linjc16/ctgov huggingface dataset:
Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The severity of minimal dialysis disequilibrium syndrome (DDS) is currently detected and graded clinically using clinical criteria. Bispectral Index (BIS), an electroencephalographic (EEG) derived parameter is widely used in anesthesia and Critical Care setting to detect effects of anesthetic/hypnotic drugs. The aim of our study was to assess the discriminative power of BIS monitoring to accurately detect DDS.

Detailed Description
-----------------
Design: A consecutive, clinical, validation study. Setting: Medical University of Graz (Graz, Austria). Patients: Twenty consecutive patients undergoing first hemodialysis are enrolled at Medical University of Graz, Haemodialysis Unit. Agitated patients or patients who fell asleep during the recording are excluded from the final analysis. During the first dialysis session of approximately 3 h, patients were observed for signs of disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual impairments or cramps. Accordingly patients were divided into 2 groups; the DDS group of patients who experienced one of the DDS symptoms of headaches, dizziness, nausea, vomiting, become obtunded, have visual impairments or cramps and patients who do not experience any of the DDS symptoms in the non-DDS group An assigned nephrologist will assess the physical and mental status of the patients.

Official Title
-----------------
The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)

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

Intervention / Treatment
-----------------
* Device: recording of Bispectral Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First Time renal Dialysis Exclusion Criteria: subjects' consumption of sedatives/hypnotics psychotropic drugs, or concomitant neurological disorders affecting mental state such as hepatic encephalopathy, stroke, stupor or dementia and renal transplant patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: recording of Bispectral Index|recording of Bispectral Index|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Bispectral Index value | Interpatient Change in the value of recorded Bispectral Index between patients undergoing first time hemodialysis (differences between patients) and intrapatient (differences in bispectral Index values between the first 3 hemodialysis sections of each recruited patient) | Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis. |
Mesenchymal Stem Cells in Central Nervous System injury2017

Study Overview
=================
Brief Summary
-----------------
Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.

Official Title
-----------------
Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017

Conditions
-----------------
Central Nervous System Injury

Intervention / Treatment
-----------------
* Drug: UCMSCC
* Drug: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CNS injury > 3 months age > 18 years willing to give consent stable vital signs absence of active infectcion Exclusion Criteria: any contradiction to intrathecal infusion age < 18 years CNS injury < 3 months CNS injury > 3 years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC<br>infusion of aUCMSC and conventional therapy | Drug: UCMSCC<br>* infusion of aUCMSC and conventional therapy<br>Drug: conventional treatment<br>* conventional treatment<br>|
| Active Comparator: conventional<br>conventional therapy | Drug: conventional treatment<br>* conventional treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| life quality score |  | 1y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 1y |
Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis. The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home. Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.

Official Title
-----------------
Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study

Conditions
-----------------
Arthritis, Rheumatoid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with RA ≥ 12 months DAS28-CRP < 5,1 Age between 18 and 85 years Computer and Internet connection at home Exclusion Criteria: Blood samples (creatinine, haemoglobin) outside the reference limits +/- 5 % at screening Blood samples (thrombocytes and leukocytes) outside the reference limit -/+ 15 % at screening Blood samples (ALAT) outside the reference limit -/+ 100 % at screening Dementia or other linguistic/cognitive/physical deficiency that prevents participation Vision impairment that prevents the use of the devices and computer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness | Intrarater reliability: day 1-3 and 56-58. Criterion validity: day 1 Responsiveness: day 1-56 | Day 1,3,56 and 58 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standford Health Assessment Questionnaire Disability Index (HAQ-DI) | Criterion validity: day 1. Responsiveness: day 1-56 | Day 1 and 56 | 
| PainDetect Questionnaire (PDQ) | For subgroups analysis | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reproducibility of Results
Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Study Overview
=================
Brief Summary
-----------------
This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement. The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.

Official Title
-----------------
A Single-center, Long-term, Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Conditions
-----------------
Penile Enhancement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits. Exclusion Criteria: Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation. Subjects deemed as ineligible to participate by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline | Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied). | 18 months | 
| Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline | Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied). | 24 months |
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)

Study Overview
=================
Brief Summary
-----------------
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)

Official Title
-----------------
Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Zyvox® / Linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Hospitalized/chronic care pediatric patients (birth through 17 years) Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections Requires a minimum of 3 days of IV medication Patients with mixed infections due to VRE & gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required. Exclusion Criteria: Potentially effective concomitant antibiotic A high surgical cure rate Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved) Having an infected device that could not be removed

Ages Eligible for Study
-----------------
Maximum Age: 17 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

| Intervention/Treatment |
| --- |
|Drug: Zyvox® / Linezolid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's and sponsor's evaluation of patient clinical outcome. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacia, Drug Resistance, Microbial
Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

