linjc16/ctgov huggingface dataset:
To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is the second most common cancer in male cancer globally and ranked third in Hong Kong. While androgen deprivation therapy (ADT) is the backbone treatment for advanced prostate cancer, it could lead to obesity, metabolic syndrome and increased cardiovascular mortality. Previous studies showed that ADT patients have different gut microbiome compared to non-ADT patients and the gut microbiome might be related to the metabolic changes. However, the underlying mechanism of these metabolic complications is still not fully understood. This study aims to investigate the relationship and related mechanism between the changes in gut microbiomes and ADT-related metabolic change in prostate cancer patients.

Detailed Description
-----------------
It is a prospective longitudinal observational human study. Fifty prostate cancer patients planned for ADT will be recruited. Fecal sample will be collected before initiation of ADT, and then at 3 and 6 months after initiation of ADT. Anthropometric, blood metabolic parameters, serum inflammation markers and panels of microbiome metabolites will be measured at these timepoints. Changes in gut microbiome from baseline to 6 months after initiation of ADT will be assessed. Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible mechanisms will be explored.

Official Title
-----------------
To Investigate the Role of Gut Microbiome in Androgen Deprivation Therapy Related Metabolic Changes in Prostate Cancer Patients

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subject with age 45 or above Histological diagnosis of prostate cancer (acinar type) Clinically decided for androgen deprivation therapy (ADT) as treatment for prostate cancer Exclusion Criteria: History of diabetes Patients that have other active treatment for prostate cancer or other cancers (except ADT) Patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of ADT Patients will be started on other treatments, including chemotherapy, new generation of androgen-receptor targeted agents, radiotherapy etc, within 6 months of the commencement of ADT. Subject with recent antibiotics usage within 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the changes in gut microbiota in prostate cancer patients after initiation of androgen deprivation therapy (ADT) | Gut microbiome related metabolites will be measured by ELISA and mass spectrometry. | Baseline, Month 3, Month 6 |
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.

Official Title
-----------------
A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: saline
* Drug: K201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms). Atrial fibrillation documented by ECG at the start of study drug infusion. Exclusion Criteria: Previous exposure to K201 QTcF (Fridericia correction) >440 ms QRS interval > 140 ms Paced atrial or paced ventricular rhythm on ECG History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization History of amiodarone (oral or IV) in the last 3 months. Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization History of failed electrical cardioversion at any time in the past History of polymorphic ventricular tachycardia (e.g. torsades des pointes) History or family history of Long QT Syndrome History of ventricular tachycardia requiring drug or device therapy Ejection fraction of 40% or less.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: saline<br>* intravenous infusion<br>|
| Experimental: K201<br>intravenous K201 | Drug: K201<br>* intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects who convert to sinus rhythm |  | 24 hours |
Splenectomy During Whole Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.

Detailed Description
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Data on patients who underwent splenectomy during liver transplantation were retrospectively analyzed . Participants underwent splenectomy as part of routine medical care. Patients undergoing simultaneous liver transplantation and splenectomy were matched to a non-splenectomy group.

Official Title
-----------------
Splenectomy During Whole Liver Transplantation

Conditions
-----------------
End Stage Liver Disease

Intervention / Treatment
-----------------
* Procedure: Splenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing liver transplantation between 1994 and 2013 Exclusion Criteria: Data from living donor patients, split liver transplantation, patients with pre- or post-operative splenectomy in medical history, and patients under 16 years were excluded from analysis

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Splenectomy<br>Patients undergoing liver transplantation with simultaneous splenectomy | Procedure: Splenectomy<br>* Splenectomy was performed after hepatectomy, in an extra-hilar manner with manual ligation of splenic vessels.<br>* Other names: Liver transplantation;|
| Liver transplantation<br>Patients undergoing liver transplantation only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month post-operative mortality |  | At 3 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative morbidity | Incidence of portal-vein thrombosis within 3 months post liver transplantation | 3 months post surgery | 
| One-year mortality |  | One year after surgery | 
| Mortality at 5 years |  | Five years after surgery |
Type 1 Diabetes Prediction and Prevention (DIPP) Study

Study Overview
=================
Brief Summary
-----------------
The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment.

Detailed Description
-----------------
Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until T1D is diagnosed. Clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of T1D are measured. Children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will develop T1D and 60% of future T1D cases will be reached by the current screening and follow-up strategy.

Official Title
-----------------
Type 1 Diabetes Prediction and Prevention (DIPP) Study

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: No intervention. DIPP is an observational study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland Exclusion Criteria: Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes
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 |
| --- | --- |
| Children at HLA-conferred risk for T1D<br> | Other: No intervention. DIPP is an observational study.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity for at least one islet autoantibody | ICA, IAA, GADA, IA-2A or ZnT8A | December 31, 2021 | 
| Clinical diagnosis of type 1 diabetes | Hyperglycemia as defined by WHO | December 31, 2021 |
Irisin Expression and Gene Polymorphism in Type II Diabetic Patients With and Without CAD

Study Overview
=================
Brief Summary
-----------------
This is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism and the presence and severity of coronary artery disease in patients with Type II DM.

Official Title
-----------------
Serum Irisin Level & FDNC5 Genetic Polymorphism Can Predict the Presence &Severity of Coronary Artery Disease in Patients With Type II DM?

