linjc16/ctgov huggingface dataset:
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

Study Overview
=================
Brief Summary
-----------------
Spinal anesthesia in newborns is one of  Gold standard  techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia. Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure. The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist. Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner. The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.

Official Title
-----------------
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

Conditions
-----------------
Newborns, Infant, Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newborns or Infants less than 7 kg Infra-umbilical surgery less than 1 hour Spinal anesthesia Exclusion criteria: parental refusal Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...). Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery<br>Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery | Drug: Dexmedetomidine IV<br>* Dexmedetomidine IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of motor block | Time at which the motor block is finished | immediately after procedure in the recovery room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
less than 7 kg, undergoing an infra-umbilical surgery, Spinal anesthesia, Dexmedetomidine, respiratory complications
Patient Empowerment With the Patient Perspective

Study Overview
=================
Brief Summary
-----------------
The overall aim with this study is to gain a deeper understanding of patient perceptions regarding empowerment in relation to a health platform.

Detailed Description
-----------------
This is a two-stage study design. The first stage consists of focus groups interviews. Three focus groups with 6-8 patients (colorectal cancer patients diagnosed at least one year ago) in each group, will be invited. The focus group interviews will be moderated by one researcher, but accompanied with a second observing researcher. The participants will be identified using the regional Swedish ColoRectal Cancer Registry in Västra Götaland. The participants will be contacted by a short letter (appendix) indicating that we will call them with more information. The participants will by phone be asked to participate in the study and then invited to the focus groups. The second phase of the project includes a questionnaire, which will be sent to 200 patients from the same population. The questionnaires will be delivered by using the Sunet Survey system, which is a system approved by University of Gothenburg. If the participants prefers a paper copy, or lack the possibility to reply online, a paper copy will be send via mail instead. At this moment the investigators have developed a questionnaire, which may be refined due to the understating achieved from the focus group interviews.

Official Title
-----------------
PEPP - Patient Empowerment With the Patient Perspective

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with colorectal cancer Exclusion Criteria: Inability to give informed consent or speaking and reading the Swedish language.

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 |
| --- |
|Other: No intervention|Interviews and questionnaires|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported experiences in themes | interview | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported experiences divided into themes | Interview | 12 months |
The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only effective method of achieving weight loss in patients with morbid obesity. The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty liver disease in patients operated on due to morbid obesity.

Detailed Description
-----------------
Investigators include 20 patients qualified for the bariatric procedure with BMI > 40 kg/m2 or a BMI > 35kg/m2 with the presence of comorbidities. The average body weight in the group was 143.85kg with an average BMI of 49.16kg/m2. Before the procedure, investigators evaluated the severity of the non-alcoholic fatty liver disease in each patient using the Sherif Saadeh ultrasound scale. Investigators also evaluated the levels of the liver enzymes. Follow up was performed twelve months after surgery.

Official Title
-----------------
The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Obesity, NAFLD

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at the age of 18-60, meeting the criteria of qualification for the surgical treatment of obesity, i.e. BMI > 40 kg/m2 or BMI > 35 kg/m2 together with accompanying diseases. Exclusion Criteria: chronic mental diseases addictions earlier bariatric procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Group 1<br>Patient with morbid obesity defined as a BMI above 40kg/m2 or 35kg/m2 with comorbidities who are qualified for bariatric surgery. | Procedure: Bariatric surgery<br>* Laparoscopic Sleeve Gastrectomy (LSG) Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAFLD | Ultrasound assessment of the severity of NAFLD with the Sherif-Saadeh scale. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss after bariatric surgery | Excess Body Mass Index loss (EBMIL) | 12 months after surgery | 
| Comorbidities | Number of patients with hypertension and diabetes | 12 months after surgery | 
| Liver function impairment | Standard set of blood liver enzymes including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) | 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, bariatric surgery, non-alcoholic fatty liver disease
Biological Therapy in Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Inflammatory bowel disease (IBD) is characterised by chronic, relapsing inflammation of the intestinal mucosa and an inability to down regulate the inflammatory immune response once activated. IBD encompasses ulcerative colitis (UC), Crohn's disease (CD) and indeterminate colitis which is not clearly diagnosed as UC or CD. The peak age of onset of IBD is 15 to 30 years, with a second smaller peak occurring between 50 and 70 years of age

Detailed Description
-----------------
The incidence of IBD is rapidly increasing in newly industrialized countries strongly implicating environmental factors. The pathogenesis of IBD is not fully understood, but key influences are thought to include genetics, environmental factors, immune response, and gut microbiota.It is recognised that the availability of vitamin D is important in regulating gut mucosal immunity; with studies suggesting that vitamin D may affect gut epithelial integrity, innate immune barrier function, and the development and function of T cells The predominant symptoms of IBD are diarrhea, abdominal pain, gastrointestinal bleeding, weight loss, malnutrition and fatigue which can substantially impact a patient's quality of life (QoL), largely due to the psychosocial impact of symptoms. A survey of IBD outpatients found that concerns about loss of bowel control, producing unpleasant odours, achieving their full potential in the workplace, feeling dirty or smelly, and issues with sexual relationships, ranked highly for both UC and CD

