linjc16/ctgov huggingface dataset:
MRI Hydronephrosis Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis.

Detailed Description
-----------------
Ultrasound is the most commonly performed imaging modality used to assess hydronephrosis. The average renal ultrasound exam takes about 15-25 minutes to complete, however, it does have several disadvantages, including substantial operator dependence, having to rely on an adequate sonographic window to see the structures of interest and difficulty in visualization of portions of the kidney and urinary tracts. Recent MRI advances have made rapid imaging possible. Such imaging has minimized motion related artifacts and need for sedation. This study is to compare traditional ultrasound imaging to a raid noncontrast protocol MRI examination of the kidneys and urinary tract that would require no sedation and less than 15 minutes to perform.

Official Title
-----------------
Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis

Conditions
-----------------
Hydronephrosis, Kidney Swelling

Intervention / Treatment
-----------------
* Procedure: MRI (Magnetic resonance imaging)
* Procedure: Ultrasound exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 2 years of age and younger Diagnosed with hydronephrosis and scheduled for an ultrasound scan Exclusion Criteria: Healthy subjects

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MRI<br>The patient will have a rapid noncontrast MRI (magnetic resonance imaging) that will take approximately 15 minutes to complete. | Procedure: MRI (Magnetic resonance imaging)<br>* Subject will complete a 15 minute scan in the MRI<br>|
| Active Comparator: Ultrasound exam<br>A noncontrast ultrasound examination | Procedure: Ultrasound exam<br>* The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the value of a rapid noncontrast MRI not requiring sedation to ultrasound in accurately diagnosing hydronephrosis in the pediatric patient. | A rapid MRI exam will be performed without IV contrast material or sedation | 45 minutes |
Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

Study Overview
=================
Brief Summary
-----------------
Prospective study of Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

Official Title
-----------------
Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

Conditions
-----------------
Esophageal Cancer, Esophageal Surgery Cancer, Overall Survival

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing during inclusion time carcinologic esophagectomy for esophageal cancer (Adenocarcinoma or epidermoid carcinoma) Exclusion Criteria: Mortality within 90 postoperative days -

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 |
| --- | --- | --- |
| Overall survival |  | 10 years |
Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

Study Overview
=================
Brief Summary
-----------------
Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. A multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. Despite accepted lower rate of morbidity, these results come from four well equipped European centers by four surgeons practiced at least 200 LVMR.

Detailed Description
-----------------
Multicenter pooled-analysis of LVMR for internal/external rectal prolapse. All events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the Clavien-Dindo classification.

Official Title
-----------------
Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

Conditions
-----------------
Rectal Prolapse

Intervention / Treatment
-----------------
* Procedure: Laparoscopic ventral mesh rectopexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse Exclusion Criteria: other condition than rectal prolapse
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectal Prolapse<br>Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological. | Procedure: Laparoscopic ventral mesh rectopexy<br>* Laparoscopic opening of the Daglous pouch, dissection till reach the levator ani muscle, mesh implementation and fixation, closure of the daglous. The mesh implemented may be synthetic or biological mesh.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative complications | All complications occur during the operation and discovered and managed during the operation or passed undiscovered and discovered postoperative during the same admission or require readmission | 30 days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal Prolapse
Anatomic Altas of the Whole Human Body

Study Overview
=================
Brief Summary
-----------------
The goal is the constitution of a statistical atlas of the human being morphology variability. This work would be a significant step forward in the field of anatomy and biomechanical simulation.

Official Title
-----------------
Anatomic Altas of the Whole Human Body

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Other: Healthy volunteers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between the ages of 18 and 99 years. Exclusion Criteria: Respiratory and cardiovascular pathology Claustrophobia Counter-argument to magnetic field exposure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Healthy volunteers<br>Healthy volunteers | Other: Healthy volunteers<br>* MRI scanner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constitution of a statistical atlas of the full human body |  | 90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atlas, Full human Body, MRI
Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 AS IOL. At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.

Official Title
-----------------
Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)

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

Intervention / Treatment
-----------------
* Procedure: cataract surgery
* Device: intraocular lens (MC 6125 AS)
* Device: capsular tension ring (CTR 13/11)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation Exclusion Criteria: Preceding ocular surgery or trauma Recurrent intraocular inflammation of unknown etiology Uncontrolled glaucoma Uncontrolled systemic or ocular disease Blind fellow eye Microphthalmus Corneal abnormality History of uveitis/iritis Iris neovascularization Pseudoexfoliation Proliferative diabetic retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC 6125 AS IOL + CTR<br>All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS). | Procedure: cataract surgery<br> <br> Device: intraocular lens (MC 6125 AS)<br> <br> Device: capsular tension ring (CTR 13/11)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL rotation |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOL rotation, capsular tension ring, IOL rotational stability
Clinical and Functional Results After Total Elbow Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is

