linjc16/ctgov huggingface dataset:
The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the severity of malnutrition and inflammation in Taiwanese hemodialysis patients.

Detailed Description
-----------------
Cardiovascular disease is the major of cause of mortality of hemodialysis patients. In addition to diabetes and hypertension, malnutrition and chronic inflammation are well-known to be major risk factors of cardiovascular diseases in normal population. For detecting the malnutrition and chronic inflammation and understanding the exact influences to hemodialysis patients, we conduct this study. We will collect the biochemical parameters, inflammatory markers, lipid parameters, hematologic parameters, and genomic DNA of patients. Then we will prospectively record the hospitalization, cardiovascular events, complications of arteriovenous fistula/graft, and mortality. According to the above results, we try to explore the exact role of malnutrition and inflammation in hemodialysis patients.

Official Title
-----------------
The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients

Conditions
-----------------
Hemodialysis, Malnutrition, Inflammation, Myocardial Ischemia, Cerebrovascular Accident

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have received hemodialysis therapy for more than three months Exclusion Criteria: Having active infection diseases now Patients who have a malignancy Had cardiovascular events in recent three months

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
-----------------
Hemodialysis, Malnutrition, Inflammation
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).

Official Title
-----------------
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy

Conditions
-----------------
Thyroidectomy, Post-operative Swallowing Disorders

Intervention / Treatment
-----------------
* Procedure: thyroidectomy
* Other: cryotherapy
* Drug: cortisone aerosol
* Drug: Dexamethasone acetate
* Drug: paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients about to undergo total thyroidectomy by cervicotomy Single surgeon: Dr Osmak-Tizon Liliana Patients who have provided written consent to take part in the research Hospitalized in the endocrine surgery unit Whose mental and physical state allows them to participate in the quantification of a symptom using a Visual Analogue Scale(VAS) Exclusion Criteria: Patients under 18 or adults under guardianship Patients about to undergo unilateral thyroid surgery (thyroid lobectomy) Patient who have had parathyroid surgery History of cervicotomy Intolerance to, contra-indication for or allergy to any of the treatments tested. Pregnant or breast-feeding women Patients without national health insurance cover

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryotherapy<br> | Procedure: thyroidectomy<br> <br> Other: cryotherapy<br> <br> Drug: Dexamethasone acetate<br> <br> Drug: paracetamol<br> <br> |
| Active Comparator: Cortisone aerosol<br> | Procedure: thyroidectomy<br> <br> Drug: cortisone aerosol<br> <br> Drug: Dexamethasone acetate<br> <br> Drug: paracetamol<br> <br> |
| Placebo Comparator: Management<br> | Procedure: thyroidectomy<br> <br> Drug: Dexamethasone acetate<br> <br> Drug: paracetamol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing Impairment Score (SIS). |  | Evolution of the SIS from baseline (inclusion), to the end of the surgery and every day thereafter until discharge of the patient(up to 3 months) |
Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.

Official Title
-----------------
Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)

Conditions
-----------------
STEMI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center. Exclusion Criteria: Pain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.

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 |
| --- | --- |
| SMuRF-less<br>Patients presenting no standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking). | |
| SMuRFs<br>Patients presenting at least one standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major Adverse Cardiovascular Event) | Composite outcome including cardiovascular death or incidence of acute coronary syndrome, ischemic stroke or heart failure. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 3 years | 
| Number of patients presenting cardiovascular death during the follow-up | Number of patients presenting death due to fatal myocardial infarction, fatal ischemic stroke, sudden death, severe heart failure and cardiogenic shock during the follow-up. | 3 years | 
| Number of patients presenting heart failure during the follow-up | Number of patients hospitalized for acute heart failure during the follow-up, as well as patients presenting persistent symptoms of chronic heart failure after their STEMI (dyspnea NYHA > 1) and/or long-terme need for diuretics. | 3 years | 
| Number of patients presenting ischemic stroke during the follow-up | Number of patients presenting fatal or non fatal ischemic stroke during the follow-up | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SMuRFs, SMuRF-less, Standard Modifiable Risk Factors, Prognosis, Family History
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with low dose cyclosporin and methotrexate can inhibit the development of new onset diabetes mellitus

Detailed Description
-----------------
Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1 diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo and mtx therapy could safely induce remission. Research Design and Methods: In an open pilot study, insulin dose and glycemic control will be compared in children with new onset Type 1 diabetes administered cyclo at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children. After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.

