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

Trial Title: Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

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:~* Adult (at least 18 years old)~* Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites~* Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients~Exclusion Criteria:~* Age less than 18~* Inability to provide proper informed consent~* Combined organ transplantation~* Re-Transplantation

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

Study Arms:
- Monotherapy (Type: ACTIVE_COMPARATOR): Tacrolimus alone
- Combination therapy (Type: ACTIVE_COMPARATOR): tacrolimus with mycophenolate mofetil

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: TRADE-Testosterone Replacement and Dutasteride Effectiveness

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:~* Generally healthy older men 50 years old or older~* Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an average of equal to or less than 300 ng/dl on two occasions)~* Prostate volume equal to or more than 30 cc by prostate MRI~* Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less than 10 ng/mL~* Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy~* International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than or equal to 20 at screening~* Comply with study procedures for the full 10 months~* No contraindications to MRI~Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and University of Washington Medical Center in Seattle.~Exclusion Criteria:~* A history of prostate or breast cancer~* Invasive therapy for BPH in the past~* History of acute urinary retention in the 3 months prior to screening~* Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride)~* Medical therapy for BPH within the past month (alpha-blocker, phytotherapy)~* Use of androgenic or antiandrogenic drugs in the past year~* History or evidence of prostate cancer including suspicious DRE or history of high-grade PIN on prostate biopsy.~* Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes)~* Known untreated obstructive sleep apnea~* Hematocrit greater than 52~* Severe skin disease which may interfere with testosterone gel absorption~* Hypersensitivity to any of the drugs used in the study~* History of a bleeding disorder or need for chronic anticoagulation~* Participation in a drug study concurrently or in the last 90 days~* History or current evidence of drug or alcohol abuse within 12 mo.~* Weight more than 300 lbs.

- Gender: MALE
- Minimum Age: 50 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- Testosterone gel + oral placebo (Type: ACTIVE_COMPARATOR): Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily
- Testosterone gel + oral dutasteride (Type: ACTIVE_COMPARATOR): Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally 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: Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patient undergoing ENTS surgery for resection of pituitary tumor.~* Adults \>18 years and \<80 years of age.~* English speaking and literate or able to understand the use of a pain scale.~* Body Mass Index \>19 and \<40 kg/m2~Exclusion Criteria:~* Renal failure (acute or chronic) or creatinine \>2.0~* Allergy or intolerance to acetaminophen, ibuprofen, or opioids~* Pre-operative opioid tolerance, dependence, or abuse~* Anaphylaxis to opioids~* History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery~* Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range, defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin\> 3x upper limit of normal range~* Subject unwilling or unable to sign informed consent for the study~* Pregnancy~* Incarcerated patients

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 79 Years
- Healthy Volunteers: f

Study Arms:
- IV Caldolor (ibuprofen) (Type: ACTIVE_COMPARATOR): Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.
- standard treatment group (Type: PLACEBO_COMPARATOR): IV placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

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 of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

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

Eligibility Criteria:
Inclusion Criteria:~* Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH)~* As per the JAS 2017 guideline, participants not meeting the LDL-C management targets.~* Participants on statins should be receiving a maximally tolerated dose.~* Participants not receiving statins must have documented evidence of intolerance to at least one statin.~* The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180~Exclusion Criteria:~* Participants diagnosed with homozygous familial hypercholesterolemia (HoFH).~* Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.~* New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%.~* Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.~* Uncontrolled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg prior to randomization despite antihypertensive therapy.~* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at screening.~* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 300 mg inclisiran sodium (Type: EXPERIMENTAL): Subcutaneous injection
- 200 mg inclisiran sodium (Type: EXPERIMENTAL): Subcutaneous injection
- 100 mg inclisiran sodium (Type: EXPERIMENTAL): Subcutaneous injection
- Placebo (Type: PLACEBO_COMPARATOR): Subcutaneous injection

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 Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy subjects of either gender~* Age between 18 and 45 years~* Body mass index between 19 and 27kg/m2~* Normal medical history~* Normal or no clinically significant physical examination findings~* Normal or no clinically significant findings in analytical tests~* Negative hepatitis B, hepatitis C or HIV serology~* Negative drugs of abuse in urine~* Negative pregnancy test in females~* The subject understands and accepts the study procedures and grants in writing his/her informed consent~Exclusion Criteria:~* Did not fulfill the inclusion criteria~* Organic disorders or underwent major surgery, within 90 days before study screening~* Psychiatric history~* Alcohol drink intake greater than 30gr/day~* Cigarette smoking greater than 10 cigarettes/day~* Excessive consumption of food or beverages containing xanthines (more than five units of coffee, tea or cola per day)~* Medical treatment within 30 days before screening, and/or any medication 7 days before starting the study~* Participation in other clinical study or donate blood within 90 days before starting this study~* Antecedents of gastric, hepatic, renal and other kind of disorder that could affect ADME (absorption, distribution, metabolism or excretion of the study drug)~* Hepatitis B, hepatitis C or HIV positive serology~* Pregnant or breastfeeding~* Clinically relevant hypersensitivities (in particular to drugs)~* Woman taking oral contraceptive drugs~* Incapable of communicating and cooperating with investigators

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- 1 Tramadol Contramid Once A Day (Type: EXPERIMENTAL): None
- 2 Zytram (R) (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: Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women

