linjc16/ctgov huggingface dataset:
Accommodating for Residual Limb Fluid Volume Change

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify residual limb fluid volume changes between morning and afternoon hours, and to determine if fluid volume change is correlated with activity.

Official Title
-----------------
Accommodating for Residual Limb Fluid Volume Change

Conditions
-----------------
Diurnal Residual Limb Fluid Volume Fluctuation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: transtibial amputation at least 18 months after amputation surgery ability to walk on a treadmill and stand for 90 seconds Exclusion Criteria: skin breakdown on the residual limb

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 |
| --- | --- |
| Transtibial amputees<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual limb fluid volume |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of walking and moving |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amputee, prosthetics
Antidepressant Treatment in Older Adults With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa) for the treatment of depressive symptoms in middle-aged and elderly patients with schizophrenia.

Detailed Description
-----------------
Older people with schizophrenia suffer from greater physical comorbidity, cognitive impairment, and medication side effects compared to their younger counterparts. Unfortunately, little research is available to guide the treatment of subsyndromal depressive symptoms in older adults. This study will compare the antidepressant citalopram to placebo to determine the most effective treatment for reducing depressive symptoms in older patients with schizophrenia After patients have been on stable treatment with antipsychotic medication for at least 4 weeks, they are randomly assigned to receive antipsychotic medication plus either citalopram or placebo for 3 months. Depressive symptoms and side effects are assessed weekly for the first month, biweekly for the second month, and again at the end of the third month. Cognition, motor and daily functioning, quality of life, and medication adherence are assessed throughout the study.

Official Title
-----------------
Citalopram Augmentation in Older Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Citalopram (Celexa)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia or schizoaffective disorder HAM-D score of 8 or above Antipsychotic medication treatment

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Participants will take placebo | Drug: Placebo<br>* Placebo for 3 months<br>|
| Active Comparator: 2<br>Participants will take citalopram (Celexa) | Drug: Citalopram (Celexa)<br>* Citalopram for 3 months<br>|

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
-----------------
Psychotic Disorders
Culture System for Isolating Circulating Tumor cells_2

Study Overview
=================
Brief Summary
-----------------
This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating tumor cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.

Official Title
-----------------
Culture System for Isolating Circulating Tumor Cells

Conditions
-----------------
Early Diagnosis, Diagnostic Techniques and Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lung cancer are between the ages of 20 and 70 Willing to sign the consent form under the informed consent Exclusion Criteria: Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| The Number of Circulating Cancer Cells from The Blood Sample | The number of circulating cancer cells from the blood sample will be investigated. To distinguish cancer cells from blood cells for the system, the lung cancer cells were immunofluorescence stained for Cytokeratin, white blood cells were stained for CD45 and nuclei were counterstained with DAPI. | about 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer Cell Isolation Efficiency of The Isolation System | The cell isolation efficiency was characterized by spiking A549 lung cancer cells with celltracker at the concentrations 1000, 100 and 10 cells into whole blood. | about 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating cancer cells, Biomedical polymer material, Cell affinity difference, White blood cell attachment
Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is the comparison of frequency of vomiting episodes (number of episodes per year) observed during the year after the begin of Q10 coenzyme treatment to frequency observed during the year before the begin of this treatment in children with cyclic vomiting syndrome. Secondary purposes are the evaluation of life quality of parents and children, of treatment safety and its economic cost compared to other recommended treatments.

Official Title
-----------------
Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children

Conditions
-----------------
Cyclic Vomiting Syndrome

Intervention / Treatment
-----------------
* Drug: Q10 Coenzyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cyclic vomiting syndrome as defined by Rome IV criteria Treated with Q10 coenzyme treatment for cyclic vomiting syndrome Q10 coenzyme treatment started between January 2000 and July 2006 Exclusion Criteria: - Refusal of processing of personal data reported in patient medical files

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Children with cyclic vomiting syndrome<br>Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome | Drug: Q10 Coenzyme<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of vomiting episodes | measured by number of episodes per year | from date of inclusion (start of Q10 coenzyme treatment) up to 1 year | 
| Frequency of vomiting episodes | measured by number of episodes per year | from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of vomiting episodes | reported by the child and/or parents | from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment) | 
| Intensity of vomiting episodes | reported by the child and/or parents | from date of inclusion (start of Q10 coenzyme treatment) up to 1 year | 
| Number of child hospitalizations |  | from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment) | 
| Number of child hospitalizations |  | from date of inclusion (start of Q10 coenzyme treatment) up to 1 year | 
| Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome |  | baseline |
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis

Study Overview
=================
Brief Summary
-----------------
The FLORACROHN project aims to compare gut microbiota of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. Fecal microbiota will be determined by 16SRNA gene sequencing.

