linjc16/ctgov huggingface dataset:
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

Study Overview
=================
Brief Summary
-----------------
This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.

Detailed Description
-----------------
Twenty (11 girls, 9 boys) patients will participate in this study. Their ages ranged from 5 to 16 years. They will randomly divide into two groups. Group A ( study group) will receive pulsed electromagnetic field in addition to medical treatment three times per week for two months , Group B(control group ) will receive medical treatment only.

Official Title
-----------------
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis : Randomized Control Trail Study

Conditions
-----------------
Osteomyelitis

Intervention / Treatment
-----------------
* Device: pulsed electromagnetic field
* Drug: Antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients suffering from localized osteomyelitis in one or both lower limbs All patients will be assessed by a physician before starting the study procedures. Exclusion Criteria: Patients with immune disorders . Patients who suffer from any systemic diseases that may interfere with the objectives of the study.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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: Group A (Study group)<br>pulsed electromagnetic field and medical treatment ( vancomycin IV injection 1gm divided 250mg every 6hours ) | Device: pulsed electromagnetic field<br>* pulsed electromagnetic field will be over the site of osteomyelitis where patient in supine lying position. the treatment parameters will be set as10 HZ frequency , 20 gauss amplitude, duration about 120 minutes.<br>* Other names: CRYOMAG PROFESSIONAL.LEVEL,s.r.l;Drug: Antibiotics<br>* Vancomycin IV injection 1gm divided 250mg every 6hours<br>|
| Active Comparator: Group B(control group)<br>medical treatment only (vancomycin IV injection 1gm divided 250mg every 6hours ) | Drug: Antibiotics<br>* Vancomycin IV injection 1gm divided 250mg every 6hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing of osteomyelitis signs | through CT scan | pre treatment and post two months of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteomyelitis, Pulsed Electromagnetic Field
NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares

Study Overview
=================
Brief Summary
-----------------
Gout is a chronic joint disease associated with deposition of monosodium urate crystals, as a consequence of hyperuricemia. Gout is an intermittent flaring condition and acute gout flares are driven by NLRP3 inflammasome and IL1-beta production. However pathogenesis of acute gout flares remains poorly known in vivo in human. The aim of this study is to evaluate NLRP3 inflammasome activation in vivo in patients cells during acute gout flares.

Detailed Description
-----------------
Blood and synovial fluid will be obtained from remainder of patients' samples during an acute gout flares. White blood cells will be isolated and NLRP3 inflammasome activation will be assessed. Then, NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity.

Official Title
-----------------
NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares

Conditions
-----------------
Gout Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score > 8 Aged > 18 Exclusion Criteria: Gout treatment already started Inflammatory Arthritis other than Gout Arthritis Pregnant or breast feeding women Patient protected by law

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| NLRP3 inflammasome activation in white blood cells. | White blood cells will be isolated from blood sample and NLRP3 inflammasome activation will be assessed by flow cytometry. | Patient admission at hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NLRP3 inflammasome activation in synovial cells. | Nucleated cells will be isolated from synovial fluid sample and NLRP3 inflammasome activation will be assessed by flow cytometry. | Patient admission at hospital | 
| Effects of NLRP3 inflammasome inhibitors on proportion of NLRP3 inflammasome activation in white blood cells/synovial cells | NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity in blood or synovial fluid. | up to 7 days after analysis of NLRP3 activity |
Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the patients'quality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items.

Official Title
-----------------
Monocentric Prospective Observational Multiparametric Study on the Quality of Life in Patients Undergone Surgery for Vulvar Cancer and Reconstruction (3233)

Conditions
-----------------
Vulvar Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Quality of life questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery for vulvar cancer Patients providing consent to be enrolled in the study Exclusion Criteria: Cognitive impairment psychiatric disorder neurodegenerative disorder
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients operated for vulvar cancer without reconstruction<br> | Behavioral: Quality of life questionnaires<br>* Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction<br>|
| Patients operated for vulvar cancer with reconstruction<br> | Behavioral: Quality of life questionnaires<br>* Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rand 36 | Changes in RAND-36 score before and after surgery | June 2020 - June 2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICIQ-SF | Changes in ICIQ-SF score before and after surgery | June 2020 - June 2025 | 
| FSFI | Changes in FSFI score before and after surgery | June 2020 - June 2025 | 
| ECOG | Changes in ECOG score before and after surgery | June 2020 - June 2025 | 
| LYM-LEG-QoL | Changes in LYM-LEG-QoL score before and after surgery | June 2020 - June 2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vulvar Neoplasms, Vulvar cancer, Vulvar Reconstruction, Vulvoperineal Reconstruction, Gynecological Cancer, Quality of Life
Clinical Performance of Masimo Rad-GT

Study Overview
=================
Brief Summary
-----------------
The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.

Detailed Description
-----------------
Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05779397, NCT05787782, and NCT05674344).

Official Title
-----------------
Clinical Performance of Masimo Rad-GT

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

Intervention / Treatment
-----------------
* Device: Masimo RAD-GT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 to 80 years of age. Subjects are able to read and communicate in English as well as understand the study and the risks involved. Exclusion Criteria: Subject is pregnant or nursing. Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. * Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff. (* = Per study staff discretion)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Subject<br>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT | Device: Masimo RAD-GT<br>* Non-contact infrared thermometry device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (Degrees Celsius). | 1-3 hours |
The Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the level of participation of thoracic cancer patients undergoing definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the association between the level of participation and patients' side effects, quality of life, and long-term survival. Additionally, this study will rate the level of participation from both the patients' and medical staff's perspectives and will compare the differences in ratings from these two viewpoints, as well as their impact on treatment outcomes.

