linjc16/ctgov huggingface dataset:
His Bundle Recording From Subclavian Vein

Study Overview
=================
Brief Summary
-----------------
His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. This would support the use of stylet driven leads for His bundle pacing.

Detailed Description
-----------------
The purpose of this prospective observational study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.

Official Title
-----------------
Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation

Conditions
-----------------
Atrial Fibrillation, Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Male or Female Patients undergoing HIS bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath Exclusion Criteria: Patients who are unwilling or unable to sign the informed consent Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 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 |
| --- | --- | --- |
| Successful recording of a His bundle potential | The pacing lead will be connected to a standard EP recording system (GE CardioLab, LS Pro, or EP Med) a copy of the intracardiac electrograms demonstrating His bundle recording will be saved electronically. | From beginning of procedure to the end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time necessary to record the HIS bundle | Both the procedural and fluoroscopy time from insertion of the pacing lead until successful measurement of the His bundle | From insertion of the pacing lead until successful measurement of HIS bundle | 
| Pacing threshold | Threshold will be measured in volts at 1 millisecond and recorded for selective His bundle capture, non-selective His bundle capture, and ventricular septal capture as appropriate for each patient. The measurement of a normal His Bundle threshold is < 2.0 V at 1.0 ms. | From beginning of procedure to the end of procedure |
Use of Dermal Matrix in Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.

Detailed Description
-----------------
We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

Official Title
-----------------
The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: DermaMatrix
* Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women who are candidates for breast reconstruction using tissue expanders after mastectomy Exclusion Criteria: Other forms of breast reconstruction after mastectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DermaMatrix<br>experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications | Procedure: DermaMatrix<br>* experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications<br>* Other names: tissue expander breast reconstruction after mastectomy;|
| Active Comparator: Standard of care<br>standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix | Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy<br>* standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix<br>* Other names: standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction With the Procedure |  | one year from time of operation | 
| Post Surgical Infection | Number of participants with post surgical infection | 4 weeks |
Quetiapine Fumarate Bipolar Maintenance Monotherapy

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent 18 years or older A diagnosis of Bipolar I Disorder Have a current manic, depressed or mixed episode Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine Female patients of childbearing potential must be using a reliable method of contraception Exclusion Criteria: Pregnancy Substance or alcohol dependence at enrollment Unstable thyroid function Unstable Diabetes Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension Use of an experimental drug within 30 days of 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to recurrence of a mood event |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to recurrence of a manic event |  |  | 
| Time from randomization to recurrence of a depressed event |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I disorder.
Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.

Study Overview
=================
Brief Summary
-----------------
Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required. This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.

Official Title
-----------------
Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis

Conditions
-----------------
Prostate Cancer, Prostate Neoplasm

Intervention / Treatment
-----------------
* Diagnostic Test: VERDICT MRI
* Diagnostic Test: Luminal Index Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 18-90 with a clinical suspicion of prostate cancer No contraindication to MRI Exclusion Criteria Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI Men unable to given informed consent Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer Ongoing hormonal treatment for prostate cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Men suspected of Prostate Cancer<br> | Diagnostic Test: VERDICT MRI<br>* Advanced Diffusion Model<br>Diagnostic Test: Luminal Index Imaging<br>* Advanced T2 mapping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of VERDICT MRI | Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone | 2 years | 
| Diagnostic accuracy of Luminal Water Imaging (LWI) | Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportions of true positives with index tests is the same as mpMRI. |  | 2 years |
The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts.

