linjc16/ctgov huggingface dataset:
Direct Use of Non-centrifuged Autologous Fat Graft

Study Overview
=================
Brief Summary
-----------------
There are a limited number of reports related to the direct use of non-centrifuged adipose tissue graft in the literature. This preliminary study aims to present our experience on the efficacy of autologous fat graft use without centrifuging in the treatment of lower extremity wounds.

Detailed Description
-----------------
16 wounds treated with non-centrifuged autologous fat grafts were included in the study. The data were retrospectively analyzed. VAC (vacuum-assisted therapy) or silver-impregnated dressing was used to achieve a healthy wound bed before fat grafting. Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.

Official Title
-----------------
Direct Use of Autologous Fat Graft on The Treatment of Lower Extremity Wounds

Conditions
-----------------
Wound Healing Delayed

Intervention / Treatment
-----------------
* Procedure: non-centrifuge fat graft application to the wounds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic, venous traumatic wounds Exclusion Criteria: Malignancy, A life expectation <1 year, Chemical or radiation exposure. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: non-centrifuge fat graft application to the wounds|Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wounds examination | Collection of the data from clinical observation and photograph records were made to follow the wounds. the observations were made during changing the wound dressing and generally every three days. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wounds classification according to data from files and photographs | In this season the data will be classified according to the wounds parameters and photograph | 3 months | 
| Final evaluation and data achieving from files and exam carts | all data will be examined and evaluated whether there is any difference between probable groups | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic food, lower extremity, fat graft, nonentrifuged
Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities

Detailed Description
-----------------
In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.

Official Title
-----------------
Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs

Conditions
-----------------
Pulmonary Disease

Intervention / Treatment
-----------------
* Radiation: Chest X-ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest radiographs of aged 14 years or older Conventional PA or AP chest radiographs Chest radiographs with confirmed radiology reports Exclusion Criteria: Chest radiographs taken in postures other than PA and AP Chest radiographs from dual-energy radiography Invert-grayscale chest radiographs

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Positive group<br>chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax) | Radiation: Chest X-ray<br>* Chest radiographs<br>|
| Negative group<br>chest radiographs with no target radiologic findings | Radiation: Chest X-ray<br>* Chest radiographs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness of the investigational device | Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings (detection of any abnormal findings among ten target radiologic findings) | through study completion, an average of 6 months |
Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure. The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients. The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.

Official Title
-----------------
Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

Conditions
-----------------
Iron Metabolism Disorders, Calcium Phosphate Metabolism, Hepatic Metabolic Disorders, Hemodialysis Complication

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult dialysis patient Patient able to understand the information necessary for the study and having signed his written consent to participate Affiliated patient or beneficiary of a social security scheme. Exclusion Criteria: Medically unstable or frail patient Patient with hemoglobin less than 7g/dl Patient with HIV+ or AIDS, patient with replicating hepatitis B or C Patient participating in another clinical study requiring an additional blood sample Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision Pregnant, breastfeeding or parturient woman

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 |
| --- | --- |
| Hemodialysis patient<br> | Procedure: Blood test<br>* 15 mL of blood to follow the evolution of hepcidin and erythroferrone levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml). | These will be dosed twice over a year of dialysis and for 5 years | 5 years |
Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha polymorphism, this study aime to assess their effects and interaction on disease severity of HBV-related chronic liver disease and HCC.

Conditions
-----------------
Chronic Liver Disease, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Genetic: TNF-alpha and HBV genotype
* Other: TNF-alpha and HBV genotypes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBV-positive patients Exclusion Criteria: HBV-negative patients
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: TNF-alpha and HBV genotype|nan|
|Other: TNF-alpha and HBV genotypes|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine gene polymorphism |  | years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine gene polymorohism on severity of disease |  | years |
A Clinical Study of KW-3357 in Patients With DIC

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.

Official Title
-----------------
A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry of Health and Welfare

Conditions
-----------------
Disseminated Intravascular Coagulation (DIC)

Intervention / Treatment
-----------------
* Drug: KW-3357


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare Antithrombin activity <= 70% Written informed consent from patient or guardian Exclusion Criteria: Anamnesis or complication of serious drug allergy Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis Pregnant, nursing, or possibly pregnant woman Possibility for the promotion of bleeding by concomitant use of heparin

Ages Eligible for Study
-----------------
Minimum Age: 20 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: KW-3357<br> | Drug: KW-3357<br>* Intravenous infusion once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of patients with adverse events | up to 6 days (or discontinuation) | 
| DIC resolution | Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare | 6 days (or discontinuation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DIC score | Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare | Screening, 2, 3, 4, 5, 6 days (or discontinuation) | 
| Mortality |  | 28 days | 
| Plasma antithrombin activity |  | Screening, 2, 3, 4, 5, 6 days (or discontinuation) |
Refractory Diffuse Large B-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
In the rituximab era, one-third of diffuse large B-cell lymphoma (DLBCL) patients experience relapse/refractory disease after first-line anthracycline-based immunochemotherapy (IChemo). Optimal management remains an unmet medical need. The aim of this study was to report the outcomes of a cohort of refractory patients according to their patterns of refractoriness and the type of salvage option. The investigators performed a retrospective analysis, which included 104 DLBCL patients treated at Lyon Sud University Hospital (2002-2017) who presented with refractory disease. The investigators retrospectively evaluated the outcomes of a cohort of 104 refractory patients according to their patterns of refractoriness and the type of salvage option.

