linjc16/ctgov huggingface dataset:
Transferrin Saturation and Asthenia in Hemochromatosis

Study Overview
=================
Brief Summary
-----------------
Observational study.

Detailed Description
-----------------
The linked HFE genetic hemochromatosis (C282Y mutation in the homozygous state) is the most common form of genetic iron overload. Its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the High Authority of Health (HAS). The first phase, called induction, aims to achieve ferritinemia <50 by performing weekly bleeds. The second phase, called maintenance, aims to maintain this ferritinemia <50 by performing bleeding every 1 to 6 months depending on the case. The treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. However, some patients report persistent asthenia during maintenance treatment, despite ferritin levels <50. This could reflect an incomplete control of their disease, and leads us to raise two points: It is known that in some subjects, the Transferrin Saturation Coefficient remains high, despite ferritinemia <50; it is also known that this elevation of the Transferrin Saturation Coefficient may be accompanied by a rise in circulating free iron, which is toxic for the organism1. The asthenia observed in some patients in the maintenance phase could be linked to a high rate of Transferrin Saturation Coefficient. Our objective is to evaluate, in patients homozygous C282Y in maintenance phase, the association between quality of life and Transferrin Saturation Coefficient .

Official Title
-----------------
Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis

Conditions
-----------------
Hemochromatoses, Genetic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: homozygous C282Y ; in the maintenance phase for at least 6 months ; follow-up at Rennes University Hospital ; patient who has not expressed his opposition to participate in the study. Exclusion criteria: Permanent: any cause of modification of the CST unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ; Temporary: infectious syndrome within 7 days before bleeding.

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 |
| --- | --- | --- |
| Quality of life questionnaire SF 36 |  | Through study completion, an average of 3 months | 
| Biological markers : Transferrin Saturation Coefficient |  | Through study completion, an average of 3 months |
Self-management for Dual Sensory Impaired

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.

Official Title
-----------------
Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?

Conditions
-----------------
Hearing Loss, Low Vision

Intervention / Treatment
-----------------
* Behavioral: Self management program
* Behavioral: self management program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of hearing loss and low vision at least one sensory loss acquired after the age of 55 living in a home for the elderly Exclusion Criteria: congenital deaf persons a dual sensory loss before the age of 55

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self management<br> | Behavioral: Self management program<br>* Professional caregivers will be trained in offering a self management program to aged persons with a dual sensory impairment. Duration of the program: 6 months<br>* Other names: Empowerment;Behavioral: self management program<br>* Learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment<br>* Other names: self efficacy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation in social, leisure and communicative activities. | 2 outcome measures will be used: Activity Card Sort (Baum & Edwards 2001): change from baseline in leisure activities and social contacts at 6 months Hearing Handicap Questionnaire (Gatehouse & Noble 2004): change from baseline in communicative contacts at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| work satisfaction professional caregivers |  | 6 months | 
| Depressive feelings |  | 6 months | 
| Autonomy. | Outcome measure: 9-item Patient Autonomy Questionnaire (Vernooij-Dassen & Osse 2005): change from baseline in dependency, losing control, and limitation of activities at 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Homes for the aged, Self management, Personal autonomy, Disease management, Self efficacy, Participation
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.

Official Title
-----------------
A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Low Strength IDP-107
* Drug: High Strength IDP-107
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Dermatological conditions of the face that could interfere with clinical evaluations Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Low Strength IDP-107<br>* Once a day for 12 weeks<br>|
| Experimental: 2<br> | Drug: High Strength IDP-107<br>* Once a day for 12 weeks<br>|
| Placebo Comparator: 3<br> | Drug: Placebo Comparator<br>* Once a day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of inflammatory lesions |  | 12 weeks | 
| Improvement from baseline in global severity |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of non-inflammatory lesions |  | 12 weeks |
First in Human Study of NI-0701 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Official Title
-----------------
A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: NI-0701
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non smokers Able to adhere to study visits and protocol requirements Exclusion Criteria: Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale Established or recurrent history of allergic reactions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NI-0701<br> | Drug: NI-0701<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NI-0701 Pharmacokinetic parameters in healthy volunteers |  |  | 
| NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion |  |  | 
| Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare |  |  | 
| Immunogenicity of NI-0701 |  |  |
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement. Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.