Official Title
-----------------
Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: cyclosporin and methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type1 diabetes mellitus and be obtaining insulin therapy for less than 4 weeks Exclusion Criteria: Ketoacidosis Body weight over 110% of ideal weight Condition where immunosuppression is contraindicated Abnormal liver or renal function tests

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cyclosporin+Methotrexate<br>cyclosporin treatment at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for on year and methotrexate 5 mg/kg/day for one year. | Drug: cyclosporin and methotrexate<br>* cyclosporin 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for one year and methotrexate 5 mg/kg/day for one year. After 6 weeks, cyclosporin doses will adjusted to maintain blood cyclo levels to 100-200 ng/ml.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin dose |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes mellitus, cyclosporin, methotrexate, renal function
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.

Detailed Description
-----------------
Total knee arthroplasty (TKA) is increasingly common in the treatment of osteoarthrosis. Despite aggressive analgesic regimes, TKA is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge. A relatively new method for controlling postoperative pain after TKA is local infiltration analgesia (LIA) which consists of local infiltration with Ropivacaine and adrenaline.3 studies haved showed promising results of LIA, but none have documented a superior analgesic effect versus placebo.Patients receiving bilateral knee arthroplasty are recruited to receive LIA and placebo infiltration.The aim of the study is to demonstrate an analgesic effect of LIA versus placebo.

Official Title
-----------------
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: local infiltration analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients eligible for total knee arthroplasty must speak and understand Danish must be able to give oral and written consent Exclusion Criteria: Alcohol or medicine abuse Treatment with opioids Allergy to local anaesthetics Severe obesity
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: local infiltration analgesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgésia consumption |  |  | 
| time to discharge |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
local infiltration analgesia, postoperative pain, ropivacaine
Role of Proteomics in Diagnosing Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the fact that its exact cause is still unknown. Consequently, diagnosing the disease is also rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical methods to evaluate the status of the lung including a chest X-ray, lung biopsy and bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather invasive and, even more important, non-conclusive. Therefore, the current study has been designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results will be compared with other currently used laboratory parameters.

Official Title
-----------------
Proteomics as a Tool for Biomarker Detection in Sarcoidosis

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pulmonary sarcoidosis stage I-IV Exclusion Criteria: Non-smoking No treatment for extra-pulmonary symptoms of sarcoidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| sarcoidosis<br>sarcoidosis patients | |
| controls<br>healthy volunteers and other interstitial lung disease (ILD) patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protein profile in blood |  | within 1 month after obtaining sample | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CYP and TNF polymorphisms |  | within 6 months after obtaining sample | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcoidosis, protein profile, CYP-450, TNF-alpha polymorphisms, HLA
Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)

Study Overview
=================
Brief Summary
-----------------
Dosimetry efficacy of the hydrogel spacer.

Detailed Description
-----------------
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.

Official Title
-----------------
Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males At least 18 years of age Undergone external beam or brachy radiation therapy with a hydrogel spacer in place Exclusion Criteria: Clinical and pathological data are not available Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiation with Hydrogel Spacer<br>Males at least 18 years of age, who underwent radiation therapy with a hydrogel spacer in place. | Other: Observation<br>* Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry Changes | Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post hydrogel injection | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate to rectum spacing | Prostate to rectum spacing as measured post hydrogel insertion based on CT simulation scans done after hydrogel insertion | 1 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Prostate Cancer, Spacer, Perirectal spacer
Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder

Conditions
-----------------
Overactive Bladder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged above 20 Patient with overactive bladder symptoms lasting at least 6 months Exclusion Criteria: Patient with a history of surgery or a disease that may affect bladder function.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuronox®<br>Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites | Drug: Neuronox<br>* intradetrusor injection<br>* Other names: Meditoxin;|
| Placebo Comparator: Placebo<br>Normal saline, same volume with Experimental arm | Drug: Placebo<br>* intradetrusor injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the daily average UI (Urinary Incontinence) episodes |  | 12 weeks |
Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

Study Overview
=================
Brief Summary
-----------------
This study aims to survey the drug disposal methods of orthopedic foot and ankle patients with excess pain medication following and operation. The study is a randomized control trial comparing the use of FDA approved at home disposal methods to current clinical methods of recommending disposal at medication drop off locations.

Official Title
-----------------
Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

Conditions
-----------------
Medication Disposal, Behavior

Intervention / Treatment
-----------------
* Device: Deterra Drug Deactivation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study will include foot and ankle orthopedic patients at Brigham and Women's Hospital undergoing a surgical procedure. Exclusion Criteria: Those under age 18 will be excluded from this study, as their variation in care could affect the data. We will also exclude adults with impaired decision-making capacity and adults who take methadone or have a history of prior opioid dependence.

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?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Disposal Instructions<br>These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal. | |
| Experimental: At Home Disposal<br>With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal. | Device: Deterra Drug Deactivation System<br>* A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Safely Disposed The Excess Medication | Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication. | 6 weeks |