linjc16/ctgov huggingface dataset:
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to find out whether dextromethorphan can prevent the short or long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve symptoms of short-term neurologic side effects if they do occur.

Detailed Description
-----------------
We believe that we are beginning to understand the biological cause of the neurotoxicity that happens after treatment with methotrexate. Dextromethorphan, an ingredient in common cough medicines, may be able to prevent and/or treat this neurotoxicity. We have given dextromethorphan to a small group of patients who developed severe neurologic side effects after methotrexate. All had a complete recovery within one day.

Official Title
-----------------
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

Conditions
-----------------
Neurotoxicity Syndromes

Intervention / Treatment
-----------------
* Drug: Dextromethorphan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed acute lymphocytic leukemia (ALL), non-Hodgkin's lymphoma (NHL) or OS. Patients will be separately stratified and randomized by disease. Patients with history of seizures are eligible but will be stratified separately. Exclusion Criteria: Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions. Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dextromethorphan|Patients will receive an inert carrier with or without dextromethorphan. The study drug will be administered at 1.5 mg/kg/dose on a BID schedule. The first dose to be given prior to each scheduled intravenous and/or intrathecal administration of methotrexate and continued for a total of seven days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate neurotoxicity
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

Official Title
-----------------
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study

Conditions
-----------------
Gynecologic Disease

Intervention / Treatment
-----------------
* Device: Mediclore
* Device: Adept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Gynecological disease (benign disease) Patients who Written informed consent Patients without clinically significant lab Exclusion Criteria: having enrolled another clinical trials within 1 month Immunosuppression or autoimmune disease Anticoagulant, general steroids within a week from surgery Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies) Patients with previous history of surgery at the same operate site

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediclore<br>adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area | Device: Mediclore<br>* apply medical device fully around intrauterine surgery area<br>* Other names: Poloxamer, Gelatin and Chitosan.;|
| No Intervention: No treatment<br>standard treatment for surgery | |
| Active Comparator: Adept<br>adhesion barrier, Adept, to apply medical device fully around surgery area | Device: Adept<br>* apply medical device fully around intrauterine surgery area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adhesion rate | 4 weeks after surgery, finding adhesion using visceral slide test | 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adhesion symptoms | 4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire | 4 weeks after surgery | 
| adverse event | identifying adverse events after surgery | 4 weeks after surgery |
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery. The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.

Official Title
-----------------
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

Conditions
-----------------
Postoperative Ileus

Intervention / Treatment
-----------------
* Other: gum chewing
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective liver transplantation surgery an ability to chew gum Exclusion Criteria: emergency surgery age less than 18 years, inability to provide written informed consent an inability to chew gum hepaticojejunostomy sedated patients reintubated patients Glasgow Coma Scale <13 reoperation before gas out previous bowel surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gum chewing<br>Gum type was standardized with all subjects receiving sugar-free xylitol gum. The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (two tablets) 3 times daily in the morning, afternoon, and evening for 15 min. The administration of the therapy was implemented by ICU nurses and recorded in the clinical report form file. All gum-chewing patients completed their course of gum chewing until gas out. | Other: gum chewing<br>* gum chewing<br>|
| Placebo Comparator: Control<br>Routine care during NPO | Other: Control<br>* Routine care during NPO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to flatus |  | an expected average of 75 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of target calories |  | an average 4 days | 
| ICU length of stay |  | an average 96 hous | 
| hospital length of stay |  | an average 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sham feeding, postoperative ileus, liver transplantation
Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD

Study Overview
=================
Brief Summary
-----------------
The non-neurosurgical management of post-traumatic cerebral hemorrhagic lesions is currently poorly codified. It consists of neurological monitoring for 24 to 48 hours, and the performance of an almost systematic brain scan. Anti-aggregation and anticoagulation treatments are stopped for 14 to 28 days and should be resumed according to the risk-benefit ratio and the advice of the patient's treating physicians and cardiologists. If the bleeding lesions do not progress, the patients are allowed to return home. If the lesions progress, the patients remain hospitalized for further monitoring, a new brain scan and neurosurgical advice. This study seeks to show that the performance of systematic brain imaging in the absence of clinical deterioration of patients admitted to the UHCD for post-traumatic intracranial hemorrhage could be avoided, and thus to administer an unnecessary dose of irradiation to the patients, and would also have a significant financial stake. Several recent studies have shown that there is no need to perform a follow-up brain scan in the absence of neurological deterioration, even in anticoagulated patients or those on antiplatelet drugs. Despite the growing number of articles, no recommendation or consensus has been proposed.

