linjc16/ctgov huggingface dataset:
EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the predictive value (in terms of remission) of a new technique for detecting circulating, functional, prostate cells among patients with localized adenocarcinoma of the prostate, and prior to any treatment.

Official Title
-----------------
The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique

Conditions
-----------------
Adenocarcinoma of the Prostate

Intervention / Treatment
-----------------
* Biological: EPISPOT detection of the number of circulating cells
* Biological: CellSearch detection of the number of circulating, functional, prostate cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan Histologically proven presence of prostate adenocarcinoma Localized disease on digital rectal examination Cancer without extensions Acceptance of a curative treatment by the patient Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is taking a hormone-modifying treatment Patient taking adrogenic supplements

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All study patients<br>All patients included according to stated inclusion and exclusion criteria. | Biological: EPISPOT detection of the number of circulating cells<br>* EPISPOT detection of the number of circulating, functional, prostate cells per unit blood<br>Biological: CellSearch detection of the number of circulating, functional, prostate cells<br>* CellSearch detection of the number of circulating, functional, prostate cells per unit blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between AUCs for the EPISPOT and Cellsearch Techniques | The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells | 1 day |
A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the maximum tolerated dose, safety and pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in steady-state sickle cell disease.

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: Intravenous (IV) citrulline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sickle cell disease genotypes (HbSS, HbS/β° thalassemia, HbS/β+thalassemia, HbSC) Exclusion Criteria: Presence of any acute illness defined by fever >100.4° F within the past 48 hours Presence of sickle cell pain crisis defined by the presence of pain requiring oral or parental opioid therapy. Presence of acute chest syndrome or presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, and patients with diabetes etc. Severe anemia (hemoglobin < 5g/dL) History of red blood cell transfusion within the last 14 days Systemic steroid therapy within the last 48 hours Pregnant (as confirmed by a negative urine pregnancy test) or lactating female Alanine/aspartate transferase >2x upper limit of normal laboratory range for age. Elevated serum creatinine >1.5mg/dL Patients with an inability to give consent will be excluded Medications that are known to be contra-indicated with use of L-citrulline (concurrent use of hydroxyurea will be allowed). History of diabetes due to risk of electrolyte imbalance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| Experimental: IV citrulline<br>IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg. | Drug: Intravenous (IV) citrulline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 2 or Higher Adverse Event According to NCI Criteria |  | 12 months |
MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.

Study Overview
=================
Brief Summary
-----------------
Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. Thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific. The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.

Detailed Description
-----------------
Sickle cell anemia and Sickle cell β thalassemia patients recieving multiple transfusions are exposed to the effects of iron deposition in the reticuloendothelial system, including cardiac muscle, liver and pancreas. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific. The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences. Patients and Methods: 27 Sickle cell anemia and 28 Sickle cell β thalassemia will undergo transthoracic echocardiography, cardiac MRI using T2* sequences and clinical and laboratory evaluation for iron overload including ferritin levels and oral glucose tolerance test .

Official Title
-----------------
Evaluation of Iron Overload in the Heart, Liver and Pancreas: Patients With Sickle β Thalassemia and Sickle Cell Anemia.

Conditions
-----------------
Iron Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions. Exclusion Criteria: contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| 1<br>Sickle cell anemia patients | |
| 2<br>Sickle cell β thalassemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcome measure: iron overload on T2* MRI in the heart , liver and pancreas. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron overload, Thalassemia, Anemia, Sickle Cell, Magnetic Resonance Imaging
MRI Findings in Inguinal Hernia

Study Overview
=================
Brief Summary
-----------------
MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The aim of the present study is to determine, whether similar inflammatory changes can be detected with MRI scan in inguinal hernia. Also, patient questionaires are used preoperatively and postoperatively to determine, if preoperative pain scores can be used as a predictive value for postoperative prolonged pain/neuralgia.

Official Title
-----------------
MRI Findings in Inguinal Hernia

Conditions
-----------------
Inguinal Hernia, Pain

Intervention / Treatment
-----------------
* Procedure: MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 50 years painful inguinal hernia Exclusion Criteria: conditions that do not allow the use of MRI conditions that prevent general anesthesia

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>All patients in this study have MRI scan prior to hernia repair surgery. If inflammatory changes are present, the scan is repeated 6 months after surgery. If not, the scan is performed only if the patient has pain problems at 6 months. | Procedure: MRI scan<br>* MRI scan with a 1,5 T MRI scanner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory changes in MRI scan | MRI scan is performed preoperatively and 6 months postoperatively to find possible inflammatory changes in the inguinal area, and the changes that a hernia mesh repair causes. If preoperative MRI scan does not have inflammatory changes, 6-month-MRI is only performed on-demand (if the patient is experiencing prolonged pain. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Preoperative and postoperative patient questionaires are used. Preoperative values are examined to determine, if they can be used to predict postoperative pain problems. | 7 months |
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.

