linjc16/ctgov huggingface dataset:
Evaluation of the Possibility to Delegate Glaucoma Surveillance to Orthoptists in Hospital

Study Overview
=================
Brief Summary
-----------------
Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension. The treatment aims to stabilize the visual field deficiencies by lowering the intraocular pressure. Due to the fluctuation of the visual field test and re-test measures, the European recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in order to know if the pathology is progressing despite the current treatment (or if the treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists renders the monitoring of a beginning glaucoma, rarely compatible with the present recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced to a decreasing medical demography and an increase the patient's needs. This study should allow to validate the possibility to delegate monitoring tasks to orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to orthoptists would permit a better distribution of the ophthalmologist's activities.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Other: Monitoring by an orthoptist then by an ophthalmologist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 years old or more Open-angle glaucoma or ocular hypertension Exclusion Criteria: Other active ocular pathology Monophthalmic patients Patients requiring a Goldmann visual field exam Opposition of the patient to participate to the trial Pregnant women or breastfeeding Patient under juridical protection Lack of affiliation to social security or universal health coverage

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 |
| --- | --- |
| Patients with glaucoma<br>Patients presenting an open-angle glaucoma or ocular hypertension | Other: Monitoring by an orthoptist then by an ophthalmologist<br>* At each visit, the usual monitoring tests will be collected and viewed by the orthoptist then by the ophthalmologist concerning the necessity of an anticipated ophthalmological consultation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation |  | 20 month of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthoptist, Glaucoma surveillance
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.

Official Title
-----------------
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Device: Xavier wheelchair controller


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported) Age 18-89 Limited mobility with use of motorized wheelchair at screening-time Impairment of hand function limiting the use of a standard joystick control Caregiver willing to assist with transfers into wheelchair and application of controllers Ability to attend study visits with a motorized wheelchair Ability to communicate and answer patient reported outcome measure questions Exclusion Criteria: Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of <10 or the opinion of the investigator A sensory impairment prohibiting safe independent mobility in the opinion of the investigator Allergy to adhesives or electrode gels (required for EMG electrodes) Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy Subjects who do not have the capacity to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xavier wheelchair controller<br>Surface electromyography control of wheelchair | Device: Xavier wheelchair controller<br>* Controlling a wheelchair using the Xavier surface EMG system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheelchair Skills Test (WST) | Questionnaire | approximately 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drive test | Driving around cones in a controlled environment | approximately 3 days |
Vitamin D Analog in Vitamin D 24-hydroxylase Deficiency

Study Overview
=================
Brief Summary
-----------------
Preclinical evaluation of a vitamin D analog for the treatment of vitamin D 24-hydroxylase using fibroblast from patients with CYP24A1 mutation.

Official Title
-----------------
Preclinic Evaluation of a Vitamin D Analog in Vitamin D 24-hydroxylase Deficiency

Conditions
-----------------
Idiopathic Infantile Hypercalcemia - Severe Form

Intervention / Treatment
-----------------
* Procedure: skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biallelic mutation in CYP24A1 consent Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with CYP24A1 mutation<br> | Procedure: skin biopsy<br>* A skin biopsy to cultivate fibroblasts.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of the analog on vitamin D induced genes' expression | RNA quantification of genes induced by vitamin D in presence of analog in patients' fibroblast | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP24A1, vitamin D
Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer

Study Overview
=================
Brief Summary
-----------------
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.

Detailed Description
-----------------
Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative and after 3 month peripheral blood samples is collected. A total of 50 patients will be included in this study. The study is approved by the local scientific ethical committee No. S-20100006

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Other: blood sampels from vena rectalis superior and vena cubiti


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological verified cancer The cancer must be located in rectum maximum of 15 cm. Age above 18 Exclusion Criteria: Disseminated cancer Perioperative radio-chemotherapy Laparoscopy surgery

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 |
| --- | --- |
| Biomarkeres<br> | Other: blood sampels from vena rectalis superior and vena cubiti<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival. |  | after the study is complete |
Autologous Chondrocyte Implantation in the Patellofemoral Joint

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the outcomes of patients who have articular cartilage lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte Implantation.

Detailed Description
-----------------
Cartilage restoration, in general, is a relatively new option for the treatment of articular cartilage lesions primarily of the knee. In the initial autologous cultured chondrocyte transplantation (ACT or, by others implantation, thus ACI) reported by Peterson et. al., the results of femoral lesions were favorable, while 5 of 7 patellofemoral treatments were poor. In the United States, the expedited FDA approval based on these results excluded the patella. As a result, in the United States, it has been difficult to further evaluate use of ACI at the patellofemoral joint in light of the exclusion of off label uses by many governmental and private insurance programs. Nevertheless, a growing body of knowledge is accumulating outside the United States that the use of ACI at the patella is a viable option and soon similar findings will be published in the US by Minas et. al. (accepted for publication)

Official Title
-----------------
Autologous Chondrocyte Implantation in the Patellofemoral Joint

Conditions
-----------------
Chondrosis, Patellar Articular Cartilage Lesions, Trochlear Articular Cartilage Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carticel Implantation of the patella and/or trochlear lesion. Patients who have reached their two-year follow-up date. All patients included in sequential order. Exclusion Criteria: Patients that have had a microfracture in the knee joint at the same time as Carticel Implantation. Patients that have implantable lesions other than the patella and trochlea.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Articular Cartilage Lesions, Patellar lesions, Trochlear lesions, Patellofemoral joint, Carticel, Autologous Chondrocyte Implantation
Clinical Data Collection in Breast Tomosynthesis (COBRIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment

Detailed Description
-----------------
After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.

