linjc16/ctgov huggingface dataset:
Cardiovascular Risk Factors in a Cohort of Latina Women

Study Overview
=================
Brief Summary
-----------------
To conduct a cross-sectional study of cardiovascular risk factors in a cohort of Latina women.

Detailed Description
-----------------
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death among Latina women (LW) in the United States. Nursing knowledge in the area of CVD and Latina women is currently underdeveloped. Most studies have included Mexican women with limited information on how predictors such as resources, situational, personal, and demographic factors have an effect on the CVD-related dietary practices, physical activity, and exercise practices among Latina women subgroups such as Central American women. DESIGN NARRATIVE: To conduct a cross-sectional and follow-up preliminary intervention study in order to describe and analyze the CVD-related diet, physical activity, and exercise practices predictors in 221 Mexican and Central American women recruited from six counties in Northern California. Face-to-face interviews were conducted with Mexican American and Central American women (ages 40-75) who had at least one risk factor for CVD to answer the following questions: What were the CVD-related risk factors, dietary practices, physical activity, and exercise behaviors in Mexican and Central American women who were 40 to 75 years and who had at least one risk factor for CVD? What was the relationship between predictor variables (resources, situational, personal, and demographic factors) with CVD-related diet practices, physical activity, and exercise behaviors (outcome variables)?, and what were the short and intermediate-term effects of a cardiovascular nursing intervention on diet, physical activity, and exercise? A sample of 221 women was targeted. Data were collected during the first two years of the project to provide substantial research-based information to develop a cardiovascular nursing intervention to support Latina women efforts to promote heart health and prevent CVD. Data were analyzed during the third year and the cardiovascular nursing intervention was developed to determine the short (3 months) and intermediate-term (6 months) effects in the outcome variables. A randomly selected sample of 60 women from the same cohort was randomly assigned to the developed intervention group (n=30 in each group) and to a delayed-intervention control group. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Frailty Assessment Among Kidney Transplant Candidates

Study Overview
=================
Brief Summary
-----------------
Frailty is common among chronic kidney disease patients who are on the kidney transplant (KT) waiting list. The aim of this study is to assess frailty according to different frailty tools among KT candidates and to establish potential biomarkers of frailty.

Detailed Description
-----------------
This is an observational study where KT candidates will be assessed for frailty according to: Frailty Fried Phenotype and FRAIL scale Sociodemographics and clinical variables will be collected and serum samples will be obtained in order to implement further studies regarding biomarkers of frailty..

Official Title
-----------------
Frailty Assessment Among Kidney Transplant Candidates on the Waiting List

Conditions
-----------------
Frailty, Kidney Transplant; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: KT candidates accepted for the KT waiting list Exclusion Criteria: No willing for participating Difficulty in understanding Spanish or English

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 |
| --- | --- | --- |
| Prevalence of frailty among KT candidates | Prevalence of frailty according FRIED and FRAIL scale | 2015-2020 | 
| Biomarkers of frailty among KT candidates | Serum samples for biomarkers | 2015-2020 |
Impact of Adult Asthma

Study Overview
=================
Brief Summary
-----------------
To assess the separate and interactive effects of asthma severity, subspecialty practice variation, asthma-related psychosocial variables, and other factors on asthma outcomes, including asthma-specific quality of life and activity limitations, health care utilization for asthma, and direct and indirect costs of asthma.

Detailed Description
-----------------
BACKGROUND: Asthma is both common and costly. Neither the risk factors of poor outcome nor the predictors of better outcome are well understood. Illness severity is clearly an important predictive factor in asthma, but may explain less variability in outcome than other determinants, such as patient-perceived asthma control, other asthma-related psychosocial measures, and the kind and extent of subspecialty care for asthma. By quantifying predictors of asthma-specific quality of life, functional status, services utilization, and the direct and indirect illness costs of asthma, this study addressed a major research gap in secondary and tertiary prevention efforts. DESIGN NARRATIVE: A random sample of pulmonary and allergy subspecialists initially enrolled 600 persons with asthma identified in patient visit logs. This established panel completed 45 minute baseline and follow-up computer-assisted telephone interviews (CATI); 539 (90%) were successfully re-interviewed after 18 months of follow-up. A supplemental sampling frame of persons with asthma identified from family practitioners was completed as was a group with rhinitis but without asthma. Interviews assessed disease severity and other covariables using validated survey instruments. Pulmonary function and medical records were used to validate severity in a sub-sample of subjects. The study extended longitudinal follow-up study of this initial cohort. Its analysis tested predictive models for the asthma outcomes of interest. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
D-dimer Levels in Pregnant With COVID-19

Study Overview
=================
Brief Summary
-----------------
D-dimer measurements act as a global indicator of coagulation and activation of fibrinolytic systems. An optimal cut-off value for D-dimer and its effect on prognosis has not yet been assessed to predict mortality in admission. Therefore, studies comparing D-dimer values of COVID-19 patients and healthy pregnant women are needed. Our study gives us the opportunity to make this comparison.

Official Title
-----------------
Assessment of D-dimer Levels in Pregnant Women Diagnosed With COVID-19

Conditions
-----------------
COVID-19, D-dimer

Intervention / Treatment
-----------------
* Other: Blood D-dimer assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with COVID-19 Exclusion Criteria: - Having a chronic disease that raises D-dimer levels

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Healthy pregnant women | Other: Blood D-dimer assay<br>* Blood samples will be taken from the patients and will be examined by the ELISA method.<br>|
| Study Group<br>Pregnant women with COVID-19 | Other: Blood D-dimer assay<br>* Blood samples will be taken from the patients and will be examined by the ELISA method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare D-dimer values of COVID-19 patients and healthy pregnant women |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
D-dimer, pregnancy, COVID-19
Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.

Detailed Description
-----------------
OBJECTIVES: To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue. To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy. OUTLINE: This is a multicenter study. Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.

Official Title
-----------------
Gene Expression Profiling Using Paraffin-embedded Tissues and the Nuclease Protection Assay in Diffuse Large B-cell Lymphoma (DLBCL) Treated With CHOP or R-CHOP: An ECOG and SWOG Correlative Study of E4494

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of diffuse large B-cell lymphoma Treated with CHOP or R-CHOP on ECOG-E4494 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genes predictive of clinical outcome |  | 1 month | 
| Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function

Study Overview
=================
Brief Summary
-----------------
Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines. Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.

Official Title
-----------------
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics

Conditions
-----------------
Cirrhosis With Ascites

Intervention / Treatment
-----------------
* Drug: hydrocortisone
* Drug: dextrose solution 5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis with ascites, with or without hepatorenal syndrome Exclusion Criteria: Age < 18 and > 75 years Shock or bacterial infection present at the inclusion or during the previous week Bleeding present at the inclusion or during the previous week Multifocal HCC Organic renal failure Hearth or pulmonary failure

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Hydrocortisone, 50 mg/6 h per day | Drug: hydrocortisone<br>* 50 mg/6 h per day<br>|
| Placebo Comparator: 2<br>dextrose solution 5% | Drug: dextrose solution 5%<br>* dextrose solution 5% 100 ml/6 h per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, Ascites, Adrenal insufficiency, Hepatorenal syndrome, Portal hypertension
Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing Syndrome.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Study Evaluating the Safety and Activity of Four Escalating Single Doses of AVE0657 in Congestive Heart Failure Patients Presenting as Cheyne-Stokes Breathing Syndrome

Conditions
-----------------
Heart Failure, Sleep Apnea Syndromes, Cheyne-Stokes Respiration

