linjc16/ctgov huggingface dataset:
Malnutrition Assessment Tools in Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.

Detailed Description
-----------------
This is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. Patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of SGA, MUST, NRS, MNA-SF etc. Clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.

Official Title
-----------------
Evaluation of Malnutrition Risk Assessment Tools in General Surgery.

Conditions
-----------------
Malnutrition, Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Patients undergoing elective or emergency surgery. Urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery: 3.Expedited (>18 hours) 2B. Urgent (6-18 hours) 2A. Urgent (2-6 hours) 1. Immediate (<2 hours) Operations involving the gastrointestinal tract Magnitude of operation graded by POSSUM [17,18]: Major+ (examples include colonic resection abdominoperineal resection of the rectum, radical total gastrectomy, intestinal bypass, whipple resection) Major (examples include adhesiolysis, stoma formation, small bowel resection, anterior resection, cholecystectomy and exploration of the bile duct) Exclusion Criteria: Age <18 years Magnitude of operation graded by POSSUM: Minor Intermediate Inability to perform nutritional assessment Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 108 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 |
| --- | --- | --- |
| serious postoperative complications | Complications >II according to Clavien-Dindo classification | 30 days after the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, malnutrition, malnutrition risk tools, nutritional assessment, surgery
ImproveR International (BI-001-IM)

Study Overview
=================
Brief Summary
-----------------
The objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following objectives; examine the aspects of safety and effectiveness of bivalirudin gain experience regarding the characteristics of patients in bivalirudin treatment evaluate the handling of bivalirudin and its practicality

Official Title
-----------------
European Registry of Consecutive Patients Undergoing PCI Evaluating the Use of the Thrombin-specific Anticoagulant Bivalirudin With Focus on Patient Selection, Convenience and Safety Aspects.

Conditions
-----------------
Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)

Intervention / Treatment
-----------------
* Drug: Bivalirudin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following; |  |  | 
| •examine the aspects of safety and effectiveness of bivalirudin |  |  | 
| •gain experience regarding the characteristics of patients in bivalirudin treatment |  |  | 
| •evaluate the handling of bivalirudin and its practicality. |  |  |
Attention and Visual Perception in Schizophrenia: A Functional Magnetic Resonance Imaging (fMRI) Study

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Processing visual information involves both automatic grouping processes and control processes. Automatic grouping processes allow the building of a global configuration from local contour information. It is necessary in order to recognize objects. Control processes allow tending to and prioritizing information parts. The paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. It is adapted to fMRI in order to explore the neurobiological basis of the deficits. The investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.

Official Title
-----------------
Attention and Grouping of Visual Information: What is Disturbed in Patients With Schizophrenia?

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Procedure: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenia (DSM-IV criteria) Healthy controls matched with patients on age, sex and education level Ages 18 to 50 Signed informed consent Right-handed Exclusion Criteria: No severe somatic illness No invalidating sensory disease No drug abuse, as defined by DSM-IV criteria No general anaesthesia in the past 3 months No intake of drugs affecting the CNS, except for patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>Healthy controls | Procedure: fMRI<br>* One 30 minute session<br>|
| Patients<br>Patients with schizophrenia | Procedure: fMRI<br>* One 30 minute session<br>|

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
-----------------
fMRI, Visual perception, Attention
Feasibility of Using the CGM GUARDIAN 2 Interstitial Fluid Glucose Measurement System in Intensive Care Medicine

Study Overview
=================
Brief Summary
-----------------
Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called CPG (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The CGM GUARDIAN 2 system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes. This device has not yet been validated in resuscitation patients.

Official Title
-----------------
Feasibility of Using the CGM GUARDIAN 2 Interstitial Fluid Glucose Measurement System in Intensive Care Medicine

Conditions
-----------------
Hyperglycemia, Hypotension, Shock, Septic

Intervention / Treatment
-----------------
* Device: CGM GUARDIAN 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in septic shock Arterial hypotension requiring noradrenaline Hyperglycaemia requiring insulin therapy Exclusion Criteria: Patients under guardianship, curatorship or deprived of liberty Pregnant or breastfeeding women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connect<br> | Device: CGM GUARDIAN 2<br>* continuous blood glucose monitoring system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose level |  | Day 6 |
Blood Recirculation and vvECMO

Study Overview
=================
Brief Summary
-----------------
A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation.

