linjc16/ctgov huggingface dataset:
MRI in Staging Ovarian Cancer Using MRI Contrast Agent

Study Overview
=================
Brief Summary
-----------------
Can MRI be used to stage ovarian cancer?

Detailed Description
-----------------
Staging of ovarian cancer can best be performed with CT or MRI compared to ultrasound. Studies have shown an increase in pos. predictive value by adding contrast i.v. to the MR-examination protocol. We compare staging of ovarian cancer by 1.MRI without contrast (standard method) to 2.MRI with contrast agent i.v. (new method)in the same patient. Golden standard are findings at operation.

Official Title
-----------------
Værdien af MRI Til Staging af c.Ovarii-et Prospektivt Studie

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of ovarian cancer Exclusion Criteria: recurrence of disease contraindication to MRI, contrast agent inoperable patients for other reasons
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Ovarian cancer, Contrast agent
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation

Study Overview
=================
Brief Summary
-----------------
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.

Official Title
-----------------
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation

Conditions
-----------------
Skin Irritability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 to 70 years old; Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark) intact skin where the product will be applied Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings Signature of informed consent form Exclusion Criteria: Pregnancy and lactation Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection; Diseases that cause immune suppression; Personal history of atopy; History of sensitisation and irritability to topical products; Active cutaneous pathologies (local and / or scattered) that may interfere in the study results; Use of new drugs and/or cosmetics during the experiment; Skin reactivity; Previous participation in a study with the same product under test; Volunteers who have congenital or acquired known immunodeficiency; Relevant medical history or current evidence of alcohol or other drugs abuse; Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator); Sponsor's employees involved in the study, or close family member of an employee involved in the study;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Evaluation of adverse effects in maximized conditions |  | 40 days |
Prone Fluid Responsiveness in Children

Study Overview
=================
Brief Summary
-----------------
In pediatric patients in the prone position, the reliability of pulse pressure variation and stroke volume variation, and pleth variability index to predict fluid responsiveness have not previously been established. Perioperatively, in this setting, optimizing fluid management can be challenging, and fluid overload is associated with both intraoperative and postoperative complications. The investigator designed this study to assess the sensitivity and specificity of baseline PPV, SVV, and PVI the tidal volume (VT) challenge (VTC) and in predicting fluid responsiveness during elective neurosurgery.

Official Title
-----------------
Study on the Prediction of Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia With Prone Position

Conditions
-----------------
Pediatric ALL

Intervention / Treatment
-----------------
* Procedure: TVC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective neurosurgery and requiring prone positioning Exclusion Criteria: (1) chronic cardiac arrhythmia; (2) depressed left (<30% of ejection fraction) (3) patients with pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tidal volume challenge<br> | Procedure: TVC<br>* Tidal volume challenge from 6ml/kg to 10ml/kg for 1 min.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid responsiveness prediction using AUC of ROC curve analysis | stroke volume index increase more than 10% from baseline after volume administration (10ml/kg) Fluid responsiveness parameters; PPV, SVV, PVI, rPVI before and after tidal volume challenge | from induction of anesthesia to end of operation, about 5 hours |
Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).

Detailed Description
-----------------
Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the international, the investigators first treat RITP with ATRA. To investigate the therapeutic effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.

Official Title
-----------------
Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia

Conditions
-----------------
Immune Thrombocytopenic Purpura

Intervention / Treatment
-----------------
* Drug: all-trans-retinoid acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of refratory idiopathic thrombocytopenic purpura Hormone and immune suppression, splenectomy is invalid Exclusion Criteria: Other autoimmune diseases
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: all-trans-retinoid acid|10 mg three times a day oral administration for 4 months|

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
-----------------
idiopathicthrombocytopenic purpura, all-trans retinoic acid, regulory T cells
Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.

Conditions
-----------------
Asthma, Bronchial, Bronchial Asthma

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma Patients treated with inhaled corticosteroid and long acting beta 2 agonist FEV1(forced expiratory volume in 1 second)>50% to 80% Exclusion Criteria: Respiratory infection within 2weeks Asthma exacerbation within 6 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Tacrolimus|nan|

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
-----------------
Tacrolimus, Immunosuppressant, Anti-asthmatic drug, Administration, inhalation
Quality of Erection Study

Study Overview
=================
Brief Summary
-----------------
The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).

Official Title
-----------------
A Multicenter, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate

Conditions
-----------------
Erectile Dysfunction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects aged 18-55 Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.) Exclusion Criteria: Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening]

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Sildenafil Citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impotence
Detection of Early Lung Cancer by Serum Protein Expression Profiling

Study Overview
=================
Brief Summary
-----------------
Promising new technology exists to examine small proteins that are shed by cancers into the blood stream. The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults.

