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

Trial Title: Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

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:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com~Inclusion Criteria:~* Men and women ≥18 years of age~* Eastern Cooperative Oncology Group Performance Status of 0 or 1~* Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer~* Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1~* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses~* Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize~Exclusion Criteria:~* Active brain metastases or leptomeningeal metastases~* Ocular melanoma~* Any active, known, or suspected autoimmune disease

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

Study Arms:
- Nivolumab, 3 mg/kg (Type: EXPERIMENTAL): Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
- Dacarbazine, 1000 mg/m^2 (Type: ACTIVE_COMPARATOR): Participants received dacarbazine, 1000 mg/m\^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

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

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

Trial Title: Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

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

Eligibility Criteria:
Inclusion Criteria:~* age: ≥ 70 years inclusive at Visit 1.~* patients with a confirmed diagnosis of T2DM~* HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled~* body mass index (BMI) in the range of 19-45kg/m2~Exclusion Criteria:~* FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)~* previous or current participation in any vildagliptin clinical study.~* history of hypersensitivity to DPP-4 inhibitors.~* concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.~* donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 70 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Vildagliptin (Type: EXPERIMENTAL): None
- Placebo (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: Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Females 18 years to 42 years of age who experienced gestational diabetes mellitus (GDM) during recent (within 12 months) pregnancy with prediabetic hyperglycemia determined by an oral glucose tolerance test (OGTT) with 75 g glucose postpartum. Study subjects will be inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum.~* Written consent for participation in the study~Exclusion Criteria:~* Cholestasis during the past pregnancy~* Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)~* Serum aspartate transaminase (AST) and/or alanine aminotransferase (ALT) level exceeding more than twice normal lab values~* Presence of hypersensitivity to sitagliptin or other DPP-4 inhibitor~* Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or over the counter \[OTC\])~* Prior use of medication to treat diabetes except gestational diabetes~* Use of drugs known to exacerbate glucose tolerance~* History of diabetes or prior use of medications to treat diabetes except GDM~* Creatinine clearance less than 60 ml/min~* Pregnancy planned during the coming two years~* Currently lactating~* Patient not willing to use adequate contraception during study period (unless sterilized)

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 42 Years
- Healthy Volunteers: f

Study Arms:
- Sitagliptin-Metformin (Type: EXPERIMENTAL): 50 mg/1000 mg twice a day (BID)
- Placebo pill (Type: PLACEBO_COMPARATOR): 1 pill/BID for 16 weeks
- Metformin (Type: ACTIVE_COMPARATOR): 1000 mg BID

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: Investigating Hearing Aid Frequency Response Curves

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:~* N2 - N4 Hearing losses~* Health Outer ear~* no visible congenital or traumatic deformity of the outer ear~* Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.~* Ability to answer questions and repeat sentences~* No history of problematic tinnitus or pain/discomfort from loud sounds~* No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature~* Willingness to wear different styles of couplings~* Willingness to wear binaural fitting~* Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)~* Ability to travel throughout facility~Exclusion Criteria:~* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)~* Limited mobility/not able to come to the scheduled visit~* Inability to produce reliable hearing test results~* History of active drainage from the ear in the previous 90 days~* Abnormal appearance of the eardrum and ear canal.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: t

Study Arms:
- Participants with Hearing Loss (Type: EXPERIMENTAL): Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.

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: Patient Registry of Intrathecal Ziconotide Management(PRIZM)

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:~* Patient is at least 18 years of age at the time of study entry.~* Patient who has severe chronic pain, whom IT therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or IT morphine.~* Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.~* Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.~* Patient has a life expectancy \>6 months as determined by the physician.~* Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.~* Patient is able to understand and complete required assessments.~Exclusion Criteria:~* Patient has a known hypersensitivity to PRIALT or any of its formulation components.~* Patient has a pre-existing history of psychosis.~* Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.~* Patient is being initiated with PRIALT in conjunction with other IT agents.~* Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.

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

Study Arms:
- Severe Chronic Pain (Type: None): 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: Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

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:~* Subject with well-characterized Epilepsy according to the 1989 International League Against Epilepsy (ILAE) classification~* Subject with Epilepsy who the investigator expects will benefit from Levetiracetam (LEV) but for whom the investigator has decided to discontinue due to nonpsychotic behavioral side effects following the introduction of LEV~* Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging from 1 g/day to 3 g/day)~* Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs) including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED~* Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method~Exclusion Criteria:~* Subject has a lifetime history of suicide attempt (including an actual, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1~* Subject whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)~* Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline~* Subject has history or presence of known psychogenic nonepileptic seizures~* Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol~* Subject is pregnant or lactating