Official Title
-----------------
Biological Therapy in Patients With Inflammatory Bowel Disease :Laboratory ,Endoscopic and Quality of Life Assessment

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Any patient who is above age of 18 years old and diagnosed to have IBD (UC and/or CD) and eligible for biological therapy will be recruited in the study. Exclusion Criteria: Patients with IBD who aren't eligible to biological therapy Pregnant patients with IBD Patients with IBD who are under age of 18 years old Patient's refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: quality of life|to assess quality among patients with patients with IBD|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life in patients with IBD after biological therapy | we use The SF-36 form | one year |
Follow-up Study of Population Vaccinated With COVID-19 Vaccine

Study Overview
=================
Brief Summary
-----------------
A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.

Detailed Description
-----------------
From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.

Official Title
-----------------
Follow-up Study of Population Vaccinated With COVID-19 Vaccine

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies. Exclusion Criteria: People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before. People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.) People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.) People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control. Pregnant woman Juvenile

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 |
| --- | --- |
| CHB Group<br>Patients with CHB | |
| Compared Group<br>Healthy people | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms and signs | symptoms and signs after vaccination will be collected | 6months | 
| antibody levels | antibody levels will be collected | 6months | 
| laboratory findings | Clinical laboratory examination were obtained during follow-up. | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Vaccination, Anti-body
The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis

Study Overview
=================
Brief Summary
-----------------
Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The investigators' aim was to study the relevance of clinical parameters in terms of underlying disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis bronchiectasis population.

Detailed Description
-----------------
Patients from the non-cystic fibrosis bronchiectasis (NCFB) outpatient clinic were recruited in our study from September 2009 till July 2010. Control healthy subjects were recruited among peers of the patient or hospital staff during the same period. For the NCFB patients, underlying etiologies of NCFB and Pseudomonas aeruginosa (PA) colonization status were analyzed and each patient was evaluated by means of spirometry (FVC and FEV1), Leicester Cough Questionnaire (LCQ) and Sputum Colour Chart (SCC). SCC assessment was both done by letting the patient predict his sputum purulence prior to sputum induction and by SCC scoring after sputum harvest by the physician.

Official Title
-----------------
The Sputum Colour Chart as a Predictor of Lung Inflammation, Proteolysis and Damage in Non-cystic Fibrosis Bronchiectasis

Conditions
-----------------
Healthy, Non-cystic Fibrosis Bronchiectasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of NCFB, based on CT findings of bronchiectatic disease in the absence of cystic fibrosis (CF) as a cause. stable Exclusion Criteria: no recent exacerbation

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 |
| --- | --- |
| non-cystic fibrosis bronchiectasis<br>patients with non-cystic fibrosis bronchiectasis will be evaluated cross-sectionally | |
| healthy control subjects<br>healthy control subjects will be evaluated cross-sectionally | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess predictive value of sputum colour chart to evaluate airway inflammation | Airway inflammation will be assessed by analysis of sputum differential cell counts and cytokine/chemokine analysis in sputum. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Link the degree of airway inflammation to the proteolytic activity of sputum enzymes. | Proteolytic activity of sputum enzymes (total gelatinolytic activity) and sputum enzymes (neutrophil elastase, MMP9) will be quantified in sputum supernatant of NCFB patients and controls. | 10 months |
A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brimonidine Tartrate Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients of any race two (2) years of age or older of either sex diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)or ocular hypertension

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

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

| Intervention/Treatment |
| --- |
|Drug: Brimonidine Tartrate Ophthalmic Solution|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
-----------------
Open-Angle Glaucoma, Ocular Hypertension
Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical coherence tomograph (OCT).

Detailed Description
-----------------
Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population). Inclusion Criteria: Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale); and an area of retinal leakage of at least 25% of the RLA map (macular area). Exclusion Criteria: Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications; and other retinal pathologies.

Official Title
-----------------
Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area). Exclusion Criteria: Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.

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 |
| --- | --- |
| NPDR<br>Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) | |
| Control Population<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical reflectivity as measured by optical coherence tomography | To analyse OCT reflectivity distribution between areas with and without fluorescein leakage in type 2 diabetic eyes. In previous studies our group found differences, when comparing the histograms of the optical reflectivity distribution, suggesting that the optical reflectivity, as measured by OCT, may change under BRB alterations | 14 months |