linjc16/ctgov huggingface dataset:
Recreational Diving Practice for Stress Management

Study Overview
=================
Brief Summary
-----------------
Within the components of Scuba diving there are similarities with meditation and mindfulness techniques. Perceived stress is known to be diminished during meditation practice. This study evaluates the benefits of scuba diving on perceived stress and mindful functioning.

Detailed Description
-----------------
Background: within the components of Scuba diving there are similarities with meditation and mindfulness techniques. Perceived stress is known to be diminished during meditation practice. This study evaluates the benefits of scuba diving on perceived stress and mindful functioning. Method: A recreational diving group, composed of 37 subjects, was compared with a multisport control group, composed of 30 subjetcs, on perceived stress, mood, well-being and mindfulness by answering auto-questionnaires before and after a one-week long course. For the diving group, stability of the effects was evaluated one month later using similar auto-questionnaires.

Official Title
-----------------
Recreational Diving Practice for Stress Management: an Exploratory Controlled Trial

Conditions
-----------------
Psychological Stresses

Intervention / Treatment
-----------------
* Behavioral: sport


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 registered at a leisure sports club Exclusion Criteria: they were undergoing medical treatment for psychological issues at the time of the study they had taken part in a stress management program prior to recruitment for the current study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| recreational diving group<br>middle-class populations registered at a leisure sports club | Behavioral: sport<br>* recreaational sport : diving or multisport<br>|
| recrational multisport course<br>middle-class populations registered at a leisure sports club | Behavioral: sport<br>* recreaational sport : diving or multisport<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived stress | questionnaire | change from baseline after one week sport (e.g. baseline and one week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mindfulness | questionnaire | change from baseline after after one week sport (e.g. baseline and one week) |
Impact of Vitamin D on Acute Ischemic Stroke Prognosis

Study Overview
=================
Brief Summary
-----------------
This is a registry for all patients admitted to hospital settings with Ischemic stroke in Mansoura University Hospital. The registry will capture patients' data, investigations and vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE

Official Title
-----------------
Impact of Vitamin D on Acute Ischemic Stroke Prognosis

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Vitamin D Level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed ischemic stroke not older than 48 hours Exclusion Criteria: Ischemic stroke due to accidents or any trauma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Vitamin D Level|Vitamin D level is measured upon the presentation of the case with ischemic stroke|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Vitamin D level and the Incidence of Ischemic Stroke | Correlation Analyses between vitamin D and ischemic stroke will be applies | On admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of vitamin D on ischemic stroke in relationship with gender | subgroup analyses per gender will be applied to check the difference of vitamin D | On admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, Ischemic Stroke
T1rho Imaging of Liver in Presence of Iron

Study Overview
=================
Brief Summary
-----------------
Liver T1rho is elevated in response to accumulation of extracellular matrix proteins during fibrosis. The presence of hepatic iron overload; however, can shorten the T1rho value. With proper correction, we can remove this confounding factor and improve the reliability of T1rho for early diagnosis of liver fibrosis. Patients with early-stage liver fibrosis confirmed by biopsy will be recruited at the Prince of Wales Hospital (Hong Kong). Thirty patients and twenty healthy volunteers will be recruited. The liver iron content will be measured using the established T2* MRI relaxometry. Breathhold black blood T1rho relaxometry will be used to collect T1rho data. The measured T1rho will be retrospectively corrected to remove the shortening effect caused by iron. We will use ANOVA to compare the measurement with and without fibrosis. We will use Pearson correlations between the disease state and the imaging measurements, and ROC analysis to determine the diagnostic value of the proposed method.

Official Title
-----------------
Quantitative Rotating Frame Relaxometry for Early Detection of Liver Fibrosis in Presence of Hepatic Iron

Conditions
-----------------
Liver Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between age 18 and age 55 Informed written consent obtained Exclusion Criteria: Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy

Ages Eligible for Study
-----------------
Maximum Age: 55 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 |
| --- | --- |
| patients with liver fibrosis<br> | |
| healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The liver iron content will be measured using the established T2* MRI relaxometry | Breathhold black blood T1rho relaxometry will be used to collect T1rho data. The measured T1rho will be retrospectively corrected to remove the shortening effect caused by iron. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quantitative rotating frame relaxometry, T1rho, early detection of liver fibrosis, hepatic iron
Geriatric Head Trauma Short Term Outcomes Project

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will examine the incidence of intracranial hemorrhage. The investigators will compare patients on anticoagulant and/or antiplatelet therapy with head trauma compared to patients not on these medications. While many studies have sought to quantify the incidence of intracranial hemorrhage in these patients, there is considerable controversy regarding their care and what to do after an initial negative head CT in anticoagulated geriatric patients who have experienced head trauma.

Official Title
-----------------
Geriatric Head Trauma Short Term Outcomes Project

Conditions
-----------------
Head Injury, Anticoagulant-induced Bleeding, Fall

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen in the emergency department for head trauma Exclusion Criteria: Penetrating head trauma

Ages Eligible for Study
-----------------
Minimum Age: 65 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 Participants with 14 Day ED Returns | Return visit to ED within 2 weeks | 14 days | 
| Number of Participants with Primary Intracranial Hemorrhage | ICH on initial head CT scan | initial hospital visit | 
| Number of Participants with Delayed Intracranial Hemorrhage | ICH on repeat CT scan | 14 days | 
| Number of Participants with Hospitalizations at 14 days | If patient is admitted for any reason after initial ED visit | 14 days | 
| Mortality of Participants | Death of patient from any cause at primary visit or up to 60 days from follow-up | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Symptoms | Any new symptoms | 60 days | 
| Life alterations | Descriptive information from telephone interviews about how patients changed activities after head trauma | 60 days | 
| New interventions since fall | Additional therapies or intervention instituted after minor head trauma | 60 days |
Nudges on Hospitalist Behavior and Patient Satisfaction

Study Overview
=================
Brief Summary
-----------------
Physician behavior plays an important role on patient perception of their care team and on patient satisfaction. Though studies have attempted to impact how physicians interact with their patients through various initiatives, the effect of more subtle nudges on physician behavior have not been studies. As such, the investigators propose a randomized controlled deception trial to evaluate the impact of nudges on hospitalist behavior and patient satisfaction.

Official Title
-----------------
Room Design Nudge on Hospitalist Bedside Etiquette and Patient Satisfaction

Conditions
-----------------
Patient Satisfaction, Etiquette, Medical

Intervention / Treatment
-----------------
* Behavioral: Nudge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalist Physicians at Parkland Memorial Hospital who are willing to participate Exclusion Criteria: None

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nudge Group<br>Encounters in this group will be nudged | Behavioral: Nudge<br>* Room intervention<br>|
| No Intervention: Control Group<br>Encounters in this group will not receive a nudge. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Sitting Rate | This will be a binary measurement of whether or not the physician sits with the patient during the observed encounter. | During the Observed Physician Encounter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAISCH: Tool to Assess Inpatient Satisfaction with Care from Hospitalists | This is a previously validated measure of patient satisfaction for hospitalists. | Immediately Following Observed Physician Encounter |
Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program

Study Overview
=================
Brief Summary
-----------------
Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a spill-over of inflammatory pulmonary molecules in the systemic milieu.

Official Title
-----------------
Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program in Patients With a Chronic Respiratory Disease: Time Course and Determinants

Conditions
-----------------
Chronic Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, …) undergoing pulmonary rehabilitation (maintenance or inpatient) Exclusion criteria: Contraindication to exercise training

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
| 6 minutes walking distance | 6 minutes walking distance | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life | health-related quality of life : VQ-11 questionnaire | 10 years | 
| Forced expiratory volume in 1 seconde | Forced expiratory volume in 1 seconde : FEV1 | 10 years | 
| BODE index | BODE index | 10 years | 
| death | death | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary rehabilitation, Maintenance program, Cohort, Microenvironment, Long-term benefits
Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients

Conditions
-----------------
Flushing

Intervention / Treatment
-----------------
* Drug: MK0524A, /Duration of Treatment : 4 Weeks
* Drug: Comparator : niacin /Duration of Treatment : 1 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or female between 18 and 70 years of age Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: Patient has a history of hypersensitivity to niacin or niacin-containing products Patient is currently experiencing menopausal hot flashes Patient consumes more than 2 alcoholic beverages per day Patient has poorly controlled Type 1 or Type 2 diabetes mellitus Patient engages in vigorous exercise or an aggressive diet regimen

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

| Intervention/Treatment |
| --- |
|Drug: MK0524A, /Duration of Treatment : 4 Weeks|nan|
|Drug: Comparator : niacin /Duration of Treatment : 1 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme. |  | Over 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater). |  | Daily |
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.

Detailed Description
-----------------
To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies . To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.

Official Title
-----------------
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer

Conditions
-----------------
Prostate Cancer, Prostate Biopsy

Intervention / Treatment
-----------------
* Device: CAMPROBE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fit and well enough to undergo a repeat prostate biopsy Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care Men on active surveillance Men on PSA monitoring Exclusion Criteria: Contraindication for a repeat prostate biopsy Contraindication for a transperineal prostate biopsies Previous perineal or anal surgery MRI suggesting anterior lesion or extra capsular disease MRI suggesting lesion that needs fusion image targeting Unable to lie down and with legs in a stirrup for at least 45 minutes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CAMPROBE|To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessment of CAMPROBE biopsy procedure | Measured using a 10 point visual pain score tool and a point based structured questionnaire | 3 weeks | 
| Patient reported adverse events related to CAMPROBE biopsy | Point based structured questionnaire assessment of adverse events after biopsy | 3 weeks | 
| Patient perception and acceptance of CAMPROBE biopsy | Point based structured questionnaire including willingness to recommend to a friend | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deterioration in urinary function after CAMPROBE biopsy | Measurement of urinary function after the procedure using a structured questionnaire | 3 weeks | 
| Deterioration in sexual function after CAMPROBE biopsy | Measurement of urinary function after the procedure using a structured questionnaire | 3 weeks |
Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through: a genome-wide association (GWA) study in VLBW neonates, a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).

Official Title
-----------------
Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia

Conditions
-----------------
Bronchopulmonary Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age < 28 weeks Inborn birth Prophylactic administration of surfactant in the delivery room Written informed consent obtained from parents Exclusion Criteria: Gestational age of 28 weeks or more Outborn birth No prophylactic administration of surfactant in the delivery room Congenital malformation Absence of written informed consent obtained from parents

Ages Eligible for Study
-----------------
Maximum Age: 8 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premature neonates<br>gestational age less than 28 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchopulmonary dysplasia |  | 36 weeks of postconceptional age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchopulmonary dysplasia, neonates, lung development, prematurity