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

Trial Title: Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A

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

Eligibility Criteria:
Inclusion Criteria:~* Severe hemophilia A, defined as \<1 IU/dL (\<1%) endogenous FVIII activity.~* Previous treatment for hemophilia A, defined as at least 150 days documented prior exposure to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 1.~* Platelet count ≥100,000 cells/µL at Screening.~* A participant known to be human immunodeficiency virus (HIV) antibody positive, either previously documented or identified from screening assessments, must have the following results prior to enrollment. (CD4 lymphocyte count \>200 cells/mm³ - Viral load of \<400 copies/mL).~Exclusion Criteria:~* Any concurrent clinically significant liver disease that, in the opinion of the Investigator, would make the participant unsuitable for enrollment. This may include, but is not limited to cirrhosis, portal hypertension, and acute hepatitis.~* Serious active bacterial, fungal or viral infection (other than chronic hepatitis or HIV) present within 30 days of Screening.~* Other known coagulation disorder(s) in addition to hemophilia A.~* History of hypersensitivity or anaphylaxis associated with any FVIII product.~* History of a positive inhibitor test defined as ≥0.6 BU/mL, or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII administrations. Family history of inhibitors will not exclude the participant.~* Positive inhibitor result, defined as ≥0.6 BU/mL at Screening.~* Major surgery within 8 weeks of Screening.~* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy.~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- efanesoctocog alfa (BIVV001) (Type: EXPERIMENTAL): Each participant will be sequentially dosed with three single intravenous (IV) doses of first rFVIII (Advate®), second Polyethylene Glycol (PEG)-rFVIII (Adynovi® or Adynovate®), and lastly, BIVV001

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: SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

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:~* Diagnosis of either open-angle glaucoma or ocular hypertension;~* Must sign an informed consent form;~* Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye\[s\]) ≥ 19 and \< 32 mmHg at 09:00.~* Willing and able to attend all study visits;~* Other protocol-specified inclusion criteria may apply.~Exclusion Criteria:~* Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;~* Any form of glaucoma other than open-angle glaucoma or ocular hypertension;~* Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;~* Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;~* Other protocol-specified exclusion criteria may apply.

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

Study Arms:
- SIMBRINZA + PGA (Type: EXPERIMENTAL): Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
- Vehicle + PGA (Type: OTHER): Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days

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

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

Trial Title: Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

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:~* Undergone total gastrectomy for gastric cancer~* Regular follow up is possible~* Serum vit,. B12 \< 200pg/ml~Exclusion Criteria:~* Has diseases other than stomach cancer~* Patients with other kinds of oral supplementation (multi-vitamins)

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

Study Arms:
- 1 (Type: EXPERIMENTAL): post total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation

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: Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

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

Eligibility Criteria:
Inclusion Criteria:~Age 18 years and older. Subject has provided informed consent. Study participant is scheduled to have a chest CT exam. Study participant is able to stand and be still during the exams.~Exclusion Criteria:~Human subject specific:~Not able or willing to provide Informed Consent, or consent is withdrawn. Study participant is a female of child bearing age.

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

Study Arms:
- Predicate & Invest. DE - Human Subjects (Type: EXPERIMENTAL): Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
- Predicate & Invest. DT - Human Subjects (Type: EXPERIMENTAL): Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
- Predicate & Invest. DT - Phantom Images (Type: EXPERIMENTAL): Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.

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: Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

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:~* Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)~* Male or female, being 18 years of age or older~* Written informed consent for study participation~Exclusion criteria:~* Persistent symptoms of VTE~* PE requiring urgent intervention~* Use of vena cava filter~* Contraindications to anticoagulant therapy~* Allergy to study medications~* Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival~* Severe renal impairment~* Patients considered unsuitable for inclusion

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

Study Arms:
- Dabigatran etexilate (150mg bid) (Type: EXPERIMENTAL): Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
- Warfarin (INR 2.0-3.0) (Type: ACTIVE_COMPARATOR): Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0

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: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

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:~1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.~2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.~3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation~4. Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.~Exclusion Criteria:~1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)~2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.~3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

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

Study Arms:
- Ceritinib (Type: EXPERIMENTAL): Patients in this arm received 750 mg of ceritinib.
- Chemotherapy (Type: ACTIVE_COMPARATOR): Patients in this arm received chemotherapy of either pemetrexed or docetaxel as determined by BIRC.

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 the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: COHORT
- Primary Purpose: None
- Time Perspective: CROSS_SECTIONAL
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* 18-40 years of age, inclusive~* Overweight or obese at time of conception based on self-report (BMI ≥25 and \<40 kg/m2)~* Willingness to participate in either the focus group or the individual interview~* Establish prenatal care by 12 weeks of gestation~* Fluent in the English language; AND~* Singleton pregnancy~Exclusion Criteria:~* Current multiple gestation~* Type I diabetes~* Self-reported gestational diabetes mellitus~* History or current psychotic disorder~* Current major depressive episode, bipolar disorder, or eating disorder~* HIV~* Current smoking, alcohol or drug use~* History of ≥ 3 miscarriages~* Current enrollment in Expecting Success (IRB#11024)

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- All Participants (Type: None): Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.

