linjc16/ctgov huggingface dataset:
Cochlear Implants : Influence of Microphone Aging and Dirtying

Study Overview
=================
Brief Summary
-----------------
Cochlear implant microphones are subject to aging and dirtying. The evolution may affect their efficiency. Several signal coding strategies are used in cochlear implants and their behaviour may be more or less affected by the aging process. In this work the investigators wish to assess this phenomenon.

Official Title
-----------------
Consequences of Aging and Dirtying of Microphones on the Performances of Cochlear Implants. Influence of Signal Coding

Conditions
-----------------
Hard of Hearing

Intervention / Treatment
-----------------
* Other: Listening to 12 Fournier's lists of words
* Other: Listening to 48 Fournier's lists of words


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French speaking persons (French native speakers; studies made in French) Ear, Nose and Throat (ENT) tests and check up for normal hearing listeners were normal (Hearing loss below 20 dBs for all frequencies situated in the 250-8000 Hz range) Not mentally retarded Exclusion Criteria: Persons with tinnitus or headache Anxious people (taking psychiatric drugs) Mental alteration or mental retard Deafened persons or taking an ENT treatment (normal hearing listeners)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implanted subjects<br>Listening to 12 Fournier's lists of words | Other: Listening to 12 Fournier's lists of words<br>* Patients will listen to words from Fournier's lists of words in presence of noise presented at different Signal to Noise Ratio (SNR). 6 disyllable words Fournier's lists are presented to the implantees: SNRs ranged from 0 to 15 decibels (dBs) (0; 3; 6; 9; 12; 15) ; the subjects repeat orally the words. Then microphone is cleaned and, again, 6 Fournier's lists are presented.<br>|
| Active Comparator: Normal hearing subjects<br>Listening to 48 Fournier's lists of words | Other: Listening to 48 Fournier's lists of words<br>* 48 disyllable Fournier's lists of words are presented to the subjects (6 SNR*2 coding strategies*4 dirtying levels) and the subjects repeat orally the words. Dirtying levels will be simulated by sounds effects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of correct syllable recognition | French spondee lists | At day 1 |
Ceramide Containing Multivesicular Emulsion Application . . .

Study Overview
=================
Brief Summary
-----------------
We believe that using a ceramide based foot cream two times a day for two weeks will prevent water loss and overall foot dryness in patients with non-insulin dependent diabetes.

Official Title
-----------------
Ceramide Containing Multivesicular Emulsion Application as a Skin Hydration Treatment for Feet of Subjects With Non-insulin Dependent Diabetes Mellitus.

Conditions
-----------------
Foot Transepidermal Water Loss in Patients in NIDDM, Foot Dryness in Patients With NIDDM

Intervention / Treatment
-----------------
* Drug: CeraVe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age non insulin-dependent diabetes moderate to severe xerosis of both feet [a score of at least 4 on a scale of 0 (normal) to 8 (deep fissuring)] capable of understanding and signing consent form Exclusion Criteria: history of ichthyosis vulgaris known hypersensitivity to the topical product used in the study previous use of high potency steroids (class I and II) in past 2 week presence of acute skin disease or infection, such as vasculitis or cellulitis presence of foot ulcer evidence of gangrene

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

| Intervention/Treatment |
| --- |
|Drug: CeraVe|Using OTC cream on foot twice daily for two weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease transepidermal water loss and foot dryness in study subjects. |  | 5 weeks |
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.

Official Title
-----------------
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Conditions
-----------------
Transgenderism, Gender Dysphoria, Insulin Sensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (transgender females): Identify as a transgender female Age 13-16 years at the time of enrollment If on a gonadotropin releasing hormone analogue, > 6 months exposure Plan to start estradiol clinically in < 4 months Inclusion Criteria (cisgender males and females): Males and females ages 13-16 years Exclusion Criteria: Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures Antipsychotic medication use Type 1 or 2 diabetes (by medical history) Polycystic ovarian syndrome (PCOS for cisgender females) Hypertension (resting BP ≥ 140/90 mm/Hg) Weight> 400 lbs On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant) Pregnancy (for cisgender females)

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transgender<br> | |
| Cisgender<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | Change from baseline to 12 months | 
| Brachial artery flow mediated dilation |  | Change from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Large artery stiffness | Carotid artery ultrasound | Change from baseline to 12 months | 
| Cerebrovascular function | Middle cerebral artery blood flow | Change from baseline to 12 months | 
| VO2 peak |  | Change from baseline to 12 months | 
| Fat mass | DXA | Change from baseline to 12 months | 
| Fat-free mass | DXA | Change from baseline to 12 months |
Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.

Official Title
-----------------
A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.

