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

Trial Title: TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* o Pregnant women attending for elective CS.~  * Women on antenatal anticoagulation ( LMWH , UFH , Fondaparinux ) for conditions such as : Prosthetic Valve , DVT , Pulmonary embolism , Dural sinus thrombosis , AF.~ * Pregnant Women with indication for postnatal warfarin anticoagulation( Prosthetic Valve , DVT , Dural Sinus Thrombosis , AF , Pulmonary embolism )~ * Age between 20-40 years.~ * Pregnancies between 37 and 39 weeks~ * BMI between (18.5 - 30.0)~Exclusion Criteria:~* o Pregnancy with risk of obstetric hemorrhage such as abnormally invasive placenta, placenta previa, placental abruption.~  * Women with Renal and Hepatic failure~ * Women with bleeding diathesis for reasons other than warfarin anticoagulation therapy~ * Women with known allergy to Tranexamic acid~ * Anemia Hb below 8g/dl

- Gender: FEMALE
- Minimum Age: 20 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Gelatin Sponges soaked with TXA (Type: EXPERIMENTAL): 21 patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle.
- Gelatin Sponges (Type: EXPERIMENTAL): 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2)
- NO SPONGE (Type: NO_INTERVENTION): 21 patients will have no sponge inserted 10 ml of saline

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: Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients with coronary disease undergoing PCI.~2. At most 2 months since last episode of ST-elevation myocardial infarction.~3. Left ventricular ejection fraction \>=20% \<=45% based on coronary angiography or echocardiography.~Exclusion Criteria:~Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.~1. Patients with non-ST-elevation myocardial infarction.~2. Patients with normal left ventricular function.~3. Patients with mechanical complications of myocardial infarction.~4. Patients with a malignant tumor.~5. Patients with infection disease.~6. Less than 6 months since last episode of stroke.~7. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).~8. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.~9. Leukocytes less than 4,000/µL or exceeding 10,000/µL.~10. Platelets less than 100,000/µL.~11. Hemoglobin less than 10 g/dL.~12. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.~13. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Atorvastatin (Type: SHAM_COMPARATOR): Atorvastatin routine dose
- Intensive Atorvastatin (Type: PLACEBO_COMPARATOR): Atorvastatin Intensive dose
- Atorvastatin+Transplantation (Type: ACTIVE_COMPARATOR): Atorvastatin routine dose+ Mononuclear cells Transplantation
- Intensive Atorvastatin+Transplantation (Type: EXPERIMENTAL): Atorvastatin intensive dose+ Mononuclear cells Transplantation

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: Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

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

Eligibility Criteria:
Inclusion Criteria:~* The subject or subject´s legally authorized representative has provided written informed consent~* Subject is 18 years of age or older~* Subject has a documented, endogenous plasma Alpha1-PI level \< 8 Micromolar~* Subject is of the genotype Pi\*Z/Z, Pi\*Z/Null, Pi\*Null/Null, Pi\*Malton/Z, or others, dependent on the approval by the Sponsor~* If the subject is female or of childbearing potential, the subject has a negative urine test for pregnancy within 7 days prior to first study product administration and agrees to employ adequate birth control measures for the duration of the study~* Laboratory results obtained at the screening visit, meeting the following criteria:~  * Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) \<= 2 times the upper limit of normal (ULN)~ * Serum total bilirubin \<= 2 times ULN~ * Proteinuria \< +2 on dipstick analysis~ * Serum creatinine \<= 1.5 times ULN~ * Absolute neutrophil count (ANC) \>= 1500 cells/mm3~ * Hemoglobin \>= 10.0 g/dL~ * Platelet count \>= 10\^5/mm3~* If the subject is treated with any respiratory medications, including inhaled bronchodilators and inhaled or oral corticosteroids, the subjects´ medication doses were unchanged for at least 14 days prior to first study product administration~* Nonsmoker for a minimum of 3 months prior to first study product administration~Exclusion Criteria:~* The subject has received any Alpha1-PI augmentation therapy (including Aralast and investigational Alpha1-PIs, by any route including intravenous and inhaled) within 42 days prior to first study product administration~* The subject has received an investigational drug or device within 1 month prior to first study product administration, or the subject is currently receiving an investigational drug~* The subject has a known selective immunoglobulin A (IgA) deficiency (IgA level \< 15 mg/dL) and/or antibody to IgA~* The subject has a pulmonary exacerbation or had a pulmonary exacerbation in the past 14 days prior to first study product administration~* The subject is pregnant or lactating, or intends to become pregnant during the course of the study~* The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance

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

Study Arms:
- ARALAST Fr. IV-1 (Type: EXPERIMENTAL): 60 mg/kg
- ARALAST (Type: ACTIVE_COMPARATOR): 60mg/kg

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: Identifying the Optimal Neural Target for Misophonia Interventions

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

Eligibility Criteria:
Interested participants will be excluded if:~1. current or past history of mania or psychosis,~2. verbal IQ \< 70,~3. not medically cleared for TMS or fMRI (for example taking medications known to reduce the seizure threshold such as Lamictal, Lithium, Clozaril, stimulants including the ADHD medications (e.g. Ritalin, Adderall), Wellbutrin/Buproprion, Provigil (Modafinil), Aminophylline, and Theophylline, implants, TBI, stroke, etc),~4. going to jail in the next 2 months,~5. pregnant,~6. high risk for suicide~7. moderate/severe current alcohol or substance dependence,~8. cannot come to Duke for the three study visits.~Inclusion criteria are:~1. stable psychotherapy and medication for at least 4 weeks~2. self reports high emotional dysregulation OR misophonia~Participants will be matched on gender and age between the two groups

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

Study Arms:
- Misophonia Group (Type: EXPERIMENTAL): Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
- Emotional Dysregulation Clinical Group (Type: ACTIVE_COMPARATOR): Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.

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: Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

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:~1. Provision of informed consent before participating in the study.~2. Diagnosed with type 2 diabetes.~3. Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG\<270 mg/dL (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG\<270 mg/dL (15mmol/L)).~4. On a stable dose of insulin for 8 weeks or longer prior to screening.~5. If taking metformin, subjects should have been taking the same daily dose for 8 weeks or longer prior to screening.~6. Insulin type should be intermediate-acting or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as one component).~7. Body mass index ≤45 kg/m\^2.~Exclusion Criteria:~1. Women of childbearing potential unable or unwilling to use acceptable birth control.~2. Women who are pregnant or breastfeeding.~3. Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms.~4. Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable clinical significant arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.~5. Congestive heart failure~6. Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).~7. History of unstable or rapidly progressing renal disease.~8. History of alcohol or drug abuse within the previous year.~9. Unstable major psychiatric disorders.~10. History of hemoglobinopathies~11. Immunocompromised status~12. Severe liver disease.~13. In subjects treated with insulin alone a calculated creatinine clearance \<50 ml/min. In patients treated with insulin in combination with metformin a calculated creatinine clearance \<60 ml/min or serum creatinine \> 1.5 mg/dL in males or \> 1.4mg/dL in females.~14. Anemia

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- Saxagliptin 5mg (Type: EXPERIMENTAL): Saxagliptin 5mg, administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
- Placebo (Type: PLACEBO_COMPARATOR): Placebo administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

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: Amyloidopathy, Cholinopathy, Dopamine Responsiveness and Freezing of Gait in PD

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

Eligibility Criteria:
Inclusion Criteria:~* PD based on the United Kingdom Parkinson's Disease Society Brain Bank~* Diagnostic Research Criteria with or without Freezing of Gait~* Duration of Disease \> 5 years~* Mini-Mental State Examination (MMSE) \> 23~Exclusion Criteria:~* Dementia~* Dementia with Lewy Bodies~* Other disorders which may resemble PD~* Subjects on neuroleptic, anticholinergic (trihexyphenidyl, benztropine) or cholinesterase inhibitor drugs~* Evidence of a stroke or mass lesion on structural brain imaging (MRI)~* Participants in whom MRI is contraindicated including, but not limited to:~  * those with a pacemaker~ * presence of metallic fragments near the eyes or spinal cord~ * cochlear implant~* Severe claustrophobia precluding MR or PET imaging~* Subjects limited by participation in research procedures involving ionizing radiation~* Pregnancy

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Parkinson's disease without FoG (Type: None): Subjects with Parkinson's disease that do not have freezing of gait observed during motor assessment while both on or off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
- Parkinson's disease with FoG only while off-meds (Type: None): Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
- Parkinson's disease with FoG worse while off-meds (Type: None): Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
- Parkinson's disease with FoG equivalent between on and off meds (Type: None): Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).

