linjc16/ctgov huggingface dataset:
Inflammatory Markers After COloRectal Surgery)

Study Overview
=================
Brief Summary
-----------------
The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas the efficacy of treatment depends on early diagnosis. By detecting such complications early it could be possible to reduce their severity, the length of hospitalisation, repeat colostomy and the number of readmissions. Our team has shown that C-reactive protein (CRP) > 125 mg/L at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a marker of sepsis currently used in intensive care, but its use in the follow-up of elective surgery, particularly colorectal surgery, has not been fully evaluated. The aim of this study is to compare the ability of CRP and PCT to detect SC as early as postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC) after elective colorectal surgery. Adult patients about to undergo elective colorectal surgery with anastomosis will be included once they have given their written informed consent. Levels of CRP and PCT will be measured the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging examinations will be performed at the discretion of the surgeon; the only obligation will be to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 > 125 mg/L with no other clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary to show the superiority of PCT over CRP in clinical terms and with regard to the cost.

Official Title
-----------------
Comparison of C-reactive Protein and Procalcitonin to Detect Infectious Complications After Elective Colorectal Surgery

Conditions
-----------------
Infectious Complications After Colorectal Surgery

Intervention / Treatment
-----------------
* Biological: C-reactive protein and procalcitonin dosages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective colorectal surgery with anastomosis for benign or malignant disease > 18 years old Giving written informed consent Included in the national health insurance Exclusion Criteria: Emergent surgery Previous infection Patients undergoing Hyperthermic Intraperitoneal Chemotherapy Pregnancy

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 |
| --- |
|Biological: C-reactive protein and procalcitonin dosages|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraabdominal infection |  |  |
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.

Official Title
-----------------
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients

Conditions
-----------------
Peritonitis

Intervention / Treatment
-----------------
* Drug: Icodextrin
* Drug: glucose-based peritoneal dialysate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis stable peritoneal dialysis with Baxter connection system willingness to give written consent and comply with the study protocol Exclusion Criteria: already on icodextrin dialysate prior to acute presentation with peritonitis known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease participation in another interventional study within last 30 days of randomization history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Experimental: Icodextrin<br>peritoneal dialysate | Drug: Icodextrin<br>* one exchange daily<br>|
| Active Comparator: Glucose-based dialysate<br>peritoneal dialysate | Drug: glucose-based peritoneal dialysate<br>* original exchange frequency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peritoneal dialysate total white cell count on day 3 of acute peritonitis |  | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of additional hypertonic exchanges, ultrafiltration volumes according to patient diary, fluid control as denoted by changes in body weight, and the timing of peritonitis resolution |  | within the period of peritonitis treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peritoneal dialysis, peritonitis, CAPD, end-stage renal disease, peritonitis outcome and ultrafiltration
Consecutive Series Outcomes Review of Patients Undergoing a New Single Portal Technique for Endoscopic Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to report a new single portal endoscopic release technique and the sequence of the first 50 patients who underwent this release. This will be a chart review of the demographics, outcomes, and complications of a sequential series of patients undergoing a Seg-Way Endoscopic carpal tunnel release (ECTR).

Official Title
-----------------
Consecutive Series Outcomes Review of Patients Undergoing a New Single Portal Technique for Endoscopic Carpal Tunnel Release

Conditions
-----------------
Carpal Tunnel

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This will be a chart review of the first 50 patients who have had surgery using the single portal technique
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes following carpal tunnel release |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications and return to work data will also be reviewed |  |  |
Cost and Cost-effectiveness of PTB+ Treatment in Southern Ethiopia

Study Overview
=================
Brief Summary
-----------------
Evidences for policy making and decision related to the cost of delivering tuberculosis (TB) control is lacking in Ethiopia. The investigators aimed to determine the cost and cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the community-based initiative in Ethiopia.

Detailed Description
-----------------
Two treatment options were compared - health facility and community DOT. In 1995, Ethiopia adopted World Health Organization (WHO) recommended DOTS strategy for TB control. The treatment regimen for new smear-positive patients includes two months of ethambutol, rifampicin, isoniazid and pyrazinamide followed by six months of ethambutol and isoniazid. For children the continuation phase treatment was replaced by four months of rifampicin and isoniazid. Follow up sputum examinations were conducted at the end of 2, 5 and 7 months treatment.

Official Title
-----------------
Improving Community Based TB Care in Southern Ethiopia Cost and Cost Effectiveness

Conditions
-----------------
Smear-positive TB Cases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary tuberculosis suspects of any age and sex Exclusion Criteria: Healthy individuals or non tuberculosis patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>Directly Observed Treatment under Health Extension Workers | Other: Treatment<br>* Directly observed treatment (DOT) by health extension workers (HEWs)<br>* Other names: community based TB care;|
| Control group<br>Directly observed treatment under general health workers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost per successfully treated smear-positive case |  | September 2006 to April 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TB, cost, HEWs, Cost-effectiveness, treatment success rate
Clinical Development of Deep Learning for the OtoSight

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.

Official Title
-----------------
Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy

Conditions
-----------------
Otitis Media Acute

Intervention / Treatment
-----------------
* Device: PhotoniCare OtoSight Middle Ear Scope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients presenting for an office visit with ear-related complaints Exclusion Criteria: Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 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 |
| --- | --- |
| Pediatric patients with possible ear infections<br>Pediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight. | Device: PhotoniCare OtoSight Middle Ear Scope<br>* PhotoniCare OtoSight imaging using a near-infrared laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PhotoniCare OtoSight imaging exam | Optical coherence tomography imaging to evaluate the middle ear. | 1-5 minutes; at first and only study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Rate of adverse events | 15-30 minutes; at first and only study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ear Infection, Otitis Media, Otitis Media with Effusion, Machine Learning
Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.

Official Title
-----------------
Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life

Conditions
-----------------
Mumps, Rubella, Measles, Varicella

Intervention / Treatment
-----------------
* Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination. Exclusion Criteria: History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Ages Eligible for Study
-----------------
Minimum Age: 11 Months
Maximum Age: 21 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody levels after vaccination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the study vaccines. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis measles, mumps, rubella and chickenpox
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

Study Overview
=================
Brief Summary
-----------------
We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.

Official Title
-----------------
Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial

Conditions
-----------------
Rectocele

Intervention / Treatment
-----------------
* Procedure: Vertical plication
* Procedure: Horizontal plication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vertical plication of the rectovaginal septum was done Exclusion Criteria: patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse patients with slow transit constipation. patients with recurrent rectocele after previous surgery. patients with pre-existing FI patients with associated anorectal pathology.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Vertical plication<br>Vertical plication of the rectovaginal septum was done | Procedure: Vertical plication<br>* Vertical plication of the rectovaginal septum was done<br>|
| Active Comparator: Horizontal plication<br>Horizontal plication of the rectovaginal septum was done | Procedure: Horizontal plication<br>* Horizontal plication of the rectovaginal septum was done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure of symptoms | Absence of symptoms of constipation with Wexner score <2 | 12 months after repair |
Patient Journey in Hospital With Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
A multicentre, prospective, observational, hospital-based registry of patients with acute heart failure (AHF) those whose care was guided by a cardiologist in Turkey.

Detailed Description
-----------------
The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests, precipitating and risk factors, management of from intensive care unit (ICU) or coronary care unit to hospital discharge, length of stay in the ICU and hospital, in-hospital mortality and discharge medications of hospitalized AHF patients in Turkish population. The etiologies, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted in hospital with acute heart failure in Turkish population will be recorded.

Official Title
-----------------
Investigate to Medications, Re-hospitalization and Mortality of Patients With Hospitalized Acute Heart Failure Patients

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years old Clinical diagnosis of acute heart failure Admitted to the participating hospitals Exclusion Criteria: Patients <18 years old Patients with acute heart failure who are discharged from the emergency room without admission. Failure to obtain informed consent

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 |
| --- | --- | --- |
| all cause mortality |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | 3 months |
The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes

Study Overview
=================
Brief Summary
-----------------
To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that are desirable in MDS.

Official Title
-----------------
A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: curcumin; coenzyme q10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as long as their IPSS score ≤ 1.5. Exclusion Criteria: Pregnant women and nursing women will be excluded. History of clinically significant liver or kidney disease. ECOG>2 IPSS score >1.5 Poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: curcumin; coenzyme q10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major hematologic improvement in any lineage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  |  | 
| Overall and progression-free survival |  |  | 
| Cytogenetic response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myelodysplasia, curcumin, coenzyme Q10, cytopenia
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.

Conditions
-----------------
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Intervention / Treatment
-----------------
* Dietary Supplement: Reflor
* Drug: mikostatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birth weight infants < 1500 gr Exclusion Criteria: Genetic anomalies Not willing to participate Allergy to S. boulardii components

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 90 Days

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S. boulardii<br>The patients in this group will be given 5 million unit/day S. boulardii until discharge. | Dietary Supplement: Reflor<br>* 5 million unit/day, orally, beginning on the second day of life, until discharge from hospital<br>|
| Active Comparator: nystatin<br> | Drug: mikostatin<br>* 50000 unit/3 times a day, both for orally and by orogastric route<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of S. boulardii on sepsis |  | 6 months |