linjc16/ctgov huggingface dataset:
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.

Official Title
-----------------
Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: Lactoserum (Dermacyd Femina®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in reproductive age Confirmed cure of bacterial vaginosis after treatment with oral metronidazole. Vaginal bacterioscopic examination negative for candida and trichomonas. Exclusion Criteria: Pregnant or breastfeeding women Allergy to dermacyd The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Lactoserum (Dermacyd Femina®)<br>* Once a day during three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence of bacterial vaginosis after three months of treatment. |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Three months | 
| Vaginal Candidiasis |  | Three months | 
| AE, particularly genital irritation (tolerability use of dermacyd) |  | During the study |
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.

Official Title
-----------------
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease: Pilot Study

Conditions
-----------------
Angina Pectoris, Variant

Intervention / Treatment
-----------------
* Device: BVS+OMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram No-ischemia producing moderate coronary artery disease(stenosis>50%, FFR>0.8) Exclusion Criteria: Ischemic coronary lesion Organic heart disease associated with myocardial ischemia or sudden cardiac death History of percutaneous coronary intervention Cerebrovascular diseases or peripheral disease NYHA III and IV Cardiac pacemaker or implantable defibrillator Pregnancy or breast feeding Life expectancy less than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BVS and OMT<br>Optimal medical treatment + BVS implantation | Device: BVS+OMT<br>* bioresorbable vascular scaffold implantation plus optimal medical treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all cause death, myocardial infarction, and angina-related hospitalization |  | 2year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variant angina | by Ergonovine test | 2year | 
| All cause death |  | 2year | 
| Cardiac death |  | 2year | 
| Repeat revascularization |  | 2year | 
| Scaffold thrombosis |  | 2year | 
| Myocardial infarction |  | 2year | 
| Stroke |  | 2year | 
| Angina-related hospitalization |  | 2year | 
| Composite event of death or myocardial infarction |  | 2year | 
| Composite event of cardiac death or myocardial infarction |  | 2year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioresorbable vascular scaffold, variant angina, moderate coronary artery disease, vasospastic angina
Cost Effectiveness Of Linezolid In Central America

Study Overview
=================
Brief Summary
-----------------
The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN) for the treatment of nosocomial Pneumonia associate to ventilator (VAP).

Official Title
-----------------
Cost Effectiveness Of Linezolid Vs Vancomycin In The Treatment Of Ventilator Acquired Pneumonia In Central America

Conditions
-----------------
Ventilator Acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: Linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of a legally acceptable representative signed and dated informed consent document indicating that him or her has been informed of all pertinent aspects of the study. Adult (18 years old or older) men and women with confirm diagnosis of VAP treated on ICU with LIN or VAN; on the selected institutions. Exclusion Criteria: Adult men or women with nosocomial pneumonia not associated to a ventilator.

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 |
| --- | --- |
| Central America and the Caribbean<br>Panama, Costa Rica, Honduras, El Salvador and Nicaragua | Drug: Linezolid<br>* Treatment for VAP as indication approved and as physician criterium.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin. |  | 4 months | 
| Rate of renal failure. |  | 4 months | 
| Rate of healing with Linezolid. |  | 4 months | 
| Rate of healing with Vancomycin. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization days average with VAN and Linezolid. |  | 4 months | 
| Variation of prices and values among the different institutions. |  | 4 months | 
| The average costs of each intervention. |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cost effectiveness, linezolid, ventilator acquired pneumonia, central america
The Significance of Sentinel Node Analysis in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This study is for the patient with colon cancer, who is going to have colon cancer surgery. The purpose of this research study is to examine a specific lymph node, called the sentinel node. Lymph nodes are located throughout your body and cancer may spread by means of those lymph nodes. The sentinel node is the one located closest to your tumor. This study will find out if examining the sentinel node can help to predict disease progression. Since the value of this exam is unknown, taking part in this study will not change your clinical care.

Official Title
-----------------
The Significance of Sentinel Node Analysis in Colon Cancer

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must consent to participate in study Patients will be tracked for five years A blood test (CEA) will be collected every six months A CT scan will be performed annually A colonoscopy will be performed at 1 and 5 years post-surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- |
|Procedure: Colectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
InterGard Synergy Post-Marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Detailed Description
-----------------
Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.