Official Title
-----------------
Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD. Indication of a Control Imaging ?

Conditions
-----------------
Head Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Admitted to Emergency department of the Strasbourg University Hospital during the year 2017 (from 01/01/2017 to 31/12/2017) Patient having given his consent to the reuse of his data for the purpose of this research Hospitalized at the University Hospital for monitoring of a post-traumatic intracranial hemorrhage Exclusion criteria: Patient having expressed opposition to participate in the study Non-isolated cranial trauma (MVA, fall greater than 6 meters ..) Subject under court protection Subject under guardianship or curatorship

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 |
| --- | --- | --- |
| Retrospective description of clinical evolution of post-traumatic intracerebral hemorrhages |  | Through study completion, an average of 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head Trauma, Intracranial hemorrhage, Cerebral hemorrhagic lesions, Neurological monitoring, Brain scan
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%). Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping the abdominal aorta. Human studies in cardiac patients have shown promising results with precondition. Instead of clamping arteries they have all performed the procedure by inflating a blood pressure cuff above arterial pressure on a arm. The investigators want to investigate if preconditioning induced by a blood pressure cuff on a arm can reduce the perioperative rate of myocardial infarction in patients open operated for ruptured abdominal aortic aneurysm.

Official Title
-----------------
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: Precondition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ruptured abdominal aortic aneurysm offered surgery Age > 18 years Exclusion Criteria: Technical inoperable

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precondition<br>Induction of precondition at start of operation on a arm | Procedure: Precondition<br>* Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm<br>|
| No Intervention: Control<br>No precondition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in myocardial infarction |  | 4 to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in survival Description on inflammatory response |  | 4 to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
precondition, ruptured abdominal aortic aneurysm, myocardial infarction
Use of Thermal and 3D Imaging to Quantify Arthritis

Study Overview
=================
Brief Summary
-----------------
One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. We have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. The goal of our studies is to test the hypothesis that this Imager can improve the clinical assessment of arthritis.

Official Title
-----------------
Use of Thermal and 3D Imaging to Quantify Arthritis

Conditions
-----------------
Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: 3D and thermal imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 4 years of age Exclusion Criteria: less than 4 years of age

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- |
| Adult RA<br> | Other: 3D and thermal imaging<br>* subjects will be imaged before and after receiving DMARD therapy<br>|
| pediatric JRA<br> | Other: 3D and thermal imaging<br>* subjects will be imaged before and after receiving DMARD therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA, JRA
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting

Official Title
-----------------
Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy

Conditions
-----------------
Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy

Intervention / Treatment
-----------------
* Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
* Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens Exclusion Criteria: Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments Use of any concomitant medication that could affect the patient's study treatment response or assessment results

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)<br>* subcutaneous injections at 8 visits<br>|
| Placebo Comparator: Arm 2<br> | Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo<br>* subcutaneous injections at 8 visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life |  | about 1.5 hours on 4 occasions over 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the study treatment by collection of adverse events |  | about 30 min. at each visit |
Sweetheart-Register: Risk Management of Diabetics With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Furthermore the register will provide data about the implementation of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.

Official Title
-----------------
Sweetheart: Risiko-Management Von Diabetikern Mit Akutem Myokardinfarkt

Conditions
-----------------
Diabetes, STEMI, NSTEMI, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction consecutive patients with acute (no older than 24 h) Non-ST-Elevation Myocardial infarction Exclusion Criteria: missing informed consent
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 |
| --- | --- | --- |
| Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany |  | 04/01/2007-09/30/2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the fraction of patients with (I) a previous know Diabetes Mellitus (DM) type I and II, (II) a newly diagnosed DM, (III) diagnosed with IFG or IGT for the first time |  | 04/01/2007-09/30/2009 | 
| Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany |  | 04/01/2007-09/30/2009 | 
| Documentation of diabetic therapy during the acute phase of a myocardial infarction |  | 04/01/2007-09/30/2009 | 
| Documentation of the hospital mortality, the serious but non-fatal complications (stroke, re-myocardial infarction) and other bleeding complications |  | 04/01/2007-09/30/2009 | 
| Verification of the implementation of a therapy according to the guidelines for STEMI / NSTEMI in daily hospital routine |  | 04/01/2007-09/30/2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, STEMI, NSTEMI, Myocardial infarction