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

Trial Title: A Study Run At Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also Be Used to Assess Changes of Severity of HMB in Women with HMB Who Are Treated During 12 Months with a Chronic Hormonal Treatment

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:~* Women in childbearing age, ≥18 years old, not intending to become pregnant during the next year.~* Women diagnosed with heavy menstrual bleeding or idiopathic menorrhagia according to medical criteria and based on clinical judgment.~* Women for whom the clinician decides, in agreement with the patient, to prescribe any of the available chronic hormonal treatments with the therapeutic indication of HMB in Spain (Mirena, Qlaira or Progevera).~* Women capable of reading and writing.~* Women who signed the informed consent.~Exclusion Criteria:~* Women with amenorrhea or menopause.~* Women with contraindications and warnings with the chronic hormonal treatment prescribed for HMB as per the summary of product characteristics (interaction with concomitant medication, etc.).~* Women receiving contraceptive hormonal therapy or using a copper intrauterine device.~* Women on hormone replacement therapy.~* Women with a history of malignancy.~* Women with degenerative diseases that could directly negatively impact their daily life.~* Women who have given birth within the previous 6 months.~* Women who are pregnant.~* Women participating in an investigational program with interventions outside of routine clinical practice.~* Women with psychiatric disorders who are unable to make decisions and follow instructions.~* Women with concomitant medication that may lead to changes in the bleeding pattern (e.g. antiplatelet and/ or anticoagulants).

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

Study Arms:
- Women with HMB (Type: None): Women with a diagnostic of HMB according to medical criteria and based on clinical judgment that have freely chosen a chronic hormonal treatment under therapeutic indication of HMB in Spain

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 BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

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

Eligibility Criteria:
Inclusion criteria:~1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1\<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC \<70% at Visit 1~2. Male or female patients, 40 years of age or older~3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:~Exclusion criteria:~1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN~2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3~3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute)~4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse~5. Patients who have undergone thoracotomy with pulmonary resection~6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.~7. Patients who regularly use daytime oxygen therapy for more than one hour per day.~8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program~9. Pregnant or nursing women~10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Olodaterol (BI 1744) Low (Type: EXPERIMENTAL): Low dose inhaled orally once daily from the Respimat inhaler
- Olodaterol (BI 1744) High (Type: EXPERIMENTAL): High dose inhaled orally once daily from the Respimat inhaler
- Formoterol 12mcg (Type: ACTIVE_COMPARATOR): 12mcg inhaled twice daily from the Aerolizer inhaler
- Placebo (Type: PLACEBO_COMPARATOR): Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler

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 Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* 10 years of age or older~* Documented diagnosis of HAE (Type I or II)~* Willing and able to give informed consent~* Acute HAE attack at time of presentation~Exclusion Criteria:~* Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)~* Pregnancy or breastfeeding~* Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment~* Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- DX-88 (ecallantide) (Type: EXPERIMENTAL): DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.

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: Improving Prospective Memory Via Telehealth

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

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of MS~* Able to read, write, and speak in English~* Between the ages of 18 and 60~* All genders~* No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse~* No relapses within the past two months~* Access to the Internet and a web camera~* Not enrolled in a cognitive rehabilitation program within the past six months~* Self-reported issues remembering places they have to be and things they have to do~Exclusion Criteria:~* No diagnosis of MS~* Unable to complete the study protocol due to language barriers~* Younger than 18 or older than 61~* No gender exclusions~* History of other serious neurologic or psychiatric illness, including drug or alcohol misuse~* Had a relapse within the past two months~* No access to the Internet and/or a web camera~* Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months~* No self-reported issues with remembering places they have to be or things they have to do

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

Study Arms:
- Prospective Memory Intervention (Type: EXPERIMENTAL): Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.
- Educational (Type: ACTIVE_COMPARATOR): The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.

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: Sipuleucel-T as Neoadjuvant Treatment in Prostate 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:~* Adenocarcinoma of the prostate.~* Subject is scheduled for RP as the initial therapy for localized prostate cancer.~* Subject is ≥ 18 years of age.~* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~* Subject has adequate hematologic, renal, and liver function.~Exclusion Criteria:~* Subject has any evidence of metastasis.~* Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.~* Subject has received prior radiation therapy or chemotherapy for prostate cancer.~* Subject has received systemic steroid therapy within 14 days.~* Subject has a history of stage III or greater cancer, excluding prostate cancer.~* Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.~* Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.

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

Study Arms:
- Sipuleucel-T with Booster (Type: EXPERIMENTAL): Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
- Sipuleucel-T without Booster (Type: EXPERIMENTAL): Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T 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: Timed Release Tablet Prednisone in Polymyalgia Rheumatica

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of PMR by standard criteria. The Bird criteria will be used. 3 or more features are required to make the diagnosis.~  * Bilateral shoulder pain/stiffness~ * Duration of symptoms \<2/52~ * Initial ESR \>40 mm/h~ * Stiffness \>1 h~ * Age \>65 years~ * Depression and/or weight loss~ * Bilateral upper arm tenderness~* Are over 50 but less than 85 years old.~* No or stable NSAID or analgesic therapy for at least 7 days.~* Currently active disease defined by a CRP at least 10mg/L, ESR at least 29mm in one hour or PV \>1.72~Exclusion Criteria:~* Currently on oral glucocorticoid treatment or taken within 2 months~* Parenteral glucocorticoid treatment with the last 2 months~* Pregnancy and lactation~* Inflammatory diseases such as inflammatory bowel disease, colitis, asthma~* Co-existent giant cell arteritis~* Other auto-immune diseases~* Cancer~* Infections, treatment with antibiotics within the past 6 weeks~* Significant renal disease (creatinine \>150 μmol/L)~* Significant hepatic impairment~* Participation in a clinical trial within the past 30 days~* Working shift employee~* Jet lag

