linjc16/ctgov huggingface dataset:
Exercise and Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of an individually educated exercise program for the lower back at home in employees over a period of 20 weeks. We hypothesize that regular exercise for the lower back results in greater improvements of low back strengths compared to controls.

Official Title
-----------------
Effects of a Home-based Exercise Program on Low Back Pain in Employees

Conditions
-----------------
Healthy Volunteers With and Without Chronic Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women age between 18 and 67 years Exclusion Criteria: beeing currently involved in an exercise program for the lower back known drug or alcohol abuse any disease that excludes the participation in an exercise program clinical relevant acute or chronic infections pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Behavioral: Exercise<br>* Educated exercise training for the trunk 3 times per week, each for 20 min. Recommendation of additional fitness courses as offered by the local healthy insurance company.<br>|
| No Intervention: Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back strength (kg) | Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention) | At baseline and after 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strenght at lateral flexion of the trunk (kg) | Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention) | At baseline and after 20 weeks | 
| Oswestry Low Back Pain Disability Score | Assessed with the Oswestry Low Back Pain Disability questionaire | At baseline and after 20 weeks | 
| Pain (scale) | Assessed with the visual analog scale | At baseline and after 20 weeks | 
| Quality of life (score) | Assessed with the short form 36 questionaire | At baseline and after 20 weeks | 
| Work ability index (score) | Assessed with the WAI questionaire | At baseline and afetr 20 weeks | 
| Physical activity (score) | Assessed with the Freiburger activity questionaire | At baseline and after 20 weeks | 
| Fat mass and fat-free mass (kg) | Assessed with Bio Impedance Analysis | At baseline and after 20 weeks | 
| sick days (numbers) | sick days at work will be assessed for the 20 weeks of the active intervention and the whole year the intervention is conducted | At baseline and after 20 weeks |
Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit

Study Overview
=================
Brief Summary
-----------------
In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017). The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge. Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.

Official Title
-----------------
Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit - a Four Years Follow-up Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients hospitalized in our Internal Medecine unit for acute heart failure or for another cause but with known chronic heart Failure Exclusion criteria: - Hemodilaysis, end stage kidney disease, heart failure cause by anuria, heart transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| re-hospitalization for heart failure or death failure assessed by spirometry | re-hospitalization for heart failure or death (yes or no) (composite outcome) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to re-hospitalization | time to re-hospitalization | 1 day | 
| time to death | time to death | 1 day | 
| cause of hospitalization | cause of hospitalization | 1 day | 
| cause of death | cause of death | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcomes, Internal medecine, Heart failure treatment, Heart failure guidelines, quality of life
Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs

Study Overview
=================
Brief Summary
-----------------
The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols. Secondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.

Official Title
-----------------
Impact of Circulating Tumor DNA on Early Cancer Detection and Evaluation of STAS in Patients With Ground Glass Opacities

Conditions
-----------------
Lung Cancer, Spreading of Tumor, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Diagnostic Test: cf DNA and ct DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 years radiological finding of pulmonary ground glass opacity absence of solid or haematological tumor Exclusion Criteria: radio / chemotherapy treatment for at least 6 months patient unable to understand and express his consent to the study

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 |
| --- | --- |
| Malignant GGOs<br>Patients with histologically proven malignant pulmonary ground glass opacities (GGOs) | Diagnostic Test: cf DNA and ct DNA<br>* Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA<br>|
| Benign GGOs<br>Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs) | Diagnostic Test: cf DNA and ct DNA<br>* Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of cf DNA | Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0 | through study completion, an average of 2 year | 
| Presence of ct DNA | Number of participants with of circulating tumor DNA using a lung pannel for genes: EGFR, KRAS, NRAS, TP53, SKT11, DDR2, PIK3CA, FGFR3, CTNNB1, MET, BRAF, ERBB2, SMAD4, PTEN, AKT, FGFR2, ERBB4, NOTCH1, FGFR1, ALK, IDH1, HRAS, IDH2, PDGFRA, RET, ROS1 | through study completion, an average of 2 year |
Pharmacogenomics of New Antiretrovirals

Study Overview
=================
Brief Summary
-----------------
Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore likely to explain some of the inter-individual variations (efficacy,toxicity,resistance) observed during ART. The most common form of human DNA variations consists of a change of a base in the nucleotide sequence of an individual at a given position, the single nucleotide polymorphism (SNP). Therefore,the purpose of this research will be the identification and characterization of the clinical impact of several SNPs in gene coding for transport proteins (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be involved in the pharmacokinetic pathway of selected ARV drugs for which the therapeutic response is difficult to predict. Aside,the influence of these SNPs on the response to treatment (CD4+cell,viral load) and on the toxicity will be evaluated. Plasma concentrations of ARV drugs correlate with therapeutic efficacy but also with the risk of toxicity and of virological failure, which is the basis of the therapeutic drug monitoring. However,given the intracellular location of HIV, analyzing intracellular drug concentrations is fundamental and the investigators will also focus of this new topic.

