linjc16/ctgov huggingface dataset:
Clinical Outcome and Cytokine Expression After TKA

Study Overview
=================
Brief Summary
-----------------
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results

Detailed Description
-----------------
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results at 3 months, 1 year and 3 years after surgery

Official Title
-----------------
Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Coated Total Knee Arthroplasty
* Device: Standard Total Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary and secondary osteoarthritis understanding of german language Exclusion Criteria: necessity of constrained TKA existence of other joint implants

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coated Total Knee Arthroplasty<br>Implantation coated Total Knee Arthroplasty | Device: Coated Total Knee Arthroplasty<br>* Implantation coated Total Knee Arthroplasty<br>|
| Active Comparator: Standard Total Knee Arthroplasty<br>Implantation Standard Total Knee Arthroplasty | Device: Standard Total Knee Arthroplasty<br>* Implantation StandardTotal Knee Arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine expression | Changes of cytokine expression 1 and 3 years after surgery compared to pre-op | pre-op, 1 and 3 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function assessed with Knee Society Score | Knee Society Score (0 - 100 points, best 100) | pre-op, 3 months, 1 and 3 years post-op | 
| Patient reported outcome assessed with Oxford Knee Score | Oxford Knee Score (0 - 48 points, best 48) | pre-op, 3 months, 1 and 3 years post-op | 
| Quality of life assessed with EQ 5D | EQ 5D Index (0 - 1.0, best 1.0) | pre-op, 3 months, 1 and 3 years post-op | 
| Activity assessed with UCLA activity score | UCLA activity score (0 - 10 points, best 10) | pre-op, 3 months, 1 and 3 years post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKA, cytokine, coating
Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and following discontinuation of DMPA. Another group electing non-hormonal contraception or abstinence will be recruited as a reference population, across all study sites. The primary variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are: Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse event reporting, laboratory evaluations, pregnancies, weight and vital signs.

Official Title
-----------------
Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls

Conditions
-----------------
Contraception, Bone Density

Intervention / Treatment
-----------------
* Drug: Depo-Provera Contraceptive Injection - DP150CI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent females who have had any menses in the 6 months prior to enrollment Must have a negative pregnancy test Exclusion Criteria: Concomitant medication exclusion use of bone modifying agents, glucocorticoids, heparin, and anticonvulsants Screening Spinal BMD with z score not greater than -2 of matched young normals

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Depo-Provera Contraceptive Injection - DP150CI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive |  |  | 
| Injection (DP150CI) users will be evaluated and compared during depo |  |  | 
| medroxyprogesterone acetate (DMPA) therapy and following discontinuation of |  |  | 
| DMPA.Another group electing non-hormonal contraception or abstinence is |  |  | 
| recruited as a reference population, across all study sites. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary variables are: Total Body Composition & Total Body Calcium (TBC), |  |  | 
| measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD |  |  | 
| markers |  |  |
Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector

Study Overview
=================
Brief Summary
-----------------
A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system. The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.

Official Title
-----------------
Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product

Conditions
-----------------
Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.

Intervention / Treatment
-----------------
* Device: Additional PET Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are at least 18 years Patients are medically stable Patients scheduled for clinically necessary PET/CT examination Exclusion Criteria: Patients who are pregnant Patients who are unwilling/unable to sign the Informed Consent Form Patients who are cognitively impaired and unable to provide informed consent Patients who have experienced adverse events to PET/CT examinations

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: Patients receiving PET/CT<br>Patients already scheduled for a clinically necessary PET/CT scan. | Device: Additional PET Scan<br>* Additional PET Scan with no additional radiopharmaceutical administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging Capabilities and Performance of the Alpha Ring | Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician. | Within 1 month of image acquisition | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, Philips
Ultrasound Assessment of the Inferior Vena Cava in Children

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-blinded observational study to compare measurement of inferior vena cava (IVC) dimensions with two placement sites of the ultrasound probe (sub-xiphoid and the side or right lateral position).

Official Title
-----------------
Ultrasound Assessment of the Inferior Vena Cava in Children; Comparison of Sub-xiphoid and Right Lateral Coronal Views During Spontaneous Ventilation

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 patients scheduled for elective dental surgery under general anesthesia. Exclusion Criteria: History of significant pulmonary disease, cardiac disease, and laparotomy.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- | --- |
| IVC diameter | Measurement of the inferior vena cava via ultrasound using the right lateral view and the subxiphoid view. | Baseline |
A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects

Study Overview
=================
Brief Summary
-----------------
The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: nalmefene hydrochloride 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a Japanese male. The subject is able to read and understand the informed consent form (ICF). The subject has a body mass index (BMI) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening visit. The subject has a resting pulse and heart rate (as read on the ECG) ≥ 45 bpm and ≤ 100 bpm at the screening visit. Exclusion Criteria: The subject has taken any prescription drugs, over-the counter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1. The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week. (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.) The subject has taken any investigational products within 4 months prior to Day 1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalmefene hydrochloride 10 mg<br>nalmefene 10 mg tablet | Drug: nalmefene hydrochloride 10 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax) |  | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | 
| Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt) |  | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | 
| Measure the Terminal-phase Elimination Half-life (T1/2) |  | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose |
Manganese in Women With Encephalopathy

Study Overview
=================
Brief Summary
-----------------
Objective: Report manganese serum levels and mortality in encephalopathic patients. Patients and participants: Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed by their families. Interventions: Patients' clinical characteristics as well as biochemical tests of renal function, hemoglobin, glucose and albumin levels were obtained as well as a blood sample to analyze manganese levels with a graphite furnace atomic absorption spectrometer. Hypothesis: There is a difference in the manganese levels between male and female patients.

Official Title
-----------------
Manganese, Possible Factor of Higher Mortality in Women With Encephalopathy

Conditions
-----------------
Hepatic Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients aged > 18 years With hepatic encephalopathy Informed consent signed by their families Exclusion Criteria: Portal bypass surgery Cancer of any localization Known malignancy and other severe diseases which shorten life expectancy < 6 months Psychiatric illness

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 |
| --- | --- | --- |
| Clinical Evolution | Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manganese Levels | From encephalopathic patients, we took individual blood samples, analyzed in the biochemistry laboratory at the National Institute of Neurology and Neurosurgery, Mexico, City, with a graphite furnace atomic absorption spectrometer, according to the technique reported by Pleban. | Up to six months we followed the recruited patients to determine who were still alive | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
manganese, hepatic encephalopathy, hepatitis C, mortality, prognosis.
Vietnam Head Injury Study - Phase III

Study Overview
=================
Brief Summary
-----------------
The Vietnam Head Injury Study (VHIS)-Phase III is a prospective, long-term follow-up study of head-injured Vietnam veterans. The purpose of this research study is to determine the long-term consequences, if any, of head injury.

Detailed Description
-----------------
The VHIS - Phase III evaluation to be conducted approximately 30 years post-injury will be devoted to examining, cutting-edge cognitive neuroscience issues and will utilize state of the art technologies to address basic research questions in the following areas: (1) Functions of the human prefrontal cortex; (2) Cognitive neuroplasticity in the aging brain; (3) Memory; (4) Long-term behavioral and psychosocial outcome; and (5) Neurological studies, including an evaluation of post-traumatic epilepsy and repeat clinical measures from Phase - II. This testing will be complemented with structural neuroimaging, electroencephalogram (EEG) and molecular genetics. The goals of the VHIS - Phase III include providing clinicians and scientists new insights into the long term recovery of function following brain injury, the role of the prefrontal cortex in executive functions, better predictors of long term outcome (including cognitive, neurological, and genetic factors), and the effects of head injury incurred in youth on aging and the development of dementia.

Official Title
-----------------
A 40+ Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.

Conditions
-----------------
Traumatic Brain Injury, Penetrating Head Injury, Closed Head Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
The researchers are seeking healthy CONTROL participants. Inclusion Criteria: Vietnam Veteran Served in active combat between 1966 - 1971 Male Exclusion Criteria: Any medical condition that would make participation detrimental to the control (i.e.: severe clinical depression, acute heart dysfunction, etc...) A history of severe head injury, stroke, loss of consciousness, or other significant neurological, psychiatric or medical condition that would render the subject unsuitable for the VHIS testing battery.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Head Injured<br>The Vietnam Head Injured Subjects | |
| Head Uninjured<br>Uninjured Vietnam Veteran Control Subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the assessment of a large number of the genetic markers and the relation to various out come measures. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury, Penetrating head wound, Closed head trauma, Vietnam Veteran
BRIANSTORM - Early Identification of Patients With Brain Metastases

Study Overview
=================
Brief Summary
-----------------
A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

Detailed Description
-----------------
In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times

Official Title
-----------------
BRIANSTORM - Early Identification of Patients With Brain Metastases

Conditions
-----------------
Metastatic Rectal Adenocarcinoma, Brain Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary rectal tumor location Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria. Able to understand written information Consent to samples for translational research Exclusion Criteria: Contraindications for MRI Priorly treated or known brain metastases

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of brain metastasis | Incidence of brain metastasis in a high risk selected group | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of brain metastases eligible for local treatment options | Number of brain metastases eligible for local treatment options | 2 years | 
| Median two year overall survival | Median two year overall survival | 2 years last patient | 
| Prognostic value of circulating DNA levels at baseline |  | 2 years last patient | 
| Descriptive biological analysis of tumor tissue and circulating tumor DNA |  | 2 years last patient |
Air Quality Monitoring and Health Surveillance of Workers in the Photocopier Units

Study Overview
=================
Brief Summary
-----------------
To monitor air quality in selected photocopier units and to assess the health status of workers who are exposed to emissions from photocopiers.

Official Title
-----------------
Air Quality Monitoring and Health Surveillance of Workers in the Photocopier Units

Conditions
-----------------
Occupational Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 2 years of exposure to photocopiers Exclusion Criteria: any clinical abnormality

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| control<br> | |
| exposure 2-3 years<br> | |
| exposure 3-5 years<br> | |
| exposure 5-10 years<br> | |
| exposure >15 years<br> | |

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
-----------------
Occupational Health Hazards, Air Pollution, Photocopiers, Other Specified Personal Exposures, History Presenting Hazards to Health