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

Trial Title: Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment

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:~* Male or female subjects ≥18 years of age.~* High-normal BP or essential hypertension.~* Any subject with recommendation for evaluation with ABPM according to the 2007 European Guidelines.~* Informed consent to participate in the study prior to any study procedures.~Exclusion Criteria:~* Known or suspected contraindications to any potential medication under investigation.~* Shift-workers.~* Inability to communicate and comply with all study requirements.~* Persons directly involved in the execution of this protocol.~* Intolerants to the use of the ABPM device.

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Treatment with all prescribed hypertension medications on awakening
- 2 (Type: ACTIVE_COMPARATOR): Treatment with at least one prescribed hypertension medication at bedtime

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 Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

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

Eligibility Criteria:
Inclusion Criteria:~* Female and male smokers, aged 18 to 30 years;~* History of smoking for the past 12 months, at least one cigarette per day; smoking status is verified with urinary cotinine levels above 10 ng/ml;~* Not seeking treatment for nicotine dependence at the time of study entry;~* In good health as verified by medical history, screening examination, and screening laboratory tests;~* For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.~Exclusion Criteria:~* History of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study~* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics);~* A psychiatric diagnosis and / or treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder in the past month~* Abuse of alcohol or any other recreational or prescription drugs in the past 30 days.~* Any allergy to propylene glycol or menthol.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 30 Years
- Healthy Volunteers: t

Study Arms:
- Menthol-Preferring Smokers (Type: EXPERIMENTAL): Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
- Non-Menthol Preferring Smokers (Type: EXPERIMENTAL): Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.

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 Background Noise on Sleep Quality

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Age between 21 and 60~Exclusion Criteria:~* Any sleep disorder~* Use of hypnotics

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 60 Years
- Healthy Volunteers: t

Study Arms:
- Background noise (Type: ACTIVE_COMPARATOR): Overnight sleep study with filtered white noise
- Silence (Type: NO_INTERVENTION): Overnight sleep study with normal environmental noise

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 Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: None
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated.~* Patients with AML (arising from an antecedent hematologic disease \[AHD\]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML.~* AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML)~* For a diagnosis of AML, a bone marrow blast count of 20% or more is required.~* For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts~* Adequate Organ Function~* ECOG Performance Status 0, 1, or 2~Exclusion Criteria:~* AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.~* Patients with known active uncontrolled central nervous system (CNS) leukemia.

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

Study Arms:
- Arm A (Phase 1B) (Type: EXPERIMENTAL): PF-04449913 in combination with low dose ARA-C (LDAC)
- Arm B (Phase 1B) (Type: EXPERIMENTAL): PF-04449913 in combination with Decitabine
- Arm C (Phase 1B) (Type: EXPERIMENTAL): PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy.
- P2 Fit (Phase 2 Single Arm) (Type: EXPERIMENTAL): PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy.
- P2 Unfit (Phase 2 Randomized) (Type: OTHER): Patients will be randomized 2:1 (low dose ARA-C in combination with PF-04449913: low dose ARA-C alone).

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 Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with acute traumatic cut, crush, abrasion, bite or stab wounds Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations~* Wounds that are a minimum of approximately 4 cm2 in size~* Ability to read and understand the German patient information sheet and informed consent form~Exclusion Criteria:~* \< 18 years of age~* Pregnancy~* Immunosuppression~* Wounds caused by a burn~* Wounds that require treatment of hyaline cartilage, the central nervous system, peritoneum, meningae, inner / middle ear or inner eye~* Simultaneous participation in another clinical trial~* Wounds that require immediate surgical or medical treatment as well patients who are critically ill~* Patient with a known allergy to the active agent or any of the excipients~* Wounds that are \>3 cm in depth~* Wounds that have not received medical treatment for ≥6 hours~* Heavily bleeding wounds~* Open fractures, joints or tendons~* Wounds of the face

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

Study Arms:
- Ringer's Solution (Type: PLACEBO_COMPARATOR): None
- Lavasept 0.04% (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: Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

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

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of glaucoma or ocular hypertension in both eyes~* Patient requires IOP-lowering drug in both eyes~Exclusion Criteria:~* Uncontrolled medical conditions~* Ocular seasonal allergies within the past 2 years

