linjc16/ctgov huggingface dataset:
Expanded Access to Epcoritamab

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to epcoritamab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Epcoritamab

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Epcoritamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The participant must not be eligible for an epcoritamab clinical trial.

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 |
| --- |
|Drug: Epcoritamab|Subcutaneous Injection|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Posterior Cavities

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in posterior cavities.

Official Title
-----------------
A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Placed in Posterior Cavities

Conditions
-----------------
Secondary Caries

Intervention / Treatment
-----------------
* Other: Surefil One
* Other: Cention N
* Other: Bulkfil resin composite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria for patient's inclusion in the study will be the presence of at least 3 occlusal or proximal carious lesion in posterior teeth, favourable and stable occlusion between the remaining teeth, the patients must be older than 18 years old with permanent dentition, moderate oral hygiene, asymptomatic vital teeth with no sensitivity to percussion, and the presence of contact with adjacent teeth Exclusion Criteria: Exclusion criteria will be, sever bruxism, patients with known unavailability to attend recall visits, patients with known allergy to any component of the study materials, pulp exposure during caries excavation, patients with unstable medical conditions and pregnant or lactating individuals.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Patients receiving Surefil One | Other: Surefil One<br>* Ion-releasing restoration<br>|
| Experimental: Group 2<br>Patients receiving Cention N | Other: Cention N<br>* Ion-releasing restoration<br>|
| Active Comparator: Group 3<br>Patients receiving bulkfil resin composite | Other: Bulkfil resin composite<br>* resin composite (No ion-release)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating surface and marginal staining | FDI criteria will be used | 2 years | 
| Evaluating fracture and retention of the materials | FDI criteria will be used | 2-years | 
| Evaluating marginal adaptation and discoloration of the materials | FDI criteria will be used | 2-years |
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB

Study Overview
=================
Brief Summary
-----------------
A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Detailed Description
-----------------
This is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wound sites. Up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment. Patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to Baseline of the preceding interventional EB-101 trial. Upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.

Official Title
-----------------
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Conditions
-----------------
RDEB

Intervention / Treatment
-----------------
* Biological: EB-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give consent/assent; If under the age of 18, guardian(s) is/are willing and able to give consent; Prior study treatment with EB-101. Exclusion Criteria: Inability to properly follow protocol as determined by the Principal Investigator

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Long-Term Extension<br>This study will follow one group of participants who were enrolled in a previous EB-101 study. | Biological: EB-101<br>* This is non-interventional and follows patients treated with EB-101<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | Proportion of RDEB wounds with healing ≥50%, ≥75%, and 100% at all clinic visits up to Month 54 as determined by direct investigator assessment. | 5 years | 
| Pain Reduction | Pain reduction assessed by Wong-Baker FACES scale at all clinic visits up to Month 54. | 5 years |
Evaluation of the Elasticity of the Mitral Valve

Study Overview
=================
Brief Summary
-----------------
There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).

Detailed Description
-----------------
The prospective study will be conducted on 20 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined. The harvested tissue will not be frozen and will kept in natural conditions as close as possible.

Official Title
-----------------
Evaluation of the Elasticity of the Mitral Valve Chordae by Uniaxial Traction in the Context of Mitral Valve Regurgitation With a Comparison of the Results: Mitral Valve Prolapse vs Restriction of Mitral Valve Movement

Conditions
-----------------
Mitral Valve Disease

Intervention / Treatment
-----------------
* Other: Data collection on patient history and intraoperative results.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients programmed for mitral valve replacement who have more than 45 years old Exclusion Criteria: Patients with mitral calcification Mitral valve rheumatic disease Mitral valve infections Redo surgery on the mitral valve

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Mitral valve prolapse<br>Patients with mitral valve prolapse | Other: Data collection on patient history and intraoperative results.<br>* Data collection on patient history and intraoperative results.<br>|
| Restrictive ischemic mitral valve<br>Patients with restrictive ischemic mitral valve | Other: Data collection on patient history and intraoperative results.<br>* Data collection on patient history and intraoperative results.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum value of Young's modulus | Comparison of elasticity difference between the two groups | Hour 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First histological evaluation | Determine the histological characteristics of living humans | Hour 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitral valve, mitral valve chords, elasticity, Young's modulus, mitral valve histology
Translation and Validation of Malay Version of painDETECT Questionnaire

Study Overview
=================
Brief Summary
-----------------
The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M and SF-36 questionnaire. Patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. Normality will be assessed using Shapiro Wilk test and histograms for continuous variables. Data will be compared between groups using chi-square test (for categorical variables) and t-test or Mann-Whitney's U test (for continuous variables). Suitability of PDQ-M data for factor analysis will be verified using the Bartlett's test of sphericity and the Kaiser-Mayer-Olkin (KMO) measure of sampling adequacy. Parallel analysis will performed to obtain the suitable factors. Construct validity will be investigated by exploratory factorial analysis (EFA) with varimax rotation. A factor loading of >0.40 will be used to determine the items for each factor. The internal consistency of the questionnaire will be assessed using Cronbach's alpha test. A p value of <0.05 is taken as statistically significant.

