linjc16/ctgov huggingface dataset:
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

Study Overview
=================
Brief Summary
-----------------
This research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease.

Official Title
-----------------
Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients With Inflammatory Bowel Diseases

Conditions
-----------------
Inflammatory Bowel Diseases, Stress

Intervention / Treatment
-----------------
* Behavioral: Stress Management and Resilience Training Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of IBD defined by a physician global assessment (PGA) of quiescent, mild, moderate, or severe disease. Access to internet/device such as smart phone, tablet, or computer Patient reports stress as a trigger to their GI symptoms Exclusion Criteria: Corticosteroids in the previous 3 months Elicit substance use (including medical marijuana)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress management and resilience training<br>Subjects will receive a 1.5 hour one-on-one stress management and resilience consult by a certified SMART trainer followed by 16 week self-guided on-line training. | Behavioral: Stress Management and Resilience Training Program<br>* One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.<br>* Other names: SMART;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL) | Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life. | Baseline, approximately 20 weeks |
Asferic Monofocal Intraocular Lens in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance a new asferic monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.

Detailed Description
-----------------
thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the Tecnis Eyhance ICB00 IOL were evaluated. Visual acuity was assessed three months after surgery for distance (CDVA), intermediate (CIVA) and near visual acuity (CNVA).

Official Title
-----------------
Asferic Monofocal Intraocular Lens With Higher Order Aspheric Optic in Pediatric Patients: Early Outcomes

Conditions
-----------------
Cataract in Child

Intervention / Treatment
-----------------
* Device: Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, CA USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: monolateral cataract Exclusion Criteria: other ocular diseases sistemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, CA USA)|pediatric cataract surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Visual Acuity | Decimal | 3 months postoperativeely | 
| Corrected Intermediate Visual Acuity | Decimal | 3 months postoperatively | 
| Corrected Near Visual Acuity | Decimal | 3 months postoperatively |
U-LABA/ICS Effects on Exercise Performance, Vilanterol

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate

Official Title
-----------------
Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol

Conditions
-----------------
Exercise Performance

Intervention / Treatment
-----------------
* Drug: Vilanterol and Fluticasone Furoate (low dose)
* Drug: Vilanterol and Fluticasone Furoate (high dose)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-39 Physically active > 5 h weekly Maximal oxygen consumption classified as high or very high Exclusion Criteria: Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid ECG abnormality ACQ score > 1.5 Severe bronchial hyperreactivity as determined by mannitol test FEV1/FVC ratio < 0.7 determined with spirometry Chronic illness determined to be a potential risk for participant during study In chronic treatment with medication that may interfere with study results Pregnancy Smoker Blood donation during the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilanterol + fluticasone furoate<br>Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing | Drug: Vilanterol and Fluticasone Furoate (low dose)<br>* Participants are administered 25 µg of vilanterol + fluticasone furoate<br>Drug: Vilanterol and Fluticasone Furoate (high dose)<br>* Participants are administered 100 µg of vilanterol + fluticasone furoate<br>|
| Placebo Comparator: Placebo<br>Participants are administered placebo from an inhaler device testing | Drug: Placebo<br>* Participants are administered placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power output during sprint testing | Power output measured in Watts during a sprint on a bike ergometer | Through study completion, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power output during time trial | Mean power output measured in Watts during a time trial on a bike ergometer | Through study completion, an average of 3 weeks |
The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human

Study Overview
=================
Brief Summary
-----------------
To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human

Detailed Description
-----------------
Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.

Official Title
-----------------
The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human

Conditions
-----------------
Coronary Heart Disease, Susceptibility to, 1

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected coronary heart disease patients received coronary angiography Exclusion Criteria: NYHA III-IV malignant tumor acute infection thyroid dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients with suspected CHD who experienced CAG<br>Patients with suspected coronary heart disease who experienced coronary angiography | Other: No intervention<br>* This is an obvertional study, and there is no intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stenosis of coronary artery | The stenosis of coronary artery based on the results of coronary angiography | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary artery calcium | The coronary artery calcification based on the results of coronary angiography | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRAF3IP2, Coronary angiography, coronary deart disease
Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle

Study Overview
=================
Brief Summary
-----------------
Over the last few years, it has been suggested that Knee Ostheoarthritis (KOA) incidence and progression could potentially be related to skeletal muscle characteristics. In particular, weakness of the quadriceps muscle would be a key determinant of KOA. However the mechanisms underpinning the influence of skeletal muscle in the pathophysiology of ostheoarthritis (OA) are poorly understood. Crosstalk between skeletal muscle and structures around and in the joint is of interest. In physical deconditioning and aging, it has been reported that skeletal muscle can be replaced by adipose tissue. Several factors involved in the development of OA but also of adipose tissue may be involved in these muscular changes. Of interest, in patients with KOA, quadriceps weakness is an ubiquitous clinical finding. Infiltration of adipose tissue in skeletal muscle has been shown to affect muscle strength and mobility and be linked to cartilage volume loss and the occurrence/progression of KOA. The main objective of this study is to compare the characteristics of the Hoffa tissus and the intamuscular fat (IMF) tissus in the quadriceps muscle in patients with gonarthrosis requiring total knee prosthesis. This is a single-centre study based on a collection of surgical waste and is categorized as Research Not Involving Human subjects.

