linjc16/ctgov huggingface dataset:
The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.

Study Overview
=================
Brief Summary
-----------------
This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.

Official Title
-----------------
The Effect of Combined Popliteal and Saphenous Block in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures: a Prospective Randomized Study

Conditions
-----------------
Ankle Fracture in Need of Surgical Fixation

Intervention / Treatment
-----------------
* Drug: Ropivacaine block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Patients in need of anaesthesia for operative fixation of ankle fractures. American Society of Anesthesiologists (ASA) score 1-3. BMI > 18 og < 35. Oral and written consent Exclusion Criteria: Weight < 50kg Allergy towards drugs used in the study Patients for re-operation Other fracture at the same time Pregnancy Daily use of opioids within two weeks before operation Infection near the application site Patients in need of dialysis Patients with neuropathy in lower extremities

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Block<br>Popliteal and saphenous Block with Ropivacaine | Drug: Ropivacaine block<br> <br> |
| Placebo Comparator: NaCl<br> | Drug: Ropivacaine block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Morphine |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional rehabilitation outcome | American Orthopaedic Foot and Ankle Society (AOFAS) score | 10-14 weeks |
Ewha Birth and Growth Study (Birth Cohort)

Study Overview
=================
Brief Summary
-----------------
Ongoing longitudinal birth cohort established at Mok-dong Hospital, Ewha Woman's University, Seoul, South Korea, between 2001 and 2006.

Detailed Description
-----------------
Cohort composed of mothers, who visited to prenatal care between 24 and 28 weeks of gestation, between 2001 and 2006. After the child was born then, we collected information at birth outcome and conducted mail surveys at 6, 12, 18, and 24 months. Regular check-up was conducted at 3, 5, and every year after 7 years of age(last check up point: 15 years old). In check-up survey, after an 8-hour overnight fast, blood and urine samples (3 ml EDTA-blood and 5 ml serum) were obtained from subjects by venepuncture. following parameters were checked: physical growth, blood pressure. metabolic biomarker(Total cholesterol, HDl-cholesterol, TG(triglyceride), glucose, uric acid, etc.), K-CBCL(Korea-child behavior checklist), 24 hour recall method for nutrition, FFQ(Food Frequency Questionnaire), Questionnaires including Socio-economic status and physical activity.

Official Title
-----------------
Evaluation of Influencing Factors Affecting Childhood Metabolic Indicators in Korea (Repeated Measures Analysis; Longitudinal Birth Study)

Conditions
-----------------
Pediatric Health

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants' mothers, who visited to prenatal care between 24 and 28 weeks of gestation. An individual who can be followed up during the study period and is capable of complying with the study requirements Exclusion Criteria: An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 17 Years

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

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 |
| --- | --- | --- |
| Profile of participants received regular medical check-up and result feed back for growth development | Changes from baseline in physical growth using anthropometric measurement | 365days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of participants received blood pressure measurement for pediatric hypertension | Changes from baseline in average blood pressure(mmHg, diastolic and systolic) as above the 95th percentile adjusted for sex, age, and height percentile | 365days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth pattern, Environmental and prenatal exposure
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.

Official Title
-----------------
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Drug: Cefotaxime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection Exclusion Criteria: Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases
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: SBP-group 1<br>Spontanous bacterial peritonitis | Drug: Cefotaxime<br> <br> |
| Experimental: CNNA-group 2<br>Culture negative neutrocytic ascites | Drug: Cefotaxime<br> <br> |
| Experimental: MNBA-group 3<br>monomicrobial non-neutrocytic ascites | Drug: Cefotaxime<br> <br> |
| No Intervention: group 4<br>no evidence of ascitic fluid infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organisms detected with their antibiotics sensitivity |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
profiles changes, microorganisms, cefotaxime, SBP, Egyptian, effective antibiotics
Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.

Official Title
-----------------
Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Procedure: Aortic valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 y-o who underwent aortic valve replacement Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| RVAo MITAVA<br>Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital | Procedure: Aortic valve replacement<br>* Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days mortality incidence rates | Mortality from aortic valve replacement to 30 days post-surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days morbidity incidence rates | Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events) | 30 days | 
| Long-term morbimortality incidence rates | Morbimortality from aortic valve replacement up to 10 years post-surgery | 10 years |
HES and Acute Kidney Injury in Adult Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.

