linjc16/ctgov huggingface dataset:
Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis

Study Overview
=================
Brief Summary
-----------------
This study's primary objective is to determine if continuous renal replacement therapy (CRRT) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows patients to receive intravenous voriconazole without the concern of SBECD accumulation.

Official Title
-----------------
Evaluation of Sulfobutylether-ß-cyclodextrin Sodium (SBECD) Accumulation and Voriconazole Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Conditions
-----------------
Fungal Infection

Intervention / Treatment
-----------------
* Drug: Voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are receiving continuous renal replacement therapy and are prescribed voriconazole therapy for the treatment or prophylaxis of a fungal infection. Exclusion Criteria: Patients expected to be on CRRT for < 5 days, Patients with Child-Pugh C cirrhosis, and Patients who are pregnant.

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 |
| --- | --- |
| Voriconazole<br>Pharmacokinetic Monitoring | Drug: Voriconazole<br>* Patients will be started on voriconazole 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h thereafter.<br>* Other names: Vfend;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine SBECD plasma and effluent concentrations | Evaluate SBECD pharmacokinetics (Cmax, Cmin, AUC, half-life, CL, seiving coefficient). Predict time to SBECD accumulation in study patients | Days 1-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Days 1-30 | 
| Determine Voriconazole and UK121-265 plasma and effluent concentrations | Voriconazole and UK121-265 Pharmacokinetics will be evaluated (Cmax, Cmin, AUC, elimination rate constant, half-life, CL, seiving coefficient) including determination and impact of any CYP2C19 mutations on plasma pharmacokinetic parameters | Days 1-7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voriconazole, SBECD, pharmacokinetics, Renal Failure
Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair

Study Overview
=================
Brief Summary
-----------------
Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal and central nervous system, and mortality ranging up to 5%. In our study, we tested the hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces postoperative morbidity and mortality and improves the outcome of the treatment of minilaparotomy AAA repair.

Detailed Description
-----------------
We investigate effects of a restricted fluid regime versus standard regimen on complications and hospital stay after minilaparatomy aortic aneurysm repair.

Official Title
-----------------
Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair

Conditions
-----------------
Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.

Intervention / Treatment
-----------------
* Procedure: Restrictive VS Standard Fluid Regime
* Drug: Drag: Crystalloids and Colloids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AAA more than 5,5 cm in diameter tube graft Exclusion Criteria: emargency comorbidity maligancy
Sexes Eligible for Study
-----------------
All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drag: Crystalloids and Colloids<br>Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour | Procedure: Restrictive VS Standard Fluid Regime<br> <br> |
| Experimental: Standard fluid regime<br>Drag: Crystalloids and Colloids Intraoperative 15 ml/kg/per hour, postoperative 150-200 ml/per hour | Drug: Drag: Crystalloids and Colloids<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of major and minor complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU and duration of Hospital stay |  | 30 days | 
| In-hospital mortality, 30-days mortality |  | 30 days | 
| Fluid balance (daily and cumulative) |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minilaparotomy, AAA, fluid regime
Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)

Study Overview
=================
Brief Summary
-----------------
Mass balance study of AT-527 in Healthy Male Subjects.

Detailed Description
-----------------
This is an open-label, single-dose study assessing the absorption, metabolism, excretion, and mass balance of [14C]-AT-527 in healthy adult male subjects.

Official Title
-----------------
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-AT-527 in Healthy Adult Male Subjects

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: AT-527 (R07496998)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 No clinically significant diseases captured in the medical history or clinically significant findings at screening physical examination. A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male). Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19 Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Other clinically significant medical conditions or laboratory abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Intervention Model: Single Group Assignment
Interventional Model Description: Open-Label, Single-Dose pharmacokinetic (PK) study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527 550 mg (R07496998)<br> | Drug: AT-527 (R07496998)<br>* Study participants will receive a single radiolabeled dose of 550 mg AT-527.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance | Total radioactivity recovery in urine and feces | Day 1 to Day 15 | 
| Mass Balance | Percent of radioactive dose excreted in urine and feces | Day 1 to Day 15 |
Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine if providing education on proper disposal of unused opioid medications to the orthopedic patient undergoing a planned hip or knee total joint replacement will increase the percentage of patients who properly dispose of unused opioids.

Official Title
-----------------
Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population

Conditions
-----------------
Knee Total Joint Replacement, Hip Total Joint Replacement

Intervention / Treatment
-----------------
* Behavioral: Education on disposal of opioids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 + years Planned total hip or knee replacement surgery English speaking Exclusion Criteria: Pediatric patients 17 and younger Non-English speaking patients Total joint replacement surgery other than Hip and Knee

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement. | |
| Experimental: Intervention Group<br>Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement will receive additional education about the disposal of opioids. | Behavioral: Education on disposal of opioids<br>* Current class curriculum including education about pain management with additional education about the disposal of opioids.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposal of unused prescription pain medication | Number of subjects to self-report disposal of unused prescription pain medication on the twelve week post operative visit survey | 12 weeks post operative | 
| Use of medication deactivation bag | Number of subjects to self-report disposal of unused prescription pain medication via the medication deactivation bag on the twelve week post operative visit survey | 12 weeks post operative |
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.

Official Title
-----------------
Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial

Conditions
-----------------
Quality of Life, Sexual Function, Urinary Incontinence, Anal Incontinence

Intervention / Treatment
-----------------
* Behavioral: Structured Rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients Exclusion Criteria: Older than 75 years Mentally or physically not able to participate Non curative surgical treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Structured Rehabilitation program<br> | Behavioral: Structured Rehabilitation program<br>* Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation<br>|
| No Intervention: Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38) |  | Baseline, 3, 6, 12,18 and 24 months postoperative. | 
| Quality of LIfe (EQ 5D) |  | Baseline, 3,6,12, 18 and 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St Marks incontinence |  | Baseline, 3, 12 and 24 | 
| ICIQ sexual function |  | baseline, 3,12 and 24 | 
| ICIQ Urinary function Short form |  | baseline,3, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary function, Anal function
Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Detailed Description
-----------------
For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Official Title
-----------------
A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms, Metastases

Intervention / Treatment
-----------------
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven adenocarcinoma of colon and rectum No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy Advanced, metastatic or recurrent not amenable to curative local therapy Measurable lesion(s) ECOG performance status 0 to 2 Normal marrow, hepatic and renal function Provision of written informed consent Exclusion Criteria: Active infection and/or severe comorbidity Known history of anaphylaxis of any origin

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate after FOLFIRI reintroduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
No prior chemotherapy
Evaluation of CIED Readers for Disease Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.

Detailed Description
-----------------
Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.

Official Title
-----------------
Evaluation of Cardiac Implanted Electronic Devices (CIED) Readers for Hospital Disease Management

Conditions
-----------------
Pacemaker Ddd, ICD

Intervention / Treatment
-----------------
* Device: CIED interrogation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a Medtronic CIED compatible with Medtronic CareLink Express being evaluated for heart failure, TIA/stroke or syncope able to read and speak English Exclusion Criteria: -CIED from other than Medtronic

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 |
| --- | --- |
| CIED subjects<br>CIED interrogation | Device: CIED interrogation<br>* CareLink Express interrogation<br>* Other names: Remote monitoring;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope | percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of minutes from transmission to analysis | number of minutes from CareLink Express interrogation to analysis | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote monitoring
SeQuent Please Neo Multicenter Registry

Study Overview
=================
Brief Summary
-----------------
The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success of the procedure and the preservation of vascular permeability.

Detailed Description
-----------------
The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal objective is to determine the success of the procedure and the preservation of vascular permeability.

Official Title
-----------------
SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO

Conditions
-----------------
Drug Coating Balloon (DCB), Sequent Please

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ISR in a coronary artery with a diameter stenosis of at least 70%, a length of the stented segment of <25 mm, and a vascular diameter of at least 2.5 and up to 3.5 mm Exclusion Criteria: There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Revascularization (TLR) with clinical follow-up at 12 months. | Target Lesion Revascularization (TLR) with clinical follow-up at 12 months. | From baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of balloon dilation. | Success of balloon dilation. | Baseline | 
| Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months. | MACE rate and MACE rate accumulated at 12 months. | From baseline to 12 months | 
| Premature follow-up indication | Premature follow-up indication | From baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug coating Balloon (DCB), Sequent Please