linjc16/ctgov huggingface dataset:
Use of Virtual Reality for Pelvic External Fixator Removal

Study Overview
=================
Brief Summary
-----------------
Assessing the role of virtual reality in decreasing pain and improving patient satisfaction in outpatient removal of pelvic external fixator constructs.

Official Title
-----------------
Use of Virtual Reality for Pelvic External Fixator Removal

Conditions
-----------------
Pelvic Fracture Pubic Rami Multiple - Unstable Closed

Intervention / Treatment
-----------------
* Other: Virtual Reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pelvis external fixator placed at study institution External fixator placed for pelvic instability Exclusion Criteria: Infected pin or pins Loose pin or pins Psych history

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of care, no Virtual Reality | |
| Experimental: Virtual Reality<br>Standard of care plus Virtual Reality | Other: Virtual Reality<br>* Utilizing Virtual Reality during external fixator removal in outpatient clinic setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain score during removal of external fixator | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Self reported patient satisfaction, comparing no virtual reality to virtual reality | immediately after procedure |
Psychological Factors in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.

Detailed Description
-----------------
If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.

Official Title
-----------------
Psychological Factors in Cardiac Surgery

Conditions
-----------------
Heart Conditions

Intervention / Treatment
-----------------
* Behavioral: Adverse event information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital Exclusion Criteria: Patients who have previously had cardiac surgery Cardiac surgery with deep hypothermia (<32 degrees Celsius) Acute surgery Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol Patients who do not speak/read Danish
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard adverse event information<br> | Behavioral: Adverse event information<br>* All patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon<br>|
| Other: Elaborated adverse event information<br> | Behavioral: Adverse event information<br>* All patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Assessed on day four | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Assessed on day 30, 90, and 180 | 
| Intensity of experienced adverse events |  | Assessed on day four, 30, 90, and 180 | 
| Hospital readmission |  | Assessed on day 180 | 
| Occurrence of specific adverse events |  | Assessed on day four, 30, 90, and 180 |
Gene Therapy for Chronic Granulomatous Disease in Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of administration of autologous hematopoietic stem cells transduced with MT-gp91 retroviral vector for patients with X-linked chronic granulomatous disease.

Official Title
-----------------
An Open-label, Uncontrolled, Single Center, Phase I/II Trial to Assess the Safety and Efficacy of Autologous Hematopoietic Stem Cells Transduced With MT-gp91 Retroviral Vector in gp91 Defective Chronic Granulomatous Disease Patients

Conditions
-----------------
Chronic Granulomatous Disease

Intervention / Treatment
-----------------
* Drug: VM106


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gp91 defective male patients with chronic granulomatous disease: confirmed by DHR Weigh greater than or equal to 15 kg History of severe infections: more than 2 times Performance status: ECOG 0-2 Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. Heart: a shortening fraction > 28%; QTc interval < 0.44 Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal; AST < 3 x upper limit of normal Kidney: creatine < 2 x normal Blood: WBC > 2,500/uL; platelet > 100,000/uL; hematocrit > 26% Written informed consent obtained from patient (or guardian if patients age < 19) Exclusion Criteria: Presence of a HLA-matched sibling for stem cell donation Evidence or history of malignant tumor Presence of a severe infection Presence of an active tuberculosis Uncorrectable electrolyte, Ca, P Unable to comply with the protocol or to cooperate fully with the Investigator or site personnel
Sexes Eligible for Study
-----------------
Male

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: VM106<br> | Drug: VM106<br>* Autologous hematopoietic stem cells with MT-gp91 retroviral vector<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events through 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RCR, insertional mutagenesis, immune response against normal gp91 protein |  | 1 year | 
| Safety and efficacy of fludarabine/busulfan conditioning |  | 1 year | 
| Functional reconstitution of respiratory burst |  | 1 year | 
| Presence of vector-positive cells |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Granulomatous Disease, Retroviral Vector, Gene Therapy
Slow Coronary Artery Flow: Influence on Morbidity and Mortality

Study Overview
=================
Brief Summary
-----------------
To compare patients with Slow Coronary Artery Flow to patients with normal flow and to determine whether there is a difference in their future incidence of heart disease.

Official Title
-----------------
Slow Coronary Artery Flow: Influence on Morbidity and Mortality

Conditions
-----------------
Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent coronary angiography Exclusion Criteria: Patients with coronary occulsion above 50% Patients with severe valve disorder

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 |
| --- | --- |
| 1<br>Patients diagnosed with slow coronary artery flow during coronary angiography | |
| 2<br>Patients with normal coronary artery flow observed during coronary angiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How many hospitalizations for major coronary events in patients with or without slow coronary artery flow. |  | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary slow flow phenomenon, Coronary angiography, Acute coronary syndrome, Chest pain, Unstable angina
Pancreatic Adenocarcinoma Gene Environment Risk Study

Study Overview
=================
Brief Summary
-----------------
After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Some participants may also be asked to provide a urine sample. Individuals undergoing procedures that require collection of biological samples for clinical purposes may have these samples saved for research purposes. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

Official Title
-----------------
The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed or CT confirmed diagnosis of pancreatic adenocarcinoma Subjects with abnormal imaging study (CT, MRI, MRCP, EUS) Control subjects with a clinical diagnosis of a pancreas, liver, or intestinal condition Control subject with acute pancreatitis Control subject with chronic pancreatitis Control subject with biliary obstruction Control subject with pancreatic cyst Member of a high risk family (≥ 1 close relative with pancreatic cancer) Healthy control (without any of the above conditions) Exclusion Criteria: Under the age of 18 years Unable to give informed consent Inability to travel to Pittsburgh for in-person enrollment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic Cancer<br>individuals who have been diagnosed with pancreatic cancer | |
| Unaffected<br>individuals who have not been diagnosed with pancreatic cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The data will be used in cohort association studies. Endpoints will depend on the number of patients in the study and the number of markers that are being evaluated. |  | 10 years |
Effects of Different Flow Anesthesia on Atelectasis

Study Overview
=================
Brief Summary
-----------------
Evaluation of atelectasis that may be caused by different flow rate anesthesia applications during the operation with lung ultrasound score.