Official Title
-----------------
Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined

Conditions
-----------------
Elbow Fracture, Elbow Arthropathy, Elbow Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Total elbow arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total elbow arthroplasty, all indication combined Exclusion Criteria: Less than 24 months of follow up Revision of total elbow arthroplasty

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total elbow arthroplasty<br>Total elbow arthroplasty, all indications combined | Procedure: Total elbow arthroplasty<br>* Total elbow arthroplasty by a single operator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo Elbow Performance Score |  | through study completion, an average of 5 years | 
| QuickDASH |  | through study completion, an average of 5 years | 
| Range of motion |  | through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant loosening | Radiolucent lines around the implant on the X Ray | through study completion, an average of 5 years | 
| Triceps deficiency |  | through study completion, an average of 5 years | 
| Bushing wear | Measure of an angle on the X Ray | through study completion, an average of 5 years |
Trial of Modafinil for Methamphetamine Dependence

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of methamphetamine dependence.

Detailed Description
-----------------
Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy. Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving. It appears to be well tolerated with a low abuse potential. Sixty dependent methamphetamine users will be allocated to 2 equal groups. The experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program. The control group will receive placebo under equivalent conditions. Primary outcome will be a between group comparison of methamphetamine negative urine samples over the 10 week study period. Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.

Official Title
-----------------
Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

Conditions
-----------------
Amphetamine Dependence

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) amphetamine dependence diagnosis Amphetamine positive urine sample at intake Regular current amphetamine use (2-3 days per week) Aged 18 years or older Exclusion Criteria: Pregnant or nursing females Hazardous concurrent uncontrolled physical or mental illness

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Modafinil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinalysis results negative for methamphetamine over 10 weeks |  | 10 weeks | 
| Adverse events |  | 10 weeks | 
| Compliance |  | 10 weeks | 
| Retention |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported drug use |  | 10 weeks | 
| Health outcomes |  | 10 weeks | 
| Psychosocial outcomes |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Modafinil, Amphetamine Dependence, Randomised placebo-controlled trial
RCT to Evaluate Biocompatibility of Resin-based Dental Materials

Study Overview
=================
Brief Summary
-----------------
In this randomized clinical trial, the bio-compatibility of 2 materials used for dental restorations will be compared: glass-ionomer vs resin-based composites. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX. Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined using UPLC-MS/MS.

Official Title
-----------------
Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials

Conditions
-----------------
Materials Testing

Intervention / Treatment
-----------------
* Procedure: Dental restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or more carious lesions in primary molars that require treatment Exclusion Criteria: carious lesions that already affected the dental pulp, large lesions requiring cusp replacement, presence of oral inflammatory conditions during the previous 2 weeks, carriage of a fixed or removable prosthesis/orthodontic appliance, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in previous 2 months, previous dental restorations

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment 1<br>Dental restoration performed with glass-ionomer materials. | Procedure: Dental restoration<br> <br> |
| Experimental: Treatment 2<br>Dental restoration performed with resin-based composites. | Procedure: Dental restoration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary bisphenol A levels |  | 1 year | 
| Salivary bisphenol A levels |  | 1 year | 
| %DNA methylation |  | 6 months | 
| %DNA hydroxymethylation |  | 6 months |
Study With Advanced Vaginal Tactile Imager

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance; To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines; To test the data collection technique and establish a reliable examination procedure.

Official Title
-----------------
Study With Advanced Vaginal Tactile Imager

Conditions
-----------------
Investigative Techniques

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women (over the age of 21) falling within one of the following groups: No evidence of pelvic floor disorder and no prior pelvic surgery; Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment. Exclusion Criteria: Active skin infection or ulceration within the vagina Presence of a vaginal septum; Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder; Ongoing radiation therapy for pelvic cancer; Impacted stool; Recent (less than three months) pelvic surgery; Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia; Severe hemorrhoids; Surgically absent rectum or bladder; Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging performance |  | 3 months |
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience

Study Overview
=================
Brief Summary
-----------------
Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure. The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (<30 days) of support appear to improve survival in the first year after transplantation. The haemodynamic parameters revealing this DPG are not clearly described in the literature. hypothesis of this research is that: DPG risk factors in strasbourg's hospital center are comparable to other European and international centers. Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly.

Official Title
-----------------
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience

Conditions
-----------------
Primary Graft Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015. Exclusion Criteria: multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.

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 |
| --- | --- | --- |
| Retrospective comparison of risk factors (incidence for ordinal and average variables for numerical variables) between patients suffering from severe primary dysfunction of the graft and those not suffering from severe primary dysfunction of the graft |  | 1 month after leaving the operating room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Graft Dysfunction, Primary Graft Dysfunction, heart transplant, heart failure, Hemodynamic parameters, Incidence of PDG