linjc16/ctgov huggingface dataset:
Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias

Study Overview
=================
Brief Summary
-----------------
Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic patients, surgery remains questionable. Although there are new European recommendations, the practice of digestive surgeons regarding the management of asymptomatic hernias is unknown. The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.

Official Title
-----------------
Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey

Conditions
-----------------
Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias, Comparison With International Recommendations

Intervention / Treatment
-----------------
* Other: Observation study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: No

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| french-speaking digestive surgeons<br>french-speaking digestive surgeons are visceral and digestive surgeons that have a general surgical activity too. They can have or not an expertise on hernia pathology. They are questioned by survey on decisions about different patient asymptomatic hernia clinical situations. | Other: Observation study<br>* French-speaking digestive surgeons are invited to respond to an online survey consisting of 13 common clinical situations concerning primary or asymptomatic incisional hernia pathology where a therapeutic decision is requested.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number and type of clinical cases for which a consensus, defined by an arbitrary value of 75% of surgeons with the same therapeutic attitude | The survey consists of general questions about the surgeons' activity and then 13 clinical situations where a decision is requested. The clinical cases are developed by the authors of the study in order to solve the frequent problems with the treatment of hernias and incisional hernias | The outcome measure is evaluated after 6 months during which the survey is online (from october 2016 to march 2017), time during which surgeons had access to answer it |
Study of the Sudden Heart Failure Participant Population in the US

Study Overview
=================
Brief Summary
-----------------
An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack

Official Title
-----------------
Characterizing the Acute Decompensated Heart Failure (ADHF) Patient Population in the United States (US)

Conditions
-----------------
Heart Decompensation

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older on the index date At least 6 months of activity in the database An inpatient visit with at least one of the following ICD-9 or ICD-10 diagnosis codes (ICD-9 diagnosis codes: 428.xx, 785.51 or ICD-10 diagnosis codes: I50.xx, R57.0) in the primary or secondary position OR mention of heart failure on the admission record Exclusion Criteria: An average LVEF ≥ 40 during the hospitalization Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as myocardial infarction, mi, infarct or heart attack occurring during the index hospitalization Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| Participants hospitalized with ADHF<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of comorbid events among hospitalized ADHF participants |  | In the 30 days after discharge | 
| Incidence of participants hospitalized with ADHF |  | Up to 66 months | 
| Incidence of participants hospitalized with ADHF |  | In the 30 days after discharge | 
| Incidence of comorbid events among hospitalized ADHF participants |  | Up to 66 months |
Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Study Overview
=================
Brief Summary
-----------------
In traditional video-fluoroscopic-swallowing study, a lipid-soluble contrast (barium sulfate) has been used more than 30 years. However, it can cause chemical pneumonitis and subsequently impair reliability of video-fluoroscopic-swallowing study if aspirated. The authors reviewed the safety and usefulness of an water soluble agent-based swallowing test.

Detailed Description
-----------------
Parallel-group, case-controlled trial was conducted from September 2015 to November 2017. All the patients who referred for video-fluoroscopic-swallowing study were screened. Based on the pre-emptive evaluation, high-risky patients were allocated to iohexol (Omnipaque)-used video-fluoroscopic-swallowing study and others were allocated to barium sulfate-used video-fluoroscopic-swallowing study. Statistical Package for the Social Sciences 24 was used to perform statistical analysis for the data. Quantitative data were presented as mean ± standard errors.

Official Title
-----------------
Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Conditions
-----------------
Dysphagia, Swallowing Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients who referred for video-fluoroscopic-swallowing study Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Iohexol<br>Iohexol was applied in video-fluoroscopic-swallowing study | |
| Barium<br>Barium was applied in video-fluoroscopic-swallowing study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngeal protection | Penetration aspiration scale (zero to eight) | within 1 hour after video-fluoroscopic-swallowing study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral feeding | Success of Oral feeding after video-fluoroscopic-swallowing study or not | within 1 week before video-fluoroscopic-swallowing study |
Assessment of Home Tonometry in Glaucoma

Study Overview
=================
Brief Summary
-----------------
Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is known to vary throughout the day and in ¾ of people is highest during the night. The result is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this might have on their glaucoma. This is a serious limitation as the treatment of glaucoma depends on lowering IOP. Recently a new device has become available, designed specifically for home IOP monitoring. The iCare HOME tonometer is a CE marked commercial device (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain insight into 24-hour IOP fluctuations. We wish to determine the feasibility of home IOP monitoring using this device. The iCare HOME tonometer depends on the patient performing self-tonometry. Testing one's own IOP may be technically difficult and it is likely that large numbers of patients will struggle with this.

Official Title
-----------------
Assessment of Home Tonometry in Glaucoma

Conditions
-----------------
Glaucoma, Intraocular Pressure

Intervention / Treatment
-----------------
* Device: iCare home tonometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma At least 4 previous visual field tests (to enable rate of change to be calculated). Age 16 years and above Age less than 100 Exclusion Criteria: Corneal disease (potentially affects pressure measurements) Neovascular glaucoma Uveitis Secondary glaucomas Inability to give informed consent. Less than 16 years of age. Pregnancy. Unable to hold iCare HOME® tonometer due to upper limb weakness or disability.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: iCare home tonometer|All subjects will be taught to use the home care tonometer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether or not the subject is deemed successful in using the home tonometer | Strict success = intraocular pressure within 5mmHg of that obtained by technician | On baseline visit |
Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.