Detailed Description
-----------------
A prospective longitudinal patient-based pilot study is proposed whereby surfaced enhanced laser desorption ionization time-of-flight mass spectroscopy (SELDI-TOF-MS) will be used to discover and validate serum proteomic expression profiles diagnostic of early lung cancer. A unique approach will be used to compare the serum proteomic expression profiles of patients with non-small cell lung cancer compared to healthy heavy smoking adults, as well as differences before and after anatomic pulmonary resection with curative intent. Discriminatory proteins will be selected by their differential expression before compared to after surgical removal of a tumor. The protein profile of blood obtained from the draining pulmonary vein at the time of resection will be used to identify materials potentially shed by the tumor that may serve as biomarkers in peripheral blood. The serum samples will be used to develop a training data set and then a test set for validation using a class prediction model. Candidate proteomic patterns will then serve as a basis for a larger prospective multi-centre clinical trial.

Official Title
-----------------
Differences in SELDI Produced Serum Protein Profiles of Non-small Cell Lung Cancer Patients Compared to Healthy Heavy Smoking Adults

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of early stage non-small cell lung cancer Elective surgical resection of lung lesion at Vancouver General Hospital (VGH) No preoperative chemoradiation therapy No previous cancer Ability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early stage (0/I) non-small cell lung cancer
Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis

Study Overview
=================
Brief Summary
-----------------
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

Detailed Description
-----------------
To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein. We perform Montelukast (10mg, q.d., p.o.) fot the treatment of symptomatic cavernous transformation of portal vein and to observe the efficacy such as the decrease of the volume of ascites and hydrothorax.

Conditions
-----------------
Portal Vein, Cavernous Transformation Of

Intervention / Treatment
-----------------
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with CTPV. Exclusion Criteria: Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 80 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 |
| --- | --- |
| CTPV without Montelukast<br>Patients with CTPV do not receive the treatment of Montelukast. | |
| CTPV treated with Montelukast<br>Patients with CTPV treated with Montelukast (10mg, q.d., p.o.). | Drug: Montelukast<br>* Montelukast (10mg, q.d., p.o.)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascites Volume (mL) | Ascites measured by CT scanning or ultrasound (If the patients had the history of ascites before) | 6 month | 
| Hydrothorax Volume (mL) | Hydrothorax measured by CT scanning or ultrasound (If the patients had the history of hydrothorax before) | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Portal Vein, Cavernous Transformation Of, Hypertension, Portal
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear vs. Systane for Dry Eye Signs, Symptoms & Refractive Regression Associated With Myopic Laser in Situ Keratomilieusis (LASIK).

Study Overview
=================
Brief Summary
-----------------
This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive regression in these patients. The 'Refractive Outcome' data point will be defined as the difference between the post-op spherical equivalent (SE) and the pre-op targeted SE.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: PEG- 400 based artificial tear
* Drug: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ranging from normal to mild dry eye per physician assessment BCVA of 20/20 Moderate to high myopia (-3 D to -10D of sphere) Patients who are scheduled to under go myopic bilateral LASIK with VISX laser Exclusion Criteria: Patients currently using topical cyclosporine Patients currently using Systane Patients currently using an oil-based artificial tear such as Soothe or Endura Any post-op epithelial defects or flap complications requiring further procedures (relifting, scraping, stretching etc.) DLK greater than stage 1 or infectious keratitis post-operatively Any uncontrolled systemic disease that may confound the results of this trial (Diabetes, Lupus, Rheumatoid Arthritis etc.) Anisometropia greater than 1D

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>1. PEG-400 based artificial tear | Drug: PEG- 400 based artificial tear<br>* Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily<br>|
| Active Comparator: 2<br>2. Systane | Drug: Systane<br>* Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dry eye signs |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| refractive regression |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye signs and symptoms, refractive regression
Factor Influencing Breast Surgery Type Decision-Making

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer. The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data: Demographic Health Status Several factors that may influence the decision Participants will complete a well-structured and organized online survey

Official Title
-----------------
Factors Influencing the Decision-making Process for Breast Surgery in Women Likely to Face Breast Cancer.

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

Intervention / Treatment
-----------------
* Procedure: Breast Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lebanese Females Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Breast Surgery|Breast-conserving Surgery or modified radical mastectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influencing Factors | Factors influencing breast surgery type decision making process | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Mastectomy, Breast Conserving Surgery, Lebanese Population, Surgical Choice, Oncoplastic Surgery