linjc16/ctgov huggingface dataset:
Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care

Study Overview
=================
Brief Summary
-----------------
To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment. The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.

Detailed Description
-----------------
This study is observational and descriptive. For this purpose, patients meeting the inclusion and non-inclusion criteria can answer, if they wish, to an online questionnaire after having read the information and non-opposition letter.

Official Title
-----------------
Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care

Conditions
-----------------
Breast Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteer Patients Patients with a good command of French in order to understand the letter of information and the questionnaire. Patients treated at the Couple Enfant Hospital in Grenoble. We have chosen to take patients who have been operated on at least 3 months ago (average time of end of radiotherapy). Exclusion Criteria: Patient having undergone a mastectomy or chemotherapy Patient with difficulties understanding, expressing or reading the French language Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion) Patient subject to a legal protection measure or out of state to express her opposition (guardianship, curatorship)
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 |
| --- | --- | --- |
| Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment | Answers to the questionnaire part 2 physiotherapy care. Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive) | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment | Answers to the questionnaire part 2  post-operative complications  Questions 16, 23, 27, 28. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative complications, physiotherapy, rehabilitation, lumpectomy, sentinel node, radiotherapy
Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Official Title
-----------------
A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PAH who had completed the 12 week pivotal study Exclusion Criteria: Any other patients with PAH that had not been included into the pivotal study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sildenafil citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Standard safety data |  |  | 
| Efficacy |  |  | 
| 6-Minute Walk Test |  |  | 
| BORG Dyspnoea Score |  |  | 
| WHO Functional Class |  |  | 
| Quality of Life SF-36 and EQ-5D |  |  |
Relationship of Endometrial Cancer and Serum Soluble L1CAM Level

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.

Official Title
-----------------
Relationship of Endometrial Cancer and Serum Soluble L1CAM Level

Conditions
-----------------
Endometrium Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: serum soluble L1CAM (sL1CAM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent endometrial biopsy due to abnormal uterine bleeding and whose pathology results were reported as benign endometrial changes, endometrial hyperplasia or endometrial cancer were included in the study. All patients participating in the study signed informed consent. Exclusion Criteria: Patients who did not have consent, received neoadjuvant therapy and who would not have surgery despite endometrial cancer were excluded from the study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| benign endometrial changes<br> | Diagnostic Test: serum soluble L1CAM (sL1CAM)<br>* blood sample<br>|
| endometrial hyperplasia<br> | Diagnostic Test: serum soluble L1CAM (sL1CAM)<br>* blood sample<br>|
| endometrial cancer<br> | Diagnostic Test: serum soluble L1CAM (sL1CAM)<br>* blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum sL1CAM level |  | one year |
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.

Official Title
-----------------
A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder

Conditions
-----------------
Naturalistic, Observational

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent. Meet DSM-IV-TR criteria for bipolar disorder (bipolar I disorder, bipolar II disorder) at the time of baseline. Exclusion Criteria: Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history. Known intolerance for or lack of response to atypical antipsychotics , as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| The change from the baseline to week 8 in Short Form of the Quality of Life Enjoyment and satisfaction Questionnaire (Q-LES-Q) score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from the baseline to week 8 in CGI-BP and GAF scale score. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar, atypical antipsychotics, quality of life, observational
Dyslipidemia and Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.

Detailed Description
-----------------
The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.

