linjc16/ctgov huggingface dataset:
S-CEI of Nexium in Paediatric Patients

Study Overview
=================
Brief Summary
-----------------
To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch

Detailed Description
-----------------
The objective of this investigation is to capture the followings when Nexium capsules or Nexium granules for suspension (single-dose package) are administered to pediatric patients in clinical practice after launch. Development of adverse reactions which are unexpected from Precaution for Use Development of adverse reactions Efficacy

Official Title
-----------------
Specific Clinical Experience Investigation of Nexium in Paediatric Patients

Conditions
-----------------
Peptic Ulcer, Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 1(inclusive) to 15 (exclusive) years Patients who have been prescribed Nexium for the first time for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, or Zollinger-Ellison syndrome, . Exclusion Criteria: Patients with a history of hypersensitivity to components contained in this product. Patients during treatment with Atazanavir Sulfate and Rilpivirine hydrochloride.
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 |
| --- | --- | --- |
| frequency of adverse drug reactions (ADRs) | Development of ADRs by unexpected from Precautions for Use of Nexium JPI, by SOC, by patient demography and by treatment | up to 8 weeks | 
| rate of improvement/worsening of symptoms | Rage of improvement/worsening of symptoms and cure rate on endoscopy | up to 8 weeks |
Follow-up for Locking Plate Fixaion of Distal Radius Fracture

Study Overview
=================
Brief Summary
-----------------
The current status of the disease under study. Including natural history, disease prognosis. Distal radial fractures (DRF, distal radius fractures) are the most common fractures, allowing the user to lock the steel plate to accelerate the recovery of the wrist, but related injuries such as the triangular fibrocartilage cartilage complex (TFCC) tear or distal radius ulna joint (DRUJ) ligament tear with DRUJ instability requires time fixed or further repair surgery. If these issues are ignored, there will be weakness in the future. The ulnar shortening commonly used by hand surgeons is to improve the damage of TFCC or DRUJ instability. In the case of distal radial fracture combined with DRUJ instability, it is not clear that the distal radial fracture combined with DRUJ instability patients has long-term prognosis.

Official Title
-----------------
Follow-up for Locking Plate Fixaion of Distal Radius Fracture

Conditions
-----------------
Distal Radius Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient following for at least one year Exclusion Criteria: (1) Injury or arthritis before; (2) Open fractures, or more wounds require surgery

Ages Eligible for Study
-----------------
Minimum Age: 24 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 |
| --- | --- | --- |
| 4-Item Pain intensity Measure | Each item is scored 0-10(0=no pain;10=pain as bad as can be) | 5 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locking Plate Fixaion
Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Biological: IGF1R antibody MK0646
* Other: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ovarian cancer Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| MK-0646<br>Tumor specimens removed from 20 women with ovarian cancer are injected into 40 mice treated with the IGF1R antibody MK-0646. The drug will be administered twice weekly, via IP injection at a dose of 500 microgram per animal. | Biological: IGF1R antibody MK0646<br> <br> |
| Control<br>Tumor specimens removed from 20 women with ovarian cancer are injected into 40 mice who receive no other treatment. | Other: Saline solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responsive to IGF1R therapy | Mean tumor volume will be calculated and growth inhibition will be reported as the percentage decrease of tumor volume compared with the control. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic Signature of IGF1R Responsive Tumors | Mass Spectrometry will be used to compare IGF1R responsive and non-responsive tumors to identify the proteins associated with sensitivity to IGF1R therapy. | One year |
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients

Study Overview
=================
Brief Summary
-----------------
An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.

Official Title
-----------------
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients

Conditions
-----------------
Dyslipidemias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are taking lipid-lowering medication after diagnosed as dyslipidaemia Subjects who have at least made 1 visit to the outpatient clinic within previous 6 months Subjects who have records of both LDL-C and HDL-C before & after statin treatment (at least four weeks after statin taking) Exclusion Criteria: Subjects who are unwilling or unable to provide their examination and lab result of medical chart.

