linjc16/ctgov huggingface dataset:
The Use of FDG-PET in Patient With Hodgkin Lymphoma: a Population Based Study From Northern Italy

Study Overview
=================
Brief Summary
-----------------
Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.

Official Title
-----------------
The Use of FDG Positron Emission Tomography (PET)in Patient With Hodgkin Lymphoma (HL) in the Real World: a Population Based Study From Northern Italy

Conditions
-----------------
Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification

Intervention / Treatment
-----------------
* Procedure: FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted). Clinical stage I-IV. No previous chemotherapy, radiotherapy or other investigational drug for HL. Exclusion Criteria: 1. 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| classical Hodgkin lymphoma<br>All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study. | Procedure: FDG-PET<br>* PET interpretation is based on a site-to-site comparison of FDG uptake both before and after chemotherapy (qualitative approach), according to the criteria defined by Cheson (2008)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | within 1 month after end of treatment | 
| Overall survival |  | within 1 month after end of treatment | 
| Disease-free survival |  | within 1 month after end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin lymphoma, FDG-PET, prognostic factor, clinical trial
Correlation of Genetic Polymorphism and Livedo Vasculitis

Study Overview
=================
Brief Summary
-----------------
Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations, followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear. It has been reported to be associated with some gene mutations, for example, factor V Leiden gene. This study is aimed to find the possible relation of these gene mutations in Taiwanese patients.

Detailed Description
-----------------
Livedo vasculitis is a chronic, recurrent painful ulcerations on the ankles and feet. This chronic disease is characterized by healed white, atrophic scars named atrophie blanche. The histopathological exam on the lesion site reveals fibrin deposition within the vessel walls. It has been reported to be related to factor V Leiden mutation (heterozygous) (22.2%), prothrombin G20210A gene mutation (8.3%), PAI promotor 4G/4G genotype and methylenetetrahydrofolate reductase (MTHFR) C677T mutation in about total 30% livedo vasculitis patients. This study is trying to find the correlation between Taiwanese patients and these four genes.

Official Title
-----------------
Correlation of Genetic Polymorphism and Livedo Vasculitis

Conditions
-----------------
Livedo Vasculitis, Livedoid Vasculitis, Livedoid Vasculopathy, Genetic Pleomorphism, Leiden Mutation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of livedo vasculitis Exclusion Criteria: No special exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Livedo vasculitis, Genetic pleomorphism
Gluten Challenge in Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days. Questionnaires and sampling of blood is done before, during and after.

Detailed Description
-----------------
Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.

Official Title
-----------------
Gluten Challenge in Celiac Disease

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Gluten challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Celiac disease confirmed by biopsy Age 18 - 80 years Gluten free diet last 6 months Subject has received information and signed the informed consent form Exclusion Criteria: Pregnant or breast feeding Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age) Drugs influencing immune system used last 3 months Current infectious disease of moderate or high severity Other chronic active intestinal disease Serious reaction on small amounts of gluten ingested

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Participants are subjected to gluten intervention in an unblinded fashion. | Dietary Supplement: Gluten challenge<br>* Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptome of gluten-specific T cells | Transcriptional differences of glutenspecific vs. unspecific T cells | Day 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gluten, antigen-specific T cells, transcriptome
Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.

Official Title
-----------------
Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia (AML)

Intervention / Treatment
-----------------
* Drug: CSL360


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute myeloid leukemia Recent bone marrow biopsy Prior treatment or medically unfit for standard therapy Exclusion Criteria: Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML Previous solid organ transplant Active GvHD or immunosuppression Concurrent treatment with other anti-cancer therapy Active 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Treatment with CSL360 | Drug: CSL360<br>* Weekly IV Infusion. Dose escalation study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, pharmacokinetics |  | September 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | September 2009 | 
| Partial, complete and overall response |  | September 2009 | 
| Biological activity |  | September 2009 |
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

Study Overview
=================
Brief Summary
-----------------
To assist patients and clinicians to reach SDM about treatment options for patients with nonvalvular chronic Atrial Fibrillation screening the investigators aim to develop an evidence-based decision aid for use before the clinical encounters. Our goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about anticoagulation treatment. It should also reflect the values and preferences of the informed patient.

