linjc16/ctgov huggingface dataset:
The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.

Detailed Description
-----------------
Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo. All patients are treated for 10 days.

Official Title
-----------------
The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study

Conditions
-----------------
Herpes Simplex, HIV Infections

Intervention / Treatment
-----------------
* Drug: Valacyclovir hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Serologically documented HSV-2 and HIV-1 infection. History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study. No contraindications to valacyclovir. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Hepatic impairment. Impaired renal function (creatinine above 2 mg/dl). Malabsorption syndrome or other gastrointestinal dysfunction. Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol. Patients with the following prior conditions are excluded: History of hypersensitivity to acyclovir or valacyclovir. Prior Medication: Excluded: Participation in any investigational drug trial within 1 month prior to entry on study. Systemic anti-HSV therapy within 7 days prior to start of study drug. 1. Probenecid. Suppressive treatment with medication that has anti-HSV activity. Required: - Stable antiretroviral therapy or no therapy for at least 1 month.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valacyclovir hydrochloride|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
-----------------
HIV-1, Antiviral Agents, Herpes Genitalis, Recurrence, DNA, Viral, RNA, Viral, valacyclovir, Herpesvirus 2, Human
SSR240600C Treatment in Women With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.

Official Title
-----------------
A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: SSR240600C
* Drug: tolterodine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of overactive bladder Exclusion Criteria: Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence) Current Urinary Tract Infection (UTI) or frequent UTIs Urinary retention or other evidence of poor detrusor function Pain during voiding or bladder pain without voiding History of radiation cystitis or history of pelvic irradiation History of interstitial cystitis or bladder related pain syndrome The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSR240600C Dose Level 1<br> | Drug: SSR240600C<br>* oral administration<br>|
| Experimental: SSR240600C Dose Level 2<br> | Drug: SSR240600C<br>* oral administration<br>|
| Experimental: SSR240600C Dose Level 3<br>dose level 3 | Drug: SSR240600C<br>* oral administration<br>|
| Active Comparator: Tolterodine<br> | Drug: tolterodine<br>* oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of micturitions per 24 hours |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void |  | at week 12 | 
| Safety of SSR240600C |  | at week 12 | 
| Quality of life |  | at week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urge urinary incontinence
SARS-CoV-2 (COVID-19) and Surgery

Study Overview
=================
Brief Summary
-----------------
Importance: During COVID-19 pandemic, it is necessary to collect and analyze data concerning management of hospitals and wards in order to work out solutions for potential future crisis. Objective: The objective of the study was to investigate how surgical wards in Poland are managing during the COVID-19 pandemic. Design, Setting and Participants: An anonymous, online survey was designed and published on the official website of The Association of Polish Surgeons. Data was collected between March the 30th and April the 6th of 2020. After data analysis responders were divided into two groups: Group 1 (responders currently working in a COVID-19-dedicated hospital) and Group 2 (responders currently working in non-COVID-19-dedicated hospital). The study group included Polish surgeons and surgery residents working in surgical departments during pandemic.

Detailed Description
-----------------
Main outcomes and Measures: Descriptive data on perceptions of current status of surgical wards during the pandemic and impact of the pandemic on conducting surgery.

Official Title
-----------------
Surgical Care in Poland After COVID19 Outbreak - a National Survey Study

Conditions
-----------------
Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Other: No intervention (survey study for medical doctors).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study group included Polish surgeons and surgery residents working in surgical departments during pandemic, who granted an informed consent to participate in the study. . Exclusion Criteria: Retired surgeons, physicians and residents with non-surgical specializations, medical interns, medical students, other health-care professionals were excluded from this study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Responders currently working in a COVID-19-dedicated hospital, which was transformed by Polish Ministry of Health during SARS-CoV-2 pandemic into institution designated only for SARS-CoV-2 patients, including those developing symptoms and quarantined. | Other: No intervention (survey study for medical doctors).<br>* No intervention<br>|
| Group 2<br>Responders currently working in non-COVID-19-dedicated hospital. | Other: No intervention (survey study for medical doctors).<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive data on perceptions of current status of surgical wards during the pandemic and impact of the pandemic on conducting surgery. |  | 1 month |
Endocardial Stem Cells Approach Efficacy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival compared to MED alone

Official Title
-----------------
Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Procedure: Autologous bone marrow mononuclear stem cells or peripheral blood stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women who are not of childbearing potential Age 21-75 years. Patients with CAD, NYHA and CCS angina III-IV functional class LVEF less than 35% measured by echocardiography or SPECT within three months of study entry Unsuitable for initial or repeated conventional revascularization (CABG or PCI) Exclusion Criteria: Failure to provide informed consent. Plan for PCI or CABG. Non-cardiac illness with a life expectancy of less than 3 year. Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode). Previous heart, kidney, liver, or lung transplantation. Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device. Recent acute myocardial infarction (AMI) within 90 days of study entry Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment History of moderate to severe aortic stenosis or prosthetic aortic valve Permanent atrial fibrillation Thrombosis in LV, based on echocardiography data

