linjc16/ctgov huggingface dataset:
Swallowing Pattern of Patients With Nasopharyngeal Cancer Before and After Radiation Therapy: Longitudinal Study and Correction With Saliva Amount

Study Overview
=================
Brief Summary
-----------------
Significant evidence has shown that radiation therapy for patients with nasopharyngeal cancer (NPC) can cause swallowing abnormality. Based on our prior cross-sectional study for 184 NPC patients from 1995 to 1999, the findings of videofluoroscopic swallowing study (VFSS) revealed continuous deterioration of swallowing function of these patients even many years after radiation. We conducted a prospective study to evaluate the longitudinal change of swallowing function based on VFSS before, one month, one year and two years after completing radiation therapy. The amount of saliva was measured at the same time of VFSS study to test the relationship of decreased amount of saliva and swallowing function. Comparison of serial VFSS studies in NPC patients (n=84) and normal volunteers (n=38) were obtained. We assume that this study may reveal a complete understanding of changing swallowing patterns in the course of radiation therapy of patients with NPC. From this study, NPC patients can understand their own swallowing function. Therefore, the information may enable for earlier intervention of swallowing training or correction to avoid morbidity of radiation therapy in this patient group.

Official Title
-----------------
Swallowing Pattern of Patients With Nasopharyngeal Cancer Before and After Radiation Therapy: Longitudinal Study and Correction With Saliva Amount

Conditions
-----------------
Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nasopharyngeal cancer patients > 20 yrs. Exclusion Criteria: pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal carcinoma, Saliva, Swallowing, Videofluoroscopy, Radiation
Cerebral Antibiotics Distribution After Acute Brain Injury

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to explore the distribution of antibiotics in the brain after an acute brain injury because brain infections treatment is still an health care problem.

Conditions
-----------------
Bacterial Infection, Brain Injury

Intervention / Treatment
-----------------
* Drug: cefotaxime
* Drug: Metronidazole
* Drug: Ciprofloxacin
* Drug: Fosfocine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute brain injury Patient who receive an antibiotic for an infection or prophylaxy Glasgow coma score < 8 Exclusion Criteria: Age < 18 years old Pregnant woman HCV, HIV, HBV infection

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 |
| --- | --- |
| Experimental: Cefotaxime<br> | Drug: cefotaxime<br> <br> |
| Experimental: Metrodinazole<br> | Drug: Metronidazole<br> <br> |
| Experimental: Ciprofloxacine<br> | Drug: Ciprofloxacin<br> <br> |
| Experimental: Fosfocine<br> | Drug: Fosfocine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cardiovascular Outcomes in the VA's Rheumatoid Arthritis(VARA) Population

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that can lead to joint deformity and destruction. However, the effects of RA are not confined simply to joint involvement. Virtually every organ system can be affected by RA if left untreated. Of particular note is RA's affect on the cardiovascular system. RA patients have a reduced lifespan compared to the general population primarily due to an increased cardiovascular disease burden (1). Recently, RA has been linked to the development of preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women with RA have also been shown to have an increased incidence of nonfatal myocardial infarctions (3). Despite these studies showing the effects of RA on the cardiovascular disease burden of those who are afflicted, no study to date has compared the number of cardiovascular events in a large RA patient population to a risk factor and age matched control group. Consequently it is the goal of this study to determine whether the cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched cohort of non-RA patients. This study will also attempt to ascertain whether specific cardiovascular risk factors contribute to the cardiovascular morbidity and mortality associated with RA and if any standard cardiovascular medicines disproportionately contribute to patient outcome. Hypothesis: Given the increased cardiovascular disease burden associated with RA patients they are likely to suffer from a statistically significant increased risk of cardiovascular events when compared to an age and risk factor matched cohort.

Official Title
-----------------
Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry

Conditions
-----------------
Rheumatoid Arthritis, Cardiovascular Disease, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient included in the VA Rheumatoid Arthritis database previously, who by definition will meet criteria for RA. Control subjects will not carry the diagnosis of RA.

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
-----------------
rheumatoid arthritis, cardiovascular disease, coronary disease
Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

Study Overview
=================
Brief Summary
-----------------
Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.

Official Title
-----------------
Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma

Conditions
-----------------
Complications of Treatment, Progression

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Open Angle Glaucoma Progression Failure to reach target IOP Non compliant Exclusion Criteria: Resurgery Systemic contraindication to bevacizumab All other forms of glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 42 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 |
| --- | --- |
| Experimental: Topical/Subconjunctival<br>Depending upon the mode of administration | Procedure: Phacoemulsification<br>* Surgery for complications of trabeculectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure control |  | For 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trabeculectomy, bevacizumab, anti-VEGF, Efficacy
Admission of Adult-onset Still Disease Patients in the ICU

Study Overview
=================
Brief Summary
-----------------
Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.

