linjc16/ctgov huggingface dataset:
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation.

Detailed Description
-----------------
The metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin resistance. This study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood. This 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC) study conducted during the same period. Participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits.

Official Title
-----------------
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline

Conditions
-----------------
Cognitive Decline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 70 to 79 White or Black Community-dwelling in Memphis, TN or Pittsburgh, PA vicinity Well-functioning (no difficulty in walking a quarter of a mile or going up 10 steps without resting) Exclusion Criteria: Any difficulty with activities of daily living Clinical dementia Inability to communicate with interviewer Intention of moving out of vicinity in the next year Active treatment for cancer in the previous 3 years Participation in a trial involving a lifestyle intervention

Ages Eligible for Study
-----------------
Minimum Age: 70 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
-----------------
Metabolic Syndrome, Alzheimer's Disease, Cognitive Impairment, Inflammation
Passiflora Extract for Benzodiazepine Withdrawal

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.

Official Title
-----------------
Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III

Conditions
-----------------
Benzodiazepine Withdrawal (Disorder)

Intervention / Treatment
-----------------
* Drug: Passiflora incarnata
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 65 years old Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent) Capable of giving consent and to answer the questionnaires according to researcher criteria Exclusion Criteria: Diagnosis of dementia moderate or severe (Test Minimental ≤ 20). Acute confusional syndrome at the inclusion Panic disorder Obsesive-compulsive disorder Any type of psycosis or bipolar disorder Severe Parkison disease diagnosed Current or past diagnosis of epilepsia Recent stroke (last month) Thyroid disorders not controlled or uncompensated Alteration of deglutition Previous drugs or alcohol abuse Hospitalization (more than 24 hours) during the last month Complex priority treatment (dialisis, chemotherapy...) Life expectation less than 1 year Benzodiazepines therapeutic uses not for anxiety or insomnio

Ages Eligible for Study
-----------------
Minimum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passiflora<br> | Drug: Passiflora incarnata<br>* Passiflora pills administration up to 6 pills per day<br>|
| Placebo Comparator: Control<br> | Drug: Control<br>* Control pills administration up to 6 pills per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose |  | 10 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benzodiazepine, Withdrawal, passiflora
Relationship of Peritoneal Solute Transport Rate With VEGF in Children Undergoing Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
Vascular endothelial growth factor(VEGF) appears to play a central role in the process leading to peritoneal angiogenesis and increased level of VEGF may contribute to high peritoneal small-solute transport rate (PSTR) in continuous ambulatory peritoneal dialysis (CAPD) patients in adult. In children, lymphatic absorption of solute is greater than adult. VEGF-C is related to lymphogenesis, but its role in peritoneal solute transport rate is not known. In this study, we evaluated possible relationship between dialysate VEGF and VEGF-C levels and PSTR in children.

Detailed Description
-----------------
There was significant correlation between dialysate VEGF165 and VEGF-C levels and significant correlation was noted between dialysate VEGF165 and PSTR. Interestingly, dialysate VEGF-C levels had significant correlation with PSTR. High PSTR seems to be related to elevated VEGF-C and VEGF.

Conditions
-----------------
Peritoneal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic renal failure children peritoneal dialysis Exclusion Criteria: acute illness

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 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 |
| --- | --- | --- |
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Study Overview
=================
Brief Summary
-----------------
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

Official Title
-----------------
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (BAY59-7939)
* Drug: Rivaroxaban (BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years or older Japanese male or female Non- valvular atrial fibrillation documented by ECG Patients aged 60 years and older or with a risk of stroke Exclusion Criteria: Prior stroke and TIA Patients in whom anticoagulants are contraindicated

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Rivaroxaban (BAY59-7939)<br>* 10mg BID, Semi-sequential, dose escalation.<br>|
| Experimental: Arm 2<br> | Drug: Rivaroxaban (BAY59-7939)<br>* 20mg BID, Semi-sequential, dose escalation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R) |  | Day 14 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each category of bleeding events and adverse event |  | Throughout treatment and followup period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15 months.

Official Title
-----------------
A Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050

Conditions
-----------------
IGA Nephropathy

Intervention / Treatment
-----------------
* Drug: Fostamatinib Disodium tablet 100 mg
* Drug: Fostamatinib Disodium tablet 150 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology) Able and willing to give written informed consent Exclusion Criteria: Unresolved Grade 2 or greater toxicity in Study C-935788-050

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fostamatinib Disodium tablet 100 mg<br>Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months | Drug: Fostamatinib Disodium tablet 100 mg<br> <br> * Other names: R788;|
| Experimental: Fostamatinib Disodium tablet 150 mg<br>Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months | Drug: Fostamatinib Disodium tablet 150 mg<br> <br> * Other names: R788;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR) |  | 15 months |
Effect of Different Music Types on Implant Surgery Anxiety

Study Overview
=================
Brief Summary
-----------------
A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed. This delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.

