linjc16/ctgov huggingface dataset:
ClotTriever Outcomes (CLOUT) Registry

Study Overview
=================
Brief Summary
-----------------
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.

Official Title
-----------------
ClotTriever Outcomes (CLOUT) Registry

Conditions
-----------------
DVT, Deep Vein Thrombosis Leg, Chronic DVT of Lower Extremity, Acute DVT of Lower Extremity

Intervention / Treatment
-----------------
* Device: ClotTriever


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination. Willing and able to provide informed consent. Exclusion Criteria: Prior venous stent in the target venous segment IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins IVC filter in place at the time of the planned index procedure Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used Life expectancy less than 1 year Chronic non-ambulatory status Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period Unavailability of a lower extremity venous access site

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Analytic<br>Patients with unilateral acute or subacute DVT of less than 6 weeks' duration. | Device: ClotTriever<br>* Thrombectomy<br>|
| Registry<br>Patients with proximal lower extremity DVT. | Device: ClotTriever<br>* Thrombectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Major Adverse Events (MAEs) | All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment | Index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ClotTriever, Thrombectomy
DMT210 Topical Gel in the Treatment of Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).

Official Title
-----------------
DMT210 Topical Gel in the Treatment of Mild to Moderate Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: DMT210 Topical Gel
* Drug: Vehicle Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 12 years or older Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas Patient is willing and able to comply with the protocol Exclusion Criteria: Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMT210 Topical Gel<br>DMT210 Topical Gel 5% applied to target lesion twice daily | Drug: DMT210 Topical Gel<br>* DMT210 Topical Aqueous Gel 5% applied twice daily<br>|
| Placebo Comparator: Vehicle Control<br>Topical Gel vehicle applied to target lesion twice daily | Drug: Vehicle Control<br>* Topical Vehicle Gel applied twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADSI (Atopic Dermatitis Severity Index) score of each Target lesion | Change from baseline in ADSI score between Vehicle and 5% gel | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion | Change from baseline in AD symptom scores between Vehicle and 5% gel | Day 28 | 
| Investigator Global Assessment (IGA) of the Treatment Area |  | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eczema, Dermatitis, Skin Diseases, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases, Eczematous, Hypersensitivity, Immune System Diseases
Impact of a Collaborative Program of Physical Activity of Newly-diagnosed Cancer Patients

Study Overview
=================
Brief Summary
-----------------
During the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. Currently, almost 4 million people are treated or followed for cancer in France. The physical, psychological and social after-effects are significant. Adaptated physical activity plays an important role in the rehabilitation process. Overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

Detailed Description
-----------------
This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.

Official Title
-----------------
Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients

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

Intervention / Treatment
-----------------
* Other: Adaptative Physical Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly-diagnosed cancer patient able to start a program of physical activity within the first year follow diagnosis performance status between 0 to 2 Exclusion Criteria: uncontrolled cardiovascular disease peripheral neuropathy grade 3-4 with risk of falling bone metastasis with risk of bone fracture platelets <100X109/L hemoglobin <8g/dL patient under legal protection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptative Physical Activity<br> | Other: Adaptative Physical Activity<br>* 12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor<br>|
| No Intervention: Standard Exercise<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physical activity session | improvement of long-term adhesion to physical activity | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adaptative physical activity, Cancer, Quality of Life
Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
Obstructed defaecation syndrome is a common problem in which patients experience difficulty to evacuate stools and feel that the bowel is incompletely empty, which causes the need to put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a significant effect on social, physical, emotional and sexual wellbeing all of which have impact on quality of life. These symptoms are caused by posterior compartment disorders such as the last part of the large bowel bulging into the vagina (rectocele), the small bowel pressing on the rectum (enterocele), a circumferential infolding of the rectal wall (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate (anismus). Currently the evacuation proctogram is the gold standard for diagnosis of posterior compartment disorders. This technique, however, exposes the patient to ionising radiation, requires preparation of the small and large bowel with contrast and defaecation in a non-private setting, which most women find embarrassing and unpleasant. Over the years, research has focussed on identifying alternatives that are better tolerated to substitute evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast and a well-tolerated method for the dynamic and static imaging of the pelvic floor without the use of ionising radiation. The level of agreement between transperineal ultrasound (TPUS) and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to proctography. The aim of this study is to assess the level of agreement between ultrasound (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment disorders.

