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

Trial Title: A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer

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:
Inclusion Criteria:~* Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer~* Post-menopausal status over 1 year~* HER2-positive as assessed by local laboratory on primary or metastatic tumor~* Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive~* At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1~Exclusion Criteria:~* Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting~* Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting~* Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment~* History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0~* Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months~* Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma~* Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease

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

Study Arms:
- Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy (Type: EXPERIMENTAL): Participants will receive pertuzumab in combination with trastuzumab plus aromatase inhibitor (AI) until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.~Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.
- Arm B: Trastuzumab + AI +/- Chemotherapy (Type: ACTIVE_COMPARATOR): Participants will receive trastuzumab plus aromatase inhibitor (AI) until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.~Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

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 Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* A total body weight \>25 kg (55 lbs).~* Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR~* Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.~Exclusion Criteria:~* Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose~* Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors~* Ongoing use of another drug for treating overactive bladder~* Uncontrolled narrow angle glaucoma, urinary or gastric retention

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Fesoterodine once daily (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: Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients between the age 13 and 70 years~2. Diagnosed with perforated appendicitis intra-operatively~3. Undergo open appendicectomy via Lanz incision~Exclusion Criteria:~1. Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy~2. Patients on steroid treatment and immunosuppressant therapy.

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Super-oxidised Solution (Type: EXPERIMENTAL): Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg
- Normal Saline (Type: PLACEBO_COMPARATOR): Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg

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

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

Trial Title: Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

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:~* Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria~* At least one other MDE before the current one~* Moderate to severe depression~Exclusion Criteria:~* Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR~* Any substance disorder within the previous 6 months~* Female patients of childbearing potential who are not using effective contraception~* Use of any psychoactive medication 2 weeks prior to screening and during the study~Randomisation Criteria: Patients in remission (MADRS total score \<=10) at both Week 10 and Week 12~Other protocol-defined inclusion and exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- Vortioxetine: 5 or 10 mg (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: D-serine and Cognitive Remediation in Schizophrenia

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:~* 18 to 64 years old,~* IQ≥85 and~* estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics (with the exception of clozapine) are allowable. Patients must be on their antipsychotic medication for 1 month and stable on dose of antipsychotic and adjunctive medications for 2 weeks prior to study entry.~Exclusion criteria:~* history of neurological visual or hearing impairment,~* active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),~* current alcohol or drug abuse (\<1 month) or substance dependence (\<4 months). All women of child-bearing potential must have a negative urine pregnancy test at the baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of candidates, suggesting that this is not an overly restrictive criterion.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- D-serine (Type: EXPERIMENTAL): D-serine

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 Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block

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:~* defined rotator cuff tear on preoperative MRI, which indicated repair~* acceptable arthroscopic surgery, including rotator cuff repair~* patients \>20 years old~* acceptable routine regional blocks and patient-controlled analgesia (PCA)~Exclusion Criteria:~* did not undergo arthroscopic rotator cuff repair~* stopped PCA before 48 h postoperatively due to side effects~* had a concomitant operation for a Bankart lesion~* had a history of shoulder operation or fracture~* had a concomitant neurological disorder around the shoulder~* underwent conversion to open surgery from the arthroscopy~* had contraindications for the routine regional blocks used in this study~* had an known allergy or hypersensitivity against ropivacaine or dexmedetomidine, including other amino-amide local anesthetics or α2-adrenoceptor agonists.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- SSNB and ANB c DEX (Type: EXPERIMENTAL): We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.
- SSNB and ANB c saline (Type: PLACEBO_COMPARATOR): We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.

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 OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria~1. Patients must have a histologically or cytologically confirmed diagnosis of NSCLC and must not have had chemotherapy or biological therapy for their disease.~2. Stage IIIB (N3 and/or pleural or pericardial effusion) or IV disease that is not amenable to either surgery or radiation therapy of curative intent.~3. Life expectancy of ≥ 12 weeks~4. If patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.~5. Radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.~6. At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors \[RECIST\] (at least 10 mm in longest diameter by spiral computed tomography \[CT\] scan, or at least 20 mm by standard techniques).~7. ECOG status must be ≤ 1~Exclusion Criteria~1. Prior chemotherapy or biological therapy (approved or experimental) for NSCLC, including adjuvant and neoadjuvant treatment.~2. Presence of central nervous system (CNS) metastases, unless the patient has completed successful local therapy for CNS metastases, with the exception of leptomeningeal disease for which patients will be excluded. Patients must be off corticosteroids for at least 21 days prior to starting treatment.~3. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).~4. Patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (This criteria is intended to exclude patients with stage IIIB disease, as defined by the presence of N3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)

