linjc16/ctgov huggingface dataset:
A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.

Official Title
-----------------
A Phase I/II, Multiple Center, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: CM313 injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects age ≥ 18 years. Subjects diagnosed with multiple myeloma. Subjects with measurable lesions. Women of childbearing potential with negative pregnancy testing. Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: Previous treatment with any anti-CD38 therapy. Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose. Positive for human immunodeficiency virus (HIV) antibodies. Syphilis antibody positive.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM313<br>CM313 injection, subcutaneous | Biological: CM313 injection<br>* CM313, subcutaneous injection<br>|
| Experimental: CM313 + concomitant medication<br>CM313 injection, subcutaneous | Biological: CM313 injection<br>* CM313, subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | up to 18 months |
the Level of Resilience Influencing Self-care in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
Adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones

Detailed Description
-----------------
Primary objective -Evaluate levels of resilience in subjects suffering from heart failure. Secondary objectives Evaluate the levels of self-care in subjects suffering from heart failure. Evaluate the correlation between the level of resilience and the level of self-care; Evaluate which characteristics positively influence the level of resilience and the degree of self-care of the person with heart failure. Consecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included

Official Title
-----------------
How Much the Level of Resilience Influences Self-care in a Group of Subjects Suffering From Heart Failure: Observational, Cross-sectional Study

Conditions
-----------------
Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects suffering from heart failure; Subject aged between >18 years and <90 years; Ability to understand the Italian language; Clinical conditions that allow the questionnaire to be completed; Ability to provide written informed consent. Exclusion Criteria: Subjects suffering from other forms of diabetes; Subjects suffering from serious psychiatric disorders; Serious clinical conditions that do not allow the questionnaire to be completed; Inability to provide written informed consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate levels of resilience in subjects suffering from heart failure |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate levels of self-care in subjects suffering from heart failure |  | 12 months | 
| Evaluate the correlation between the level of resilience and the level of self-care |  | 12 months | 
| Evaluate which characteristics positively influence the level of resilience and the degree of self-care of patients with heart failure |  | 12 months |
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Study Overview
=================
Brief Summary
-----------------
To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.

Official Title
-----------------
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Conditions
-----------------
Artificial Intelligence, Colonoscopy, Quality Control

Intervention / Treatment
-----------------
* Diagnostic Test: DeFrame
* Diagnostic Test: Classified DeFrame
* Diagnostic Test: conventional colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required. Exclusion Criteria: History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The DeFrame Group<br>Subjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy. | Diagnostic Test: DeFrame<br>* The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.<br>|
| Experimental: The Classified DeFrame Group<br>Subjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy. | Diagnostic Test: Classified DeFrame<br>* The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.<br>|
| Experimental: The Control Group<br>Subjects in the control group underwent standard colonoscopy. | Diagnostic Test: conventional colonoscopy<br>* conventional colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate | Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies. | up to 9 months | 
| adenomas per colonoscopy | Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. | up to 9 months |
Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.

Study Overview
=================
Brief Summary
-----------------
This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients who received first COVID-19 prophylaxis dose between March 2022 and October 2022.

Detailed Description
-----------------
This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients. All CLL or indolent B-cell NHL patients (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab according to AIFA indication between March 2022 and October 2022 will be included in the study. Each patient will be followed for a maximum of 12 months from the first COVID-19 prophylaxis dose.

Official Title
-----------------
Incidence of Severe COVID-19 Infection in Patients With Chronic Lymphocytic Leukemia or Indolent B-cell Non-Hodgkin Lymphoma Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy: an Observational Study by the GIMEMA Working Party on Chronic Lymphoproliferative Disorders and by the Fondazione Italiana Linfomi

Conditions
-----------------
Chronic Lymphocytic Leukemia, Indolent B-Cell Non-Hodgkin Lymphoma, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient with CLL or indolent B-NHL who received the first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab as per label indication between March 2022 and October 2022. Signed informed consent, if applicable Exclusion Criteria: None

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 |
| --- | --- | --- |
| Assess the percentage of patients who develop severe COVID-19 infection | Evaluation of prophylaxis efficacy in terms of percentage of patients with CLL or indolent B-NHL who develop severe COVID-19 infection, defined as COVID-19-related hospitalization or COVID -19 related death | at 12 months |
Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve PCR to Neoadjuvant Chemoradiotherapy

Study Overview
=================
Brief Summary
-----------------
It has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (PCR) to neoadjuvant chemoradiotherapy have better survival than those with non-PCR. Howeve, there is still recurrent diseases developed in PCR patients after esophagectomy. Herein, we aimed to investgate the risk factors of recurrence in PCR patients.

Detailed Description
-----------------
Between January 2008 and December 2018, a total of 96 patients with pathological complete response were enrolled in this study. Sterilized lymph nodes (SLN) were defined as those lymph nodes without residual tumor but with the presence of treatment response to neoadjuvant chemoradiotherapy. Prognostic factors for recurrence-free survival (RFS) were analyzed with univariate and multivariate analyses.