Official Title
-----------------
The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study

Conditions
-----------------
Acute Kidney Injury After Adult Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: HES
* Drug: Crystalloid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 yo Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014 Exclusion Criteria: Off pump surgery Use of Blood or Albumin in the cardiopulmonary bypass priming solution Preoperative dialysis

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 |
| --- | --- |
| HES<br>Balanced HES 130/0.4 used as and pump prime and for intraoperative fluid therapy. | Drug: HES<br>* 2500 mL of balanced HES 130/0.4<br>* Other names: Volulyte®;|
| Crystalloid<br>Balanced Crystalloid used as a pump prime and for intraoperative fluid therapy. | Drug: Crystalloid<br>* 2500 mL of balanced crystalloid.<br>* Other names: Plasmalyte A ®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKIN SCr | Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria. | Forty eight hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKIN SCr+UO | Stage of acute kidney injury using the Acute Kidney Injury Network Classification including the diuresis criteria. | Forty eight hours | 
| Postoperative dialysis | Requirement of postoperative renal replacement therapy | 30 days | 
| Respiratory complication | Need for reintubation, non-invasive ventilation or prolonged intensive care unit stay as a consequence of atelectasis, pulmonary edema or pneumonia. | 30 days | 
| ICU stay | Length of stay at the intensive care unit | 30 days | 
| Hospital stay | Length of stay at the hospital | 30 days | 
| 30-day mortality | Death in hospital or within 30 days of surgery | 30 days |
Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model

Study Overview
=================
Brief Summary
-----------------
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.

Detailed Description
-----------------
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. They need adjust themselves and their crisis lives, and some plan they had made the near or distant future. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.Research methods will separate three year project to describe. First year project will use qualitative methods from bio-psychosocial aspects to interview participants who may suffer illness after diagnosis or stable treatment during middle phase of illness. Second year will invite diabetes and hypertension patients from different phase of illness with different levels of health anxiety trait, meta-cognitive and control strategies if derived different coping and emotions outcome. The third year will design motivational psycho-education program for patients to alleviate the emotions and use cold meta-cognition to due good health behavior and self care with their illness. The expected results will like to test the investigators new model in caring chronic disease patients.

Official Title
-----------------
Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model

Conditions
-----------------
Drug or Chemical Induced Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults aged 20 and above, with hypertension or diabetes or both diseases. Exclusion Criteria: adults with other severe physical diseases. adults with relevant psychological diseases.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-monitoring and self-control scale |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| meta-thinking awareness scale |  | one year | 
| negative self thinking scale |  | one year | 
| depression and anxiety scale |  | one year | 
| life change scale |  | one year | 
| health anxiety scale |  | one year |
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Study Overview
=================
Brief Summary
-----------------
To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.

Official Title
-----------------
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Conditions
-----------------
Ulcerative Colitis in Remission

Intervention / Treatment
-----------------
* Drug: Asacol®
* Drug: Mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ulcerative colitis in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0. Exclusion Criteria: Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asacol®<br>Import Mesalazine | Drug: Asacol®<br>* 400 mg tablets<br>* Other names: Import Mesalazine;|
| Active Comparator: Mesalazine<br>Marketed Mesalazine | Drug: Mesalazine<br>* 400mg tablets<br>* Other names: Marketed Mesalazine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-emergence of bloody stool |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score |  | Week 48 |
Treatment Outcome After Surgical Treatment of Osteoid Osteoma

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To retrospectively determine the clinical results in an unselected group of consecutive patients with osteoid osteoma treated by surgery. Materials and Methods: In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at any location, the clinical symptoms and imaging findings (radiographs and computed tomography (CT)) were assessed before and after surgery. There were no exclusion criteria for this study. A good response was defined as disappearance of symptoms that were manifested at presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12 months follow-up. After 24 months, a postal questionnaire was used for assessment. Radiographic evaluation (radiographs and thin-slice CT) was performed routinely pre-operatively and one year after surgery. In case of persisting or recurring symptoms the follow-up protocol was again performed according to the initial protocol. All patients gave their informed consent both for the surgical intervention as for the use of their patient data in this retrospective study.

Official Title
-----------------
Treatment Outcome After Surgical Treatment of Osteoid Osteoma, a Retrospective Study

Conditions
-----------------
Osteoid Osteoma

Intervention / Treatment
-----------------
* Procedure: surgical removal of osteoid osteoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with osteoid osteoma at any location. Exclusion Criteria: none.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| osteoid osteoma<br>patients with osteoid osteoma at any location | Procedure: surgical removal of osteoid osteoma<br>* surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion<br>|

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
-----------------
osteoma, osteoid, surgical procedures, operative, bone neoplasms