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: Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate 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:~* Documented prostate cancer regardless of Gleason score~* Patients should be considered hormone refractory and androgen independent. They must fail LHRH analogues, and anti-androgen withdrawal trial.~* Failure is confirmed by an increase in PSA value of 10% or more than the value immediately before, and confirmed by another assessment 2 weeks later.~* Patients have to have measurable disease either biochemically using rising PSA or/and with metastatic disease to the bone or visceral organs.~* Performance status of 2 or less using ECOG scale.· Adequate liver function tests with ALT/AST being \< 3x normal, total bilirubin of 1.5 or less, and adequate renal function measured by a creatinine of 2.0 mg/dl or less. Alkaline phosphatase values are never exclusion criteria if it is deemed related to bone metastases.~* Patients need to have adequate bone marrow function. ANC of 1000 or above, Hgb of 9.0 g/dl or above, and platelets of 100,000 or above. If other causes are affecting plts counts such as autoimmune disorders, patients are allowed on study.~* Patients with inadequate bone marrow function that is deemed related to bone marrow involvement with prostate cancer are allowed at the investigator's discretion.~* Patients with other malignancies are allowed as long as there is no evidence of the other malignancy present at entry time, and it has been 3 years or more since the treatment for the other disorder was completed.~* Patients with prior exposure to investigational therapies including vaccines are allowed on this study as long as their last exposure was 4 weeks prior to study entry.Patients with known bone metastases are allowed to receive intravenous bisphosphonates such as aredia or zometa.~* Patients on oral bisphosphonates are also allowed.~* Chemo Naive~Exclusion Criteria:~* Patients with prior exposure to Tarceva~* Patients who have received any prior systemic chemotherapy for prostate cancer. Exposure to chemotherapy for other malignancies is allowed as long as last chemotherapy was completed 3 years prior to study entry.~* Patients with prior malignancies are excluded except for those who have non-melanoma skin cancers or other cancers that are in remission with the last therapy given 3 years prior to enrollment.~* Prior exposure to any form of steroids is allowed and is not considered exclusion criteria.~* Performance status of 3 or above using ECOG scale.~* Known HIV positive status Known CNS involvement with prostate cancer

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

Study Arms:
- Tarceva (Type: EXPERIMENTAL): Tarceva 150 mg QD

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: Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy

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

Eligibility Criteria:
Inclusion Criteria:~* Patients aged 18-70~* ASA class I, II, and III~* undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery~Exclusion Criteria:~* patients undergoing emergency surgeries~* pregnant patients~* patients with end stage renal disease or chronic kidney disease(GFR less than 60)~* patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration~* patients' refusal~* patients with allergy to recuronium

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

Study Arms:
- Group 1 : (NS) (Type: ACTIVE_COMPARATOR): Group 1 Drug combination:~patients receive half of the recommended dose of sugammadex plus dose of neostigmine~1. Sugammadex IV= -1 mg/kg( moderate NMB) or~   * 2 mg/kg (deep NMB)~2. neostigmine IV = 50mcg/kg~3. glycopyrrolate 10 mcg/kg
- Group 2 : (S) (Type: ACTIVE_COMPARATOR): patients receive Full recommended dose of sugammadex~Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)

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 Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: COHORT
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~1. cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;~2. a current regimen of opioids equivalent to 60-360 mg/day of oral morphine or 25-150 mcg/hr of transdermal fentanyl for one week or longer;~3. at least partial relief of breakthrough pain by use of opioid therapy;~4. able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly;~5. willing and able to complete patient diary with each pain episode.~6. 20 to 80 years of age;~Exclusion Criteria:~1. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;~2. history of hypersensitivity or intolerance to fentanyl;~3. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;~4. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;~5. Severe (Grade 4) mucositis (subjects with less than severe mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);~6. abnormal oral mucosa which will impede drug absorption;~7. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;~8. use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study;~9. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.

- Gender: ALL
- Minimum Age: 20 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: Honey & Nigella Sativa Trial Against COVID-19

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:~* Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result with SSC-2 score\> 5~* Patients admitted in Corona centers~Exclusion Criteria:~* Participants not giving consent.~* Pregnant and lactating females.~* History of allergy to any drug being administered in this study~* Severely terminally ill patients~* Patients on Nil Per Oral

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

Study Arms:
- Nigella Sativa & Honey Group (Type: EXPERIMENTAL): Drug: Nigella Sativa seed Powder 80 mg/Kg/day grinded in capsule upto a max of 14 days) Drug: Natural Honey 1gm/kg/day orally upto a max of 14 days)~along with standard medical care
- Standard Medical Care (Type: PLACEBO_COMPARATOR): Standard supportive medical care prescribed by treating physician, Lahore which includes standard symptomatic care along with use of antibacterial or antiviral (if advised by pulmonologist or infectious disease specialist)

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: Intervention to End Recurrent Unscheduled Bleeding Trial

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:~* Women age 18-45~* Implant placed \>90 days and \<3 years prior to enrollment~* Patient complaint of bothersome irregular bleeding with implant~* Willing to be abstinent or use condoms during study period~* Willing to complete 30-day bleeding diary~* Willing to be randomized to placebo or ulipristal acetate~* Ability to send/receive SMS text message~Exclusion Criteria:~* Non-English speaking~* Implant placed \>3 years prior to enrollment~* Contraindication to ulipristal acetate (current use of barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, known or suspected pregnancy, hypersensitivity to active substance or excipients, uterine/cervical/ovarian/breast cancer, severe asthma insufficiently controlled by oral glucocorticoids)~* Inability or unwillingness to comply with medication protocol~* Inability or unwillingness to comply with bleeding diary~* Breastfeeding

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- Ulipristal Acetate (Type: EXPERIMENTAL): 15mg ulipristal acetate (capsule) daily for 7 days
- Placebo (Type: PLACEBO_COMPARATOR): Identical placebo (capsule) daily for 7 days

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

Answer: outcome: complete