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

Trial Title: Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer

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: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Histological proven adenocarcinoma of the prostate~* Prior local therapy for prostate cancer~* Biochemical recurrence or clinical progression after local therapy (PSA \> 0.2 µg/l),~* PSA-DT \< 6 months~* Gallium-68 (68Ga)-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 10 metastases (at least 1 lesion with a lesion size of ≥1 cm to enable adequate dosimetry studies)~* Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions)~* No prior hormonal therapy or chemotherapy; testosteron \> 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 3 months~* No visceral metastases~* Laboratory values:~  * White blood cells \> 3.5 x 109/l~ * Platelet count \> 150 x 109/l~ * Hemoglobin \> 6 mmol/l~ * Alanine transaminase, aspartate aminotransferase \< 3 x upper limit of normal~ * Modification of Diet in Renal Disease Study glomerular filtration rate ≥ 60 ml/min~* Signed informed consent~Exclusion Criteria:~* No detectable lesions on the Ga-68 PSMA PET/CT with an uptake level below the liver uptake.~* A known subtype other than prostate adenocarcinoma~* Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial.~* Prior hip replacement surgery potentially influencing performance of PSMA PET/CT and nano Magnet Resonance Tomography (nMRI)~* Contra-indication for MRI imaging (claustrophobia, implanted electric and electronic devices (heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators), intracranial metal clips, metallic bodies in the eye)~* Contra-indication for Buscopan (allergy to hyoscine or any other ingredients of this medication, allergy to to other atropines (e.g. atropine, scopolamine), myasthenia gravis, enlarged colon, glaucoma or obstructive prostatic hypertrophy)~* Additional contra-indications for the intravenous injection form of Buscopan (taking blood thinning medication (e.g. warfarin, heparin), narrowing of the gastrointestinal tract, fast heartbeat, angina or heart failure)~* Contra-indication to glucagon (pheochromocytoma)

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

Study Arms:
- Lu-177 PSMA-617 (Type: EXPERIMENTAL): Two cycles with 3 and 3-6 GBq Lu-177 PSMA-617 (including 3D-dosimetry)

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: BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

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

Eligibility Criteria:
Inclusion criteria:~1. Signed informed consent consistent with ICH-GCP~2. Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.~3. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.~4. Diagnosis of asthma prior to 40 years.~5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.~6. Male or female 18 to 65 years.~7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.~8. Able to perform pulmonary function testing.~Exclusion criteria:~1. Significant diseases other than asthma or allergic rhinitis.~2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.~3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.~4. Uncontrolled asthma on iCS + other controller.~5. Respiratory tract infection or exacerbation within 4 weeks.~6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.~7. Participation in another interventional study.~8. Pregnant or nursing women.~9. Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.

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

Study Arms:
- BI 671800 (Type: EXPERIMENTAL): Patients receive BI 671800 capsules twice daily
- Montelukast (Type: ACTIVE_COMPARATOR): Patients receive Montelukast encapsulated tablets once daily
- Placebo (Type: PLACEBO_COMPARATOR): Patients receive placebo capsules and/or encapsulated placebo tablets

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: Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
All patients were enrolled after receiving a regular medical care bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP).~INCLUSION CRITERIA~* ≥ 18 years old at the time of the drug administration~* ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen (PSA) \> 10 micrograms/L OR recurrent breast or prostate cancer~* Capable of complying with study procedures~* Able to remain still for duration of imaging procedure (about one hour)~* Written informed consent~EXCLUSION CRITERIA~* Pregnant or nursing~* Metallic implants that contraindicate MRI~* Renal function impairment that contraindicates MRI

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

Study Arms:
- Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans (Type: EXPERIMENTAL): Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
- Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans (Type: EXPERIMENTAL): Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
- Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan (Type: EXPERIMENTAL): Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.

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: Effect of Topical Dexmedetomidine on Intraocular Pressure

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with healthy eyes and no history of glaucoma~Exclusion Criteria:~* history of glaucoma, IOP \> 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery

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

Study Arms:
- BSS (Type: SHAM_COMPARATOR): Balanced salt solution
- Dexmedetomidine (Type: ACTIVE_COMPARATOR): dexmedetomidine (0.0055%)

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: Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Co-operative males or females with a diagnosis of moderate COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria with an age at onset ≥ 40 years.~* Current or previous smokers with a smoking history of ≥ 10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.~* Pre-bronchodilator forced expiratory volume in one second (FEV1) \< 70% of patient's predicted normal value and ≥ 1.00 L, with FEV1/forced vital capacity (FVC) \< 70% at Visit 2.~* A total symptom score from the patient diary of more than 0 on at least 4 of the last 7 days prior to Visit 3~Exclusion Criteria:~* Pregnant women, nursing mothers, and females of childbearing potential, regardless of whether or not sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception).~* Patients who have been hospitalized for an acute exacerbation of their airway diseases in the month prior to Visit 1 or during screening.~* Patients who have had a respiratory tract infection within 1 month prior to Visit 1. Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).~* Patients with concomitant pulmonary disease including a history of cancer (all), pulmonary tuberculosis or congenital bronchiectasis.~* History of asthma

- Gender: ALL
- Minimum Age: 40 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: Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)~Exclusion Criteria:~* Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.~* Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 79 Years
- Healthy Volunteers: f

Study Arms:
- Caduet (Type: EXPERIMENTAL): Open label caduet added to usual care regimen followed by investigators.

