linjc16/ctgov huggingface dataset:
The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement

Study Overview
=================
Brief Summary
-----------------
Percutaneous endoscopic gastrostomy (PEG) is commonly used for long term enteral feeding of patients with severe dysphagia. The most common complication is peristomal wound infection. The possible mechanism the bacterial from the oral cavity disseminate during the PEG insertion through the stomach to the abdominal wall, in spite the routine use of antibiotic prophylaxis, have reported low rates of wound infection in patients who were already receiving antibiotics at the time of PEG Our hypothesis that washing the oral cavity with antibiotic solution prior the insertion PEG , We planned a prospective, randomised, double blind, one centre study of antibiotic mouth wash solution (0.2% Chlorhexidine gluconate) as.prophylaxis in PEG

Official Title
-----------------
Predicting Oral Care Before Percutaneous Endoscopic Gastrostomy (PEG). The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With PEG Placement

Conditions
-----------------
Dysphagia, Peristomal Wound Infection

Intervention / Treatment
-----------------
* Drug: Chlorhexidine gluconate 0.2%
* Other: Plain water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled to undergo PEG Exclusion Criteria: Previous GI surgery Coagulopathy Sepsis

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Chlorhexidine gluconate 0.2%<br>* Mouth wash prior to procedure<br>|
| Placebo Comparator: 2. Plain water<br> | Other: Plain water<br>* Mouth wash prior to procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion. |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing. |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous endoscopic gastrostomy, peristomal wound infection, antibiotic mouth wash solution, prophylaxis prior Percutaneous endoscopic gastrostomy (PEG)
Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Study Overview
=================
Brief Summary
-----------------
Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.

Official Title
-----------------
Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest Presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS Exclusion Criteria: Patients with: pregnancy acute aortic dissection pulmonary thromboembolism drug poisoning poor daily activity

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 |
| --- | --- |
| hypothermia<br>Patients with therapeutic hypothermia after cardiac arrest in hospitals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival and functional outcome (CPC: Cerebral Performance Categories) |  | after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival and/or functional outcome |  | after 24 hours | 
| Survival and/or functional outcome |  | after 7 days | 
| Survival and/or functional outcome |  | after one month | 
| Survival and/or functional outcome |  | at discharge | 
| Survival or functional outcome |  | after three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
therapeutic hypothermia after cardiac arrest
Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery Laparoscopic surgery at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm) with or without anchoring transparietal sutures or double crown technique

Official Title
-----------------
Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent from the patient or his/her legal representative ventral hernia requiring elective surgical repair Exclusion Criteria: no written informed consent 'hostile' abdomen; open abdomen treatment contraindication to pneumoperitoneum emergency surgery (incarcerated hernia) parastomal hernia

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair | Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair<br>* use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity rate |  | perioperative | 
| quality of life |  | after 1 year | 
| postoperative pain |  | within 1 week | 
| long term complication rate |  | after 1 year |
Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Study Overview
=================
Brief Summary
-----------------
Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce relapse in such cases. Patients will be randomized to receive the adjuvant combination therapy or no therapy. All patients will be monitored closely for signs of relapse and treated appropriately with conventional salvage therapy.

Official Title
-----------------
A Phase IIb Randomised Clinical Trial of the Tolerability, Safety and Efficacy of Adjuvant Docetaxel-Zoledronic Acid After Prostatectomy for High-risk Early Prostate Cancer (AD-ZAP).

