linjc16/ctgov huggingface dataset:
Prevalence of Anal Sphincter Defects After Childbirth

Study Overview
=================
Brief Summary
-----------------
The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-

Detailed Description
-----------------
The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years. It is of great importance not only an early detection but to indicates the best possible management as soon as posible. The design is a prospective observational study including primiparous woman, without previous anal surgery.

Official Title
-----------------
Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women

Conditions
-----------------
Fecal Incontinence, Childbirth Problems

Intervention / Treatment
-----------------
* Other: Endoanal Ultrasound (EAUS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous pregnant patients aged >18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries. Exclusion Criteria: Non primiparous patients and patients with a history of anal surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EAUS<br>Patients with EAUS pre and postpartum | Other: Endoanal Ultrasound (EAUS)<br>* Endoanal Ultrasound pre- and postpartum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrity of anal sphincter | No defect detected on EAUS | 4 months | 
| Defects on anal canal | Disruption of any of the anal canal sphincters | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | According to a dedicated questionnaire | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal Ultrasound, Fecal Incontinence, Childbirth
Long-Term Study On Home Spirometry After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients

Detailed Description
-----------------
Study period between 1/2/2000 and 31/12/2003 Follow-up until 31/12/2007 Patient will be stratified according to adherence to HS during the first 2 postoperative years Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months Non-adherent patient: patient performed < 50% of predicted HS within 24 months. Primary outcome measure graft loss at end of follow-up Secondary outcome measure number of acute rejections during follow-up number of hospitalisation during follow-up Incidence of bronchiolitis obliterans syndrome during follow-up

Official Title
-----------------
Long-Term Study On Home Spirometry After Lung Transplantation

Conditions
-----------------
Lung Transplantation, Rejection, Death, Bronchiolitis Obliterans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any type of lung transplant incl single, double, combined and re-do > 18 years of age LTx or HLTx ≥ 6mts post Tx Stable health condition at study entry (pt stays within home environment) Sufficient language skills for AMOS training Successful AMOS training Follow-up at our center (≥6 mts post LTx) Willingness to participate by informed consent Exclusion Criteria: Refused consent BOS diagnosis before study inclusion Malignancy before study inclusion Loss for follow-up (≤ 6 mts after study inclusion

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months | |
| 2<br>Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months | |
| 3<br>Non-adherent patient: patient performed < 50% of predicted HS within 24 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft loss |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOS |  | 3 year | 
| Number of acute rejections |  | 3 year | 
| Number of hospitalizations |  | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung transplantation, Home spirometry, non-adherence, outcomes, bronchiolitis obliterans
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and radiological findings associated with Modic changes.

Detailed Description
-----------------
Ten radiologists from six hospitals across six cities in Spain, consecutively recruited 487 adult patients (263 women and 224 men) in whom lumbar MRI had been prescribed for low back pain lasting ≥ 3 months. Patients' characteristics and imaging findings were assessed through previously validated instruments. A multivariate logistic regression model was developed to assess the features associated with Modic changes. Outcome measures were: Gender, age, body mass index (BMI), life time smoking exposure, degree of physical activity, and image features (disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis).

Official Title
-----------------
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 35 and 50 years of age having a diagnosis of chronic low back pain (of 3 or more months' duration, and including sciatica and lumbar cytalgia), who get a prescription for an MRI. Exclusion Criteria: Racial characteristics suggesting a non-Spanish origin; central nervous system pathology (with or without treatment); Diagnosis or suspicion of systemic disease (inflammatory disease such as rheumatoid arthritis, or infections).

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Modic change | Modic change type, extension and volume | Upon assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' characteristics | Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity | Upon assessment | 
| Image features | Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis | Upon assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MODIC changes, chronic low back pain, magnetic resonance imaging (MRI), vertebrae, intervertebral disc
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment. Study hypothesis: CBT is an effective treatment for adult ADHD.

Detailed Description
-----------------
ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies. Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion.

Official Title
-----------------
CBT for Residual ADHD Symptoms in Adults

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral therapy
* Drug: Drug therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ADHD of at least moderate severity On current drug therapy for ADHD Exclusion Criteria: Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders Current substance abuse or dependence IQ less than 90 Suicide risk History of cognitive behavioral therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive behavioral therapy|nan|
|Drug: Drug therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, ADHD, ADD
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.

