linjc16/ctgov huggingface dataset:
Hepatitis A Vaccination in the Elderly

Study Overview
=================
Brief Summary
-----------------
A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people above 40 years of age have a slower immune response to hepatitis A vaccination. However, a lot of travelers seek pre-travel advice only shortly before their journey. More information about the time to adequate antibody response after hepatitis A vaccination is required to provide good protection during travelling. Alternative protection with immunoglobulins are available. Study design: Observational, longitudinal pilot study Study population: 20 adults over 60 years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as controls. Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28. Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: hepatitis A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of blood.

Official Title
-----------------
Hepatitis A Vaccination in the Elderly

Conditions
-----------------
Hepatitis A

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: previous hep A vaccination known hepatitis A serology status immunodeficiency

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 |
| --- | --- |
| >60 years<br> | |
| < 40 years<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How fast do patients> 60 year reach protective anti-HAV levels after vaccination? |  | 0, 1,2,3,4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis A, vaccination, elderly, protection to hepatitis A after vaccination
Arthroscopic Treatment for Femoral Acetabular Impingement Syndrome With Gluteus Medius Lesions.

Study Overview
=================
Brief Summary
-----------------
To evaluate the prognosis of femoral acetabular impingement syndrome (FAIS) patients with gluteus medius lesions after hip arthroscopy.

Detailed Description
-----------------
The data of FAIS patients with gluteus medius lesions were retrospectively extracted pre- and postoperatively after hip arthroscopy. The prognosis of the surgery was evaluated through MRI images.

Official Title
-----------------
Arthroscopic Treatment for Femoral Acetabular Impingement Syndrome With Gluteus Medius Lesions.

Conditions
-----------------
Femoral Acetabular Impingement

Intervention / Treatment
-----------------
* Other: Demographic data and MRI images extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosed FAIS Ineffective conservative treatment Available pre- and postoperative images Exclusion Criteria Revision arthroscopy Osteoarthritis History of hip joint disease or surgery Sacroiliac joint disease Loss of follow-up
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Femoral acetabular impingement syndrome (FAIS) patients with gluteus medius lesions | Other: Demographic data and MRI images extraction<br>* The data were retrospectively extracted pre- and postoperatively after hip arthroscopy. The prognosis of the surgery was evaluated through MRI images.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI images | Characteristics of postoperative MRI images | at least 1-year after hip arthroscopy |
The Endothelial Count in Pxf

Study Overview
=================
Brief Summary
-----------------
Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count.

Detailed Description
-----------------
The corneal Endothelium is essential for the maintenance of normal corneal hydration, thickness, and transparency. In patients with pseudoexfoliation syndrome , quantitative and qualitative morphological changes of the corneal endothelium have been demonstrated in specular and electron microscopic studies. Specular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium. Our research question is to study Endothelial cell count in patients with pseudoexfoliation syndrome & compare it to age matched group.

Official Title
-----------------
The Corneal Endothelial Cell Count in Eyes With Pseudoexfoliation Syndrome

Conditions
-----------------
Pseudoexfoliation Syndrome

Intervention / Treatment
-----------------
* Other: Specular microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pseudoexfoliation syndrome Exclusion Criteria: Patients with previous intra ocular surgeries. Patients with uveitis Patients with fuck's endothelial dystrophy
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 |
| --- | --- |
| patient with pseudoexfoliation syndrome<br>The corneal Endothelial cell count will be measured by specular microscopy | Other: Specular microscopy<br>* Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group<br>|
| Normal people at same age<br> | Other: Specular microscopy<br>* Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls. | The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy & compared with the normal endothelial count in people at the same group | One year |
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

Official Title
-----------------
A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: aripiprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine. Exclusion Criteria: Patients known to be allergic to aripiprazole Hospitalized patients Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: aripiprazole<br>* Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).<br>* Other names: Abilify;|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine. |  |  | 
| The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (PANSS, CGI) |  |  | 
| Effectiveness (IAQ, GAF) |  |  | 
| Patient Reported Outcomes |  |  | 
| Safety |  |  |
Audit of Tolerability and Safety of Acute Pain Service

Study Overview
=================
Brief Summary
-----------------
Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other countries. With accumulation of experience and clinical evidence, APS has been well established. A study conducted in 1997 suggested that monitoring, management protocol and nursing experience were mandatory to the safety for APS. Our recent study showed that pain relief of our post-operative patients using patient controlled analgesic with morphine was still not adequate. The results has driven us to continue the improvement of post-operative outcomes for our surgical patients. Tolerability and safety are always our concerns for patients using our APS. Therefore, the investigators aim to conduct this retrospective study in order to assess if the tolerability and safety of our present APS are adequate or not. The study results will help us to further improve our APS at QMH if necessary.

