linjc16/ctgov huggingface dataset:
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients

Study Overview
=================
Brief Summary
-----------------
The investigators intend to find a way to lower drug rash occurrence by applying drug tolerance induction protocol at the beginning of lamotrigine administration. Genotyping of participants with rash and those without rash after taking lamotrigine and genetic testing to find common gene mutations in these participants.

Official Title
-----------------
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study

Conditions
-----------------
Lamotrigine Allergy

Intervention / Treatment
-----------------
* Drug: Lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18-85 years old Epilepsy patients Patients who started Lamotrigine first time Exclusion Criteria: Those who do not agree with prior consent Women taking oral contraceptives. history of drug rash Taking enzyme-inducing antiepileptic drugs (EIAED) or valproate (VPA)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lamotrigine tolerance<br>The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks. | Drug: Lamotrigine<br>* The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks. In addition, the ratio of regulatory T cells was measured before lamotrigine administration, and the proportion of regulatory T cells was measured by two-week administration of lamotrigine after tolerance induction protocol. Add 6 ml of EDTA tube to each cryovial, and dispense 1 ml each in cryovial. After the appropriate number of patients of the same phenotype were collected, the analysis was performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin rash incidence rate |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Treg cell ratio in peripheral blood |  | 2 weeks | 
| Severity of skin rash (CTCAE version 4.0) |  | 2 weeks | 
| Lamotrigine drug level in blood (mcg/ml) |  | 2 weeks |
Brain Aging Project--Kansas University

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of exercise and cardiorespiratory fitness on age-related brain changes.

Detailed Description
-----------------
The mission of the KU Brain Aging Project is to promote healthy brain aging. How the brain changes with age is not well-characterized and even less is known about the factors influencing the rate of brain aging. Thus, we are using MRI scans to examine the structure of the brain in relation to important lifestyle factors. This will allow us to better understand the processes influencing the brain as it ages. In turn, this will help identify specific ways to promote healthy brain aging and, perhaps, prevent the onset of Alzheimer's disease. Participants complete 4 visits over several months. The first visit entails a clinical evaluation and memory testing involving the use of paper and pencil testing. The second visit is an MRI brain scan which lasts approximately one hour. The third visit involves drawing blood for laboratory testing and blood banking for future lab studies, lasting roughly 4 hours. The glucose tolerance test is administered. The fourth and final visit is an assessment of the participant's metabolism and exercise testing. This visit lasts approximately two hours.

Official Title
-----------------
KU Brain Aging Project

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 years or older Healthy male or female Normal control volunteers and early Alzheimer's disease patients Clinical Dementia Rating of 0, 0.5, or 1.0 On stable doses of medications Exclusion Criteria: Unstable angina Schizophrenia Clinical signs of depression; major depression; mental health disorder; nervous system disorder Significant visual/auditory impairment Significant system illness; cancer Pacemaker/metal Thyroid problems Kidney dialysis Organ transplant Alcoholism Heart surgery Insulin

Ages Eligible for Study
-----------------
Minimum Age: 65 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>elderly people who have normal cognition | |
| 2<br>elderly people who have mild to moderate Alzheimer's disease | |

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
-----------------
cognitive decline, dementia, neuroimaging
Use of v Care in Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.

Conditions
-----------------
Uterine Fibroid

Intervention / Treatment
-----------------
* Device: uterine manipulator (v care)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: benign causes for hysterectomy Exclusion Criteria: malignant causes for hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: v care group<br>In this group we will use (v care) uterine manipulator during abdominal hysterectomy. | Device: uterine manipulator (v care)<br> <br> * Other names: v care;|
| No Intervention: control group<br>In this group we will do abdominal hysterectomy without v care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal length |  | within 1 week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder injury |  | within 1 week postoperative |
MR-guided Focal Laser Ablation of the Prostate

Study Overview
=================
Brief Summary
-----------------
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.

Official Title
-----------------
MR-guided Focal Laser Ablation of the Prostate

Conditions
-----------------
Prostate Cancer, MRI, Focal Laser Ablation

Intervention / Treatment
-----------------
* Device: MR-guided focal laser ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed and biopsy proven prostate cancer Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b) No previous treatment for prostate cancer Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images Signed informed consent by patient Age 18 years or older Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia) Exclusion Criteria: Impossibility to obtain a valid informed consent Patients unable to undergo MR imaging, including those with contra-indications Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection) Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging Patients with evidence for nodal or metastatic disease Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2

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

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

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: MR-guided focal laser ablation<br> | Device: MR-guided focal laser ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months. | 36 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focal laser ablation, MR-guided therapy, Prostate cancer
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.

Official Title
-----------------
Interrupting Traumatic Memories: An Emergency Room Intervention for the Prevention of PTSD

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: Computer game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65, no loss of consciousness, ability to understand study procedures and give informed consent, Hebrew as first language, experienced a potentially traumatic event as defined in DSM (objective danger and subjective feeling of fear). Exclusion Criteria: current or past psychiatric treatment, current or past PTSD.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Subjects will be assessed, but no active intervention given | |
| Experimental: Computer game<br>Subjects will play with computer game while in the Emergency Room | Other: Computer game<br>* Playing with specially designed computer game while in emergency room<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptoms | PTSD status and symptoms as measured by the PSS | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, prevention
Endoscopic Subsurface Optical Imaging for Cancer Detection

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.

