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

Trial Title: An Open Label Study of FT218 in Subjects With Narcolepsy

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:~* Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218~* Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate~* Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate)~* Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014)~* Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations.~Exclusion Criteria:~* Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8~* Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.)~* A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other devices for sleep apnea.

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- FT218 (Type: EXPERIMENTAL): once nightly sodium oxybate extended release oral solution (FT218)

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 II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

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:~* Females 18 years old and older~* Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy~* Radiologically confirmed relapse after \>6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.~* The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study~Exclusion Criteria:~* FIGO I,II epithelial ovarian cancer~* FIGO III, IV clear cells epithelial ovarian cancer~* Non-epithelial ovarian cancer~* Borderline tumors (tumors of low malignant potential)~* Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\] except first line Platinum-based chemotherapy (with or without bevacizumab)~* Previous radiotherapy to the abdomen and pelvis~* Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas

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

Study Arms:
- DCVAC/OvCa in parallel with chemotherapy (Type: EXPERIMENTAL): Combination therapy with DCVAC/OvCa and Standard of Care
- Standard of Care (Type: ACTIVE_COMPARATOR): Standard of Care carboplatin and gemcitabine

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 Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain

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 include:~* Moderate to severe acute pain for which parenteral opioid therapy is warranted~* Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.~Exclusion Criteria include:~* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of safety, tolerability, or efficacy data in the study.~* Hemodynamic instability or respiratory insufficiency.~* Advanced cancer in palliative or end-of-life care.~* Another current painful condition (other than acute pain for which parenteral opioid therapy is warranted) that would confound the interpretation of safety, tolerability, or efficacy data in the study.~* Clinically significant, immune-mediated hypersensitivity reaction to opioids.

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

Study Arms:
- TRV130 (Type: EXPERIMENTAL): For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed.~For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.

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: Transversus Abdominis Plane Block on Stress Response

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

Eligibility Criteria:
Inclusion Criteria:~* Consent~* ASA 1-3~* No contraindication to epidural or ropivacaine~* First time surgery for current conditions~* Not on chronic pain medications or sedative~Exclusion Criteria:~* The subject has a known or suspected allergy to opioid analgesics or ropivacaine~* Emergency patients~* The subject has know central nervous system disease or neurological impairment~* The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.

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

Study Arms:
- Transversus abdominis plane block (Type: EXPERIMENTAL): The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
- Epidural anesthesia (Type: ACTIVE_COMPARATOR): The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
- Control (Type: PLACEBO_COMPARATOR): The Control group receives standard IV-inhaled general anesthesia.

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

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

Trial Title: Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent must be obtained before any assessment is performed~* Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization~* Moderate to severe plaque psoriasis as defined at baseline by:~  * ≥10% Body Surface Area (BSA) involvement and~ * PASI total score of ≥12 and~ * IGA mod 2011 score of ≥3 (based on a scale of 0-4)~Exclusion Criteria:~* Forms of diagnosed psoriasis other than chronic plaque psoriasis~* Medication-induced or medication exacerbated psoriasis~* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors~* Ongoing use of prohibited treatments~* Pregnant or nursing (lactating) women~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- Secukinumab (Type: EXPERIMENTAL): Eligible patients received secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48
- Placebo (Type: PLACEBO_COMPARATOR): Eligible patients received placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients were switched to treatment with secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48

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: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy adult men and women~* Age 18-49 years~* Who reside geographically close to one of the four study sites in Michigan~Exclusion Criteria:~* Persons with any of the health conditions for which the inactivated vaccine is recommended~* Persons for whom either vaccine is contraindicated

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 49 Years
- Healthy Volunteers: t

Study Arms:
- TIV (Type: ACTIVE_COMPARATOR): the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
- LAIV (Type: ACTIVE_COMPARATOR): live-attenuated influenza vaccine Flumist, manufactured by MedImmune
- Placebo (Type: PLACEBO_COMPARATOR): Physiologic saline administered as a nasal spray or intramuscular injection

