linjc16/ctgov huggingface dataset:
Randomized Double Blind Controlled Trial Comparing a Blind Sciatic Nerve Block in the Popliteal Fossa to Intravenous Morphine for Traumatic Severe Acute Pain in the Prehospital Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the efficacity of a simple blind technic of loco regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the prehospital setting and mountain rescue.

Detailed Description
-----------------
Severe pain due to leg, ankle or foot trauma do not beneficiated of a simple loco regional anaesthesia technic. Loco regional anesthesia is superior to intravenous morphine for treating severe pain and specially during transportation and mobilization of the patient. The purpose of the study is to assessed a new technic of blind sciatic nerve block in the popliteal fossa in the pre hospital setting compared to the intravenous morphine. The blind technic is a modified technic of the classic sciatic nerve block with nerve stimulation.

Conditions
-----------------
Injuries, Pain, Emergencies

Intervention / Treatment
-----------------
* Drug: Mepivacaine
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe pain (VAS > or = 60mm); injuries of the leg, ankle or foot Exclusion Criteria: Hypersensitivity to student agents Local infection Nerve or vascular pathology in the affected limb, coagulation pathology, Chronic use of opoids, use of opoids within 6 hours Drug addiction Pregnancy Systolic blood pressure less than 90 mmHg Respiratory rate less than 16 per minute Glasgow coma scale < 14.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blind block with mepivacaine<br>Blind block with mepivacaine and intravenous morphine | Drug: Mepivacaine<br>* mepivacaine 1% 20 ml corresponding to 200 mg<br>* Other names: experimental group;|
| Active Comparator: Morphine<br>Intravenous Morphine and placebo blind block | Drug: Morphine<br>* Morphine alone with a placebo nerve block<br>* Other names: control group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale pain score |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, injuries, Block, Nerve, morphine, Prehospital Emergency Care
Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Botulinum toxin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices Pain score ≥40 mm of the index knee Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen Exclusion Criteria: Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin<br>Single intra-articular injection | Drug: Botulinum toxin<br> <br> |
| Placebo Comparator: Placebo<br>Single intra-articular injection | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | Up to 6 weeks |
Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics

Study Overview
=================
Brief Summary
-----------------
The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.

Detailed Description
-----------------
The main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in SCD patients. Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. At 5 time points blood will be drawn from these subjects. (T0: Before transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after transfusion, T4: 6 months after transfusion). At each time point specific markers of the immune system will be measured.

Official Title
-----------------
Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics

Conditions
-----------------
Alloimmunization, Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sickle cell disease Receiving a red blood cell transfusion Exclusion Criteria: Previous positive screen for allo-antibodies >25 red blood cell units in the past
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 |
| --- | --- | --- |
| The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion | Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls | 6 months |
Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.

Detailed Description
-----------------
Nuclear stress testing is currently the established non-invasive modality in detecting flow-obstructing coronary artery disease (CAD). Recently, multi-detector CT (MDCT) has emerged as a new modality that offers a non-invasive means to directly visualize coronary anatomy and any CAD. Studies have shown that MDCT has excellent sensitivity and a high negative predictive value in detecting significant CAD. The purpose of this study is to compare MDCT with nuclear stress testing for detecting CAD in previously undiagnosed patients.

Official Title
-----------------
Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test

Conditions
-----------------
Coronary Arteriosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for a clinical indicated stress SPECT MPI Adequate IV access in both arms Exclusion Criteria: History of coronary angioplasty or stent placement History of coronary bypass surgery Angiographic history of flow-limiting CAD Documented history of elevated cardiac markers Documented history of injury or infarct on ECG Absence of sinus rhythm Current history of renal insufficiency Known allergy to contrast dye Pregnant

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 |
| --- | --- | --- |
| Calcium score |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Arteriosclerosis, Tomography, X-Ray Computed, Tomography, Emission-Computed, Single-Photon
Investigations Into ISCU Myopathy or Iron Sulfur Scaffold U Protein Myopathy

Study Overview
=================
Brief Summary
-----------------
Background: - A mutation in a gene known as ISCU was found to be the cause of a rare myopathy that affects the muscles. Researchers collected clinical samples from people with this myopathy. More research is being done to develop a therapy for this disease. Researchers are asking for permission to study the samples already collected. Objectives: - To allow researchers to use clinical samples collected to study new treatments for ISCU myopathy. Eligibility: - People with ISCU myopathy who have provided clinical samples for study. Design: Participants will allow researchers to study clinical samples already collected. Blood, urine, muscle, and cell samples may be used. Medical records and photographs may also be studied. Treatment will not be provided as part of this study.

