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

Trial Title: Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

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:~* Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.~* Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.~* Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).~Exclusion Criteria:~* Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1.~* Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit 1.~* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

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

Study Arms:
- Atogepant 60 mg (Type: EXPERIMENTAL): Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 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: MyPhonak App Junior Pediatric Usability and Benefit Investigation

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

Eligibility Criteria:
Inclusion Criteria:~* Children and adolescents between the ages of 7 and 17 years old.~* bilateral mild to severe hearing loss~* experienced hearing aid users for 6+ months~Exclusion Criteria:~* any additional disabilities to the hearing impairment~* inability to complete the study procedures

- Gender: ALL
- Minimum Age: 7 Years
- Maximum Age: 17 Years
- Healthy Volunteers: t

Study Arms:
- Experimental Study Group (Type: EXPERIMENTAL): Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE hearing aids and given access to the Phonak hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.

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 and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis

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

Eligibility Criteria:
Inclusion Criteria:~* Newly diagnosed cutaneous leishmaniasis (untreated) with localized lesions ( without maximum 6 injuries ) and Direct Examination positive : amastigotes display in tissue samples ;~* Age: 16-64 years;~* Sex: male and female patients to eligible ;~* Disease Clinical Evolution not longer than 3 months .~Exclusion Criteria:~* AST \> 3 times the upper limit of normal;~* ALT \> 3 times the upper limit of normal;~* Alkaline phosphatase \> 3 times the upper limit of normal;~* Serum creatinine and urea \> 1.5 times the upper limit of normality;~* Blood glucose above 110 mg / dl;~* Evidence of serious underlying disease ( heart , kidney , liver or lung);~* protein and / or caloric severe malnutrition;~* Any uncompensated or uncontrolled condition like active tuberculosis, malignant disease , severe malaria , HIV, leprosy , systemic fungal disease (histoplasmosis, paracoccidioidomycosis) or any other infectious disease;~* Pregnant women or who are breastfeeding;~* Lack of ability or willingness to provide informed consent (patient and / or parent / legal representative); lack of availability for the visits or to comply with study procedures.

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- Single dose of Pentamidine (Type: EXPERIMENTAL): Fifty three patients using Pentamidine at a dose of 7 mg/kg will be included, in a single dose.
- Two doses of Pentamidine (Type: EXPERIMENTAL): Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during two weeks.
- Three doses of Pentamidine (Type: EXPERIMENTAL): Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during three 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: Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with idiopathic PD.~* Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours.~* Patients with a Modified Hoehn and Yahr stage ≤3 in the ON state.~* Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline.~* Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa.~* Patients who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation.~Exclusion Criteria:~* Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.~* Patients with a clinically significant or unstable vascular disease.~* Patients who have undergone a neurosurgical intervention of PD.~* Patients with severe disabling dyskinesias.~* Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.~* Patients with a Mini Mental State Examination (MMSE) score ≤24.~* Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.~Other inclusion and exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- Azilect® (Type: EXPERIMENTAL): 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: Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

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

Eligibility Criteria:
Inclusion Criteria:~* Moderate to severe dry eye disease~* Normal lid/lash anatomy, blinking function and closure as determined by the Investigator~* Literate, able to speak English, and able to complete questionnaires independently~Exclusion Criteria:~* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding~* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas~* Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator~* Corneal transplant in either or both eyes~* A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit~* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

- Gender: ALL
- Minimum Age: 22 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Intranasal Application (Type: EXPERIMENTAL): Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.
- Extranasal Application (Type: SHAM_COMPARATOR): Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

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: Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' in Peripheral Neuropathic Pain

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:~* both male and female who are over 19-year-old~* patient whose pain scale is 4\~9~* patient who has pain of mononeuropathy~Exclusion Criteria:~* patient whose CCr is \<60ml/min~* patient who has other pain which is not from mononeuropathy~* patient who is going to have an operation during this study~* patient who has abnormal ECG

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- GLA5PR GLARS-NF1 & Pregabalin placebo (Type: EXPERIMENTAL): GLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months
- GLA5PR GLARS-NF1 placebo & Pregabalin (Type: ACTIVE_COMPARATOR): GLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 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: Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

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. Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach~2. Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs \< 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.~3. Male and female patients aged \> 18 years~4. ECOG ≤ 1~5. neutrophils ≥ 1500/µl~6. Haemoglobin ≥ 9 g/dl~7. Platelets ≥ 100,000/µl~8. AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;~9. Total bilirubin ≤1.0 x ULN~10. Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min~11. Written patient informed consent~Exclusion Criteria:~1. A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)~2. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure~3. Malignant secondary disease dating back \< 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)~4. Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection~5. Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment~6. Peripheral polyneuropathy \> NCI grade II~7. Severe hepatic impairment (AST/ALT \> 2.5 x ULN, , bilirubin \> 1 x ULN)~8. Chronic inflammatory bowel disease~9. Participation in another study~10. Pregnancy or lactation

