linjc16/ctgov huggingface dataset:
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2203

Detailed Description
-----------------
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With C2202 and C2203

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Treatment Period(JW0201)
* Drug: Treatment Period(Placebo)
* Drug: Extension Period(JW0201)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus Exclusion Criteria: Type 1 Diabetes Mellitus The subject not meet the specified HbA1c and FPG

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JW0201+C2202+C2203<br>Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) | Drug: Treatment Period(JW0201)<br>* JW0201: 200mg/day For 24 weeks(PO, BID) C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)<br>* Other names: JW0201+C2022+C2203;Drug: Extension Period(JW0201)<br>* JW0201: 200mg/day For 28 weeks(PO, BID) C2022: ≥1,000 mg/day for 28 Weeks(PO, BID) C2203: 25 mg/day for 28 Weeks(PO, BID)<br>* Other names: JW0201+C2022+C2203;|
| Placebo Comparator: C2202+C2203<br>Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) | Drug: Treatment Period(Placebo)<br>* C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)<br>* Other names: C2022+C2203;Drug: Extension Period(JW0201)<br>* JW0201: 200mg/day For 28 weeks(PO, BID) C2022: ≥1,000 mg/day for 28 Weeks(PO, BID) C2203: 25 mg/day for 28 Weeks(PO, BID)<br>* Other names: JW0201+C2022+C2203;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (24 Weeks) lowering effect | change in HbA1c | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c lowering effect | change in HbA1c | 6, 12, 18, 32, 40, 52 Weeks |
The Molecular Basis of Inherited Reproductive Disorders

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to learn more about the genes that control puberty and reproduction in humans.

Detailed Description
-----------------
All study subjects will undergo the same activities. Subjects will provide up to five tubes of blood for genetic analysis, complete a smell test, and answer questions about their health and family history.

Official Title
-----------------
The Molecular Basis of Inherited Reproductive Disorders

Conditions
-----------------
Hypogonadotropic Hypogonadism, Reproductive Disorder, Kallmann Syndrome, Delayed Puberty

Participation Criteria
=================
Eligibility Criteria
-----------------
Participants must belong to one of the following categories: Failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low/normal gonadotropins or, Abnormally early development of puberty or, Normal puberty with subsequent development of low gonadotropin levels or, Evidence of a reproductive disorder with high gonadotropin levels or, Pre-pubertal individuals with features suggestive of hypogonadotropic hypogonadism or, Affected and unaffected family members of individuals that fit criteria above

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Reproductive Disorders<br>Individuals with reproductive disorders and their affected and unaffected family members | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variation | Identification of one or more genetic variations related to reproductive disorders | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadotropic hypogonadism, Reproductive disorders, Kallmann syndrome, Kisspeptin, Delayed Puberty
Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.

Official Title
-----------------
Dynamic Predictive Model for Postoperative Nausea and Vomiting for Patient Received Gynecological Laparoscopic Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Other: The presence of nausea and vomiting within 24 hours after surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All female patients receiving gynecological laparoscopic surgery. Exclusion Criteria: -Patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to ICU.

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br> | Other: The presence of nausea and vomiting within 24 hours after surgery<br>* This is a prospective risk prediction model building, thus there is no traditional definition of intervention.<br>|
| Control group<br> | Other: The presence of nausea and vomiting within 24 hours after surgery<br>* This is a prospective risk prediction model building, thus there is no traditional definition of intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV | The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS). | Within 24 hours after surgery |
Vitamin D Supplementation in Acne

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is: • To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone. Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid. Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.

Official Title
-----------------
Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Dietary Supplement: D Max Drops
* Drug: Azithromycin 250 milligram Oral Capsule
* Drug: Adapalene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included. Exclusion Criteria: Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs) Those with obesity Individuals employing vitamin supplementation Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br> | Dietary Supplement: D Max Drops<br>* Vitamin D<br>Drug: Azithromycin 250 milligram Oral Capsule<br>* Anti Biotic<br>Drug: Adapalene<br>* Retinoid<br>|
| Active Comparator: Placebo<br> | Drug: Azithromycin 250 milligram Oral Capsule<br>* Anti Biotic<br>Drug: Adapalene<br>* Retinoid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacious | Improvement in Global Acne Grading System Score from baseline to after 2 months of treatment | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AcneVulgaris, Vitamin D
Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery in babies less than 6 kg of weight is a complex and high-risk procedure. Despite advances in medical technology, mortality and morbidity rates remain high. This study seeks to identify risk factors associated with mortality and morbidity in this population

Official Title
-----------------
Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality

Conditions
-----------------
Cardiac Surgery in Neonates

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates undergoing surgery for congenital heart diseases Exclusion Criteria: larger body weights than 5 kg

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac surgery|Operations for congenital heart diseases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death after surgery | 1 month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Complications after surgery | 1 month postoperative |
Identification of Clinically Significant Markers of ATTRv in Pre-symptomatic Mutation Carriers.

