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

Trial Title: An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* a documented hemoglobin level to be less than 10 g/dL at screening~* diagnoses of CKD 4 or 5~* body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the height and weight at screening~* ferritin levels ≥100 ng/ml or Tsat ≥20% at screening~* erythropoietin (EPO) level greater than 8 ng/mL~* able to provide written informed consent~* able to understand and follow all trial procedures~* willing to use contraception as detailed in the protocol~Exclusion Criteria:~* receipt of red blood cell (RBC) transfusion within four weeks before screening~* overt gastrointestinal bleeding or other bleeding episode that required transfusion within 2 months prior to screening~* infection necessitating antibiotic or anti-viral treatment within a month prior to screening~* requiring Coumadin (warfarin), Pradaxa®, Eliquis®, or Xarelto®~* hemoglobinopathies such as homozygous sickle-cell disease or thalassemias of all types~* active hemolysis or chronic hypoxia~* active malignant diseases (except non-melanoma skin cancer) or life expectancy less than 6 months~* chronic, uncontrolled or symptomatic inflammatory disease or non-renal cause of anemia such as rheumatoid arthritis, systemic lupus erythematosus, HIV, or systemic acute infection~* on immunosuppressive therapeutics except topical corticosteroids or nasal sprays~* chronic congestive heart failure (New York Heart Association Class III, IV)~* significant hypertension (≥90 diastolic) based on a sitting diastolic blood pressure at screening~* kidney transplant within the past year: patients who are off immunosuppressive agents following a failed transplant are eligible for the trial~* end-stage liver disease~* known hypersensitivity to recombinant protein therapies~* female patients who are pregnant or breast feeding~* previous exposure to FMX-8~* previous exposure to Epogen®, Procrit® (erythropoietin) Aranesp® (darbepoietin alpha), Omontys® or Hematide® (peginesatide) anemia treatment~* uncontrolled hyperparathyroidism (PTH \>750) based upon latest PTH determination within the past 4 months~* inability to comply with the trial scheduled visits

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

Study Arms:
- FMX-8 (Type: OTHER): FMX-8 for injection, 15mg/kg, twice weekly, 29 days

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive 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:~* With signed consent~* Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique~* Breast cancer stage at presentation: stage I-III~* HER2-positive breast cancer defined as 3+ score by immunohistochemistry in \> 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization~* Known hormone receptor status (estrogen receptor and/or progesterone receptor)~* Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1~* Baseline left ventricular ejection fracture \>= 50% measured by echocardiography~* Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male~* Negative serum pregnancy test for women with fertility~* Willing to obey the study protocol~Exclusion Criteria:~* Stage IV disease~* Previous anti-cancer therapy or radiotherapy for any malignancy~* History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer~* Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy~* Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered~* Serious cardiac illness or medical condition~* Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness~* Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization~* Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol~* Not able to swallow the drug~* Pregnant or lactating

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

Study Arms:
- Pyrotinib in combination with nab-paclitaxel (Type: EXPERIMENTAL): Prior to surgery: pyrotinib and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.
- Trastuzumab in combination with nab-paclitaxel (Type: ACTIVE_COMPARATOR): Prior to surgery: trastuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with new diagnosis of CSC and no other comorbidities or prior retinal treatment~* Patients ranging from 30 to 60 years of age~Exclusion Criteria:~* Patients with no case of CSC~* Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration~* Patients with prior retinal treatment

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Micropulse Laser Treatment (Type: EXPERIMENTAL): Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine
- No Treatment (Type: PLACEBO_COMPARATOR): Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: An Open Label Study for Participants With Rheumatoid Arthritis

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:~* Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM~* Woman must not be pregnant, breastfeeding, or become pregnant during the study~Exclusion Criteria:~* Current presence of a serious disorder or illness

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

Study Arms:
- 120 milligrams (mg) of LY2127399 (Type: EXPERIMENTAL): Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment.~Or~Given every 4 weeks for 168 weeks for those participants from Study BCDM.
- 90 mg LY2127399 (Type: EXPERIMENTAL): Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment.~Or~Given every 2 weeks for 168 weeks for those participants from Study BCDM.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of prostate cancer~* Prostate specific antigen (PSA) greater than or equal to 5 ng/mL~* Recent completion of first hormone treatment \[intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue\]~* Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)~Exclusion Criteria:~* Bone or soft tissue metastases~* Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack

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

Study Arms:
- vandetanib (Type: EXPERIMENTAL): 300 mg orally, once daily for up to 18 months
- Placebo (Type: PLACEBO_COMPARATOR): orally, once daily for up to 18 months

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2/PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Positive infection test by microscopy for at least one of the following STH: T. trichiura, hookworms and/or larvae of S. stercoralis.~* Weight ≥15 Kg.~* Male or female, aged 5 to 18 years.~* Female participants who are ≥12 years old (or female post menarche) must have a negative urine pregnancy test at screening or at the time of randomization.~* Ability to take oral medication and willingness to comply with all study procedures.~* Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. In addition, verbal assent will be obtained from children aged 12-18 years.~Exclusion Criteria:~* Intake of ALB, mebendazole and/or IVM, or any potentially interacting drug three months before screening.~* Residence outside the study area or planning to move away in the four weeks following recruitment.~* Epidemiological risk of infection by Loa loa.~* Serious medical illness, per investigator's criteria.~* Any participant's condition that would prevent the appropriate evaluation and followup, as per investigator's criteria.~* Known hypersensitivity to any components of either of the study treatment.~* Positive pregnancy urine test, pregnant or first week postpartum.

