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

Trial Title: Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Locally advanced squamous cell cancer of the head and neck, stage III or IV disease (T1-2, N2a-3 or T3-4).~* Measurable disease~* No prior chemotherapy or radiation for head and neck squamous cell cancer~* Life expectancy of greater than 3 months.~* Adequate labs~Exclusion Criteria:~* Known metastatic disease.~* Nasopharyngeal carcinoma~* History of allergic reactions attributed to metformin or other agents used in study.~* Known diagnosis of diabetes requiring insulin for control.~* Administration of metformin within last 4 weeks.

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

Study Arms:
- Metformin with Chemoradiation (Type: EXPERIMENTAL): Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.

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: Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

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

Eligibility Criteria:
Inclusion Criteria:~* Suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified Duke criteria (Li J, et al. Clin Infect Dis. 2000).~* Patients over 18 years.~Exclusion Criteria:~* Patients who did not sign informed consent.~* Patients with active consumption intravenous drug.~* Patients with emergent surgery criteria (\<72 hours).~* Patients or cardiogenic shock.~* Patients with antibiotic active against MRSA over 72 hours or they may need another antibiotic active against MRSA than those in the study.~* Patients with chronic renal failure on hemodialysis who received empirical treatment with vancomycin as a single dose and have a valley ≥ 15 mcg / mL on the third day.~* Patients with MRSA strains resistant to fosfomycin (MIC\> 64 mg / L) (\<10%) or vancomycin (MIC\> 2 mg / L) or with an MIC to vancomycin of 2 mg / L.~* Patients with any formal contraindication to be treated with study drugs~* Patients treated with any investigational drug within 30 days prior to entering the study.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): IV fosfomycin and imipenem adjusted to renal function
- 2 (Type: ACTIVE_COMPARATOR): IV Vancomycin twice a day with valley leves higher than 15 mcg/kg

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: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

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:
* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label~* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)~* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study~* Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial~Exclusion Criteria:~- None

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

Study Arms:
- Participants with HCV genotype 1 or 4 (Type: None): Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 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: Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder

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

Eligibility Criteria:
Inclusion Criteria:~* Able to provide written informed consent~* In good physical health as confirmed by a complete physical exam, electrocardiogram, neurological exam, and routine laboratory tests of blood and urine~* A negative urine toxicology screen~* Completion of psychiatric evaluations, medical evaluations, and self-report questionnaires through separate protocol- Biological Correlates of Personality Disorders (GCO #88-244)~  1. meet DSM-IV criteria for borderline personality disorder and have an overt aggression scale- modified aggression subscale score of six or above on one of two OASM pre-treatment screens.~ 2. not currently be taking any psychiatric medications. If they have taken psychiatric medications in the past, they must be at least 2 weeks (6 half-lives) medication-free prior to participating in the study. These medications include mood stabilizers, antidepressants, antipsychotics, and benzodiazepines.~Exclusion Criteria:~* meet criteria for schizophrenia, bipolar I disorder, schizoaffective disorder or any other psychotic disorder.~* have met criteria for substance abuse or dependence during the 6 months prior to entry into the study~* have a past history of intravenous drug use, cocaine abuse or dependence, or any substance dependence that resulted in serious medical sequelae~* meet criteria for current MDE, as they may require antidepressant treatment~* have made a suicide attempt or had a psychiatric hospitalization during the 6 months prior to entry into the study~* be on any psychotropic medication(s) upon entry into the study~* be in concurrent psychotherapy (case management services and work therapy programs are not considered individual psychotherapy)~* be pregnant or lactating

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- Dialectical Behavior Therapy (Type: OTHER): Dialectical Behavior Therapy
- Healthy Controls (Type: NO_INTERVENTION): Healthy controls

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

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

Trial Title: A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

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

Eligibility Criteria:
Inclusion Criteria:~* Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)~* Patients in whom MTX therapy (\>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration~* Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.~Exclusion Criteria:~* Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab~* Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc~* Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- CNTO 148 50 mg + methotrexate (Type: EXPERIMENTAL): None
- CNTO 148 100 mg + methotrexate (Type: EXPERIMENTAL): None
- Placebo + methotrexate (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: Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically confirmed adenocarcinoma of the colon or rectum~  * Stage II disease~ * Stage III disease~ * Stage IV disease (completely resected with no evidence of residual tumor)~* Must have undergone curative resection for stage II or III disease~* Scheduled to receive 6 months of adjuvant treatment with either of the following FOLFOX chemotherapy regimens:~  * FOLFOX4, comprising leucovorin calcium, fluorouracil, and oxaliplatin (2-week course)~ * Modified FOLFOX6, comprising high-dose leucovorin calcium, high-dose fluorouracil, and oxaliplatin (2-week course)~PATIENT CHARACTERISTICS:~* Absolute neutrophil count ≥ 1,500/mm\^3~* Platelet count ≥ 100,000/mm\^3~* Hemoglobin ≥ 10 g/dL~* WBC ≥ 3,000/mm\^3~* Bilirubin ≤ 1.5 times upper limit of normal (ULN)~* Creatinine ≤ 1.5 times ULN~* Calcium normal~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* No pre-existing peripheral neuropathy of any grade~* No hypercalcemia~* No concurrent heart block or a history of heart block~* No other medical condition that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient~* No family history of a genetic/familial neuropathy~PRIOR CONCURRENT THERAPY:~* See Disease Characteristics~* No prior treatment with neurotoxic chemotherapy such as oxaliplatin, cisplatin, taxanes, or vinca alkaloids~* Concurrent use of bevacizumab or cetuximab in combination with FOLFOX as part of a clinical trial or clinical practice are allowed~* No concurrent digitalis medication~* No concurrent digoxin~* No concurrent treatment with anticonvulsants such as carbamazepine, phenytoin, or valproic acid~* No other concurrent neurotropic agents such as gabapentin