Official Title
-----------------
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: DA4Afib Prototyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Must be 18 or older Must have an appointment for Atrial Fibrillation Must not have dementia Must not have severe hearing or vision impairment Patients will be given a written consent Guests that accompany patients will be given an oral consent KER unit PAG members will be given an oral consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA4Afib<br>Developing a tool to use during the encounter | Other: DA4Afib Prototyping<br>* We will develop a prototype from patients with atrial fibrillation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict | Decisional conflict will be measured using the decisional conflict scale | Immediatly following clinical visit |
The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.

Detailed Description
-----------------
This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital. Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission. Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. RIC is performed at inclusion and repeated 12 h and 24 h later. Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.

Official Title
-----------------
Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis

Conditions
-----------------
Septic Shock, Sepsis

Intervention / Treatment
-----------------
* Procedure: Remote ischemic conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sepsis or septic shock within the first 24 h after ICU admission. Exclusion Criteria: age < 18 years, pregnancy, advanced malignancy, peripheral artery disease affecting both arms, oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.

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: Remote ischemic conditioning<br>Remote ischemic conditioning (RIC) is performed at inclusion and repeated 12 h and 24 h later. | Procedure: Remote ischemic conditioning<br>* Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV) | The differences in MFI and PPV between pre- and post-RIC performance. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microcirculation, Remote ischemic conditioning, Sepsis
24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relationship between Intraocular Pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty (SLT) for routine treatment of glaucoma.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must correspond to all other inclusion criteria in order to be eligible for the investigation. Subject is able to comply with the study procedures 18-80 years old Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment. Subject has consented to be in the trial Visual acuity of 20/200 or better Ability to understand the character and individual consequences of the study For women of childbearing potential, adequate contraception Exclusion Criteria: Subjects presenting with any of the following criteria will not be included in the trial: Subjects with contraindications for wearing contact lenses Severe dry eye syndrome Keratoconus or other corneal abnormality Conjunctival or intraocular inflammation Eye surgery prior to and throughout the study. Full frame metal glasses during SENSIMED Triggerfish® monitoring Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine) Pregnancy and lactation Simultaneous participation in other clinical studies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: SLT<br> | Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish<br>* SLT (single session; 180 to 360 degrees of angle will be treated)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  | 2 months after SLT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOP fluctuations, during two 24-hour periods
Combined Effects of Energy Density and Eating Rate on Appetite

Study Overview
=================
Brief Summary
-----------------
This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake.

Official Title
-----------------
Combined Effects of Energy Density and Eating Rate on Energy Intake and Biomarkers of Satiety

Conditions
-----------------
Appetite

Intervention / Treatment
-----------------
* Behavioral: Eating rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-27 kg/m2 Weight stable Exclusion criteria: Chronic used of OTC or prescription drugs known to affect metabolism Chronic disease Gastric bypass surgery Disordered eating Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy density<br>Low or high energy density meal | Behavioral: Eating rate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake |  | 1 meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite |  | 0-180 min | 
| Postprandial peptide-YY response |  | 0-180 min | 
| Postprandial ghrelin response |  | 0-180 min | 
| Postprandial glucagon-like peptide-1 response |  | 0-180 min | 
| Postprandial pancreatic polypeptide response |  | 0-180 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Modifiable environmental, behavioral factors
Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism

Study Overview
=================
Brief Summary
-----------------
Patients with chronic inflammatory rheumatism (RIC) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a treat to target strategy with rapid adaptation of treatments to the activity of their disease. according to French recommendations. They are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (JAK inhibitors) They can also be treated transiently or over the long term with corticosteroids. These treatments expose them to greater infectious risks, especially with regard to COVID19. The objective is on the one hand to assess the impact of the Covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.

Official Title
-----------------
Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism According to a Management Strategy in the Rheumatology Department of Limoges University Hospital

Conditions
-----------------
Rheumatism

Intervention / Treatment
-----------------
* Other: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges. Exclusion Criteria: Patients who object to the use of their data.

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 |
| --- | --- |
| Exposed patients<br>Those who had the management strategy implemented by the service during confinement | Other: questionnaires<br>* Questionnaire completion<br>|
| Unexposed patients<br>Those who could not benefit from this strategy | Other: questionnaires<br>* Questionnaire completion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-traumatic stress | Presence or absence of post-traumatic stress disorder due to the COVID19 pandemic assessed by the Post-traumatic stress disorder Check-list version DSM-5 (PCL-5) | Day 1 |