Official Title
-----------------
A Prospective Observational Study on the Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.

Conditions
-----------------
Lung Cancer, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and esophageal cancer. Planned to undergo definitive chemoradiotherapy ± immunotherapy; Males or females aged 18 to 75; Able to communicate with medical staff. Exclusion Criteria: Patients with cognitive impairments.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br>Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of >=Grade 3 toxicities | The percentage of patients who develop >=Grade 3 toxicities | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 2-year survival rate | 2 years | 
| Progression-free survival | 2-year progression-free survival rate | 2 years |
Assessment of Long-term Effects of Tachosil

Study Overview
=================
Brief Summary
-----------------
This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application.

Official Title
-----------------
Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?

Conditions
-----------------
Fibrin Sealant, Haemostasis

Intervention / Treatment
-----------------
* Device: TachoSil®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type of surgery, indication for surgery, type of disease Exclusion Criteria: dead patients, not available on call.

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 87 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 40 patients<br>There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years. | Device: TachoSil®<br>* TachoSil®, a carrier-bound fibrin sealant (CBFS), is a haemostatic tissue sealant composed of a collagen sponge, made from horse tendons, coated on one side with dried human fibrinogen and human thrombin.<br>* Other names: carrier-bound fibrin sealant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrotic reaction | The evaluation focused on individuation of the area treated with CBFS, comprehensive analysis of the dimensions of the area treated if visible, and evolution, focusing on the presence of fibrosis, sclerosis, collections, cysts, or pseudocysts. The formation of a fibrotic reaction was related to the presence of residual tissue on CT during follow-up. | 10 years |
Correlation of Structure and Function in Glaucoma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to correlate structure and function in patients with glaucoma. To this end, a cross-sectional study unsing perimetry and optical coherence tomography is performed.

Official Title
-----------------
Correlation of Structure and Function in Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of glaucomatous optic neuropathy Exclusion Criteria: Age < 18 years Diabetes Pregnancy Hypertensive retinopathy Smoking Intraocular surgery 1 month prior to study entry Systemic or ocular disease, excluding glaucoma, which the investigator believes could affect the test results Insufficient quality of the optical coherence tomography imaging Insufficient cooperation during examinations or measurements

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Optical coherence tomography|Heidelberg Engineering Spectralis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of retinal sensitivity with peripapillary retinal nerve fiber layer thickness |  | 1 day | 
| Association of retinal sensitivity with peripapillary vessel density |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glaucoma Activity Limitation score |  | 1 day |
Perioperative Parameter and Treatment Outcomes of ECIRS in Asia

Study Overview
=================
Brief Summary
-----------------
This is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ECIRS.

Detailed Description
-----------------
Patients diagnosed with urinary stones and planned for ECIRS in different centres will be recruited for the study. This registry collects clinical data on patients with ECIRS performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. Treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. In summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ECIRS.

Official Title
-----------------
A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia

Conditions
-----------------
Renal Stone

Intervention / Treatment
-----------------
* Other: ECIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urinary calculi Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS) Agreed to consent for the study Exclusion Criteria: Patients who have ECIRS for other conditions, such as urothelial cancer etc. Patients who intraoperative record was incomplete. Patients only have either PCNL or ureteroscopy done (not both)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ECIRS|Endoscopic Combined Intrarenal Surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Stone status | The fragmentation rate of target stone | up to 1 year | 
| Treatment related complication | he 30-day complications will be graded according to the Clavien-Dindo classification | Thirty days after the operation |
Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate xylitol wipes as an oral hygiene protocol for haemophilic children

Official Title
-----------------
Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children: A Randomized Clinical Trial

Conditions
-----------------
Haemophilia

Intervention / Treatment
-----------------
* Other: xylitol wipes
* Other: placebo wipes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemophilic children A or B with No other systemic diseases. Aged (6-12 years). Co-operative. Exclusion Criteria: Children on long-term antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br> | Other: xylitol wipes<br>* group A will receive xylitol wipes and group B will receive placebo wipes<br>|
| Placebo Comparator: group B<br> | Other: placebo wipes<br>* group A will receive xylitol wipes and group B will receive placebo wipes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental plaque | Measure for estimating status of oral hygiene by measuring dental plaque that occurs in areas adjacent to gingival margin. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary levels of mutans Streptococcus |  | One week |
Infant Respiratory Interface and Accessories Evaluation Study

Study Overview
=================
Brief Summary
-----------------
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.

Official Title
-----------------
Infant Respiratory Interface and Accessories Evaluation Study

Conditions
-----------------
Respiratory Distress Syndrome, Newborn

Intervention / Treatment
-----------------
* Device: Respiratory interface


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneously breathing infants who require non-invasive respiratory support Parent(s)/guardian(s) at least 18 years of age Exclusion Criteria: Parent(s)/guardian(s) unable to give written informed consent Neonate or infant not requiring non-invasive support Suspected or confirmed abnormalities or trauma to the skull or airway

Ages Eligible for Study
-----------------
Maximum Age: 2 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: Respiratory interface<br>Use of the new respiratory interface and accessories to deliver non-invasive therapy | Device: Respiratory interface<br>* Application of the new interface and accessories and provision of non-invasive respiratory support through the device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback score |  | 12 hours |