Official Title
-----------------
Study to Translate and Determine the Validity and Reliability of Malay Version of painDETECT Questionnaire (PDQ-M)

Conditions
-----------------
Neuropathic Pain, Nociceptive Pain

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to read and understand the Malay language diagnosed to have neuropathic or nociceptive pain by clinician stable disease condition pain duration of at least 4 weeks Exclusion Criteria: acute illness poor mental health status that prevents them from understanding or responding to the proposed questions cultural or language barrier

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuropathic pain<br>Questionnaire administration and socio-demographic data collection | Other: Questionnaire<br>* Questionnaire administration (PDQ-M, NRS, SF-36)<br>|
| Nociceptive pain<br>Questionnaire administration and socio-demographic data collection | Other: Questionnaire<br>* Questionnaire administration (PDQ-M, NRS, SF-36)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDQ-M scores | Total of PDQ-M scores | 2-5 weeks |
Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.

Detailed Description
-----------------
The aim of our study is to evaluate the contribution of the variation of the LUS score performed at the time of admission (LUS1) and at discharge (LUS2) in predicting the clinical course of patients admitted for acute cardiac decompensation 30 days after discharge. Delta LUS score=((LUS2-LUS1) *100)/LUS1

Official Title
-----------------
Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure Within 30 Days of Discharge

Conditions
-----------------
Emergencies, Acute Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years, Patients hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit). Exclusion Criteria: Age less than 18 years Dyspnea of non-cardiac etiology (cause: pulmonary, traumatic, toxic...) Altered state of consciousness (Glasgow score<14) Hemodynamic instability: presence of peripheral signs of shock, use of vasoactive drugs Mechanical ventilation from the outset Cardiorespiratory arrest Inability to give consent to the study Missing one of two ultrasound examinations Unable to make telephone contact after one month.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Delta lus | The primary outcome evaluate the contribution of the variation of the LUS score performed at the time of admission (LUS1) and at discharge (LUS2) in predicting the clinical course of patients admitted for acute cardiac | 30 days | 
| Readmission | Readmission | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delta-lus score, heart failure
Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting

Study Overview
=================
Brief Summary
-----------------
Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of use. Methods: A cross-sectional research was done in Egyptian community pharmacies by community pharmacists. Patients who were administered oral ciprofloxacin during the research period were included.

Detailed Description
-----------------
From September 2021 to February 2022, a cross-sectional, research was undertaken to evaluate ciprofloxacin usage. The investigation was carried out by community pharmacists in seven Egyptian community pharmacies. Data Collection: data gathered from pharmacy patients' records on a data collection form that included the factors indicated. The General Symptoms Questionnaire, physical examination, and blood testing were used to identify adverse occurrences. Study variables: age, gender, pregnancy/lactation Department/indication Dose, Frequency, Duration, Adverse events, Drug interactions. Data was categorized and analyzed using appropriate software.

Official Title
-----------------
Drug Utilization Evaluation Study of Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting: A Cross-Sectional Study

Conditions
-----------------
Ciprofloxacin Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ciprofloxacin included prescription during the study period. Exclusion Criteria: un included ciprofloxacin prescription.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ciprofloxacin<br>151 record of Ciprofloxacin | Drug: Ciprofloxacin Tablets<br>* Ciprofloxacin antibiotic<br>* Other names: Ciprofloxacin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indications | Appropriate Indications of ciprofloxacin (frequency ) | 6 months | 
| ciprofloxacin prescription (frequency ) | Number of appropriate ciprofloxacin prescription | 6 months | 
| adverse events | adverse events occured during ciprofloxacin therapy (frequency ) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ciprofloxacin, Use evaluation, Drug interaction
Deep Learning Radiomics Model for Predicting Post-cystectomy Outcome in Muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
Muscle invasive bladder cancer (MIBC) has a poor prognosis even after radical cystectomy. Postoperative survival stratification based on radiomics and deep learning may be useful for treatment decisions to improve prognosis. This study was aimed to develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC.

Official Title
-----------------
Deep Learning Radiomics Model for Predicting Post-cystectomy Outcome From Preoperative CT in Muscle Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Other: develop and validate a deep learning radiomics model based on preoperative enhanced CT image


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pathologically confirmed MIBC after radical cystectomy; contrast-CT scan less than two weeks before surgery; complete CT image data and clinical data. Exclusion Criteria: patients who received neoadjuvant therapy; non-urothelial carcinoma; poor quality of CT images; incomplete clinical and follow-up data.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIBC<br>patients with pathologically confirmed MIBC after radical cystectomy | Other: develop and validate a deep learning radiomics model based on preoperative enhanced CT image<br>* develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival（OS） | the time from the date of surgery to death from any cause or the date of last contact (censored observation) at the date of data cut-off. | up to 10 years | 
| Recurrence free survival（RFS) | the time from the date of surgery to the date of first documented disease recurrence. Patients without recurrence at the time of analysis will be censored. | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tomography, X-ray computed, Muscle-invasive bladder cancer, Radiomics, Deep Learning
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.

Official Title
-----------------
To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Antibiotic-associated Diarrhea.

Conditions
-----------------
Fecal Microbiota Transplantation, Antibiotic-associated Diarrhea

Intervention / Treatment
-----------------
* Procedure: Fecal Microbiota Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples. Exclusion Criteria: non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT group<br> | Procedure: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in defecation frequency after FMT. |  | Baseline and three months after treatment | 
| Changes in gut microbiota after FMT. |  | Baseline and three months after treatment. |