linjc16/ctgov huggingface dataset:
Influence Continuous Veno-venous Hemodialysis the Autoregulation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to characterize the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.

Detailed Description
-----------------
Patients at the intensive care unit who suffered acute renal failure with the need of continuous veno-venous hemodialysis will be investigated with continuous veno-venous hemodialysis and in a time window without continuous veno-venous hemodialysis to investigate the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.

Official Title
-----------------
Influence of Continuous Veno-venous Hemodialysis on Cerebrovascular Autoregulation in Patients With Acute Renal Failure

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

Intervention / Treatment
-----------------
* Procedure: continuous veno-venous hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute renal failure need for continuous veno-venous hemodialysis age >18 Years Exclusion Criteria: Sepsis Preexisting cerebral illness traumatic brain injury Meningitis or encephalitis Pregnancy

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 |
| --- | --- |
| acute renal failure<br>patients at intensive care unit with definition of acute renal failure and the need for continuous veno-venous hemodialysis | Procedure: continuous veno-venous hemodialysis<br>* continuous veno-venous hemodialysis<br>* Other names: CVVHD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline cerebrovascular autoregulation to cerebrovascular autoregulation during continuous veno-venous hemodialysis | Is there an influence of continuous veno-venous hemodialysis at the cerebrovascular autoregulation, which would be a side effect with limiting use in patients with brain injury or the need of intensive monitoring of cerebral perfusion pressure in this patients. | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute renal failure, cerebrovascular autoregulation, transcranial Doppler, continuous veno-venous hemodialysis
A Working Memory Training in Burnout Patients

Study Overview
=================
Brief Summary
-----------------
Burnout patients show deficient working memory functioning. Several studies showed a training can increase working memory capacity. In the current study we explored whether training working memory can reduce burnout and burnout related symptoms and increase working memory capacity.

Conditions
-----------------
Burnout

Intervention / Treatment
-----------------
* Behavioral: Working memory training
* Behavioral: Placebo training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undifferentiated somatoform disorder with a work related cause Exclusion Criteria: age which exceeded the range of 18 to 67 years a severe major depressive episode substance dependence or abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Working memory training<br> | Behavioral: Working memory training<br> <br> |
| Placebo Comparator: Placebo training<br> | Behavioral: Placebo training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Utrechtse Burnout Scale (UBOS) score on pre and post training and two months after training | The Dutch translation of the Maslach Burnout Inventory - General Survey (Schaufeli, Leiter, Maslach, & Jackson, 1996), the Utrechtse Burnout Scale-A, measures the severity of burnout symptoms. | Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Failure Questionnaire (CFQ) score on pre and post training and two months after training | The Cognitive Failure Questionnarie measures the frequency of participants' experienced cognitive failures regarding memory, action, perception and attention. | Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burnout, working memory, working memory training, cognitive behavioral therapy, executive control
Study of Oral AEE788 in Adults With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.

Official Title
-----------------
A Phase I/II, Multicenter, Randomized Dose-Escalation Study of Oral AEE788 on Intermittent Dosing Schedules in Adult Patients With Advanced Cancer (Effective Amendment 5) Previously Entitled A Phase IA, Multicenter, Dose-Escalating Study of Oral AEE788 on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Cancer

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

Intervention / Treatment
-----------------
* Drug: AEE788


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed solid tumor Adequate hematologic, renal and hepatic function Age ≥ 18 years Karnofsky performance status score ≥ 70% Life expectancy ≥ 12 weeks Exclusion Criteria: Active brain metastases Peripheral neuropathy > grade 2 Diarrhea > grade 1 Gastrointestinal (GI) dysfunction Compromised cardiac function Concurrent severe and/or uncontrolled medical conditions

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Continuous daily dosing | Drug: AEE788<br> <br> |
| Experimental: 2<br>Monday, Wednesday, Friday Dosing | Drug: AEE788<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum-tolerated dose and dose-limiting toxicity of AEE788 |  | 4.5 years | 
| Maximum-tolerated dose, safety and tolerability of AEE788 |  | 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose and repeated dose pharmacokinetic profile of AEE788 |  | 4.5 years | 
| Pharmacodynamic effects |  | 4.5 years | 
| Changes in glucose metabolism/cell viability |  | 4.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR, Advanced cancers, Her2, VEGFR
BIS Monitoring in Relation to Muscle Relaxant Administration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the overall optimal timing of when the Bispectral Index (BIS) monitor should be started: before or after the muscle relaxant is given.

Official Title
-----------------
Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration

Conditions
-----------------
Cardiovascular Surgery, Bispectral Index, Anesthesia

Intervention / Treatment
-----------------
* Device: Bispectral Index (BIS) monitoring system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing elective cardiac surgery Muscle relaxation administration by rocuronium Exclusion Criteria: Patient refusal Pediatric patients Emergency procedure Patients with known or suspected carotid or cerebrovascular disease Patients with prior stroke Skin condition or anatomy preventing proper sensor placement Patients who receive ketamine during the study timeframe

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 |
| --- | --- |
| BIS Monitoring<br>Subjects will have BIS sensors applied to forehead | Device: Bispectral Index (BIS) monitoring system<br>* Left and right sensors to record EEG activity and muscle reaction to anesthesia utilized in the operating room by anesthesia providers to assess the depth of sedation in patients with anesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS Values | Parameters measured from both left and right BIS sensors. BIS monitor algorithm to process EEG information second by second and outputs a number (0-100) that corresponds with a patient's level of consciousness. A level of 0 indicates no EEG activity; a level of 100 indicates awake EEG activity. | 25-minute period in the operating room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIS, Paralysis
Survival Rates of Patients With Mobile Bearing Total Knee Arthroplasty After 10 Years

Study Overview
=================
Brief Summary
-----------------
The total knee replacement has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models. In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses.

Conditions
-----------------
Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Patients wearing total knee prosthesis with mobile plate for over 10 years Exclusion Criteria: Patients under 18 years

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 |
| --- | --- | --- |
| Compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses. |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Replacement, Prosthesis, Mobile-bearing
CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension. The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.

Detailed Description
-----------------
Obstructive Sleep Apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of CPAP treatment on BP. But only few studies have raised data about the effect of CPAP treatment on BP in patients with resistant hypertension. Hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension. The purpose of this study is to demonstrate that OSA has a major impact in resistant hypertension, whose effects on BP and arterial stiffness can partially be reversible with CPAP treatment.

Official Title
-----------------
Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension

Conditions
-----------------
Hypertension, Resistant to Conventional Therapy, Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents Patient with severe OSA (apnea-hypopnea index > 30 or > or equal to 15 with excessive daytime sleepiness), or with mild to moderate OSA without excessive daytime sleepiness, or without OSA. Ambulatory patient Exclusion Criteria: Body mass index ≥40 kg/m2 Other identifiable causes of hypertension Contraindication to CPAP treatment or patient already treated with CPAP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring |  | 6 months from baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSA prevalence in patients with resistant hypertension |  | 6 months | 
| BP variability assessed by home self BP measurments |  | 6 months | 
| Arterial stiffness assessed by pulse wave velocity and QKD interval |  | 6 months | 
| Antihypertensive treatment consumption |  | 6 months | 
| CPAP treatment observance |  | 6 months |
To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers

Official Title
-----------------
An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Male Volunteers

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: DWN12088
* Drug: Nebivolol
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male adults aged ≥ 20 and ≤ 55 years at screening Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information Exclusion Criteria: Subjects unable to have the standard meal provided at the study site Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWN12088 and Nebivolol<br>Period 1 - Nebivolol A mg, Tablet, oral, once daily, Period 2 - DWN12088 X mg, Tablet, oral, twice daily, Period 3 - 1) Nebivolol A mg, Tablet, oral, once daily & DWN12088 X mg, Tablet, oral, twice daily, 2) DWN12088 X mg, Tablet, oral, once daily | Drug: DWN12088<br>* Prolyl-tRNA synthetase (PRS) inhibitor<br>Drug: Nebivolol<br>* Nebivolol<br>|
| Experimental: DWN12088 and Paroxetine<br>Period 1 - DWN12088 X mg, Tablet, oral, once daily , Period 2 - Paroxetine B mg, Tablet, oral, once daily, Period 3 - 1) DWN12088 X mg, Tablet, oral, once daily & Paroxetine B mg, Tablet, oral, once daily, 2) Paroxetine B mg, Tablet, oral, once daily | Drug: DWN12088<br>* Prolyl-tRNA synthetase (PRS) inhibitor<br>Drug: Paroxetine<br>* Paroxetine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Nebivolol | Cmax of Nebivolol | Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8 | 
| AUCt of Nebivolol | AUCt of Nebivolol | Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8 | 
| Cmax of DWN12088 | Cmax of DWN12088 | Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12 | 
| AUCt of DWN12088 | AUCt of DWN12088 | Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12 |
Cryptogenic Stroke Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.

Official Title
-----------------
Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke

Conditions
-----------------
Cryptogenic Stroke

Intervention / Treatment
-----------------
* Device: Sleuth AT Implantable ECG Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours. Negative brain image for hemorrhagic stroke In sinus rhythm at time of enrollment Exclusion Criteria: Know history of atrial fibrillation Previous implanted cardiac device (ppM or ICD) Serious illness making it unlikely to survive one year Known secondary cause of stroke

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Sleuth AT Implantable ECG Monitoring System|The study device provides monitoring only. It cannot provide intervention or treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of atrial fibrillation at one year from Sleuth implantation. |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECG, cardiac monitor, loop recorder, stroke, Implantable Loop Recorder, cryptogenic, ILR
Sunbit UV Measuring Device to Track Sun Behavior

Study Overview
=================
Brief Summary
-----------------
Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit.

Detailed Description
-----------------
A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks. After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be extracted and analyzed. Patients will be recruited in the Department of Dermatology of the University Hospital Zürich. The target population comprises patients with a high risk of melanoma and non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to organ transplantation.

Official Title
-----------------
An Observational Single Center Pilot Study Using a Wearable UV Sensor (Sunbit) Measuring UV Exposure of Patients at High Risk for Skin Cancer - SUNBIT Study

Conditions
-----------------
Immunosuppression, Skin Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years History of skin cancer (melanoma or NMSC) or patients with high risk of skin cancer (e.g. immunosuppressive therapy) Oral and written informed consent Exclusion Criteria: Any medical condition that renders the patient bedridden for the duration of 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| number of days wearing the device | patient compliance | after 4 weeks wearing the device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between measured UV Indices and reference values | technical accuracy of the device | after 4 weeks wearing the device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sun behavior, immunosuppression, skin neoplasms, sunbit, uv sensor, uv dosimeter, solar radiation, uv exposition, uv index