linjc16/ctgov huggingface dataset:
The BASA Study: Breath Analysis for Severe Asthma Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. In the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (FeNO, GC-MS and EBC). A control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.

Official Title
-----------------
The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics

Conditions
-----------------
Severe Asthma

Intervention / Treatment
-----------------
* Device: exhaled breath analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe asthma diagnosis according to the latest recommendation Eligible or in treatment with a biologic treatment for severe asthma Able to follow istructions Able and willing to sign the informed consent Exclusion Criteria: Not able to perform lung function measurements and the procedures of the study Acute respiratory or non respiratory infection (<4 weeks) Not willing to continue the study

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 |
| --- | --- |
| Severe Asthma patients on biologics<br> | Device: exhaled breath analysis<br>* non invasive technology to measure components of exhaled breath<br>|
| Healthy controls<br> | Device: exhaled breath analysis<br>* non invasive technology to measure components of exhaled breath<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe asthma, exhaled breath, biologics, monitoring
Mental Health, Gender-Based Violence, and Stunting in Tanzania

Study Overview
=================
Brief Summary
-----------------
One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. However, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting. This study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in Tanzania. The needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural Tanzania. This project's primary aims are: To determine the prevalence of mental health and family relationship problems in five villages To determine associations between intimate partner violence (IPV) mental health and substance use and childhood stunting

Official Title
-----------------
Establishing a Community-led, Family-centered Mental Wellness Initiative in Rural Tanzania

Conditions
-----------------
Mental Health Issue, Substance Use, Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living within the 5 rural villages participating in a local nonprofit pregnant or having a child under 2 years old Exclusion Criteria: Living outside of the 5 villages Not participating in the local nonprofit Not pregnant or having a child under 2 years old
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 |
| --- | --- |
| Mothers involved in a local non-profit<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression and anxiety | Hopkins Symptom Checklist | Through study completion, approximately 2 months | 
| Substance use | Alcohol Use Disorders Identification Test (AUDIT) | Through study completion, approximately 2 months | 
| World Health Organization (WHO) Violence Against Women | WHO Violence Against Women | Through study completion, approximately 2 months | 
| Childhood stunting | Height, weight, and head circumference of child under 2.5 years old | Through study completion, approximately 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Women's Empowerment | Women's Empowerment measure | Through study completion, approximately 2 months |
Investigation of Risk Factors Encountered by Operating Room Nurses

Study Overview
=================
Brief Summary
-----------------
Operating Room Nurses (ORN) are exposed to a lot of risks related to the working environment. There is a limited number of studies describing the risks faced by ADs in the work environment. Aims: In this study, we aimed to determine the risk factors faced by AHs in operating rooms.

Detailed Description
-----------------
Background: Operating Room Nurses (AH) are exposed to a lot of risks related to the working environment. There is a limited number of studies describing the risks faced by ADs in the work environment. Aims: In this study, we aimed to determine the risk factors faced by AHs in operating rooms. Study Design: This is a prospective descriptive study. Methods: The study was carried out with the operating room nurses working in the operating rooms of six hospitals affiliated to the General Secretariat of the Gaziantep Provincial Public Hospitals Association between September 2019 and February 2023.

Official Title
-----------------
Investigation of Risk Factors Encountered by Operating Room Nurses

Conditions
-----------------
Work-Related Condition

Intervention / Treatment
-----------------
* Other: the operating room environment risk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteer nurse Being an operating room nurse Exclusion Criteria: • Nurses working outside the operating room
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 |
| --- | --- |
| Operation Room Nurses<br> | Other: the operating room environment risk<br>* in determining the risks they face in the operating room environment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the exposure of ORNs to radiation, biological, ergonomic, chemical, psychological and physical risks in the working environment. |  | 15 minutes |
Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis

Study Overview
=================
Brief Summary
-----------------
This study will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options.