Intervention / Treatment
-----------------
* Drug: AVE0657
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of Congestive heart failure (CHF) defined as ejection fraction ≤40% by history of echocardiography data and New York heart Association (NYHA) class II-III and of typical cyclic crescendo and decrescendo change in breathing amplitude AHI ≥10 and <60 and majority of the apneas to be ≥60% central in origin. Exclusion Criteria: Subject on supplemental oxygen 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: 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: Dose Level 1<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Experimental: Dose Level 2<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Experimental: Dose Level 3<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Experimental: Dose Level 4<br> | Drug: AVE0657<br>* capsules once a day at bedtime<br>|
| Placebo Comparator: Placebo<br>12 subjects: 3 subjects per dose level | Drug: placebo<br>* capsules once a day at bedtime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Apnea Hypopnea Index (AHI) |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cheyne-stokes breathing
RT-PCR Database Analysis for COVID-19 Infections and Re-infection

Study Overview
=================
Brief Summary
-----------------
The SARS-Cov2 pandemic remains associated with many concerns. One of the them is the real frequency of likely re-infection and subsequently the level of protection conferred by the acquired immunity following primary-infection. We propose to analyze a large set of laboratory data produced since the early beginning of the SARS-Cov2 spread in the French population to identify recurrent infection events and, more generally, gain insight about infection kinetics.

Official Title
-----------------
SARS-Cov2 (COVID-19) Infection and Reinfection Through the Analysis of a RT-PCR Results Database

Conditions
-----------------
Covid-19, SARS-CoV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - People with at least one positive SARS-Cov2 RT-PCR result with a known sampling date Exclusion criteria: - Patient refusing to participate in research
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 |
| --- | --- | --- |
| SARS-CoV-2 reinfection rate | SARS-CoV-2 reinfection rate | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-Cov2 infection, Positive SARS-Cov2 RT-PCR, SARS-Cov2 immune status, reinfection, kinetics, Rt-PCR, immunity
Post-Cholecystectomy Quality of Life

Study Overview
=================
Brief Summary
-----------------
The study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones.

Official Title
-----------------
Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy

Conditions
-----------------
Gallstone

Intervention / Treatment
-----------------
* Other: No intervention, observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic cholecystectomy patients indication for operation symptomatic gallstones Exclusion Criteria: previous complication of gallstone disease indication for cholecystectomy other than symptomatic gallstones illness significantly lowering quality of life inability to fill in questionnaires denies participation

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

| Intervention/Treatment |
| --- |
|Other: No intervention, observational|Observation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: Gastrointestinal Quality of Life GIQLI score | 10 point improvement in Gastrointestinal Quality of Life GIQLI score | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholecystectomy, quality of life
Randomized Clinical Trial to Evaluate the Predictability of 5.5 mm Dental Implants

Study Overview
=================
Brief Summary
-----------------
The main aim of this clinical trial is to analyze the survival rate of short-length implants (<4.5 mm) in partial edentulism subjects. 6.5 mm length implants will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.

Official Title
-----------------
Randomized Clinical Trial to Evaluate the Predictability and Evolution of Extra-short 5.5 mm Dental Implants Splinted in Partial or Complete Prostheses

Conditions
-----------------
Partial-edentulism

Intervention / Treatment
-----------------
* Device: BTI Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Clinical indication to place a prosthetic bridge supported by a maximum of 4 implants in the posterior sectors Bone height in the area of interest sufficient to place implants 6.5mm length dental implants Availability to be observed during the follow-up period Signature of the informed consent Exclusion Criteria: Need to perform bone augmentation surgery prior to implant placement surgery Smokers (> 10 cigarettes per day) Patients with poorly controlled diabetes Patients on chronic treatment with non-steroidal anti-inflammatory drugs Patients receiving oral or intravenous bisphosphonates Patients under chemotherapy or radiotherapy treatment Patients receiving systemic corticosteroids

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5.5 mm implants<br> | Device: BTI Implant<br>* Placement of dental implants of 5.5 vs >6.5 mm length<br>|
| Active Comparator: >6.5 mm implants<br> | Device: BTI Implant<br>* Placement of dental implants of 5.5 vs >6.5 mm length<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of implants | Survival of implants at one year post-implantation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Marginal bone loss at one year post-implantation | 1 year | 
| Incidence of bleeding on probing |  | 1 year | 
| Incidence of prosthetic or implant complications |  | 1 year | 
| Probing pocket depth |  | 1 year |