linjc16/ctgov huggingface dataset:
Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. Interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. Ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy.

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Ketorolac tromethamine and remote ischemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA l and ll age 20-65 patients undergoing partial nephrectomy Exclusion Criteria: preoperative liver or renal dysfunction, coagulopathy, chronic alcoholism, hypersensitivity of NSAID, history of warfarin, history of gastric ulcer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keromin Group<br> | Drug: Ketorolac tromethamine and remote ischemic preconditioning<br>* Ketorolac tromethamine/ single / 1mg/kg/ intravenous administration 30 min before renal artery clamping, remote ischemic preconditioning / 200 mmHg / 5 min inflation and 10 min deflation / 3 cycles / after anesthetic induction<br>|
| Placebo Comparator: Placebo Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine |  | at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance |  | at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release | 
| urinary NAG |  | at base line, 2 hr, 12 hr after clamping release | 
| serum NGAL |  | at base line, 2 hr, 12 hr after clamping release | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketorolac, remote ischemic preconditioning, partial nephrectomy
Effect of Rice Fortification With Iron on Anemia Among Children

Study Overview
=================
Brief Summary
-----------------
This was a double-blind community-based trial, placebo controlled. During 16 weeks, children in the intervention group (GI, n=180) received iron fortified rice, and children in the control group (GC, n=174) received rice with placebo. Anemia was considered present when hemoglobin < 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed by using Student's t-test. Hemoglobin concentration improved in both groups, with mean increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p < 0.001), and 0.49 g/dL in GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p < 0.001). Anemia decreased (p < 0.01) in both groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them. Hemoglobin increase was significantly higher in children who received total amount of iron ≥ 53.76 mg from fortified rice, compared to those who received less than this cut-off value (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be useful in anemia control if fortified food intake is adequate.

Official Title
-----------------
Effect of Weekly Rice Fortification With Iron on Frequency of Anemia and Hemoglobin Concentration Among Children Attending Public Day Care Centers From Rio de Janeiro

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Other: iron bisglycine chelate
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-school children attending public day care centers Exclusion Criteria: sickle cell anemia, purpura

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 60 Months

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: iron bisglycine chelate<br> <br> Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin in crease |  |  |
Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI

Study Overview
=================
Brief Summary
-----------------
The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.

Official Title
-----------------
Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial

Conditions
-----------------
Acute Coronary Syndrome, Percutaneous Coronary Intervention, Bleeding

Intervention / Treatment
-----------------
* Behavioral: AI based mHealth system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form. Exclusion Criteria: ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: normal follow-up group<br>normal follow-up in ACS patients after PCI | |
| Experimental: AI based mHealth system follow-up group<br>AI based mHealth system follow-up in ACS patients after PCI. ACS patients in this group will receive message to take more notice to bleeding events. | Behavioral: AI based mHealth system<br>* AI based mHealth system is used to deliver self-management contral message and health education message to make patients take notice of bleeding events after PCI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of major bleeding during each visit between normal group and smartphone based group | Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, Percutaneous coronary intervention, Bleeding
ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis

Study Overview
=================
Brief Summary
-----------------
COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.

Official Title
-----------------
ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: MR-Pro-ADM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient admitted in the ICU with COVID-19 pneumonia Exclusion Criteria: Pregnancy Legal reasons (patients under guardianship, curatorship) Patient's refusal

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

| Intervention/Treatment |
| --- |
|Other: MR-Pro-ADM|Dosage of MR-pro-ADM|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation. | Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation. | comparison to day 1 and day 3 | 
| mortality at day 28 and day 90. | mortality at day 28 and day 90. | admission until day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between MR-ProADM and mortality at day 28. | Association between MR-ProADM and mortality at day 28. | admission until day 28 | 
| Association or correlation between patient factor or treatment, and the onset or aggravation of visceral failures (day 3 and day 10), evolution until day 28. | Association or correlation between patient factor or treatment, and the onset or aggravation of visceral failures (day 3 and day 10), evolution until day 28. | admission until day 28 |
Monocyte Chemoattractant Protein-1 2518A/G Polymorphism

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood. Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated with diabetic microvascular or macrovascular complications. However, the relationship between SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial. In the present study, we evaluated the association of a single nucleotide polymorphism (SNP) in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese population from Southern China with type 2 diabetes.

Detailed Description
-----------------
The association between polymorphism of MCP-1 c.2518A/G and DR had been reported in Japan and Korea, but their opinion were inconsistent. However there is no report in China so far. This study was designed to clarify the relationship of polymorphism of MCP-1 c.2518A/G with type 2 diabetes with or without DR. The relationship between MCP-1 c.2518A/G and different stage of DR has also been studied.This article proved that the MCP-1 c.2518G/G genotype is a susceptibility gene for DR in Chinese type 2 diabetic patients, especially the High-risk PDR. There is no association with DME and c.2518G/G.

