linjc16/ctgov huggingface dataset:
Dietary Sodium Restriction in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased risk for cardiovascular diseases. These complications are associated with end stage renal disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the effects of nutritional counseling restricting dietary sodium and its relation to clinical and diet factors, nutritional knowledge and quality of life in hemodialysis patients.

Official Title
-----------------
Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial

Conditions
-----------------
Hemodialysis Patients

Intervention / Treatment
-----------------
* Other: Sodium restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study. Exclusion Criteria: Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.

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: Intervention<br>Nutritional education on sodium restriction diet. | Other: Sodium restriction<br> <br> |
| No Intervention: Control<br>Standard treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium intake | Sodium intake will be evaluated by food record and a food frequency questionnaire. | Baseline, 30, 90, 180 and 360 days | 
| Quality of life | Quality of life will be evaluated by the Brazilian Portuguese version of the Kidney Disease and Quality-of-Life Short-Form (KDQOL-SF) questionnaire. | Baseline, 180 and 360 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interdialytic weight gain | Will be considered the amount of weight gain between 2 dialysis sessions. | Baseline, 30, 90, 180 and 360 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Sodium-Restricted, Food and Nutrition Education, Renal Dialyisis
China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Three purpose of this study: Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients; Evaluation on specificity and sensitivity of STAF score; Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.

Detailed Description
-----------------
Inclusion criteria: Hospitalized patients with ischemic stroke that are diagnosed definitely; Age ≥ 18 years; Within 7 days after the onset of diseases; Signed the consent informed form. Exclusion criteria: Patients with noncerebrovascular diseases that are diagnosed definitely; Silent cerebral infarction (CI) without symptoms and signs; Those refuse to sign the consent informed form of the study.

Official Title
-----------------
China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients

Conditions
-----------------
Atrial Fibrillation, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with ischemic stroke that are diagnosed definitely; Age ≥ 18 years; Within 7 days after the onset of diseases; Signed the consent informed form. Exclusion Criteria: Patients with noncerebrovascular diseases that are diagnosed definitely; Silent cerebral infarction (CI) without symptoms and signs; Those refuse to sign the consent informed form of the study.

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 |
| --- | --- | --- |
| Accumulated detection rate of AF | ECG was monitored for all patients enrolled in a single center for consecutive 6 days | 1.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Screening, Stroke patients
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

Official Title
-----------------
Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Conditions
-----------------
Colorectal Adenoma

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization. The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study. Exclusion Criteria: The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer. The subject has a history of inflammatory bowel disease.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Celecoxib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of colorectal adenomas in study subjects |  | 3 years | 
| the histopathologic grade of colorectal adenomas |  | 3 years | 
| the size of colorectal adenomas measured after one year and three years of study drug use. |  | 3 years |
Glulisine + Lantus in Type I Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.

Official Title
-----------------
Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy

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

Intervention / Treatment
-----------------
* Drug: Insuline Glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men and women (>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40) An HbA1c range of >6.5 - <11% And on multiple injection regimen (more than 1 year of continuous insulin treatment) Body mass index <35. Exclusion Criteria: Active proliferative diabetic retinopathy Diabetes other than type I diabetes mellitus Pancreatectomised subjects Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine Hypersensitivity to insulin Major systemic diseases Impaired hepatic or renal function 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

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: Insuline Glulisine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c. |  | from baseline to endpoint. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c. |  | from baseline (week 1) to weeks 12 and 26 | 
| Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins. |  | from baseline to endpoint. |
Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.

Official Title
-----------------
Serum Maresin-1 Level Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis Patients

Conditions
-----------------
Pancreatitis, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Severe Acute Pancreatitis Biliary pancreatitis 7 days of the onset Exclusion Criteria: Surgical patients Serious diseases and infection Alcoholic pancreatitis Hypertriglyceridemia pancreatitis Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI>30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| normal level of serum maresin-1<br> | |
| abnormal level of serum maresin-1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | The level of serum maresin-1 predicts the severity of severe acute pancreatitis | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of MODS | The level of serum maresin-1 predicts the severity of severe acute pancreatitis | through study completion, an average of 1 year | 
| The incidence of IPN | The level of serum maresin-1 predicts the severity of severe acute pancreatitis | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maresin-1, SAP, IPN, MODS, Mortality
Mitigating Pain Following Refractive Surgery

Study Overview
=================
Brief Summary
-----------------
Using Contact lens following refractive procedure to reduce pain.