Official Title
-----------------
Refractory Diffuse Large B-cell Lymphoma After First-line Immuno-CT: Treatment Options and Outcomes

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -≥18 years of age diagnosed with DLBCL at Lyon Sud University Hospital (LSUH) from January 2002 to January 2017 presented with refractory disease in response to front-line therapies including anthracycline-based chemo and a monoclonal anti-CD20 antibody Exclusion Criteria: Patients with a history of indolent lymphoma, Patients with a primary central nervous system (CNS) lymphoma or immunosuppression-related lymphoma

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Outcome according to pattern of refractoriness | OS was defined as the time from first relapse, or progression, to death from any cause. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome according to pattern of refractoriness | EFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause). Patients who did not experience an event were censored at the last follow-up. | Up tp 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diffuse large B-cell lymphoma, refractory, rituximab
The Effect of Cocoa on Platelet Function Profiles in Patients

Study Overview
=================
Brief Summary
-----------------
The effects of chocolate on cardiovascular health are still a matter of debate. It can potentially favor cardiovascular health through the antioxidative effects of cocoa ingredients, such as polyphenols (present in dark but not white chocolate).

Detailed Description
-----------------
Epidemiologic studies have shown inverse associations between dietary polyphenols (present in dark chocolate and cocoa) and mortality from coronary heart disease. However, the basis for this protective association is uncertain. Food polyphenols such as in cocoa reportedly have antioxidant properties and decrease platelet function in vitro. The goal of the present study was to investigate whether the beneficial antioxidant effect of polyphenol-rich cocoa can induce an improvement of endothelial and platelet function in patients with stable coronary artery disease with known platelet hyperreactivity.

Official Title
-----------------
The Effect of Cocoa on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago: The ECLAIR Study

Conditions
-----------------
Platelet Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Cocoa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable coronary artery disease. Patients > 18y of age. Exclusion Criteria: Patients with T2DM. Patients who already ingest any cocoa-based products.

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Blood samples will be collected from participants in 2 separate instances. Initially, a baseline VerifyNow P2Y12 PRU test assay, followed by a subsequent repeat test 2-week after a 2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cocoa<br>2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars) | Dietary Supplement: Cocoa<br>* 2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P2Y12 Reaction Units | P2Y12 Reaction Units pre- and post-Cocoa | 2-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocoa, Platelet Dysfunction, Polyphenol
50/50% Tilt and Tuned Defibrillation Waveform

Study Overview
=================
Brief Summary
-----------------
Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance. Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the 50/50% tilt waveform. Study Methods This is an acute, paired-sample, randomized (waveform testing sequence) study Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other standard output ICD after Epic+) and defibrillation lead system. All study testing is completed at implant. Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned waveform. The HVLIC feature is used to measure the high voltage lead impedance and to program the Tuned and 50/50% tilt waveform pulse widths. The DFT is determined by an optimized binary search method that is designed to reduce the overall number of VF inductions to an average of 5.13 while maintaining very high resolution and accuracy. Total # of centers - 15 centers Sample size - 60 patients

Official Title
-----------------
50/50% Tilt and Tune Defibrillation Waveforms Utilizing High Voltage Lead Integrity Check Impedance

Conditions
-----------------
DFT Testing

Intervention / Treatment
-----------------
* Procedure: DFT Testing with a 50/50% tilt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is a candidate for ICD implantation. Patient is able to tolerate DFT testing. Exclusion Criteria: Patient has a mechanical valve in the tricuspid position. Patient is pregnant. Patient is less than 18 years old.

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 50/50% Tilt<br> | Procedure: DFT Testing with a 50/50% tilt<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Validation and Exploration of Sleep and Mood Predictors

Study Overview
=================
Brief Summary
-----------------
To determine whether objectively recorded sleep durations were mortality risk factors, whether sleep duration could be distinguished from depression as a risk factor in Women's Health Initiative (WHI) data, and whether sleep-associated risks were attributable to specific pathophysiologic processes such as sleep apnea, circadian rhythm phase advances, or deficiencies of melatonin, or deficiencies of reproductive steroids. The study was ancillary to the WHI.

Detailed Description
-----------------
BACKGROUND: Both reported short sleep and reported long sleep are major predictors of excess mortality risk, but the importance of reported sleep duration as a risk factor is not yet known. Sleep-related risks are of special interest to The Women's Health Initiative (WHI), because insomnia increases among women at menopause, and because WHI's hormone replacement therapy (HRT) and dietary modification (DM) may influence sleep. The WHI is an exciting opportunity to examine whether risks associated with reported sleep durations can be explained by a selection of intercurrent conditions, but the broad WHI design does not control for important potential confounders. Explicitly, the broad WHI design by itself cannot determine if behaviorally-modifiable objective sleep durations are the primary risk factor. DESIGN NARRATIVE: This ancillary project supplemented the WHI Observational Study (OS) by performing additional examinations on 600 San Diego OS women. These volunteers underwent home sleep recordings, hormone measurement, and detailed psychiatric interviews. To facilitate distinction of affective and sleep factors in WHI outcomes, the types and severity of depression in the OS subsample and the validity and reliability of sleep items in questionnaires given to WHI women were examined. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Sleep, Sleep Apnea Syndromes, Depression, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |