linjc16/ctgov huggingface dataset:
Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with different drugs) is to prevent damage to the kidneys and renal function. The aim of this study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder.

Detailed Description
-----------------
Neurogenic bladder is often seen in children with myelomeningocele, tumors in the spinal canal, or a traumatized spinal cord. The majority of the patients have high pressure bladders which can lead to reflux and frequent infections in the urinary tract. Although children experience insufficient bladder emptying, many of them also experience urinary incontinence and have to perform clean intermittent catheterization (CIC). If no intervention is made, the children are at high risk of renal deterioration.

Official Title
-----------------
Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele

Conditions
-----------------
Myelomeningocele, Bladder, Neurogenic

Intervention / Treatment
-----------------
* Drug: Botulinum A toxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myelomeningocele Neurogenic bladder with untreated leak point pressures > 40 mmH2O Treated with oxybutynin or other parasympatholytics Exclusion Criteria: Acute urinary tract infection Compromised neuromuscular transmission

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum A toxin|Intravesical injection. 12 IE/kg b.w.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder capacity and pressures: measures from cystometry |  | at 4 weeks and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence: score from an incontinence rating scale |  | 2 days before and 4 weeks and 6 months after | 
| Constipation: score on the Bristol scale |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelomeningocele, Neurogenic Bladder, Intervention, Botulinum A toxin, Oxybutynin
Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

Study Overview
=================
Brief Summary
-----------------
Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.

Detailed Description
-----------------
A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.

Official Title
-----------------
Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial

Conditions
-----------------
Hemorrhoids

Intervention / Treatment
-----------------
* Drug: Trimebutine
* Procedure: Hemorrhoidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included Exclusion Criteria: Patients with grade I/II internal hemorrhoids or external hemorrhoids. Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\ Patients with recurrent hemorrhoids after previous surgery.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Hemorrhoidectomy<br>Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before | Procedure: Hemorrhoidectomy<br>* Patients will undergo classic Milliagn-Morgan hemorrhoidectomy<br>|
| Active Comparator: trimebutine<br>Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours. | Drug: Trimebutine<br>* Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.<br>* Other names: Gastreg suppository;Procedure: Hemorrhoidectomy<br>* Patients will undergo classic Milliagn-Morgan hemorrhoidectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment assessed using visual analogue score from 0-10 | Anal pain will be assessed using visual analogue score from 0-10 | Pain will be assessed at 12 hours after the procedure |
Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses

Study Overview
=================
Brief Summary
-----------------
A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. and trauma (SOFCOT) (1). Data obtained from the Norwegian Register of Hip Prostheses show that the best survival curve for these prostheses is found for prostheses cemented with gentamycin cement (all causes combined). Independently of the risk of aseptic loosening, infection on the prosthesis is the second complication of arthroplasty. The defense mechanism against pathogens in contact with an implant is the formation of a biofilm. Biofilm bacteria are metabolically inactive and characterized by stationary growth. Due to their slower replication, bacteria in biofilm are up to 1000 times more resistant to antibiotics. Therefore, the optimization of local antibiotic prophylaxis is essential.

Official Title
-----------------
Local Antibiotic Prophylaxis With Antibiotic Cement: Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses

Conditions
-----------------
Hip or Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject (≥18 years old) Patient operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses Patient having given their consent for the reuse of their data for the purposes of this research Exclusion criteria: - Patient who expressed their opposition to participating 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of surgical site infections (SSI) after changes of hip and knee prostheses | Retrospective description of the benefit of high-dose gentamicin cement combined with clindamycin in hip and knee prosthesis changes | Through study completion, an average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Replacement, knee Replacement, Local antibiotic prophylaxis, Antibiotic cement, Gentamicin cement, Clindamycin
Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula

Study Overview
=================
Brief Summary
-----------------
It is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence.

Official Title
-----------------
Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula

Conditions
-----------------
Perianal Fistula

Intervention / Treatment
-----------------
* Procedure: prolene seton treatment
* Procedure: silk seton treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes and aged 20 years and above with high perianal fistula Exclusion Criteria: Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prolene seton<br>Prolene thread will be used as seton treatment for perianal fistulas | Procedure: prolene seton treatment<br>* patients with perianal fistulas will treated with seton placement by prolene thread<br>|
| Active Comparator: silk seton<br>Silk thread will be used as seton treatment for perianal fistulas | Procedure: silk seton treatment<br>* patients with perianal fistulas will treated with seton placement by silk thread<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fistula healing | fistula healing, complete healing of wound with no external opening of fistula | 8 to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula recurrence | Recurrence of perianal fistula after treatment | 6 months |
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) Relapsed/Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

Detailed Description
-----------------
The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice. The study will enroll approximately 480 patients. • Ixazomib 4 mg This multi-center trial will be conducted in Japan.