Official Title
-----------------
Obstructed Defaecation: Proctography Versus Ultrasound (TPUS and EVUS) in Symptomatic Patients

Conditions
-----------------
Obstructed Defaecation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients Symptoms of obstructed defaecation Planned for evacuation proctography Exclusion Criteria: Inability to understand English Unwilling to consent for evacuation proctography Under 18 years of age Virgo intacta

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 |
| --- | --- | --- |
| The primary objective is to assess the level of agreement between ultrasound (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment disorders |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructed defaecation syndrome, Transperineal Ultrasound, Endovaginal Ultrasound, Evacuation Proctography
Does Coronary Angiography Cause Cognitive Dysfunction?

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

Detailed Description
-----------------
We have previously shown, using transcranial doppler, that coronary angiography cause cerebral microembolism. Cerebral microemboli were more common using the radial than femoral approach. Previously, cerebral microembolism has been associated with new cerebral lesions on MRI. The clinical significance of these new lesions is not determined. The primary aim of this pilot study is to see if coronary angiography cause cognitive dysfunction determined by the MoCA-test. A secondary aim is to relate cognitive dysfunction to cerebral microembolism measured by transcranial doppler. A third aim is to study potential differences between the femoral and radial approaches.

Official Title
-----------------
Study of Cognitive Function Before and After Coronary Angiography

Conditions
-----------------
Coronary Heart Disease, Heart Valve Diseases

Intervention / Treatment
-----------------
* Procedure: Arterial approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective coronary angiography irrespective of cause Exclusion Criteria: Previous CABG, language problems, not willing to participate

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary angiography<br>Patents scheduled for elective coronary angiography | Procedure: Arterial approach<br>* Randomization to right radial or femoral approach<br>* Other names: Coronary arteriography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive dysfunction from baseline to two days after coronary angiography | The Montreal Cognitive Assesment test will be performed before, 2 and 30 days after coronary angiography | Baseline and two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with cerebral microemboli | Cerebral microembolism will be studied by transcraniell doppler at the time of angiography. Findings will be related to change in cognitive function between baseline and two days. | Baseline |
Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.

Official Title
-----------------
Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Drug: clopidogrel (SR25990C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image Body weight : > 50 kg Exclusion Criteria: Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement) Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction Patients with serious impairment that would hinder detection of new ischemic event Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease Patients with history of intracranial hemorrhage Patients with diabetic retinopathy Hypertensive patients with a persistent increase of blood pressure.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>50 mg | Drug: clopidogrel (SR25990C)<br>* oral administration<br>|
| Experimental: 2<br>75 mg | Drug: clopidogrel (SR25990C)<br>* oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding adverse events |  | study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events. |  | study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet Aggregation Inhibitors, Ischemic cerebrovascular disease
Pulmonary Embolism After Liver Resection

Study Overview
=================
Brief Summary
-----------------
Major surgery is associated with a postoperative hypercoagulable state related to the surgical trauma that may lead to thromboembolic complications. To the investigators knowledge, only two series have reported the risk of PE after liver surgery with an incidence of up to 6.3% The purpose of this study is to identify the independent risk factors associated with the development of PE after elective liver surgery.

Official Title
-----------------
Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors

Conditions
-----------------
Liver Disease, Pulmonary Embolism, Thrombophilia, Death

Intervention / Treatment
-----------------
* Procedure: Liver resection
* Radiation: Computed Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Malignant liver diseases Benign liver diseases Exclusion Criteria: Age <18 years Previous history of thromboembolic events Living Donor hepatectomies

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver resection patients<br>All patients that underwent elective liver resection for both malignant and benign diseases. | Procedure: Liver resection<br>* Hepatectomy including both minor and major.<br>* Other names: Hepatectomy, liver resection;Radiation: Computed Tomography<br>* Computed Tomography +/- pulmonary angiography<br>* Other names: CT, CTPA, CT-PA, MSCT, MSCT-PA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary embolism | Blood clots in the lungs that may lead to sudden death. | up to January 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications | up to January 2012 | 
| Length of hospital stay | The duration of hospitalization in days. | up to January 2012 | 
| Mortality | Post-operative 90-Day Mortality | up to January 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver disease, Pulmonary embolism, Thrombophilia, Death
F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With Acute Myeloid Leucemia(AML)

Study Overview
=================
Brief Summary
-----------------
PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution. Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic disease either in bone marrow or extramedullary. F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive study can replace bone marrow biopsy and predict response vs. non response to therapy.

Official Title
-----------------
F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With AML

Conditions
-----------------
Acute Myeloid Leucemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new diagnosis of AML Exclusion Criteria: 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AML<br>patients with AML prior and after treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of extent and intensity ( by standardized uptake value - SUV) of disease in bone marrow demonstrated on PET/CT images before and after treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of treatment response by dynamics of FLT uptake(by SUV)in comparison to bone marrow biopsy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FLT, PET, bone marrow, AML