linjc16/ctgov huggingface dataset:
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicentre, prospective study is: Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years. Report Safety and Survivorship up to 10 years F/up.

Detailed Description
-----------------
This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.

Official Title
-----------------
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

Conditions
-----------------
Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Device: Arthroplasty hip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis Correction of functional deformity Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. Revision procedures where other treatments or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties Exclusion Criteria: Absolute contraindications include: infection, sepsis, osteomyelitis Additional contraindications include: Uncooperative patient or patient with neurologic disorders who are incapable of following directions, Osteoporosis, Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy or neuromuscular disease.

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

| Intervention/Treatment |
| --- |
|Device: Arthroplasty hip|Hip replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Change in Harris Hip Score from Baseline to 1 Year post-surgery, Harris Hip Score, 0-100 points. The higher the positive difference between baseline and follow up the better the result | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip score | Oxford Hip Score at 1,3,5, 7 and 10 year postop, Oxford Hip score 0-48 points, The higher the positive difference the better the result. | 10 years |
PREdiction of Chronic LUng Allograft Dysfunction

Study Overview
=================
Brief Summary
-----------------
Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Moreover, in clinical practice, no integration of the different risk factors is achieved. CLAD is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. Several blood biomarkers that can predict the occurrence of CLAD more than 6 months before clinical diagnosis have been identified and validated. From these preliminary results, a composite score is being developed from independent samples from the COLT (COhort in Lung Transplantation) cohort. The main objective of this project is to validate this robust and predictive composite score (biological and clinical) of CLAD.

Official Title
-----------------
PREdiction of Chronic LUng Allograft Dysfunction

Conditions
-----------------
Lung Transplant Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to receive lung transplants awaiting registration on the transplant waiting list Patients affiliated to a social security system Patients who have given their informed consent Patients weighing more than 26 kg Patients over 16 years of age Exclusion Criteria: Pregnant or breastfeeding women Patients unable to follow the protocol Patients with concomitant inflammatory diseases, regardless of acute, chronic or infectious rejection. Patients with a history of cancer in remission for less than 5 years, with the exception of localized skin cancers, excluding melanoma.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Lung transplant<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD |  | 3 years | 
| MMP-9 levels over time associated with CLAD |  | 3 years | 
| Transitional B lymphocytes rate over time associated with CLAD |  | 3 years | 
| T lymphocytes levels over time associated with CLAD |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic lung allograft dysfunction, lung transplantation, biomarkers, personalized medecine
Assessment of Cortical Plasticity Following Short Term Limb Immobility

Study Overview
=================
Brief Summary
-----------------
The proposed project will study the consequence of short term limb immobility on the patterns of brain activity using functional imaging (fMRI)

Official Title
-----------------
Assessment of Cortical Plasticity Following Short Term Limb Immobility

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Other: this is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: wrist fracture. Fit for MRI scanning. Exclusion Criteria: Unwillingness to sign informed consent. Neurological disease s/p fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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> | Other: this is an observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the tolerance of a higher dose of arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.

Official Title
-----------------
Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects: a Randomized, Placebo-Controlled Cross-Over Study

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

Intervention / Treatment
-----------------
* Dietary Supplement: arabinoxylan-oligosaccharides (AXOS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 18-45 years regular eating pattern Exclusion Criteria: gastrointestinal complaints antibiotic intake medication influencing gut transit or microbiota abdominal surgery pregnancy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: arabinoxylan-oligosaccharides (AXOS)|intake period: 3 weeks, 10 g/day|

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
-----------------
tolerance, prebiotic, gastrointestinal effects
Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

Study Overview
=================
Brief Summary
-----------------
Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.