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Albendazole (Type: ACTIVE_COMPARATOR): Albendazole 400 mg single dose
- FDCx1. Albendazole and Ivermectin Fixed Dose Coformulation (Type: EXPERIMENTAL): Single dose of a tablet of FDC 400mg18mg or 400mg9mg. (i) For participants \<45 kg of body weight at baseline: FDC of 400mg ALB 9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB18mg IVM
- FDCx3. Albendazole and Ivermectin Fixed Dose Coformulation 3 days (Type: EXPERIMENTAL): Daily dose of a tablet of FDC 400mg18mg or 400mg 9mg for 3 days. (i)For participants \<45 kg of body weight at baseline: FDC of 400mg ALB9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB 18mg IVM.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: SHARED Study (Saguenay Hospitals Anaphylaxis Rule for Early Discharge)

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

Eligibility Criteria:
Inclusion Criteria:~* Patients of all ages with anaphylaxis (meeting the NIAID/FAAN criteria)~* Patients of all ages considered to be inevitably evolving torwards overt anaphylaxis by the threading physician~Exclusion Criteria:~* Adverse reaction to a medication (eg ACEI)~* Hereditary angioedema~* Known immune mediated Angioedema~* Anaphylactoid reaction

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

Study Arms:
- All anaphylaxis reactions seen during the phase 2 period of the SHARED study. (Type: None): All patients presenting to the 3 sites emergency departments (Chicoutimi, Alma, Jonquière) diagnosed with an anaphylactic reaction or a severe allergic reaction that is rapidly evolving towards anaphylaxis in the opinion of the treating physician.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

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:~* 55\< Age \<70~* Tumor size ≤ 2 cm~* pN0 (SN biopsy or ALND)~* ER/PgR positive~* Margins \> 5 mm (either at initial surgery or at re-excision)~* Clips placed in the surgical bed (minimum of 4 clips)~* Unicentric only~* No lymphovascular invasion~* Any grade~* No extensive intraductal component (\>25%)~* Written informed consent~Exclusion Criteria:~* Prior thoracic radiation therapy~* Oncoplastic surgery / No clips in the surgical bed~* Multicentric cancer~* Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae

- Gender: FEMALE
- Minimum Age: 55 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Hypofractionated WBI (Type: ACTIVE_COMPARATOR): Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).
- Accelerated Partial Breast Irradiation (Type: EXPERIMENTAL): Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

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: None

Eligibility Criteria:
Inclusion Criteria:~* Radiologically confirmed brain metastases from Non Small Cell Lung Cancer~* No symptoms due to brain metastases~* No previous radiotherapy treatment for the Brain metastases~Exclusion Criteria:~* No prior chemotherapy~* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ~* Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal 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: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: The Pharmacokinetics of Dexmedetomidine in Children

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:~* Age 3 - 11.9 years~  * 2 age groups: 3.0 - 5.9 years, 6.0 - 11.9 years~* Patients will be equally distributed within each age group~* Meets criteria to receive dexmedetomidine sedation for MRI:~  * Active, uncontrolled gastroesophageal reflux - an aspiration risk~ * Active, uncontrolled vomiting - an aspiration risk~ * Current (or within past 3 months) history of apnea requiring an apnea monitor~ * Active, current respiratory issues that are different from the baseline status (pneumonia,exacerbation of asthma, bronchiolitis, respiratory syncytial virus)~ * Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy,significant cardiac dysfunction)~ * Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed~ * Current use of digoxin~ * Moya Moya Disease~ * New-onset stroke~ * Provide written consent to take part in the research study~Exclusion Criteria:~* Do not meet established sedation criteria~* History of allergy, intolerance, or reaction to dexmedetomidine or hypersensitivity~* Previous diagnosis of hepatic insufficiency/failure or a serum glutamate pyruvate transaminase level \> 2 times the normal limit determined by Children's Hospital Boston (TCH)~* Current diagnosis of renal insufficiency/failure or a current serum creatinine level \> 1.5 times the normal limit determined by TCH~* Have received digoxin in the past (no time limit)~* Received phenobarbital, clonidine or valproic acid within 30 days~* Current, repaired or risk of Moya-Moya disease~* Recent stroke (cerebrovascular accident) within past 6 months~* Uncontrolled hypertension~* Concomitant use of beta antagonist, or calcium channel blocker~* Participated in a clinical investigation within the past three months

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Female and male~* Age ≥ 18~* Diagnosis of having advanced melanoma , stage III-IV~* Scheduled for clinically indicated anti-PD-1 immunotherapy~* Informed Consent as documented by signature~* FDG PET/CT within 4 weeks before screening~* Biopsy available~* Minimum 3 lesions detected in FDG PET/CT~Exclusion Criteria:~* Age under 18~* Ocular melanoma~* Women who are pregnant or breast feeding,~* Intention to become pregnant during the course of the study,~* Previous enrolment into the current study,~* Enrolment of the investigator, his/her family members, employees and other dependent persons,~* Previous immunotherapy,~* History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment~* The subject has a known allergy to or has had an adverse reaction to dextran exposure~* Insufficient knowledge of project language, inability to give consent or to follow procedures~* The patient makes use of his/her right not to know and refuses to be informed about incidental findings

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

Study Arms:
- Treatment group (Type: EXPERIMENTAL): Patients diagnosed with advanced melanoma (stage III-IV) will receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m before the first cycle of clinically scheduled anti-PD-1 immunotherapy.

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

Answer: outcome: terminate
termination_type: safety issues