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

Trial Title: Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

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

Eligibility Criteria:
Inclusion Criteria:~* Individuals of 6 through 47 months of age on the day of informed consent.~* Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.~* Individuals who can comply with study procedures including follow-up~* Individual is in generally good health as per the Investigator's medical judgement~Exclusion Criteria:~* Acute (severe) febrile illness~* History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study~* A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis~* Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study~* Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 47 Months
- Healthy Volunteers: t

Study Arms:
- QIVc (Type: EXPERIMENTAL): Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
- Comparator QIV (Type: ACTIVE_COMPARATOR): Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

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

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

Trial Title: A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Having received at least one dose of emapalumab.~* Having signed the Informed Consent by the participant or the participant's legal representative(s), as applicable, with the assent of participant who are legally capable of providing it.~Exclusion Criteria:~* None

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

Study Arms:
- Enrolled-04 Cohort (Type: OTHER): Participants enrolled in Study NI-0501-04 (NCT01818492) will be invited to participate for long-term follow-up for 1 year either after haematopoietic stem cell transplantation (HSCT) or after the last administration of emapalumab.~In Study NI-0501-04, participants received emapalumab for 4 to 8 weeks. After the treatment period, participants could have undergone HSCT.~Participants for whom an appropriate donor was not identified by Week 8, or in a case where HSCT will be delayed for reasons unrelated to the administration of emapalumab, can continue receiving treatment with emapalumab beyond the foreseen 8 weeks in the current study (NI-0501-05, NCT02069899) at the request of the investigator, providing a favorable benefit/risk assessment of treatment is established.~The dose and timing was either carried forward from the last administered emapalumab dose as part of the parent protocol or an adjusted dose was administered, if necessary.
- Enrolled-06 Cohort (Type: NO_INTERVENTION): All participants who received at least 1 dose of emapalumab and were monitored for at least 4 weeks after the last drug administration in Study NI-0501-06 (NCT03311854) will be invited to participate for long-term follow-up for 1 year after the last administration of emapalumab.~Participants will not receive emapalumab in the current study (NI-0501-05, NCT02069899).
- Enrolled-CU Cohort (Type: OTHER): In exceptional cases, at the spontaneous request of a treating physician, CU treatment will be granted to the participants who had exhausted all possible treatment options and who could not be enrolled in a clinical study. All participants who receive at least 1 dose of emapalumab under CU will be invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~Participants can continue treatment in the context of the current Study (NI-0501-05, NCT02069899) while stem cell donor search is ongoing, or if the investigator assesses that continuation of treatment is beneficial.

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

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

Trial Title: A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

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:~* Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0.~* Subject must have a Nail Psoriasis Physical Functioning Severity score of \> 3, OR a Nail Psoriasis Pain Numeric Rating Scale (NRS) score of \>3.~* Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate.~* Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0.~* Target fingernail must have mNAPSI score of ≥ 8.~* Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months).~Exclusion Criteria:~* Prior adalimumab therapy.~* Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis.~* Recent infection requiring treatment.~* Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse.~* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.~* History of cancer, except successfully treated skin cancer.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Adalimumab (ADA) (Type: ACTIVE_COMPARATOR): Period A: ADA 40 mg subcutaneous every other week (sc eow) for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
- Placebo (Type: PLACEBO_COMPARATOR): Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

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: Immediate Anterior Chamber Paracentesis With A 30-Gauge Needle for Acute Primary Angle - Closure

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

Eligibility Criteria:
Inclusion Criteria:~* patients aged more than 18 year old with the first attack of APAC~* IOP of more than or equal to 40 mmHg.~Exclusion Criteria:~* patient unable to cooperate for paracentesis~* patients with APAC in the only remaining eye~* patients received any glaucoma treatments prior to the study~* patients with secondary causes of acute angle closure~* patients with intraocular inflammation or infection; (6) patients with APAC in the eye with a history of previous intraocular surgery~* patients known hypersensitive to tetracaine hydrochloride or tobramycin.

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

Study Arms:
- Paracentesis (Type: EXPERIMENTAL): Immediate anterior chamber paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure.~Acetamide, given in this study, is a standard treatment for acute angle-closure glaucoma. The participant will receive 1 tablet(250mg) at 1 hours after paracentesis. The following dose will be adjusted according to the level of IOP. The maximal dose is 4 tablets per day. It will be discontinued if the IOP is less than 21 mmHg.~All affected eyes will receive laser peripheral iridotomy with 24 hours after presentation. This a standard treatment for Acute angle-closure glaucoma

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: Statin Contrast Induced Nephropathy Prevention

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

Eligibility Criteria:
Inclusion Criteria:~Are eligible for the study all patients admitted to CCU for Acute Coronary Syndrome without ST elevation (NSTEMI) candidates for early invasive strategy (coronary angiography within 48 hours from the admission) and without previous therapy with statins.~Exclusion Criteria:~1. inability to provide consent~2. pregnancy or lactation~3. intolerance to statins~4. therapy with other lipid lowering drugs~5. acute or chronic liver disease~6. chronic muscle disease~7. acute renal failure or chronic renal failure stage IV~8. neoplastic~9. exposure to iodinated contrast medium in the previous 10 days

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- Rosuvastatin (Type: ACTIVE_COMPARATOR): None
- Control (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: To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

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

Eligibility Criteria:
Inclusion Criteria:~* women that underwent cesarean section with sinal anesthesia~Exclusion Criteria:~* Women who suffer from chronic pain~* Women using chronic pain medications~* Women with allergy to any drug used in the study~* Women underwent general anesthesia during the surgery~* Women who suffer from sleep apnea~* Women who suffer from obesity (BMI\>40)~* Women who suffer from severe nausea and vomiting after previous surgery~* Women who received perioperative magnesium~* Women who suffer from hypertension~* Women who suffer from renal failure

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

Study Arms:
- Fix protocol - Oral treatment (Type: EXPERIMENTAL): During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):~At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams~After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).~After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.~Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.~The total amount of paracetamol is limited to 4 gr per day.
- Spinal morphine (Type: EXPERIMENTAL): The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section

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 Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis

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

Eligibility Criteria:
Inclusion Criteria:~Patients, male or female, greater than 18 years with a clinical diagnosis of systemic sclerosis fulfilling the criteria of the American College of Rheumatology (formerly the American Rheumatism Association) classification criteria for systemic sclerosis, and diffuse cutaneous involvement based on the criteria of LeRoy et al~* Onset of skin sclerosis less than or equal to 48 months before study entry.~* Extent of skin sclerosis involving the trunk and/or arms and legs proximally to the elbows and/or knees.~* Present regimen consisting of one of the following: cellcept, D-penicillamine, methotrexate or cyclophosphamide.~* Previous history of using an alternative antifibrotic agent prior to present regimen will be permitted.~* Total antifibrotic treatment regimen duration should be less than or equal to 48 months.~Exclusion Criteria:~* Systemic sclerosis with skin involvement confined to face or acral regions of the body.~* Chemically induced scleroderma.~* Diffuse fasciitis.~* Mixed connective tissue disease and overlap syndromes.~* Pregnancy or nursing.~* Use of non-reliable method of contraception.~* Major surgery in the past month.~* Inability or unwillingness to provide written informed consent.~* Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.~* Known hypersensitivity or contraindication to ambrisentan

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- open label: medication Ambrisentan (Type: OTHER): Open label study of Ambrisentan.~Ambrisentan will begin at 5mg daily for the first month.~Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week. Subjects will continue their present dose and schedule of disease modifying/antifibrotic medication for the duration of the study.~\*\* Dose escalation was attempted however none of the patients were able to increase. Therefore all subjects remained on 5 mg daily throughout the study. 12 patients on mycophenolate mofetil, 2 on mycophenolic acid and one on methotrexate

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 Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

Study Design Characteristics:
- Allocation: NON_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:~* HCV RNA ≥ 10\^4 IU/mL at screening~* Chronic genotype 4 or 5 HCV Infection~* Individuals may be treatment naive or treatment experienced~* Presence or absence of cirrhosis, a liver biopsy may be required~* Healthy according to medical history and physical examination with the exception of HCV diagnosis~* Agree to use two forms of highly effective contraception for the duration of the study~Exclusion Criteria:~* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator~* Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors~* History of any other clinically significant chronic liver disease~* Evidence of or history of decompensated liver disease~* HIV or chronic hepatitis B (HBV) infection~* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)~* Chronic use of immunosuppressive agents or immunomodulatory agents

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

Study Arms:
- Genotype 4 (Type: EXPERIMENTAL): LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection
- Genotype 5 (Type: EXPERIMENTAL): LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

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 Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

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:~* Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.~* Been treated for early breast cancer with standard of care duration of trastuzumab.~* Could have been treated neoadjuvantly but have not reached pathologic complete response.~Exclusion Criteria:~* Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.~* History of heart disease.~* Corrected QT (QTc) interval \>0.45 seconds~* History of gastrointestinal disease with diarrhea as the major symptom.

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

Study Arms:
- Neratinib (Type: EXPERIMENTAL): 240 mg orally daily for one year
- Placebo (Type: PLACEBO_COMPARATOR): orally daily for one year

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 Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

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:~* Japanese individuals at least 12 years of age~* Diagnosis of PNH \> 6 months~* At least one transfusion in the past 2 years for anemia or anemia-related symptoms~* LDH level ≥ 1.5 x upper limit of normal within 12 weeks~* Presence of a glycosylphosphatidylinositol (GPI)-deficient red blood cell (RBC) clone (type III cells) by flow cytometry of ≥10%~* Negative serum pregnancy test for women of child-bearing potential~Exclusion Criteria:~* Platelet count \< 30,000/µL~* Absolute neutrophil count ≤ 500/µL~* Known or suspected hereditary complement deficiency~* History of hematopoietic stem cell transplant~* History of meningococcal disease

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Eculizumab (Type: EXPERIMENTAL): Eculizumab intravenous infusions every week x 4 doses, then 900 mg 1 week later for 1 dose, then 900 mg every 2 weeks for 4 doses

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

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

Trial Title: A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

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

Eligibility Criteria:
Inclusion Criteria:~* Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound \[transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)\].~* Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) \> 80 mL during 1 menses in screening as measured by the alkaline hematin method.~* Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.~* Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.~Exclusion Criteria:~* Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.~* Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.~* Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.~* Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).~* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 51 Years
- Healthy Volunteers: f

Study Arms:
- Elagolix 150 mg (Type: EXPERIMENTAL): Elagolix 150 mg once daily (QD)
- Placebo (Type: EXPERIMENTAL): Placebo 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: Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

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

Eligibility Criteria:
Inclusion Criteria:~* Congenital FVII deficiency~* Never been treated with NovoSeven® before~* Patients already in treatment with NovoSeven®~Exclusion Criteria:~* History of hypersensitivity to any of the components in NovoSeven®

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

Study Arms:
- A (Type: None): None

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

Answer: outcome: complete