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

Study Arms:
- Cabazitaxel (Type: EXPERIMENTAL): Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22

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: Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

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:~* Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma~* Age \> 15 years~* Written informed consent~Exclusion Criteria:~* Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected~* HIV infection~* Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy~* Known severe allergy to foreign proteins~* Pre-treatment other than 1 cycle CHOP or similar; \< 1 week of another chemotherapy.~* Pregnancy or nursing~* Participation in other studies that interfere with study therapy

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Experimental (Type: EXPERIMENTAL): This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement

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 of Nalmefene in Patients With Alcohol Dependence

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:~In- and outpatients who:~* had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria~* had had ≥6 HDDs in the 4 weeks preceding the Screening Visit~* had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit~Exclusion Criteria:~The patient:~* had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence~* had an antisocial personality disorder~* had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)~* had a history of delirium tremens or alcohol withdrawal seizures~* reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists~* reported current or recent treatment with antipsychotics or antidepressants~* was pregnant or breast-feeding~Other protocol-defined inclusion and exclusion criteria may apply.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- Nalmefene (Type: EXPERIMENTAL): 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: Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. In-hospital cardiac arrest~2. Age ≥ 18 years~3. Received at least one dose of adrenaline during cardiopulmonary resuscitation~Exclusion Criteria:~1. Clearly documented do-not-resuscitate order prior to the cardiac arrest~2. Prior enrollment in the trial~3. Invasive mechanical circulatory support at the time of the cardiac arrest~4. Known or suspected pregnancy at the time of the cardiac arrest

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

Study Arms:
- Vasopressin and methylprednisolone (Type: EXPERIMENTAL): The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).
- Placebo (Type: PLACEBO_COMPARATOR): The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl (normal saline) from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.

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: Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects with traumatic brain injury~* Glasgow Coma Score (GCS) score 3-8(inclusive),or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology~* Hemodynamically stable with a systolic BP \>90 mm Hg~* At least one reactive pupil~* A negative pregnancy test in females~* Age at least 18 years~* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR~* Subjects with subarachnoid hemorrhage (SAH)~* SAH documented by CT scan~* Hunt-Hess grade 3-5, inclusive~* Hemodynamically stable with a systolic BP\> 90 mm Hg~* At least one reactive pupil~* A negative pregnancy test in females~* Age of at least 18 years~* Signed informed consent and HIPAA authorization for research form~Exclusion Criteria for enrollment~* No venous access~* Spinal cord injury~* History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage~* Hemodynamically unstable~* Suspected anoxic events~* Other peripheral trauma likely to result in liver failure~* Positive pregnancy test in females~* Age less than 18 years of age~* Known hypersensitivity to any anticonvulsant~* An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.~* Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).~* Inability to obtain signed informed consent or HIPAA authorization for research.

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

Study Arms:
- Levetiracetam (Type: ACTIVE_COMPARATOR): Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days.
- Phenytoin (Type: ACTIVE_COMPARATOR): Group 2-The phenytoin group will receive a loading dose of 20 mg/kg IV to a maximum of 2000mg, then started on maintenance dose at 5 mg/kg/day (rounded to nearest 100mg dose, IV, divided into three doses a day) as prophylaxis for 7 days. Phenytoin levels are to be checked daily and dose adjusted as needed to maintain therapeutic levels of 10-20 µg/dL.

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: AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1/PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible~* ECOG performance status 0 or 1~* Male or female ≥ 18 years of age~Exclusion Criteria:~* Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma~* Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy.~* Subjects with resectable disease or suitable for definitive chemoradiation~* Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy~* Tumors of squamous cell histology~* Known central nervous system metastases~* Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization~* Serious or non-healing wound

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

Study Arms:
- Phase 2 Arm C (Type: PLACEBO_COMPARATOR): AMG 102 placebo plus ECX
- Phase 1b (Type: OTHER): Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
- Phase 2 Arm B (Type: ACTIVE_COMPARATOR): AMG 102 at 7.5mg/kg plus ECX
- Phase 2 Arm A (Type: ACTIVE_COMPARATOR): AMG 102 at 15mg/kg plus ECX

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

Answer: outcome: complete