linjc16/ctgov huggingface dataset:
Prosthetic Hip Infections: Prospective Study

Study Overview
=================
Brief Summary
-----------------
Data from large prospective cohort studies of prosthetic joint infections are lacking. Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy. Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).

Detailed Description
-----------------
Aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy Methods: prospective cohort study in a French referral center for osteoarticular infections from November 2002 to March 2010. Population all patients who consented to participate in the study with prosthetic hip infections treated by: debridement-synovectomy for acute infection or with one-stage or two-stage exchange arthroplasty or resection arthroplasty for chronic infection antibiotic therapy Outcome: Follow-up: minimum of 2 years Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths

Official Title
-----------------
Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years

Conditions
-----------------
Hip Prosthesis Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hip arthroplasty infection Surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection Antibiotic therapy Signed informed consent Exclusion Criteria: Prolonged suppressive antibiotic therapy No surgical treatment

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 |
| --- | --- | --- |
| Incidence of reinfection (relapse and new infection) | The aim of this study was to prospectively determine the incidence of reinfection in patients with prosthetic hip infection after two years of follow up. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and causes of mechanical revision |  | 2 years | 
| Incidence and causes of death: infection or treatment related death, unrelated death |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip prosthesis infection, Reinfection, Excision-synovectomy, One stage/two stage revision, Antibiotherapy
The Study of Long-term Deterioration of Kidney Transplants.

Study Overview
=================
Brief Summary
-----------------
This study is being done to create a kidney transplant database with information from many transplant centers for the purpose of studying ways to help improve transplant outcomes and the care of transplant recipients. This is also being done to learn why kidney transplant recipients have worsening of their kidney function, and whether there are specific findings that could result in future treatments.

Detailed Description
-----------------
Data will be collected from the participant's medical records, local health care providers and participant's to clarify or add any information. Participants will have samples of blood, and urine obtained during their routine visits, that will be saved for testing in this study. In addition, participant's receiving a kidney biopsy performed as a part of their clinical care, will have a piece of the biopsy used for the study. This study will be followed for five years.

Official Title
-----------------
Long-term Kidney Function (2 Arms-Prospective and Retrospective)

Conditions
-----------------
Kidney Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
In the prospective group, all participants who will be receiving a kidney transplant are eligible. In the retrospective group, kidney transplant recipients who are undergoing a kidney biopsy to determine the cause of change in their serum creatine level.
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 |
| --- | --- | --- |
Major Pelvic Hemorrhage in Complex Surgery

Study Overview
=================
Brief Summary
-----------------
Hemorrhage is a challenging complication of pelvic surgery. In this study, the investigators aimed to analyze the causes, management, and outcomes of major pelvic hemorrhage in patients undergoing complex abdomino-pelvic surgery. Participants who had a major intraoperative pelvic hemorrhage during complex abdomino-pelvic surgery at 11 tertiary referral centers were included. Participant characteristics, causes of hemorrhage, management strategies, and outcomes including morbidity and mortality analyses were evaluated.

Official Title
-----------------
Management and Outcomes of Major Pelvic Hemorrhage in Patients Undergoing Complex Abdomino-Pelvic Surgery: A Cohort Study

Conditions
-----------------
Pelvic Bleeding

Intervention / Treatment
-----------------
* Procedure: Stopping of pelvic bleeding via several surgical methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had major pelvic bleeding during complex abdominopelvic surgery Patients operated in hospitals where over 225 colorectal cases were performed every year Exclusion Criteria: Patients operated for palliative intent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who had pelvic hemorrhage<br>Patients who had pelvic hemorrhage during complex abdomino-pelvic surgery | Procedure: Stopping of pelvic bleeding via several surgical methods<br>* Those surgical methods were pelvic packing, electrocautery, energy devices, suturing, fastener, muscle welding, procoagulant chemicals, and combination of those<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative outcomes | Complication rate (Number of participants who had a complication divided by total number of participants) | Within postoperative day 30 |
Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

Study Overview
=================
Brief Summary
-----------------
This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

Detailed Description
-----------------
This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes (focusing initially on the UGT2B7 enzyme) and tamoxifen (TAM) toxicity. Pre- & post-menopausal women (aged ≥18 years) taking TAM (20 mg/day) as standard therapy or chemopreventive therapy will be included in this study. Patients will be enrolled after they complete all primary surgery, radiation, and adjuvant chemotherapy. Patients will be excluded if they are undergoing other adjuvant endocrine therapies. Other reasons for exclusion will include patients who are pregnant or lactating, or are currently on corticosteroids, phenobarbital, or megestrol acetate. The goal will be to recruit a total of 45 eligible patients over a 1 year accrual period. The investigators expect to treat  50 new patients per year with TAM at the standard dose of 20 mg/day.

Official Title
-----------------
An Observational Trial of the Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

Conditions
-----------------
Breast Cancer, Ductal Carcinoma in Situ

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention Age 18 years and above May be pre- and post-menopausal Females Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy Must use a reliable form of birth control Exclusion Criteria: Pregnant Breastfeeding Concurrent use of corticosteroids, megestrol, or phenobarbital History of allergy to tamoxifen Unwilling to have a yearly gynecological exam

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

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

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 |
| --- | --- | --- |
| Hot flashes |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, hot flashes, tamoxifen
Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome

Study Overview
=================
Brief Summary
-----------------
Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.

Detailed Description
-----------------
The aim of the study is to compare the content of exosomes between two goups of 20 patients, with and without endothelial dysfucntion. the endothelial function will be evaluated after polysomnography, on obese patients with OSA (AHI >15).

Official Title
-----------------
Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS

Conditions
-----------------
Endothelial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: ENDOPAT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult subject Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent Subject with OSA (defined by AHI >15/h) Exclusion Criteria: cardiac or vascular desease

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endothelial dysfunction (DE+)<br>obsese patient with OSA (AHI>15) and endothelial dysfunction | Diagnostic Test: ENDOPAT<br>* digital plethysmography<br>|
| Sham Comparator: No endothelial dysfunction (DE-)<br>obsese patient with OSA (AHI>15) and no endothelial dysfunction | Diagnostic Test: ENDOPAT<br>* digital plethysmography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA cointained in exosomes | compare exosome content between obese-OSA patients with endothelial dysfunction and without | immediately after the consultation |
Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance

Study Overview
=================
Brief Summary
-----------------
In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program.

Detailed Description
-----------------
Obesity is rising at alarming rates, currently at nearly 40%. There are very few tools, specifically questionnaires, for healthcare providers to help their patients lose weight or maintain their weight loss. The Hunt Motivational Scale is one such tool to help patients identify areas that need improvement in order to aid in weight loss and weight maintenance. The HMS is designed to motivate patients to track, plan, and practice other healthy weight loss and weight maintenance practices so that they will have success. In this study, approximately 75 subjects in the Penn Medicine Princeton Health weight management program will be randomly assigned to either receive the HMS or not (standard of care). They will be followed for a period of six months at the end of which it will be determined whether the group that received the HMS lost more weight than the control group.

Official Title
-----------------
Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Other: Hunt Motivational Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient in weight management program at Penn Medicine Princeton Health Exclusion Criteria: does not have a visit every three to four weeks not in active weight loss phase of the program diminished intellectual capacity to complete questionnaire i.e. Down's syndrome
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
Interventional Model Description: There are two arms in this study. One group will receive the HMS and the other will not and will receive standard of care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>The treatment arm will receive the HMS as well as standard of care of the weight management program. | Other: Hunt Motivational Scale<br>* The Hunt Motivational Scale is a tool to help facilitate weight loss and motivate patients to track, plan, and practice healthy weight loss and weight maintenance practices.<br>|
| No Intervention: Control arm<br>The control arm will not receive the HMS and will receive standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | Six months |
Enoxaparin Versus Unfractionated Heparin in PCI

Study Overview
=================
Brief Summary
-----------------
Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI

Official Title
-----------------
Enoxaparin Versus Unfractionated Heparin in PCI

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

Intervention / Treatment
-----------------
* Drug: Enoxaparin i.v.
* Drug: unfractionated heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCI for stable ischemia or ACS Exclusion Criteria: Cardiogenic shock, Pretreatment with study drugs, Lack of informed consent
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

| Intervention/Treatment |
| --- |
|Drug: Enoxaparin i.v.|nan|
|Drug: unfractionated heparin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadruple endpoint: death, MI, urgent TVR, major bleeding |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major bleeding, minor bleeding, thrombocytopenia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enoxaparin, heparin, hemorrhages
A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

Study Overview
=================
Brief Summary
-----------------
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

Detailed Description
-----------------
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients

Official Title
-----------------
A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

Conditions
-----------------
ICU Patients With Indication of Sedation

Intervention / Treatment
-----------------
* Drug: Short term sedation with sevoflurane in ICU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ventilated requiring invasive procedure in ICU Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients Exclusion Criteria: BMI <30 Sevoflurane anaphylaxia

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: burn ICU patients<br>Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients | Drug: Short term sedation with sevoflurane in ICU<br> <br> |
| Other: non burn ICU patients<br>Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients | Drug: Short term sedation with sevoflurane in ICU<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of sevoflurane |  | at 5min, 15 min, 60 min and just before the end of sedation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of HFIP and fluoride |  | at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Sedation, Pharmacokinetics, Sevoflurane
Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: PEGASYS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hepatitis B Not pregnant Exclusion Criteria: Treatment for hepatitis B in past 6 months Other hepatitis infections Severe liver disease 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?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impacts of Training on Effortful Listening

Study Overview
=================
Brief Summary
-----------------
Human listeners will hear speech masked by single-talker speech before and after auditory training.

Detailed Description
-----------------
Human listeners will hear speech masked by single-talker speech before and after auditory training. Training-related changes in EEG dynamics and behavioral measures of accuracy and effort will be assessed.

Official Title
-----------------
Impacts of Training on Effortful Listening

Conditions
-----------------
Training Group

Intervention / Treatment
-----------------
* Behavioral: training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal hearing Exclusion Criteria: hearing loss

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups. One group is trained to listening through simulated hearing protection. The other receives no such training.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trained group<br>group receives training with sounds that correspond to simulated hearing protection | Behavioral: training<br>* training with filtered speech<br>|
| No Intervention: Control<br>group receives no training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pretest EEG alpha power | power in the alpha-band | one day before training | 
| posttest EEG alpha power | power in the alpha-band | one day after training | 
| pretest accuracy | proportion correct for identifying speech | one day before training | 
| posttest accuracy | proportion correct for identifying speech | one day after training |