linjc16/ctgov huggingface dataset:
Bethaherpesviruses in Children Who Are Immune Suppressed

Study Overview
=================
Brief Summary
-----------------
Unexplained fever in children with cancer is a common occurrence, often requiring hospital admission for evaluation and treatment with intravenous antibiotics. While empiric use of intravenous antibiotics is the norm in this population, between 48-70% of febrile and neutropenic episodes remain without an identifiable source. An understudied area is the potential role of betaherpesvirus infections in such febrile episodes. These viruses are significant pathogens in patients who become immunocompromised in conjunction with organ transplantation or acquired immune deficiency syndrome (AIDS). It is possible that they are similarly pathogenic in children who become immunocompromised due to cancer chemotherapy. Thus, we will investigate the association between the betaherpesviruses and fever in children with cancer. The betaherpesviruses include cytomegalovirus (CMV), human herpesvirus 6A (HHV-6A), human herpesvirus 6B (HHV-6B), and human herpesvirus 7 (HHV-7). These viruses are grouped based on shared biological and genetic properties. Each is commonly acquired in childhood, persists in the human host, and can reactivate. Reactivation occurs intermittently throughout life in healthy individuals and is seldom associated with disease. Immune suppression is associated with a higher likelihood of reactivation and clinical disease. Latency of these viruses involves highly regulated processes that result in the viruses evading destruction and persisting within the host. Should balance be disrupted, as with cancer and anticancer therapy altering the normal host state, the environment may become favorable for betaherpesvirus reactivation, leading to disease and further alterations of the immune system.

Official Title
-----------------
Bethaherpesviruses in Children Who Are Immune Suppressed

Conditions
-----------------
Immune Suppressed Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with cancer (leukemia, lymphoma, or solid tumor) Undergoing solid organ pre-transplantation evaluation Age birth to 21 years Exclusion Criteria: Unwilling to participate in the study Unwilling to have specimens stored for future research Clinical conditions preclude the required amount of blood to be drawn for the study Patient has malignancy that has relapsed Patient is not a primary transplant candidate (ie. has already had a solid organ transplant) -

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |
Self-Hypnotic Relaxation Therapy During Invasive Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.

Detailed Description
-----------------
Pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures. Unabated distress may interfere with the ongoing procedure and may negatively impact future interventions. Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients' pain, anxiety, drug use, and number of complications. The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures. Participants in this study will be randomly assigned to one of three groups: a standard care group, an empathic control group, and a self-hypnotic relaxation group. The emphatic control group will meet with a clinician who will offer encouragement and support. The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure. Self-report questionnaires will be used to assess pain and anxiety.

Official Title
-----------------
Midcareer Development of Nonpharmacologic Analgesia

Conditions
-----------------
Uterine Neoplasms, Leiomyoma

Intervention / Treatment
-----------------
* Behavioral: Self-hypnotic relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors Able to hear and understand English Exclusion Criteria: Impaired mental function Psychosis Severe chronic obstructive pulmonary disease Intolerance of midazolam or fentanyl Weigh less than 121 lbs Pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Self-hypnotic relaxation|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
-----------------
Hypnosis, Analgesia, Embolization, Therapeutic, Chemoembolization, Therapeutic
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Study Overview
=================
Brief Summary
-----------------
Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition at a temperature of approximately -110 degrees. A considerable increase in the popularity of WBC has occurred in rheumatologic patients, despite a lack of evidences of its efficiency. Because of its interesting anti-inflammatory properties, the investigators think that WBC could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs) and corticosteroids, in patients suffering from axial spondyloarthritis. This is a proof of concept study.

Official Title
-----------------
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Conditions
-----------------
Spondylarthritis

Intervention / Treatment
-----------------
* Other: cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from axial spondyloarthritis diagnosed according to ASAS criteria, with sacroiliitis on X-rays or MRI, with active disease (BASDAI > 4/10) despite a stable treatment will be included. Exclusion Criteria: contra indication to cooling, previous WBC treatment, no social security cover

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryotherapy<br> | Other: cryotherapy<br>* The treatment arm :Whole body cryotherpy (WBC) (20 sessions of 3 minutes at a temperature of -110 degrees Celsius, on the basis of two sessions a day, spread over two weeks). The control arm : Whole body cryotherpy (WBC) (20 sessions of 1 minute at a temperature of -60 degrees Celsius, on the basis of two sessions a day, spread over two weeks).<br>|
| Placebo Comparator: light cryotherapy<br> | Other: cryotherapy<br>* The treatment arm :Whole body cryotherpy (WBC) (20 sessions of 3 minutes at a temperature of -110 degrees Celsius, on the basis of two sessions a day, spread over two weeks). The control arm : Whole body cryotherpy (WBC) (20 sessions of 1 minute at a temperature of -60 degrees Celsius, on the basis of two sessions a day, spread over two weeks).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body cryotherpy (WBC) efficacy assesment | assess WBC efficacy on disease activity with Bath Ankylosing Spondylitis Activity Index improvement between baseline and week 2 in patients with active axial spondyloarthritis. a difference of 20 points on BASDAI scale is expected between the experimental arm and the placebo is expected | 15 days |
Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2

Study Overview
=================
Brief Summary
-----------------
Familial partial lipodystrophic syndromes are characterized by an increase in visceral adipose tissue and an atrophy of subcutaneous adipose tissue. They are associated with a severe metabolic syndrome especially when linked to the mutation of the R482 codon of the LMNA gene (Familial partial lipodystrophy type 2, FPL2). Data in lipodystrophy induced by antiretroviral therapy of HIV suggests an increase in the activity of 11β-hydroxysteroid dehydrogenase type 1 (11bHSD1). This enzyme reactivates cortisone in cortisol in adipose tissues and liver and has associated to obesity and type 2 diabetes mellitus. Hence, the hypothesis is that in patients suffering from FPL2 with the R482 codon mutation of the LMNA gene, there is an increase in the activity of HSD11B1 which could participate to the metabolic phenotype of the disease.

