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

Trial Title: The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18 to 85 years~* Mild to severe hearing impairment between 125 to 4000 Hz~* No significant conductive hearing impairment~* Able and willing to commit to travel and time demands of the study~Exclusion Criteria:~* Must not have known or active medical issues that would preclude having a device including:~  1. an abnormal tympanic membrane~ 2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes~ 3. an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane~* Must not have other known or active medical issues including:~  1. history of chronic and recurrent ear infections in the past 24 mouths~ 2. history of dizziness and/or vertigo in the past 24 months~ 3. taking medications/treatments with known ototoxic effects~ 4. a rapidly progressive or fluctuating hearing impairment~ 5. having been diagnosed with having a compromised immune system~* Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56~* Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Mild to severe hearing impairment (Type: EXPERIMENTAL): Sound amplification provided via the EarLens System assistive hearing device.

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: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly

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

Eligibility Criteria:
Inclusion Criteria:~* Man or woman aged from 65 to 75 years~* Right-handed subject (Edinburgh Handedness inventory)~* Subject having signed the consent form~* Subject having agreed to be listed on the French National Healthy Volunteers database~* Subject affiliated or beneficiary to French social insurance~Exclusion Criteria:~* Subject presenting a neurological or psychiatric disease notably cognitive, progressing~* Anxious subject (Hamilton score \> 7 and/or Spielberger score \> 51 for a man or \> 61 for a woman)~* Left-handed subject (Edinburgh Handedness inventory)~* Subject presenting a not corrected visual disease or a motor function disease that could interfere with tests realization~* Smoker~* Subject taking one or more psychotropics or apparent products~* Subject having taken, during the previous month, one or more drugs that could interfere with study drugs metabolism~* Subject drinking too much coffee or tea (\> 4 cups per day) or alcohol (\>½ liter of wine or equivalent per day)~* Subject presenting contra-indication to one of the drugs used in the study~* Subject with past history of intolerance to drugs used in the study~* Subject not capable to use the CANTAB cognitive evaluation system~* Subject which may not be able to participate to the whole study~* Subject under tutelage or guardianship~* Subject not able to well-understand French and so to understand cognitive tests~* Subject not capable to swallow capsules~* Subject participating to another study or in exclusion period (3 months after a previous trial).

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: 75 Years
- Healthy Volunteers: t

Study Arms:
- etifoxine (Anxiolytic) (Type: EXPERIMENTAL): etifoxine, 100 mg, a single oral intake
- lorazepam (Type: ACTIVE_COMPARATOR): lorazepam, 2 mg, a single oral intake
- Placebo (Type: PLACEBO_COMPARATOR): 2 capsules of Placebo, a single oral intake

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: Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week~Exclusion Criteria:~* Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min

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

Study Arms:
- Arm 1 (Type: EXPERIMENTAL): Rivaroxaban 10 mg once daily for 12 months
- Arm 2 (Type: EXPERIMENTAL): Rivaroxaban 20 mg once daily for 12 months
- Arm 3 (Type: ACTIVE_COMPARATOR): ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months

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

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

Trial Title: Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

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

Eligibility Criteria:
Inclusion Criteria:~* Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization~* Currently taking 1 to 3 concomitant marketed antiepileptic drugs~* 18 years and older at study entry~Exclusion Criteria:~* Previous use of lacosamide~* Hypersensitivity to any component of lacosamide~* Patients with partial onset seizures not clearly identifiable~* History of generalized epilepsy~* History of status epilepticus within last 12 months~* Uncountable seizures due to clustering within last 12 weeks~* Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures~* History of drug or alcohol abuse~* History of suicide attempt~* Progressive cerebral disease~* Concomitant treatment of felbamate~* Prior or concomitant vigabatrin use~* Under legal protection

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

Study Arms:
- Lacosamide (Type: EXPERIMENTAL): Flexible dosing between 200mg/day and 400mg/day

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

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

Trial Title: Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

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

Eligibility Criteria:
Inclusion Criteria:~* Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4~* Otherwise healthy~Exclusion Criteria:~* No active STIs

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- 0.5% SPL7013 Gel (Type: EXPERIMENTAL): None
- 1.0% SPL7013 Gel (Type: EXPERIMENTAL): None
- 3.0% SPL7013 Gel (Type: EXPERIMENTAL): None
- Placebo Gel (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung 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:~1. Patients must have biopsy proven metastatic NSCLC (Stage IV).~2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.~3. Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.~4. Age 18 to 75 years old.~5. Patients must have measurable disease at baseline.~6. The amount of metastatic focus \<5.~7. ECOG score 0-2~8. Adequate normal organ and marrow function for TKI treatment and radiotherapy.~9. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)~10. Patients must provide written informed consent to participate in the study.~Exclusion Criteria:~1. Patients who previously received radiotherapy to the primary site.~2. Patient can't tolerate radiotherapy or targeted therapy;~3. Pregnant or nursing women

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

Study Arms:
- SBRT plus TKI group (Type: EXPERIMENTAL): SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
- TKI treatment group (Type: ACTIVE_COMPARATOR): Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid

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: Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* ≥ 18 and ≤ 70 years of age~* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach~* Have failed for 2 lines of chemotherapy~* Life expectancy of more than 3 months~* ECOG performance scale ≤ 2~* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)~* Duration from the last therapy is more than 6 weeks for nitroso or mitomycin~* More than 4 weeks for operation or radiotherapy~* More than 4 weeks for cytotoxic agents or growth inhibitors~* Adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 × 109/L, neutrophil \> 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN).~Exclusion Criteria:~* Pregnant or lactating women~* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix~* Any factors that influence the usage of oral administration; Evidence of CNS metastasis~* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix~* Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure~* Receiving the therapy of thrombolysis or anticoagulation~* Abuse of alcohol or drugs~* Allergy to the ingredient of the agent or more than two kinds of food and drug~* Less than 4 weeks from the last clinical trial~* Disability of serious uncontrolled intercurrence infection.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- A 850 (Type: EXPERIMENTAL): apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- B 425 (Type: EXPERIMENTAL): apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- C pla (Type: PLACEBO_COMPARATOR): placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

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: Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy infant 46 to 74 days (both inclusive)~* Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth~* Parent(s)/legal representative able to comply with the study procedures~Exclusion Criteria:~* Participation in any study with an investigational compound or device since birth~* History of congenital or acquired immunodeficiency~* Chronic illness that could interfere with study conduct or completion~* Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines~* Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®~* History or maternal history of HBsAg seropositivity~* Coagulation disorder that contraindicate intramuscular injection~* History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)~* History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection~* Receipt of immune globulin, blood or blood-derived products since birth~* Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start~* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

- Gender: ALL
- Minimum Age: 46 Days
- Maximum Age: 76 Days
- Healthy Volunteers: t

Study Arms:
- PR5I (V1); Pediacel® (V2); PR5I (V3) (Type: EXPERIMENTAL): \[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.

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: Neuromuscular Blocking Agents in the Elderly

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

Eligibility Criteria:
Inclusion Criteria:~* Patients \> 18 years old~* Informed consent~* Scheduled for elective surgery (\>1 hour) under general anaesthesia with intubation and use of rocuronium.~* American Society of Anaesthesiologists (ASA) physical status classification I to III~* Can read and understand Danish~Exclusion Criteria:~* Known allergy to rocuronium~* Neuromuscular disease that may interfere with neuromuscular data~* Indication for rapid sequence induction

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

Study Arms:
- Elderly (>80 years) (Type: None): Patients planned for elective surgery above 80 years
- Younger (18-40 years) (Type: None): Patients planned for elective surgery between 18-40 years

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: Isotretinoin in Preventing Skin Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of autosomal recessive disorder xeroderma pigmentosum Diagnosis must be documented by the clinical signs and symptoms listed in standard text books, e.g.: Sun sensitivity Increased number of freckles and other pigmentary lesions Cutaneous atrophy and telangiectasia Actinic keratoses Skin cancers Ocular abnormalities (e.g., photophobia, conjunctivitis, keratitis, or premalignant or malignant tumors of the eye or lid) allowed Neurologic abnormalities (e.g., progressive hearing loss, diminished reflexes, or progressive mental deterioration) allowed OR Diagnosis of autosomal dominant nevoid basal cell carcinoma syndrome Diagnosis must be documented by the clinical signs and symptoms listed in standard text books, e.g.: Basal cell carcinomas Palmar pits Skeletal abnormalities Falx calcification History of at least 2 documented skin cancers a year during the 2 years before study, but currently clear of all skin cancer Patients not previously treated with isotretinoin must agree to undergo a 1 year follow-up period without isotretinoin (to facilitate observation of any chronic toxicity and observe for new tumors) Must undergo appropriate treatment for any skin cancers that arise during study No evidence of metastatic cancer~PATIENT CHARACTERISTICS: Age: Over 2 Hematopoietic: Complete blood cell counts normal Hepatic: SGOT or SGPT less than 3 times upper limit of normal (ULN) Triglycerides less than 200 mg/dL Renal: Creatinine less than 3 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No hypersensitivity to parabens (used in drug formulation) No proven active malignancy except skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study therapy~PRIOR CONCURRENT THERAPY: See Disease Characteristics No recent, chronic, high-dose vitamin A use (greater than 30,000 IU/day) No concurrent supplemental vitamin A No other concurrent therapy for the skin (except sunscreens) unless approved by the investigators

- Gender: ALL
- Minimum Age: 2 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: Swallowing Function Before and After Surgery for Thyroid Goiter

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:~* thyroidectomy~Exclusion Criteria:~* na

- 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: CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)

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

Eligibility Criteria:
Inclusion Criteria:~1. Individuals age 18 and older with BD Type 1 or 2 as confirmed by the Mini International Psychiatric Inventory (MINI).~2. Known to have medication treatment adherence problems as identified by the Treatment Routines Questionnaire (TRQ, 20% or more missed medications in past week or past month)~3. Screening the Brief Psychiatric Rating Scale (BPRS) score of ≥ 36~4. Ability to be rated on psychiatric rating scales.~5. Willingness to take long-acting injectable antipsychotic medication (LAI)~6. Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation~7. Able to provide written, informed consent to study participation.~Exclusion Criteria:~1. Individuals on LAI immediately prior to study enrollment.~2. Individuals with known intolerance or resistance to either oral aripiprazole or LAI formulation of aripiprazole~3. Prior or current treatment with clozapine~4. Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial~5. Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist~6. Immediate risk of harm to self or others~7. Female who is currently pregnant or breastfeeding

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

Study Arms:
- Patient Noncompliance (Type: EXPERIMENTAL): Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention

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

Answer: outcome: complete