linjc16/ctgov huggingface dataset:
Vitamin D Status in Children With Sickle Cell Disease Living in Lyon, France

Study Overview
=================
Brief Summary
-----------------
Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.

Official Title
-----------------
Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France

Conditions
-----------------
Vitamin D Deficiency, Sickle Cell Disease

Intervention / Treatment
-----------------
* Biological: 25-OH Vitamin D measure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children: under 18 years old Sickle cell any genetic type homozygous or composite heterozygous To receive an assessment independently of the study, during a presentation to the emergency ward and/or a follow-up consultation by the hematologist no parental opposition signed by at least one parent/legal representative and no child opposition social security beneficiary Exclusion Criteria: History of hematologic grafting

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 |
| --- | --- |
| Sickle cell disease children from Lyon, France<br>Sickle cell disease children, followed in IHOPe (Institut d'Hématologie et d'Oncologie Pédiatrique) center, consulting their referring haematologist doctor or in emergency ward, with prescribed blood sample. | Biological: 25-OH Vitamin D measure<br>* As a complement to the off-study prescription, the investigator are taking two 1 mL tubes of extra blood to measure vitamin D, calcium, phosphorus, parathyroid hormone (PTH) and creatinine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of 25-OH Vitamin D level | We classify vitamin D status as follows : Sufficiency > >75nmol/L (>30 ng/mL) Insufficiency 50-75 nmol/L (20-30 ng/mL) Deficiency 12-50nmol/L (5-20 ng/mL) Severe deficiency <12 nmol/L (<5 ng/mL) | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D deficiency prevalence rate, Vitamin D level, Children with sickle cell disease
20 Week Bridging Study in Type II DM

Study Overview
=================
Brief Summary
-----------------
A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus

Official Title
-----------------
A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus Type II

Intervention / Treatment
-----------------
* Drug: Insulin Glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus diagnosed at least 3 years ago Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry Treated with OHA monotherapy over at least 1 year HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit) BMI < 40 kg/m2 No history of ketonemia Women of childbearing potential using the medically approved contraceptive method Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin Glargine|Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG. |  |  |
Encouraging Healthy Food Shopping and Eating Behaviors by Price Reduction: A Community Supermarket Study

Study Overview
=================
Brief Summary
-----------------
The investigators plan to test the effect of price reduction of fruits and vegetables and non-caloric beverages on food purchasing, food intake, body weight, and body composition of primarily single adult shoppers. One hundred subjects will be randomized to an experimental or control group for a 4 month period. In the experimental group, there will be an automated 50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month period. The investigators expect to observe significant changes in food shopping and eating behavior during this period, which should lead to body weight and fat loss. Some of these new shopping patterns should persist in the last month of the study even though prices revert.

Official Title
-----------------
Encouraging Healthy Food Shopping and Eating Behaviors by Price Reduction: A Community Supermarket Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Discount intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regularly buy 50% of groceries at designated supermarket primary food shopper for household, shopping for up to one other person, not counting children ≤ 6 years old Exclusion Criteria: significant medical or psychiatric conditions participation in a weight loss program or a related study

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

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

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

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: Discount intervention<br>Receives 50% discount intervention on selected fruits and vegetables at participating supermarket. | Behavioral: Discount intervention<br>* 50% discount on selected fruits and vegetables at participating supermarket<br>|
| No Intervention: Control<br>Received no discount at the participating supermarket. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Weekly Purchasing of Fruits and Vegetables | Gross weekly purchasing of fruits and vegetables from the discounted items list in $ | week |
Neutrophil Extracellular Traps and Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea treatment.The study hypothesis is that NETs formation by neutrophils has a role in the induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte count in children with sickle cell anemia is a bad prognostic sign due to NETs formation supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil count and inhibiting NETs formation.

Conditions
-----------------
Sickle Cell Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children who suffer from sickle cell disease and/or children with sickle cell disease treated with hydroxyurea Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- | --- |
| measurements of neutrophil function |  | at first admition (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurements of neutrophil function |  | at sickle cell crisis while hospitalized |
Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify normal values of colloid osmotic pressure in interstitial fluid and plasma in healthy children between 2 and 10 years.

Detailed Description
-----------------
Measurements of colloid osmotic pressure (COP) by sampling of interstitial fluid from subcutaneous tissue and plasma are well documented in animal models and human adult studies. COP plays a major role in transcapillary fluid balance and is valuable in fluid therapy planning in critically ill patients. There are no data regarding interstitial fluid COP values in neither sick nor healthy children. Sampling of interstitial fluid by the wick method in children who is under general anaesthesia (ear-nose-throat operations) gives the opportunity to identify normal COP values in this age group.