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 |
| --- | --- |
| 3000 patients<br>Who have at least made 1 visit to the outpatient clinic within previous 6 months . | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate current LDL/HDL ratio in Korean patients (between baseline & after treatment) |  | After Treatment : at least 4 weeks before statin taking /Baseline : no limitation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate difference of LDL/HDL ratio among different statins & dosages (between baseline & after treatment) |  | After Treatment : at least 4 weeks before statin taking / Baseline : no limitation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ratio improvement, LDL-C, HDL-C, Ratio of Low Density Lipoprotein Cholesterol to High Density Lipoprotein Cholesterol Improvement, High Density Lipoprotein Cholesterol
Identification of Cytokine Profiles and T Cell Subsets Among Immunosuppressed Patients at Risk of Developing Active Tuberculosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify differences in TB specific immune responses among immunosuppressed patients latently infected with TB and patients with active TB.

Detailed Description
-----------------
Immunosuppressed patients latently infected with TB are at higher risk of developing active TB than patients with normal immune functions. Especially two patient categories are at risk: HIV positives and patients receiving TNF-a blocking medication. Existing methods of diagnosis and surveillance of latent TB infection can not identify who will develop active TB and who can control the infection. There is a need for better understanding of TB specific immune functions,as we believe deficient TB specific immune reactions is a key in reactivation of latent TB infection. In this study we follow groups of latent TB infected patients with either rheumatoid arthritis or HIV. We follow the patients during treatment with TNF-a blocking medication, HAART treatment or prophylactic TB medication. Results are correlated to patients with active TB, latent TB and healthy controls.

Conditions
-----------------
Tuberculosis, HIV Infections, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Latent TB infection + rheumatid arthritis Latent TB infection + HIV Active TB Exclusion Criteria: Age < 18yrs Pregnancy Patients not able to understand the given information

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Chinese Liver Cancer Clinical Survey

Study Overview
=================
Brief Summary
-----------------
In order to make better use of clinical resources of the real world, strengthen the standardization of PLC diagnosis and treatment, and constantly improve the academic level of liver cancer in China, we intends to launch Chinese Liver Cancer clinical Survey project in cancer specialized hospitals and large general hospitals and to explore the best clinical pathway of PLC multidisciplinary consultation.

Detailed Description
-----------------
Primary liver cancer (PLC) is one of the most common malignant tumors of digestive system and also a serious threat to the health and safety of Chinese people, and has caused serious economic burden to the country. Research purposes: To understand the clinical characteristics of patients with primary liver cancer (PLC) in China; To investigate the etiology and pathogenesis of PLC in China; To understand the current status of clinical treatment of PLC in China, and to analyze the gaps among these conditions and domestic treatment guidelines, industry consensus, the international treatment guidelines; To understand the different treatment options and its clinical outcomes, and to explore the best treatment options; To explore the best clinical pathway of PLC multidisciplinary consultation; To provide the basis for the development of clinical guidelines for PLC in China.

Official Title
-----------------
Chinese Liver Cancer Clinical Survey

Conditions
-----------------
Primary Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PLC after January 1,2012; First treatment and efficacy evaluation. Exclusion Criteria: Complicated with another primary malignant tumor and secondary liver cancer.
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 |
| --- | --- | --- |
| Overall survival | Overall survival | 5 years |
Investigating the Relationship Between Parents and Their Children With ADHD and Conduct Disorder

Study Overview
=================
Brief Summary
-----------------
This study aims to uncover mechanisms of action underlying any long-term change in youth antisocial behavior by considering the role of child and family characteristics as mediators and moderators of change. The study design is qualitative interviews to be conducted face-to-face with parents of children previously diagnosed with Conduct Disorder and Attention Deficit Hyperactivity Disorder (ADHD) but no longer meet diagnostic criteria. Questions will be asked to understand participants' parenting experience over time (before, during and after their children's treatment).

