linjc16/ctgov huggingface dataset:
Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)

Study Overview
=================
Brief Summary
-----------------
Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the Patient Blood Management, which is a concept recommended by health regulatory agencies in many countries. The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients undergoing a scheduled major surgery, applying the French recommendations (determination of ferritinemia and Transferrin Saturation Factor).

Official Title
-----------------
Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)

Conditions
-----------------
Diagnostic

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, over 18 years of age Patient with scheduled major surgery Patient with signed consent Exclusion Criteria: Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant or breastfeeding woman

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with scheduled major surgery<br>Patients with scheduled major surgery | Diagnostic Test: Diagnostic test<br>* Blood iron status : ferritin and transferrin saturation factor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood iron status | Ferritin | Preoperative | 
| Complete blood iron status | Transferrin Saturation Factor | Preoperative |
Brain Genomics Superstruct Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the effects of genes and genetic variation on brain structure and function. Investigators at Harvard plan to explore the relationship between candidate genes that affect cognitive performance and brain structure/function. Since brain phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show greater sensitivity than cognitive performance to measure gene effects.

Official Title
-----------------
Brain Genomics Superstruct Project

Conditions
-----------------
Autism Spectrum Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13 years or older Subject must have a current DSM-IV diagnosis of high functioning ASD, based on past evaluations at the Bressler Clinic. Subjects must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. Each subject must understand the nature of the study. The subject must sign an IRB approved informed consent. Exclusion Criteria: IQ < 70 bassed on evaluation in the Bressler Clinic. Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items). Neuropsychiatric conditions (such as dementia) which sufficiently impair cognition such that a surrogate consent would be required. Neurological disorders associated with gross brain pathology (other than atrophy), e.g., stroke, tumors, or demyelinating diseases. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |
| Neuroimaging phenotype |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism Spectrum Disorders, Brain Imaging, Genetics
Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection

Study Overview
=================
Brief Summary
-----------------
Introduction: Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development. Methods: In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.

Official Title
-----------------
Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection

Conditions
-----------------
Child Health, Bypass Graft Occlusion

Intervention / Treatment
-----------------
* Procedure: pediatric vascular bypass grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age <18 years planned vascular bypass grafting Exclusion Criteria: age >18 years no vascular intervention

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 18 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 |
| --- | --- |
| orthopedic surgery group<br>Planned tumor resection | Procedure: pediatric vascular bypass grafting<br>* pediatric vascular bypass grafting<br>|
| traumatic surgery group<br>Patients with traumatic vascular injury | Procedure: pediatric vascular bypass grafting<br>* pediatric vascular bypass grafting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bypass growth | bypass growth | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autologous vs. PTFE graft | patients will either receive an autologous bypass graft or PTFE graft | patency rate in 1 year | 
| revision surgery | revision surgery | <30 days |
Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.

Detailed Description
-----------------
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Patients will be randomly allocated to the control group (= no input from pharmacist) or intervention group (= with pharmaceutical care at baseline and follow-up visits over 6 months).

Official Title
-----------------
Pharmaceutical Care for Asthma Control Improvement

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Procedure: Pharmaceutical care for asthma patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with persistent asthma Asthma treatment for at least 12 months Regular visitors of the participating community pharmacy Exclusion Criteria: Severe co-morbidity > 10 pack-years smoking history Asthma Control Test score < 15 or =25

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pharmaceutical care for asthma patients|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between study groups in the change of asthma control from baseline and follow-up visits |  | after 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak flow |  | after 3 and 6 months | 
| Knowledge of asthma and treatment |  | after 6 months | 
| Asthma quality of life questionnaire (AQLQ) |  | after 6 months | 
| Therapy adherence |  |  | 
| Inhalation techniques |  | after 6 months | 
| Smoking |  | after 6 months | 
| Asthma exacerbations |  | after 6 months | 
| General Practitioner (GP) visits, emergency room visits and hospitalisations |  |  | 
| Working days lost and school days lost |  |  |
Patients Decision-making in Rotator Cuff Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to evaluate the effect on patient treatment decision-making if information was given based on the benefit or on the side effect in rotator cuff disorders.

Official Title
-----------------
Do we Really Allow Patient Decision-making in Rotator Cuff Surgery? A Prospective Randomized Study

Conditions
-----------------
Rotator Cuff Disease

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with rotator cuff tears at their first clinical visit Exclusion Criteria: patients with a previous shoulder surgery, patients with worker's compensation and patients who were unwilling to participate and thereby not sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| group A (benefit-inform)<br>filling questionnaire based on benefits of surgery | Other: questionnaire<br>* fulfillment of questionnaire<br>|
| group B (side effect-inform)<br>filling questionnaire based on side-effects of surgery | Other: questionnaire<br>* fulfillment of questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire of surgery decision | two proposals for surgery based on information given to the patient | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score | functional evaluation of shoulder function | immediate |
Labial Biopsy in Patients With Tuberculosis Disease

Study Overview
=================
Brief Summary
-----------------
The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician. The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.

Official Title
-----------------
The Value of Labial Biopsy in 65 Patients With Tuberculosis Disease

Conditions
-----------------
Tuberculosis, Sarcoidosis

Intervention / Treatment
-----------------
* Other: labial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults above 18 years, bacteriologically confirmed tuberculosis Exclusion Criteria: patient not able to sign written 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bacteriologically confirmed tuberculosis<br> | Other: labial biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of granuloma on labial biopsy |  | at day zero of treatment of tuberculosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
usefullness of labial biopsy to distinguish between tuberculosis and sarcoidosis
Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo for 4 weeks.

Official Title
-----------------
Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Ulmus macrocarpa water extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject has peripheral white blood cells between 4,000/Ul and 8,000/Ul Exclusion Criteria: History of renal disease History of diabetes mellitus History of immune disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ulmus<br>Ulmus macrocarpa water extract 250mg orally 2 times a day for 4 weeks | Dietary Supplement: Ulmus macrocarpa water extract<br> <br> |
| Placebo Comparator: Placebo<br>placebo 250mg orally 2 times a day for 4 weeks | Dietary Supplement: Ulmus macrocarpa water extract<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum natural killer cell activity |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral white blood cell |  | 1 month | 
| serum tumor necrosis factor-alpha level |  | 1 month | 
| serum interferon-gamma |  | 1 month | 
| serum interleukins(1betta, 2,4,8,10, and 12) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulmus macrocarpa water extract, immunity
Brain Tissue Specimen Collection

Study Overview
=================
Brief Summary
-----------------
The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain procedures.

Detailed Description
-----------------
The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain procedures. Leftover tissue removed during the course of brain surgery will be collected and stored in neurosurgical laboratories for use in medical research that might be currently ongoing or for future research. In addition, blood and cerebral spinal fluid samples will also be collected and stored. Leftover cerebral spinal fluid (CSF) will be collected during standard of care procedures (lumbar punctures or ventricular drains) that take place at time of diagnosis, completion of therapy and relapse of disease or during neurosurgery. Blood will be drawn at time of routine lab draws required during the surgery or procedure.

Official Title
-----------------
Molecular Neurosurgical Tissue Bank

Conditions
-----------------
Brain Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects having any type of brain surgery, where a specimen will be collected. Exclusion Criteria: none
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 |
| --- | --- | --- |
Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium.

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the routine clinical care setting in the Antwerp region (Belgium).

Detailed Description
-----------------
The favourable results of a number of phase III-trials with gefitinib in NSCLC patients with activating EGFR-mutations, have resulted in the licensing of gefitinib in this indication. This offers the prospect of a true personalized treatment of patients with NSCLC. Implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the EGFR-mutation analysis and on the timely reporting of the mutation analysis results. Ideally the results should be available in all patients within 2 weeks of the analysis request.

Official Title
-----------------
Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or above newly diagnosed NSCLC written informed consent tumor sample available Exclusion Criteria: mixed histology of small cell and NSCLC

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 |
| --- | --- | --- |
| testing turn around time (in days) | how long does it take to get the mutation analysis result | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographics | age, gender, tumor histology, smoking history | baseline | 
| correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status |  | baseline | 
| correlation between family history with regards to cancer and EGFR-mutation status |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, observational study, EGFR mutation analysis, EGFR mutation status, testing turn around time
Cell Transplant in Spinal Cord Injury Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.

Official Title
-----------------
Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Conditions
-----------------
Chronic Spinal Cord Injury

Intervention / Treatment
-----------------
* Procedure: Autologous bone marrow transplant
* Procedure: Physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic spinal cord injury No concomitant systemic disease No progress on physiotherapy for at least 6 months Duration of injury from 10 months to 3 years Exclusion Criteria: Non-traumatic spinal cord injury whether transverse myelitis or demyelination Concomitant systemic disease Progress can be observed on physiotherapy Acute injury or duration of injury less than 10 months

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 36 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BM transplant with physiotherapy<br>Autologous BM transplant | Procedure: Autologous bone marrow transplant<br> <br> Procedure: Physical therapy<br> <br> |
| Active Comparator: Physiotherapy only<br>conventional physical therapy for chronic spinal cord injury. | Procedure: Physical therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI. |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injury