linjc16/ctgov huggingface dataset:
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.

Official Title
-----------------
Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >/=18 years of age Patients with rheumatoid arthritis eligible for RoActemra Exclusion Criteria: Hypersensitivity to RoActemra Active, severe infections

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 |
| --- | --- |
| Cohort<br>Cohort | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Disease Activity Score 28 (DAS28) |  | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a change in Disease Activity Score 28 (DAS28) |  | 5 months | 
| European League Against Rheumatism (EULAR) response rates |  | 20 weeks | 
| Proportion of patients with disease remission |  | 20 weeks | 
| Proportion of patients with low disease activity |  | 20 weeks | 
| Incidence of adverse events |  | 11 months |
The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the roles of IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis.

Official Title
-----------------
The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis

Conditions
-----------------
Sepsis, Intestinal Mucosal Barrier, Ferroptosis

Intervention / Treatment
-----------------
* Procedure: Standard treatments for sepsis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of sepsis Within 3 days of sepsis onset before ICU admission No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission Exclusion Criteria: Ileus Digestive tract hemorrhage Inflammatory bowel disease Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction) Malnutrition or immunodeficiency Long-term use of hormones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Sepsis group<br>Adult septic patients admitted into the intensive care unit (ICU) of Nanjing First Hospital. The diagnostic criteria for sepsis were in accordance with the surviving sepsis guidelines. | Procedure: Standard treatments for sepsis<br>* Standard treatments for others<br>|
| Control group<br>Baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in our ICU. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intestinal barrier injury incidence of intestinal barrier injury | intestinal barrier injury | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ferroptosis | ferroptosis | 7 days |
Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.

Official Title
-----------------
PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study

Conditions
-----------------
Severe Sepsis and Septic Shock

Intervention / Treatment
-----------------
* Device: EISS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis with at least one organ failure (severe sepsis) or septic shock Exclusion Criteria: Participation in another study within the last 30 days Earlier participation in this study Pregnancy Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day) Hemodynamic shock for more than 12 hours (systolic BP <90mmHg) despite adequate therapy HIV infection HCV infection, active

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EISS-treatment<br>In this arm patients receive additional treatment with the EISS-bioreactor | Device: EISS<br>* Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single organ functions (circulation, kidney, lung, liver) |  | 28day post inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 28day post inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, immunoparalysis, extracorporeal, granulocyte bioreactor, plasmapheresis
S-Shearwave Elastography for Assessment of Hepatic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.

Official Title
-----------------
Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study

Conditions
-----------------
Liver Fibroses

Intervention / Treatment
-----------------
* Diagnostic Test: S-Shearwave and TE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers Signed informed consent Exclusion Criteria: Acute hepatitis or bile duct obstruction Serum ALT> 5 times the upper limit of normal within 3 months s/p Rt. hemihepatectomy s/p liver transplantation Large mass or infiltrative lesion in the right lobe of the liver

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-Shearwave and TE<br> | Diagnostic Test: S-Shearwave and TE<br>* S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance to detect severe hepatic fibrosis (F3) | Reference standard: histologic diagnosis or Transient elastography | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes |  | 3 months | 
| Intra-observer and inter-observer agreement of S-Shearwave measurements |  | same day | 
| Comparison of diagnostic performance: Shearwave vs. Transient elastography | Reference standard: histologic diagnosis | 3 months | 
| Usefulness of auto-profile function in S-Shearwave measurements |  | 3 months | 
| Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound elastography, S-Shearwave, liver, fibrosis
Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.

Detailed Description
-----------------
Investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of visualization fully will be also analyzed.

Official Title
-----------------
Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound assessment of gastric content


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The preoperative fasted patients with previous subtotal gastrectomy Exclusion Criteria: Other anatomical abnormality or mass of stomach except gastrectomy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| fasted patient with previous gastrectomy<br>The fasted patient with previous subtotal gastrectomy except exclusion criteria are included | Diagnostic Test: Ultrasound assessment of gastric content<br>* Ultrasound assessment of gastric body is performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of full cross section image | The gastric remnant body is assessed by ultrasound and the incidence of cross sectional image visualized fully is evaluated | Before the induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of gastric content assessed by gastric ultrasound | The type of gastric content is assessed by gastric ultrasound; solid, fluid, empty | Before the induction of anesthesia | 
| Cross section area of stomach body assessed by gastric ultrasound | Cross section area is assessed by gastric ultrasound in the supine and right lateral positions | Before the induction of anesthesia | 
| Incidence of full stomach | It is determined if the contents is solid or the amount of fluid is large. | Before the induction of anesthesia |
Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer. PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.