Official Title
-----------------
Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension

Conditions
-----------------
Oxygen Saturation

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in American Society of Anesthesiology (ASA) classification I and II Patients undergoing elective septoplasty operation Exclusion Criteria: Patients in ASA classification III and higher Emergency surgery Patients in New York Heart Association classification III-IV Patients with known allergy to drugs used in the study

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br> | Drug: Sevoflurane<br>* Sevoflurane %2-3 for general anesthesia maintenance<br>|
| Experimental: Desflurane<br> | Drug: Desflurane<br>* Desflurane %6-8 for general anesthesia maintenance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygen saturation as measured by Near Infrared Spectroscopy | The effect of sevoflurane and desflurane on NIRS values | Duration of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total remifentanil consumption as measured in micrograms |  | Duration of surgery | 
| The effect of anesthetics on hemodynamic variables | The effects of sevoflurane and desflurane on mean arterial pressure | Duration of surgery | 
| The effect of anesthetics on hemodynamic variables | The effects of sevoflurane and desflurane on heart rate | Duration of surgery | 
| The effect of anesthetics on hemodynamic variables | The effects of sevoflurane and desflurane on bispectral index | Duration of surgery |
DBS of the Third Ventricle for Cluster Headache and Obesity

Study Overview
=================
Brief Summary
-----------------
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.

Conditions
-----------------
Cluster Headache, Obesity

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation V3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Male or female aged between 18 and 65 years Ambulatory or hospitalized monitoring Fluent in French and able to understand the study procedures, including completing the auto-questionnaires Registered in the French social security scheme Signed informed consent of the patient will be collected before inclusion in the study Cluster Headache or Obesity patients Exclusion Criteria: Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG) Contraindication to Magnetic resonance imaging (MRI) All categories of protected persons

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS V3<br>Deep Brain Stimulation V3 | Device: Deep Brain Stimulation V3<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire |  | weekly up to 3 years |
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Implant placement may trigger bone trauma, which might result in 3-dimensional bone changes. While the process of peri-implant disease is not well understood, implant position within the bony structure might play a role. However, there is no data available on this regard.

Official Title
-----------------
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study

Conditions
-----------------
Periimplantitis, Oral Surgery

Intervention / Treatment
-----------------
* Device: Implant placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 80 years old Patients requiring oral rehabilitation through supported prosthesis Patients with partial edentulism No antibiotic in the last 2 months No smoking or smoking <10 cigarettes a day Exclusion Criteria: Systemic diseases uncontrolled Implants that because prosthetic characteristics can not be registered probing depth or attachment level appropriately Smoking> 10 cigarettes a day Pregnant Patients Implants that can not be followed in CICOM Patients who do not return to regular maintenance therapy every 3-6meses Patients who are not controlled periodontal disease

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

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

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

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 |
| --- | --- |
| Other: Routine implant placement<br>No comparison needed | Device: Implant placement<br>* Routine implant placement in the ideal three dimensional implant position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of peri-implantitis | Control by routine x-ray peri-implant bone loss | 3-years |
A Multisite Trial of ACQUIREc Therapy

Study Overview
=================
Brief Summary
-----------------
A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.

Official Title
-----------------
A Multisite Trial of ACQUIREc Therapy

Conditions
-----------------
Hemiparetic Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Therapy services (ACQUIREc Therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 3-6 years of age Hemiparetic CP Exclusion Criteria: No prior CI therapy treatments No Botox for 6-months

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment dosage levels examined<br> | Other: Therapy services (ACQUIREc Therapy)<br>* Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.<br>* Other names: ACQUIREc Therapy;|

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
-----------------
Dosage, Pediatric CI Therapy, ACQUIREc Therapy, Occupational Therapy, Physical Therapy, Cerebral Palsy, Hemiparesis
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.

Official Title
-----------------
A Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers

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

Intervention / Treatment
-----------------
* Drug: desvenlafaxine SR
* Drug: venlafaxine ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women between 18 to 55 years of age Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and no clinically significant abnormalities on 12-lead electrocardiogram (ECG) History of nonsmoker for at least 1 year Exclusion Criteria: Presence or history of any disorder or significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure), or psychiatric disease that may prevent the completion of the study Known or suspected alcohol abuse or consumption of more than 2 standard units per day within past 6 months or known or suspected abuse of prohibited drugs or other substances Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day -1 until the end of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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: desvenlafaxine SR|nan|
|Drug: venlafaxine ER|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects, Major Depressive Disorder, Depression, Cytochrome P-450 CYP2D6, Pharmacokinetics, Health