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: RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients who give a written informed consent obtained according to local guidelines~2. Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:~   1. Histolocial analysis of newly diagnosed disease must not be older than 8 weeks from signed consent~  2. Relapse must be confirmed by histology~  3. Neuroendocrine differentiation~3. World Health organisation (WHO) performance status grade ≤ 1~4. measurable disease~5. Adequate bone marrow function~6. Adequate liver function~7. Adequate renal function~Exclusion Criteria:~1. History or clinical evidence of central nervous system (CNS) metastases.~2. Presence of SCLC cells~3. Patients who have a history of another primary malignancy ≤ 3 years, with the exception of inactive basal or squamous cell carcinoma of the skin or cervical cancer in situ, early stages of breast cancer (LCIS and DCIS) and prostate cancer (stage T1a)~4. prior chemotherapy for the treatment of advanced lung cancer and/or not having recovered from the side effects of any other therapy (adjuvant treatment for earlier stages I-III is allowed if finished at least one year before study entry)~5. Patients who have received any investigational drug ≤ 28 days before starting study treatment or who have not recovered from side effects of such therapy~6. Patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study~7. Patients who have received prior therapy with RAD001 or other mTOR inhibitors~8. Having any severe and/or uncontrolled medical conditions~9. Women who are pregnant or breast feeding~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- RAD001 plus paclitaxel/carboplatin (Type: EXPERIMENTAL): Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.

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 Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

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

Eligibility Criteria:
Inclusion Criteria:~* Rheumatoid arthritis fulfilling the 1987 ACR criteria~* Women equal and above 18 years, less than 75 years old~* L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry)~* Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year~* Patient who would be taking glucocorticoids for more than 3 months after enrollment~Exclusion Criteria:~* Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis~* Patient diagnosed with malignancy within 5 years~* Patient with endocrine dysfunction~* RA functional class 4~* Patient who took bisphosphonates within 6 months~* Patient on medication affecting bone mineral metabolism

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

Study Arms:
- Ibandronate treatment (Type: EXPERIMENTAL): Ibandronate 150mg PO once every 4 weeks
- Placebo arm (Type: PLACEBO_COMPARATOR): Placebo PO once every 4 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: Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)

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:~1. Age ≥ 18 - \< 65 years.~2. Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry:~   * Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like- and primary CNS lymphomas and cases with leptomeningeal lymphoma involvement. Morphologically discordant lymphomas (most often follicular lymphoma and diffuse large cell B-cell lymphoma in different biopsy specimens, e.g. lymphatic gland and bone marrow) and transformed lymphomas are not to be included.~  * Follicular lymphomas grade III The diagnosis made by the local pathologist of the participating centre will be accepted for registration~3. Patients in at least stage II with age adjusted IPI score of 2 or 3:~   Stage III /IV and elevated LDH and/or WHO performance status 2 - 3 Stage II and elevated LDH and WHO performance status 2 - 3.~4. Previously untreated.~5. Performance status \< 4 (Appendix 2).~6. Written informed consent~Exclusion Criteria:~1. Severe cardiac disease: cardiac function grade 3-4 (Appendix 2) or Left Ventricular Ejection Fraction (LVEF) \< 45% (based on MUGA scintigraphy or echo Doppler cardiography).~2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.~3. Pregnancy.~4. Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment.~5. Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons.~6. Known HIV positivity.~7. Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ.~8. Uncontrolled infectious disease.~9. Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- Chemoimmunotherapy (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: Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma

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: None

Eligibility Criteria:
Inclusion Criteria:~* Burkitt's leukemia or lymphoma (new diagnosis)~* Written informed consent~* Age \> 15 years~Exclusion Criteria:~* pre-treated Burkitt's leukemia or lymphoma~* psychiatric disorders~* active second malignancy~* pregnancy~* absence of patient's written informed consent~* participation in other studies that interfere with the study therapy

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: None
- Healthy Volunteers: f

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

Answer: outcome: complete