Official Title
-----------------
Clinical Data Collection in Breast Tomosynthesis: COBRIS

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

Intervention / Treatment
-----------------
* Device: Breast Tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 35 years or older; Women referred for unilateral or bilateral 2D and 3D mammography; Women able and willing to comply with study procedures; Women able and willing to participate in this study who have signed and dated the informed consent form; and Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test Exclusion Criteria: Women who have been previously included in this study; or Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or Women with BRCA 1 or BRCA 2 gene mutation

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Subjects with investigational acquisition | Device: Breast Tomosynthesis<br>* Three dimensional mammography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection | Collect clinical breast images obtained with the investigational application. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Image Quality | Assess image quality through subjective and open expert evaluation of patient motion, visibility of replication artefacts and visibility of clinical findings. | 1 year |
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.

Official Title
-----------------
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance

Conditions
-----------------
Transient Insomnia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged >/= 18 years Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening Exclusion Criteria: Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition) Recreational drug use within past 30 days

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin 250 mg<br> | Drug: Gabapentin<br>* Gabapentin 250 mg oral capsule 30 minutes prior to bedtime<br>|
| Experimental: Gabapentin 500 mg<br> | Drug: Gabapentin<br>* Gabapentin 500 mg oral capsule 30 minutes prior to bedtime<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matched placebo 30 minutes prior to bedtime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep latency |  | Hour +8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of sleep refreshment |  | Hour +8 | 
| Subjective assessment of sleep quality |  | Hour +8 | 
| Karolinska Sleep Diary-Sleep (KSD) Quality Index |  | Hour +8 | 
| KSD individual scores |  | Hour +8 | 
| Digit Symbol Substitution Test |  | Hour +8 | 
| Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) |  | Hour +8 | 
| Stanford Sleepiness Scale |  | Hour +13 | 
| Vital signs |  | Hour +8 | 
| Adverse events |  | Hour +13 | 
| Subjective number of awakenings |  | Hour +8 | 
| Subjective wake after sleep onset |  | Hour +8 | 
| Subjective total sleep time |  | Hour +8 |
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Detailed Description
-----------------
Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women. The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Official Title
-----------------
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Retrospective Cohort

Conditions
-----------------
Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with a uterus presence of a mullerian variation Maximum age 45y Exclusion Criteria: women without a uterus aged >45y

Ages Eligible for Study
-----------------
Maximum Age: 45 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 |
| --- | --- |
| patients with a mullerian variation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertility | Time to clinical pregnancy | 10 years after trying to conceive | 
| Fertility | Early pregnancy loss | 18 weeks after conception | 
| Surgical approach | Different surgical approaches used | during surgery | 
| Surgical success | Relief of symptoms after surgery | 15 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | The ability of a test to detect a Mullerian variation when it is present and detect the absence of a Mullerian variation when it is absent | at the time of diagnostic workup | 
| Obstetric complications | Complications during pregnancy, labor, delivery, and the postpartum period | 1 year after conception | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mullerian anomaly, Diagnostic tools, Surgical treatment, Reproductive function, Obstetric complications
Web-based International Register of Emergency Surgery and Trauma

Study Overview
=================
Brief Summary
-----------------
The WIRES-T project (Web-based International Registry of Emergency General Surgery and Trauma) has been set up to allow to all the EGS (Emergency General Surgery) and Trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. This will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.

Official Title
-----------------
Web-based International Register of Emergency Surgery and Trauma

Conditions
-----------------
Acute Appendicitis, Acute Cholecystitis, Acute Diverticulitis, Post-operative Complications, Acute Pancreatitis, Perforated Gastro-duodenal Ulcers, Adhesive Small Bowell Occlusion, Colonic Neoplastic Emergencies, Gynecological Emergencies, Vascular Emergencies, Intestinal Ischemia, Abdominal Wall Hernia, Foreign Bodies, Caustic Ingestion, Trauma

Intervention / Treatment
-----------------
* Procedure: Emergency General Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by an acute surgical disease Patients with indication to be referred to the emergency surgeon attention Patients to be operated or to be treated with non-operative approach without surgical intervention Exclusion Criteria: Patients not affected by an acute surgical disease Patients without indication to be referred to the emergency surgeon attention
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Emergency General Surgery|Emergency General Surgery and Trauma operative/non operative management|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients treated with surgery | Evaluate the rate of operative treatment for each different disease according to the different enviroment; for each intervention the surgical approach (laparotomic, mini-invasive, laparoscopic) will be evaluated. | Until hospital discharge, approximately 2 weeks | 
| Rate of patients treated with conservative treatment | Evaluate the conservative treatment rate for each different disease according to patient's characteristics and the enviroinment. | Until hospital discharge, approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | To evaluate the differences in mortality rate linked to the different managements, techniques, environments and patient variables. | Until hospital discharge, approximately 2 weeks | 
| Morbidity | To evaluate the differences in morbidity rate linked to the different managements, techniques, environments and patient variables. | Until hospital discharge, approximately 2 weeks |