Official Title
-----------------
Association of Monocyte Chemoattractant Protein-1 (MCP-1)2518A/G Polymorphism With Proliferative Diabetic Retinopathy in Northern Chinese Type 2 Diabetes

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic retinopathy age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years. Exclusion Criteria: eyeball atrophy epimacular membrane age-related macular degeneration (ARMD) intravitreal injection medicine vitreous hemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 41 Years
Maximum Age: 68 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic association | age at diagnosis of diabetes ≥30 years and a known duration of diabetes of ≥5 years. | 1 year |
An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

Study Overview
=================
Brief Summary
-----------------
The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.

Official Title
-----------------
A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Ketoconazole
* Drug: Verapamil
* Drug: AZD1305


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A body mass index (BMI=weight/height2) of 19 to 30 kg/m2 Exclusion Criteria: Potassium outside normal reference values ECG findings outside normal range

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ketoconazole tablet + AZD1305 Extended Release tablet | Drug: Ketoconazole<br>* Tablet, administered as repeated doses.<br>* Other names: Fungoral;Drug: AZD1305<br>* Extended Release tablet, administered as a single dose.<br>|
| Experimental: 2<br>Verapamil Extended Release tablet + AZD1305 Extended Release tablet | Drug: Verapamil<br>* Extended Release tablet, administered as repeated doses.<br>* Other names: Isoptin Retard;Drug: AZD1305<br>* Extended Release tablet, administered as a single dose.<br>|
| Experimental: 3<br>AZD1305 Extended Release tablet | Drug: AZD1305<br>* Extended Release tablet, administered as a single dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | During all dosing visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, vital signs, ECG, laboratory variables and physical examination |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1305, Verapamil, Ketoconazole, pharmacokinetics
Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective effect measured by the incidence of postoperative pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator release.

Conditions
-----------------
Intraoperative Mechanical Ventilation

Intervention / Treatment
-----------------
* Device: mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing laparoscopic colorectal or gynaecologic surgery with expected time more than two hours Exclusion Criteria: refusal, preoperative pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>mechanical ventilation with Tidal volume 4 ml/kg and PEEP 8-10 cm H2o | Device: mechanical ventilation<br> <br> |
| Active Comparator: Group2<br>mechanical ventilation with Tidal volume 6 ml/kg and PEEP 8-10 cm H2o | Device: mechanical ventilation<br> <br> |
| Active Comparator: Group 3<br>mechanical ventilation with Tidal volume 8 ml/kg and PEEP 8-10 cm H2o | Device: mechanical ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pulmonary complications |  | 1 week |
A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)

Study Overview
=================
Brief Summary
-----------------
To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.

Official Title
-----------------
A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Tenecteplase
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients giving informed consent Patients with a large acute myocardial infarction randomised within 6 hours of symptom onset Patients scheduled to undergo primary PCI Patients reaching the cath lab not before 60 min and not later than 3 hours after randomisation (Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI) Exclusion Criteria: None

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: Tenecteplase|nan|
|Procedure: PCI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or cardiogenic shock or congestive heart failure within 90 days |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or cardiogenic shock or congestive heart failure within 30 days |  | 30 days | 
| Cardiogenic shock or congestive heart failure within 90 days |  | 90 days | 
| Death |  | 90 days | 
| Cardiogenic shock |  | 90 days | 
| Reinfarction |  | 90 days | 
| Repeat target vessel revascularisation (TVR) |  | 90 days | 
| Rehospitalisation for congestive heart failure |  | 90 days | 
| Rehospitalisation for cardiogenic shock |  | 90 days | 
| Rehospitalisation for other cardiac reasons |  | 90 days | 
| Congestive heart failure |  | 90 days | 
| N-terminal pro-brain natriuretic peptide (NT pro-BNP) |  | 90 days | 
| Disabling stroke |  | 90 days | 
| Total stroke |  | 90 days | 
| Rehospitalisation for stroke or ICH (intrancranial haemorrhage) |  | 90 days |
Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study

Study Overview
=================
Brief Summary
-----------------
This is the first prospective study which evaluate patients with small B-cell clones to diagnose monoclonal gammopathy of renal significance (MGRS) and characterize it clinically, anatomopathologically and pathophysiologically taking int account a geriatric approach.

Official Title
-----------------
Diagnosis of Monoclonal Gammopathy of Renal Significance in Patients With Paraproteinemias

Conditions
-----------------
Monoclonal Gammopathy of Renal Significance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paraproteinemias Exclusion Criteria: Multiple Myeloma Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia Malignant Lymphoma Monoclonal gammopathy of unknown significance (MGUS) secondary to Infections MGUS secondary to Autoimmune Diseases Uncompleted hematological evaluation Renal tumor except for cysts Bosniak type I/II Other malignant neoplasia Unresolved obstructive uropathy Patients with only one kidney except for renal transplant Co-morbidities which would limit the ability to receive aggressive therapeutic intervention Fragile old people Pregnancy Prison Impatient in psychiatric institutions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal histopathology compatible with MGRS |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal physiopathological changes |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paraproteinemias[Mesh], Kidney Diseases[Mesh]