Detailed Description
-----------------
This study is an electronically delivered, one time cross sectional survey study. The investigators want to understand how patients with triple negative breast cancer at high risk for disease recurrence will prioritize additional benefit over toxicity when considering treatment options, and if their knowledge of ctDNA positivity versus negativity will further shift this balance toward benefit.

Official Title
-----------------
Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis

Conditions
-----------------
Triple Negative Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self- reported history of non-metastatic breast cancer Self- reported history of receiving chemotherapy for breast cancer Self- reported history of chemotherapy completed at least 6 months ago but no more than 10 years ago Able to complete an online survey English speaking Exclusion Criteria: N/A

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 |
| --- | --- | --- |
| Examine whether knowledge of ctDNA negativity influences patient decision-making | Ratings- based analysis will be used to examine whether knowledge of ctDNA negativity increases patient acceptability (and if so, by how much) of no therapy in the adjuvant setting, compared to standard of care capecitabine. | Once all surveys in the sample size are completed, 6 months anticipated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate at what degree of benefit a given treatment would be acceptable to patients | When assuming risk of recurrence of ctDNA positivity, we will use ratings- based conjoint analysis to determine part-worth utilities of each attribute - potential toxicity and potential benefit. Comparison of part-worth utilities will be used to estimate at what degree of benefit a given treatment would be acceptable, which will inform future trials. | Once all surveys in the sample size are completed, 6 months anticipated | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, ctDNA
Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment

Study Overview
=================
Brief Summary
-----------------
Aim to measure the predictability of medical pre -Operative Fitness Assessment to the actual rates of morbidity and mortality related to surgery in Assiut university Hospital.

Detailed Description
-----------------
Perioperative morbidity and mortality remain the mostly important barrier to surgical interventions worldwide. Therefor, decision making relies upon accurate risk Assessment to be balanced with hoped benefit. For elective surgeries, multiple clinical tools have been used to Assessment perioperative Fitness, but with limited applicability. For instance, the american society of anesthesiologists phesical status score (ASA-PS) does not consider the type of surgery, nor the patient's age. The physiological and Operative severity score for the enumeration of mortality (POSSUM) evaluates the intra-operative difficulties, limiting the preoperative prediction. Recently, researchers layer and his colleagues at University Hospital Bonn, modified the preoperative score to Predict Postoperative Mortality (POSPOM) to be applied in daily practice. In investigator 's practice, Assiut university Hospitals already have a Pre-Operative Fitness Assessment (POFA) clinical and investigator aim to adapt and evaluate the POSPOM system in investigator' s practice.

Official Title
-----------------
Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment

Conditions
-----------------
Perioperative Medical Fitness Assessment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (>18 years old ) preparing for elective intervention. Exclusion Criteria: those who do not require anaesthesia Those who did not undergo surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidance of 22 adverse events according to the Eurepian perioperative clinical outcom definitions | Follow up of preoperative medically diseased patients after surgery to detect outcoms | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fitness Assessment
Translation and Validation of the Arabic Version of the OHIP Questionnaire

Study Overview
=================
Brief Summary
-----------------
OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. As people living in middle east are mainly influenced by the Arabic culture, which differs significantly from the Western culture where the OHIP questionnaire was first developed. 254 participants having removable prosthesis will be asked to complete translated Arabic version of OHIP questionnaire for validation.

Official Title
-----------------
Translation and Validation of the Arabic Version of the Oral Health Impact Profile Questionnaire

Conditions
-----------------
Oral Health, Surveys and Questionnaires

Intervention / Treatment
-----------------
* Other: Arabic version of OHIP questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having removable partial denture in the last year Native Arabic patients Exclusion Criteria: Patients non familiar with Arabic language patients with mental or perception problems

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Arabic version of OHIP questionnaire|Translated Arabic version of Oral Health Impact Profile questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and validity | Reliability of Translated Arabic version of OHIP questionnaire using internal consistency | 3 months |
Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013

Study Overview
=================
Brief Summary
-----------------
Fibroblast activation protein (FAP) emerges as a highly promising target for cancer diagnostic imaging and targeted radionuclide therapy. To exploit the therapeutic potential of current FAP inhibitors (FAPIs), this study presented the design and synthesis of a series of FAPI dimers to increase tumor uptake and retention. Preclinical evaluation and a pilot clinical PET imaging study were conducted to screen the lead compound with the potential for radionuclide therapy.

