linjc16/ctgov huggingface dataset:
Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of skin tests with platinum salts in patients suspects with immediate hypersensitivity reactions. All patients adressed in consultation to the Allergy Department of university hospital of nancy for an immediate hypersensitivity reaction to platinum salts between 2015 and 2021 were retrospectively recruited.

Official Title
-----------------
Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy

Conditions
-----------------
Drug Allergy

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult suspected immediate hypersensitivity reaction to platinum salts Exclusion Criteria: skin tests not achievable

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 |
| --- | --- |
| Allergic<br>suspected of immediate hypersensitivity reaction to platinum salts with positiv skin tests | Other: no intervention<br>* no intervention descriptiv study<br>|
| Non allergic<br>suspected of immediate hypersensitivity reaction to platinum salts with negativ skin tests | Other: no intervention<br>* no intervention descriptiv study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of skin test | prick test and if negativ => intradermoreaction | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate hypersensitivity, platinum salts, skin tests, tolerance induction
Predicting Favorable Outcomes in Hospitalized Covid-19 Patients

Study Overview
=================
Brief Summary
-----------------
Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours

Detailed Description
-----------------
To assess if display of low risk of adverse event in EPIC can safely reduce length of stay and plan for discharge.

Official Title
-----------------
Predicting Favorable Outcomes in Hospitalized Covid-19 Patients

Conditions
-----------------
COVID, Corona Virus Infection, Adverse Event

Intervention / Treatment
-----------------
* Other: EPIC risk score display


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a threshold at 90% PPV, with at least one low risk during their admission who are discharged alive and have not been in the ICU Exclusion Criteria: Age < 18 years not hospitalized for COVID19+.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Quality improvement - Display<br>Display of risk score/ colored flag in Epic patient list column; will be viewable to all frontline workers | Other: EPIC risk score display<br>* Display of risk score/ colored flag in Epic patient list column<br>|
| No Display<br>No display (hidden) of risk score/ colored flag in Epic patient list column; not viewable to all frontline workers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in days from first low-risk score to discharge | Reduction in days from first low-risk score to discharge | 96 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in length of stay (LOS) | Reduction in LOS for green patients that have not been in the ICU | 96 hours | 
| Reduction in GTD vs. LOS | Reduction in GTD vs. LOS for all green patients discharged alive vs all patients discharged alive | 96 hours | 
| No change in 30 day re-ED presentation or hospital admission rate for cohort | No change in 30 day re-ED presentation or hospital admission rate for cohort | 96 hours |
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Study Overview
=================
Brief Summary
-----------------
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.

Official Title
-----------------
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Combination Product: Combined kidney and bone marrow transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age older than 18 years Matched siblings No contra-indication to thymoglobuline or total lymphoid irradiation Exclusion Criteria: Pregnant women or breast feeding Infection with HIV, HBV or HCV Previous or presnt malignancy

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Combined kidney and bone marrow transplantation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kidney and bone marrow transplantation<br>Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation | Combination Product: Combined kidney and bone marrow transplantation<br>* Combined kidney and bone marrow transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation. | Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, Bone marrow transplantation, Immune tolerance, Immunosuppression
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.

Official Title
-----------------
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome

Conditions
-----------------
PCOS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Absence of significant abnormalities on physical examination except hirsutism No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy Normal thyroid function and prolactin level Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease Exclusion Criteria: Pregnant Possible ovarian tumors, Congenital adrenal hyperplasia or BMI greater than 35 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS patients<br> | |
| Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome | Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of PTX3 with insuline resistance in patients with PCOS. | PTX3 was positively correlated with HOMA-IR. This means that inflamation may cause insuline resistance in patients with PCOS. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS and PTX3 levels
Immediate Intra Uterine Isemination (IUI) Versus Expectant Management in Postoperative Endometriosis Patients

Study Overview
=================
Brief Summary
-----------------
Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).

Official Title
-----------------
Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?

Conditions
-----------------
Endometriosis, Infertility

Intervention / Treatment
-----------------
* Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recent (<6months) complete laparoscopic endometriosis resection endometriosis fertility index (EFI) at least 7/10 Regular menstrual cycles (min 24days - max 38days) with proven ovulation At least one functional tube at surgery, normal uterus Sperm sample of partner: normal or mild male factor Exclusion Criteria: frozen (donor or partner) sperm clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization FSH > 20 IU/L

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: expectant<br>7 menstrual cycles of expectant management | |
| Experimental: postop IUI<br>4 IUI cycles within 7 menstrual cycles | Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination<br> <br> * Other names: postop IUI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative clinical pregnancy rate |  | participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, endometriosis
LEAFix Adhesion in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study compares the adhesiveness of the 3M material to be used in the final design.

Detailed Description
-----------------
The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal. Participants will also be assessed and followed up for any adverse skin issues.

