linjc16/ctgov huggingface dataset:
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms

Study Overview
=================
Brief Summary
-----------------
Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.

Official Title
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Post-marketing Surveillance of Spesolimab I.V. Infusion in Improvement of Generalized Pustular Psoriasis (GPP) With Acute Symptoms in Japan

Conditions
-----------------
Generalized Pustular Psoriasis

Intervention / Treatment
-----------------
* Drug: Spesolimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GPP patients with acute symptoms who are administered Spesolimab Intravenous (I.V.) Infusion in Japan Patients who have never been treated with Spesolimab I.V. Infusion before enrolment 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with generalized pustular psoriasis (GPP)<br> | Drug: Spesolimab<br>* Spesolimab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) | Incidence of adverse drug reactions (ADRs). An ADR is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors. | Up to 36 weeks |
TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS

Official Title
-----------------
ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Adhesive Hernia Repair System (TAHRS) for Atraumatic Laparoscopic Hernia Repair

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subject is 18 years old or older; Patient willing and able to provide a signed Patient Informed Consent Form; Has a midline primary ventral, umbilical or incisional hernia; Scheduled for a laparoscopic IPOM hernia repair; Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect Key Exclusion Criteria: Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures); BMI > 35; Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day; Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent; Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding; Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus; Patient has more than one hernia defect (to be confirmed intraoperatively);

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Hernia repair<br>There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Adhesive Hernia Repair System (TAHRS) | Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS)<br>* The TAHRS is intended for fixation of prosthetic material to soft tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Effect (SADEs) | Cumulative incidence of complications (CIC) related to the TAHRS including: Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction, | through 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hernia recurrence through 12 months post- surgery |  | through 12 months post-surgery |
An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C).

Detailed Description
-----------------
The present study was an observational study aimed to explore risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus. The observation items included clinical characteristics, blood glucose control and incidence of complications of PPDM-C.

Official Title
-----------------
An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment on Post-chronic Pancreatitis Diabetes Mellitus

Conditions
-----------------
Chronic Pancreatitis, Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: blood test
* Drug: pharmacologic approaches to glycemic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diagnosis of chronic pancreatitis and diabetes mellitus. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis. Exclusion Criteria: participants with suspected malignant tumors of the pancreas or other sites of body, or participants in the terminal stage of severe disease serious mental illness, lesion of liver or kidney, pregnancy, breast-feeding or planning pregnancy definitely diagnosed type 1 diabetes, type 2 diabetes, or other metabolic diseases that affect blood glucose autoimmune pancreatitis Scarcity of information related to HbA1c death or loss of follow-up during follow-up
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood test|Testing the peripheral blood for PPDM-C, including blood glucose, glycated hemoglobin A1c, fasting insulin and C-peptide, etc.|
|Drug: pharmacologic approaches to glycemic treatment|documenting the change of glycemic treatment during the follow-up period|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) | measure the control of blood glucose of every 3 months | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and frequency (number of events) of adverse events (%) such as hypoglycemia, cardiovascular disease, etc. | through study completion, an average of 1 year |
Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo

Study Overview
=================
Brief Summary
-----------------
This study was a retrospective, non-interventional, longitudinal, descriptive study. This study did not have a key underlying hypothesis, rather it was designed to explore the onboarding and adherence of SPMS patients in Australia to Mayzent (siponimod) treatment. Initiating siponimod involves pre-screen tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing, and patients underwent a 6-day titration prior to maintenance. The MSGo platform was developed to support onboarding. It is an integrated digital platform that functions as a patient support service.

Official Title
-----------------
Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo

Conditions
-----------------
Secondary Progressive Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adult patients with SPMS as per the treating physician's clinical assessment (Therapeutic Goods Administration [TGA]-approved indication of Mayzent). Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 (inclusive). Patients accessing Mayzent via the Mayzent Experience Program (MEP) must have met the MEP criteria, and if available, the Pharmaceutical Benefits Scheme (PBS) restrictions recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). Patients accessing Mayzent via the PBS must have met the PBS restrictions. Exclusion criteria Patients who were contraindicated for Mayzent treatment according to the TGA-approved Product Information. Patients diagnosed with clinically isolated syndrome or primary progressive multiple sclerosis (MS).

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 |
| --- | --- | --- |
| Average time for siponimod onboarding |  | Up to 168 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to siponimod onboarding in pre-specified sub-groups |  | Up to 168 days | 
| Percentage of patients who adhered to the titration protocol |  | Up to 168 days | 
| Time on maintenance therapy |  | Up to 168 days |
Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is: • How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology

Detailed Description
-----------------
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H&E slides, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.

