linjc16/ctgov huggingface dataset:
Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium

Study Overview
=================
Brief Summary
-----------------
To assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

Detailed Description
-----------------
Neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. Postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. Post-anesthesia care unit (PACU) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery. It is unclear, whether PACU delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. The aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without PACU delirium three months after radical prostatectomy.

Official Title
-----------------
Influence of Post-anesthesia Care Unit Delirium After Radical Prostatectomy on Self-reported Cognitive Function and Health-related Quality of Life

Conditions
-----------------
Delirium, Neurocognitive Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective radical prostatectomy >60 years fluent in German Exclusion Criteria: preexisting cognitive impairment cerebrovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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 |
| --- | --- | --- |
| Self-reported cognitive failures | Cognitive Failures Questionnaire | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Short Form Health Survey 36 | three months |
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort

Study Overview
=================
Brief Summary
-----------------
This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study. Approximately 28 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.

Official Title
-----------------
An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort

Conditions
-----------------
Hepatic Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each subject must satisfy all of the following criteria to be enrolled in this study: Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. Subject participated in the CC-90007-CP-003 study. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study. Subject has any condition that confounds the ability to interpret data from the study. Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.

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 |
| --- | --- | --- |
| Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria | DNA Quality | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse event | Time from ICF to Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic impairment, CC-90007-CP-003, Healthy Subject
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.

Detailed Description
-----------------
Each year approximately 256,000 children and adults around the world develop a form of leukemia, and 209,000 died from it. Recently, some studies have evaluated the relationship between the concentration of some cytokines and prognosis of acute lymphoblastic leukemia. XCL1 is a lymphotactin that belongs to a cytokine subfamily called C or γ with only one cysteine in the N-terminal residue. It has been found with significant expression of receptor mRNA XCL1 (XCR1) in T and B lymphocytes and related to hematological neoplasms. For these reasons, XCL1 could be a efficient marker of prognosis in patients with acute lymphoblastic leukemia.

Official Title
-----------------
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed acute lymphoblastic leukemia . Exclusion Criteria: Patients with prior treatment with chemotherapeutic agents. Patients treated with immunosuppressants. Patients under 12 months old. Patients with a diagnosis or history of autoimmune diseases. Patients with a diagnosis or history of immunosuppressive diseases. Patients who do not agree to sign a Letter of Informed Consent.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 Lymphoblastic Leukemia<br>We will invite patients with newly diagnosed acute lymphoblastic leukemia in the Department of Hematology, who had not received anticancer therapy and regardless the subtype and immunophenotype of the disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with poor prognosis and high levels of XCL1 | Number of patients with high levels of XCL1, expression of its receptor and other cytokines. | 3 months | 
| Number of patients with poor prognosis and high levels of cytokines | Measurements obtained will be evaluated to assess the prognosis of patients and made correlations with the concentration of IL-1β, IL-2 and XCL1 as well as the relationship XCR1 XCL1 and in leukemic cells. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL, XCL1, Cytokines, Prognosis
The Effects of Health Education in Cardiovascular Diseases Prevention and Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of health education given by nurse on out-patient compliance in cardiovascular diseases prevention and treatment.

Official Title
-----------------
The Effects of Health Education Given by Nurse on Out-patient Compliance in Cardiovascular Diseases Prevention and Treatment in China

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: no intervention
* Other: health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first diagnosis cardiovascular disease Exclusion Criteria: Severe liver and kidney disease or cancer Limb movement disorder Cognitive impairment History of malignant arrhythmia or severe heart failure patients have a high risk of sudden death Diabetes Cerebrovascular disease History of atherosclerotic disease hospital

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | Other: no intervention<br>* no intervention<br>|
| Experimental: nurse education<br> | Other: health education<br>* 15 minutes health education given by nurse according to  The Chinese Resident Meals Guide  , National Revision Committee of the Guidelines of Hypertension Prevention and Control in 2005 ,  Guidelines on Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults  ,  Guideline for diagnosis and treatment of patients with chronic stable angina , Guideline for prevention and treatment overweight and obesity in chinese adults <br>* Other names: health education given by nurse;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | SBP and DBP | 1 year | 
| lipid | TC,LDL,TG | 1 year | 
| Adherence drug administration | Adherence drug administration in one month and in one year | 1 year | 
| Hospitalization | hospitalization due to cardiovascular and cerebrovascular disease | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise time(hours/week) |  | 1 year | 
| smoking | Number of smoker and Amount of smoke per day | 1 year | 
| body weight |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Out-patient Compliance, Nurse, Heath Education, Cardiovascular Diseases, Treatment and Prevention
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease.