- 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: A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Recipient of a first-time kidney transplant~* Between the ages of 18 and 70 years, inclusive~Exclusion Criteria:~* Recipient of any non-kidney transplant

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

Study Arms:
- CP-690,550 15 mg BID (Type: EXPERIMENTAL): None
- CP-690,550 30 mg BID (Type: EXPERIMENTAL): None
- tacrolimus (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: Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

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:~* History of migraines within the past year~* 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated~* Use acceptable contraception throughout the study~* Able to complete the study questionnaire(s) and paper diary~* Limit consumption of grapefruit juice to no more than one 8 ounce glass a day~Exclusion Criteria:~* Pregnant or breast-feeding or is expecting to become pregnant during the study~* Difficulty distinguishing his/her migraine attacks from tension or interval headaches~* A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours~* More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months~* Greater than 50 years old at the age of migraine onset~* Previously taken telcagepant

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

Study Arms:
- Telcagepant 140 mg (Type: EXPERIMENTAL): Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
- Telcagepant 280 mg (Type: EXPERIMENTAL): Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
- Control Group 1 (Type: PLACEBO_COMPARATOR): Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
- Control Group 2 (Type: PLACEBO_COMPARATOR): Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.

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: Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

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

Eligibility Criteria:
Inclusion Criteria:~* \> 18 years old~* cancer diagnosis~* GFR \< 60 and \> 30 ml/min/1,73m2 by MDRD formula or diabetic~* CT with contrast~Exclusion Criteria:~* dialysis needed~* uncontrolled hypertension~* changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure~* recent exposure to radiographic contrast agents (within previous two days of the study)~* administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study

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

Study Arms:
- sodium bicarbonate (Type: ACTIVE_COMPARATOR): Solution 154 mEq/L of sodium bicarbonate
- Sodium chloride (Type: ACTIVE_COMPARATOR): Solution of 154 mEq/L of 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: Cardiac Safety Study in Patients With HER2 + Breast 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:~* Female or male patient diagnosed with stage I-IV breast cancer~* HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) ≥ 2.0 on breast specimen or biopsy of a metastatic site~* LVEF \< 50% and ≥ 40% documented in echocardiogram done within the last 30 days~* HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy~* Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation~* Age ≥ 18 years~* Patient is willing and able to comply with protocol required assessments and procedures~Exclusion Criteria:~* Previous hospitalization due to documented heart failure in the last 12 months~* Current signs or symptoms of heart failure or ischemia~* History of arrhythmia requiring pharmacological or electrical treatment~* Concomitant use of anthracyclines or use of anthracyclines in the last 50 days~* Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.~* History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 120 Years
- Healthy Volunteers: f

Study Arms:
- HER2 therapies, cardiac medications (Type: OTHER): Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses~Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:~* Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.~* Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.~* Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every 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: Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

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 at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria \>/= 6 months at the time of baseline visit~* Patient must have active disease defined as DAS28-CRP\>/=3.2~* Patients must have CRP level above ULN \>5mg/l) or erythrocyte sedimentation rate (ESR) \>/=28mm/h~* Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards~Exclusion Criteria:~* Previous exposure to etanercept in the past~* Patients with functional status class IV according to the ACR 1991 revised criteria~* History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening

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

Study Arms:
- 50mg GP2015 (Type: EXPERIMENTAL): Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).
- 50mg EU-authorized Enbrel (Type: ACTIVE_COMPARATOR): Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).

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 Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

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:
Key Inclusion Criteria:~* HCV RNA ≥ 10\^4 IU/mL at screening~* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy~Key Exclusion Criteria:~* Any other chronic liver disease~* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)~* Clinical hepatic decompensation~* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor~Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

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

Study Arms:
- SOF/VEL (Type: EXPERIMENTAL): SOF/VEL for 12 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: Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression

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

Eligibility Criteria:
Inclusion Criteria:~* Major depressive disorder~* Use of an SSRI for at least 6 weeks prior to study entry with partial or no response~Exclusion Criteria:~* History of psychosis~* Allergy to SAMe~* Alcohol or drug abuse in the past 3 months prior to study entry

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

Study Arms:
- 1 Oral SAMe Tosylate (Type: EXPERIMENTAL): Participants receiving the oral SAMe tosylate
- 2 Oral Placebo Pill Twice Daily (Type: PLACEBO_COMPARATOR): Participants receiving placebo

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

Answer: outcome: complete