linjc16/ctgov huggingface dataset:
Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.

Detailed Description
-----------------
77 randomized, 37 paricalcitol, 40 no treatment

Official Title
-----------------
Consultant in Nephrology. MD., Ph.D.

Conditions
-----------------
Proteinuria

Intervention / Treatment
-----------------
* Drug: Paricalcitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: kidney transplant patients Exclusion Criteria: Previously transplanted

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Paricalcitol<br>Paricalcitol 2 ug/daily for 48 weeks | Drug: Paricalcitol<br>* Zemplar (paricalcitol) 2ug daily, oral intake<br>|
| No Intervention: no intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in albumin/creatinine ratio from baseline to end of study. | Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplant patients, Albuminuria
Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia

Study Overview
=================
Brief Summary
-----------------
Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack of sweat glands, sparse hair, and missing or malformed teeth. Inability to sweat may result in episodes of severe hyperthermia and cause sudden infant death. To assess sweat gland function in HED patients, the investigators will first quantify gland pores in a defined area of the palm and then stimulate the glands by pilocarpine followed by sweat collection in a special capillary for volume determination. This will be combined with non-invasive skin conductance measurement prior and subsequent to stimulation of the sympathetic nervous system. The data should provide a basis for genotype-phenotype correlation.

Official Title
-----------------
Validation of Non-invasive Technologies for the Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia, Their Heterozygous Family Members and Healthy Controls

Conditions
-----------------
Hypohidrotic Ectodermal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for patients: hypohidrotic ectodermal dysplasia caused by mutations in the genes EDA or EDAR written informed consent Exclusion Criteria: febrile disease pregnancy or breastfeeding implantable electronic devices, e.g. pacemaker hypersensitivity to self-adhesive electrodes

Ages Eligible for Study
-----------------
Maximum Age: 60 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 |
| --- | --- |
| HED children<br> | |
| HED adults<br> | |
| Control children<br> | |
| Control adults<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Spirometry in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist both in ventilating an obstructed patient and in weaning from mechanical ventilation. Currently there are no accepted extubation criteria in COPD patients that could predict successful weaning from mechanical ventilation. In this study we will attempt to correlate spirometric data to eventual weaning from mechanical ventilation.

Detailed Description
-----------------
COPD patients who deteriorate to Respiratory Failure will be recruited. Sedation will be interrupted daily, and each day once the patient is awake and cooperative, spirometry will be performed. FEV1 and FVC will be recorded and later correlated to eventual rate of successful extubation.

Official Title
-----------------
Spirometry in Mechanically Ventilated COPD Patients: Correlation of Lung Function Tests to Successful Weaning From Mechanical Ventilation

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 Mechanically ventilated due to COPD exacerbation Exclusion Criteria: decreased level of consciousness uncooperative patient Bronchial asthma

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Spirometry, Weaning
Neurological Complications - Pulmonary Transplant

Study Overview
=================
Brief Summary
-----------------
A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.

Official Title
-----------------
Neurological Complications - Pulmonary Transplant

Conditions
-----------------
Cognitive Dysfunctions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients more than 18 years of age. Enregistered in lung transplant waiting list Have given their agreement to be enrolled in the study Exclusion Criteria: Patients had a previous lung transplant patients with insufficient level of french language that may affect the comprehension and answering the psychometric test

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 |
| --- | --- | --- |
| Rey auditory verbal learning test |  | 3 months | 
| Rey complex figure test |  | 3 months | 
| Boston naming test of 30 figures |  | 3 months | 
| Visual construction skills |  | 3 months | 
| Grooved Pegboard test |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary transplant
Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

Study Overview
=================
Brief Summary
-----------------
This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis

Official Title
-----------------
Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan Patient is at least 18 years old Subjects included as patients have rheumatoid polyarthritis according to ACR EULA 2010, DAS28>3.2 criteria Subjects included as controls are healthy volunteers who have no overexpression of cytokines Exclusion Criteria: The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study The subject refuses to sign the consent It is impossible to give the subject informed information The patient has had at least 3 months of specific treatment that can potentially impact cytokine profile

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br> | Procedure: Blood sample<br>* 2ml blood taken into TruCulture tube<br>|
| Other: Rheumatoid arthritis patients<br> | Procedure: Blood sample<br>* 2ml blood taken into TruCulture tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of cytokines between groups | Concentration measured by ELISA and flow cytometry | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of biobank | Storage of blood samples | Day 0 |
Strabismus Surgery and Driving Ability

Study Overview
=================
Brief Summary
-----------------
The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of patients with strabismus may be reduced. The goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; Patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.