Study Overview
=================
Brief Summary
-----------------
More than 200,000 new cases of renal cancer are diagnosed in the world each year, with more than 63,000 new cases in Europe alone. Of those, renal cell carcinoma (RCC) is the most common type in adults, making up more than 90% of the cases. Deciding on the benign or malignant nature of some RCC on the basis of medical images (CT, MRI, US) is an issue, which often leads to unnecessary surgery, morbidity and costs. A categorization for renal cysts was introduced in the late 1980s known as the Bosniak classification. The Bosniak classification system classifies them into groups that are benign (I and II) and those that need surgical resection (III and IV), based on specific imaging features. However, defining the malignancy of category III lesions still remains a challenge. Though Bosniak classification for renal cysts is used worldwide and underwent a number of modifications, Bosniak III cysts still have almost a 1:1 chance of being malignant. So the problem is that approximately half of the Bosniak category III cystic lesions prove to be benign after surgery. The proposed project aims to develop a quantitative image analysis (QIA) based multifactorial decision support system (mDSS) capable of classifying renal cysts with high accuracy into benign or malignant status, thus reducing the amount of unnecessary surgeries performed. Using standard-of-care CT images and clinical parameters, the customized DSS will then guide experts in planning a safe and effective diagnostic and treatment strategy for all RCC patients.

Official Title
-----------------
The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts.

Conditions
-----------------
Renal Cyst Complex

Intervention / Treatment
-----------------
* Diagnostic Test: Radiomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent contrast-enhanced CT-Scan, with radiological findings suggestive of Bosniak 3 renal cyst and have available results for pathology analysis of the cyst. Exclusion Criteria: CT-Scans that are reformatted or secondary.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Radiomics|The high-throughput extraction of large amounts of quantitative image features from radiographic medical images|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malignancy classifier | Machine learning algorithm that can differentiate between malignant and beingn bosniak 3 renal cysts. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiomics, Bosniak classification, Renal cell carcinoma, Medical imaging
A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HX-1171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 40 years at screening. Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders. History of known hypersensitivity to drugs including HX-1171.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HX-1171 20 mg (20mg 1T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 40 mg (20mg 2T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 80 mg (20mg 4T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 160 mg (20mg 8T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 300 mg (200mg 1T, 20mg 5T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 600 mg (200mg 3T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 1200 mg (500mg 2T, 200mg 1T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 1500 mg (500mg 3T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|
| Experimental: HX-1171 2000 mg (500mg 4T)<br> | Drug: HX-1171<br>* 20mg, 200mg, 500mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (normal results for safety tests) | Physical examination, Vital signs | 14days |
Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: R89674 0.025% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of positive diagnostic test for ragweed within the past 2 years; positive bilateral response to ragweed as induced by conjunctival allergen challenge Exclusion Criteria: ocular infection; history of retinal detachment, diabetic neuropathy, or any progressive retinal disease; moderate to severe asthma; dry eye syndrome; history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease; pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 10 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: R89674 0.025% ophthalmic solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching and redness scores at defined timepoints |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic conjunctivitis, ophthalmology, multicenter, controlled
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort

Study Overview
=================
Brief Summary
-----------------
The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.

Official Title
-----------------
Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort.

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women and men > 60 years of age medical history of low energy fracture DXA Tscore -2,5 DS FREE AND INFORMED CONSENT SIGNED Exclusion Criteria: women and men < 60 years of age Corticoids treatment Breast cancer or prostat cancer medical history High energy fracture (traumatic fracture) No social security affiliation Incapacity to informed consent signed.

Ages Eligible for Study
-----------------
Minimum Age: 60 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
-----------------
Osteoporosis
Lymphatic Mapping After Previous Breast Surgery

Study Overview
=================
Brief Summary
-----------------
Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging. Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.

Official Title
-----------------
Lymphatic Mapping After Previous Breast Surgery

Conditions
-----------------
Breast Cancer, Sentinel Node

Intervention / Treatment
-----------------
* Radiation: Lymphoscintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment with BCT with SNB and/or ALND for primary breast cancer previous primary breast cancer located in the upper-outer quadrant of one breast Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy. Exclusion Criteria: breast surgery for other reasons than breast cancer recurrent breast cancer former allergic reaction to 99mTc-colloidal albumin.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sentinel Node Biopsy<br>All women who has Sentinel Node Biopsy as their primary treatment of the axilla | Radiation: Lymphoscintigraphy<br>* in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla<br>* Other names: 99mTc-colloidal-albumin;|
| Axillary Lymph Node Dissection<br>All women who had Axillary Lymph Node Dissection as primary axillary treatment | Radiation: Lymphoscintigraphy<br>* in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla<br>* Other names: 99mTc-colloidal-albumin;|

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

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