Study Overview
=================
Brief Summary
-----------------
Irrigated catheter for ablation of isthmus-dependent atrial flutter

Detailed Description
-----------------
This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter

Official Title
-----------------
Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: Cardiac Ablation (Gen2 Cardiac Ablation System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for ablation of isthmus-dependent atrial flutter Exclusion Criteria: Prior ablation of isthmus-dependent atrial flutter Atypical or scar flutter Significant heart disease Intracardiac thrombus Prior cardiac surgery (within 1 month) Contraindication to heparin

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Gen2 Cardiac Ablation System)<br>Ablation of isthmus-dependent atrial flutter | Device: Cardiac Ablation (Gen2 Cardiac Ablation System)<br>* Ablation of isthmus-dependent atrial flutter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraprocedural, serious cardiac adverse event | Defined as the Incidence of intraprocedural, serious cardiac adverse event | 7 days post-procedure |
To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

Study Overview
=================
Brief Summary
-----------------
The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015 to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion criteria will be included in the study and will be categorized and evaluated. The patient will followed over a period of 3 months.

Official Title
-----------------
To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

Conditions
-----------------
Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients presenting to hospital with bilirubin ≥5 and INR≥1.5 Cirrhosis with or without Decompensation presenting with acute deterioration in less than 3 month Exclusion Criteria: Cirrhosis with chronic decompensation. Patient on anticoagulant Hepatocellular carcinoma Septic shock Post-liver transplant or resection

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 |
| --- | --- |
| Severe acute hepatitis<br>Severe acute hepatitis without ascites. | |
| Non-cirrhotic<br> | |
| Cirrhotic patients with ascites<br> | |
| decompensated cirrhosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 3 months | 
| total number of patients underwent Transplantation |  | 3 months | 
| Mortality |  | 3 months | 
| Number of patients develop liver failure. |  | 3 months | 
| Number of patients develop SIRS (Systemic Inflammatory Response Syndrome). |  | 3 months | 
| Number of patients develop sepsis. |  | 3 months |
Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)

Study Overview
=================
Brief Summary
-----------------
Gene fusions are defined as two separate genes joined together (gene 1, gene 2), generating a novel fusion gene. NRG1 fusions are rare and complex with regard to the fusion/fusion partner. The specific NRG1 gene fusion will be identified by a specialized molecular testing lab.

Detailed Description
-----------------
Afatinib is provided on a single-patient protocol basis to patients suffering from tumors harboring NRG1 fusions, a disease for which no satisfactory authorised alternative therapy exists. In the context of this mechanism it is planned to collect and analyze limited clinical data in order to investigate the safety and efficacy of afatinib in patients with advanced and/or metastatic solid tumours harboring NRG1 gene fusions.

Official Title
-----------------
Assessment of Prospective Real-world Outcomes Based on Single-patient Protocol Data Collection of Afatinib (GILOTRIF®) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: afatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria to participate in this program: Confirmed diagnosis of an advanced, unresectable and/or metastatic tumor harboring NRG1 gene fusions characterized as follows: Gene 1: NRG1 (prerequisite: conservation of the epidermal growth factor (EGF) domain - this will be identified by the lab performing the molecular testing) Gene 2: All fusion partners are allowed (prerequisite: the region must be a coding region - this will be identified by the lab performing the molecular testing) Patient must have measurable or evaluable lesions (according to RECIST 1.1). At least 18 years of age at the time of consent. Exclusion Criteria: Treatment with a systemic anti-cancer therapy or investigational drug within 14 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication. Tumors carrying additional gene mutations other than NRG1 fusion where FDA-approved targeted therapy is available Prior treatment with a therapy targeting erythroblastic leukemia viral oncogene homologue receptors (ErbB) Any patient considered ineligible by the treating physician.

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 |
| --- |
|Drug: afatinib|afatinib|

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
-----------------
NRG1 fusion
Screening for Fabry Disease in a Pediatric Population at Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the frequency of Fabry disease in children with chronic abdominal pain or chronic pain in the extremities

Conditions
-----------------
Chronic Pain in the Extremities, Chronic Abdominal Pain, Fabry Disease

Intervention / Treatment
-----------------
* Other: Screening for Fabry disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age below 18 years One of the following criteria: Diagnosis or suspicion of a rheumatological disorder with recurrent complaints for more than 6 months Chronic, recurrent abdominal pain for more than 6 months Planned blood sample for routine diagnostics Written informed consent Exclusion Criteria: - Patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Screening population<br> | Other: Screening for Fabry disease<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Fabry disease |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Fabry disease in predefined sub-populations |  | day 1 |