Official Title
-----------------
The Patterns and Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve Pathologic Complete Response to Neoadjuvant Chemoradiotherapy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Other: follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) patients with histopathologically confirmed ESCC;(2) patients received nCRT and radical esophagectomy in our hospital;(3) patients received the cisplabin plus or cisplain plus as the preoperative chemotherapy regimen; (4) those patients achieved PCR in the postoperative specimens (both primary tumor and resected lymph nodes). Exclusion Criteria: (1) patients who did not receive preoperative treatment or received preoperative chemotherapy alone;(2) patients who underwent Ivor-Lewis esophagectomy or Sweet esophagectomy;(3) patients who received preoperative chemotherapy other than NP or DP regimens;(4) patients with non-PCR to nCRT.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCR patients with eaophageal squamous cell carcinomas<br>patients with esophageal squamous cell carcinoma (ESCC) patients who achieved pathologic complete response after neoadjuvant chemoradiotherapy (nCRT). | Other: follow up<br>* collecttion of clinicopathological data from a prespectively collected databse, including survival data.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival | recurrence-free survival (RFS) was calculated from the date of esophagectomy to the date of first detected recurrent disease | 2008-2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
risk factor
Motor Function and Activity of Daily Life in Spinal Muscular Atrophy

Study Overview
=================
Brief Summary
-----------------
This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Detailed Description
-----------------
Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease that causes progressive muscle weakness and atrophy and eventually leads to loss of function. Despite recent advances in disease-modifying treatments, SMA can still significantly impact an individual's functioning in daily living and quality of life. This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Official Title
-----------------
Translation of Motor Function to Daily Activity Performance in Individuals With SMA

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a diagnosis of SMA with genetics confirmed as 5q SMA. Above 3 years of age (capable of performing motor assessments). Exclusion Criteria: Having severe respiratory and other medical conditions precluding safe participation in standardized motor function tests. Having any orthopedic surgery during the past 6 months. Women who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Revised Upper Limb Module | The physiotherapist will perform a serious of motor test to evaluate the patient's upper limb motor function. This test is to observe the manual ability on different tasks in sitting position, including drawing along the path, opening Ziploc container, or lifting weight. And the therapist will score for each item. The Revised Upper Limb Module (RULM) are consist of 19 items. It takes about 15-20 minutes for testing. | 15-20 minutes |
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. Patients referred for surgical aorticvalve replacement will be offered to participarte in the study. The main questions the study aims to answer are: Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, Angiotensin-II, ACE, ACE2 and Angiotensin receptor 1 and 2. Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system. Gender differences in LV remodelling associates with different levels of sexual hormones. Patients participating in the study will be asked to undergo: Cardiac ultrasound, MR- and CT-scan prior to surgery Blooddraw prior to surgery. Heartmuscle biopsy during surgery Cardiac MR-scan 1 year after surgery.

Official Title
-----------------
Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe AS (estimated by the local heart team, aortic valve area<1cm2) referred for AVR at the cardiology department at Odense University Hospital Age > 18 years Signed informed consent Exclusion Criteria: Bicuspid aortic valve. LV systolic dysfunction (LVEF<50%). Patients with concomitant moderate-severe aortic valve regurgitation. Concomitant moderate-severe mitral valve regurgitation. Moderate to severe nephropathy (s-creatinine >200 mmol/l) Unwilling to participate in the study. Claustrophobia. Permanent cardiac devices (pacemaker and ICD)

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 |
| --- | --- | --- |
| Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients |  | At the time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low flow low gradient aortic valve stenosis
Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD. The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.

Official Title
-----------------
Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients

Conditions
-----------------
Rejection Acute Hepatic, Transplant; Failure, Liver, Liver Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for liver transplantation following National and International Guidelines Exclusion Criteria: No agreement or inability to give informed consent Re-transplant patients Liver transplant in fulminant hepatitis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Allograft dysfunction (EAD) | Olthoff criteria: bilirubina≥ 10 mg/dL in 7th post-operative day, international normalized ratio (INR) ≥ 1.6 in 7th post-operative day 7; ALT or AST> 2000 IU/L during the first 7 days after liver transplantation | 2 weeks from Liver transplantation |
Nutritional Assesment in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluated nutritional status in patiets with cirrhosis

Official Title
-----------------
Nutritional Assesment in Patients With Cirrhosis

Conditions
-----------------
Cirrhosis, Liver

Intervention / Treatment
-----------------
* Dietary Supplement: BCAA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent age >18, <75 years old hepatic cirrhosis diagnosis Exclusion Criteria: refuse to participate/to give consent presence of musculo-skeletal disease previous diagnosed, neuropathic diseases, malignancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: BCAA|status of nutrition evaluation after 3 months of BCAA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass improvement |  | 3 months |