Detailed Description
-----------------
Denture stomatitis is a prevalent disease among removable denture wearers. The cause of this disease stems from a myriad of factors including host immunity and poor oral hygiene. Denture acrylic material is very conducive for the growth and adhesion of bacteria because of its porous nature. The application of plasma enhanced chemical vapor deposited (PECVD) coatings on the surface of acrylic dentures can produce a less porous surface which may minimize the adhesion of bacteria and therefore colonization. The goal is the application of these coatings will help minimize the occurrence of denture stomatitis. Another issue of removable dentures is the low wear resistance of denture teeth. The application of these coatings on denture teeth should minimize wear of these teeth and prolong the life of removable dentures.

Official Title
-----------------
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic

Conditions
-----------------
Denture Stomatitis, Wear of Denture Teeth

Intervention / Treatment
-----------------
* Device: PECVD coating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are missing some teeth and will need removable dentures Exclusion Criteria: Medical contraindication for dental treatment

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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 |
| --- | --- |
| Control<br>The patients will be given removable dentures with no coatings. These dentures are part of the standard of care to treat their edentulism. | |
| PECVD Coatings<br>The patients will be given removable partial dentures with PECVD coatings on both the tissue surface of the dentures and the acrylic denture teeth. | Device: PECVD coating<br>* SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bacterial Count | Biofilms on the tissue surface of the dentures will be obtained for the aforementioned time intervals. Biofilm counts will be analyzed to determine the effect of the coatings on the number of disease causing bacteria on the surface of the denture | 2,4 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wear of denture teeth | Denture teeth will be analyzed for wear at 6 months to determine the effect of PECVD coatings on the wear of denture teeth. | 6 months |
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

Study Overview
=================
Brief Summary
-----------------
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.

Official Title
-----------------
A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil [CellCept]
* Drug: mycophenolate mofetil [CellCept]
* Drug: Cyclosporine or tacrolimus
* Drug: Cyclosporine or tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients participating in study ML17225. Exclusion Criteria: N/A.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 75 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: 1<br> | Drug: mycophenolate mofetil [CellCept]<br>* Concentration-controlled<br>Drug: Cyclosporine or tacrolimus<br>* Reduced<br>|
| Experimental: 2<br> | Drug: mycophenolate mofetil [CellCept]<br>* Concentration-controlled<br>Drug: Cyclosporine or tacrolimus<br>* Standard, as prescribed<br>|
| Experimental: 3<br> | Drug: mycophenolate mofetil [CellCept]<br>* 1g po bid<br>Drug: Cyclosporine or tacrolimus<br>* Standard, as prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral kinetics |  | Throughout study |
Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate

Study Overview
=================
Brief Summary
-----------------
The purpose of this ex-vivo study is to evaluate the insertion procedure for the ProstaPlant implant in human prostates and the support that it supplies to the prostate.

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: ProstaPlant Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, 18 years old and up, Suffer from BPH, Candidate for radical prostatectomies Exclusion Criteria: According to the physician's decision

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

Sexes Eligible for Study
-----------------
Male

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ProstaPlant Stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is a feasibility study, in which initial evaluation of stent insertion procedure is obtained |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH, Prostate, Stent, Benign prostatic hyperplasia (BPH)
Post Pancreatitis Complications Study (Based on a Prospective Data Base)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational epidemiological study is to investigate the management and the complications associated with pancreatitis. Datas will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed Description
-----------------
Anonymous datas will be collected by study coordinators in a secured e-database. Cross audit will be performed to check datas.

Official Title
-----------------
Prospective Cohort of Patients With Pancreatitis Hospitalized in West French Intensive Care Units

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Other: Collection of medical datas from ICU patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pancreatitis Exclusion Criteria: consent withdrawal

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients<br>Patients with pancreatitis | Other: Collection of medical datas from ICU patients<br>* Collection of medical datas from ICU patients with pancreatitis on a secured electronic database<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In ICU stay main complications | Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors) | Within the 28 first days after ICU admission date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Mechanical Ventilation |  | During ICU stay (up to 90 days) | 
| Length of ICU stay |  | During ICU stay (up to 90 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatitis
Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?

Study Overview
=================
Brief Summary
-----------------
Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major source of iron, but much of this is not bioavailability due to it being bound by the high amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can release iron and increase its bioavailability. In a human cell model of iron uptake, sourdough fermentation, which included activation of phytase, the enzyme that breaks down phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate that this concept also works in humans

Official Title
-----------------
Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?

Conditions
-----------------
Iron Bioavailability, Anaemia

Intervention / Treatment
-----------------
* Other: Whole grain rye bread
* Other: Whole grain sourdough rye bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women under 50 years old Exclusion Criteria: Pregnancy or breast feeding Use of mineral or other dietary supplements Use of medical or recreational drugs Donation of blood within the previous 3 months

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Whole grain rye bread<br>Whole grain rye bread, 200 g/d. Control intervention. | Other: Whole grain rye bread<br>* Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation)<br>|
| Experimental: Whole grain sourdough rye bread<br>Whole grain rye bread, 200 g/d. Experimental intervention. | Other: Whole grain sourdough rye bread<br>* Whole grain rye bread fermented with sourdough culture before baking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin |  | 12 week values corrected for baseline | 
| Serum transferrin receptor |  | 12 week values corrected for baseline | 
| Haemoglobin |  | 12 week values corrected for baseline |