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

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radical prostatectomy for prostate cancer within last 2 months. Post-operative Kattan nomogram predicts >25% risk of PSA relapse by 5 years. 6-week post-operative serum PSA<0.2ng/mL. Low levels of circulating prostate cancer cells in the blood, detected by PCR amplification of PSA mRNA 6 weeks post-prostatectomy. Exclusion Criteria: Pre-operative serum PSA level >20ng/ml. Clinical evidence of metastases by 6-week post-operative visit. Prior treatment with either ADT or bisphosphonate therapy. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants) Other protocol defined inclusion / exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic Acid<br> | Drug: Zoledronic Acid<br> <br> |
| Active Comparator: Docetaxel<br> | Drug: Docetaxel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa |  | 6 months after study entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zoledronic acid, prostate cancer, high risk, PSA, docetaxel
Provincial Roll-Out Bone Health Strategy

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to investigate the effect of two different group-based exercise programs on fall risk (muscular strength and balance) and bone strength in older women aged over 65-75 years who have low bone mass. We are also trying to determine if once a week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a week exercise will be more effective than once a week or sham exercise.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inactive (less than twice weekly exercising) women aged 65-75 years old

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Resistance training|See Detailed Description.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic Profile Assessment (Fall Risk) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone strength using peripheral quantitative computed tomography (pQCT) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Resistance training
[18F]MC225 PET to Evaluate Gender Differences in BBB P-gp Function

Study Overview
=================
Brief Summary
-----------------
P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. P-gp plays an important role in the bio-availability, drug distribution, metabolism and elimination of pharmaceuticals labelled as P-gp substrates (e.g. the majority of antidepressants and antipsychotics). A difference in P-gp function was already reported in hepatic P-gp expression. The aim of the current study is to evaluate the influence of gender on cerebral P-gp function. Outcomes of this study can be of great importance in gender-based prescription of P-gp substrate pharmaceuticals.

Official Title
-----------------
The Impact of Gender Differences in P-glycoprotein Function Measured With [18F]MC225 and PET

Conditions
-----------------
Gender

Intervention / Treatment
-----------------
* Drug: [18F]MC225


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Use of medication with a known effect on the BBB P-glycoprotein transporter Any history of neurological or psychiatric conditions affecting the BBB P-glycoprotein function

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of healthy volunteers (5 male, 5 female)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Male<br>5 male participants will undergo a [18F]MC225 PET scan | Drug: [18F]MC225<br>* [18F]MC225 PET scan<br>|
| Active Comparator: Female<br>5 female participants will undergo a [18F]MC225 PET scan | Drug: [18F]MC225<br>* [18F]MC225 PET scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET kinetic modeling outcome parameters [18F]MC225 | volume of distribution, K1, k2 | 60 minutes after administration [18F]MC225 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET kinetic modeling outcome parameters [15O]H2O | K1 to evaluate Cerebral Blood Flow (CBF) | 10 minutes after administration of [15O]H2O | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
P-glycoprotein, MC225, [18F]MC225, PET
Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets

Official Title
-----------------
Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: green coffee extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg Exclusion Criteria: insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC | Dietary Supplement: green coffee extract<br>* Patients in treatment group take 400 mg GCE supplements twice a day for tow month<br>|
| Placebo Comparator: placebo group<br>placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch | Dietary Supplement: green coffee extract<br>* Patients in treatment group take 400 mg GCE supplements twice a day for tow month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intercellular adhesion molecule-1 (ICAM-1) |  | 8 weeks | 
| interleukin-6 (IL-6) |  | 8 weeks | 
| high sensitivity C-reactive protein (hs-CRP) |  | 8 weeks | 
| malondialdehyde (MDA) |  | 8 weeks |
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.

Detailed Description
-----------------
The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

Official Title
-----------------
A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Biological: Pangramin Plus D. pteronyssinus 100%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild/moderate persistent asthma Positive skin prick test or specific IgE to mites Age: 14-55 years old Exclusion Criteria: Immunotherapy contraindications Allergy to other inhalant allergens Previous immunotherapy (5 years)with mites

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pangramin Plus Dermatophagoides pteronyssinus 100% | Biological: Pangramin Plus D. pteronyssinus 100%<br>* Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo<br>|
| Placebo Comparator: 2<br>Pangramin Plus placebo | Biological: Pangramin Plus D. pteronyssinus 100%<br>* Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in inhaled corticosteroids |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in symptoms and rescue medication Tolerability |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Specific immunotherapy, Mite, Asthma