Detailed Description
-----------------
Three new FAPI dimers were synthesized by linking two quinoline-based FAPIs with different spacers. The in vitro binding affinity and preclinical small animal PET imaging of the compounds were compared with their monomeric counterparts, FAPI-04 and FAPI-46. The lead compound, 68Ga-LNC1013, was then evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Official Title
-----------------
Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013

Conditions
-----------------
Gastrointestinal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: 68Ga-FAPI dimer(68Ga-LNC1013)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically and/or clinically confirmed and/or suspicious of gastrointestinal cancer. Signed informed consent. Exclusion Criteria: pregnancy; breastfeeding; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 68Ga-FAPI dimer(68Ga-LNC1013)|68Ga-LNC1013 was evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of discrepancies between [68Ga]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG PET scans | Compare the diagnostic performance between [68Ga]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG in patients with gastrointestinal cancer | 5 months | 
| SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value) | Comparison of 68Ga]Ga-LNC1013, 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FAPI dimer
A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During S1 STE

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are: The main question it aims to answer is: • whether there is a difference in intravascular rate between using a straight needle and a curved needle in S1 transforaminal epidural injection Participants in this study will be randomly assigned to receive an S1 transforaminal epidural injection using either a straight needle or a curved needle. The researchers will then observe the intravasation rate and compare it between the two groups.

Official Title
-----------------
A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During Sacral 1 Transforaminal Epidural Block

Conditions
-----------------
S1 Transforaminal Epidural Injection

Intervention / Treatment
-----------------
* Other: needle type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for a lumbar 1 epidural nerve block in the outpatient department of anesthesiology and pain medicine at Kyungpook National University Hospital. Exclusion Criteria: Patients with a history of allergy to local anesthetics or steroids Patients with a history of allergy to contrast media Patients with a bleeding tendency Patients with symptoms of infection in the sacroiliac region Patients under 18 years of age or over 80 years of age Patients who are pregnant or planning to become pregnant Other medically incapable of consent, such as the mentally retarded. Translated with www.DeepL.com/Translator (free version)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S1 transforaminal injection with a straight needle<br> | Other: needle type<br>* straight or curved<br>|
| Experimental: S1 transforaminal injection with a curved needle<br> | Other: needle type<br>* straight or curved<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravasation rate |  | in the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
S1 transforaminal epidural injection, curved needle
Microscopy Imaging of Whole-mount Stained Human Tissues

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are: • to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology. Participants will provide a small piece of their surgical specimens from tumor removal surgery . If there is a comparison group: Researchers will compare normal specimens to see if we can observe the difference.

Official Title
-----------------
Microscopy Imaging of Whole-mount Stained Human Tissues: Development of an Imaging Platform for Intraoperative Tumor Margin Delineation

Conditions
-----------------
Tumor, Brain, Tumor, Breast, Tumor Skin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are more than 20 years old. Diagnosed as patients suffered by skin tumor, brain tumor and breast tumor. Exclusion Criteria: Patients who can't speak and communicate with others. Patients who can't make eventual and exact pathological assessment for his/her diseases. Patients who only can fit for slicing tumor. Removed tissues which obviously vary after severe ray radiation under microscopy observation. Diameter of tumors are under 1 centimeter. Breast carcinoma in situ.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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 |
| --- | --- | --- |
| The assessment between tumor cases and control cases | Do comparison with images acquired by our microscopy (with the whole-mount staining method) and bright field microscopy (with standard FFPE method) and do assessment to interpret tumor characteristics | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative assessment, whole-mount H&E staining, surgical border assessment