- 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 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

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

Eligibility Criteria:
Inclusion Criteria:~* Chronic hepatitis C virus (HCV) infection~* All participants must have HCV genotype 1 or 2 infection, determined at screening~* HCV ribonucleic acid (RNA) plasma levels greater than or equal to (\>=)10,000 international units per Milliliter (IU/mL), determined at screening~* Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed~* Participants without cirrhosis or with compensated cirrhosis~Exclusion Criteria:~* Infection with HCV genotype - 3, 4, 5, or 6~* Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen \[HBsAg\] positive)~* Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free~* Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator~* Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Cohort 1 (Chronic Hepatitis C Without Cirrhosis) (Type: EXPERIMENTAL): Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
- Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) (Type: EXPERIMENTAL): Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).

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: Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* To be clinically healthy~* To have the ability to voluntarily grant your signed informed consent~* To have the willingness to comply with scheduled visits treatment plan and other study procedures~* Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period.~* To have a better corrected visual acuity of 20/30 or better in both eyes.~* To have vital signs in normal parameters.~* To have an intraocular pressure between ≥10 and ≤ 21 mmHg.~Exclusion Criteria:~* To be user of ophthalmic topical products of any kind.~* To be user of medicines, or herbal products, by any other route of administration.~* In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period.~* Having participated in clinical research studies 90 days prior to inclusion in this study.~* Having previously participated in this same study.~* To be a user of contact lenses and can not suspend their use during the study.~* Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study.~* To have a history of any chronic degenerative disease.~* Having inflammatory or infectious disease, active at the time of admission to the study.~* Having injuries or unresolved injuries at the time of admission to the study.~* Having a history of any type of eye surgery.~* Having undergone surgical procedures, not ophthalmological, in the last 3 months.~* To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Lagricel® Ofteno Multidose (Type: EXPERIMENTAL): Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
- Lagricel® Ofteno Single dose (Type: ACTIVE_COMPARATOR): Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

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 Tremelimumab in Patients With Advanced Solid Tumors

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:~1. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.~Exclusion criteria:~1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 150 Years
- Healthy Volunteers: f

Study Arms:
- treme mono to be sequenced to MEDI4736 mono or combination (Type: EXPERIMENTAL): tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)

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: Development and Feasibility of an Incentive Scheme to Promote Walking/Cycling to School

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

Eligibility Criteria:
Inclusion Criteria:~* Year 5 children in any of the selected schools~* Consent from parent and assent from child~Exclusion Criteria:~* No consent/assent

- Gender: ALL
- Minimum Age: 9 Years
- Maximum Age: 10 Years
- Healthy Volunteers: t

Study Arms:
- Intervention group school (Type: EXPERIMENTAL): School where the incentive scheme will be run.
- Control group school (Type: NO_INTERVENTION): School with no intervention; ongoing advice on active school travel.

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: Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

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

Eligibility Criteria:
Inclusion Criteria:~* Admitted to intensive care~* Able to give informed consent by themselves or informed consent can be obtained via next of kin~* Indication for treatment with cefotaxime (as judged by treating physician) in the context of our standard treatment protocol of Selective decontamination of the digestive tract (SDD).~Exclusion Criteria:~* Renal replacement therapy~* Contra-indication for cefotaxime, including known or suspected allergy to cefotaxime~* No indication for an arterial line; an arterial line will not be placed solely for the purpose of this study; thus, only patients with an indication for an arterial line outside this protocol are eligible.

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

Study Arms:
- Intermittent cefotaxime (Type: ACTIVE_COMPARATOR): Cefotaxime 1 gram (1000 mg) is to be administered 4 times daily for 4 days
- Continuous cefotaxime (Type: EXPERIMENTAL): After a 1 gram (1000 mg) Cefotaxime loading dose, Cefotaxime 4 gram (4000 mg) is to be administered as a continuous infusion in 24h for 4 days .

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

Answer: outcome: complete