Detailed Description
-----------------
In 2008, NIH investigators collaborated to find a mutation in the human gene, ISCU, which is the official human gene name for a gene involved in assembly of iron sulfur clusters, and is abbreviated from Iron Sulfur Cluster assembly protein, U, which was identified as the cause of a rare myopathy that affected about 25 patients in Sweden. This protocol is intended to allow for the collection and analysis of clinical specimens and medical information from several research subjects who previously participated in studies that led to identification of the disease gene.

Official Title
-----------------
Investigations Into ISCU Myopathy or Iron Sulfur Scaffold U Protein Myopathy

Conditions
-----------------
Myopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Subjects will be eligible for this study if they have ISCU myopathy or carry a mutation in ISCU. No exclusions will be made based on gender or, ethnicity and adults will be the only patients included.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolism, Muscle, Mutation, ISCU Myopathy, Myopathy
Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled.

Official Title
-----------------
Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer

Conditions
-----------------
Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 18 years of age or older. Subjects must be AA or Caucasian. Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined. Exclusion Criteria: Patients of races other than AA or Caucasian. No tumor block available from initial diagnosis. No tumor or very little tumor (<5% tumor present) in block as assessed by examination of the H&E slide by the Genomic Health, Inc (GHI) - designated pathologist. Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by the GHI-designated pathologist. Insufficient RNA (<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis. Failure of assay to meet pre-specified quality control (QC) specifications.

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 |
| --- | --- |
| Sample Collection<br>This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the prognosis of colon cancer patients compared to gene expression. | Compare the values of the Recurrence Score and expression levels of gene groups and individual genes between African Americans and Caucasians with Stage II colon cancer | 1 year |
Ultrasound Staging in the Placenta Accreta

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Detailed Description
-----------------
Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.

Official Title
-----------------
Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta

Conditions
-----------------
Obstetric Labor Complications, Staging of Placental Invasion

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior lower segment cesarean section Low lying anterior placenta Singleton pregnancy Exclusion Criteria: Medical disorders vasa previa

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Pregnant women in 3rd trimester
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Morbidly adherent placenta<br>This arm was given stage according to ultrasound features. | Device: Ultrasound<br>* Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of the stage of myometrial placental invasion | By ultrasound, placental invasion in myometrium was given a stage | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Documentation of complications intraoperative | 1 hour |
A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia

Study Overview
=================
Brief Summary
-----------------
Asparaginase is an important drug i the treatment of childhood leukaemia. The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment. Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries

Official Title
-----------------
PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.

Conditions
-----------------
Acute Lymphoblastic Leukaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study Exclusion Criteria: Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- | --- |
| Asparagine depletion | Blood samples and cerebrospinal fluid samples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analyzed for asparagine, asparaginase-enzyme activity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase. | Up to 30 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibodies, PEG-asparaginase, children, pharmacokinetics, acute lymphoblastic leukaemia, adverse effects
Prognostic Value of Anti-Ro52 Antibodies in Connective Tissue Diseases (a-Ro52)

Study Overview
=================
Brief Summary
-----------------
Anti-Ro52 autoantibodies can be detected in patients with several autoimmune diseases. Clinical significance of anti-Ro52 is controversial. The presence of anti-Ro52 may be a factor associated with disease severity (interstitial lung disease, vasculopathy) and cancers. The aim of this study is to assess interstitial lung disease and vasculopathy prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.

Official Title
-----------------
Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases

Conditions
-----------------
Connective Tissue Diseases

Intervention / Treatment
-----------------
* Other: Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Connective tissue disease (differenciated or not) Presence of anti-Ro52 antibodies at diagnosis Exclusion Criteria: Healthy subjects
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTD patients with anti-Ro52 antibodies<br>Connective tissue disease patients with anti-Ro52 antibodies at diagnosis | Other: Follow-up<br>* Clinical data, radiological data and laboratory tests follow-up<br>|
| CTD patients without anti-Ro52 antibodies<br>Connective tissue disease patients without anti-Ro52 antibodies at diagnosis | Other: Follow-up<br>* Clinical data, radiological data and laboratory tests follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ILD prevalence | Clinical (cough, dyspnea) and/or radiological (tomodensitometry) data | baseline (J0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ILD severity | PFT (pulmonary function test): FVC, FEV1, DLCO (percentages of predicted values) | baseline (J0) | 
| Vasculopathy occurence | Raynaud disease, digital ulcers or gangrene | baseline (J0) and follow-up | 
| Cancer occurence |  | baseline (J0) and follow-up |