Official Title
-----------------
Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2

Conditions
-----------------
Familial Partial Lipodystrophy Type 2

Intervention / Treatment
-----------------
* Other: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Familia partial lipodystrophy type 2 (FPL2) with the R482 codon mutation of the LMNA gene Social insured Ability to give consent Exclusion Criteria: urinary incontinence or inability to collect urine for 24 hours moderate and severe kidney insufficiency hepatic insufficiency history of hypercortisolism or adrenal insufficiency treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months pregnant and lactating woman.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Patients with FPL2 genetically confirmed<br>patients suffering with FPL2 with the R482 codon mutation of the LMNA gene. | Other: Biopsy<br>* Biopsy of subcutaneous adipose tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THE/(THF+αTHF) ratio measured in the 24h urine collections in patients |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11BHSD1 expression in subcutaneous adipose tissue in patients |  | Baseline | 
| Cortisol metabolites excretion in patients |  | Baseline | 
| Correlation of 11BHSD1 activity and metabolic parameters in patients |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortisol, Lipodystrophy 3, Hydroxysteroid 11-β dehydrogenase 1 (HSD11B1), Insulin Resistance, Hypertriglyceridemia
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Study Overview
=================
Brief Summary
-----------------
Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months & 12 months. CT scan of the orbits are performed preop, 6 months & 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos & diplopia are assessed in follow-up.

Detailed Description
-----------------
Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months & 12 months. CT scan of the orbits are performed preop, 6 months & 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos & diplopia are assessed in follow-up.

Official Title
-----------------
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Conditions
-----------------
Orbital Trauma, Orbital Fractures

Intervention / Treatment
-----------------
* Device: Osteosheet(r)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 70 years facial trauma with orbital fractures Exclusion Criteria: No other coexistent conditions eg. diabetes, heart disease, etc

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Osteosheet(r)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 
| Enophthalmos |  |  | 
| Diplopia |  |  | 
| Cosmetic appearance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orbit, orbital, trauma, fractures, facial
Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

Detailed Description
-----------------
The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed to evaluated the added value in BI-RADS 4A nodules

Official Title
-----------------
Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules Graded With the Breast Imaging Reporting and Data System

Conditions
-----------------
Ultrasound, Breast Cancer, Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion Exclusion Criteria: (i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEUS | if the result of CEUS is positive，the nodule was downgraded. if the result of CEUS is negative, the nodule was kept as BI RADS 4A category. Then all nodules were submitted to biopsy or surgery. | up to 3 months |
Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers

Study Overview
=================
Brief Summary
-----------------
We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers. PRIMARY OBJECTIVES: 1. To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers. SECONDARY OBJECTIVES: Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories Collect details about the tumor specimen extracted from patient charts.

Official Title
-----------------
Collection of Biospecimen and Clinical Information in Patients With Gastrointestinal Cancers

Conditions
-----------------
Gastrointestinal Neoplasms, Gynecologic Cancers, Gynecologic Cancers Cervical Cancer, Gastric (Stomach) Cancer, Gastro-Esophageal(GE) Junction Cancer, Gastrointenstinal Stromal Tumor (GIST), Colon/Rectal Cancer, Colon/Rectal Cancer Colon Cancer, Colon/Rectal Cancer Rectal Cancer, Colon/Rectal Cancer Anal Cancer, Anal Cancer, Hepatobiliary Cancers, Hepatobiliary Cancers Liver, Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Blood Draw
* Procedure: Frozen Tumor Specimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Patients are eligible if they have a histologically proven gastrointestinal cancer (esophageal, gastroesophageal junction, gastric, small intestine, appendix, colon, rectum, anus, liver, gallbladder, bile ducts, pancreas, neuroendocrine, and GI stromal tumor). 2. 18 years of age or older 3. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood Draw|nan|
|Procedure: Frozen Tumor Specimens|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| None: Biospecimen will be collected for future research. |  |  |
A New Approach to a Personalized Patient Blood Management Program (pPBM) in Total Hip Arthroplasty (THA)

Study Overview
=================
Brief Summary
-----------------
The study evaluates the patient related risk and predictive factors concerning perioperative homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert max-certified orthopedic hospital in Germany. A patient oriented preoperative decision-making algorithm (a personalised Patient Blood Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy. The aim is to increase the patient safety by using the pPBM App and to reach a more efficient management of resources.

Detailed Description
-----------------
Retrospective audit of 470 consecutive primary THA in 2013 and 2014

Official Title
-----------------
A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty

Conditions
-----------------
Postoperative Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary THA on patients with coxarthrosis Exclusion Criteria: any kind of old or acute fractures about the basin and hip combined surgery, like first extracting a femur nail and than undergoing THA any other kind of combined or simultaneous surgery any kind of coagulopathy

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 |
| --- | --- | --- |
| Events and circumstances of Homologous Blood Transfusion (erythrocyte concentrate transfusion) | Multivariate analysis of predictive variables like age, sex, BMI, hip and belly circumference, chronic kidney disease, chronic cardio-vascular disease, chronic inflammatory disease, diabetes mellitus, cancer, ASA Score, cemented, hybrid or not cemented prosthesis, surgery duration, medication and hemoglobin level before surgery | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pPBM Computer Simulation | Introducing the pPBM App as a safe blood-sparing strategy | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Homologous Blood Transfusion, Total Hip Replacement, Patient Blood Management