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Timed Release Tablet Prednisone (Type: EXPERIMENTAL): 12 patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.
- Standard Prednisolone (Type: ACTIVE_COMPARATOR): 12 patients will be taking morning Prednisolone at a dose of 7mg over 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: Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension

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:~* Patients over 18 years of age~* Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)~* Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)~Exclusion Criteria:~* mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening~* mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment~* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers~* Secondary hypertensive patient or suspected to be~* Uncontrolled diabetes mellitus patients~* Severe heart disease or severe neurovascular disease~* Known as severe or malignant retinopathy~* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)~* History of malignancy tumor~* History of autoimmune disease~* History of alcohol or drug abuse~* Positive to pregnancy test, nursing mother, has an intention on pregnancy~* Considered by investigator as not appropriate to participate in the clinical study with othe reason

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

Study Arms:
- amlodipine/losartan 5/100mg (Type: EXPERIMENTAL): None
- losartan 100mg (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: Uniform Multidrug Therapy Regimen for Leprosy Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* All newly diagnosed leprosy cases with characteristic skin lesions, with or without systemic symptoms or confirmed by histopathological study previously untreated PB and MB leprosy patients.~* Never treated or patient treated more than five years ago~Exclusion Criteria:~Safety concerns:~* History of intolerance to one of the medications~Lack of suitability for the trial:~* Absence of leprosy skin lesions~* Pure neural leprosy (PNL)~* Patient previously (defaulters and relapse) treated for leprosy less than 5 years ago~* Association with other serious diseases such as HIV/AIDS, Tuberculosis, Malaria, American Cutaneous leishmaniasis, Visceral Leishmaniasis, Lymphoma, Leukaemia, Immunosuppression, etc.~Administrative reasons~* Patients who are not permanent residents of the area or who are unable to come to the clinic every month during their treatment and in the first half year (the intensive follow-up period) after their treatment.~* Patients who do not give informed consent or are not capable to give informed consent due to mental impairment.~* Patients with overt signs of AIDS because it is unlikely that we can follow them up for the whole study period. As we will not be testing patients for HIV positivity, HIV-infected leprosy patients can be included in the study.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- R-MDT PB (Type: ACTIVE_COMPARATOR): R-MDT PB group: standard/regular treatment recommended by WHO - All patients presenting fewer than 6 skin lesions will receive the standard treatment regimen for paucibacillary patients as the intervention; Intervention - PB 6 doses of rifampicin and dapsone
- U-MDT PB (Type: EXPERIMENTAL): U-MDT PB group: a unified treatment for all patients - All patients presenting fewer than 6 lesions (WHO PB) will receive 6 doses of rifampicin, clofazimine and dapsone as the intervention; Intervention - PB 6 doses of rifampicin, clofazimine and dapsone
- R-MDT MB (Type: EXPERIMENTAL): R-MDT MB group: standard/regular treatment recommended by WHO - All patients presenting 6 skin or more lesions will receive the standard treatment regimen for multibacillary patients as the intervention; Intervention - MB 12 doses of rifampicin, clofazimine and dapsone
- U-MDT MB (Type: EXPERIMENTAL): U-MDT MB group: a unified treatment for all patients - All patients presenting 6 lesions or more (WHO MB) will receive 6 doses of rifampicin, clofazimine and dapsone as the intervention; Intervention - MB 6 doses of rifampicin, clofazimine and dapsone

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: An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)

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:~* Subjects must have presbyopia.~Exclusion Criteria:~Subjects must not:~* Have any contraindications to the study medications or diagnoses that would confound the study.

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- CSF-1 (Type: EXPERIMENTAL): One drop bilaterally twice daily for approximately 2 weeks.
- Vehicle (Type: PLACEBO_COMPARATOR): One drop bilaterally twice daily for approximately 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: Darbepoetin Alfa With or Without Intravenous (IV) Iron

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

Eligibility Criteria:
Inclusion Criteria:~* Active non myeloid malignancy(cies) including lymphocytic leukemias~* Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy~* Anemia due to chemotherapy (screening Hgb \<or = 10.0 g/dL)~* at least 18 years of age at screening~Exclusion Criteria:~* Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)~* Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy~* Active bleeding~* Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)~* Active, unstable systemic or chronic infection~* Planned elective surgery during the study where significant blood loss is expected~* Unstable angina, or uncontrolled cardiac arrhythmia~* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg)~* History of pure red cell aplasia (PRCA)~* History of deep venous thrombosis~* Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status~* Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening~* Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy~* Currently receiving or planned to receive myeloablative radiation therapy~* Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study~* Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)~* Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study~* Known sensitivity to iron administration~* Pregnant or breast feeding

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

Study Arms:
- Darbepoetin alfa 300 μg plus IV Iron (Type: EXPERIMENTAL): Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
- Darbepoetin alfa 300 μg (Type: EXPERIMENTAL): Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
- Darbepoetin alfa 500 μg (Type: EXPERIMENTAL): Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
- Darbepoetin alfa 500 μg plus IV Iron (Type: ACTIVE_COMPARATOR): Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

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: Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects must meet diagnostic criteria for fibromyalgia;~* Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.~Exclusion Criteria:~* History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;~* Use of medications known to affect sleep wake function by Visit 2;~* Involved in night or rotating shift work, or travel across \>4 time zones 14 days prior to screening and during study; regular daytime napping~* PSG finding of apnea/hypopnea or periodic limb movement with arousal index \>10/hr on either night of PSG.

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

Study Arms:
- Lyrica (Type: EXPERIMENTAL): flexible dosing Lyrica 300-450mg/day
- Placebo (Type: PLACEBO_COMPARATOR): Placebo

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

Answer: outcome: complete