linjc16/ctgov huggingface dataset:
A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
This prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.

Official Title
-----------------
A Multicenter, Prospective, Non-interventional Study of Maintenance Avastin® (Bevacizumab) Following Induction Treatment With Platinum Doublet Plus Avastin® in Patients With Advanced Lung Adenocarcinoma

Conditions
-----------------
Lung Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab Participant who received only 1 cycle of bevacizumab maintenance treatment Meet summary of product characteristics guidelines Exclusion Criteria: Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment Pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bevacizumab<br>Participants who have received the induction phase of 4-6 cycles of bevacizumab plus platinum doublet chemotherapy will be treated with bevacizumab as maintenance treatment, according to approved label and local reimbursement. | Drug: Bevacizumab<br>* Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.<br>* Other names: Avastin®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause |  | Baseline up to 40 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause |  | Baseline up to 40 months | 
| 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause |  | 12 months | 
| Percentage of participants by best overall response |  | Baseline up to 40 months | 
| Percentage of participants with adverse events |  | Baseline up to 40 months |
The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational clinical trail which will recruit 1000-1500 participants over 65 years with frailty and acute coronary syndrome (ACS) in Beijing Friendship hospital. The investigators will conduct frailty assessment (FRAIL scale, CFS, SPPB), comorbidities, functional status (Barthel index, ADL, IADL), nutritional risk (MNA-SF), and then observe the clinical outcomes of elderly ACS participants with frailty. Then, the investigators will follow-up these participants separately in 1,3,6 and 12months, the anticipate follow-up time is 1 year. According to the follow-up results, investigators will evaluate the impact of frailty and other senile syndromes on the short-term and long-term prognosis of ACS, and develop a scoring system for the prognosis evaluation of elderly ACS participants.

Official Title
-----------------
The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome

Conditions
-----------------
ACS, Frail Elderly Syndrome, Elderly Patient

Intervention / Treatment
-----------------
* Other: this is an observational study with none intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly participants over 65 Clinical diagnosis of acute coronary syndrome Must be able to follow-up Sign in the informed consent Exclusion Criteria: Myocardial infarction caused by other acute disease Mental disorders who cannot cooperate to complete the assessment Severe liver dysfunction, kidney disease (CKD 5), end-stage malignant tumor Totally disabled and bedridden

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: this is an observational study with none intervention|this is an observational study with none intervention|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause death and cardiac death events | During hospitalization, assessed up to 2 months | 
| Major Adverse Cardiac and Cerebrovascular events | Major Adverse Cardiac and Cerebrovascular events including heart failure, cardiac shock, malignant arrhythmia, myocardial infarction, revascularization, and cerebral infarction | During hospitalization, assessed up to 2 months | 
| Death | All-cause death and cardiac death events | 1 year | 
| Major Adverse Cardiac and Cerebrovascular events | Major Adverse Cardiac and Cerebrovascular events including heart failure, cardiac shock, malignant arrhythmia, myocardial infarction, revascularization, and cerebral infarction | 1 year |
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Study Overview
=================
Brief Summary
-----------------
To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection. Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

Detailed Description
-----------------
Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

Official Title
-----------------
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Recent HIV infection. No prior antiretroviral therapy. No acute opportunistic infection at study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Intractable diarrhea. Bilateral peripheral neuropathy. Any other condition that would preclude study therapy. Concurrent Medication: Excluded: Myelosuppressive, neurotoxic, or hepatotoxic drugs. Patients with the following prior condition are excluded: History of bilateral peripheral neuropathy. Prior Medication: Excluded: Prior antiretroviral therapy. Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Stavudine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS-Related Complex, Stavudine
Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

Official Title
-----------------
A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Brain Neoplasms

Intervention / Treatment
-----------------
* Drug: Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Age greater than or equal to 18 Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) At least one brain metastasis diagnosed within 30 days of randomization Brain metastases must not have been previously treated with WBRT or radiosurgery No more than 2 sites of extracranial metastases May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites Meets protocol requirements for specified laboratory values. Written informed consent and cooperation of patient Appropriate use of effective contraception if of childbearing potential. Karnofsky Performance Status KPS greater than 70 Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Temozolomide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to radiological CNS progression |  |  |
The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.