Official Title
-----------------
InterGard Synergy Post-Marketing Surveillance Study

Conditions
-----------------
Aortic Aneurysm, Abdominal, Occlusive Disease of Artery of Lower Extremity

Intervention / Treatment
-----------------
* Device: InterGard Synergy Vascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring an InterGard Synergy Vascular Graft Exclusion Criteria: Patients with contra-indications per InterGard Synergy Vascular Graft Patients with current graft infection Patients with a known allergy to collagen, triclosan or silver acetate Patients who require urgent or emergent surgery
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: InterGard Synergy Vascular Graft<br> | Device: InterGard Synergy Vascular Graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Patency and Complications | Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation. Complications including the occurrence of graft infections will be assessed up to post implantation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Mortality rate will be assessed up to 6 months post implantation. | 6 months |
Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.

Detailed Description
-----------------
This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Official Title
-----------------
A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: Hu5F9-G4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment. Adequate hematologic status Adequate coagulation function Adequate hepatic function Adequate renal function Exclusion Criteria: Known primary tumors of central nervous system disease Known active brain metastases Known cardiopulmonary disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Hu5F9-G4)<br>Hu5F9-G4 monotherapy | Drug: Hu5F9-G4<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Hu5F9-G4 | The CTCAE criteria will be used to assess adverse events on this trial. | The first 28 days on study, for determination of Dose Limiting Toxicities |
Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The energy and nutrition states are closely associated with dialysis patients' complications and outcomes. To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations do not focus on and applicable to peritoneal dialysis patients, so we aim to develop and validate an equation for estimating resting energy expenditure in peritoneal patients.

Official Title
-----------------
Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients

Conditions
-----------------
Resting Energy Expenditure, Peritoneal Dialysis, Equation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal dialysis patients and hemodialysis patients Dialysis length >3 months >18 years old Consented to participate in all aspects of the study Exclusion Criteria: Acute complications to hospitalization 1 month prior to the study; Acute or chronic infections, cancer, and other wasting diseases in the past year; Thyroid dysfunction; Acute onset of podagra; Musculoskeletal diseases; Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD); History of hormonal drug use; During pregnancy or lactation; Can not maintain posture and complete the REE test.

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 |
| --- | --- | --- |
| Novel equation development | Developed equation for estimating resting energy expenditure in peritoneal dialysis patients | March 18, 2021 to October 30, 2021 | 
| Novel equation validation | Validate the novel equation with resting energy expenditure obtained by indirect calorimetry (IC). | October 30, 2021 to December 30, 2021 |
Japanese CTO PCI Expert Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a consensus of treatment strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI for CTO performed by Japanese certified operators.

Official Title
-----------------
Patient Registry of Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusion (CTO) by Japanese Experts

Conditions
-----------------
Chronic Total Occlusion of Coronary Artery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for PCI Patients who underwent PCI for CTO lesions that contain the following: Thrombolysis in myocardial infarction trial (TIMI) 0 The occlusive period more than 3 months or unknown The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft Exclusion Criteria: Patients ineligible for PCI judged in clinical practice

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| PCI for CTO<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up | early and late results on major adverse cardiocerebral events (MACCE): all-cause death, coronary artery bypass grafting, re-PCI (target lesion revascularization/target vessel revascularization), admission for heart failure, myocardial infarction, admission for unstable angina, cerebrovascular disease, stent thrombosis in 19000 patients in and outside Japan | within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up |
Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
Vitamin D supplementation in patients with uterine fibroids who present hypovitaminosis D to re-establish their normal serum values could stabilize the size of the uterine fibroids and thus prevent their growth or reduce their size thanks to the anti-proliferative action of Vitamin D on the myoma cells.

Official Title
-----------------
Pilot Clinical Study to Evaluate the Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency

Conditions
-----------------
Size of the Uterine Fibroids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with at least one fibroid > 3 cm With hypovitaminosis D (25(OH)D < 30 ng/ml) BMI < 30 No hormonal treatment in the 3 months prior to the ultrasound study Exclusion Criteria: Black race Symptomatic fibroids subsidiary to hormonal or surgical treatment Desire of gestation in the next 6 months Presence of degenerating adenomyosis or fibroids Treatment with sexual hormones: mifepristone, aGnRH or any other medication that may interfere with fibroids. History of neoplasia of gynecological origin and/or existence of uterine malformations. Hypercalcemia or abnormal liver or kidney function is present

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of the uterine fibroids |  | 3 months |
Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangiopancreatography

Study Overview
=================
Brief Summary
-----------------
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.

Detailed Description
-----------------
There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.

Official Title
-----------------
EXEMPT: Prospective Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangio-pancreatography (ERCP)

Conditions
-----------------
Biliary Stricture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ERCP Patients Exclusion Criteria: Non ERCP Patients
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 |
| --- | --- | --- |
| To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, Positive Biliary Brush Cytology