linjc16/ctgov huggingface dataset:
Impact of Screening Patients With HIV for Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The Infectious Disease Society of America has recently recommended that patients with Human Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening involves non-invasive urine and blood test and a screening program has already been initiated here in the University of Mississippi HIV clinic. This study looks at the effect of this new screening program. Our Hypothesis is that screening for kidney disease is a cost effective and important addition to the care of patients with HIV.

Detailed Description
-----------------
The Infectious Disease Society of America has recently recommended that patients with Human Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening involves non-invasive urine and blood test and a screening program has already been initiated here in the University of Mississippi HIV clinic. However nobody knows for sure whether this will help doctors take better care of patient with HIV. This study looks at the effect of this new screening program. We want to see how frequently abnormalities are seen on screening, how frequently certain kidney diseases are diagnosed, how often patients are referred to a nephrologist and how often a patient's management is changed by the screening. We will also estimate the cost-benefit ratio of the screening. We will review patient charts to determine what has happened in each case where screening was conducted. This study will not involve any additional testing. The benefit of this study will be improving our understanding of kidney disease in HIV. It will help us determine the value of screening for kidney disease and the frequency of certain kidney diseases in HIV in our clinic population.

Official Title
-----------------
Impact of Screening Patients With HIV for Kidney Disease

Conditions
-----------------
HIV Infections, Renal Insufficiency, Chronic, Proteinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with HIV who are seen by the University of Mississippi Infectious disease clinic at the Jackson Medical Mall or patient seen at the University of Mississippi Nephrology Clinic.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Clinical Evaluation of Cordio App in Adult ADHF Patients

Study Overview
=================
Brief Summary
-----------------
Observational study on ADHF patients at one site in Israel. After signing informed consent and undergoing screening assessments, eligible patients will record sentences into a smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital: admittion, release. Before hospital release, if applicable and upon patient agrreement, an app will be installed in a smartphone in order to continue the recording at home.

Official Title
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Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Cordio App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ADHF (pulmonary congestion) Known diagnosis of HF, with either preserved or reduced LVEF. 18+ years old. Able to understand and provide written informed consent. Exclusion Criteria: Subjects unable to comply with the daily use of the application due to mental disorders. GFR <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis. Subjects with congenital heart disease or mechanical right heart valve(s). Airway and lung infection and Sepsis Patients with severe alcohol or drug use. Women who are pregnant or lactating.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cordio App|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter) | Anyalysis of voice recordings; admission vs. discharge | 5 years |
Autotaxin: a Potential Biomarker for Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to test the efficiency of Autotaxin (ATX) as a biomarker for breast cancer patients. The main questions it aims to answer are; is ATX a reliable tumor marker for breast cancer patients in diagnosis can ATX differentiate cancer patients from non-cancer ones

Detailed Description
-----------------
80 breast cancer patients and 30 normal patients with no known cancer history were enrolled in this study. All patients were female. The mean ages of cancer patients were 58.2 and 52.7 consecutively for cancer and non-cancer patients. The mean serum ATX levels of cancer and non-cancer patients were 1570.72 and 121.86 ng/mL consecutively (p=0.001). The cut-off value of ATX serum level was 178.49ng/mL according to the ROC analysis. The area under the ROC curve was 0.901showing that ATX is very efficient in distinguishing between two diagnostic groups (diseased/normal). ATX also showed good correlations with known tumor markers (CEA, CA15-3, CA125 levels). ATX levels were still higher than the cut-off value even in cancer patients with normal or low classical tumor marker levels.

Official Title
-----------------
Is Autotaxin a Promising Biomarker for Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Biological: measurement of serum autotaxin serum level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders. Exclusion Criteria: Patients with benign breast diseases and no known cancer history.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Breast Cancer Patients<br>Group of patients with verified breast cancer diagnosis | Biological: measurement of serum autotaxin serum level<br>* autotaxin expression<br>|
| Sham Comparator: Non-Cancer patients<br>Group of healthy patients with no verified any type of cancer. | Biological: measurement of serum autotaxin serum level<br>* autotaxin expression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autotaxin as a tumor marker | Diagnostic value of Autotaxin in breast cancer | preoperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, autotaxin, tumor marker
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in the attention commonly reported by patients with more advanced Parkinson's disease (PD) and Lewy body disease (LBD).

Detailed Description
-----------------
The main aims of this study are: 1. To investigate whether in PDD and DLB th specific disturbances in the basal ganglia thalamocortical network, measured through the Electroencephalography (EEG) frequency analysis, are ameliorated by armodafinil. Our main hypothesis is that armodafinil can restore the attention and improve cognitive disturbances in PDD and DLB, through a specific effect on striatal-thalamo-cortical activity.

Official Title
-----------------
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Conditions
-----------------
Parkinsons Disease, Lewy Bodies Disease

Intervention / Treatment
-----------------
* Drug: Armodafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established criteria for diagnosis of PDD (Parkinsons Disease) {Emre M et al. Mov Disord 2007;22:1689-707} and DLB (Lewy Bodies Disease) {McKeith et al. Neurology 2005;65:1863-72} Mini Mental State Examination (MMSE) score between <24; and/or Dementia Rating Scale-2 (DRS-2) score <134; Clinical Assessment of Fluctuation (CAF)>4; Stable anti-parkinsonian medication in the 4 weeks preceding the study Exclusion Criteria: Use of cognitive enhancers (Donepezil, Rivastigmine, Galantamine, Modafinil, Memantine) in the last 4 weeks: Concomitant use of any medication contraindicated with modafinil/armodafinil; History of alcohol and substances abuse. Use of medications known to alter the normal EEG activity in humans during the study period (i.e. clonazepam) History of psychiatric disorders, other than depression and psychiatric complication of PDD and DLB

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Armodafinil<br> | Drug: Armodafinil<br>* Armodafinil 150 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks) |  | 2 hours |
Prospective Randomized Trial Between WBRT Plus SRS Versus SRS Alone for 1-4 Brain Metastases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.