Official Title
-----------------
Investigation of Mohs Surgical Margins Using Two Photon Microscopy

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Device: Two photon microscopy imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing treatment for BCC with Mohs surgery at the performance site Able to read and understand consent form 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPFM imaging of surgical margins<br>Patients will be imaged with TPFM | Device: Two photon microscopy imaging<br>* Excised tissues will be imaged with two photon microscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between frozen sections and two photon microscopy on Mohs margins | The fraction of Mohs surgical margins in which TPFM agrees with FSA will be determined. | During Mohs surgery |
Liquid Biospy for Urinary Cancers

Study Overview
=================
Brief Summary
-----------------
The project aims to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Detailed Description
-----------------
Bladder cancer (BCa) is the 9th most common cancer worldwide, with an estimated prevalence of around 2.7 million cases and an incidence around 350.000 new cases/year. The proper management of BCa remains an unmet clinical need, because one of the main problems in BCa treatment is the inability to efficaciously prevent high-grade non-muscle invasive bladder cancer (NMIBC) relapse and progression, which occur in 80% and 45% of patients respectively. Indeed, as a consequence of the lack of efficient established prognostic, diagnostic and predictive biomarker of high-risk NMIBC, Bca patients undergo multiple treatments and cystoscopic assessments along their life, with consequent poor quality of life and high healthcare costs. Circulating Tumor Cells (CTCs) in blood represent an invaluable source of tumor material that can be easily collected yhrough a simple blood draw and may represent the clonal component of the primary tumor that left the primary site. For this reason, the aim of this study is to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Official Title
-----------------
Use of Urinary Tumor Cells and Circulating Tumor Cells (CTCs) in the Prognosis and Therapy of Patients With Bladder (BCa) and Upper Urinary Tract (UTUC) Cancer

Conditions
-----------------
Urothelial Carcinoma

Intervention / Treatment
-----------------
* Genetic: Genetic analysis on isolated cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of urothelial neoplasia, naive for therapy Exclusion Criteria: Absence of previous neolpastic disease or genetic diseases

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| 1<br>Urothelial neoplasia | Genetic: Genetic analysis on isolated cells<br>* Isolation of cells from blood and urine<br>|
| 2<br>Age-matched individuals free of neoplasia | Genetic: Genetic analysis on isolated cells<br>* Isolation of cells from blood and urine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic role of the liquid biopsy | Gene signature in CTC and UTC predicting tumor relapse | 2020-2023 |
H19 in Acute Lymphoblastic Leukemia.

Study Overview
=================
Brief Summary
-----------------
Study the expression level of H19 gene in the samples from ALL patients by real-time PCR. Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.

Detailed Description
-----------------
Acute lymphoblastic leukemia (ALL) is the most common cancer affecting children and adolescents (Zeng XL et al, 2023). ALL is a haematological malignancy characterized by the malignant clonal expansion of lymphoid hematopoietic precursors (Hong Z et al, 2021). It arises from B- or T-lineage lymphoid progenitors: B-cell-precursor ALL (B-ALL) and T-cell ALL (T-ALL) (Brady SW et al., 2022). Rrelapse in ALL is the fundamental cause of treatment failure in 15-20% of patients (Hulleman E et al, 2009). Therefore, the exploration of novel functional molecules that play a role in ALL pathogenesis could be effective therapeutic targets for this disease (Asadi M et al, 2023). Long non-coding RNAs (lncRNAs) are non-protein coding transcripts longer than 200 nucleotides (Kopp F et al, 2018). H19 was the first lncRNA to be discovered and submitted for genomic imprinting (Yoshimura H et al, 2018). It has a role in embryogenesis and tumorigenesis (Yoshimura H et al, 2014). It also has an indispensable role in enhancing cell proliferation, differentiation, migration, invasion, and chemo resistance (Li Y et al, 2020). Recent evidence has shown that H19 is an oncogene and is overexpressed in breast, liver, endometrial, lung, cervical, and esophageal cancers (Asadi M et al, 2023). A similar pattern of H19 expression was observed in various types of leukemias, including chronic myeloid leukemia (CML) (Morlando M et al, 2015) and acute myeloid leukemia (AML) (Zhang Tj et al, 2018).

Official Title
-----------------
Expression of Long Non-Coding RNA H19 in Acute Lymphoblastic Leukemia

Conditions
-----------------
Acute Lymphoid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed ALL patients. Exclusion Criteria: - 1-Presence of other haematological disorders, history of other malignancies or relapsed ALL. 2-Patients under chemotherapy or radiotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALL patients<br> | |
| control group free from the disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Study the expression level of H19 gene in the samples from ALL patients by real-time PCR. |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients. |  | baseline |
Addressing Inequity in Dermatology

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to understand the variation in dermatoses presenting in individuals from different ancestry backgrounds. This will be conducted at multiple NHS hospitals in England. The Investigators specifically aim to 1) assess features of dermatoses in individuals of different ancestry. 2) Understand the language used by patients describing their condition.

Official Title
-----------------
Skin Images and Nomenclature for Diverse Populations (SkIN DP)

Conditions
-----------------
Dermatologic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dermatologist diagnosed disease, with visible active dermatological disease Exclusion Criteria: No dermatological disease, no active pathology identifiable, aged 18 and above but lacks capacity to consent.

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 100 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 features of dermatoses in individuals of different ancestry | Conducted through visual inspection of photographic images taken of the dermatological condition. | Baseline | 
| Asses the language used by patients when describing their skin condition | Content analysis and a framework analysis approach will be used. | Baseline |
Investigating Medical Research Trends in Osteoarthritis Clinical Trials

Study Overview
=================
Brief Summary
-----------------
Clinical research participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future osteoarthritis patients during clinical study.

Official Title
-----------------
Analyzing Factors Impacting Patient Involvement in Osteoarthritis Clinical Research

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. Participant has a diagnosis of osteoarthritis. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. Pregnant or lactating woman Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in an osteoarthritis clinical study. |  | 3 months | 
| Number of osteoarthritis patients who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis