linjc16/ctgov huggingface dataset:
EndogenousTestosterone Response to a Testosterone Boosting Supplement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a proprietary 'testosterone-boosting' supplement, when used as recommended by the manufacturer, results in an increase in testosterone levels as measured by a salivary free testosterone assay.

Detailed Description
-----------------
The experimental intervention in this study is the daily administration of a testosterone boosting supplement or sham supplement for 4 weeks. The supplement will be administered daily in capsule form. The control group will be given a sham capsule containing the carrier components of the supplement. Participants will be asked not to modify their current lifestyle. Salivary testosterone levels will be assessed prior to the intervention to collect a baseline measurement for each subject, and following the intervention to evaluate any changes in hormone levels.

Official Title
-----------------
EndogenousTestosterone Response to a Testosterone Boosting Supplement

Conditions
-----------------
Testosterone

Intervention / Treatment
-----------------
* Dietary Supplement: Testosterone boosting supplement
* Dietary Supplement: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male aged 20 to 40 years. Fluent in English. Exclusion Criteria: Currently receiving hormonal therapy or testosterone boosting supplement. Has received hormonal therapy or testosterone boosting supplement within 3 months prior to study. Has experienced adverse event following previous exposure to testosterone boosting supplements.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Receive daily authentic Testosterone boosting supplement | Dietary Supplement: Testosterone boosting supplement<br>* Proprietary formulation of Testosterone boosting supplement administered daily<br>|
| Placebo Comparator: Placebo<br>Receive daily placebo supplementation | Dietary Supplement: Placebo Comparator<br>* Daily administration of Placebo Comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of salivary free testosterone from baseline measured by ELISA | Change in concentration of salivary free testosterone from baseline to 4 weeks will be measured by ELISA | 4 weeks |
The Surgery After Stenting (SAS) Registry

Study Overview
=================
Brief Summary
-----------------
The SAS registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. The relevant clinical, procedural and outcome data (within index surgical admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF).

Official Title
-----------------
A Multicenter Registry of Consecutive Patients Undergoing Cardiac and Noncardiac Surgery or Operative Endoscopic/Endovascular Procedures After Implantation of a Coronary Stent

Conditions
-----------------
PERCUTANEOUS CORONARY INTERVENTION, STENTS, SURGERY

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible will be male and female patients > 18 years of age. Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery. Both candidates to elective/urgent operations and those undergoing emergency operations will be included in the SAS registry, and will be considered as two separate cohorts. Exclusion Criteria: - Unwillingess/inability to sign the Informed Consent Form (ICF). There are no other selection criteria.

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 |
| --- | --- |
| stenting undergoing surgery<br>Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of death, myocardial infarction, probable/definite stent thrombosis according the Academic Research Consortium definition and bleeding events of Bleeding Academic Research Consortium (BARC)grade >3 during index surgical admission. |  | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of bleeding events of Bleeding Academic Research Consortium (BARC) grade >3 within 30 days of index admission/procedure |  | within the first 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CORONARY STENT, CARDIAC SURGERY, NON CARDIAC SURGEY
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations

Study Overview
=================
Brief Summary
-----------------
In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic). This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.

Official Title
-----------------
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)

Conditions
-----------------
Brain Arteriovenous Malformations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 years old with brain Arteriovenous Malformations embolization treatment scheduled Exclusion Criteria: patient's refusal to participate in the study contraindication to undergo MRI examination patient under legal protection

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 |
| --- | --- | --- |
| sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization |  | within 3 months after embolization |
Extra-short vs. Non-extra-short Dental Implants Splinted on the Same Prosthesis

Study Overview
=================
Brief Summary
-----------------
The main aim of this prospective study is to analyze the survival rate of short-length implants (<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.

Official Title
-----------------
Prospective Observational Study on Evolution of Extra-short Implants (<6.5 mm) Compared to Non-extra-short Implants (≥ 6.5 mm) Splinted on the Same Prosthesis

Conditions
-----------------
Partial-edentulism

Intervention / Treatment
-----------------
* Device: BTI Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Have planned a fixed multiple prosthesis supported by implants <6.5 mm in length and implants ≥ 6.5 mm in length within 15 days before the inclusion of the patient in the study. Planning of supported prostheses from 2 to 4 implants dental Have a previously performed CBCT (Cone Beam Computed Tomography) Availability to be observed during the period of tracing Signature of the informed consent Exclusion Criteria: Smokers> 10 cigarettes / day Complete prostheses Unitary prostheses

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| short-length implant (<6.5 mm)<br> | Device: BTI Implant<br>* BTI Dental implants are non-active medical device, single use, non resterilizable, biocompatible and sterile devices made of alloplastic materials (Titanium) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g. bridge, single-tooth, overdenture).<br>|
| non-short length implant (≥6.5 mm)<br> | Device: BTI Implant<br>* BTI Dental implants are non-active medical device, single use, non resterilizable, biocompatible and sterile devices made of alloplastic materials (Titanium) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g. bridge, single-tooth, overdenture).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of dental implants | Survival of dental implants at one year post-implantation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Marginal bone loss at one year post-implantation | 1 year | 
| Incidence of prosthetic or implant complications |  | 1 year |
ILF With/Without Cisplatin for Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Detailed Description
-----------------
Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen [Pozzo C, et al. Ann Oncol 2004]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Official Title
-----------------
A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer

Conditions
-----------------
Stomach Neoplasm

Intervention / Treatment
-----------------
* Drug: irinotecan
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven gastric adenocarcinoma Advanced, metastatic or recurrent ECOG performance status 0 to 2 No prior chemotherapy Measurable or evaluable indicator lesion(s) Normal marrow, hepatic and renal functions Provision of written informed consent Exclusion Criteria: Active infection, bleeding or severe comorbidities Pregnant or breastfed women Active CNS metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan|nan|
|Drug: cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Quality of life |  |  |
A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

Study Overview
=================
Brief Summary
-----------------
A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks
* Drug: Comparator: placebo / Duration of Treatment: 16 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females between the ages of 18 and 70 with asthma

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks|nan|
|Drug: Comparator: placebo / Duration of Treatment: 16 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of days of asthma exacerbations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of asthma free days |  |  | 
| Percentage of nocturnal awakenings |  |  | 
| Beta agonist use |  |  |
New Score for Pseudo- Acanthosis Nigricans

Study Overview
=================
Brief Summary
-----------------
Each side of the neck pseudo acanthosis nigricans was randomized in to either receiving glycolic acid peel or saline. Evaluation was done at baseline and after 3 sessions 2 weeks apart by percentage involvement and by ANASI score

Official Title
-----------------
Use Of A Novel Quantitative Tool For Evaluation of Pseudo- Acanthosis Nigricans: Acanthosis Nigricans Area And Severity Index

Conditions
-----------------
Pseudo Acanthosis Nigricans

Intervention / Treatment
-----------------
* Procedure: Glycolic acids peel 70%
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate severity age > 18 years old Exclusion Criteria: Pregnant and lactating patients, patients with systemic diseases as connective tissue disease, diabetes, skin infection use of immunosuppressive drugs Susceptibility for post peel hazards as hyperpigmentation scarring and keloidal tendency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glycolic acid peel<br> | Procedure: Glycolic acids peel 70%<br>* Glycolic acid peel 70% applied in 3 coats medium depth<br>|
| Placebo Comparator: Saline<br> | Other: Saline<br>* Sodium chloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage involvement | Degree of severity expressed as a percentage | 6 months to 1 year | 
| Acanthosis Nigricans Area and Severity Index score | New Score calculating severity and area as a number minimum value is 0 and maximum value is 40 the higher the number of the score the worse the affection | 6 months to 1 year |
Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.

Official Title
-----------------
A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Local Tolerability, and Clinical Outcome of Ertapenem Versus Ceftriaxone in Pediatric Patients With Complicated Urinary Tract Infection, Skin and Soft Tissue Infection, or Community-Acquired Pneumonia

Conditions
-----------------
Urinary Tract Infections, Bacterial Pneumonia, Soft Tissue Infections

Intervention / Treatment
-----------------
* Drug: MK0826, ertapenem sodium /Duration of Treatment: 14 Days
* Drug: Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with UTI must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both Patients with SSTI must have a recent infection Patients with CAP must have a chest x-ray indicating bacterial pneumonia and a fever Exclusion Criteria: Patients with complete urinary tract blockage or kidney abscess Patients with infected burn wounds, bone infection, or bacterial arthritis Patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 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

| Intervention/Treatment |
| --- |
|Drug: MK0826, ertapenem sodium /Duration of Treatment: 14 Days|nan|
|Drug: Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of any clinical and/or laboratory drug-related serious adverse experience during the parenteral therapy period in pediatric patients treated with ertapenem. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety of ertapenem versus ceftriaxone during the parenteral therapy period with respect to the proportion of patients with any drug-related adverse experiences in pediatric patients with UTI, SSTI, or CAP. |  |  |
Impact of Time to Coronary Angiography on Survival for NSTEMI

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI.

Detailed Description
-----------------
The use of an invasive strategy for the management of NSTEMI according to estimated risk of 6 month mortality is recommended by international guidelines. NSTEMI appropriate for coronary angiography (and percutaneous intervention) have better outcomes compare with NSTEMI who are medically managed. Whilst the national and international guidelines recommend that the timing of (in-hospital) coronary angiography (<24, 24-72, 72-96 and <96 hours) is based upon estimated clinical risk (using the GRACE risk score) there is scientific and clinical uncertainty as to the incremental benefit that more urgent invasive treatments strategies have over and above that of delayed strategies. Moreover, the investigators recent research has shown that in the UK, may NSTEMI (eligible) for coronary angiography fail to achieve care according to the recommended time thresholds, and this is associated with potentially avoidable premature death. This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI. It will characterise patients according to their estimated risk of death, their time to angiography, and associated outcomes. The investigators anticipate that this observational study will provide Level B evidence for the benefits of the timing of an invasive strategy according to the GRACE risk score. The investigators are aware that the NICE guidelines for the management of acute chest pain are to be updated in 2016.

Official Title
-----------------
Impact of Time to Coronary Angiography on Survival for NSTEMI: an Observation Study Using a Nationwide Registry

Conditions
-----------------
Non ST-elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The target population will be all patients aged 18 to 100 years recorded within MINAP from 2004 to 2013 who have been hospitalised with NSTEMI and received coronary angiography. Exclusion Criteria: Age below 18 or above 100 or age missing Diagnosis not NSTEMI Patients who did not receive coronary angiography - as this is the investigators explanatory variable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| All-cause mortality |  | 30-day mortality since hospitalisation | 
| Mortality |  | 1-year mortality since hospitalisation |