Official Title
-----------------
Investigating the Relationship Between Children With ADHD and Conduct Disorder and Their Parents in Reduction of Symptoms

Conditions
-----------------
Observation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children who participated in previous study Supplements and Social Skills Intervention conducted by Singapore Institute of Mental Health Child Guidance Clinic. Children no longer meet the criteria for Conduct Disorder and ADHD, as measured by Antisocial Process Screening Device (APSD) Callous-Unemotional score of 7 or less, and who do not meet the cut-off for rule-breaking and aggressive behavior determined by Child Behavior Checklist (CBCL). These data were collected from a previous study. Exclusion Criteria: Children who still meet the requirements of Conduct Disorder and ADHD as defined above. Parents who did not indicate that they wish to be contacted for follow-up studies.
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 |
| --- | --- | --- |
| Parental style and interactions with children | Qualitative interview based on a phenomenological analysis will seek to understand from parents before, during, and after the treatment (previous intervention) about their interactions with their children, especially when problematic behavioural issues occur. All interviews were transcribed verbatim as much as possible, then subjected to a first round of open coding through identification of words, sentences or paragraphs expressing common ideas. Thereafter, a framework of themes was derived and interview content was organized systematically for analysis. The transcripts will also be rotated among researchers for the various stages of coding, such that each transcript was coded by at least two different people. This was to minimize subjectivity in coding and ensure the inter-rater consistency of the codes. | 1 year |
Infectivity of Norovirus in Groundwater-Human Challenge Study

Study Overview
=================
Brief Summary
-----------------
Norwalk virus and related Norwalk-like viruses are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States. These viruses are sometimes found in drinking water, ice, shellfish and in other foods. They can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick. The purpose of this research study is to see how long Norwalk virus can survive in water and still be able to cause sickness. When this is determined the researchers will be able to recommend risk levels for norovirus contaminated waters. Another purpose for this study is to see how a person's body's immune cells respond to Norwalk virus in the body. During this study volunteers will receive a dose of Norwalk virus in water that may make them sick.

Official Title
-----------------
Assessment of Calicivirus Survival in Surface Water and Subsurface Water

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Safety tested norovirus inoculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy volunteer Must be within 33% of normal body mass index Exclusion Criteria: Have a job in which they handle food Work in a child care, elderly care center or if they live with young children or anyone who has a weak immune system Are not willing or able to wash their hands every time after they go to the bathroom, or before and after they prepare or handle food for up to eight days after they take the virus Are over the age of 50 Are pregnant Have tested positive for the HIV virus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norovirus in groundwater<br>We dosed volunteers with safety tested infectious norovirus in groundwater (that met EPA standards for drinking water). The length of time norovirus remained in groundwater varied by volunteer. | Biological: Safety tested norovirus inoculum<br>* This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards<br>* Other names: Norwalk virus in groundwater;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection with norovirus |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis, Norovirus, Clinical Trial, Stomach flu
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy. Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.

Official Title
-----------------
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

Conditions
-----------------
Biliary Colic, Cholecystitis

Intervention / Treatment
-----------------
* Device: Senhance Assisted Cholecystectomy
* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs Exclusion Criteria: Patients unable tor unwilling to consent BMI >40

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Senhance Cholecystectomy<br>Cholecystectomy operation performed using Senhance robotic system | Device: Senhance Assisted Cholecystectomy<br>* Cholecystectomy performed using Senhance surgical robotic system<br>|
| Active Comparator: Laparoscopic Cholecystectomy<br>Cholecystectomy operation performed using standard laparoscopic instruments | Procedure: Laparoscopic Cholecystectomy<br>* Standard laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity Data |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic Surgery
Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI<25) To analyze the CPAP treatment over the clinical evolution of OSA patients To determine if OSA is a independent predictor of cardiovascular risk

Detailed Description
-----------------
Obstructive Sleep Apnea (OSA) is a condition with important cardiovascular repercussions. However, the association between OSA, cardiovascular diseases, and obesity has not been totally clarified. We hypothesized that the cardiovascular consequences of OSA are due to obesity.

Official Title
-----------------
Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with OSA (apnea-hypopnea index higher than 5 events/hour) Exclusion Criteria: Body mass index higher than 40

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Cardiovascular events |  | five years |