linjc16/ctgov huggingface dataset:
The Becoming of Children With Doose Syndrome

Study Overview
=================
Brief Summary
-----------------
Doose syndrome is a rare epileptic syndrome that can lead to learning difficulties and a poor quality of life. The goal of this study is to evaluate the evolution of epilepsy and its consequences on cognitive development and learning issues in children with Doose syndrome.

Detailed Description
-----------------
Doose syndrome is a rare epileptic syndrome beginning between ages two and five, characterized by myoclonic-astatic seizures which can be associated with myoclonic seizures, astatic seizures, absences and generalized tonic-clonic seizures. These seizures can be difficult to treat effectively and may lead to learning difficulties. During this study, parents of children with Doose syndrome will receive a questionnaire regarding learning disabilities, quality of life and epilepsy of their children.

Official Title
-----------------
The Becoming of Children With Doose Syndrome

Conditions
-----------------
Doose Syndrome, Epileptic Syndromes, Learning Disabilities

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with doose syndrome diagnosed between ages 1 and 6 normal development until onset of seizures Exclusion Criteria: unconfirmed diagnoses abnormal diagnoses abnormal psychomotor development before onset of seizures cerebral MRI abnormalities other child epileptic syndromes

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire|questionnaire send to the parents|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease effects on the learning ability of children with doose syndrome | disease effects on the learning ability of children with doose syndrome base on scholar informations | day of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of epilepsy in children with doose syndrome based on pathological symptoms | Evolution of epilepsy in children with doose syndrome based on pathological symptoms | day of inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
doose syndrome, Epileptic Syndromes, Learning Disabilities
Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

Study Overview
=================
Brief Summary
-----------------
The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.

Official Title
-----------------
The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Drug: Verdye Green


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operative rectal cancer Exclusion Criteria: known allergy toward indocyanic green
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Intraoperative verdye green iv administration to visualize blood supply to the anastomosis | Drug: Verdye Green<br>* intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection<br>* Other names: Indocyianic Green;|
| No Intervention: Control<br>No administration of verdye green intraoperatively | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak | Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line | Up to two weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postsurgical Ileus | Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery | Up to 10 days post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, laparoscopic anterior resection, intraoperative angiography, ICG
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.

Official Title
-----------------
A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast Cancer

Conditions
-----------------
Breast Cancer, Colorectal Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label Exclusion Criteria: Contraindications according to label and off-label use

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 |
| --- | --- |
| Capecitabine<br>Participants will receive capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. | Drug: Capecitabine<br>* Capecitabine will be given according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed. | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Dose of Capecitabine | Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented. | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first |
Comparison of Preparation Regimens for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.

Conditions
-----------------
Colonoscopy Preparation

Intervention / Treatment
-----------------
* Drug: one of two possible colon preparation regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing colonoscopy Exclusion Criteria: patient refusal to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium picosulphate and magnesium citrate (Picoprep)<br> | Drug: one of two possible colon preparation regimens<br>* Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate<br>* Other names: Picoprep;|
| Active Comparator: polyethylene glycol (Fortrans)<br> | Drug: one of two possible colon preparation regimens<br>* Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate<br>* Other names: Picoprep;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colon preparation | the impact of colon preparation as assessed by the endoscopist (scale from 1 to 4, 1 representing the worst and 4 the best prepared colon) on the quality of the endoscopic examination | 24 h |
Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients

Study Overview
=================
Brief Summary
-----------------
The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.

Official Title
-----------------
State of congEstive heArt Failure Before the onSet of atrIal Tachyarrhythmias Detected by Implanted devicE in Pacemaker Patients (SEASIDE)

Conditions
-----------------
Heart Failure，Congestive, Atrial Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent implant of DR pacemaker according to current guidelines Sinus Rhythm at enrollment Exclusion Criteria: Pregnant women

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 |
| --- | --- |
| PMK patients<br>Patients already implanted with double chamber pacemaker able to detect automatically congestive heart failure and collect atrial events. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate relationship between atrial tachyarrhythmias and congestive heart failure | Relationship between thoracic impedance variations and atrial events collected by device | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect optimal device programming | Identify useful index congestion trigger value | twelve months |
Development of Upper Aerodigestive Tract Splint

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.

Detailed Description
-----------------
This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.