Detailed Description
-----------------
Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days. prospective comparative study

Official Title
-----------------
Contact Lens for Mitigating Pain Following Refractive Procedure

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent bilateral Refractive surgery for myopic correction. Age 18-60. Evidence of an epithelial defect. Patient complains of significant pain. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits. Exclusion Criteria: Any other anterior segment abnormality other than that associated with Refractive surgery. Any abnormalities associated with the eye lids. Prior laser treatment of the retina. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery. Diagnosis of glaucoma. Active diabetic retinopathy. Clinically significant inflammation or infection within six (6) months prior to study. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material. Intolerance or hypersensitivity to topical anesthetics, Specifically known intolerance or hypersensitivity to contact lenses. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>bilateral post refractive surgery subject | |

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
-----------------
refractive surgery
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant

Study Overview
=================
Brief Summary
-----------------
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned. The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).

Official Title
-----------------
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Procedure: craniectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter Exclusion criteria: - Patient who does not accept to take part in the study after being informed
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| craniectomy<br>craniectomy | Procedure: craniectomy<br>* craniectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explantation rate after 2 years of follow-up | The main objective of the study is to measure the explantation rate after the implantation of a Custombone TM prosthesis. We will measure the number of patients whose prosthesis has an been removed, with or without any relationship with the implant or the procedure | 24 months after implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cranial prosthesis
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the benefits of Exercising Together-a partnered strength training program for married couples coping with prostate cancer- on the physical and emotional health of prostate cancer survivors and their spouse and on marital quality.

Official Title
-----------------
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Randomized Exercise Intervention
* Behavioral: Randomized Exercise Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria For PCS: Received treatment for histologically confirmed prostate cancer Not currently undergoing radiation therapy or chemotherapy for prostate cancer Currently residing with an identifiable spouse willing to participate 60 years and older at enrollment Inclusion Criteria for Spouses: Currently residing with prostate cancer survivor Exclusion Criteria for prostate cancer survivor and Spouses: Current participation in moderate/vigorous intensity resistance training 2 or more hours per week Cognitive difficulties that preclude answering the survey questions, participating in performance tests, or giving informed consent Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise Unwillingness to be randomized

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercising Together<br>Partnered progressive resistance exercise | Behavioral: Randomized Exercise Intervention<br>* The Exercising Together training group will participate in 6 months of supervised, progressive partnered resistance exercise. Couples will participate in 2 exercise sessions a week for 6 months.<br>|
| Placebo Comparator: Usual Care<br>Usual Care Control | Behavioral: Randomized Exercise Intervention<br>* Couples will continue doing their usual daily activities for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function |  | baseline, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marital quality |  | 0,3,6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized clinical trial, prostate cancer, partnered exercise
Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, non-randomized, retrospective study to collect long term (4 years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05 study (NCT00466804) to evaluate participant and graft survival.

Official Title
-----------------
A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)

Conditions
-----------------
Cardiac Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects previously enrolled in the CTOT-05 study Subjects 4 years post-transplant (+/- 6 months). Exclusion Criteria: 1. Withdrawal of consent from the CTOT-05 study.
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 |
| --- | --- | --- |
| Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading | Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT) | 48 months (+/- 6 months) after primary transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of death |  | 48 months (+/- 6 months) after primary transplantation | 
| Incidence of re-transplantation or re-listed for transplantation |  | 48 months (+/- 6 months) after primary transplantation | 
| Incidence of coronary stent |  | 48 months (+/- 6 months) after primary transplantation | 
| Incidence of myocardial infarction |  | 48 months (+/- 6 months) after primary transplantation | 
| Incidence of clinical evidence of CAV per ISHLT grading | Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT) | 48 months (+/- 6 months) after primary transplantation |