Detailed Description
-----------------
This is a pilot, feasibility study to determine if the subsurface imaging technology warrants advancement to a larger clinical trial.

Official Title
-----------------
Endoscopic Subsurface Optical Imaging for Cancer Detection

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be scheduled for a bladder procedure (TURBT or Cystectomy) at the University of California Davis Medical Center. Exclusion Criteria: Non bladder surgical procedures at University of California Davis Medical Center.

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 |
| --- | --- |
| 1<br>Patients undergoing a surgical bladder procedure in the main O.R. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the subsurface laser to determine cancer cells versus normal cells when viewed endoscopically during a surgical procedure. | Does the subsurface laser allow enough light to visually assess the cells. Logical metric of either Yes or No. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder Cancer, Laser, Optical
The Role of Genetic Factors in the Development of Idiopathic Scoliosis in the Kazakh Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify genetic determinants of susceptibility to idiopathic scoliosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic scoliosis

Official Title
-----------------
Preventive and Personalized Medicine (2021-2023)

Conditions
-----------------
Idiopathic Scoliosis

Intervention / Treatment
-----------------
* Genetic: SNP analysis of the DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with a doctor-confirmed diagnosis of idiopathic scoliosis; Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs; Hereditary history of scoliosis; Persons who are able and willing to provide written informed consent; Exclusion Criteria: Patients diagnosed with idiopathic scoliosis under 4 and over 40 years of age; Representatives of the Kazakh ethnic group less than 3 generations; No family history of bilateral idiopathic scoliosis; Patients with an acute period of the inflammatory process (laboratory and clinical signs); Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; Pregnant or lactating women; Tuberculosis of any localization in the active phase and in history; Severe and decompensated diseases of the liver and kidneys, cardiovascular system; Severe and decompensated course of endocrine diseases; Autoimmune diseases; Systemic diseases; Oncological diseases;

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group:<br>patients with idiopathic scoliosis | Genetic: SNP analysis of the DNA<br>* SNP analysis of the DNA obtained from peripheral blood sample<br>|
| Control group<br>patients without idiopathic scoliosis | Genetic: SNP analysis of the DNA<br>* SNP analysis of the DNA obtained from peripheral blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotyping for the SNP associated with liver cirrhosis | Genotype frequency of SNP in the study genes of participants and control participants. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNP
Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver

Study Overview
=================
Brief Summary
-----------------
this is a prospective, interventional, open-label, randomized study on the efficacy of omega 3 fatty acids supplementation in Egyptian children with non-alcoholic fatty liver disease who had been selected from nutrition and outpatient clinic at Pediatric hospital, Ain Shams University

Official Title
-----------------
the Effect of Omega 3 Fatty Acids Supplements on Antioxidant Capacity in Egyptian Children With Non Alcoholic Fatty Liver Disease

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Dietary Supplement: omega 3 fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 5 - 16 years old with diffusely hyper echogenic liver at ultrasonography were included in the study. Exclusion Criteria: Patients with secondary causes of steatosis including total parenteral nutrition, drugs causing fatty liver disease for example steroids, hepatitis A, B, C, cytomegalovirus, Epstein-Barr virus infections, autoimmune liver disease, metabolic liver diseases, Wilson's disease, and alpha-1-antitrypsin deficiency. Patients currently taking fish oil supplements. Patients with systemic illness such as cardiac and kidney diseases.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supplemented<br>Life style modification, diet regimen and Omega-3 fatty acids supplementation | Dietary Supplement: omega 3 fatty acids<br>* : Life style modification, diet regimen and Omega-3 fatty acids supplementation: The dose of omega-3 fatty acids depended on the weight of patients according to World Health Organization recommendations 400 milligrams per 10 kilograms of body weight and had been given into two doses per day, before morning and evening meals<br>|
| Active Comparator: non supplemented<br>Life style modification and diet regimen | Dietary Supplement: omega 3 fatty acids<br>* : Life style modification, diet regimen and Omega-3 fatty acids supplementation: The dose of omega-3 fatty acids depended on the weight of patients according to World Health Organization recommendations 400 milligrams per 10 kilograms of body weight and had been given into two doses per day, before morning and evening meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade of fatty liver in children | improvement | 3 month |
Registry for Pulmonary Hypertension Due to Left Heart Disease in China

Study Overview
=================
Brief Summary
-----------------
Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.

Official Title
-----------------
National, Prospective, Multicenter,Observational Registry Study on Pulmonary Hypertension Due to Left Heart Disease in China

Conditions
-----------------
Pulmonary Hypertension Due to Left Heart Disease

Intervention / Treatment
-----------------
* Other: Routine therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary Hypertension due to left heart disease Exclusion Criteria: Other forms of Pulmonary Hypertension Heart failure due to valvular heart disease Hypertrophic obstructive cardiomyopathy Right ventricular outflow tract stenosis Pericardial disease Patients with chronic lung disease

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 |
| --- | --- |
| No treatment<br> | Other: Routine therapy<br>* Routine therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Pulmonary Hypertension, Left Heart Disease, Heart failure, China