linjc16/ctgov huggingface dataset:
Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.

Official Title
-----------------
Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers

Conditions
-----------------
Diabetes, Foot Ulcer, Healing

Intervention / Treatment
-----------------
* Device: hyperbaric air
* Device: HBOT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus, foot ulcer with duration > 3 months, treatment at Diabetes foot clinic for > 2 months, vascular surgical intervention had not been recommended for the affected lower limb. Exclusion Criteria: severe obstructive pulmonary disease, malignancy and untreated thyrotoxicosis), current drug or alcohol misuse, vascular surgery in the lower limbs within the last two months, participation in another study or suspected poor compliance.

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 |
| --- | --- |
| Active Comparator: HBOT<br>100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks | Device: HBOT<br>* 100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber<br>|
| Placebo Comparator: Placebo<br>air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks | Device: hyperbaric air<br>* air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing |  | 3, 6, 9, 12, 18, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputationrate |  | 6, 12, 24 months | 
| time to ulcer healing |  | 24 months | 
| QoL |  | 3, 6, 12, 18, 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Foot ulcer, Neuropathy, Ischemia
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C. II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio. The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued. The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: interferon alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative No decompensated cirrhosis --Prior/Concurrent Therapy-- No concurrent immunosuppressives At least 1 year since interferon --Patient Characteristics-- Hepatic: No other cause of liver disease Other: Not HIV positive

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interferon alfa|nan|

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
-----------------
hepatitis C, immunologic disorders and infectious disorders, rare disease, viral infection
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

Study Overview
=================
Brief Summary
-----------------
Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only. Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).

Official Title
-----------------
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

Conditions
-----------------
Sickle Cell Disease, Infant, Newborn, Disease, Drepanocytosis

Intervention / Treatment
-----------------
* Other: SCD newborn screening with the MS/MS method from Zentech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with SCD newborn screening conducted in the hospital center of Lyon Exclusion Criteria: Insufficient quantity of sampling Parents' opposition to their newborn's participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 27 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| newborn screening for sickle cell disease<br>Newborns with a targeted neonatal screening for sickle cell disease carried out at the University Hospital of Lyon | Other: SCD newborn screening with the MS/MS method from Zentech<br>* The analysis of the SCD newborn screening with the MS/MS method from Zentech will be realized after achievement and biological validation of the SCD newborn screening in the usual care pathway. The results will be compared with the method used at the Lille Academic Hospital (CHU Lille) (sub-contractor for SCD newborn screening of Lyon)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent agreement between the two techniques | Non-inferiority (difference <1%) in terms of sensitivity and specificity between the results obtained with the MS/MS method and those obtained with the technique currently used at the Lille CHU (sub-contractor for SCD newborn screening of Lyon) | 6 months |
The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

Study Overview
=================
Brief Summary
-----------------
Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.

Detailed Description
-----------------
In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.

Official Title
-----------------
The Impact of Visual Axis Position on the Optical Quality After Implantation of Multifocal Intraocular Lenses With Different Asphericity Values

Conditions
-----------------
IOL, Cataract

Intervention / Treatment
-----------------
* Procedure: Cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: corneal astigmatism less than 1 diopter Exclusion Criteria: ocular pathology others than cataract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tecnis;<br>Patients who received the Tecnis multifocal IOL. | Procedure: Cataract surgery<br>* Phacoemulsification surgery<br>|
| Diffractiva<br>Patients who received the Diffractiva multifocal IOL. | Procedure: Cataract surgery<br>* Phacoemulsification surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Schnellen VA | 6 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multifocal IOL, optical quality, angle alpha
The Immune System and Psychiatric Disorders

Study Overview
=================
Brief Summary
-----------------
The study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. To study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.

Detailed Description
-----------------
Our hypotheses are first that activity in the immune system influences the psychiatric status in general, second that changes in activity in psychiatric status affect activity in the immune system and third that there are connections between certain psychiatric conditions/disorders and certain features of the immune system. All patients admitted to a psychiatric acute ward covering an area with a population of 130.000 and with around 1000 admittances to an acute psychiatric ward a year (some readmittances) are asked to participate in the study. Patients fill in a question form regarding psychiatric as well as somatic health with emphasis on diseases involving immune activity. When possible also slight information on the family is registered. Both at the time of admittance and after recovery clinical laboratory tests on somatic status are registered. In addition the level of different cytokines is measured. The psychiatric state and precise diagnoses are registered during the stay. The data will be analysed to uncover connections between psychiatric stress in general as well as specific psychiatric diagnoses and activity in the immune system.

Official Title
-----------------
The Immune System and Psychiatric Disorders

Conditions
-----------------
Stress Disorders, Traumatic, Depressive Disorder, Bipolar Disorder, Personality Disorders, Schizophrenia, Psychotic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the adult acute psychiatric ward of a certain geographical area during the study period Exclusion Criteria: Patients that do not agree to participate in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients admitted to a psychiatric acute ward<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokines |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunity, Immune System, Cytokines, Psychophysiology, Psychoneuroimmunology
The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter study. All patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. Per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. Intraoperative samples will also be collected and sent for NGS analysis

Detailed Description
-----------------
Pre-operative D-dimer testing should be performed if this is in keeping with the local institutional standard of care. Otherwise, D-dimer testing will be omitted from the pre-operative panel of tests collected. NGS results will be made available to the Investigator. Treatment will remain within keeping with the Investigator's standard of care. NGS results may be used at the discretion of the treating surgeon in guiding patient treatment.

Official Title
-----------------
The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection

Conditions
-----------------
Prosthetic Joint Infection

Intervention / Treatment
-----------------
* Other: No intervention: sample collection study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication. Exclusion Criteria: 1. Patients undergoing second stage re-implantation surgery for PJI.

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 |
| --- | --- |
| Suspected PJI<br> | Other: No intervention: sample collection study<br>* Sample collection and collection of laboratory values<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection | MSIS criteria incorporates pre-operative laboratory values with tissue and fluid samples collected during surgery in an attempt to diagnose infection | Immediate post-operative period (usually within 5 days following surgery) |
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.

Official Title
-----------------
Open, Randomized, Phase II, Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals' DTaP-IPV Vaccine (Infanrix®-IPV) Co-administered With a Booster Dose of Merck and Company's M-M-R®II, to That of Separate Injections of GSK Biologicals' DTaP Vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II Administered as Booster Doses to Healthy Children 4 to 6 Years of Age.

Conditions
-----------------
Diphtheria, Acellular Pertussis, Tetanus

Intervention / Treatment
-----------------
* Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children between and including 4 and 6 years of age. Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period Administration of immunoglobulins and/or blood products within 3 months prior to vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity after vaccination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity and safety after vaccination. |  |  |
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

Study Overview
=================
Brief Summary
-----------------
This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.

Official Title
-----------------
A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Esomeprazole 40mg
* Drug: Pantoprazole 40mg
* Drug: Lansoprazole 30mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Males and females ages 18-69 who are of Hispanic origin Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months Exclusion Criteria: Female patients who are pregnant or breastfeeding Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole 40mg|nan|
|Drug: Pantoprazole 40mg|nan|
|Drug: Lansoprazole 30mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare nocturnal intragastric pH in Hispanic patients with GERD |  |  | 
| Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD |  |  | 
| Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, acid reflux, heartburn, PPI, Hispanic