Official Title
-----------------
Evaluation Of Peroperative Atelectasis In Minimal, Low And Medium Flow Anesthesia By Lung Ultrasound Score

Conditions
-----------------
Atelectasis; Due to Anesthesia, General Anesthesia, Low- Flow Anesthesia, Minimal Flow Anesthesia

Intervention / Treatment
-----------------
* Procedure: Lung Ultrasound Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operation time 2-5 hours elective septoplasty and rhinoplasty ASA I-II Exclusion Criteria: morbid obesity malignant hyperthermia opioid sensitivity alcohol or drug addiction congestive heart failure chronic obstructive pulmonary disease coronary artery disease anemia liver and kidney diseases pregnancy breast-feeding history of allergy to drugs used

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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 |
| --- | --- |
| Group I<br>Minimal Flow Anesthesia (0.25L/dk oxygen, 0,25 L/min air) | Procedure: Lung Ultrasound Score<br>* Measuring the atelectasis area by ultrasound guidance from 12 different regions of the lung<br>|
| Group II<br>Low Flow Anesthesia (0.5L/dk oxygen, 0,5 L/min air) | Procedure: Lung Ultrasound Score<br>* Measuring the atelectasis area by ultrasound guidance from 12 different regions of the lung<br>|
| Group III<br>Medium Flow Anesthesia (1L/dk oxygen, 1 L/min air | Procedure: Lung Ultrasound Score<br>* Measuring the atelectasis area by ultrasound guidance from 12 different regions of the lung<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of lung ultrasound score | Effect of different flow anesthesia on lung ultrasound score | Change from Baseline and 30 minute after emergence | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Ultrasound Score, Minimal Flow Anesthesia, Atelectasis
A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study with no treatment and only samples being collected.

Detailed Description
-----------------
The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-072.

Official Title
-----------------
A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-072 After Discontinuation of ABT-072 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-072 Clinical Studies

Conditions
-----------------
Hepatitis C Virus Infection

Intervention / Treatment
-----------------
* Drug: ABT-072


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Main Selection Criteria: A subject that has received either ABT-072 or placebo in a prior study involving ABT-072. Exclusion Criteria: - The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in a prior ABT-072 clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 - Follow-up Study<br>This is a follow-up study with no treatment and only samples being collected. | Drug: ABT-072<br>* Blood samples are being taken from subjects previously treated with ABT-072.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the prevalence of resistance of specific mutations over time will be summarized. |  | Approximately 48 weeks. | 
| Analysis of the degree of phenotypic resistance (fold change in susceptibility of ABT-072 compared to wild-type virus) will also be summarized. |  | Approximately 48 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of serious adverse events related to study procedures only. |  | Approximately 48 weeks. |
Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12 supplementation can ameliorate cell plasma membrane features in pediatric patients with cystic fibrosis

Detailed Description
-----------------
Cystic fibrosis (CF) is one of the most common fatal autosomal recessive disorders in the Caucasian population caused by mutations of gene for the cystic fibrosis transmembrane conductance regulator (CFTR). New experimental therapeutic strategies for CF propose a diet supplementation to affect the plasma membrane fluidity and to modulate the cellular amplified inflammatory response in CF target organs. Red blood cells (RBCs) were used to investigate plasma membrane, because RBCs share lipid, protein composition and organization with other cell types.

Official Title
-----------------
Preliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cystic fibrosis Exclusion Criteria: diabetes chronic infections of the airways regular antibiotics intake

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12|children with cystic fibrosis were supplementated for 6 months with 5-MTHF, 7,5 mg/day ; vitamin B12, 0,5 mg/day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We evaluated membrane protein oxidative damage of red cells |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| we evaluated cation transport pathways of red cells |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, folate, vitamin B12
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.

Official Title
-----------------
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study

Conditions
-----------------
Acute Circulatory Failure

Intervention / Treatment
-----------------
* Drug: Iohexol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient admitted to intensive care for less than 12 hours Acute circulatory failure Patient carrying an arterial catheter Informed consent obtained Affiliated to social security system Exclusion Criteria: Administration of iohexol the week before intensive care admission Administration of iohexol expected within 24 hours of study entry Known history of cutaneous immediate or delayed allergic reaction to the injection of the product Indication for albumin transfusion within 24 hours of potential inclusion in the study Pregnancy or breastfeeding in progress Patient under guardianship or judicial protection known at the time of inclusion Withdrawal of consent Administration of iohexol outside the study within 24 hours after administration of iohexol in the context of the study Administration of intravenous albumin in the 24 hours following administration of iohexol in the context of the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iohexol<br>injection of 5 ml of iohexol | Drug: Iohexol<br>* Iohexol, 300 mg/mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma clearance of iohexol |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma clearance of iohexol in patients developping or not acute kidney injury |  | 7 days | 
| Link between plasma iohexol clearance and kindney injury markers |  | 24 hours | 
| Link between injury and/or functional kidney dammage and subsequent acute kidney injury |  | 7 days | 
| Link between plasma iohexol clearance and urinary metabolomic markers |  | 24 hours | 
| Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points |  | 24 hours |