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

Trial Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

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:~1. Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.~2. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.~3. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.~Exclusion Criteria:~1. Women who are pregnant, planning a pregnancy, or lactating.~2. Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes.~3. Current treatment of cancer or diagnosed with cancer in the past 6 months~4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).~5. Current use of TN or other forms of NRT.~6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- Extended Patch Treatment (Type: EXPERIMENTAL): Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions.
- Standard Patch Treatment (Type: ACTIVE_COMPARATOR): Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.

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: Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female subjects aged ≥18 years~* Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry~* At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1~* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2~* Adequate organ function~Exclusion Criteria:~* Prior chemotherapy for extensive-stage SCLC~* Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.~* Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure~* Known history of stroke or cerebrovascular accident within 6 months prior to enrollment~* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol~* Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)~* Receipt of any investigational medication within 4 weeks prior to enrollment

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

Study Arms:
- trilaciclib + carboplatin/etoposide (Type: EXPERIMENTAL): All patients in part 1 will receive trilaciclib (G1T28) prior to standard chemotherapy- carboplatin and etoposide. Patients will have PK assessments completed on days 1 and 3 in cycle 1 only. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
- trilaciclib/placebo + carboplatin/etoposide (Type: EXPERIMENTAL): All patients enrolled in part 2 will be randomized to receive either trilaciclib (G1T28) or placebo administered prior to standard chemotherapy- carboplatin and etoposide. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.

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 Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

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

Eligibility Criteria:
Inclusion Criteria:~1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.~2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.~Exclusion Criteria:~1. Subjects who used any of the following systemic treatments during the washout periods given below:~   1. Oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.~  2. Treatment with more than 1 NSAID within 14 days at baseline.~  3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.~  4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.~  5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.~2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.~3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

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

Study Arms:
- Group A (Type: EXPERIMENTAL): None
- Group B (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: Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Legal guardian(s) must provide informed consent prior to any study procedures~* Documented diagnosis of severe HPP as indicated by:~  * Total serum alkaline phosphatase at least 3 standard deviations (SD) below the mean for age~ * Plasma pyridoxal 5'-phosphate (PLP) at least 4 times the upper limit of normal~ * Radiographic evidence of HPP (hypophosphatasia), characterized by:~    * Flared and frayed metaphyses~   * Severe, generalized osteopenia~   * Widened growth plates~ * One or more HPP-related findings:~    * History or presence of:~      * Non-traumatic post-natal fracture~     * Delayed fracture healing~   * History of elevated serum calcium~   * Functional craniosynostosis with decreased head circumference growth~   * Nephrocalcinosis~   * Respiratory compromise~ * Rachitic chest deformity and/or vitamin B6 dependent seizures~ * Failure to thrive~* Onset of symptoms prior to 6 months of age~* Age ≤ 36 months~* Otherwise medically stable (patient may be on ventilatory support)~* Legal guardian(s) must be willing to comply with the study~Exclusion Criteria:~* History of sensitivity to any of the constituents of the study drug~* Current or prior clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, infectious, urologic, pulmonary, neurologic, dermatologic, renal condition and/or other major disease which, in the opinion of the investigator, precludes study participation~* Treatment with an investigational drug within 1 month prior to the start of study drug administration~* Current enrollment in any other study involving an investigational new drug, device or treatment for HPP (e.g., bone marrow transplantation)~* Low serum calcium, phosphate or 25(OH) vitamin D~* Current evidence of a treatable form of rickets~* Prior treatment with bisphosphonate

- Gender: ALL
- Minimum Age: None
- Maximum Age: 36 Months
- Healthy Volunteers: f

Study Arms:
- asfotase alfa (Type: OTHER): asfotase alfa

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: Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial 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:~* Histologically confirmed ovarian epithelial carcinoma~  * Recurrent or persistent disease~    * Must have received greater than or equal to (≥) 2 prior cytotoxic chemotherapy regimens, including ≥ 1 platinum-containing regimen~ * Disease not amenable to curative treatment with surgery and/or radiotherapy~* Must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or a serum cancer antigen 125 (CA-125) level that is rising and meets 1 of the following criteria:~  * Serum CA-125 level greater than (\>) upper limit of normal (typically 35 μ/mL) on two evaluations at least 2 weeks apart~ * Serum CA-125 level less than (\<) 35 μ/mL but has risen progressively \> 200% over successive specimens ≥ 2 weeks apart~* Estrogen receptor-positive tumor~* Gynecologic Oncology Group (GOG) performance status 0-3~* Platelet count ≥ 50 x 10\^9/Liter~* Serum creatinine less than or equal to (≤) 2.5 mg/deciliter~* Bilirubin ≤ 1.5 times upper limit of normal (ULN)~* Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times upper limit of normal (ULN)~* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)~* Alkaline phosphatase ≤ 3 times ULN~* Prothrombin time-International Normalized Ratio (INR) ≤ 1.6~* Not pregnant or nursing~* Negative pregnancy test~* Must be sterile or fertile patients must use effective contraception (i.e., double method including ≥ 1 barrier, injectable, implantable, condoms plus spermicide)~* Prior malignancy allowed provided the patient has been disease-free for ≥ 5 years~  * Patients with previously diagnosed basal cell skin cancer are eligible immediately after completing therapy~* No history of bleeding (i.e., disseminated intravascular coagulation or clotting factor deficiency)~* No documented sensitivity to active or inactive excipients of fulvestrant (i.e., castor oil or mannitol)~* Recovered from the effects of prior surgery, radiotherapy, and/or chemoradiotherapy~* At least 3 weeks since prior chemotherapy~* At least 3 weeks since prior complete radiotherapy regimen alone or chemoradiotherapy~  * An incomplete radiotherapy regimen (\< 500 Gray) is allowed within the 3-week time frame~Exclusion Criteria:~* Concurrent hormone replacement therapy~* Prior long-term anticoagulation therapy other than anti-platelet therapy

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

Study Arms:
- Fulvestrant (Type: EXPERIMENTAL): Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.