Detailed Description
-----------------
Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.

Official Title
-----------------
Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases

Conditions
-----------------
Brain Metastasis

Intervention / Treatment
-----------------
* Procedure: Whole-Brain Radiation Therapy, Stereotactic Radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more Exclusion Criteria: Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.

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

| Intervention/Treatment |
| --- |
|Procedure: Whole-Brain Radiation Therapy, Stereotactic Radiosurgery|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
-----------------
Whole Brain Radiation Therapy, Stereotactic Radiosurgery, Brain metastases
Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)

Study Overview
=================
Brief Summary
-----------------
Patients with malignancies are at high risk of developing a thromboembolic complication and their treatment with chemo- and or radiation therapy further enhances this risk. Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG) Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention. In this study we investigate the correlation between TEG measurements and thromboembolic events in patients with newly diagnosed malignancies. The hypotheses of this study are: Patients with malignancies and hypercoagulability, defined as a TEG MA>69 mm and /or R<4 min is at increased risk of developing thromboembolic complications as compared to those with a MA<69 mm and/or a R>4 min. Hypercoagulability and hence TEG R and MA values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.

Official Title
-----------------
Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cancer Exclusion Criteria: Mamma cancer

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombelastograph, Cancer, Thromboembolism, Hypercoagulable
Evaluation of Patient Analgesia After Bloc Serratus

Study Overview
=================
Brief Summary
-----------------
Thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the FIRST study). These thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis). The national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. The loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...). The anterior Serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology. The investigators perform this anterior Serratus block almost systematically in patients with thoracic trauma in the Hautepierre surgical intensive care unit.

Official Title
-----------------
Evaluation of Patient Analgesia After Bloc Serratus for the Management of Thoracic Trauma

Conditions
-----------------
Thorax Traumas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Gender (Male and Female) Patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior Serratus block analgesia from January 1, 2018 to February 28, 2019 Patient who has given his consent to the reuse of his data for the purposes of this research Criteria for non-inclusion: Patient who has expressed opposition to participating in the study Impossibility of giving the subject informed information (difficulties in understanding the subject,...) Subject under the protection of justice Subject under guardianship or curatorship

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 |
| --- | --- | --- |
| Retrospective analysis of analgesia after Bloc serratus |  | Files analysed retrospectily from January 1st, 2018 to February 28, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thorax trauma, head injury, Multi-modal analgesia, Paravertebral block, Thoracic epidural, Serratus Block
Corneal Epithelial Wound Healing Difference Between Human Autoserum and Cord Blood Serum

Study Overview
=================
Brief Summary
-----------------
Human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. However, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. The purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. Primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human serum and umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared between human serum and umbilical cord serum with ELISA kits.

Official Title
-----------------
Phase 1 Study of Comparison of the Effects on Promoting Corneal Epithelial Wound Healing Between Human Autoserum and Cord Blood Serum-in Vitro Cell Culture Experiment

Conditions
-----------------
Corneal Epithelial Wound Healing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women Cesarean section for labor Complete placenta with umbilical cord retained Healthy individual Exclusion Criteria: The retained placenta and umbilical cord were not complete Individual with anemia or other hematologic disorder unsuitable for blood donation
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 |
| --- | --- |
| 1<br>Corneal epithelial tissue with wound cultured in human autoserum | |
| 2<br>Corneal epithelial tissue with wound cultured in umbilical cord serum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell proliferation |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell migration |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal epithelial wound, Human autoserum, Cord blood
Using MRI in Patients With Non-dystrophic Myotonia to Access Muscle Contractility

Study Overview
=================
Brief Summary
-----------------
The aim of this project is (1) to investigate whether or not structural muscle abnormalities could be a consequence of the disorder and (2) to provide further clinical description of this rare phenotype. To do so, the investigators will (1) use Dixon MRI to quantify fatty infiltration in muscle tissue and compare it to muscle strength measurements from isometric dynamometry in order to access contractility and (2) describe the myotonic phenotype with simple squeeze test and questionnaires.

Detailed Description
-----------------
Non-dystrophic myotonias are rare genetic diseases in which the membrane excitability is altered by mutations in genes encoding muscle ion channels. Patients suffer from myotonic stiffness, pain, fatigue and sometimes paralysis. Non-dystrophic myotonia is distinct from myotonic dystrophies with the absence of muscle degeneration. Paramyotonica congenita is characterzied by paradoxial myotonia, which, in contrast to the more common myotonia congenita, is myotonic stiffness that worsens with activity. Typically, the first few contractions seem normal, whereas repetition leads to severe stiffness. Our hypophysis is that these patient might also suffer from muscle degeneration.

Official Title
-----------------
Using MRI to Quantify Fatty Infiltration in Muscle Tissue, and Compare it to Isometric Muscle Strength Measurements and (2) Use Questionnaires, Systemic Interview and Simple Myotonic Bed-side Tests to Describe the Phenotype.

Conditions
-----------------
Paramyotonia Congenita, Nondystrophic Myotonia

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Diagnosed with non-dystrophic myotonia Exclusion Criteria: MRI contraindications

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

| Intervention/Treatment |
| --- |
|Other: MRI|Using MRI for fat fraction and Biodex for isometric strength|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractile properties | Contractility = strength (kg) divided with cross sectional area of the muscle (CCSA) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Peak torque (maximal contraction in kg) accessed from isometric dynamometry | 1 year | 
| Cross sectional area (CCSA) | By using MRI to visualize the muscle | 1 year |