linjc16/ctgov huggingface dataset:
Collecting Information From Patients Enrolled in the Breast Specialized Program of Research Excellence

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting and storing information from patients with cancer to study in the future may help doctors learn more about cancer. PURPOSE: This study is collecting information from patients enrolled in the Breast Specialized Program of Research Excellence.

Detailed Description
-----------------
OBJECTIVES: Provide a database for administrative and biostatistical support for the Breast Specialized Program of Research Excellence. OUTLINE: Data is collected from patients for future research studies. PROJECTED ACCRUAL: A total of 535 patients will be accrued for this study.

Official Title
-----------------
The Breast Cancer Specialized Program of Research Excellence (SPORE): Core A-Administrative/Biostatistics Core

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

Intervention / Treatment
-----------------
* Other: informational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of breast cancer PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: informational intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administrative and biostatistical support for the Breast Specialized Program of Research Excellence |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer
Etiology of Lymphopenia in Covid19 Infection

Study Overview
=================
Brief Summary
-----------------
Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.

Detailed Description
-----------------
Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm. Correlation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients.

Official Title
-----------------
Study of the Etiology of Lymphopenia in Covid19 Viral Infection

Conditions
-----------------
Lymphopenia

Intervention / Treatment
-----------------
* Diagnostic Test: Complete blood picture, bone marrow aspiration cytology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient admitted with the diagnosis of Covid19 viral infection Exclusion Criteria: Any patient who died within one day of admission
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic or mild symptoms patients patients<br>Patients with no or mild symptoms and need no respiratory support. | Diagnostic Test: Complete blood picture, bone marrow aspiration cytology<br>* none except the regular routine investigations in such cases<br>|
| Severe symptoms patients<br>Patients who need admission to ICU because he needs oxygen by nasal canula and needs drugs whether azthromycin or remdesivir according to treatment protocol. | Diagnostic Test: Complete blood picture, bone marrow aspiration cytology<br>* none except the regular routine investigations in such cases<br>|
| Critically ill patients<br>Patients who need artificial ventilation because of many causes and may need plasma from convalescent patients | Diagnostic Test: Complete blood picture, bone marrow aspiration cytology<br>* none except the regular routine investigations in such cases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or recovery | Follow up | Up to 24 weeks |
Evaluation of the Muscle Strength and Motor Ability in Children With Spinal Muscle Atrophy(SMA) Treated With Valproic Acid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the treatment with valproic acid can increase the muscle strength and motor ability of children with spinal muscular atrophy.

Detailed Description
-----------------
Spinal muscular atrophy (SMA) is an autosomal recessive disorder that affects the motoneurons of the spinal anterior corn, resulting in hypotonia and muscle weakness. The knowledge about its molecular mechanism has led to clinical tests with drugs that increase survival motor neuron (SMN) protein level. The valproic acid (VA) that acts as a histone deacetylase inhibitor activates the SMN2 gene increasing the protein level. Methods: Twenty-two patients with type II and III SMA, aged between 2 and 18 years old, were treated with VA and were evaluated five times along a period of one year using the Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score, and the Barthel Index. The first evaluation was coincident with the introduction of VA. Results: After 12 months of therapy, the patients did not gain muscle strength but their motor ability has improved. Children younger than 6 years of age had a higher pronounced gain in motor ability. Conclusion: treatment of SMA patients with VA is one alternative to alleviate the progression of the disease.

Official Title
-----------------
Evaluation of the Muscle Strength and Motor Ability in Children With Spinal Muscle Atrophy Type II and III Treated With Valproic Acid

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regularly attended at the Out-patient Service of Neuromuscular Disorders and Child Neurology of our Institution; More than 2 years olf and had a molecular analysis of Spinal Muscular Atrophy; Exclusion Criteria: Had been submitted into a surgery recently; Did not come to the evaluation and medical sessions: Did not take the medication correctly

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 |
| --- | --- | --- |
| Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular atrophy, Valproic acid, HMAS, MRC scale
Topical vs Oral Metronidazole After Benign Anorectal Surgery

Study Overview
=================
Brief Summary
-----------------
While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results. No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.

Official Title
-----------------
Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study

Conditions
-----------------
Hemorrhoids, Anal Fissure, Anal Fistula

Intervention / Treatment
-----------------
* Drug: Topical metronidazole
* Drug: oral metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either sex aged below 70 years Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula. Exclusion Criteria: Grade I-II hemorrhoids. acute anal fissure. complex anal fistula perianal abscess perianal Crohn's disease malignancy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical metronidazole<br>Topical application of metronidazole cream on the anal verge after surgery | Drug: Topical metronidazole<br>* Topical application of metronidazole cream on the anal verge every 8 hours after surgery<br>|
| Active Comparator: Oral metronidazole<br>oral metronidazole 500 mg tablets after surgery | Drug: oral metronidazole<br>* Patients received oral metronidazole 500 mg tablets every 8 hours after surgery<br>|
| No Intervention: Control<br>No metronidazole was received | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain | at one day after surgery | 
| Postoperative pain score | Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain | at two days after surgery | 
| Postoperative pain score | Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain | at seven days after surgery |
Biorepository to Support Research in Kidney Diseases

Study Overview
=================
Brief Summary
-----------------
To support advances in the understanding of pathophysiology and therapies of kidney diseases by creating a BioBank of kidney tissue, DNA, plasma, and urine from patients with kidney diseases.