Official Title
-----------------
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) Relapsed/Refractory Multiple Myeloma

Conditions
-----------------
Relapsed/Refractory Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Ixazomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have been confirmed as administration of the drug. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ixazomib 4 mg<br>The usual adult dosage for oral administration is 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle will be repeated for 6 cycles. The dose may be reduced appropriately according to the patient's condition. Participants will receive interventions as part of routine medical care. | Drug: Ixazomib<br>* Ixazomib capsules<br>* Other names: MLN9708;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting One or More Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 24 Week (From start of administration to the end of 6 cycles) | 
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug. | Up to 24 Week (From start of administration to the end of 6 cycles) |
Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.

Official Title
-----------------
Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity

Conditions
-----------------
Critically Ill, Enterobacteriaceae Infections, Antibiotic Resistant Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults critically ill patients admitted to the the participating ICUs during the study period with colonization and/or infection with a third group enterobacteriacea and with a lenght of stay > 24h Exclusion Criteria: minors patients lenght of stay < 24h

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 |
| --- | --- |
| critically ill patients<br>critically ill patients admitted in one of the 5 ICUs of the university hospital of Nancy during the year 2016 with documented third group enterobacteriaceae infection and/or colonization with third group enterobacteriaceae | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality | Evaluation of the impact of colonization and/or infection with third group enterobacteriaceae on mortality during hospitalization and up to 180 day | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance strains of sub type enterobacter | Evaluation of number of resistant strains among Enterobacter subtype in comparison with other third group enterobacteriaceae | DAY 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Third group Enterobacteriaceae, infection, colonization, resistance, AMPc cephalosporinase
Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.

Detailed Description
-----------------
During this study investigators will longitudinally collect discarded stool biosamples throughout the MICU admission when available. Stool Bio specimens will be recorded/coded and processed by the investigators. Stool Bio specimens will be analyzed for 16sRNA and metabolomics. Surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge. By longitudinally sampling discarded biospecimens from subjects throughout their MICU admission in additionally to describing long term following up. We will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.

Official Title
-----------------
Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

Conditions
-----------------
Critical Illness, Microbiome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients admitted to the intensive care unit Exclusion Criteria: none

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 |
| --- | --- | --- |
| Long Term Mortality | Death from any cause 90 day, 1 year | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality | death from any cause during hospitalization | 28 day | 
| ICU length of stay | number of days admitted to the ICU | hospitalization up to 6 weeks | 
| Hospital length of stay | number of days admitted to the hospital | hospitalization up to 6 weeks | 
| Functional Status Score | Katz Index of Independence in activities of daily living; minimal score = 0; maximum score = 6; higher score better outcome | up to 12 months after discharge | 
| Cognitive Dysfunction | Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome | Up to 12 months after discharge | 
| Quality of Life score | SF-36 score: including physical component summary (PCS) and mental component summary (MCS) | up to 12 months after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
short term outcomes, long term outcomes
Ultrasound Examination and Guided Injection Into the Acromio-clavicular Joint

Study Overview
=================
Brief Summary
-----------------
Is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound?

Official Title
-----------------
Ultrasound Measurement of the Acromio-clavicular Joint and Injection of Standard Contrast Material Into the Joint Under Ultrasonic Control

Conditions
-----------------
Osteoarthritis of Acromioclavicular Joint

Intervention / Treatment
-----------------
* Other: contrast material injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults over 18 years with AC joint degenerative changes

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: contrast material injection|using ultrasound to locate ac joint and injecting contrast material to ensure that the dye is actually in the joint|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray | standard x-ray will be taken after the contrast dye has been injected into the joint to see whether it has successfully been placed into the joint. | outcome assessed at the time of the injection (1 day) |
The Association Between Blood Eosinophilsp in Thai COPD Patients: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity.

Detailed Description
-----------------
The prospective one year study in Thai COPD patients for the clinical outcomes of COPD compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.

Official Title
-----------------
The Association Between Blood Eosinophils and Clinical Outcomes of Chronic Obstructive Pulmonary Disease Patients: A Prospective Study

Conditions
-----------------
Copd

Intervention / Treatment
-----------------
* Other: observatory


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of COPD by GOLD criteria Exclusion Criteria: high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection Patients who had previous acute exacerbation within 30-day before study entry Patients who had previous systemic corticosteroids used within 30-day before study entry

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| eosinophilic COPD patient<br>COPD patient with blood eosinophil equal or > 300 cells/µL | Other: observatory<br>* observation for 1 year period<br>* Other names: clinical outcomes;|
| non-eosinophilic COPD patient<br>COPD patient with blood eosinophil < 300 cells/µL | Other: observatory<br>* observation for 1 year period<br>* Other names: clinical outcomes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute worsening of respiratory symptoms | acute severe worsening of respiratory symptoms | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological outcomes | Forced expiratory volume in one second | 1 year | 
| health related quality of life | Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores which the minimum 0 and maximum 40 values, and whether higher scores mean a worse outcome. | 1 year |