Official Title
-----------------
Pharmacogenetics of New Antiretroviral Drugs

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 positive treated with drug of interest Exclusion Criteria: <18 years old

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 |
| --- | --- | --- |
| Impact of pharmacogenomics on plasma concentration of new antiretroviral drugs |  | up to 48 months | 
| Impact of pharmacogenomics on intracellular concentration of new antiretroviral drugs |  | up to 48 months |
Improvement in Baroreflex Sensitivity in OSAS

Study Overview
=================
Brief Summary
-----------------
Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death, was investigated in OSAS patients.

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: continuous positive airway pressure therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstructive sleep apnea syndrome Exclusion Criteria: diabetes mellitus, chronic obstructive lung disease, coronary or valvular heart disease, congestive heart failure, renal failure, or endocrine dysfunction. Moreover, none of them were taking b-blockers, vasodilators, or inotropic agents at the time of enrollment in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: continuous positive airway pressure therapy|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
-----------------
obstructive sleep apnea,, baroreceptors
Adaptive Support Ventilation in the Weaning of COPD

Study Overview
=================
Brief Summary
-----------------
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.

Official Title
-----------------
Adaptive Support Ventilation for Faster Weaning in COPD: A Randomized Controlled Trial

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Procedure: Comparison of two different modes for weaning from mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure Exclusion Criteria: Mechanical ventilation less then 24 hours (self extubation or death), Having a tracheotomy and COPD coexisted with severe cardiac or neurologic diseases.

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pressure support ventilation<br> | Procedure: Comparison of two different modes for weaning from mechanical ventilation<br>* Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.<br>* Other names: weaning protocol;|
| Active Comparator: Adaptive support ventilation<br> | Procedure: Comparison of two different modes for weaning from mechanical ventilation<br>* Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.<br>* Other names: weaning protocol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning duration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning success |  |  | 
| Length of stay in the ICU |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weaning, adaptive support ventilation, COPD
Does Skyla Insertion Timing Impact Bleeding?

Study Overview
=================
Brief Summary
-----------------
Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.

Official Title
-----------------
Does Skyla Insertion Timing Impact Bleeding?

Conditions
-----------------
Vaginal Bleeding

Intervention / Treatment
-----------------
* Device: Intrauterine system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-45 Parous or nulliparous Desire Skyla for contraception Regular menstrual cycles (21-35 days) Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days Exclusion Criteria: Vaginal or cesarean delivery in the past 12 weeks Abortion in the past 6 weeks Uterine anomaly distorting the uterus Acute pelvic inflammatory disease Uterine bleeding of unknown etiology Acute liver disease or tumor History of progestin-sensitive cancer Abnormal pap smear awaiting diagnostic or therapeutic intervention

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early cycle insertion<br>Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle. | Device: Intrauterine system<br>* Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.<br>* Other names: Intrauterine device;|
| Late cycle insertion<br>Participants in this group have the intrauterine system inserted during the remainder of their cycle. | Device: Intrauterine system<br>* Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.<br>* Other names: Intrauterine device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding and spotting as collected by daily texts | Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, bleeding
Ocular Biometrics in a French Population

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to study ocular biometrics parameters and their association with age, gender and the prevalence of high myopia in a population of cataract surgery candidates in the South of France. The investigators also aimed to define proportion of an usual eye and know the rate of inhomogeneous eyes in our population.

Official Title
-----------------
Ocular Biometric Measurements in Cataract Surgery Candidates in The South of France : a Multicenter Cross Sectional Study

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: aged 40 years olderpatients who underwent ocular biometrics before cataract surgery Exclusion criteria: incomplete examination previous cataract surgery age < 40 years

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| number of patients with Distribution of ocular biometrics | Distribution of ocular biometrics and their association with age and gender | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with Prevalence of high myopia | Prevalence of high myopia | 1 day | 
| rate of inhomogeneous eyes | rate of inhomogeneous eyes | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biometry, Axial length, Cataract, Gender, High myopia
Physical Activity Recommendation Behaviour in German Mental Health Nurses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German nurses working with patients with mental disorders.

Detailed Description
-----------------
Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations. Nurses play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German nurses. The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German nurses working with patients with mental disorders.

Official Title
-----------------
Physical Activity Recommendation Behaviour in German Nurses Working With Patients With Mental Disorders

Conditions
-----------------
Mental Disorder, Physical Activity

Intervention / Treatment
-----------------
* Diagnostic Test: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurse Currently working with patients with mental disorders At least 18 years old Sufficient German skills for answering the questionnaire Exclusion Criteria: None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mental Health Nurses in Germany<br>Nurses in Germany currently working with patients with mental disorders | Diagnostic Test: Online questionnaire<br>* Online questionnaire via SoSciSurvey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise in Mental Illness Questionnaire (EMIQ) - German Version | Questionnaire assessing the following areas: knowledge, beliefs, behaviours regarding and participation in physical activity in mental health professionals. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, Mental Disorder, Recommendation Behaviour, Mental Health, Exercise