Official Title
-----------------
A Dose-Finding Study of the Safety of Gemtuzumab Ozogamicin as Single Agent Treatment of Patients With Relapsed Acute Myelogenous Leukemia After Autologous or Allogenic Hematopoietic Stem Cell Transplant (HSCT)

Conditions
-----------------
Acute Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: Mylotarg (gemtuzumab ozogamicin) Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment) The patient must be greater than or equal to 60 days post-HCST Patients of all ages may be entered in this study Exclusion Criteria Peripheral white blood count (WBC) greater than or equal to 30,000/uL at the time of initial Gemtuzumab Ozogamicin administration. (In order to reduce the peripheral blood count, patients may be treated with Hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to Gemtuzumab Ozogamicin administration.) Known active central nervous system (CNS) or testicular leukemia at time of study entry. Prior therapy with anti-CD33 antibodies.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mylotarg (gemtuzumab ozogamicin) Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Stem Cell Transplant
Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (RaProRad)

Study Overview
=================
Brief Summary
-----------------
The investigators provided a multicenter analysis aiming to investigate, in a clinical practice setting, the prognostic relevance of previous primary radical prostatectomy (RP) or external beam radiotherapy (RT) in terms of Overall Survival as opposed to patients with no primary treatment performed, in a cohort of patients enrolled in 223-Ra treatment for mCRPC. 223-Ra has been administered from investigators according to the current label authorization and all patients underwent 223-Ra treatment, until disease progression or unacceptable toxicity.

Official Title
-----------------
Evaluation of Previeus Radical Prostatectomy and/or External Beam Radiotherapy as Protective Factors in mCRPC Patients Treated With 223Radium-dicloride and Correlation With Overall Survival: an Italian Multicenter Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: Radium223


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological confirmation of prostatic adenocarcinoma, at least two symptomatic bone secondary lesions detected by bone scan and no known visceral metastases, except for malignant lymphadenopathy with less than 3 cm in the short axis diameter Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status (PS) score >2 and inadequate hematological, hepatic and renal function
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radium223<br> | Other: Radium223<br>* 55 kBq/ Kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of overal survivall | The survival function, possibly stratified by categorical covariates of interest, was computed using the Kaplan-Meier product-limit estimator. | From date of first 223Ra administration until the date of death from any cause or the date of the first documented progression disease, assessed up to 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
223-Radium-dicloride, Radical prostatectomy, overall survival
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.

Detailed Description
-----------------
The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.

Official Title
-----------------
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial

Conditions
-----------------
Management of Delivery

Intervention / Treatment
-----------------
* Procedure: Placental drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low risk pregnant women Pregnancy at term Women at low risk for assisted labor / delivery and postpartum care. Live Fetus Exclusion Criteria: Women under 18, mentally handicapped and indigenous; Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps; Instrumental Delivery by forceps or c-section

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine clamping<br>After delivery of the newborn, umbilical cord at mothers end, will be left clamped until delivery of the placenta. | |
| Experimental: Placental drainage<br>After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta. | Procedure: Placental drainage<br>* After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the third period of labor | Time from delivery of the baby to the delivery of the placenta | Six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum blood loss | Volume of blood lost 24 hours after birth | 24 hours | 
| PPH | Postpartum hemorrhage | 24 hours | 
| Need of uterotonics | use of aditional uterotonics ( prophylkatic use not included) | 24 hours | 
| Need of blood transfusions | Need of blood transfusions | until discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drainage, pregnancy, active management, postpartum hemorrhage
Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of exercise on diverse cardiometabolic risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Aerobic Exercise Group
* Behavioral: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes stable body weight sedentary lifestyle Exclusion Criteria: smoked cigarettes cardiovascular disease chronic kidney chronic liver disease pregnant or breastfeeding any other major illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Behavioral: Control Group<br>* maintaining usual activities<br>|
| Active Comparator: Exercise<br> | Behavioral: Aerobic Exercise Group<br>* 12 weeks Aerobic exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in soluble receptor for advanced glycation endproducts (sRAGE) after 12 weeks of aerobic exercise |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric parameters | body weight, waist circumference, body fat percentage, visceral fat area | 12 weeks | 
| biochemical parameters | HbA1c, apolipoprotein B, free fatty acid | 12 weeks | 
| energy expenditure | activity energy expenditure, total energy expenditure | 12 weeks |
Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia.

Detailed Description
-----------------
Bacterial alveolar invasion is followed by a compartmentalized inflammatory response. Data suggest that some antimicrobials may induce a differential release of cytokines, with the potential of either accelerating or down regulating cytokine production. The aim of our study was to compare the effects of ceftriaxone compared with levofloxacin on cytokine systemic concentrations in patients with pneumococcal pneumonia.

Official Title
-----------------
Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia

Conditions
-----------------
Pneumonia, Pneumococcal

Intervention / Treatment
-----------------
* Drug: levofloxacin
* Drug: ceftriaxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with an acute febrile respiratory illness accompanied by a new radiographic infiltrate consistent with this diagnosis. and with a confirmed pneumococcal aetiology Exclusion Criteria: age < 18 years, pneumonia distal to endobronchial obstruction, pulmonary tuberculosis, bronchiectasis, known allergy to B-lactams or fluoroquinolones, underlying systemic autoimmune disease immunocompromised states including patients on maintenance oral corticosteroids, HIV infection, pregnancy, patients that received antimicrobial therapy in the 15 days preceding the current episode and those who had received fluoroquinolones in the last month, or non steroidal anti-inflammatory therapy in the last two weeks. Patients with renal failure (serum creatinine > 2 mg / dL), and patients with a documented pneumococcal pneumonia in the previous 4 weeks

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levofloxacin|nan|
|Drug: ceftriaxone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relationship between cytokine expression, clinical variables and severity of disease. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluorquinolones,, b-lactams,, immunomodulation.