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous bone marrow mononuclear stem cells or peripheral blood stem cells|Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1 |  | 2007-2010 |
Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. The objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. Body composition was assessed by computed tomography (CT) and bioelectrical impedance test was conducted to evaluate the phase angle. Handgrip strength was used to determine functionality. The percentage of weight loss in relation to usual weight was the anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis. Postoperative complications were classified according to the Dindo and Clavien classification. Overall time survival was the period between the first assessment of the patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and the Log Rank test and regression analysis will be used (p <0.05).

Official Title
-----------------
Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients

Conditions
-----------------
Cancer, Postoperative Complications, Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic cancer confirmed Over 18 years old Accepted the terms of survey Exclusion Criteria: Tumor synchronic Inflamattory disease Under 18 years old No accepted the terms of survey

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 |
| --- | --- |
| Cancer group 1<br>Colorectal cancer patients, under 18 years old, no inflammatory disease, weight loss greater 10% habitual body weight, sarcopenic. | |
| Control group<br>No cancer patients, under 18 years old, no inflammatory disease, no weight loss, no sarcopenic. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | According to the Dindo-Clavien protocol | August, 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Follow up using medical records and telephone contacts | July, 2016 |
Measurement of Vaginal Squeeze Pressure in Incontinent Patients

Study Overview
=================
Brief Summary
-----------------
The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

Detailed Description
-----------------
Several techniques had been proposed for pelvic floor muscles assessment, however none of them were able to measure the two main functions of these muscles: rising and force of compression. Vaginal palpation is frequently used in clinical evaluation routine and especially the modified Oxford score, but some articles question the Oxford scale sensitivity and its correlation with objective force contraction measurements. Methods: 45 patients with urinary incontinence treated at the Uroginecology Ambulatory Service of the Hospital de Clínicas de Porto Alegre were included. The patients had been submitted to vaginal palpation using the Oxford score, assessed by a skilled physical therapist, and to the compression force measurement by means of an air filled ballonet connected to a pressure transducer. The two evaluations had been carried in the same day.

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stress, urge or mixed stress and urge urinary incontinence. Understanding and signing a letter of informed consent Exclusion Criteria: Urinary tract infection. Genitourinary surgery during the previous six months. Pregnancy or in puerperal period. BMI > 40

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perineometry, Modified Oxford Score, pelvic muscles evaluation, urinary incontinence, vaginal palpation
Chest Compression and Sustained Inflation

Study Overview
=================
Brief Summary
-----------------
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.

Official Title
-----------------
Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants

Conditions
-----------------
Newborn Infants Having Asystole or Bradycardia at Birth

Intervention / Treatment
-----------------
* Procedure: CC+SI
* Procedure: 3:1 CPR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn infants with asystole Newborn infants with bradycardia Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI+CC<br>Chest compression will be superimposed by sustained inflations during CPR: CC+SI group Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC. | Procedure: CC+SI<br>* Chest compression will be superimposed by sustained inflation during CPR<br>|
| Active Comparator: 3:1 CPR<br>CPR using 3:1 C:V ratio: 3:1 C:V group Infants randomized into the 3:1 group requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. | Procedure: 3:1 CPR<br>* CPR using 3:1 ratio (control group)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to achieve Return of Spontaneous Circulation | We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique | within the first 10 minutes after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest compression, Delivery Room, NICU,
COPING With COVID-19( CWC-19)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is 1) to understand effects of COVID-19 crisis on wellness of pulmonary and critical care faculty and trainees who are at frontline fighting this pandemic 2) Assess the effectiveness of series of weekly web based crisis management coaching from world renowned experts in coaching and 3) identify future areas of opportunities in physician wellness

Official Title
-----------------
Effectiveness of Crisis Management Coaching on Faculty and Trainee Wellness During COVID-19 Crisis

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Behavioral: Crisis management coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any faculty, staff, or trainee from Duke pulmonary and critical care that consents to being in the study Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Care Workers<br>Faculty, staff, and trainees dealing with COVID-19 pandemic | Behavioral: Crisis management coaching<br>* Crisis management coaching will be offered to faculty, staff, and trainees dealing with COVID-19 pandemic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress level as measured by survey |  | Baseline, mid-session (up to 4 weeks), post-intervention (up to 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change wellness as measured by survey | Survey is 14-items asking about wellness on a scale from Strongly Agree to Not at all | Baseline, mid-session (up to 4 weeks), post-intervention (up to 8 weeks) |