Detailed Description
-----------------
A biorepository of human samples to support research to advance understanding of human kidney diseases will be created. Clinically, kidney diseases are detected by blood and urine laboratory tests. However, the underlying cause of kidney disease is often not clear on blood and urine tests. In such cases, a clinician may choose to perform a kidney biopsy to establish the diagnosis. Patients who are scheduled to undergo a kidney biopsy will be invited to participate in this proposed study.

Official Title
-----------------
Biorepository to Support Research in Kidney Diseases

Conditions
-----------------
Acute Kidney Injury, Acute Interstitial Nephritis, Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo a clinically indicated kidney biopsy English speaking Exclusion Criteria: Under 18 years or age Known pregnancy Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study) Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Biorepository<br>Participants who contributed biospecimen samples (kidney tissue, blood, urine, DNA). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological diagnosis | Histological diagnosis of kidney disease determined by evaluation by renal pathologists | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of chronic kidney disease, end stage kidney disease or death | Track outcomes in participants recruited for up to 10 years | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Kidney Disease, Acute Kidney Injury, Kidney biopsy, Kidney Biorepository
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

Official Title
-----------------
A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: MT10109


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment. Women of childbearing potential must have a negative serum pregnancy test at screening Exclusion Criteria: Patients with an inability to substantially lessen glabellar lines by physically spreading them apart. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication Patients with an anaphylactic response history to botulinum toxin type A. Patients who have been administered botulinum toxin type A within the previous 6 months. Pregnant or lactating women. Participation in any research study involving drug administration within 90 days preceding enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: MT10109<br>Clostridium botulinum toxin type A | Biological: MT10109<br>* Single dose intramuscular injection MT10109 vs Botox®<br>|
| Active Comparator: Botox (registered trade mark)<br>Clostridium botulinum toxin type A | Biological: MT10109<br>* Single dose intramuscular injection MT10109 vs Botox®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's rating of glabellar line severity at maximum frown by live assessment. |  | at Day 30 |
Effects of PA-1 Transcriptional Regulation on Monocyte Function

Study Overview
=================
Brief Summary
-----------------
Researching genetic differences in people with no prior medical conditions for better understanding of cardiac diseases through genetic research.

Detailed Description
-----------------
The discovery and subsequent application of small interfering RNA (siRNA) methods to achieve individual gene silencing in mammalian cells is a robust method that is well-described and validated in mammalian cell culture systems. We will apply this technique to achieve post-transcriptional silencing of PAI-1 in monocytes obtained from otherwise healthy volunteers, and study the subsequent loss of this gene's function on the migratory capacity of these cells in the proposed in vitro experimental system. This concept has not yet been demonstrated in the literature, and if validated, would be a novel and fundamental description of the role of PAI-1 in human monocyte biology as related to the development of atherosclerosis.

Official Title
-----------------
Angiotensin, the Vascular Endothelium, and Fibrinolysis - The Effects of PAI-1 Transcriptional Regulation on Human Monocyte Function

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 -50 No current or past medical problems Exclusion Criteria: Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic pathways, Atherosclerosis, Monocyte Function
Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used: to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and to predict progression of heart failure in patients with ICD.

Official Title
-----------------
Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure

Conditions
-----------------
Arrhythmia, Congestive Heart Failure, Sudden Cardiac Death, Cardiomyopathies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of acute MI at least 4 weeks old non-ischemic LV dysfunction for at least 9 months who have an EF < or = to 35% who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia) undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD Exclusion Criteria: inability or unwillingness to provide valid informed consent pregnancy any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP) |  | from enrollment up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite heart failure outcome (HF hospitalization, HF death, heart transplant) |  | from enrollment up to 72 months | 
| All-cause mortality |  | from enrollment up to 72 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, Cardiac Arrest, Cardiomyopathy, Heart Failure
Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound

Study Overview
=================
Brief Summary
-----------------
To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.

Detailed Description
-----------------
Objectives: To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound. To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure. Methods: The study design is prospective observational study. We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured. The data will be analyzed.

Official Title
-----------------
Validity and Reliability of Non-invasive Estimation of Central Venous Pressure by Measurement of Internal Jugular Size Using 2-dimensional Ultrasound

Conditions
-----------------
Internal Jugular Size Measured by Ultrasound, Central Venous Pressure

Intervention / Treatment
-----------------
* Diagnostic Test: cross sectional area


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for cardiac surgery need central venous catheterization intraoperatively elective surgery age > 18 Exclusion Criteria: neck pathology history of internal jugular or SVC thrombosis limited neck mobility severe valvular lesion decompensated heart failure

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 |
| --- | --- |
| cross sectional area<br>internal jugular cross sectional area measured by ultrasound | Diagnostic Test: cross sectional area<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| internal jugular size | Cross-sectional area of internal jugular vein measured by ultrasound | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
internal jugular vein, cross sectional area, ultrasound, central venous pressure