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

Eligibility Criteria:
Inclusion Criteria:~1. HIV-1 positive serology by at least two different serological tests (rapid test, ELISA, Western Blot) or a viral load higher than 3,000 copies/mL.~2. 18 years and older.~3. Self-identified as TGW~4. ART naïve.~5. Written informed consent provided.~Exclusion Criteria:~1. Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel 2013.~2. Alcohol or drug use that might affect adherence.~3. Concomitant use of lipid-lowering drugs, interferon, interleukin-2, cytotoxic chemotherapy, dofetilide (or pilsicainide) or immunosuppressors, antacids drugs containing Ca++ and or Mg++ at study entry.~4. Opportunistic infection (CDC C category) or other disease and/or clinical conditions that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia.~5. Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of the investigational product.~6. Contraindication to any of the study drugs (history of renal diseases, lab abnormalities grade 4 or any other clinical condition prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements).~7. Anticipated need for Hepatitis C virus (HCV) therapy during the study.~8. Creatinine clearance of \<50 mL/min via Cockroft-Gault method.~9. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.

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

Study Arms:
- single arm (Type: EXPERIMENTAL): ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine

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: This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Age of 18 to 55 years (incl.)~* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Female subjects of childbearing potential willing to use adequate contraception.~* Further inclusion criteria apply~Exclusion criteria:~* Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* Further exclusion criteria apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- Test treatment (T) (Type: EXPERIMENTAL): Low strength empagliflozin/linagliptin/metformin XR fixed dose combination tablet
- Reference treatment (R) (Type: EXPERIMENTAL): Single tablets of empagliflozin + linagliptin + metformin XR

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 a Naked DNA-based Vaccine Therapy in Patients With Chronic Hepatitis B

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:~* chronic HBV carriers~* biopsy proven chronic hepatitis~* active HBV replication for \> 6 months~* non responding to Interferon-alpha or lamivudine treatment~Exclusion Criteria:~* co-infection with HIV, HCV, delta hepatitis virus~* alcohol consumption\> 40g/day~* decompensated liver disease~* HLA DR2

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- intramuscular injections (Type: EXPERIMENTAL): Patients received 4 injections of DNA vaccine at M0, M2, M4 and M10

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: Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant 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: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects must be 18 or older, weigh more than 34kg and may be of either sex and race.~* Subjects must be willing to give informed consent (IC) in writing and be able to do and follow the study. If a subject cannot give informed consent in writing , a legal representative could sign in his place.~* Women of childbearing potential should perform a pregnancy test at the time of entry and accept the use of a medically acceptable contraceptive method during the study.~Exclusion Criteria:~* Creatinine Clearance (CrCl )\<10 mL / min.~* Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to drugs ganciclovir/valganciclovir~* Pregnancy women.~* Women breast feeding~* Subjects may not present at time of inclusion any clinically significant disease that could interfere with study evaluations.~* Previous participation in another clinical trial sponsored by pharmaceutical industry, in which the promoter and the protocol set which should be the treatment for CMV.

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

Study Arms:
- 1.A (Prophylaxis-SPC) (Type: ACTIVE_COMPARATOR): Prophylaxis for CMV infection and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).
- 1.B (Prophylaxis- PK model) (Type: EXPERIMENTAL): Prophylaxis for CMV infection and Ganciclovir/Valganciclovir doses according to pharmacokinetic model.
- 2.A (Treatment-SPC) (Type: ACTIVE_COMPARATOR): Treatment for CMV infection/disease and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).
- 2.B (Treatment-PK model) (Type: EXPERIMENTAL): Treatment for CMV infection/disease and Ganciclovir/Valganciclovir doses according to pharmacokinetic model

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: Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

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:
DISEASE CHARACTERISTICS:~* Histologically confirmed primary intracranial Central Nervous System (CNS) atypical teratoid/rhabdoid tumor OR~* Tumor tissue that possesses the INI-1 gene mutation~* No metastases that disseminate outside the CNS by abdominal and chest computer tomography (CT) scans, kidney imaging, and bone marrow biopsy~  * No obstruction of cerebrospinal fluid (CSF) flow by CSF flow study~* Definitive surgical resection of tumor within the past 35 days~PATIENT CHARACTERISTICS:~Age~* 18 and under~Performance status~* Karnofsky 50-100% OR~* Lansky 50-100%~Life expectancy~* Not specified~Hematopoietic~* Hemoglobin \> 10 g/dL~* Absolute neutrophil count \> 1,000/mm\^3~* Platelet count \> 100,000/mm\^3~Hepatic~* Bilirubin ≤ 1.5 mg/dL~* SGPT \< 10 times normal~Renal~* Creatinine ≤ 1.5 times normal~Other~* Willing to have placement of central venous access line~PRIOR CONCURRENT THERAPY:~Biologic therapy~* Not specified~Chemotherapy~* No prior chemotherapy~Endocrine therapy~* Prior steroids allowed~Radiotherapy~* No prior radiotherapy~Surgery~* See Disease Characteristics~Other~* No other prior or concurrent investigational agents~* Concurrent anticonvulsant agents allowed

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

Study Arms:
- Multi-agent Intrathecal and Systemic CT with RT (mod IRS III) (Type: EXPERIMENTAL): Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.

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

Answer: outcome: complete