Official Title
-----------------
Strabismus Surgery and Driving Ability

Conditions
-----------------
Strabismus, Esotropia, Exotropia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Strabismus Age > 18 yrs old Driving license Exclusion Criteria: Inability to driving under French law

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of strabismus surgery on driving ability by using a Performance score (number of errors, braking velocity, speed variations of the vehicle position). |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
driving
VEINEX : Venous Investigations During Exercise

Study Overview
=================
Brief Summary
-----------------
Successfully develop and confirm with the Higher School of Electronics West Plethysmographic a multichannel recorder to perform measurements staggered volume of the lower limbs at rest, walking and recovery (6 storied measures on members lower).

Detailed Description
-----------------
Validate the measurement made by EAP (Electroactive polymer) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.

Official Title
-----------------
VEINEX : Venous Investigations During Exercise

Conditions
-----------------
Venous Insufficiency

Intervention / Treatment
-----------------
* Other: plethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: present or not venous pathology Exclusion Criteria: amputation of a lower limb heart failure Severe respiratory disease Unstable angina or myocardial infarction Parkinson's disease, hemiplegia and paraplegia

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

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

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

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: measures of the volumes<br>Measures of the volumes of the lower limbs. A measure to rest, a measure of effort (walk) and a measure recovery. Intervention. | Other: plethysmography<br>* Validate the measurement made by electroactive polymer sensors (plethysmography) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs) | plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs) | Maximum 3 months |
Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients

Detailed Description
-----------------
We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups

Official Title
-----------------
Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.

Conditions
-----------------
Postoperative Patients

Intervention / Treatment
-----------------
* Procedure: weaning protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated. Exclusion Criteria: Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NAVA group with a specific catheter<br>The patients were allocated in the NAVA weaning protocol group | Procedure: weaning protocol<br>* The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group<br>|
| Other: PSV group without a specific catheter<br>The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group | Procedure: weaning protocol<br>* The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic electromyographic activity description |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAVA: neurally adjusted ventilatory assist, Diaphragm electromyographic activity, Weaning
Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

Study Overview
=================
Brief Summary
-----------------
This trial will evaluate the outcome of placement of silicone breast prosthetics.

Detailed Description
-----------------
Patients will be evaluated for complications following placement of silicone breast prostheses.

Official Title
-----------------
Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 undergoing breast reconstruction Exclusion Criteria: patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc. Study Closed

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Silicone<br>patients undergoing placement of silicone breast prosthetics | |

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
-----------------
Breast, reconstruction, silicone
Calcium Intake and Fat Excretion

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.

Detailed Description
-----------------
Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles. The aim of this study is to examined for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight

Official Title
-----------------
Calcium Intake and Fat Excretion - an Observational Study

Conditions
-----------------
Fat Excretion, Energy Excretion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 - 50 years healthy weight stable within 4 months prior to the inclusion Exclusion Criteria: pregnant or lactating uses cholesterol lowering drugs on diet suffering from, now or previously, any gastrointestinal diseases elite athletes participation in other concomitant trial

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fat and energy excretion | Total fat and energy excretion in faeces during the test period of 5 consecutive days | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p-vitamin D |  | 1 day | 
| p-PTH | Parathyroid hormone (PTH) | 1 day | 
| Selected genetic variations | DNA from blood sample | 1 day | 
| Blood lipids and cholesterol | Total p-cholesterol, p-LDL, p-HDL, p-TG and p-FFA | 1 day | 
| calcium excretion | Total calcium excretion in faeces and urin during the test period of 2 consecutive days | 2 days | 
| Gut micro flora | Identification of gut micro flora | 1 day | 
| NMR-spectroscopy based metabonomics profiling of urin | NMR-spectroscopy based metabonomics profiling of each test subject | 1 day | 
| blood pressure | Resting blood pressure | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium intake, Fat excretion, Energy excretion, Gut micro flora