Official Title
-----------------
Neural Effects of Exercise, Cognitive, or Combined Training in AD At-Risk Elders

Conditions
-----------------
Aging, Alzheimer's Disease

Intervention / Treatment
-----------------
* Other: Exercise Training
* Other: Cognitive Training
* Other: Flexibility Training
* Other: Educational Sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First or Second-degree relative of someone with Alzheimer's Disease Not currently engaging in regular exercise Able to undergo an MRI Fluent in English Exclusion Criteria: Neurological illnesses/conditions Medical illness/conditions that may affect brain function Any unstable or severe cardiovascular disease or asthmatic condition Severe depressive symptoms Inability to walk unassisted

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Training<br> | Other: Exercise Training<br>* Aerobic exercise training program designed by the Cardiac Rehabilitation department<br>|
| Active Comparator: Combined Cognitive/Exercise Training<br> | Other: Exercise Training<br>* Aerobic exercise training program designed by the Cardiac Rehabilitation department<br>Other: Cognitive Training<br>* Based on cognitive training program Brain Fitness®<br>|
| Active Comparator: Cognitive Training<br> | Other: Cognitive Training<br>* Based on cognitive training program Brain Fitness®<br>|
| Active Comparator: Combined Low Intensity Training<br> | Other: Flexibility Training<br>* Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department<br>Other: Educational Sessions<br>* DVD-based educational programs on history, art, and literature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation patterns measured by functional MRI |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Testing |  | baseline and 12 weeks | 
| Exercise assessment |  | baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Aging
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.

Detailed Description
-----------------
Over 1 million catheter-associated urinary tract infections (CAUTIs) occur annually in U.S. healthcare facilities and account for approximately 40% of the nosocomial infections. This investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (Tyco Healthcare DOVER Silver Foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

Official Title
-----------------
A Prospective, Randomized, Controlled Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Device: Standard Latex Foley Catheter
* Device: Silver Coated Latex Foley Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age. Subject is expected to be catheterized with a 14, 16 or 18 French Foley catheter for at least 72 hours. Subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation. Exclusion Criteria: Subjects who present with ongoing, active, symptomatic UTI. Subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis. Subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis. Subjects known to be pregnant. Prisoners.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Standard Latex Foley Catheter|nan|
|Device: Silver Coated Latex Foley Catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter associated urinary tract infection (UTI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter tolerance |  |  | 
| Cost of care |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Catheterization
Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning problems experienced by girls with Turner's syndrome. PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental and social functioning in girls who have Turner's syndrome.

Detailed Description
-----------------
PROTOCOL OUTLINE: Participants are evaluated for cognitive and social function at entry and 4 years following entry. Assessments include the Wechsler Intelligence Scale for Children-Revised, a child behavior checklist, the Children's Self-Concept Scale, and visual-spatial, visual-motor, attention, memory, language, and facial recognition tasks. Patients (and parents) undergo X-chromosome analysis; brain magnetic imaging is optional. Controls are matched using school selection and telephone interviews. A study duration of 12 years is estimated.

Official Title
-----------------
Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome

Conditions
-----------------
Turner's Syndrome

Intervention / Treatment
-----------------
* Drug: Estrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Girls aged 8 and 12 years with Turner's syndrome-compatible karyotype Age-matched girls without Turner's syndrome entered as controls Concurrent registration on Thomas Jefferson University growth study required of subjects with Turner's syndrome

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
Bacterial Colonization of Suction Drains Following Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Closed suction drains are commonly used following surgery, if the wound is expected to discharge significant amounts of fluid. To this date, no evidence base exists as to the exact post operative time period or discharge volume necessitating presence of a drain. In orthopedic common practice, drains are removed on the second post operative day, fearing the drain will serve as a point of entry for nosocomial infection. In this study, drains will be left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of days following surgery. Daily cultures and antibiotic levels will be taken from the drains receptacle, to determine if and when the drains is colonized by aerobic bacteria.

Official Title
-----------------
Bacterial Colonization of Suction Drains Following Spine Surgery

Conditions
-----------------
Surgical Site Infection, Closed Suction Drains

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing spine surgery that requires suction draining,and do not meet the exclusion criteria for this study. Exclusion Criteria: Known active infection in the spine or elsewhere.

Ages Eligible for Study
-----------------
Maximum Age: 120 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 |
| --- | --- | --- |
| Growth of bacteria in drain fluids |  | up to 10 days per patient, (from first post operative day until removal of drains). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibiotic level in drain fluid |  | up to 10 days per patient (from first post operative day until removal of drains). |
Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice

Official Title
-----------------
A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events Patients who have given written informed consent Exclusion Criteria: Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1 Pregnant females or nursing mothers Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 Years

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

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: Omalizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, anti immunoglobulin E, omalizumab