Official Title
-----------------
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis

Conditions
-----------------
Crohn Disease, Spondyloarthritis

Intervention / Treatment
-----------------
* Other: analysing microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Crohn's disease and axial spondyloarthritis according to the criteria below. Patients with Crohn's disease (CT patients) diagnosed according to clinical, biological, radiological, endoscopic and / or histological criteria for 3 months. With diagnosis of spondyloarthritis exclusion on modified ASAS and / or New York criteria. Patients with axial spondyloarthritis (SpA patients) diagnosed according to the modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease. Patient with the capacity to give free and informed consent. Exclusion Criteria: Antecedent of colonic resection Antibiotic or colonic colonoscopy preparation in the 8 weeks prior to stool collection (against temporary indication = collection possible before colic preparation or on the first saddle after the start of the colic preparation). Ostomy at time of collection BMI> 30 extreme diet unbalanced diabetes Patient under guardianship, under curatorship or under safeguard of justice

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD alone<br> | Other: analysing microbiota<br>* 16SRNA gene sequencing of feces<br>|
| Experimental: SPA alone<br> | Other: analysing microbiota<br>* 16SRNA gene sequencing of feces<br>|
| Experimental: CD + SPA<br> | Other: analysing microbiota<br>* 16SRNA gene sequencing of feces<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota analysis | 16SRNA gene sequencing | 6 months after last patient inclusion |
Efficacy of Losartan in Preventing Progression of COPD

Study Overview
=================
Brief Summary
-----------------
Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).

Detailed Description
-----------------
Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.

Official Title
-----------------
Efficacy of Losartan in Preventing Progression of COPD

Conditions
-----------------
COPD, Emphysema, Chronic Bronchitis, Smoking

Intervention / Treatment
-----------------
* Drug: Losartan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with COPD who are either active or former smokers Exclusion Criteria: Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Experimental: Losartan<br>Losartan 100 mg daily | Drug: Losartan<br>* Losartan 100 mg daily<br>* Other names: Cozaar;|
| Placebo Comparator: Placebo<br>Placebo 1 pill daily | Drug: Placebo<br>* Placebo pill daily<br>* Other names: Sugar pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Emphysema on CT Scan | Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline. | Change between baseline and month 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 (L) | Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline. | Measured at Baseline and Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, emphysema, angiotensin receptor blocker
Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.

Detailed Description
-----------------
In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A receives only autologous MSCs suspended in fibrin glue, group B receives autologous MSCs+ Fibroblasts. Both groups receive 4 injections inside the wall and lumen of the fistula. Injections will be repeated every month.

Official Title
-----------------
Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: mesenchymal cell transplantation
* Biological: mesenchymal cell and fibroblast injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1- Poor response to routine treatments in refractory Crohn's disease with fistula. 2- CDAI>220 3- Age 18 to 60 years 4- GFR>30, Cr<2 5- The presence of perinea fistula. Exclusion Criteria: pregnancy

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mesenchymal cell and fibroblast transplantaion<br>The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection. | Biological: mesenchymal cell and fibroblast injection<br>* Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.<br>|
| Active Comparator: mesenchymal cell transplantaion<br>The patients with Crohn's disease who underwent mesenchymal cell transplantation. | Biological: mesenchymal cell transplantation<br>* Mesenchymal cell transplantation in patients with Crohn's disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fistula closure | Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease. | 4months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI | Evaluation the decrease of CDAI after mesenchymal cell transplantation. | 4months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, mesenchymal stem cell, fistula
Autofluorescence in Uveitic and Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered.

Detailed Description
-----------------
After macular pigment measuring we will perform fundus autofluorescence, fluorescein angiography and optical coherence tomography. any associations of macular pigment distribution and fundus autofluorescence with macular anatomic features are analyzed. primary outcome measure is the macular pigment distribution in patients with altered fundus autofluorescence. Furthermore we will compare the findings between diabetic and inflammatory edema.

Conditions
-----------------
Uveitis, Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diabetic or uveitis macular edema Exclusion Criteria: children patients with known allergy to fluorescein

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uveitic patients<br> | |
| patients with diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation

Study Overview
=================
Brief Summary
-----------------
Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients

Detailed Description
-----------------
In the case of confirmation of the PO- Bado long version, that means for 240 patients a caregiver support time longest 15 minutes than usually suggested, since in 6 items of the Po- Bado usually explored in the caregiver support time, add 6 other additional items provided in the long version. This further time, can be considered as an additional contribution to the free expression. For the 120 patients seen during the validation of the short version , there is no change in the duration of the caregiver support time.

Official Title
-----------------
French Validation of an Interview Guide to the Announcement of Cancer: the Psycho Oncology Basic Documentation

Conditions
-----------------
Cancer, With Caregiver Support Time, 18 Years and Over

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer having a caregiver support time Aged 18 years and over Exclusion Criteria: without known psychiatric history

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 |
| --- | --- | --- |
| Validation of a questionnaire concerning psychosocial status | traduction of questionnaire and validity évaluation (reliability and validity) | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychology, caregiver support time