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

Trial Title: Preventing Anaphylaxis With Acalabrutinib

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:~* History of immunoglobulin E (IgE)-mediated food allergy to peanut or tree nut~* Positive skin prick test to the trigger food (either peanut or tree nut)~* Objective clinical reaction to the food allergen during baseline oral food challenge~* Women of child bearing potential must agree to two forms of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of acalabrutinib therapy.~* Ability to understand and the willingness to sign a written informed consent~* Ability to clearly understand and speak English at an 8th grade reading level~Exclusion Criteria:~* Participants who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to enrollment~* Participants with symptoms consistent with food reactions other than type 1 hypersensitivity~* History of allergic reaction to acalabrutinib~* History of idiopathic urticaria, dermatographism, idiopathic or unexplained anaphylaxis, or anaphylaxis (to foods or otherwise) resulting in intubation, prolonged hypotension, or neurological sequelae- History of cardiovascular disease~* History of a bleeding disorder, or those currently taking blood thinners~* History of stroke~* History of gastrointestinal ulcer~* History of cancer (other than skin cancer)~* Positive HIV status or history of other immunodeficiency~* Active or latent Hepatitis B or C infection based on laboratory testing~* Currently pregnant or nursing~* Current use of proton pump inhibitors (Note: participants currently receiving proton pump inhibitors who switch to H2-receptor antagonists or other antacids are eligible for enrollment to this study).~* Active significant infection~* Major surgical procedure within 28 days of enrollment~* Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura~* Difficulty swallowing oral medication, or significant gastrointestinal disease that would limit absorption of oral medication~* Concurrent participation in another therapeutic clinical trial

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

Study Arms:
- Acalabrutinib (Type: EXPERIMENTAL): Participants will be given acalabrutinib (four doses of 100 mg of acalabrutinib to be taken orally twice 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: A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes~* Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry~* Body mass index 22-40 kg/meter squared~* HbA1c \> 11% and/or FPG \>270 mg/dL~Exclusion Criteria:~* Pregnant or lactating female~* History of type 1 diabetes~* Evidence of significant diabetic complications~* Treatment with insulin or any other oral antidiabetic agent~Other protocol-defined inclusion/exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 78 Years
- Healthy Volunteers: f

Study Arms:
- vildagliptin + metformin (Type: EXPERIMENTAL): None

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

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

Trial Title: Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months~* Body Mass Index (BMI): 24-35 kg/m\^2 inclusive~Exclusion Criteria:~* SUBJECTS WITH TYPE 2 DIABETES~* Receipt of any investigational drug within three months prior to this trial~* Recurrent severe hypoglycemia as judged by the investigator~* Cardiac disease~* Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level~* Haemoglobin maximum 10 g/L~* HbA1c above 12%~* Loss of more than 400 mL blood during the 3 months prior to trial start~* HEALTHY SUBJECTS~* Receipt of any investigational drug within 3 months prior to this trial~* Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)~* Use of any drug that in the investigator's opinion could interfere with the blood glucose level~* Haemoglobin max. 10 g/L~* HbA1c at least 6%

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

Study Arms:
- NNC 90-1170 (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): None
- Healthy (Type: NO_INTERVENTION): 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: Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

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

Eligibility Criteria:
Inclusion Criteria:~* Ability and acceptance to provide informed consent;~* No perception of light by the subject's own report;~* Diagnosis of N24HSWD as determined by:~  1. History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and~ 2. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.~* Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;~* Fluent in English;~Exclusion Criteria:~* Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;~* Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;~* History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;~* History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;~* Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;~* Unable to perform calls to the study IVR system to report questionnaire results;~* Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening;~* Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle~* Use of melatonin or melatonin agonist

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

Study Arms:
- tasimelteon (Type: EXPERIMENTAL): 20 mg tasimelteon capsules, PO daily for 6 months
- placebo (Type: PLACEBO_COMPARATOR): Placebo capsules, PO daily for 6 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: Mifepristone at Same Time Multicenter Study

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:pregnancy equal to or less than 63 days at enrollment -~Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound~-

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

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 Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV 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:~* Willing and able to provide written informed consent~* HCV RNA ≥ 10\^4 IU/mL at screening~* HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.~* Genotype 1 HCV at screening~* HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy~Key Exclusion Criteria:~* Pregnant or nursing female~* Chronic liver disease of a non-HCV etiology~* Current or prior history of any clinically-significant illness (other than HCV)~* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)~NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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

Study Arms:
- LDV/SOF (Type: EXPERIMENTAL): Treatment-experienced and treatment-naive participants will receive LDV/SOF 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: Efficacy and Safety of Varenicline Among HIV-infected Patients

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

Eligibility Criteria:
Inclusion Criteria:~* HIV-infected patients~* adults~* regular smokers (at least 10 cigarettes a day during the last year)~* motivated to stop smoking~* followed in one of the participating clinical ward,~* signed written inform consent~Exclusion Criteria:~* current co-dependency to another psychoactive substance~* ongoing depressive episode~* history of suicidal attempt~* ongoing treatment by interferon~* treatment by efavirenz for less than three months or not tolerated~* previous use of varenicline~* ongoing treatment by bupropion-SR or nicotinic substitute~* ongoing pregnancy~* ongoing breastfeeding~* hypersensitivity to varenicline or to one of its excipients~* drivers, air traffic controller

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

Study Arms:
- Varenicline (Type: EXPERIMENTAL): Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks
- Placebo (Type: PLACEBO_COMPARATOR): placebo titrated to 2 pills twice daily 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: The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.

