancy~* smoking~* desire for pregnancy~* psychiatric disorders~* lack of compliance

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

Study Arms:
- islet transplantation (Type: EXPERIMENTAL): Each participant received up to three sequential fresh islet infusions within three 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: Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)

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:~* Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines~* Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks~* Is able to demonstrate an FEV1 \>60% and ≤90% predicted~* Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.~* Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.~* Is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.~* Has laboratory tests that are clinically acceptable to the investigator.~Exclusion Criteria:~* Requires \>8 inhalations per day of albuterol (100 mcg per actuation), and/or \>2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days~* Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.~* Is considered by the investigator to have unstable asthma at the end of the run-in period~* Has had \> 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1~* Has had a history of life-threatening asthma~* Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 11 Years
- Healthy Volunteers: f

Study Arms:
- MF/F MDI 100/10 mcg BID (Type: EXPERIMENTAL): Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.
- MF MDI 100 mcg BID (Type: ACTIVE_COMPARATOR): Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 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: GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.~Exclusion Criteria:~* GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.~* Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Celecoxib (Type: EXPERIMENTAL): dosing as per USPI label
- NSAIDs (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: The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Greater than 17 years of age~Exclusion Criteria:~* Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism~* Hypocalcemia~* Renal impairment (creatinine \>1.5x ULN)

- Gender: ALL
- Minimum Age: 17 Years
- Maximum Age: 70 Years
- 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: Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients

Study Design Characteristics:
- Allocation: NON_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:~* acute lymphoblastic leukemia~* 18-39 years old~* in first complete remission -Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤2.5 times the institutional ULN -~* Adequate renal function defined as creatinine ≤3 times the institutional ULN~* No uncontrollable infection~* Performance Status(PS)score 0-2(WHO)~* Subjects able to provide written informed consent~Exclusion Criteria:~* having HLA-matched donor~* high-risk ALL: (1)Ph+ALL (2)Hypodiploidy (3)t(v;11q23) (4) complex karyotype（≥5 chromosome abnormalities）（5）high white blood cell (WBC) count (B-ALL≥30×109/L;T-ALL ≥100×109/L).~* pregnancy~* Loss of ability to freely provide consent due to psychiatric or physical illness

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 39 Years
- Healthy Volunteers: f

Study Arms:
- chemotherapy (Type: ACTIVE_COMPARATOR): Drugs:~Drug:Methotrexate 1g/m2 d1,IV (in the vein) , used in cycle 1,3,5 Drug:arabinoside 2-3g/m2,q12h, d2-3, IV, used in cycle 1,3,5 Drug:cyclophosphamide:300mg/m2 q12h, d1-3, IV,used in cycle 2,4,6 Drug:Epirubicin 60mg/m2.d，d4,used in cycle 2,4,6 Drug:Vindesin 4mg/d，d4，d11, IV,in cycle 2,4,6 Drug:dexamethasone 40mg/d，d1-4，d11-14, IV, in cycle 2,4,6 Drug:Methotrexate 20 mg/m2/w,po, during maintenance treatment for 2 years Drug:6-mercaptopurine 60 mg/m2/d，po，d1-d28,during maintenance treatment for 2 years Drug:Vindesin 4mg/d，Predisone:1mg/kg, d1-7, every month during maintenance treatment for 2 years
- Haplo-identical HSCT (Type: EXPERIMENTAL): Haplo-identical HSCT Protocol:G, donor treatment with recombinant granulocyte colony-stimulating factor (rhG-CSF); I, intensified immunologic suppression; A, antihuman thymocyte immunoglobulin (ATG) for the prevention of GVHD; C, combination of peripheral blood stem cell transplantation (PBSCT), and bone marrow transplantation (BMT)，named GIAC regimen. Graft versus-host disease(GVHD) prevention regimen: CSA/MMF/MTX, cyclosporine A(CSA) 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HSCt and then gradually tapered. Every 12h, 0.5g mycophenolate mofetil (MMF)(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60. Methotrexate (MTX) was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.

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 Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

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

Eligibility Criteria:
Inclusion Criteria:~The inclusion criteria included, but were not limited to the following:~1. Male or female, 18 years or older;~2. Chronic Atopic Dermatitis (AD) for at least 3 years;~3. History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.~Exclusion Criteria:~1. Prior treatment with REGN668;~2. Presence of certain laboratory abnormalities at the screening visit;~3. Treatment with an investigational drug within 8 weeks ;~4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;~5. Certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study;~6. Known history of human immunodeficiency virus (HIV) infection;~7. History of malignancy within 5 years before the baseline visit, with certain exceptions;~8. Planned surgical procedure during the length of the patient's participation in this study;~9. History of clinical parasite infection;~10. Any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;~11. Pregnant or breast-feeding women.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection.
- Dupilumab 300 mg (Type: EXPERIMENTAL): Dupilumab 300 mg once weekly for 12 weeks by SC injection.

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

Answer: outcome: complete