Official Title
-----------------
Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol

Conditions
-----------------
Adhesion

Intervention / Treatment
-----------------
* Device: Covatech Stoma bag material


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Not been in a trial in last 12 weeks mild to no skin issues Exclusion Criteria: any significant allergies any allergies to skin adhesive any medium to severe skin issues

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Main Cohort<br>Cohort of healthy volunteers to have device affixed | Device: Covatech Stoma bag material<br>* Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion after 24 hours | Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin outcomes | Asses for any issues with adhesion to the skin with a questionnaire on day 7 - likehart scale for different skin parameters ie. degree of itchiness with 0 being none and 3 being severe | 7 days |
CMR in Patients With Myocarditis

Study Overview
=================
Brief Summary
-----------------
To evaluate the additive values of T1 mapping in patients with acute myocarditis.

Detailed Description
-----------------
Cardiac magnetic resonance (CMR) is an established non-invasive diagnostic tool for acute and chronic myocarditis. Established CMR criteria for diagnosing myocarditis are edema on black-blood T2-weighted imaging, relative contrast enhancement seen on T1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis. Recently, tissue characterization based on calculation of myocardial T1 relaxation time (T1 mapping) as well as T1-derived extracellular volume fraction has become available. Recently, reference values for myocardial T1 relaxation times at 3T for healthy volunteers were published for CMR. However, to date no comprehensive data for multiparametric CMR in patients with suspected myocarditis at 3 Tesla is available. Therefore, the purpose of this prospective study was to evaluate the diagnostic value of CMR at 3T in patients with suspected acute myocarditis using a multiparametric CMR approach including T1 mapping as novel tool for tissue characterization. CMR will be performed within 7 days after hospital admission for suspected acute myocarditis.

Official Title
-----------------
Value of CMR Including T1 Mapping in Patients With Acute Myocarditis

Conditions
-----------------
Suspected Acute Myocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with suspected acute myocarditis and otherwise unremarkable cardiac history Exclusion Criteria: exclusion of CAD in invasive coronary angiography pregnancy contraindications for MR imaging

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| SAM<br>patients with suspected acute myocarditis | |
| HC<br>Healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 relaxation times | quantification of T1 relaxation times | time of CMR, CMR will be performed within 7 days after hospital admission for suspected acute myocardtitis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular volume (ECV) | calculation of extracellular volume based on T1 relaxation time | time of CMR, CMR will be performed within 7 days after hospital admission for suspected acute myocardtitis. |
Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Research question: What is the response of the heart's pumping function to changes in heart chamber pressures? Experimental design: Patients undergoing routine cardiac catheterization will be studied. A thermodilution pulmonary artery catheter will be inserted through a venous sheath and threaded into the pulmonary artery. After several minutes of quiet rest, baseline hemodynamics will be obtained, including a determination of cardiac output using thermodilution techniques and 30 seconds of pressure recordings from the left ventricle and proximal aorta. In addition, a brief echocardiogram will be performed, to determine ejection fraction and indices of diastolic filling. Finally, arterial tonometry will be obtained in quick succession from the brachial, radial, femoral, and carotid arteries. Following the collection of baseline data, a bolus and infusion of nesiritide will be started. After 10 minutes of nesiritide infusion, with the drug still infusing, a full set of invasive hemodynamics will again be obtained, as well as brief echocardiographic and arterial tonometry examinations.

Official Title
-----------------
Acute Responses in Diastolic Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: nesiritide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac catheterization Exclusion Criteria: Unstable coronary syndrome, Critical coronary stenoses (>90%), Severe peripheral vascular disease, Symptomatic hypotension at completion of routine diagnostic cath, Significant valvular disease, resting heart rate >120 beats/min, Ejection fraction <45%, Presence of contraindications to nesiritide administration, Any evidence of clinical instability.

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nesiritide|a bolus, then infusion of nesiritide for 10-15 minutes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial tonometry |  | following catheterization, then following 10 minutes of nesiritide infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial stiffness, echocardiography, nesiritide, high heart pressures, cardiac catheterization
Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Study Overview
=================
Brief Summary
-----------------
It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.

Official Title
-----------------
Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Conditions
-----------------
Post-Traumatic Orbital Deformity

Intervention / Treatment
-----------------
* Procedure: repair of orbital floor fractures using resorbable plates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Class I, II blowout floor fracture. Presented within 2 weeks of trauma. Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus. Exclusion Criteria: Comminuted orbital fractures involving the rim. Associated globe injuries. Delayed presentation.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 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 |
| --- | --- |
| Other: patients with traumatic recent orbital blow out fractures<br> | Procedure: repair of orbital floor fractures using resorbable plates<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical reduction of the fracture | reduction of the fractured segment and restore the normal orbital volume and contents . assessment of reduction by measuring the changes in the orbital volume using computed tomography | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of symptoms | improvement of the patient complaints as diplopia and enophthalmos using questionnaire | 6 to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resorbable, blow out fractures