Official Title
-----------------
Measurment of Blood Recirculation and Adjustment of vvECMO Blood Flow During Veno-venous Extracoporeal Membrane Oxygenation

Conditions
-----------------
ARDS, Extracorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Other: Measurment of blood recirculation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 years or older ARDS veno-venous ECMO Exclusion Criteria: age < 18 years hemodynamic instability during measurement of recirculation pregnancy inability to obtain patient's consent or consent of legal guardian

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: Measurment of blood recirculation|Ultrasound based measurments of blood recirculating through the vvECMO circuit.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recirculation of vvECMO blood flow | Amount of ECMO blood flow recirculating through the vvECMO circuit | Once within first week after ICU admission during 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of vvECMO blood flow | Reduction of vvECMO blood flow if a significant recirculation can be measured | Once within first week after ICU admission during 4 hours | 
| Arterial blood oxygen content after reduction of vvECMO blood flow | Change in arterial blood oygen content after reduction of vvECMO blood flow | Once within first week after ICU admission during 4 hours |
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.

Detailed Description
-----------------
This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects. Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or placebo subcutaneously.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety, Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects

Conditions
-----------------
Cicatrix, Scar Prevention

Intervention / Treatment
-----------------
* Drug: LEM-S401
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects aged 19 to ≤ 65 years at screening Exclusion Criteria: Significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other History of drug abuse or positive urine drug screen at screening For all female subjects, pregnant (Urine-HCG positive) or breast-feeding subjects

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEM-S401<br> | Drug: LEM-S401<br>* siRNA encapsulated in DegradaBALL®<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of LEM-S401 evaluated by incidence of adverse events | Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events. | Up to 16 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scars, Scar prevention, Fibrosis
Hydrogen and Methane Breath Test Questionnaire

Study Overview
=================
Brief Summary
-----------------
Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production. Recently there has been a lot of work to done by experts in the field, to ensure that performance and interpretation of these tests are standardised, to help improve the clinical utility of these investigations. Although there is a lot of information currently available demonstrating the risk factors and symptoms associated with these conditions, there is a lack of data demonstrating the factors that might lead to a positive test according to these new parameters. This study aims to collect data on symptoms and medical history, in patients referred for lactulose and glucose HMBT in order further improve the effectiveness of this test in the future.

Official Title
-----------------
A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes

Conditions
-----------------
Small Intestinal Bacterial Overgrowth

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic Participant has capacity to understand written English Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|The HMBT-Q is a 26-item questionnaire, split into four main sections: food related symptoms; general digestive symptoms; extra-intestinal symptoms and co-morbidities and Medication and onset.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine positive predictive symptoms for SIBO positive participants determined by HMBT | Using the HMBTQ | At same time as breath test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine positive predictive symptoms for excessive methane positive participants determined by HMBT | Using the HMBTQ | At same time as the breath test | 
| Determine the frequency of recognised and potential risk factors in SIBO positive participants | Using the HMBTQ | At the same time as the breath test | 
| Determine the frequency of recognised and potential risk factors in excessive methane positive participants | Using the HMBTQ | At the same time as the breath test |
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System

Study Overview
=================
Brief Summary
-----------------
The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization with antigens will be utilized.

Detailed Description
-----------------
The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization with antigens will be utilized.

Official Title
-----------------
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System

Conditions
-----------------
Immunologic Deficiency Syndromes, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients will be studied if a disorder of the immune system is suspected.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Cellular Immunity, Humoral Immunity, Immunodeficiency Disease
Preoperative Frailty Assessment With Ultrasound in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.

Official Title
-----------------
Preoperative Frailty Assessment With Point-of-care Ultrasound in Elderly Patients Scheduled for Total Knee Arthroplasty

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Diagnostic Test: Point of care ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 60 years old or older scheduled for total knee arthroplasty Exclusion Criteria: Unable to communicate with the patient or the patient's guardian Myopathy History of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle. History of total knee arthroplasty in the recent 3 months prior to surgery

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients scheduled for total knee arthroplasty surgery<br> | Diagnostic Test: Point of care ultrasound<br>* Measurement of thickness of rectus abdominis, biceps brachii muscles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction accuracy of the thickness of rectus abdominis, biceps brachii muscles measured with point of care ultrasound |  | Preoperative evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of quadratus femoris muscle measured with point-of care ultrasound |  | Preoperative evaluation | 
| Circumference of thigh |  | Preoperative evaluation | 
| Difference between thickness of left and right rectus abdominis muscles |  | Preoperative evaluation | 
| Difference between thickness of left and right biceps brachii muscles |  | Preoperative evaluation | 
| Difference between thickness of left and right quadriceps femoris muscles |  | Preoperative evaluation | 
| Unplanned ICU admission |  | First 30 days post surgery | 
| Unplanned discharge to nursing facility |  | First 30 days post surgery | 
| Incidence of postoperative delirium |  | First 30 days post surgery | 
| ICU stay duration |  | First 30 days post surgery | 
| Total length of stay |  | First 30 days post surgery | 
| Number of falls |  | First 30 days post surgery | 
| Readmission in the 30-day postoperative period |  | First 30 days post surgery | 
| Mortality |  | First 30 days post surgery |