Detailed Description
-----------------
Retrospective audit. Acute pain service records at Division of Pain Management, Department of Anaesthesiology, Queen Mary Hospital will be identified, validated and analysed. Data Collection Demographic data Type of operation Type of pain relief modality Pain score up to 72 hours postoperatively Types of operations and clinical variables Incidence of adverse events during APS care; Patients safety (ie respiratory depression) Data Analysis For summarising analysis, mean or median with standard deviation or interquartile range will be reported. Parametric and non-parametric comparative tests will be used for analysis between/among patients with various characteristics. Kaplan Meier survival analysis and log-rank test will be used for duration of APS use.

Official Title
-----------------
Retrospective Study to Evaluate the Tolerability and Safety of Acute Pain Service at Queen Mary Hospital Between 2009 to 2012

Conditions
-----------------
Acute Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postoperative patients who were cared by the Acute Pain Service, Pain Management Team, Department of Anaesthesiology, Queen Mary Hospital between 2009 to 2012. Exclusion Criteria: Essential data were missing; Patient participating in other research projects.
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 |
| --- | --- | --- |
| Pain score |  | From postoperative 1 hour to postoperative 72 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | From postoperative 1 hour to postoperative 72 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute pain, Audit, Safety, Tolerability
A Nation-wide Multicenter Clinical Epidemiologic Study of Chinese Females With Advanced Breast

Study Overview
=================
Brief Summary
-----------------
To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results

Detailed Description
-----------------
In this study, the investigators conducted a hospital-based retrospective clinical study, recruiting female advanced breast cancer patients from 14 tertiary hospitals at 7 classic geographic regions, to study the clinical epidemiologic characteristics of advanced breast cancer and the current standard of clinical diagnosis and treatment in order to provide references for standardized treatment therapy, and to improve the quality of life and prolong survival time. To study the epidemiological trends and characteristics for advanced BC patients, to analyze these trends and report the results. To learn about the current treatment therapy for advanced BC patients in different areas in China.To provide references for standardized treatment therapy, to improve the quality of patients' life and to prolong the survival time for the advanced BC patients.To assess the different treatment therapies for advanced BC with consideration of economic cost-effectiveness

Official Title
-----------------
A Nation-wide Multicenter Clinical Epidemiologic Study of Chinese Females With Advanced Breast

Conditions
-----------------
Advanced Breast Cancer

Intervention / Treatment
-----------------
* Drug: standard therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as advanced breast cancer during Jan1st,2012-Dec31st,2014 complete with surgical pathology data, auxiliary treatment, there is a clear recurrence, transfer time, place, transfer of recurrence after treatment, and curative effect evaluation details.In any age, ethnic group cases. Exclusion Criteria: no available medical record

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: standard therapy|standard therapy for advanced/metastatic breast cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival status at 3 years | percentage of patients still alive at 3 years | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival of first line therapy | 3 years | 
| Survival status at 5 years | percentage of patients still alive at 5 years | 3 years |
Contraception in Normal and Subnormal Men

Study Overview
=================
Brief Summary
-----------------
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.

Detailed Description
-----------------
Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Twenty-five men will be recruited for each group. They will be exposed to hormonal male contraception for six months.

Official Title
-----------------
Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters

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

Intervention / Treatment
-----------------
* Drug: injection of hormonal male contraceptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers with normal and subnormal semen parameters

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testosterone injections<br>injections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2) | Drug: injection of hormonal male contraceptive<br>* testosterone injections 4 times<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| semen parameters |  | 2005 - 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormones |  | 2005 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male fertility, semen parameters
Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures

Study Overview
=================
Brief Summary
-----------------
The study will help in identifying the best empiric antibiotic option for Linezolid resistant Vancomycin-resistant Enterococci (VRE) infections. This research is important because it allows the determination of resistance rates to antibiotics that may not be frequently tested to by the clinical microbiology laboratory at UPMC-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for Linezolid-resistant VRE infections.

Detailed Description
-----------------
After 20 linezolid-resistant VRE isolates are identified, genetic relatedness will be determined using a method known as Pulse-field gel electrophoresis (PFGE). No patient related data will accompany these isolates, nor will any related identifiers. These isolates will be tested using standardized susceptibility methods. We will then grow each isolate and test via approved laboratory standards (E-test, AB Biodisk, Stockholm, Sweden) to the drug linezolid. Those determined to be resistant using this approved methodology will be saved until 20 isolates are identified. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Official Title
-----------------
Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures

Conditions
-----------------
Isolate, Linezolid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dr. Harrison's laboratory collected the rectal surveillance isolates for infection control purposes. The isolates will be from January 1, 2006 to December 31, 2006.

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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infection, isolate, linezolid
Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.

Official Title
-----------------
Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: within 1 year the siblings of premature coronary heart disease(male<55years old, female<65years old: Framingham Heart Study)patients admitted relevant hospital Exclusion Criteria: Documented coronary heart disease Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Drug: Atorvastatin<br>* Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction<br>|
| Experimental: Atorvastatin<br> | Drug: Atorvastatin<br>* Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of endothelial dysfunction with endo-PAT2000 |  | 6 weeks later drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjects with family history of coronary heart disease