Official Title
-----------------
Development of Upper Aerodigestive Tract Splint

Conditions
-----------------
Splints

Intervention / Treatment
-----------------
* Device: Use of Splint for UADT Visualization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Require a procedure involving the upper aerodigestive tract (UADT) Exclusion Criteria: Prior surgery to tongue or mouth that precludes the use of the splint Trismus with mouth opening that does not allow for use of the splint TMJ dysfunction that precludes the use of the splint Allergy to local anesthetic
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of Splint for UADT Visualization<br>Use of device to view UADT | Device: Use of Splint for UADT Visualization<br>* The use of a splint to assist the patient and the surgeon with UADT procedures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Splint Satisfaction Questionnaire | Self-administered, 6-item questionnaire to evaluate splint satisfaction. | Immediately after the intervention/procedure/surgery | 
| Physician Splint Satisfaction Questionnaire | A 14-item questionnaire to evaluate the surgeon satisfaction with the splint. | Immediately after the intervention/procedure/surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper Aerodigestive Tract, Visualization, Surgical Instrumentation
Follow-Up Study to Assess Implementation of Ultrasound-Guided Regional Anesthesia Skills

Study Overview
=================
Brief Summary
-----------------
The investigators hope to survey anesthesiologists who have participated in a non-CME regional anesthesia workshop at VAPAHCS over the past 4 years on the number and types of nerve block procedures that they performed, nerve localization method (e.g., ultrasound, electrical stimulation, or both), and whether the nerve blocks performed were single-injection or catheter-based.

Detailed Description
-----------------
The investigators expect to recruit approximately 100 participants through the use of an IRB-approved survey and cover letter which will be distributed to anesthesiologists who have participated in a non-CME regional anesthesia workshop at VAPAHCS over the past 4 years. Prospective subjects will provide consent to participate by completing the requested survey. Subjects will not receive monetary remuneration for their participation. Selection for inclusion will not be based on gender, race, or socioeconomic status. There will be no recruitment of participants from vulnerable populations. Participants will receive a link to an online survey and if they prefer an alternate method, the investigators will send the participant the survey in Word document format or survey by telephone. The survey will ask for the number and types of nerve block procedures that the participant performed, nerve localization method (e.g., ultrasound, electrical stimulation, or both), and whether the nerve blocks performed were single-injection or catheter-based.

Official Title
-----------------
A Long-Term Follow-Up Study to Assess Implementation of Ultrasound-Guided Regional Anesthesia Skills Training by Practicing Anesthesiologists

Conditions
-----------------
Implementation of Anesthesiologists' Practice Change

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthesiologists in practice who have participated in a regional anesthesia workshop at VAPAHCS; and willingness to complete a survey. Exclusion Criteria: Anesthesiologists who have visual, hearing, or other communication impairment that would interfere with survey completion.
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 |
| --- | --- | --- |
| Implementation of Ultrasound-Guided Regional Anesthesia skills |  | 1 year |
The Clinical and Laboratory Characteristics of Recurrent Drug- Related Hyponatremia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify factors associated with hyponatremia among patients hospitalized in the internal medicine ward. Consequtive patients hospitalized because of hyponatremia will be recruited. Follow up will include clinical factors such as background diseases, complete drug history, blood tests including Biochemistry tests (Sodium, renal function), endocrinological evaluation, thyroid function tests, cortisol,urinary sodium on addmition. One month following discharge follow up Sodium level will be taken.

Official Title
-----------------
Observational Cohort Study- The Clinical and Laboratory Characteristics of Recurrent Drug- Related

Conditions
-----------------
Hyponatremia, SIADH

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients hospitalized to the internal medicine ward due to hyponatremia Exclusion Criteria: None
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 |
| --- | --- | --- |
Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns

Study Overview
=================
Brief Summary
-----------------
EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites). Objectives: Comparison of antimicrobial susceptibility using disc-diffusion method Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients

Detailed Description
-----------------
n/a n/a

Official Title
-----------------
Expert Group On Antibiotic Susceptibility Testing [EGAST] 2008: A Non-Interventional, Multicenter In-Vitro Study To Evaluate The Prevalence Of Beta-Lactamase Producing Strains Among Clinical Isolates Obtained From Hospital In-Patients And Comparison Of Antimicrobial Susceptibility Using Disc-Diffusion Method

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolates (as specified in the observational plan) from hospitalised patients Exclusion Criteria: Isolates obtained from outpatients will not be included for the study. Isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded. Isolates identified as commensals or contaminants will be excluded
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 |
| --- | --- | --- |
| Comparison of antimicrobial susceptibility using disc-diffusion method |  | duration of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients |  | duration of trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic susceptibility; beta lactamase; ESBLs
Methods for Nutritional Assessment in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis. Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.

Official Title
-----------------
Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis

Conditions
-----------------
Liver Cirrhosis, Cachexia, Malnutrition

Intervention / Treatment
-----------------
* Other: Bioelectrical impedance vector analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cirrhosis No restriction of etiology 18-75 years Child-Pugh stage A/B/C Signed informed consent Exclusion Criteria: Pregnancy Extremity amputation Malignancy different from hepatocellular carcinoma

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Bioelectrical impedance vector analysis|Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Characterization of nutritional status by three methods of nutritional assessment Bioelectrical impedance vector analysis CT scan Handgrip strength | Evaluation at time of recruitment |