Conditions
-----------------
Irisin Gene Polymorphism in Type II Diabetic Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study will include type II diabetic patients aged between 18 and 45 years old Exclusion Criteria: Recent acute myocardial infarction. patients with Heart Failure Active infection End stage renal failure (GFR < 30 ml/min) or on dialysis Liver cell failure Athletes or having heavy muscular exercise in the previous 3 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diseased<br>type II diabetic patients with documented coronary artery disease. | |
| Control<br>type II diabetic patients without coronary artery disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irisin level | detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl) | 6 months | 
| FNDC5 Genotyping | whether homogenetic or heterogenetic | 6 months |
Does Oral Intake Decreases Postoperative Pain Score in Children

Study Overview
=================
Brief Summary
-----------------
Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score. A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting. The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.

Official Title
-----------------
The Effect of Oral Intake on Pain Score in Children Undergoing Herniorrhaphy

Conditions
-----------------
Fasting, Postoperative Pain

Intervention / Treatment
-----------------
* Other: two hours
* Other: one hour


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery Exclusion Criteria: neurological disease, developmental delay

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 12 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 hours after surgery<br>the investigators permit the patients to resume oral intake two hours after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability | Other: two hours<br> <br> |
| Experimental: 1 hour after surgery<br>the investigators permit the patients to resume oral intake one hour after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability | Other: one hour<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether oral intake influences postoperative pain score in children | pain degree is assessed using mCHEOPS and FLACC in young children, and using FPS-R in older (8 years or older) children | 90 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting | all children have to stay in hospital for 3 hours, and then, doctors visit the child and decide to discharge or not. Therefore, most of children stay in hospital approximately for 4 hours. | 4 hours on average |
Comparison of Brain Volumes Measured by 2D USG and MRI

Study Overview
=================
Brief Summary
-----------------
Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.

Detailed Description
-----------------
All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.

Official Title
-----------------
Comparison of Brain Volumes of Preterm Infants Measured by Two Dimensional Ultrasonography and Cranial Magnetic Resonance Imaging

Conditions
-----------------
Central Nervous System Vulnerabilities in Preterm Infants

Intervention / Treatment
-----------------
* Other: Cranial MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams Born in our hospital Alive during discharge Exclusion Criteria: congenital anomalies cranial bleeding early death

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cranial MRI|Cranial MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of two different brain volumes | Patients in cohort will have both USG and cranial MRI | 6 months |
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Despite technological advances, incontinence and impotence remain significant side effects of radical prostatectomy (RP). Strategies have been developed to reduce the injury to the erection nerves (i.e. neurovascular bundle - NVB)during surgery to further improve functional outcomes after RP. Adipose tissue is known for its stabilizing and even healing potential. These features include reducing the inflammatory process and improving blood supply to an injured nerve. We hypothesized that covering the NVB with periprostatic fat during surgery may potentially improve neural recovery and enhance functional recovery after RP. We sought to examine our hypothesis in a randomized controlled trial.

Official Title
-----------------
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy; a Randomized Control Trial

Conditions
-----------------
Prostate Cancer, Erectile Dysfunction, Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Technical modification during radical prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 18 years and older. Patients diagnosed with prostate cancer. Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner. Patients scheduled for Radical Prostatectomy with NVB preservation (at least unilateral). Exclusion Criteria: Patients who did not undergo NVB preservation or technical inability to create flap
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose Flap<br>Covering neurovascular bundle with fat | Procedure: Technical modification during radical prostatectomy<br>* Covering the NVB with fat<br>|
| No Intervention: Control<br>No adipose flap | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function | IIEF erectile function score | Change from Baseline IIEF score at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence status | King's Health Questionnaire score | Change from Baseline King's score at 12 months |
Examining Genetic Factors That Affect the Severity of 22q11.2 Deletion Syndrome

Study Overview
=================
Brief Summary
-----------------
22q11.2 deletion syndrome is a genetic disorder that can cause heart defects, facial abnormalities, and developmental and learning disabilities. The severity of the disorder can vary widely among people. This study will analyze DNA from people with 22q11.2 deletion syndrome to identify genetic variations that may affect the severity of the disorder.

Detailed Description
-----------------
22q11.2 deletion syndrome is a disorder caused by the deletion of a small piece of chromosome 22. Most people with this disorder are missing a sequence of about 3 million DNA building blocks on chromosome 22 within each cell. This disorder affects many areas of the body. People with 22q11.2 deletion syndrome may have heart defects, immune deficiency, kidney abnormalities, hearing loss, and cleft palate or other facial deformities. Many children experience developmental delays and learning disabilities, and they have an increased risk of developing mental illnesses, including schizophrenia, depression, anxiety, and bipolar disorder. All people with 22q11.2 deletion syndrome are missing the same sequence of DNA, but the severity of this disorder varies widely; some people are diagnosed with multiple health and developmental problems, while others experience very few symptoms. In some people, the symptoms may be so minimal that they are not even aware they have 22q11.2 deletion syndrome. This study will examine genetic material-either from blood or saliva-among people with 22q11.2 deletion syndrome. Participants will attend one study visit and undergo either blood or saliva collection. By analyzing the DNA sequences of participants, the study will aim to identify any genetic variations that may affect the severity of 22q11.2 deletion syndrome.

Official Title
-----------------
Genetic Modifiers of 22q11.2 Deletion Syndrome

Conditions
-----------------
DiGeorge Syndrome, 22q11.2 Deletion Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has 22q11 deletion of 3 megabases (Mb) Exclusion Criteria: Has 22q11 deletion smaller than 3 Mb or no deletion
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital Heart Defects, Single Nucleotide Polymorphisms, Copy Number Variations, Whole Genome Association Study