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: Perindopril Amlodipine for the Treatment of 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: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Essential hypertension~* For female subjects, a negative serum pregnancy test~* Ability to provide written informed consent~Exclusion Criteria:~* Night shift workers whose work hours include midnight to 4:00 a.m.~* Secondary hypertension~* An arm size that precludes the use of the digital blood pressure monitor cuff (arm size \> 42 cm)~* Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects~* Female subjects who are pregnant, planning to become pregnant~* History of malignancy within 5 years~* Primary aldosteronism~* Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve~* Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina~* Known hypersensitivity to any component of the study drugs~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- XOMA 985 (Type: EXPERIMENTAL): fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
- Amlodipine Besylate (AMLb) (Type: ACTIVE_COMPARATOR): None
- Perindopril Erbumine (PERe) (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: Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Be diagnosed with CKD and creatinine clearance less than 60 ml / minute secondary to hypertension and / or diabetes.~* Age over 18 years~Exclusion Criteria:~* Malignant neoplasms whose last treatment was less than 5 years~* Having received antibiotics for any reason during the month prior to enrollment~* Have received probiotics in the last 3 months~* Have been diagnosed with Clostridium difficile infection in the last year~* Have been previously submitted to TMF~* Having presented ERC exacerbations during the 3 months prior or present at the time of enrollment

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

Study Arms:
- Faecal microbiota transplant (Type: EXPERIMENTAL): This group will receive frozen capsules to be ingested orally constituted of TMF with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
- Placebo (Type: PLACEBO_COMPARATOR): This group will receive frozen capsules to be ingested orally placebo with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.

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: EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

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 of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomization and with at least one ECG-documented AF/AFL episode in the last 3 months.~Exclusion Criteria:~* MAIN CRITERIA (non-exhaustive list, see protocol for details):~Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Dronedarone 400mg bid (Type: EXPERIMENTAL): dronedarone 400mg tablets
- Placebo (Type: PLACEBO_COMPARATOR): matching 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: Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically confirmed diagnosis of a solid tumor malignancy~* Baseline hemoglobin value of \<11 g/dL~* Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks~* \< 2 prior chemotherapy regimens in a metastatic setting~* Adequate hematologic \& renal function and platelet count \>100,000/mm3~* Estimated life expectancy of \> 6 months~* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2~Exclusion Criteria:~* History of stem cell or bone marrow transplant~* Anemia due to factors other than cancer/chemotherapy~* Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 months~* Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy~* Uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis~* new onset of seizures~* history of second active malignancy~* Major infection requiring hospitalization and antibiotics within 14 days of randomization~* Transfusion of white blood cells or packed red blood cells within 28 days of randomization.

- 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: Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

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:~* Age above 18 years;~* Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);~* Current edema in the cutaneous, abdominal and/or laryngeal areas;~* Current edema moderate to severe according to the investigator's Symptom Score.~Exclusion Criteria:~* Diagnosis of angioedema other than HAE,~* Participation in a clinical trial of another investigational medicinal product (IMP)within the past month~* Treatment with any pain medication since onset of the current angioedema attack~* Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack~* Treatment with Tranexamic acid replacement therapy within a week before onset of the current angioedema attack~* Treatment with ACE inhibitors~* Contraindications for Tranexamic acid~* Evidence of coronary artery disease based on medical history or Screening examination in particular unstable angina pectoris or severe coronary heart disease~* Congestive heart failure (class 3 and 4)~* Serum creatinine level of ≥ 250 μmol/L~* Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial~* Pregnancy (as assessed prior to treatment) and/or breast-feeding

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

Study Arms:
- Randomized controlled -Icatibant (Type: EXPERIMENTAL): Subjects received S.C icatibant+ oral placebo~Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL)~Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart
- Randomized controlled-Tranexamic acid (Type: ACTIVE_COMPARATOR): Subjects received oral Tranexamic acid+ S.C. placebo~Tranexamic acid Form: over encapsulated film tablet Single dose: 1000 mg (2 capsules) Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart~Placebo Form: solution for injection, matched to icatibant for injection Single dose: 3 mL Frequency: one subcutaneous injection in the abdominal region
- Controlled Open-label / laryngeal attack (Type: EXPERIMENTAL): Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
- Untreated patients at the baseline (Type: EXPERIMENTAL): Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant

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: Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults

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

Eligibility Criteria:
Inclusion criteria:~* have at least 5 teeth with exposed root surfaces and not indicated for extraction, and~* living in the community and have self-care ability for normal daily activities.~Exclusion Criteria:~* have life-threatening or serious health problems,~* have cognitive problems in communication or in receiving oral hygiene instructions~* have salivary gland diseases or received radiotherapy in the head and neck region.

- Gender: ALL
- Minimum Age: 56 Years
- Maximum Age: 85 Years
- Healthy Volunteers: t

Study Arms:
- control (Type: PLACEBO_COMPARATOR): instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
- silver diammine fluoride (Type: EXPERIMENTAL): the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
- silver diammine fluoride and KI (Type: ACTIVE_COMPARATOR): the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.

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

Answer: outcome: complete