linjc16/ctgov huggingface dataset:
The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The compliance of salt restriction in patients with CKD may be associated with taste sensitivity.

Official Title
-----------------
The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease

Conditions
-----------------
Renal Insufficiency, Chronic, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: salt restriction education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage 3-5 CKD patients clinical stable Exclusion Criteria: renal replacement therapy cancer systemic infection Alzheimer's disease acute cardiovascular events, active hepatitis all other study-obstructive conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: salt restriction education|Salt intake target：<5g/d Method：the standard salt restriction education will be lasting for 10-15 minutes by oral explanation at baseline.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratings of taste sensitivity assessed by the ISO method of investigating sensitivity of taste（ISO 3972:1991） | Taste sensitivity is measured by five taste solutions（salty、sour、bitter、sweet、umami). Every taste solution contains 8 different concentration. Detection , recognition and difference thresholds will be measured .Their definitions are as bellow. Detection threshold：minimum value of sensory stimulus needed to give rise to a sensation. The sensation need not be identified. Recognition threshold：minimum value of a sensory stimulus permitting identification of the sensation perceived. Difference threshold：value of the smallest perceptible difference in the physical intensity of a stimulus. | up to 12 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
taste threshold, salt restriction
Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.

Detailed Description
-----------------
This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.

Official Title
-----------------
Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

Conditions
-----------------
Cardiovascular Risk Factors, Fasting

Intervention / Treatment
-----------------
* Biological: biochemical parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cardiovascular risk factors in stable conditions Ramadan fasting Exclusion Criteria: Impossibility, contraindication or interruption of fasting

Ages Eligible for Study
-----------------
Minimum Age: 18 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 cardiovascular risk factors who fast Ramadan<br>Stable clinical and biochemical parameters before Ramadan fasting | Biological: biochemical parameters<br>* patients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation. All these tests should be practice before, during and after Ramadan fasting for comparison.<br>* Other names: verify now assay;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause clinical complications |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of acute coronary complications |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ramadan fasting, variation of biochemical parameters, variation of hematological parameters, verify now assay
Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.

Official Title
-----------------
Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid

Conditions
-----------------
Hepatitis C, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: tacrolimus + steroid
* Drug: tacrolimus + mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient of living donor liver transplantation for HCV-related cirrhosis Exclusion Criteria: ABO blood type incompatible transplant case Renal dysfunction (serum creatinine >2.0 mg/dL) WBC < 1,000/mm3 Hemoglobin < 8 g/dL Platelet <30,000 /mm3

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Drug:<br>tacrolimus + steroid | Drug: tacrolimus + steroid<br> <br> |
| Active Comparator: 2 Drug:<br>tacrolimus + mycophenolate mofetil | Drug: tacrolimus + mycophenolate mofetil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival time at the end of first year after living liver transplantation. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplantation,, HCV recurrence,, immunosuppression
Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers

Study Overview
=================
Brief Summary
-----------------
The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.

Official Title
-----------------
A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Procedure: Intra-nasal allergen challenge with Phleum pratense.
* Procedure: Collection of nasal effluent using filter paper.
* Procedure: Measurement of nasal congestion using acoustic rhinometry.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense. Exclusion Criteria: Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intra-nasal allergen challenge with Phleum pratense.|nan|
|Procedure: Collection of nasal effluent using filter paper.|nan|
|Procedure: Measurement of nasal congestion using acoustic rhinometry.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post allergen challenge effects on acoustic rhinometry and symptoms at 16, 31, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge. |  |  |
Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)

Study Overview
=================
Brief Summary
-----------------
A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.

Official Title
-----------------
Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: Imiquimod and Interferon alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nodular or superficial basal cell carcinoma on the skin excluding scalp or face Exclusion Criteria: Pregnancy
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: Treated<br> | Biological: Imiquimod and Interferon alpha<br>* Imiquimod first two weeks and last two weeks. Interferon middle five weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of basal cell carcinoma |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of basal cell carcinoma at a lower cost and less inflammation. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BCC, Basal Cell Carcinoma, Intron-A, Aldara, Basal Cell Carcinoma excluding scalp and face
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Study Overview
=================
Brief Summary
-----------------
Primary objective : To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus. Secondary objective : Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM. Recording adverse events.

Official Title
-----------------
Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin glargine
* Drug: insulin glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed type I diabetic patients Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day BMI, 26-40 kg/m2 HbA1c, 7.5%-10% Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L) FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L) Willingness to accept, and ability to inject insulin Glargine therapy Exclusion Criteria: Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population 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: 18 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>combination of insulin Glargine & insulin Glulisine as basal bolus regimen | Drug: insulin glargine<br>* in combination with insulin Glulisine as bolus regimen<br>Drug: insulin glulisine<br>* in combination with insulin Glargine as bolus regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the Glycemic control of the regimen : Change in A1C levels |  | from baseline to study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ? |  | from baseline to study end |
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.

Official Title
-----------------
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers

Conditions
-----------------
Chronic Lower Leg Ulcer

Intervention / Treatment
-----------------
* Other: Autologous Platelet Enriched Gel
* Other: Metalloproteinase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 year or older A non-healing chronic lower leg ulcer Platelet ranges of 150000 per ml circulating blood Exclusion Criteria: Presence of a tumor or metastatic disease Hypersensitive to collagen regenerated cellulose Hemodynamic unstable patient Hypercoagulability Heart decompensation or angina pectoris

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Autologous Platelet Enriched Gel | Other: Autologous Platelet Enriched Gel<br>* Treatment with Autologous Platelet Enriched Gel<br>|
| Active Comparator: 2<br>Metalloproteinase Inhibitor (Promogran) | Other: Metalloproteinase Inhibitor<br>* Treatment with Metalloproteinase Inhibitor (Promogran)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | 6 months |
Cryoablation of AF: Improving the Use of the Achieve Catheter

Study Overview
=================
Brief Summary
-----------------
According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to assess strategies using the Achieve catheter that can improve this performance.

Official Title
-----------------
Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Maneuvers for documenting the disconnection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients undergoing atrial fibrillation cryoballoon ablation monitored with the Achieve catheter. Exclusion Criteria: patients in AF at the beginning of the procedure patients with a previous AF ablation procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Cryoablation of atrial fibrillation<br> | Other: Maneuvers for documenting the disconnection<br> <br> * Other names: type 4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time Documentation of Pulmonary Vein Disconnection | Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as yes or no, and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4. | atrial fibrillation cryoablation procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, balloon cryoablation, pulmonary veins
Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility

Study Overview
=================
Brief Summary
-----------------
Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

Detailed Description
-----------------
The first group includes non active ectopic pregnancies defined by score or algorithm. In this case, we propose a randomized controlled trial between medical and conservative surgery. In all others clinical situations, we proposed surgery treatment. In a randomized controlled trial we compare conservative versus radical treatment. The patients are followed-up during 2 years with phone contact every 6 months.

Official Title
-----------------
Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility

Conditions
-----------------
Tubal Pregnancy

Intervention / Treatment
-----------------
* Procedure: Treatment of ectopic pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis by ultra sound of ectopic pregnancy (EP) Patients aged > 18 years old Desire of future pregnancy Exclusion Criteria: EP by failure of contraception EP associated with in vitro fertilization (IVF)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: Treatment of ectopic pregnancy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent fertility with 2 years follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of treatments |  |  | 
| Time of hospitalisation |  |  | 
| Decrease curve of beta-hCG after treatment |  |  | 
| Success rate in each group |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ectopic pregnancy, Surgical treatment, Medical treatment, Fertility