linjc16/ctgov huggingface dataset:
Comparison of Triphasic CT, PET and MR Tumour With Pathological Findings in Colorectal Cancer Liver Metastases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine tumor size.

Detailed Description
-----------------
The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine tumor size.

Official Title
-----------------
Comparison of Triphasic CT, CT/PET and MR Defined Gross Tumour With Pathological Findings in Patients With Colorectal Cancer Liver Metastases

Conditions
-----------------
Liver Metastases, Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: CT, PET and MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver metastases from colorectal cancer undergoing liver resection Exclusion Criteria: contraindication to CT, MRI or PET

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CT, PET and MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis: (LOARAL 2)

Study Overview
=================
Brief Summary
-----------------
The LOARAL 2 project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into three groups: a control group where patients will do standard rehabilitation associated with the judgments of videos represented non-human action and two experimental groups where patients will do standard rehabilitation associated with the judgement of human point-light display. The aim of this study is to measure the benefits of attentional focus and sex correspondence in the use of point-light display for the rehabilitation of patients with a total arthroplasty of the knee.

Official Title
-----------------
Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis

Conditions
-----------------
Knee Surgery, Rehabilitation, Point Light Display

Intervention / Treatment
-----------------
* Other: Point light display


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers over 18 years of age who have undergone knee surgery Exclusion Criteria: Any locomotor condition not due to knee surgery Uncorrected visual disturbances Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism) Non randomization criteria: Cognitive disorders (Mini Mental State Examination <21) Depressive disorders (Beck Inventory index> 9)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Control group who will do usual rehabilitation + visualization of videos representing monuments + a 3-meter round-trip walk | |
| Experimental: Experimental group 1<br>Experimental group 1 who will do usual rehabilitation + visualization of non focused point-light human actions + a 3-meter round-trip walk | Other: Point light display<br>* Visualization of point-light human actions<br>|
| Experimental: Experimental group 2<br>Experimental group 2 who will do usual rehabilitation + visualization of focused point-light human actions + a 3-meter round-trip walk | Other: Point light display<br>* Visualization of point-light human actions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score obtained on the Western Ontario and McMaster (WOMAC) test at inclusion and at the end of the program. |  | Rehabilitation during 3 weeks |
Non Interventional Post Marketing Programme in Neuroendocrine Tumours

Study Overview
=================
Brief Summary
-----------------
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners (Home Injection Group) and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) (Reference Group).

Official Title
-----------------
An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-Term Safety and Efficacy of Somatuline Autogel in the Treatment of Neuroendocrine Tumours When Administered by Patients or Their Partners (Home Injection Group) or Administered by Healthcare Professionals

Conditions
-----------------
Neuroendocrine Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this Post Marketing Surveillance programme and any subsequent analysis. The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months. The patient must have a diagnosis of neuroendocrine tumours The patient must be at least 18 years of age For patients receiving or intending to receive Somatuline Autogel by home injection: The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP/Pharmacy on a monthly basis, or receive the medication by a home delivery service. Exclusion Criteria: The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).

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 |
| --- | --- | --- |
| safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional |  | End of observational period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of Somatuline Autogel |  | End of observational period | 
| training requirements for patients / partners to perform home injection of Somatuline Autogel |  | End of observational period | 
| acceptability of home injections to patients, partners and healthcare professionals |  | End of observational period |
Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for administration in the intravenous route. It is approved for treatment of class I - pulmonary hypertension functional capacity stage III-IV. A key factor for the success of pulmonary hypertension therapy is maintaining near constant blood level of a given medications along the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt increase in the pulmonary artery pressure which might lead to acute right ventricular failure and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to end-stage renal disease there is a need to document the variation of the blood level along the dialysis cycle.

Detailed Description
-----------------
After giving informed consent 10 ml of blood will be drawn from the study population at the following occasions. Baseline measurement immediately before starting HD therapy. During the hemo-dialysis therapy - every one hour. After the end of the hemo-dialysis therapy - every one hour (a total of four measurements) to record recovery of Treprostenil blood levels.

Conditions
-----------------
Pulmonary Hypertension, End-Stage Renal Disease, Hemo-dialysis Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study. Exclusion Criteria: none

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary hypertension, Remodulin (Treprostenil sodium), End-stage renal disease, Hemo-dialysis
Entia Liberty: Usability Validation

Study Overview
=================
Brief Summary
-----------------
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.