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 Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania

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

Eligibility Criteria:
Inclusion Criteria:~1. Male volunteers aged between 18 and 45 years for the adult group, and children of both sexes aged 5-9 years for schoolchildren group~2. Written informed consent obtained from the volunteer (adult) or guardian/ legal representative (children). In case patient is illiterate, an impartial witness should be present during the entire consent procedure~3. Free of obvious health problems as established by medical history and clinical examination before entering the study~4. Body Mass Index between 18 and 30 for adults; MUAC less than 12 for children~Exclusion Criteria:~1. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up~2. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose~3. Any chronic drug therapy to be continued during the study period~4. Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency~5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine~6. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever (defined as temperature more than 37.5°C)~7. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests~8. Acute or chronic diabetes~9. History of chronic alcohol consumption and/or intravenous drug abuse

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- 1 PEV301&302 (Type: EXPERIMENTAL): The vaccine includes two antigens (CSP and AMA1- derived)in combination and formulated with virosomes
- 2 Influenza vaccine (Type: ACTIVE_COMPARATOR): Inflexal V is the comparator that includes 3 antigens from flu formulated in virosomes

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: CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)

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. Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction.~* 2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score \> 10 points and to be judged to not have rapid clinical deterioration by the investigator since the subject's last tumor measurement leading to irPD assessment.~* 3. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.~* 4. Patient is able and willing to provide written informed consent to participate in the study.~* 5. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.~Exclusion Criteria:~* 1. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.~* 2. If lesions are too small to be visualized or palpable for accurate injection.~* 3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.

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

Study Arms:
- CVA21 (Type: EXPERIMENTAL): Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals

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 CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

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

Eligibility Criteria:
Inclusion Criteria:~* All patients must have a diagnosis of T2DM~* Patients in the main study must have a Hemoglobin A1c (HbA1c) between \>=7% and \<=10% and a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)~* Patients in the High Glycemic Cohort Substudy must have an HbA1c between \>10% and \<=12% and a FPG \<=350 mg/dL (19.44 mmol/L)~Exclusion Criteria:~* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Canagliflozin 100 mg (Type: EXPERIMENTAL): Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
- Canagliflozin 300 mg (Type: EXPERIMENTAL): Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
- Placebo/Sitagliptin (Type: EXPERIMENTAL): In the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.

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: Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions

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

Eligibility Criteria:
Inclusion Criteria:~* All patients aged 18 years to 80 years old presenting to the ED with suspected acute corneal abrasion from mechanical trauma or removal of a foreign body by the physician were included~Exclusion Criteria:~* Patients were excluded if they wore contact lenses, had previous corneal surgery or transplant in the affected eye, presented more than 36 hours after their injury, had a grossly contaminated foreign body or coexisting ocular infection. Additional exclusion criteria were pregnancy, retained foreign body, penetrating eye injury, immunosuppression, allergy to study medication, inability to attend follow up, inability to fluently read and speak English or Spanish, or any injury requiring urgent ophthalmologic evaluation (large or complicated abrasions with significant vision loss, corneal ulcers, corneal lacerations).

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

Study Arms:
- Topical tetracaine (Type: EXPERIMENTAL): Topical tetracaine hydrochoride 1%
- Balanced artificial tear solution (Type: PLACEBO_COMPARATOR): Balanced artificial tear solution (Systane)

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 Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis

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: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female patients at the age of 18 years or older who have diagnosis of chronic, posterior uveitis, intermediate uveitis or panuveitis~Exclusion Criteria:~* Patients receiving specific medication/interventions as specified per protocol~* Pregnant or nursing patients

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

Study Arms:
- PP-001 (Type: EXPERIMENTAL): Single intravitreal injection of 3 up to 4 doses of PP-001

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 Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

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

Eligibility Criteria:
Inclusion Criteria:~* Must be ≥18 yrs old on the day of signing informed consent~* Diagnosed with Primary Insomnia~* Good physical and mental health~* Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination~* A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception~* Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)~* Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1~* Regular bedtime is between 9 pm-1 am~* Willing to refrain from napping while in study~* Able to read, understand and complete questionnaires and all diaries~* Willing to limit alcohol, caffeine, and nicotine consumption while in the study~* For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory~Exclusion Criteria:~* Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study~* History or diagnosis of another sleep disorder~* Difficulty sleeping due to a medical condition~* History of a neurological disorder~* History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication~* Ongoing depression~* History of substance abuse or dependence~* History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit~* Taking certain prohibited medications~* Consumption of the equivalent of \>15 cigarettes a day~* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer~* Participant is considered morbidly obese~* Previously randomized in another investigational study of suvorexant

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

Study Arms:
- Suvorexant HD (Type: EXPERIMENTAL): Drug
- Suvorexant LD (Type: EXPERIMENTAL): Drug
- Placebo (Type: PLACEBO_COMPARATOR): Placebo Comparator

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

Answer: outcome: complete