Conditions
-----------------
Adult Patients With Peripherally Inserted Central Catheters

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Age > 18 years requiring central venous access Ability to comply with study requirements Written Informed Consent Exclusion Criteria: Previous enrollment in study Current or recent upper extremity thrombosis, occlusion or stenosis Previous axillary lymph node dissection Skin inflammatory condition or rashes within 15 cm from insertion site Pre-existing history of hypercoagulability unrelated to malignant disease Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies Positive blood culture within 48 hours from planned PICC placement Known, renal insufficiency with chronic creatinine levels > 1.7 mg/dl

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 |
| --- | --- | --- |
| Rate of PICC Line Occlusions | The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects. | Insertion to Removal / maximum 3 months |
Comparison Between Effects of Two Iron Preparations on Protein in the Urine

Study Overview
=================
Brief Summary
-----------------
This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein

Official Title
-----------------
A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients

Conditions
-----------------
Kidney Failure, Chronic, Anemia, Iron-Deficiency

Intervention / Treatment
-----------------
* Drug: iron sucrose injection, USP
* Drug: sodium ferric gluconate complex in sucrose injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease, not receiving dialysis Age ≥ 18 or greater and able to give informed consent Exclusion Criteria: Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components Clinically unstable Indication of iron sufficiency Bladder obstruction conditions that would not allow for good urine output

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron Sucrose<br> | Drug: iron sucrose injection, USP<br>* iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks<br>|
| Active Comparator: Ferric Gluconate<br> | Drug: sodium ferric gluconate complex in sucrose injection<br>* sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine protein |  | 6 weeks |
Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

Study Overview
=================
Brief Summary
-----------------
The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine signature in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: HUMIRA 40mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy. Adalimumab prescribed in usual practice Exclusion Criteria: Patients presenting a contraindication to the use of Adalimumab: hypersensibility in Adalimumab or in one of the excipients. Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections presenting patients one cardiac insufficiencies moderated in severe Patients under anakinra or abatacept current participation in another study of clinical research

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab<br> | Drug: HUMIRA 40mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze modifications of the skin inflammatory | comparaison skin biopsy in non-lesional area between skin biopsy lesional area | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin transcriptomic profile | 5 mL blood sample for serum preparation | 1 month |
Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.

Official Title
-----------------
A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy

Conditions
-----------------
Colon Cleansing

Intervention / Treatment
-----------------
* Drug: oral sodium phosphate tablets
* Drug: polyethylene glycol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged from 18 to 75 years (included). Scheduled for a colonoscopy as an outpatient. Normal renal function Exclusion Criteria: Having a disease or condition as follows: repeated episodes of nausea and vomiting abdominal pain due to severe infection or requiring surgery clinically significant abnormal electrolytes values congestive heart failure, unstable angina pectoris or recent myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within previous 3 months known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis, inflammatory bowel disease, history of gastric stapling or bypass procedure or gastric retention Sodium phosphate preparation taken within the past three weeks prior to colonoscopy. Known allergy to any of the active ingredients or excipients of the study drugs. History of phenylketonuria

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polyethylene glycol<br>4 Liters of PEG administered split in 2 doses | Drug: polyethylene glycol<br> <br> |
| Experimental: oral sodium phosphate tablets<br>oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid | Drug: oral sodium phosphate tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall quality of bowel cleansing |  | day 1 |
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls

Study Overview
=================
Brief Summary
-----------------
Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested. This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects: 100 patients with scleroderma 300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.

Detailed Description
-----------------
The data of patients with scleroderma and healthy controls will be compared regarding: a standardized questionnaire about cursus laboris at initial inclusion a search for toxics in blood, urine and hair: at initial exvaluation, 6 month and 2 year-follow-up

Official Title
-----------------
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls

Conditions
-----------------
Scleroderma

Intervention / Treatment
-----------------
* Other: Questionnary for environmental factors research


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with scleroderma with: age range : 18 to 76 years written consent Exclusion Criteria: patients with other connective-tissue disorders pregnant women patients with psychiatric conditions unwritten consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 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 |
| --- | --- |
| Patients With Scleroderma<br>Assessments of questionnary for environmental factors research | Other: Questionnary for environmental factors research<br>* Questionnary for environmental factors research<br>|
| Healthy Controls<br>Assessments of questionnary for environmental factors research | Other: Questionnary for environmental factors research<br>* Questionnary for environmental factors research<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of environmental factor |  | Day 1 |
B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This case-control study investigated B-vitamin and homocysteine in relation to the presence or the absence of type 2 diabetes and clinical signs of polyneuropathy.

Detailed Description
-----------------
Blood samples were collected and clinical investigations were performed at the same time.

Official Title
-----------------
B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Complications

Intervention / Treatment
-----------------
* Device: Blood collection and electrophysiological tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with or without diabetes. Exclusion Criteria: Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months Liver or renal dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Patients with type 2 diabetes<br>Patients (both men and women) with diagnosed type 2 Diabetes for at least 5 years. Blood collection and electrophysiological tests were performed. | Device: Blood collection and electrophysiological tests<br>* Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.<br>|
| Controls free of diabetes<br>Controls (both men and women) are people of the same age who are free of Diabetes. Blood collection and electrophysiological tests were performed. | Device: Blood collection and electrophysiological tests<br>* Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell cobalamin levels |  | Baseline | 
| Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations | Polyneuropathy grade was accessed using a questionnaire and a clinical examination (electrophysiology) after nerve stimulation. A score includes the combination of questionnaire data and electrophysiology data. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma methylmalonic acid levels |  | Baseline | 
| Plasma choline levels |  | Baseline | 
| Plasma cobalamin levels |  | Baseline |