linjc16/ctgov huggingface dataset:
Clearance of Inflammatory Cytokines During Renal Replacement Therapy Using the EMIC®2 Filter

Study Overview
=================
Brief Summary
-----------------
This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy. The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.

Detailed Description
-----------------
In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor.

Official Title
-----------------
Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter

Conditions
-----------------
Acute Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (≥18 years) in the Critical Care Unit with AKI and sepsis clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is necessary Exclusion Criteria: lack of consent pre-existing dialysis dependent renal failure life expectancy <24 hours patients with haemoglobin <7g/dL (unless transfused for clinical reasons) need for extracorporeal membrane oxygenation (ECMO)

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 |
| --- | --- | --- |
| Removal of inflammatory mediators | Clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adsorption of inflammatory mediators | Adsorption of IL-1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor | 48 hours |
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance imaging (MRI) scans as the main measure.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: SB683699


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of multiple sclerosis (MS). Expanded Disability Status Score 0 - 6.5. One or more relapse of MS in previous 12 months. Currently not taking any medications for MS (apart from those used to treat symptoms). Exclusion criteria: Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results. Subjects who cannot have MRI scans. Women who are pregnant, breast feeding or planning to become pregnant during the study.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB683699|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new gadolinium-enhancing lesions on monthly MRI scans |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of other lesion types on MRI |  |  | 
| Number of relapses during treatment |  |  | 
| Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC) |  |  | 
| Circulating lymphocyte and neutrophil counts |  |  | 
| Health Outcomes: MSIS-29, Employment status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, relapsing, remitting, Relapsing-Remitting MS (RRMS)
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Study Overview
=================
Brief Summary
-----------------
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.

Detailed Description
-----------------
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Official Title
-----------------
A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Rapamune® (Sirolimus)
* Drug: Tacrolimus
* Drug: Corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria At least 18 years of age End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months Exclusion criteria Planned antibody induction Multiple organ transplants Patients at high risk of acute rejection

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

| Intervention/Treatment |
| --- |
|Drug: Rapamune® (Sirolimus)|nan|
|Drug: Tacrolimus|nan|
|Drug: Corticosteroids|Perioperative|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft function as measured by calculated creatinine clearance at month 6 post-transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy. |  |  |
Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer may help doctors learn more about the disease and plan the best treatment. PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.

Detailed Description
-----------------
OBJECTIVES: To examine the association of secondary lymphedema, symptoms, functional status, and quality of life after treatment in patients with head and neck cancer. To examine the possible factors contributing to the development of secondary lymphedema in these patients. OUTLINE: Participants undergo a physical and external (e.g., submental area) and internal (e.g., larynx, pharynx, and oral cavity) lymphedema examination. Demographics, background, and lymphedema treatment information are also collected. Participants' medical records with head and neck cancer information and treatment are reviewed. Participants complete surveys on Vanderbilt Head and Neck Symptom (VHNSS), Lymphedema Symptom Intensity and Distress Survey Head and Neck (LSIDS-HN), Functional Assessment Cancer Therapy-Head Neck (FACT-HN), Quality of Life Scale, Hospital Anxiety and Depression Scale (HADS), and Body Image Scale.

Official Title
-----------------
The Impact of Secondary Lymphedema After Head and Neck Cancer Treatment on Symptoms, Functional Status, and Quality of Life

Conditions
-----------------
Cancer Survivor, Head and Neck Cancer, Lymphedema

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with head and neck cancer At least 3 months since completion of head and neck cancer treatment Participating in the Pain and Symptom Management Program at the Vanderbilt-Ingram Cancer Center No current evidence of cancer No metastatic disease PATIENT CHARACTERISTICS: No other active cancer Able to understand informed consent PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent chemotherapy or radiotherapy

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 |
| --- | --- | --- |
| Association between the severity of lymphedema with symptoms, functional status, and quality of life |  | Cross-sectional | 
| Factors contributing to the development of secondary lymphedema |  | Cross-sectional Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer survivor, lymphedema, head and neck cancer
Elastography in Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.