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: Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

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:~ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:~* Post-abdominal surgery.~* Elderly \> 65 years old.~* Renal insufficiency / failure / hemodialysis.~* Solid tumor.~* Solid-organ (liver, kidney, lung, heart) transplant recipients.~* Hepatic insufficiency.~* Neutropenic including hematology oncology patients.~Exclusion Criteria:~Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

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

Study Arms:
- Treatment Group (Type: EXPERIMENTAL): Option to treat with oral azole therapy following treatment with anidulafungin

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: Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Emergency~* Trauma patient admitted in participating trauma care centers~* Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.~* Inclusion performed within the first 6 hours after trauma.~Exclusion Criteria:~* Patient taking anticoagulants~* Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)~* Minor Patient~* Pregnant or breastfeeding women

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

Study Arms:
- Freezed-dried plasma (Type: EXPERIMENTAL): transfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)
- Fresh-frozen plasma (Type: ACTIVE_COMPARATOR): transfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)

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: Adjunctive Cilostazol Versus High Maintenance-dose ClopidogrEL in Acute Myocardial Infarction (AMI) Patients According to CYP2C19 Polymorphism

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:~1. The patient must be at least 18 years of age.~2. clinical symptoms compatible with acute myocardial ischemia within 12 h before admission with a subsequently documented increase in cardiac markers.~3. Measured pre-discharge platelet reactivity in case of normalized CK-MB value after coronary stenting.~Exclusion Criteria:~1. A history of active bleeding and bleeding diatheses.~2. Oral anticoagulation therapy with coumadin.~3. Contraindication to antiplatelet therapy.~4. LV ejection fraction \< 30% or NYHA 3/4.~5. Leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3.~6. AST or ALT ≥ 3 times upper normal.~7. Serum creatinine level ≥ 2.5 mg/dl.~8. Stroke within 3 months.~9. Non-cardiac disease with a life expectancy \< 1 year.~10. Inability to follow the protocol.

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

Study Arms:
- triple group (Type: ACTIVE_COMPARATOR): Additive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) in patients with acute myocardial infarction (AMI).~Received cilostazol 100 mg twice daily in addition to aspirin 100 mg and clopidogrel 75 mg once daily.
- high maintenance dose group (Type: ACTIVE_COMPARATOR): High maintenance dose dual antiplatelet therapy in patients with acute myocardial infarction (AMI).~Received clopidogrel 150 mg/day with aspirin 100 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 Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Patients undergone resection of stomach, intestine, or rectum, having the indication of nutrition~* Nutrition risk screening scores around 3~* The age of the patients must be between 18 to 80~* The patients sign the confirmed consent letter~* Weight falls in the range of either 45-56 kg or 60-75 kg~Exclusion Criteria:~* Pregnant or breast feeding~* Contraindication of fluid infusion, acute pulmonary edema, brain edema and functional insufficiency of the heart~* Hypersensitive to the ingredient of the trial product nutrient~* Chemotherapy within 7 days before the beginning of this trial~* Unstable angina pectoris~* Diabetes mellitus~* Disorder of lipid metabolism: triglycerides, cholesterol increased by 1.5 times above the reference value~* Abnormal renal function: serum creatinine or BUN 1.5 times above normal reference value~* Abnormal liver function: ALT or serum total bilirubin 1.5 times above normal reference value~* Having severe drug allergy history and/or asthma~* On operation day, blood loss above 800 ml~* Contraindication to parenteral nutrition~* Receiving regular parenteral nutrition within 7 days before the trial

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- 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: Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

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

Eligibility Criteria:
Inclusion Criteria:~* diagnosed for infantile colic according to Wessel's criteria~Exclusion Criteria:~* previous treatment with probiotic or synbiotic~* previous treatment with antibiotics

- Gender: ALL
- Minimum Age: 3 Weeks
- Maximum Age: 6 Weeks
- Healthy Volunteers: f

Study Arms:
- Simethicone Solution (Type: ACTIVE_COMPARATOR): Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.
- Vivatlac Baby (Type: EXPERIMENTAL): Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.

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: CMV-TCR-T Cells for CM Virus Infection After HSCT

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:~1. Age 1-70 years, including boundary values, gender unlimited;~2. Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia;~3. At least one of the following conditions after allogeneic HSCT:~   * After trested with 2-week standard antiviral drug, compared to the baseline of treatment, the decrease of CMV DNA copies number was less than 1log10, and the CMV DNA copies number is greater than 1000 copies/ mL ;~  * Unable to tolerate the toxic and side effects of antiviral drugs,such as bone marrow hematopoietic suppression, nephrotoxicity;~4. Estimated life expectancy ≥3 months；~5. ECOG 3;~6. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.~Exclusion Criteria:~1. Patients with active aGVHD III-IV and / or mild and severe cGVHD;~2. Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment.~3. Pregnant or lactating women;~4. Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;~5. patients with organ failure:~   * Heart: NYHA heart function grade IV;~  * Liver: Grade C that achieves Child-Turcotte liver function grading;~  * Kidney: kidney failure and uremia;~  * Lung: symptoms of respiratory failure;~  * Brain: a person with a disability;~6. The researchers found that it was unsuitable for the recipients to be enrolled.

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- CMV-TCR-T cells (Type: EXPERIMENTAL): The patients will receive one dose of CMV-TCR-T.The dosage ranges from 0.1×10\^6 to 1×10\^6 TCR+T/Kg.

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

Answer: outcome: complete