linjc16/ctgov huggingface dataset:
Medtronic Observational Study in the Real World of Implantable Electronic Cardiac Devices

Study Overview
=================
Brief Summary
-----------------
The Observational Study in the Real World of Implantable Electronic Cardiac Devices will enable the construction of an electronic database with local access to clinical information, which will collect and disseminate epidemiologic data on demography, cardiovascular mortality and morbidity, and potential risk factors for a selected group of patients. These clinical variables will be analyzed against the data, as based in the programming of devices and the diagnostics. Approved descriptive statistics and analyses will be made available via Internet. The study will describe statistical indexes on sub-groups representing more than 10% of total of datasets. The study will be open to include any patient that had a Medtronic electronic device implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices implanted in the present and for devices to be implanted in patients in the future.

Detailed Description
-----------------
This study is a Prospective, Multicenter Observational Post Market Release Study. It shall involve around 2,000 patients that are eligible for Implantable Cardiac Pacemakers (IPG) implantation, 500 patients eligible for Cardiac Resynchronization Pacemakers (CRT-P) implantation, 1,000 patients eligible for the implantation of Implantable Cardioverter Defibrillators with or without Cardiac Resynchronization Pacemakers (CDI, CRT-D), and around 20 centers in Brazil. Patients will be consecutively enrolled in centers among those selected for the implantation of a Medtronic device in accordance with indications approved.

Official Title
-----------------
Medtronic Observational Study in the Real World of Implantable Electronic Cardiac Devices

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than18 years of age Patient agrees to participate in the study and is able to sign the Data Release Form High probability of adherence to follow-up requirements Exclusion Criteria: Patients who want to be enrolled in another clinical study during at the same time that he/she is part of OBSERVE study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real World Electronic Database with clinical information, related to Implantable Cardiac devices.
Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

Study Overview
=================
Brief Summary
-----------------
Band ligation and injection sclerotherapy are two modalities of treatment that are applied using the endoscope. The purpose of this study is to determine which of two methods is better for controlling bleeding from the upper gut.

Detailed Description
-----------------
The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.

Official Title
-----------------
Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.

Conditions
-----------------
Hematemesis, Portal Hypertension

Intervention / Treatment
-----------------
* Procedure: Endoscopic control of hematemesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active hematemesis esophageal varices Exclusion Criteria: Hemodynamic unstability Hepatic coma or precoma Tense ascitis Coagulopathies concomitant gastric varices

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: band ligation group<br>this group will have immediate control of the hematemesis by endoscopic band ligation. | Procedure: Endoscopic control of hematemesis<br>* Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy<br>* Other names: Ehanolamine oleate sclerosant material;|
| Active Comparator: sclerotherapy group<br>This group will have immediate control of hematemesis by endoscopic sclerotherapy | Procedure: Endoscopic control of hematemesis<br>* Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy<br>* Other names: Ehanolamine oleate sclerosant material;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control of hematemesis | Success for either techniques to be able to stop the bleeding promptly and maintain that for 72 hours | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of complications from the intervention | the study subjects are reveiwed in 30 days to detect any complications secondary to the endoscopic intervention. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal varices, hematemesis, endoscopy
Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair. Patients will be randomised to injection of Marcaine© og a needle prick per-operatively. Pain will be estimated using the VAS score in: 1. the wound 2 the abdomen 3 the shoulder Scoring will be performed: pre-operatively 1 hour postoperatively at discharge from the hospital d day 1,2 and 3 post OP e. 1 year post OP

Detailed Description
-----------------
as above

Official Title
-----------------
Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair

Conditions
-----------------
Post Operative Pain as Estimated by the Sue of the VAS Score

Intervention / Treatment
-----------------
* Drug: Marcaine ½%
* Procedure: Needle prick


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 year Informed consent a diagnosis of an inguinal hernia ASA group ≤ 3 BMI ≤ 35 Exclusion Criteria: Communication problems No consent Open procedure (not laparoscopic) ASA-group 4 Use of Steroid or immunosuppressive tretament Regular morphine use.

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of Marcaine ½ %<br>Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine | Drug: Marcaine ½%<br> <br> |
| Placebo Comparator: Needle prick<br>Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine | Procedure: Needle prick<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | VAS score of pain from: wound abdomen shoulder | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia, postoperative pain, localanesthesia, nerve blockage
Improvement of Body Image Flexibility in High School Female Athletes Doing Educational About Nutrition and Body Image

Study Overview
=================
Brief Summary
-----------------
Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image

Detailed Description
-----------------
This study was a prospective cohort design. Female high school athletes were asked to participate in three educational sessions about nutrition, body image flexibility, and RED-S (relative energy deficiency in sport). Pre and post-tests were done with a validated tool measuring body image flexibility.

Official Title
-----------------
Improvement of Body Image Flexibility in High School Female Athletes Undergoing Three Educational Sessions About Nutrition and Body Image

Conditions
-----------------
Body Image, Nutrition, Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: identify as female athlete at local high school willing to fill out survey at beginning and end of sessions willing to provide consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| female high school athletes<br>Athletes who identify as female at a local high school who are in an athletic program. There was no control group as the school wanted everyone to have the 3 educational sessions. The athletes underwent 3 educational sessions. No medication was used. Education was the intervention | Other: Education<br>* 3 educational sessions about body image and nutrition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BI-AAQ Scores | scores on body image flexibility | 2 months |
Magnetic Resonance Imaging Using Innovative Pulse Sequences

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.