Official Title
-----------------
Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children

Conditions
-----------------
Colloid Osmotic Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 2 to 10 years Exclusion Criteria: Medication Ongoing illness Syndromes

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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 |
| --- | --- | --- |
| Colloid osmotic pressure |  | 60 minuttes after wick insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colloid Osmotic pressure in interstitial fluid, Colloid Osmotic pressure in plasma, Protein fractions in interstitial fluid
A Study of CI-1012 in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.

Detailed Description
-----------------
Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

Official Title
-----------------
A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: CI-1012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Serologic evidence of infection with HIV-1. CD4+ cell count >= 200 cells/mm3. HIV-1 RNA >= 10,000 copies/ml. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Viral, fungal, or bacterial infection requiring therapy other than topical medications. Concurrent Medication: Excluded: Prophylactic systematic antibacterial, antifungal or antiviral agents. Antiretroviral therapy. NOTE: Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication. Prior Medication: Excluded: Experimental therapy for >= 4 weeks prior to initiation of study medication. Antiretroviral treatment for 3 weeks prior to initiation of study medication. Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CI-1012|nan|

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
-----------------
Dose-Response Relationship, Drug, Administration, Oral, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents
Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd wipes.

Official Title
-----------------
Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: lactoserum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototypes: I, II, III and IV; Integral skin test in the region; Exclusion Criteria: Lactation or gestation Use of Anti-inflammatory and/or immune-suppression drugs Personnel history of atopy; History of sensibilization or irritation for topic products; Active cutaneous disease; Use of new drugs and/or cosmetics during the study

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lactoserum|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG) |  |  |
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Study Overview
=================
Brief Summary
-----------------
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)

Official Title
-----------------
An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: OTX-101 0.09%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of Study OTX-101-2016-001 Exclusion Criteria: -

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: OTX-101 0.09%<br>0.09% cyclosporine nanomicellar solution | Drug: OTX-101 0.09%<br>* 0.09% cyclosporine nanomicellar solution<br>* Other names: Seciera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of subjects reporting any AEs | 40 weeks |
Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents. Dehydration caused by fasting prior to surgery is associated with the development of PONV. The aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of PONV undergoing spinal surgery.

Conditions
-----------------
Spinal Disease

Intervention / Treatment
-----------------
* Other: oral carbohydrate beverage
* Other: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ patient scheduled for elective spine surgery no smoking history Exclusion Criteria: hepatorenal disease BMI > 35 kg/m2 gastrointestinal disease vomiting within 24h administration of antiemetics or opioids within 24 h prior to surgery pregnant problem with communication

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral carbohydrate beverage group<br> | Other: oral carbohydrate beverage<br>* oral carbohydrate beverage (12.8% carbohydrates, 50 kcal/100ml, 290 mOsm/kg, NO-NPO®, Daesang WelLife Co., Ltd., Korea) 400ml in the evening of the day before surgery and at 6 am on the day of surgery, respectively<br>|
| Placebo Comparator: control group<br> | Other: control group<br>* NPO from midnight of the day before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of nausea and vomiting |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of nausea | 11-point numerical rating scale (0: no nausea  10: worst imaginable nausea) | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative nausea and vomiting, oral carbohydrate beverage
Endonasal Dacryocystorhinostomy and Evolution of the Stoma Size

Study Overview
=================
Brief Summary
-----------------
Dacryocystorhinostomy (DCR) is a procedure of choice for nasolacrimal duct obstruction. Endonasal procedures for DCR were described as early as 1893 by Caldwell. However, external DCR was practiced more commonly because of better visualization of anatomic features. The miniaturization of surgical instruments and close partnership between ophthalmologist and otorhinolaryngologist had led to a renewal of endonasal approach. The main objective of the study is to show the evolution of stoma size after endonasal DCR and validate the direct measurement of mucous orifice. It will also allow determining if the stoma evolution size may be a predictive factor for operational effectiveness.

Official Title
-----------------
Endonasal Dacryocystorhinostomy: Prospective Study of the Evolution of the Stoma Size

Conditions
-----------------
Endonasal Dacryocystorhinostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with chronic epiphora or chronic dacryocystitis Exclusion Criteria: -

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 |
| --- | --- | --- |
| Evolution of the stoma size | Measurement of the stoma size by endonasal photography | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucous orifices size | Measurement of the osteotomy orifices size from photography | Month 2 | 
| Ratio of patients for whom the operation is a success | A success corresponds to the complete disappearance of epiphora symptomatology, on the contrary, a failure equals to the persistence of tearing or a recurrence of dacryocystitis | Month 12 |