Official Title
-----------------
Study to Compare the Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Other: BIOPSY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, aged between 40 and 85 years Patient having a confirmed diagnosis of knee ostheoarthritis Patient undergoing a surgery for a total knee prosthesis for knee ostheoarthritis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| Patients suffering of knee ostheoarthritis undergoing a surgery for a total knee prosthesis.<br> | Other: BIOPSY<br>* biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): adipose tissue size differences | size mesured in mm | 4 months | 
| Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): lipid levels | level mesured in % | 4 months | 
| Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps):fibrotic tissue | rate mesured in % | 4 months |
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.

Study Overview
=================
Brief Summary
-----------------
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.

Official Title
-----------------
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?

Conditions
-----------------
COVID-19 Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2 admitted to one of the ICUs of the participating hospitals Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| ICU mortality |  | 90 days from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ventilation |  | 90 days from inclusion | 
| 28-day ventilator free days |  | 90 days from inclusion | 
| 28-day, 90-day mortality |  | 90 days from inclusion | 
| ICU and hospital length of stay |  | 90 days from inclusion |
Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to utilize transrectal ultrasound (TRUS) images of the intact and post-hysterectomy female pelvis in order to provide feasibility information for a Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in image guided brachytherapy. The fusion and needle guidance will be performed using Eigen Health's navigation system that currently provides targeted MR/Ultrasound fusion based prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.

Official Title
-----------------
Acquisition of Trans-Rectal Ultrasound [TRUS] Images of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking for Image-Guided Brachytherapy: A Pre-feasibility Study

Conditions
-----------------
Uterine Cancer

Intervention / Treatment
-----------------
* Other: Transrectal ultrasound (TRUS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma. Treatment plan must include curative-intent definitive radiation that includes brachytherapy treatments with or without concurrent chemotherapy Adults ≥ 18 years of age ECOG Performance Status 0-2 Exclusion Criteria: Patients with active rectal bleeding or rectal ulcer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intact anatomy<br>Patients with intact anatomy (uterus and cervix) | Other: Transrectal ultrasound (TRUS)<br>* Transrectal ultrasound (TRUS) images of the female pelvis<br>|
| Post-hysterectomy<br>Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy | Other: Transrectal ultrasound (TRUS)<br>* Transrectal ultrasound (TRUS) images of the female pelvis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients whose MRI and ultrasound images are fused |  | up to 5 weeks |
Comparative Effects of Ciprofol and Propofol on Pain Intensity on the First Day After Surgery: a Retrospective, Propensity Score Matched, Cohort Study

Study Overview
=================
Brief Summary
-----------------
Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.

Official Title
-----------------
Comparative Effects of Ciprofol and Propofol on Pain Intensity of the Patients Without PCA on the First Day After Surgery: a Retrospective, Propensity Score Matched, Cohort Study

Conditions
-----------------
Anesthesia, Acute Pain, Risk Reduction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery. Exclusion Criteria: The basic information such gender, age, height, weight, and body mass index (BMI) were missing. Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Numeric Rating Scale (NRS) score after surgery <4<br> | |
| Numeric Rating Scale (NRS) score after surgery ≥ 4<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  | October 2022 to October 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Data Platform, Machine Learning, Postoperative Acute Pain
Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.

Official Title
-----------------
Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2

Conditions
-----------------
Diabetic Neuropathy Peripheral

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin. Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old. Exclusion Criteria: Breastfeeding female. Pregnant female. Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2. Patients with type 1 diabetes mellitus. Patients with diabetic ketoacidosis. Patients with urinary tract infections. Dehydrated patients till normalized. Lower limb amputation patients. SGLT2 inhibitors hypersensitivity. Severe hepatic patients. Patients on neuroprotective drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: Control group<br>include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin) | |
| Experimental: Empagliflozin group<br>include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin) | Drug: Empagliflozin 25 MG<br>* treatment<br>* Other names: empagliflozin tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities. | The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups. | change from baseline at three month | 
| Change in HbA1c % | HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups. | change from baseline at three months |