linjc16/ctgov huggingface dataset:
Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.

Official Title
-----------------
TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Obese (BMI >= 30) Recruited from the nutrition service of Hôpital Européen Georges-Pompidou Informed consent provided Exclusion Criteria: PTSD symptoms (score > 33 ; PTSD Checklist-5) Bariatric surgery patients Difficulties to understand French language Patients under social protection

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 |
| --- | --- | --- |
| Self-reported binge eating pathology (BES) | Binge Eating Scale | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety and depression (HADS) | Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression | Baseline | 
| Self-reported mindfulness skills (FFMQ) | Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react | Baseline | 
| Self-reported emotion regulation (CERQ) | Cognitive Emotional Regulation Questionnaire (2 subscales): adaptive regulation and non-adaptive regulation | Baseline | 
| Self-reported eating patterns (TFEQ-R18) | Three Factor Eating Questionnaire (3 subscales): emotional eating, uncontrolled eating, restraint eating | Baseline | 
| Self-reported impact of traumatic event (IES-R) | Impact of Event Scale revised version (3 subscales): avoidance, intrusion, hyperarousal | Baseline | 
| Self-reported childhood trauma (CTQ) | Childhood Trauma Questionnaire (5 subscales): emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse | Baseline | 
| Self-reported lifetime traumatic events (LEC-5) | Life Event Checklist (DSM-5) | Baseline | 
| Body Mass Index (kg/m2) | BMI as measured by a physician | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma exposure, Psychological distress, Emotion regulation, Mindfulness, Eating pathology
Diagnostic Value of the Electrocardiogram in Fabry Disease

Study Overview
=================
Brief Summary
-----------------
Cardiac complications occur in 78% of patients with Fabry disease and are mainly characterized by a high frequency of left ventricular hypertrophy resulting from an accumulation of GL3 in cardiomyocytes. Apart from family screening, left ventricular hypertrophy is an important factor in the diagnosis of Fabry disease. This left ventricular hypertrophy is more often concentric and homogeneous, but it can also be asymmetric and mimic the patterns seen in so-called familial hypertrophic cardiomyopathies caused by mutations in the sarcomere protein genes. Electrocardiogram has been suggested as a screening tool for Fabry disease. Analysis of the PQ interval would be of interest. An algorithm has even been proposed to differentiate Fabry disease from amyloidosis with excellent sensitivity and specificity. The only criterion of left ventricular hypertrophy used in all studies is the Sokolov-Lyon index, but this index has many limitations and does not appear to be discriminatory for Fabry disease. Other validated criteria for left ventricular hypertrophy, such as the Cornell, Lewis, Gubner index or the Romhilt-Estes point score, have never been tested in Fabry disease. The primary objective of our study is to evaluate the diagnostic value of different electrocardiographic scores of left ventricular hypertrophy in Fabry disease.

Official Title
-----------------
Diagnostic Value of the Electrocardiogram in Fabry Disease

Conditions
-----------------
Fabry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged > 18 years, with genetically confirmed Fabry disease complicated by LVH. Patients aged > 18 years, with sarcomeric hypertrophic cardiomyopathy. Exclusion Criteria: Patients aged < 18 years. Sarcomeric hypertrophic cardiomyopathy for which Fabry disease has not been excluded by alpha-galactosidase A assay (in men) and genetic analysis (GLA gene mutation) in women.

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 |
| --- | --- |
| Fabry cardiomyopathy<br> | |
| Hypertrophic cardiomyopathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the PQ interval with a new algorithm | Determine whether electrocardiographic criteria of left ventricular hypertrophy allow to distinguish between Fabry disease and sarcomeric hypertrophic cardiomyopathy | baseline |
HDL Dysfunction During the Acute Stage of Stroke

Study Overview
=================
Brief Summary
-----------------
The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.

Detailed Description
-----------------
MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke. Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases. The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke. Plasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.

Official Title
-----------------
HDL Dysfunction During the Acute Stage of Stroke

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Other: Ischemic stroke
* Other: Haemorrhagic stroke


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with less than 12 hours stroke clinical signs: hemiparesis or hemiplegia unilateral sensitivity disorder language impairment balance disorder dizziness, bilateral or monocular vision totally or partially lost Exclusion Criteria: Pregnancy head trauma since the last 3 months stroke since the last 3 months myocardial infarction since the last 3 months patient disagrees to be enrolled in 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 |
| --- | --- |
| Ischemic stroke<br>Patients with ischemic stroke diagnosed by MRI or CT scan | Other: Ischemic stroke<br>* Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan<br>|
| Haemorrhagic stroke<br>Patients without haemorrhagic stroke diagnosed by MRI or CT scan | Other: Haemorrhagic stroke<br>* Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan<br>|
| Mimick stroke<br>Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma MPO concentrations | Assessment of plasma MPO concentrations during acute stage of stroke | Through study completion, an average of 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-MPO concentrations | Assessment of HDL-MPO concentrations during acute stage of stroke | Through study completion, an average of 6 hours |
Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)

Detailed Description
-----------------
Voiding dysfunction is not uncommon in Tabriz.About 20% of patients in female urology clinic of Tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).There is limited information about medical treatment of those patients. On the other hand alpha adrenergic blockers are the first choice medication in BENIGN PROSTATIC HYPERPLASIA. There is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.The purpose of this study is to comparision whether Tamsolusin 0.4/daily or Prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(BOO)

Official Title
-----------------
Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

Conditions
-----------------
Neurogenic Bladder

Intervention / Treatment
-----------------
* Drug: tamsolusin
* Drug: prazosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females with voiding difficulty with MFR<12 and post void residual urine>50cc Exclusion Criteria: History of pelvic floor surgury during last 3 month Any contraindication for Tamsolusin or prazosin

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 1<br>taking Tamsulosin | Drug: tamsolusin<br>* 0.4 mg /day<br>* Other names: Flomax;|
| Active Comparator: 2<br>taking prasosin | Drug: prazosin<br>* 1 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient symptoms improvement(Standard questionare) |  | every month untile 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamics parameters improvement |  | three months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female voiding dysfunction, Tamsolusin, prazosin
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft

Study Overview
=================
Brief Summary
-----------------
The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under Protocol BMTI-2006-01. Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2006-01. STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up. REGULATORY PHASE: Post-approval study

Official Title
-----------------
A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

Conditions
-----------------
Ankle and Hindfoot Arthrodesis

Intervention / Treatment
-----------------
* Device: AUGMENT® Bone Graft
* Procedure: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who meet the following criteria may be included in the study: Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1). Exclusion Criteria: 1) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.

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 |
| --- | --- |
| Group 1<br>Standard Rigid Fixation plus autograft | Procedure: Standard of Care<br>* Autologous Bone Graft<br>|
| Group 2<br>Standard rigid fixation plus AUGMENT® Bone Graft | Device: AUGMENT® Bone Graft<br>* AUGMENT® Bone Graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of bridging bone via CT |  | Months 60 or greater | 
| Subject function as determined by pain on weight bearing |  | Months 60 or greater | 
| Subject function as determined by AOFAS - AHS score |  | Months 60 or greater | 
| Subject function as determined by Foot Function Index |  | Months 60 or greater | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Fusions, AUGMENT® Bone Graft, Autologous Bone Graft, arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture
Developing a Simple Test to Diagnose Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
In order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. As such, this study will compare the performance of the device in development to the performance of existing methods.

Official Title
-----------------
Translation of a Novel Overactive Bladder 'Fingerprint' Into a Breakthrough Non-invasive Diagnostic Test for Use in a Point of Care Setting

Conditions
-----------------
Overactive Bladder, Overactive Bladder Syndrome, Detrusor Overactivity

Intervention / Treatment
-----------------
* Diagnostic Test: Urodynamics aka filling cystometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is willing and able to give informed consent for participation in the study The participant has been diagnosed with over-active bladder Aged 18 years or above Male or Female Exclusion Criteria: The participant is unwilling to give informed consent for participation in the study The participant is unable to represent their own interests or is particularly susceptible to coercion (i.e. is deemed as vulnerable) The participant has been diagnosed with neurologic disease (stroke, MS, Parkinson's disease, spinal cord injury); history of uterine, cervical, vaginal or urethral cancer; history of cyclophosphamide use or any type of chemical cystitis; history of benign or malignant bladder tumours; has had Botulinum injections, neuromodulation or augmentation cystoplasty Aged 17 years or younger.

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 |
| --- |
|Diagnostic Test: Urodynamics aka filling cystometry|Participants will be undergoing a routine diagnostic test to characterise bladder function and volume|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of accuracy of a diagnostic test for overactive bladder | A prototype lateral flow immunoassay dipstick to detect specific urinary biomarkers for OAB, based on specific urinary biomarkers and with a dynamic range and sensitivity required for accurate OAB diagnosis. | December 2022 - November 2023 |
Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.

Detailed Description
-----------------
This is a non-treatment study. This study has no effect on the care the participant will receive. In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).

Official Title
-----------------
Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Androgen deprivation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adenocarcinoma of the prostate, clinical stage M0 About to initiate GnRH agonist therapy Karnofsky Performance Status 90 or 100 Serum creatinine < 2.0mg/dl Exclusion Criteria: Hormone therapy within 12 months History of diabetes mellitus or glucose intolerance Anabolic agents or metabolic agents known to affect insulin or glucose levels Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Androgen deprivation therapy|According to standard medical care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitity |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen deprivation therapy, insulin resistance
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation

Study Overview
=================
Brief Summary
-----------------
The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.

Official Title
-----------------
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation

Conditions
-----------------
Major Depressive Episode

Intervention / Treatment
-----------------
* Other: Placebo nasal spray
* Other: Film sequence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major depression (mild to moderate) fluent in German language Exclusion Criteria: bipolar disorder, psychotic disorder, substance dependence cardiovascular disease, severe kidney or liver disease, epilepsy change of psychotropic medication intake within the last four weeks allergic to capsaicin allergic to sesame oil students in medicine, pharmacy, or psychology in their third year or older completed studies in medicine, pharmacy or psychology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive placebo group<br>Participants receive a placebo nasal spray. However, they are told that it protects from experiencing negative emotions. Participants watch a film sequence that is supposed to induce sadness. | Other: Placebo nasal spray<br>* The placebo nasal spray consists of sesame oil and does not contain any active drug.<br>Other: Film sequence<br>* All groups watch the film sequence that is supposed to induce sadness.<br>|
| Placebo Comparator: Placebo control group<br>Participants receive a placebo nasal spray and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness. | Other: Placebo nasal spray<br>* The placebo nasal spray consists of sesame oil and does not contain any active drug.<br>Other: Film sequence<br>* All groups watch the film sequence that is supposed to induce sadness.<br>|
| Other: No-treatment control group<br>Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness. | Other: Film sequence<br>* All groups watch the film sequence that is supposed to induce sadness.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sadness | Items of PANAS-X | Directly after watching the film sequence, no follow-up assessments |