Detailed Description
-----------------
This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization

Official Title
-----------------
Magnetic Resonance Imaging Using Innovative Pulse Sequences

Conditions
-----------------
Clinical Indication for a Head MRI

Intervention / Treatment
-----------------
* Device: pulse sequences


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be at least 18 years of age Subject must be willing and able to undergo verbal and written informed consent Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration Exclusion Criteria: Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study. Any contraindication to an MRI scan per the policy of Spectrum Health Any contraindication to administration of an MRI contrast agent per the policy of Spectrum Health Off-label utilization of contrast agents administered for the subject's clinical exam

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pulse sequence software<br>The central aim of this study is to acquire a set of images and associated technical and clinical information to facilitate regulatory submission of the pulse sequences being studied by GEHC. Segment 1 allows to collect a minimum of 10 subjects then evaluate if additional scans/enrollment needed Segment 2 will allow an additional 90 subjects if data needed | Device: pulse sequences<br>* Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence<br>* Other names: zero TE pulse sequences;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Head Images Successfully Collected | Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence. | 6-months |
Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft

Study Overview
=================
Brief Summary
-----------------
In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.

Detailed Description
-----------------
The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.

Official Title
-----------------
Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute

Conditions
-----------------
Pes Plano Valgus, Flatfeet

Intervention / Treatment
-----------------
* Procedure: Lateral lengthening osteotomy of calcaneus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pain gait disturbance Exclusion Criteria: post traumatic conditions

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 20 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 |
| --- | --- |
| Pes plano valgus<br>Children with painful flatfeet | Procedure: Lateral lengthening osteotomy of calcaneus<br>* Use of artificial bone graft<br>* Other names: Hydroxyapatite;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of osteotomy | Will be followed with repeated clinical examinations until healing | 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial bone graft, Hydroxyapatite, Children, Osteotomy, Pes plano valgus, Flatfeet
ZIKAlliance Natural History Study

Study Overview
=================
Brief Summary
-----------------
Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.

Detailed Description
-----------------
Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil. Following enrolment (day 0), patients will be followed up at days 2-3, 7, 14, 21, 30, 90, 180 and 360 with clinical and biological procedures (blood and urine samples). For patients with proven ZIKA Virus (ZIKV) infection, follow-up samples will include blood, saliva, urine and genital samples. For non-ZIKV infected patients, follow-up samples will include serological monitoring at days 14, 30, 180 and 360, and for men, possible assessment of genital fluids at day 180. All patients will be evaluated for impact on disability up to one year. Household adult contacts of ZIKV patients will be invited for ZIKV evaluation including collection of blood and urine samples.

Official Title
-----------------
Longitudinal Clinical and Virological Study Among Symptomatic Patients With Zika Virus Infection in the City of Sao Paulo, Brazil

Conditions
-----------------
Zika Virus, Zika Virus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rash or Fever illness within 72 hours of symptom onset Exclusion Criteria: presence of symptoms or complications indicative of a bacterial infection

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 |
| --- | --- |
| Symptomatic adults<br>adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ZIKA Virus Infection | Clinical Characterization | up to one year | 
| DENGUE Virus Infection | Clinical Characterization | up to one year | 
| Chikungunya Virus Infection | Clinical Characterization | up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHIKV, DENGUE, Chikungunya, DENV
Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation. The association is examined by comparing the difference in oxidative modifications before and after 90 days treatment with 25 mg empagliflozin plus insulin compared to insulin treatment. The study is randomised and double-blinded. Each treatment group consists of 20 patients. Oxidative stress markers are measured by serum level of superoxide dismutase activity ,lipid peroxidation assay kit, glutathione assay, glutathione peroxidase activity , total antioxidant capacity assay oxidant status , carbonyl content assay and bca protein assay . . A student t-test will be performed to compare adding empagliflozin . The results will be published in a peer-review journal.

Detailed Description
-----------------
With the purpose of studying the antioxidant activity of empagloflozin 25mg will add on insulin in 20 patients after kidney transplant and will compare with 20 diabetic recipient of kidney transplant on insulin therapy alone.

Official Title
-----------------
Effects of Empagliflozin in Reducing Oxidative Stress of Diabetic Recipients After Kidney Transplantation

Conditions
-----------------
Kidney Transplant; Complications

Intervention / Treatment
-----------------
* Drug: Empagliflozin 25 MG
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes HbA1c: 6.5-9.0% post kidney transplant stable graft function Exclusion Criteria: pancreas and kidney transplant history of recurrent urinary tract infection

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br>Adding 25mg Empagliflozin on Insulin | Drug: Empagliflozin 25 MG<br>* 25 mg<br>Drug: Insulin<br>* Insulin<br>|
| Active Comparator: Insulin alone<br>Just contriling the blood glucose with Insulin | Drug: Insulin<br>* Insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of superoxide dismutase | Serum level of antioxidant levels | Change from baseline after 90 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of malondialdehyde | Serum level of antioxidant levels | Change from baseline after 90 days of intervention |