Detailed Description
-----------------
OBJECTIVES: I. Assess the antitumor activity of danazol in patients with advanced or recurrent endometrial cancer. II. Determine the nature and toxicity of danazol in these patients. OUTLINE: Patients receive oral danazol 4 times per day for at least 4 weeks. Patients with partial response, complete response, or stable disease continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study within 26 months.

Official Title
-----------------
Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Drug: danazol


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically proven advanced or recurrent endometrial cancer that is not amenable to curative surgery or radiotherapy Measurable disease Tumor at least 1.0 cm by 1.0 cm per x-ray or physical exam OR Tumor at least 2.0 cm by 2.0 cm per CT scan, MRI, or ultrasound PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 No history of porphyria Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2 mg/dL Other: No concurrent or prior malignancy within past 5 years (except nonmelanoma skin cancer) or for which patient received chemotherapy Not pregnant or nursing Fertile patients must use effective contraception Must have tissue available for estrogen receptor/ progesterone receptor analysis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: danazol|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
-----------------
stage IV endometrial carcinoma, recurrent endometrial carcinoma
Radiofrequence Microtenotomy for Treatment of Achilles Tendinose

Study Overview
=================
Brief Summary
-----------------
Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose

Detailed Description
-----------------
Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT & ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.

Official Title
-----------------
Treatment of Achilles Tendinose

Conditions
-----------------
Achilles Pain

Intervention / Treatment
-----------------
* Procedure: RFM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pain in Achilles tendon for at least 6 weeks. MR / ultrasound confirms diagnosis tendinose. Pain in sport and daily activities Exclusion Criteria: Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency microtenotomy<br>Treatment of Achilles tendinose with radio-frequency microtenotomy | Procedure: RFM<br> <br> |
| Active Comparator: Phusical therapy<br>Supervised eccentric training | Procedure: RFM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Pain reduction. Change of pain from baseline measured with VAS | 6.12 weeks and 6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | Change from baseline in functionality measured by (FAOS) FOOT & ANKLE SURVEY | 6.12 weeks and 6,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles, tendinose, tendinopathy, pain
Frequency and Distribution of Mixed Falciparum-vivax Infections in French Guiana

Study Overview
=================
Brief Summary
-----------------
Malaria is still endemic in the interior of French Guiana. mixed infections by 2 or more different malaria parasites lead to complex and potentially harmfull therapeutic problems. The aim of the study was to look at malaria smears between 2000 and 2008 and determine using PCR the frequency of mixed infections, and their distribution in the terrtory of French Guiana. Overall 10.75% of 400 smears showed mixed infection with P. falciparum and P. vivax. The Maroni river where Duffy negative populations live was largely devoid of vivax infections. These results suggest that mixed infections are frequent in french guiana except on the Maroni river which leads to practical implications for clinicians facing a patient with clinical malaria.

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Other: cross sectional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: malaria diagnosis Exclusion Criteria: no malaria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cross sectional|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malaria | PCR positive for malaria parasites | At the time of diagnosis of malaria |
Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes.

Official Title
-----------------
Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Device: ECOM ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing liver transplantation surgery Exclusion Criteria: Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| OLT patients intubated with ECOM ETT<br>Patients undergoing liver transplantation and intubated with ECOM endotracheal tube (ETT). | Device: ECOM ETT<br>* Intubation with ECOM endotracheal tube (ETT)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endotracheal cardiac output monitor (ECOM), a non-invasive cardiac output monitor, is accurate and predictive | Pulmonary artery catheters are a standard of care for intraoperative hemodynamic assessment during liver transplantation. We propose to compare hemodynamic parameters obtained from PA catheters and ECOM. Use the endotracheal cardiac output monitor (ECOM) to evaluate multiple hemodynamic parameters (invasive blood pressure from the indwelling arterial catheter, noninvasive cardiac output via ECOM), and compare these to the parameters obtained from PA catheter. | Less than 24 hours |
Examining Macrophage Influx and Vascularization in Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Our aim in this study is to find out if we can locate the similar reduction in the recruitment of macrophages, remodeling of vasculature and do they correlate in the number and area of the islets in pancreas as in the mouse model.

Official Title
-----------------
Examining Macrophage Influx and Vascularization in Chronic Pancreatitis

Conditions
-----------------
Pancreatitis, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreas tissue sections from preparates from pancreatic surgery. Patients having chronic pancreatitis with or without diabetes

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

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

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

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