Official Title
-----------------
The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: 0.2 ml sucrose 25%
* Other: 0.5 ml sucrose 25%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born preterm more than 1000 gram Exclusion Criteria: severe intraventricular hemorrhage cerebral malformations other malformations requiring surgery medication that may impair pain expression (opioids, paracetamol, sedatives)

Ages Eligible for Study
-----------------
Maximum Age: 8 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.2 ml sucrose<br>on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling | Other: 0.2 ml sucrose 25%<br>* Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling<br>Other: 0.5 ml sucrose 25%<br>* Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling<br>|
| Experimental: 0.5 ml sucrose<br>on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling | Other: 0.2 ml sucrose 25%<br>* Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling<br>Other: 0.5 ml sucrose 25%<br>* Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | assessed by Premature Infant Pain Profile-Revised (PIPP-R). Pain score related to the blood sampling will be performed two times: at skin puncture and immediately after the needle has been removed | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sucrose, Anesthesia, Blood specimen collection, Injections, Intravenous
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed Description
-----------------
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Official Title
-----------------
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

Conditions
-----------------
Renal Disease

Intervention / Treatment
-----------------
* Drug: Dotarem
* Other: Time of Flight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged more than 18 years Strongly suspected of having renal arterial disease Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination Exclusion Criteria: Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²) Contraindication to MRI Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotarem<br>Each subject will receive one injection of Dotarem 0.2ml/kg. | Drug: Dotarem<br>* Each subject will receive one injection of Dotarem 0.2ml/kg<br>* Other names: gadoteric acid, gadoterate meglumine;|
| Other: Time Of Flight<br>Each subject will undergo a TOF Magnetic Resonance Angiography | Other: Time of Flight<br>* Each subject will undergo a TOF MRA<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Non Assessable Renal Artery Segments | For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared | 1 to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal disease, Contrast agent, MRA
Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Official Title
-----------------
A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: thiazolidinedione (TZD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2) Agreement to maintain the same dose of metformin from screening to the end of the study Age in the range of 18-80 years Body mass index (BMI) in the range of 22-40 kg/m2 HbA1c in the range of 7.0 to 10% FPG <270 mg/dL (15 mmol/L) Exclusion Criteria: A history of type 1 diabetes Liver disease Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vildagliptin 100mg + Met | Drug: vildagliptin<br>* vildagliptin as add-on to metformin<br>* Other names: Galvus;|
| Active Comparator: TZD<br>TZD + metformin | Drug: thiazolidinedione (TZD)<br>* TZD add-on to metformin<br>* Other names: Actos (pioglitazone), Avandia (rosiglitazone);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HemoglobinA1c (HbA1c) |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight |  | after 12 weeks of treatment | 
| Change from baseline in fasting plasma glucose (FPG) |  | after 12 weeks of treatment | 
| Incidence of prespecified adverse events while on treatment with study drug |  | 12 week treatment duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin, hemoglobin A1c, metformin
Post-market Observational Study Zenith® t-Branch™

Study Overview
=================
Brief Summary
-----------------
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.

Detailed Description
-----------------
Both retrospective and prospective patients will be enrolled

Official Title
-----------------
Post-market Observational Study Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

Conditions
-----------------
Aortic Aneurysm, Thoracoabdominal

Intervention / Treatment
-----------------
* Device: Zenith® t-Branch™ Thoracoabdominal Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with the off-the-shelf Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Signed informed consent Exclusion Criteria: Inability or refusal to give informed consent by the patient or a legally authorized representative
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular treatment<br>Zenith® t-Branch™ Thoracoabdominal Endovascular Graft | Device: Zenith® t-Branch™ Thoracoabdominal Endovascular Graft<br>* Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality and morbidity |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracoabdominal aortic aneurysm, Endovascular, Fenestration, Branch, Off-the-shelf
Indications and Outcomes of Endoscopic Ultrasound in Tanta

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate the initial experience for the indications and outcomes of EUS in Tanta university hospital.

Detailed Description
-----------------
Detection of main causes for referral to EUS in Tanta, Egypt.

Official Title
-----------------
Indications and Outcomes of Gastrointestinal Endoscopic Ultrasound in Tanta-Egypt: Initial Experience.

Conditions
-----------------
Gastric Disease, Intestinal Disease, Pancreatic Diseases, Esophageal Diseases

Intervention / Treatment
-----------------
* Device: Endoscopic Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases of gastrointestinal EUS Exclusion Criteria: Missed data
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastrointestinal diseases<br>Endoscopic Ultrasound | Device: Endoscopic Ultrasound<br>* Indication of EUS<br>* Other names: EUS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of different indications for Endoscopic Ultrasound in Tanta, Egypt | Evaluation of the initial experience of the indications and outcomes of GIT EUS | 10 months |