Official Title
-----------------
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Drug: Icodextrin (dialysate)
* Drug: Physioneal (dialysate) 1.36% and 2.27%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal dialysis patients Exclusion Criteria: Insulin dependent diabetes mellitus AV-fistula, cardial arrhythmia persistence, or severe cardiac and lung disease Recent infectious disease Severe psychiatric disease Hypersensitivity to icodextrin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Icodextrin (dialysate)|2 liter of extraneal are given with one fill for 4 hours.|
|Drug: Physioneal (dialysate) 1.36% and 2.27%|2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance) |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasopressin, icodextrin, cardiac output
Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer

Study Overview
=================
Brief Summary
-----------------
The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma

Detailed Description
-----------------
The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company.

Official Title
-----------------
A Single Arm, Single-centre, Open-label, Exploratory Trial of Recombinant Interleukin-21 Administered Subcutaneously for 4 Weeks as Neo-adjuvant Treatment Prior to Sentinel Lymph Node/Complete Lymph Node Dissection Followed by 8 Weeks of Adjuvant Treatment in Subjects With Stage III Malignant Melanoma

Conditions
-----------------
Cancer, Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: recombinant interleukin-21


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III melanoma ECOG performance status 0-1 Exclusion Criteria: Signs of stage IV melanoma Safety variables

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: recombinant interleukin-21<br>* Fixed and equal dose for s.c. injection, 3 times weekly<br>* Other names: rIL-21, NN028;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pathological response rate in the lymph nodes |  | After 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | For the duration of the trial | 
| Immunomodulatory effects |  | For the duration of the trial | 
| Relapse free survival |  | For up to 4 years after the final visit or until progression of the disease in order to assess the relapse free survival (RFS) |
Pharmacokinetic Evaluation of Testosterone Gel (1%)

Study Overview
=================
Brief Summary
-----------------
Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).

Official Title
-----------------
Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age

Conditions
-----------------
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)

Intervention / Treatment
-----------------
* Drug: Testosterone Gel (1%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP) Exclusion Criteria: Clinically significant uncontrolled medical condition or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone Gel (1%)|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
-----------------
Hypogonadism
Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
The renal transplant patient is at high cardiovascular risk compared to the general population. The cardiovascular mortality represents one of the most important causes of late graft loss. Cardiovascular risk prediction tools applied to the general population, however, are caught failing on the population of kidney transplant and tend to underestimate the actual risk. Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is directly related to the target organ (heart, kidney, brain). Central blood pressure could be a cardiovascular risk factor more robust and powerful than brachial blood pressure. Central blood pressure may in part explain the increased risk of cardiovascular disease in the population of kidney transplant patients. A cohort of 250 kidney transplant patients will be constituted with a measure of concomitant central hemodynamic monitoring to the annual review will be conducted. The main objective of this study is to describe the central blood pressure measured by oscillometric method in renal transplanted population.

Official Title
-----------------
Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Device: oscillometric device (Arteriograph®, Medexpert)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Patient Renal transplant patient Exclusion Criteria: Minor patient

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal transplant patient<br> | Device: oscillometric device (Arteriograph®, Medexpert)<br>* Central blood pressure recorded in the non-fistula arm using a validated oscillometric device (Arteriograph®, Medexpert).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central blood pressure |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient, renal transplant
Caregiver-aided Powered Wheelchair Skills

Study Overview
=================
Brief Summary
-----------------
There has been only minimal research on wheelchair skills by the caregivers of manual or powered wheelchair. There are no published data on the extent to which caregivers can enhance the mobility of powered wheelchair users. The primary objective of this study is to test the hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance of the powered wheelchair users to whom they provide assistance. Our secondary objective is to add to the literature on the measurement properties of the wheelchair skills test (questionnaire and capability version) for powered wheelchair users and their caregivers.

Official Title
-----------------
The Extent to Which Caregivers Enhance the Wheelchair Skills of Powered Wheelchair Users: a Descriptive Cross-sectional Study

Conditions
-----------------
Caregivers

Intervention / Treatment
-----------------
* Other: wheelchair skills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age able to communicate in English and/or French (depending upon the site) live within 50 km of the research centre be willing to participate (as evidenced by completion of the assessment) be able to set a scheduled time for the study visit when both the caregiver and wheelchair user will be present and provide informed consent Caregivers: must be an unpaid caregiver (e.g. a family member or friend) spend an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility. Wheelchair user: must have his/her own powered wheelchair use the powered wheelchair for at least 6 hours per week have a caregiver who spends an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility. Exclusion Criteria: have unstable medical conditions (e.g. angina, seizures) that might make the use of a powered wheelchair dangerous emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant

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 |
| --- | --- |
| caregiver<br>dyad of caregiver and the wheelchair user to whom they provide care | Other: wheelchair skills<br>* the extent to which caregivers enhance the wheelchair skills of powered wheelchair users<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheelchair Skills Test (WST) | Objective (WST) and Questionnaire (WST-Q) versions | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Qualitative open ended questions on wheelchair skills | one day |