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

Study Arms:
- Ca/Mg (Type: EXPERIMENTAL): Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
- Placebo (Type: PLACEBO_COMPARATOR): Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.

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: Pharmacokinetic Study to Determine Time to Steady-state

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:~* Male, age 18-75~* Morning serum testosterone (T) \<300 ng/dL on two occasions~* Naive to androgen-replacement therapy or willing to wash-out from current T therapy~Exclusion Criteria:~* Significant intercurrent disease~* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.~* Serum transaminases \>2 times upper limit of normal~* Serum bilirubin \>2.0 mg/dL~* Hematocrit \<35% or \>50%~* BMI \>36~* Untreated, obstructive sleep apnea.

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

Study Arms:
- Testosterone Undecanoate (Type: EXPERIMENTAL): Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.

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: Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)

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

Eligibility Criteria:
Inclusion Criteria:~* Patients scheduled for ERCP~Exclusion Criteria:~* Age under 18 years~* American Society of Anesthesiologists' (ASA) physical classification IV - V~* History of sulfite, egg or soy bean allergy~* Emergency need for ERCP~* Informed consent could not be obtained

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

Study Arms:
- conventional group (Type: ACTIVE_COMPARATOR): For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered. To maintain conscious level of patient at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary.
- cocktail group (Type: EXPERIMENTAL): For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered. To maintain conscious level of patient at moderate or deep level, 1% propofol at the rate of 1 mg/kg/hr was administered. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.

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 Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients must have received radiation therapy for histologically confirmed head and neck cancer.~2. Clinical evidence support the diagnosis of radiation-related neuropathic pain (confirmed by the Michigan Neuropathy Screening Instrument) and had a daily pain score of 4 or higher based on a numerical rating scale (0-10 points).~3. Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score\>= 12 in Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire by two neurology specialists.~4. The mean duration of pain is more than 4 weeks.~5. Fertile women who are willing to take contraception during the trial.~6. Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.0 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; Hb \>/=9.0.~7. Ability to understand and willingness to sign a written informed consent document.~Exclusion Criteria:~1. Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain.~2. Evidence of secondary neuropathic pain other than radiation.~3. Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment.~4. Ongoing treatment for neuropathic pain.~5. History of anaphylactic response to pregabalin.~6. Evidence of sever systematic diseases.

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

Study Arms:
- Pregabalin (Type: ACTIVE_COMPARATOR): Arm I:At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.
- Placebo (Type: PLACEBO_COMPARATOR): Arm II:At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.

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 Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis~* Has RA greater than or equal to 3 months and less than or equal to 2 years~Exclusion Criteria:~* Received any previous treatment with MTX~* Received any previous treatment with ETN or other tumour necrosis factor antagonist

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

Study Arms:
- 1a (Type: ACTIVE_COMPARATOR): Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
- 1b (Type: ACTIVE_COMPARATOR): Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
- 2a (Type: ACTIVE_COMPARATOR): Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
- 2b (Type: ACTIVE_COMPARATOR): Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 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: Mail Order Mifepristone Study

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

Eligibility Criteria:
Inclusion Criteria:~* Women seeking medication abortion through 63 days gestation~* Eligible for MifeprexⓇ at a study site~* English or Spanish speaking~* Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit~Exclusion Criteria:~* Not pregnant~* Not seeking medication abortion~* under the age of 15~* Over 63 days gestation~* Contraindicated for medication abortion

- Gender: FEMALE
- Minimum Age: 15 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- Medication Abortion Patients (Type: EXPERIMENTAL): Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)

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 Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

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

Eligibility Criteria:
Inclusion Criteria:~Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.~Exclusion Criteria:~1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.~2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.~3. Known or suspected impairment/alteration of immune function.~4. Individuals with a known bleeding diathesis.~5. History of Guillain-Barré syndrome.~6. Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).~7. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.~8. Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.~9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.~10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.~11. Individuals with history of substance or alcohol abuse within the past 2 years.~12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.~13. Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.~14. Subjects from whom blood could not be drawn at visit 1.

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- aTIV (Type: EXPERIMENTAL): Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
- Licensed TIV (Type: EXPERIMENTAL): Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

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

Answer: outcome: complete