Official Title
-----------------
Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study

Conditions
-----------------
Adult-Onset Still Disease, Critically Ill

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AOSD (history of newly diagnosed) ICU admission between January 2001 and June 2017 Exclusion Criteria: adults under protection admission in step-down unit

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 |
| --- | --- |
| critically ill AOSD patients<br>no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome) | Other: data collection<br>* biological, administrative, clinical, outcome date<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients | Number of patients fulfilling the inclusion criteria | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APACHE II | Acute Physiologic Assessment and Chronic Health Evaluation II | 24hour after ICU admission | 
| Mortality | Kaplan Meier | through study completion, maximum 17,5 years after admission | 
| Number of rehospitalisation in ICU | need for critical care after the first hospitalisation in ICU | through study completion, maximum 17,5 years after admission | 
| number of hospitalisation in internal medicine ward | number of hospitalisation in internal medicine ward after the first ICU stay | through study completion, maximum 17,5 years after admission | 
| recurrent relapses | number of recurrent flares after the first hospitalisation in ICU | through study completion, maximum 17,5 years after admission |
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

Official Title
-----------------
A Prospective, Blinded, Randomized Clinical Trial Investigating the Effect on Postoperative Pain and Nausea, When Performing a Ventilator-piloted PRM at the End of Laparoscopic Cholecystectomy

Conditions
-----------------
Pain, Postoperative, Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Procedure: Pulmonary Recruitment Maneuver
* Procedure: Laparoscopic cholecystectomy
* Device: Ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective laparoscopic cholecystectomy American Society of Anesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2) written consent Exclusion Criteria: conversion to open surgery Clavien-Dindo grade ≥ II

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary recruitment maneuver<br>One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen. | Procedure: Pulmonary Recruitment Maneuver<br> <br> Procedure: Laparoscopic cholecystectomy<br> <br> Device: Ventilator<br> <br> |
| Active Comparator: Control group<br>Ordinary ventilation at the end of laparoscopic cholecystectomy. | Procedure: Laparoscopic cholecystectomy<br> <br> Device: Ventilator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative pain assessed with a numeric rating scale | A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively. | 4, 12, 24, 36 and 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative nausea assessed with a Questionnaire | A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. | 4, 12, 24, 36 and 48 hours after surgery |
Osteoarthritis Initiative (OAI): A Knee Health Study

Study Overview
=================
Brief Summary
-----------------
Knee osteoarthritis (OA) is the most common cause of disability in adults. The Osteoarthritis Initiative (OAI): A Knee Health Study is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA.

Detailed Description
-----------------
Knee OA causes more health problems and medical expenses that any other form of arthritis. Symptoms of OA can range from stiffness and mild pain to severe joint pain and even disability. Previous research has shown that certain factors, such as knee pain, prior knee injury or knee surgery, OA of the hand, or obesity, may lead to knee OA. The OAI is a multicenter, observational study of knee OA that will collect information on potential biomarkers for OA and trends in OA onset and progression. The OAI will recruit and follow participants who have knee OA or are at high risk for developing knee OA for an eight-year period at one of four clinical centers. Blood and urine collection, magnetic resonance imaging (MRI), and X-rays will be completed at each of four annual follow-up visits. A questionnaire and physical examination at screening will assess for risk factors for the development and progression of knee OA. Levels of knee pain and physical disability will be assessed at study start and at each of the follow-up visits by questionnaire and examination.

Official Title
-----------------
Osteoarthritis Initiative (OAI): A Knee Health Study

Conditions
-----------------
Osteoarthritis, Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must meet one of the following criteria: Overweight Previous knee injury or surgery Knee pain during the past year. Participants do not need to have current knee pain to take part in the study. Parent or sibling who had knee replacement Exclusion Criteria: Rheumatoid arthritis Joint replacements in both knees Unable to walk without assistance Unable to undergo MRI of the knee

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 79 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee Pain, Knee Health
Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.

Detailed Description
-----------------
Besides the main objective, there are 3 other objectives as follows: To evaluate the anti-cancer effect of HM95573 in solid tumor patients To investigate the pharmacokinetic profile of HM95573 after oral administration. To investigate biomarkers related to the safety and efficacy of HM95573.

Official Title
-----------------
Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors

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

Intervention / Treatment
-----------------
* Drug: HM95573


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 20 years of age or older Subjects who have provided voluntary consent to participate in the study, and signed the written consent document. Estimated life expectancy of at least 12 weeks Histologically or cytologically confirmed advanced solid tumor Exclusion Criteria: Symptomatic or uncontrolled central nervous system metastases Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug. Patients who, in the investigator's opinion, are not suitable for the study for any other reason.

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

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

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: HM95573<br>single arm | Drug: HM95573<br>* BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall rsponse rate |  | 6-12 weeks |
Molecular Screening for Lynch Syndrome in Denmark

Study Overview
=================
Brief Summary
-----------------
A clinically applicably strategy for molecular screening for Lynch Syndrome is being implemented in Denmark. Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling. The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone. Prospective data collection is performed using established clinical databases.

Official Title
-----------------
Molecular Screening for Lynch Syndrome in Denmark

Conditions
-----------------
Colorectal Cancer, Lynch Syndrome, HNPCC

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of colorectal adenocarcinoma Diagnosed at one of the departments of pathology in Denmark Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All colorectal cancer patients<br> | Other: Observation<br>* Observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Lynch Syndrome in a population of primary colorectal cancer |  | 1 year |