Detailed Description
-----------------
Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue. Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood

Official Title
-----------------
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery

Conditions
-----------------
Submandibular Gland Tumor, Parotid Gland Tumor

Intervention / Treatment
-----------------
* Drug: Alda-341


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor Ability to adhere to study visit schedule and other protocol requirements Operable candidate base on the surgeon's note Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Nursing or pregnant Diagnosis of kidney disease, history of renal disease with creatinine > 1.5 mg/dL, or currently on dialysis Diagnosis of end stage liver disease Any unstable medical condition Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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: Alda-341 treatment<br>Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery. | Drug: Alda-341<br>* Dietary supplement d-limonene orally administered as a drug.<br>* Other names: d-limonene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of Alda-341 in salivary gland tissue using GCMS | Bio availability of Alda-341 in salivary gland tissue will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of Alda-341 in saliva and blood | Bio availability of Alda-341 in saliva and blood will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL. | 2 week |
Retinal Microvasculature Before and After Silicone Oil by OCTA

Study Overview
=================
Brief Summary
-----------------
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

Detailed Description
-----------------
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal. The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Official Title
-----------------
Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography

Conditions
-----------------
Retinal Vascular

Intervention / Treatment
-----------------
* Other: Microperimtery and optical coherence tomography angiography OCTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal Exclusion Criteria: Proliferative diabetic retinopathy, recurrent detachment or macular hole Patients with chorioretinal degenerations involving the macula Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma Media opacity hindering proper imaging
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Microperimtery and optical coherence tomography angiography OCTA|observational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular and optic nerve head vascular density | Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal | one year | 
| Retinal sensitivity by microperimetry | Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vascular density and best corrected visual acuity | Correlate the change in the retinal vascular density with best corrected visual acuity | one year | 
| Optic nerve head vascular density and best corrected visual acuity | Correlate the change in the optic nerve head vascular density with best corrected visual acuity | one year | 
| Retinal sensitivity and best corrected visual acuity | Correlate the change in the retinal sensitivity with best corrected visual acuity | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal microvasculature, microperimtry, OCTA, Silicone oil
Study Investigating Enbrel Treatment for Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations. Unknown adverse reactions, especially serious adverse reactions Change of the incidences of adverse reactions under the routine drug uses Factors that may affect the safety of the drug Factors that may affect the effectiveness of the drug

Official Title
-----------------
A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy Exclusion Criteria: Patients with known hypersensitivity to Enbrel or any component of the product Patients with sepsis or risk of sepsis Patients with active infections including chronic or localized infections such as tuberculosis.

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 |
| --- |
|Drug: Etanercept|Etanercept 25mg Injection, 2 times/week|

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
-----------------
Ankylosing Spondylitis
Intra-peritoneal Environmental Changes Following Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the presence of tumor cells and tumor markers in peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve our understanding of tumor spread and disease recurrence.

Official Title
-----------------
Intra-peritoneal Environmental Changes Following Colorectal Surgery for Cancer

Conditions
-----------------
Tumor Cells and Tumor Markers in Peritoneal Cavity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colon and rectal cancer 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor cells and tumor markers |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels in the abdomen |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon and rectal tumors, colon cancer markers
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

Detailed Description
-----------------
This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis. Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Official Title
-----------------
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Procedure: Staged ETS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II Exclusion Criteria: Patients under 16 years. Patients with bradycardia (heart rate <80 beats per minute). Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion. Patients with cardiac problems with ejection fraction less than 60%. Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis. Patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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: Staged ETS<br>Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side | Procedure: Staged ETS<br>* Thoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months | decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale | 24 months |