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

Study Arms:
- Brivaracetam (Type: EXPERIMENTAL): The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 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: Deliberate Ultraviolet Light Exposure to Get a Tan by Young Adult Sexual Minority Males

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

Eligibility Criteria:
Inclusion Criteria:~* Young adult SMM (age 18-39)~* Able to read English~* Have internet access~* Willing to complete the online survey~Exclusion Criteria:~* None

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 39 Years
- Healthy Volunteers: None

Study Arms:
- Males who never deliberately tan (Type: None): Males responded to an anonymous online survey that they never deliberately tan
- Males who ever deliberately tan (Type: None): Males responded to an anonymous online survey that they had ever deliberately tan

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 Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

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

Eligibility Criteria:
Inclusion Criteria: Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.~-~Exclusion Criteria: Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.~-

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

Study Arms:
- povidone-iodine (Type: ACTIVE_COMPARATOR): preoperative skin preparation with povidone-iodine
- chlorhexidine-alcohol (Type: EXPERIMENTAL): preoperative skin preparation with scrub and paint technique

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: Intrathecal Morphine in Knee Arthroplasty

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

Eligibility Criteria:
Inclusion Criteria:~* Patients for elective total knee arthroplasty~Exclusion Criteria:~* No contraindication to spinal~* No allergy to morphine, rescue analgesia or anti-emesis treatment.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): patients in this group got 100mcg of intrathecal morphine.
- 2 (Type: EXPERIMENTAL): patients in this group got 200 mcg intrathecal morphine
- 3 (Type: EXPERIMENTAL): patients in this group given 300 mcg intrathecal morphine.

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: Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)~* Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.~* Patients who have been following a fat and cholesterol restrictive diet.~Exclusion Criteria:~* Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.~* Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.~* Abnormal pancreatic, liver, or renal function~* Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level~* Significant heart disease

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

Study Arms:
- Pitavastatin 4 mg QD (Type: EXPERIMENTAL): Pitavastatin 4 mg once daily

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 Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis

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

Eligibility Criteria:
Inclusion Criteria:~* Newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on HPS and PRS sepsis score criteria~Exclusion Criteria:~* Major congenital anomalies of the gastrointestinal tract.~* Continuous vomiting.~* Newborns with hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (NEC) and hormonal disorders.~* Septic shock.

- Gender: ALL
- Minimum Age: 28 Weeks
- Maximum Age: 36 Weeks
- Healthy Volunteers: f

Study Arms:
- Control Group (Type: PLACEBO_COMPARATOR): The control group will receive standard therapy and placebo.
- Treatment Group (Type: EXPERIMENTAL): The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg

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: S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or 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:
DISEASE CHARACTERISTICS:~* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one of the following stages:~  * Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0)~ * Newly diagnosed stage IV disease (any T, any N, M1)~ * Recurrent stage IV disease after prior surgery or radiotherapy~* The following subtypes are eligible:~  * Adenocarcinoma~ * Squamous cell carcinoma~ * Large cell carcinoma~ * Unspecified~* Measurable disease by CT scan, MRI, x-ray, or physical exam~  * Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease~ * Not within prior radiotherapy field unless a new lesion is present~ * Not within area of prior surgical resection~* No known brain metastases by CT scan or MRI~PATIENT CHARACTERISTICS:~Age~* 18 and over~Performance status~* Zubrod 0-1~Life expectancy~* Not specified~Hematopoietic~* Absolute neutrophil count ≥ 1,500/mm\^3~* Platelet count ≥ 100,000/mm\^3~* Hemoglobin ≥ 9 mg/dL~Hepatic~* Bilirubin ≤ 2 times upper limit of normal (ULN)~* SGOT or SGPT ≤ 2 times ULN~* Alkaline phosphatase ≤ 2 times ULN~* No known acute hepatitis~Renal~* Creatinine ≤ ULN~* Creatinine clearance ≥ 50 mL/min~Cardiovascular~* No significant cardiac disease~* No uncontrolled hypertension~* No unstable angina~* No congestive heart failure~Other~* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission~* No active or uncontrolled infection~* No sensory neuropathy ≥ grade 2~* No known human anti-mouse antibodies~* Not pregnant or nursing~* Fertile patients must use effective contraception~PRIOR CONCURRENT THERAPY:~Biologic therapy~* No prior biologic therapy for NSCLC~* No prior chimeric or murine monoclonal antibody therapy~* No prior cetuximab~Chemotherapy~* No prior systemic chemotherapy for NSCLC~Endocrine therapy~* Not specified~Radiotherapy~* See Disease Characteristics~* At least 3 weeks since prior radiotherapy and recovered~Surgery~* See Disease Characteristics~* At least 2 weeks since prior thoracic or major surgery and recovered~Other~* No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): None
- 2 (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: complete