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

Eligibility Criteria:
Inclusion Criteria:~* HIV infected woman~* 18 - 40 years of age~* able and willing to sign Informed Consent~* pregnant for a maximum of 31 weeks~Exclusion Criteria:~* history of sensitivity/idiosyncrasy to the drug~* relevant history of interference with drug metabolism~* inability to understand trial procedures~* abnormal specific serum levels~* use of specific concomitant medications~* active hepatobiliary or hepatic disease~* previous failure of saquinavir/ritonavir regimen

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 40 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: Effect of a Reduced Dose Enzalutamide in Frail (m)CRPC Patients on Cognitive Side Effects

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

Eligibility Criteria:
Inclusion Criteria:~* Frailᵃ male patients with prostate cancer who will start treatment with enzalutamide within label~* Age at least 18 years~* Patient who are able and willing to give written informed consent prior to screening~* Patients from whom it is possible to collect blood samples~* Patients who are willing to answer the questionnaires and test~* Life expectancy of \> 6 months~* Capable of understanding and answering Dutch tests and questionnaires, as determined by the investigator~ᵃ Frail is defined as:~* a score on the comprehensive G8 assessment with cut-off ≤14 points and~* score ≥grade 1 for Central Nervous Disorders according to the Common Toxicity Criteria Adverse Event (CTCAE) criteria, of one of the following: Fatigue, Concentration impairment, cognitive disturbance, amnesia, depressed level of consciousness, memory impairment, hypersomnia.~Exclusion Criteria:~* change in dose of opioids/sedatives/benzodiazepines during last 2 weeks before study)~* Use of psychostimulants such as methylphenidate within 1 week of start of study~* Diagnosed with medical conditions that affect cognition: Dementia, Alzheimer disease, Parkinson's disease, psychiatric disorders that affect cognition other than depression or anxiety complaints related to the disease~* Active infection or other comorbidities that may contribute to REDOSE, February 2019 Page 7 of 53 fatigue or cognition change within 4 weeks of study entry~* Clinical relevant anaemia~* MoCa score \<20~* Hypersensitivity to the active substance or to any of the excipients.

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

Study Arms:
- reference (normal) dose (Type: ACTIVE_COMPARATOR): Normal dose of enzalutamide (160mg once daily)
- test (reduced) dose (Type: EXPERIMENTAL): Reduced dose of enzalutamide (120mg 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: An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea

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

Eligibility Criteria:
Inclusion Criteria:~* Plaque psoriasis for at least 6 months~* Moderate to severe disease~* Candidate for phototherapy or systemic therapy~Exclusion Criteria:~* Other forms of psoriasis~* History of recent infection~* Prior exposure to BMS-986165~Other inclusion/exclusion criteria may apply.

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

Study Arms:
- Arm A:BMS-986165 oral administration (Type: EXPERIMENTAL): None
- Arm B: Placebo oral administration (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: AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* adults \>/=18 years of age~* inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)~* at least 1 measurable lesion meeting RECIST criteria~* ECOG performance status 0-2~* adequate hematological, liver and renal function~Exclusion Criteria:~* prior chemotherapy or treatment with another systemic anti-cancer agent~* malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS~* evidence of tumor invading major blood vessels~* current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes~* history of haemoptysis \>/=grade 2~* clinically significant cardiovascular disease

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

Study Arms:
- Part 1 (Type: EXPERIMENTAL): None
- Part 2A (Type: EXPERIMENTAL): None
- Part 2B (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 Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Documental congenital FXIII deficiency~* Normal platelet count and clotting parameters~* Adequate renal and hepatic function~* If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment~* If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits~* Negative drug and alcohol screens~Exclusion Criteria:~* Received blood products or FXIII concentrates within 4 weeks of study enrollment~* Known antibodies to FXIII~* Hereditary or acquired coagulation disorder other than FXIII deficiency~* Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus~* Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment~* Received treatment with any experimental agent within 30 days of study enrollment~* Any surgical procedure in the 30 days prior to enrollment~* Donated blood within 30 days prior to enrollment

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

Study Arms:
- rFXIII (Type: EXPERIMENTAL): 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: The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance

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:~* HIV-infected as documented by positive HIV antibody test~* Antiretroviral naïve~* Starting ARV prophylaxis from 28th weeks of gestation or at least 4 weeks before delivery~* Not intending to relocate out of the area for the duration of study participation~* Willingness of subject to adhere to follow up schedule (note: this is more intensive for the pilot PK phase)~* Ability and willingness of subject to give written consent~* Pregnant women aged 18 years and above~* Willing and able to regularly attend the antenatal clinic~Exclusion Criteria:~* Serious illness that requires systemic treatment or hospitalization~* Use of concomitant medication, which interferes with the ARV prophylaxis for PMTCT or phenytoin~* Any condition that in the opinion of the investigator would compromise the subjects' ability to participate in the study~* Previously treated for HIV infection with antiretroviral agents, including ARV prophylaxis for PMTCT~* Inability to understand the nature and extent of the trial and the procedures required~* CD4 count \<350 cells/µl because such a patient is eligible for HAART

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

Study Arms:
- Control (Type: NO_INTERVENTION): ARV prophylaxis for PMTCT follows national guidelines.
- phenytoin interaction (Type: EXPERIMENTAL): ARV prophylaxis for PMTCT follows national guidelines + start phenytoin 184 mg (2 tablets of 92mg) OD at onset of labour and continue for seven days

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

Answer: outcome: complete