Official Title
-----------------
Effect of Different Music Types on Implant Surgery Anxiety - Randomized Controlled Study

Conditions
-----------------
Anxiety, Dental

Intervention / Treatment
-----------------
* Behavioral: implant anxiety


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Will undergo elective implant surgery, between 40-70 years Exclusion Criteria: Who does not agree to participate in the study, Under 40, over 70 years, Patients with ear disorders (ie, not suitable for musical intervention), arrhythmia patients with physical condition III or higher (American Society of Anesthesiologists)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Turkish music group<br>Turkish music group (Saba or rast makam) | Behavioral: implant anxiety<br>* to determine the type of music that reduces anxiety in patients undergoing implant surgery.<br>|
| classical western music<br>classical western music (vivaldi) | Behavioral: implant anxiety<br>* to determine the type of music that reduces anxiety in patients undergoing implant surgery.<br>|
| soft rock music<br>soft rock music (elvis) | Behavioral: implant anxiety<br>* to determine the type of music that reduces anxiety in patients undergoing implant surgery.<br>|
| control group (group not listening music)<br>control | Behavioral: implant anxiety<br>* to determine the type of music that reduces anxiety in patients undergoing implant surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corah's dental anxiety scale | the type of music that reduces anxiety in patients undergoing implant surgery. | six month |
Mortality and Related Risk Factors After Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The patients who underwent hip arthroplasty in our hospital from January 2017 to December 2020 were reviewed. The perioperative data were collected, and then the mortality was calculated and the risk factors were analyzed.

Official Title
-----------------
Mortality and Related Risk Factors After Hip Arthroplasty, a Retrospective Study

Conditions
-----------------
Fracture of Neck of Femur (Hip), Femoral Head Necrosis, Dislocation of Hip Joint, Dysplasia of Hip Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing hip arthroplasty in Renji Hospital during 2017.1-2020.12 Exclusion Criteria: Patients who did not undergo surgery after admission Age < 18 years Patients undergoing the second operation

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 |
| --- | --- |
| All patients were reviewed<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of mortality one year after operation |  | From about even days before operation to 12 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of lower activities of daily living score at 12 months after operation |  | From about even days before operation to 12 months after operation |
Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control

Study Overview
=================
Brief Summary
-----------------
Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU. Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin

Detailed Description
-----------------
The investigators enrolled 69 consecutive patients with severe sepsis or septic shock and divided them in two different groups after randomization with sealed envelopes. One group called intensive glycemic control with glycemic levels been between 80 to 110 mg/dl with exogenous insulin. The other group called conventional glycemic control with glycemic levels been between 180 and 220 mg/dl. Blood samples were collected at 0, 12, 24, 48 and 72 hours to measure HDL, LDL, Total cholesterol, free fatty acids and oxidized LDL. Clinical data as creatinine, P/F ratio, bilirubins, platelets, lactate, arterial blood gasometry were either monitored.

Official Title
-----------------
Tight Glycemic Control and Sepsis Related Dyslipidemia

Conditions
-----------------
Septic Shock, Sepsis

Intervention / Treatment
-----------------
* Procedure: glycemic control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients aged between 18 and 80 years old with the diagnostic of septic shock or severe sepsis Exclusion Criteria: pregnants, previous diagnosis of any cancer, diagnosis of leptospirosis, diagnosis of aids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glycemic control between 180 and 220 mg/dl<br> | Procedure: glycemic control<br>* exogenous insulin<br>|
| Active Comparator: glycemic control for levels between 80 and 110 mg/dl<br> | Procedure: glycemic control<br>* exogenous insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| establish a relationship between lipid metabolism alterations and glycemic control |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, glycemic control, icu, lipid metabolism, septic patients
Biomarkers of Metabolic Syndrome and Prediabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the feasibility of using salivary biomarkers to screen for complications of metabolic syndrome including prediabetes.

Official Title
-----------------
Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome, Diabetes, Prediabetes, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 65 years Males and females will be included in this study All ethnic backgrounds will be included in this study Acceptable health based on interview and medical history Ability to comply with requirements of the study Ability and willingness to provide signed informed consent Exclusion Criteria: Eating or drinking anything but water within 10 hours of sample collection Autoimmune disease Type 1 diabetes Pregnancy (< 6 weeks postpartum) History of Sjorgren's Syndrome Dental work within the last two weeks Ongoing or active parasitic, fungal, viral or bacterial infection

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Biomarker Levels |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salivary biomarker, metabolic syndrome, prediabetes, diabetes hypertension
Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD

Study Overview
=================
Brief Summary
-----------------
A prospective observational multi centre research study in GP practices clustered within up to 10 UK Primary care trusts.

Official Title
-----------------
Prospective Observational Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Indacaterol (Onbrez®) /QAB149


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with active diagnosis of COPD, confirmed by spirometry documented in medical notes Exclusion Criteria: Patients who are currently receiving other maintenance therapy (except LAMA) for COPD. Patients previously prescribed Indacaterol.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indacaterol/QAB149<br>Patients treated with Indacaterol for COPD prior to enrollment in study | Drug: Indacaterol (Onbrez®) /QAB149<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol |  | 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol |  | 6 months | 
| Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol. |  | 6-8 weeks | 
| Physician Global Evaluation of Treatment effectiveness (GETE) at 6-8 weeks and 6 months. |  | 6-8 weeks and 6 months | 
| Patient Global Evaluation of Treatment effectiveness (GETE) at 6 months |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD