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

Trial Title: Autologous Serum Efficacy Study in Patients With Severe Dry Eye

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

Eligibility Criteria:
Inclusion Criteria:~* Age \> 18 years~* Severe Dry Eye, as defined by a OSDI score \> or = 40~Plus:~* Tear Break Up Time (TBUT) \< 5 seconds~* Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score.~Exclusion Criteria:~* No dry eye associated ocular disease~* Unable to comply protocol~* Severe anemia~* Previous use of autologous serum~* Concomitant use of other topical ocular drug~* Hypersensibility to any proposed interventions

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

Study Arms:
- Autologous serum -Systane (Type: OTHER): Crossover arm starting with autologous serum for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using artificial tears (Systane)
- Systane- Autologous serum (Type: OTHER): Crossover arm starting with artificial tears (Systane) for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using autologous serum.

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 Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study:~* Patient has completed the Month 18 visit of Study Fx-005.~* If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication.~* Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements.~* Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study.~Exclusion Criteria:~Patients meeting any of the exclusion criteria will not be enrolled in the study:~* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).~* If female, patient is pregnant or breast feeding.~* Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) \>2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.

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

Study Arms:
- Fx-1006A (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: Azithromycin in the Prevention of Lung Injury in Premature Newborn

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:~* preterm infants of less than 37 weeks of gestational age who have undergone mechanical ventilation within the first 72 hours of life~Exclusion Criteria:~* Major congenital malformations or chromosomal syndromes Mothers carrying the HIV virus.

- Gender: ALL
- Minimum Age: 1 Minute
- Maximum Age: 72 Hours
- Healthy Volunteers: t

Study Arms:
- azithromycin group (Type: EXPERIMENTAL): A control group composed of 40 newborns receiving azithromycin
- placebo group (Type: PLACEBO_COMPARATOR): comparative group composed of 40 newborns who would receive saline 0.9%

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: GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma

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:~* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated~* Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3~* Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.~* Preserved organ functions for: absolute neutrophil counter (ANC)\>1.0×109/L, Platelet\>50×109/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<2×ULN, alanine transaminase (ALT)\<2×ULN, serum creatinine\<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%~* No history of chemotherapy or radiotherapy.~* Signed Informed consented~Exclusion Criteria:~* Concurrent cancers need surgery or chemotherapy within 6 months.~* Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.~* Mental disorders.~* Pregnant or lactation~* HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.~* History of pancreatitis~* Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.~* Enrolled in other trial treatment

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- GELAD/Radiation (Type: EXPERIMENTAL): Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.

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 Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female subjects 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee.~* Screening TSAT \< 20%~* Screening Hemoglobin \< 11 g/dL~* For subjects who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for \> 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial~Exclusion Criteria:~* Known hypersensitivity reaction to any component of Ferric Carboxymaltose.~* Subject previously randomized and treated in this study or any other clinical study of Ferric Carboxymaltose (FCM or VIT-45).~* Body mass index (BMI) ≤ 5th percentile for age (see APPENDIX 2)~* Male or Female subject 1 year of age weighing \< 12kg.~* History of acquired iron overload, hemochromatosis or other iron accumulation disorders.~* Chronic kidney disease subjects on hemodialysis.~* Screening Ferritin level \> 300ng/mL~* Subjects with significant severe diseases of the liver, hemopoietic system, cardiovascular system, psychiatric disorder or other conditions which on the opinion of the investigator may place a subject at added risk.~* Any active infection.~* Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.~* Known positive HIV-1/HIV-2 antibodies (anti-HIV).~* Anemia due to reasons other than iron deficiency (i.e. hemoglobinopathy). Subjects treated with vitamin B12 or folic acid deficiency are permitted.~* Intravenous iron and /or blood transfusion in the 4 weeks prior to screening.~* Immunosuppressive therapy that may lead to anemia (i.e. cyclophosphamide, azathioprine, mycophenolate mofetil). Note steroid therapy is permitted.~* Administration and / or use of an investigational product (drug or device) within 30 days of screening.~* Alcohol or drug abuse within the past six months.~* Female subjects who are pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study.~* Subject is unable to comply with study assessments.

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Ferric Carboxymaltose (FCM) (Type: EXPERIMENTAL): FCM at 7.5 mg/kg or 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller

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 of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

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

Eligibility Criteria:
Inclusion Criteria:~* Have T2DM for at least 6 months~* Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry~* Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin~* Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) \>3 months prior to screening~Exclusion Criteria:~* Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination~* Impaired renal estimated glomerular filtration rate (eGFR) \<45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)~* Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- Tirzepatide 15 mg (Type: EXPERIMENTAL): Participants received 15 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.
- Semaglutide 1 mg (Type: ACTIVE_COMPARATOR): Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.
- Placebo (Type: PLACEBO_COMPARATOR): Participants received Placebo administered SC once weekly for 28 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: HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically or cytologically confirmed breast cancer~* Stage IV~* No prior or not more than one prior chemotherapy for metastatic disease~* Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method)~* Performance status 0-2 (ECOG)~Exclusion Criteria:~* Absence of measurable disease~* Life expectancy \< 3 months~* Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated~* Previous treatment with trastuzumab or vinorelbine~* Neutrophils \< 1500/mm3 or platelets \< 100000/mm3 or haemoglobin \< 8 g/dl~* Creatinine \> 1.5 x the value of the upper normal limit~* GOT and/or GPT \> 2.5 x the value of the upper normal limit and/or bilirubin \> 1.5 x the value of the upper normal limit in the absence of liver metastases~* GOT and/or GPT \> 5 x the value of the upper normal limit and/or bilirubin \> 3 x the value of the upper normal limit in the presence of liver metastases~* Left ventricular ejection fraction \< 50% (measured by ultrasound or MUGA angiography)~* Concomitant conditions that contraindicate the use of the drugs in the protocol~* Male gender~* Pregnancy or lactation·~* Incapacity or refusal to provide informed consent~* Inability to comply with followup

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: None
- 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: A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 7.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent~* Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)~* Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy~* If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug~* If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.~Exclusion Criteria:~* History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease~* Has a contra-indication to anti-TNF therapy~* Has a history of chronic or recurrent infectious disease~* Has a nonplaque form of psoriasis or has drug-induced psoriasis~* Has been previously treated with adalimumab~* Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab \[ABT-874\], AIN457, and SCH900222) within 6 months of the first administration of study agent.

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

Study Arms:
- CNTO 1959 (5 mg) (Type: EXPERIMENTAL): CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
- CNTO 1959 (15 mg) (Type: EXPERIMENTAL): CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
- CNTO 1959 (50 mg) (Type: EXPERIMENTAL): CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
- CNTO 1959 (100 mg) (Type: EXPERIMENTAL): CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
- CNTO 1959 (200 mg) (Type: EXPERIMENTAL): CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
- Adalimumab (approved psoriasis dosing) (Type: ACTIVE_COMPARATOR): Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)
- Placebo to CNTO 1959 (100 mg) (Type: PLACEBO_COMPARATOR): Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40

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 Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients with type 2 diabetes mellitus between 30 and 70 years of age.~2. Failure to triple OHA and on stable doses of insulin for atleast 3 months.~3. On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.~4. HbA1c \< 8.5%.~5. Insulin requirement ≥0.4 IU/kg/d.~6. GAD antibody negative status.~Exclusion Criteria:~1. Patients with T1DM or secondary diabetes.~2. Patients with serum creatinine \> 1.5 mg/dl.~3. Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).~4. History of cholecystitis/ cholelitiasis/ cholecystectomy~5. Seropositivity for HIV, HBsAg and HCV.~6. History of myocardial infarction or unstable angina in the previous 3 months.~7. History of malignancy~8. Patients with active infections.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Group 1:Stem cell Recipient (Type: None): Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of \>0.4U/Kg for blood glucose control. They will undergo stem cell therapy initialy and G-CSF therapy at 2 months
- Group-2: Controls (Type: None): Type 2 Diabetes mellitus patients on full doses of vildagliptin+metformin+pioglitazone and on Insulin \>0.4U/Kg who will act as active control.They will receive injectable placebo at Day 1 in addition to above and will be followed up for 6 months.Follow up investigation and Insulin dose titration will be similar to Group 1.

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: Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy

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:~* primary diagnosis of infiltrating breast cancer~* HR positivity (ER ≥ 10% and/or PgR ≥10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification), as assessed by local laboratory.~* Stage II-IIIA~* age \>18 yrs~* ECOG Performance Status 0-1~* Postmenopausal status, defined by at least one of the following:~  60 years of age; \< 60 years of age and amenorrheic for \>/=12 months prior to day 1 \< 60 years of age, without a uterus, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months~* Cardiac ejection fraction within the institutional range of normal (as measured by echocardiogram or MUGA scan).~* Normal organ and marrow function as defined below:~(leukocytes \>=3000/mcL; absolute neutrophil count \>=1,500/mcL; platelets \>=100,000/mcL; total bilirubin within 1.25 x normal institutional limits (with the exception of Gilbert's syndrome); AST (SGOT)/ALT(SGPT) within 1.25 x institutional upper limit of normal creatinine within normal institutional limits~* Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment~* Ability to understand and the willingness to sign a written informed consent document~Exclusion Criteria:~* Stage IIIB, IIIC, and inflammatory breast cancer~* Stage IV breast cancer~* Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with HER2 targeting therapies~* LVEF below the ULN~* Uncontrolled hypertension (systolic \>150 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication.~* Received any investigational treatment within 4 weeks of study start.~* Subjects with known infection with HIV, HBV, HCV~* Known hypersensitivity to any of the study drugs or excipients.~* Dyspnoea at rest or other disease requiring continuous oxygen therapy.~* Psychiatric illness/social situations that would limit compliance with study requirements~* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

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

Study Arms:
- Pertuzumab, Trastuzumab, Letrozole (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: A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

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:~* Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.~Exclusion Criteria:~* Patients known to be allergic to aripiprazole~* Hospitalized patients~* Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.

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

Study Arms:
- A1 (Type: ACTIVE_COMPARATOR): None
- A2 (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: complete