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective observational study is to periodically monitor pre-symptomatic subjects carrying a mutation of Transthyretin (TTR), identified in the context of a family screening of affected proband, through instrumental methods and clinical scales in order to identify the first signs of clinically significant organ involvement by the disease. Healthy asymptomatic carriers will be subjected to regular monitoring through clinical evaluations and instrumental investigations defined by the consensus group (Conceicao et al.) in order to validate the criteria defined by this group to define the onset of the disease. A subgroup of carriers with scales and instrumental tests negative for damage to the peripheral nervous system or cardiac, but with subjective symptoms compatible with the disease, will be subjected to further instrumental tests not indicated by consent.

Official Title
-----------------
Identification of Clinically Significant Markers of Hereditary Transthyretin Amyloidosis (TTR) in Pre-symptomatic Mutation Carriers: a Prospective Longitudinal Multicentre Study

Conditions
-----------------
Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Pre-symptomatic carriers of TTR mutation in regular follow-up at the Centres. Signature of the written informed consent. Age not less than 10 years compared to the age of onset of the relative with the youngest age of onset and/or a history of bilateral carpal tunnel syndrome undergoing surgery. Exclusion criteria Other causes of neuropathies (diabetes; MGUS; alcoholism; vitamin deficiency). Other causes of hypertrophic heart disease.
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 |
| --- | --- | --- |
| Evaluation of a cohort of pre-symptomatic subjects carrying a TTR mutation | To evaluate in a cohort of pre-symptomatic subjects carrying a TTR mutation the disease onset according to the European consensus criteria (Conceicao et al.). | 3 years |
Telerehabilitation for Visually Impaired

Study Overview
=================
Brief Summary
-----------------
the purpose of the study is to evaluate the software usability and patient's adherence from five vision rehabilitation centres. In addition, the effect and benefits of a customizable telerehabilitation program were tested.

Detailed Description
-----------------
The software is used in our practice for every day vision rehabilitation training. So it is part of our routine medical care, and a we are going to study studies the effect of the intervention in several different centers.

Official Title
-----------------
Usability and Adherence of Visually Impaired to Telerehabilitation: a Multicentre Study

Conditions
-----------------
Visual Impairment

Intervention / Treatment
-----------------
* Device: Telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification. Exclusion Criteria: Subjects were excluded if they had a cognitive/psychiatric impairment or a motor disability that prevents the use of a computer pointing device (mouse).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br> | Device: Telerehabilitation<br>* The home visual telerehabilitation path using the EyeFitness software consisted of performing one visual training session per day, 5 days a week (from Monday to Friday) for a total of 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of EyeFitness telerehabilitation | The aim of this study is to evaluate the utility of the EyeFitness telerehabilitation software and the adherence of patients to the treatment. In order to evaluate the utility of the software the primary outcome measures were PSSUQ Version 3 scores defined as Overall, System Usefulness (Sysuse), Information Quality (Infoqual), Interface Quality (Iterqual). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment | The secondary outcome measures selected for the effectiveness analysis were distance Best Corrected Visual Acuity, MNRead reading acuity, reading speed (words per minute), contrast sensitivity (at Pelli - Robson charts) and fixation stability according to Microperimeter exame classification. | 6 months |
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)

Study Overview
=================
Brief Summary
-----------------
The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).

Official Title
-----------------
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application

Conditions
-----------------
Transposition of Great Arteries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Case group: The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who: are admitted to UNICCA, the Adult Congenital Heart Unit or are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution Control group: The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group. Exclusion Criteria: (case and control group) Subjects with intrabody ferromagnetic material precluding subject's safety Subjects with non CMR-conditional devices Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality Pregnant women

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 |
| --- | --- |
| Case<br>The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who: are admitted to IRCCS Policlinico San Donato, the Adult Congenital Heart Unit or are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution | |
| Control<br>The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Outcome definition | A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds). | 5 years |
18F-FAPI-RGD PET/CT in Various Tumor Types

Study Overview
=================
Brief Summary
-----------------
The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.

Detailed Description
-----------------
The aim of this study is to evaluate, in patients with various types of tumor, the radiotracer uptake and clinical feasibility of 18F-FAPI-RGD PET/CT compared with those of 18F-FDG PET/CT. To evaluate the diagnostic performance of 18F-FAPI-RGD and 18F-FDG PET imaging, the results of the visually interpreted PET images will be compared with the histopathologic results (via surgery or biopsy), which are used as the gold standard for the ﬁnal diagnosis. For patients for whom tissue diagnosis is not applicable, clinical and radiographic follow-up data will be used as the reference standard to validate the PET/CT ﬁndings.

Official Title
-----------------
Clinical Evaluation of 18F-FAPI-RGD PET/CT for Imaging of Fibroblast Activation Protein and Integrin avb3 in Various Tumor Types

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically suspected or diagnosed tumors Exclusion Criteria: Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg Complicated with chronic liver disease, myocardial infarction, stroke Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors | Tracer uptake in normal organs (background) is quantiﬁed by SUVmean, which is delineated with a sphere that had a diameter of 1 cm (for small organs, including thyroid, salivary gland, and pancreas) to 2 cm(for other organs, including brain, heart, liver, kidney, spleen, muscle, and bone marrow) placed inside the organ parenchyma. The tumor-to background ratio (TBR) is calculated as tumor SUVmax/background SUVmean. | 1 month |