Official Title
-----------------
Entia Liberty: Usability Validation

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Entia Liberty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old at the time of study entry Can provide written informed consent Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle Sufficient hearing to be able to participate in a video training session Exclusion Criteria: Known inherited or acquired bleeding disorder History of haematological malignancy Known poorly controlled anti-coagulation Inadequate use and understanding of the English language, requiring a translator Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result Previously taken part in the 'PERTH-2' study involving a prototype device

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

| Intervention/Treatment |
| --- |
|Device: Entia Liberty|Home Monitoring solution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%. | At least 24 of the participants are able to complete the Entia Liberty test. | 3 months | 
| Number of participants with new severe usability problems identified. | Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves | 3 months | 
| Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E) | Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E) | 3 months |
Pulse Oximetry- Evaluating Resp Rate- PCBA-1

Study Overview
=================
Brief Summary
-----------------
To assess performance of resp rate parameter in a monitoring system PCBA-1

Official Title
-----------------
Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1

Conditions
-----------------
Healthy Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects ages 18 or older. Subject is willing and able to provide written consent. Exclusion Criteria: Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors. Subjects with abnormalities that may prevent proper application of the device. Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds). Women who are pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| ME (mean error) of Respiration Rate values for each subject |  | 1-2 hours per subject |
Risk Prediction in Type II Diabetics With Ischemic Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease

Detailed Description
-----------------
In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected. In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity. The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal (severe autonomic failure). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).

Official Title
-----------------
Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function

Conditions
-----------------
Type-2 Diabetes Mellitus, Ischemic Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type-2 diabetes coronary artery disease Exclusion Criteria: age >80 years acute coronary syndrome life expectancy <1 year unable to give informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular event | Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 2 years | 
| sudden cardiac death |  | 2 years | 
| Total mortality |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, coronary artery disease, ischemic heart disease, autonomic function, heart rate turbulence, deceleration capacity, severe autonomic failure
Peripheral Registry of Endovascular Clinical Outcomes The PRIME Registry

Study Overview
=================
Brief Summary
-----------------
The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral artery disease (PAD).

Detailed Description
-----------------
The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME Registry) represents the collaborative effort among seven centers across the US with the goal of reaching 10 sites globally. PRIME explores all aspects of advanced peripheral arterial disease (PAD) and critical limb ischemia (CLI) care including the collection of comprehensive clinical, diagnostic, procedural, and follow-up data for three years following an index endovascular procedure. Data collection activities began in January of 2013 with the goal of collecting data on 1500 subjects. Analysis of this multi-site registry will produce generalizable findings that describe the clinical epidemiology and management practices of advanced PAD and CLI patients.

Official Title
-----------------
Peripheral Registry of Endovascular Clinical Outcomes

Conditions
-----------------
Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are to receive or have received lower extremity endovascular intervention Rutherford III-VI Classification Ability to provide informed consent within 30 day prior to 60 days post index endovascular intervention. Ability to follow up at enrollment site. Exclusion Criteria: Inability or unwillingness to consent for participation in the registry.

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 |
| --- | --- | --- |
| Amputation free survival rates |  | At 36 month follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access site and procedural complications |  | At 36 month follow-up visit | 
| Target lesion revascularization |  | At 36 month follow-up visit | 
| Target vessel revascularization |  | At 36 month follow-up visit | 
| Procedural success |  | At 36 month follow-up visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRIME, PAD, PVD, Observational, CLI, PRIME Registry
The Effect of Muscular Strength Training in Patients With Drug Addiction

Study Overview
=================
Brief Summary
-----------------
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. There are few studies today that provide information about SUD patient's physical health, and especially there is little information about their muscular strength. One of the project's aims is to measure muscular strength in SUD patients who are being treated for their addiction, and see if they have decreased neuromuscular function. If so, we will investigate the effect of maximal strength training on neuromuscular function in these patients.

Official Title
-----------------
The Effect of Muscular Strength Training in Patients With Drug Addiction

Conditions
-----------------
Substance-related Disorders

Intervention / Treatment
-----------------
* Behavioral: strength training
* Behavioral: no training (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being treated for drug abuse not using drugs during intervention period Exclusion Criteria: participated in strength training in previous 6 months cardiovascular disease any other disease that impedes to finish tests not showing up for testing sessions carried out less than 85% of planned exercise sessions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: strength training<br>Strength training for leg muscles during10 weeks, 3 times a week: hack squat and plantar flexion, standing upright in a hack squat machine and lying down in a calf rise machine. Exercises will be carried out at 85% of 1-RM intensity under supervision at the institution where participants are having their SUD treatment. | Behavioral: strength training<br> <br> |
| Other: control<br>patients treated for substance-related disorder but not participating in strength training intervention (no training control group) | Behavioral: no training (control)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | Assessed peripheral muscle strength by one repetition maximum test (1RM) | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, strength training, muscle strength, physical fitness