Official Title
-----------------
Dyslipidemia and Diabetic Retinopathy

Conditions
-----------------
Diabetic Retinopathy, Dyslipidemia

Intervention / Treatment
-----------------
* Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
* Other: Healthy Controls 15 age matched control subjects


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any man or woman Greater than 18 years of age Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children. Exclusion Criteria: Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test. Have retinal abnormalities other than diabetic retinopathy.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Diabetic | Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy<br> <br> * Other names: PDR -Proliferative Diabetic Retinopathy;|
| Group 2<br>Healthy Controls | Other: Healthy Controls 15 age matched control subjects<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in acid sphingomyelinase (ASM) expression and activity in bone marrow-derived endothelial progenitor cells (EPCs) | Peripheral blood of 150 cc, about 8-10 tablespoons will be collected from vein in the arm of both diabetic and control subjects | 3 years |
To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Ramipril 10 Capsule (Sandoz)
* Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ramipril 10 Capsule (Sandoz) | Drug: Ramipril 10 Capsule (Sandoz)<br> <br> |
| Active Comparator: 2<br>Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical) | Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 30 days |
Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The ability to label specific cells and image their natural movements in vivo would allow researchers to investigate the mechanisms of disease progression. In addition, cell-based therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells to follow their bio-distribution and biological function. Because of recent interest in stem cell treatment, several methods have been investigated for in vivo cell tracking. The investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo tracking using MRI. The investigators will use 20 healthy human volunteers to: Assess the feasibility of imaging Endorem-labelled cells in vivo Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem

Official Title
-----------------
The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously
* Drug: Administration of Endorem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age >18 years Exclusion Criteria: Pregnancy Contraindication to MRI scanning (detected by safety questionnaire) including severe claustrophobia Inability or refusal to give informed consent Renal or hepatic dysfunction HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis Intercurrent illness Blood dyscrasias

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of labelled cells<br>MRI scanning before and after administration of iron-labelled cells | Biological: Administration of autologous Endorem-labelled mononuclear cells intravenously<br>* single dose<br>|
| Experimental: Administration of Endorem<br>MRI scanning before and after intravenous administration of Endorem | Drug: Administration of Endorem<br>* single dose, intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in signal intensity in the region of interest on MRI scanning |  | 0 hours, 24 hours, 48 hours, 5-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, SPIO
Detection of Viral Particels in Urticaria Patients

Study Overview
=================
Brief Summary
-----------------
Blood samples from urticaria patients will be analyzed for viral particles

Detailed Description
-----------------
After digestion with DNase to eliminate human DNA, RNA will be reversed-transcribed and amplified with random primer/ Amplification products will be pooled and sequenced/ After substruction of sequences of vertebrates and highly repetitive sequences, contiguous sequences will be assembled and compared with motifs represented in databases of viruses. which will enable identification of putative protein sequences consistent with viruses

Official Title
-----------------
Detection of Viral Particels in Urticaria Patients

Conditions
-----------------
Urticaria Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic spontaneous urticaria 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 |
| --- | --- | --- |
| viral particles | presence of viral particels | 6 months |
Incorporating Patient Capacity Into the Clinical Landscape

Study Overview
=================
Brief Summary
-----------------
This study is designed to answer why patient capacity (i.e. patient available abilities and resources to enact self-care and access healthcare) is not regularly documented in the Electronic Medical Record (EMR) in a way that is useful for clinicians. Through the implementation of communication tools designed for patient capacity assessment and engagement of stakeholders in a process of user-centered design, the study team hypothesizes that the study can help clinicians elicit this information in conversation and regularly document it in the medical record for future healthcare discussions.

Official Title
-----------------
Incorporating Patient Capacity Into the Clinical Landscape

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Other: Patient Capacity Assessment Instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation Arm<br> | Other: Patient Capacity Assessment Instrument<br>* The Patient Capacity Assessment instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinicial conversations of primary care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of resource limitations measured by medical record review |  | Baseline up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Capacity
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Visanne (BAY86-5258, SH T00660AA)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with endometriosis-associated pelvic pain Exclusion Criteria: Pregnant or lactating women history or suspicion of hormone dependent tumor therapy resistant endometriosis need for primary surgical treatment any other conditions which forbid the participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Visanne (BAY86-5258, SH T00660AA)<br>* orally once daily<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | Assessment of pain relief at end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | Assessment at end of study | 
| Treatment satisfaction by patient |  | Assessment at end of study |