Detailed Description
-----------------
Aims: Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population. Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA. Patient selection: Inclusion criteria: Age > 18 yr. Recruitment in Endocrinology Clinics. Nodular goiter. Multinodular goiter with dominant nodule > 1 cm. Exclusion criteria: Toxic nodules Non-accessible nodules to US or FNA Cystic nodules Nodules with calcifications in egg rind Contraindication for FNA

Official Title
-----------------
Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

Conditions
-----------------
Nodular Goiter, Thyroid Cancer

Intervention / Treatment
-----------------
* Device: Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yr. Recruitment in Endocrinology surgery. Nodular goiter. Multinodular goiter with dominant nodule > 1 cm. Exclusion Criteria: Toxic nodules Non-accessible nodules to US or FNA Cystic nodules Nodules with calcifications in egg rind Contraindication of FNA

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Goiter<br>Patients with nodular goiter | Device: Elastography<br>* Performance of US, elastography and FNA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of elastography for thyroid cancer | Sensitivity, specifity, predictive values | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elastography, thyroid nodule, fine-needle aspiration
The Chinese Mutation Hotspot of ENaC Causing Liddle's Syndrome and the Association of ENaC Variations and Hypertension

Study Overview
=================
Brief Summary
-----------------
The variations of ENaC have an impact on the degradation of epithelial sodium channels and sodium reabsorption, and thus are associated with hypertension and hypokalemia. Liddle's syndrome is a rare monogenic form of autosomal-dominant hypertension caused by truncating or missense mutations in the C-termini of epithelial sodium channel β- or γ-subunit encoded by SCNN1B or SCNN1G. Our purpose is to determine the hotspot of mutation causing Chinese Liddle's syndrome. The second purpose is to determine wether the polymorphisms of ENaC are associated with hypertension in Chinese. Some polymorphisms of ENaC associated with hypertension may be genetic risk factors for Chinese hypertension.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypertension and Liddle's syndrome Clinical diagnosis of normal controls with no cardiovascular disease Exclusion Criteria: Hypertension caused by other single gene mutation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, ENaC, Liddle's syndrome, variation
Comparison of Standard Versus Low Bicarbonate Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.

Official Title
-----------------
Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis

Conditions
-----------------
Chronic Kidney Disease, Metabolic Acidosis

Intervention / Treatment
-----------------
* Other: Low bicarbonate dialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months Age > 18 years Exclusion Criteria: Use of oral alkali within the previous month Hospitalization within the previous month Inability to provide written informed consent Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Low bicarbonate dialysis<br> | Other: Low bicarbonate dialysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in beta-hydroxybutyrate clearance | Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations | 1-2 weeks | 
| Change in lactate clearance | Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations | 1-2 weeks | 
| Post-dialysis pH |  | 1-2 weeks | 
| Post-dialysis bicarbonate |  | 1-2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bicarbonate, dialysis
Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Inositol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polycystic Ovary Syndrome Age >18 and <35 Exclusion Criteria: Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inositol<br>Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment | Drug: Inositol<br>* Inositol 4g/die for four months<br>|
| Placebo Comparator: Placebo<br>Patients will be randomized to receive placebo for four months | Drug: Placebo<br>* Placebo for four months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ CD28 null T-lymphocyte frequency |  | five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulinaemic area OGTT AUCi, lipid profile, androgen levels |  | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome, Cardiovascular risk, Metabolic Syndrome
Poznan Prospective Study of Type 1 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the development and progression of chronic complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular events) in patients with type 1 diabetes treated from the onset of the disease with recommended method of intensive insulin therapy. All patients attended a five-day structured training program during first hospitalization and re-education once year during the observation. After five years of observation and next - once a year chronic complications are assessed. The investigators would like to evaluate also the relationship of the management of the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory markers with development and progression of chronic complications.

Official Title
-----------------
Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease.

Conditions
-----------------
Microangiopathy, Macroangiopathy, Insulin Treatment Overcorrection, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed type 1 diabetes mellitus with features of complete insulin deficiency (serum C-peptide level <0.05 ng/ml, acetonuria, blood gases disturbances such as: pH <7.30, BE< -6 mmol/l, HCO3 <18 mmol/l) Age < 35 years old Educational course in intensive insulin therapy started at the onset of the disease after treatment of ketoacidosis Written consent Exclusion Criteria: Uncertain type of diabetes mellitus Kidney failure (serum creatinine level > 1.1 mg/dl) Liver dysfunction (AspAt > 31 U/l, AlAt > 34 U/l) Acute inflammatory process Other concomitant diseases (i.e. neoplasm)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Newly diagnosed diabetes mellitus type 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinopathy |  | 1 year | 
| Diabetic chronic renal disease |  | 1 year | 
| Neuropathy |  | 1 year | 
| Cardiovascular events | stroke, heart infarct, death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic management of diabetes | HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI | 1 year | 
| Quality of life |  | 1 year | 
| Intima media thickness |  | 1 year |