linjc16/ctgov huggingface dataset:
Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.

Detailed Description
-----------------
A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans. To assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.

Official Title
-----------------
Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Hypochlorous acid
* Drug: Iodopovidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over 18 years old, who are going to be operated Classification of surgical wounds according to the National Research Council as class I or II Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2 Exclusion Criteria: Patients requiring mesh or prosthesis or orthesis

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Hypochlorous acid | Drug: Hypochlorous acid<br>* Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray<br>* Other names: NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA;|
| Active Comparator: B<br>Iodopovidone | Drug: Iodopovidone<br>* Iodopovidone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection rates |  | until one month (weekly) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypochlorous Acid, Colony forming units, surgical site infection, nosocomial infection, bacterial bioburden, wound healing
Validation of HyperDetector for SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples. To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.

Official Title
-----------------
Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection

Conditions
-----------------
SARS-COV2 Infection

Intervention / Treatment
-----------------
* Device: Screening Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects at COVID-19 testing site for Rt-PCR test. Exclusion Criteria: Minors under the age of 5

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| Comparison to Rt-PCR<br> | Device: Screening Device<br>* Screening device comparing Rt-PCR positive and negative results to HyperDetector results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | To determine the sensitivity of the screening assay | By 12/30/2022 | 
| Specificity | To determine the specificity of the screening assay | By 12/30/2022 |
Efficacy of MK0557 in Combination With Sibutramine or Orlistat (0557-015)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Study medicine will be given alone, or in combination with either sibutramine or orlistat, to obese subjects to compare the effect on body weight over a six month period.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: MK0557


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of 18-65 who are considered obese (have a body mass index between 30 and 43) Exclusion Criteria: Subject has high blood pressure or is taking any high blood pressure medicine History of psychiatric disorder, stroke, or heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0557|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Epidemiology of Speed Skating-related Injuries

Study Overview
=================
Brief Summary
-----------------
Speed skating is a sport in which there´s a lack of epidemiological studies. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. This way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.

Detailed Description
-----------------
A retrospective study will be performed in speed skaters. 100 speed skaters will be recruited. Data of all injury along a whole season will be collected. Patients' information, including age, number of years playing, skill level and injured body part, will be analysed

Official Title
-----------------
Epidemiology of Speed Skating-related Injuries

Conditions
-----------------
Sports Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a speed skater and having competed in the 2018 spanish national championship Exclusion Criteria: Being unable to understand the questionaire, do not accept on participating in the study.
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 |
| --- | --- | --- |
| 1.Injury prevalence | Injury prevalence rates [Injury prevalence rates calculated per 1000 hours of play] | [Time Frame: January 2018-December 2018] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury burden | Days lost per 1000 hours of exposure | [Time Frame: January 2018-December 2018] | 
| Injury prevalence according to occurrence | Number of injuries sustained during training/ Number of injuries sustained during a match (% of all) | [Time Frame: January 2018-December 2018] | 
| Injury prevalence by mechanism of injury | Number of injuries according to the mechanism of injury (Contact (Direct or indirect) or Non-Contact) (% of all) | [Time Frame: January 2018-December 2018] | 
| Injury prevalence according to location | Distribution of injuries according to location of the injury (on the body, % of all) | [Time Frame: January 2018-December 2018] | 
| Injury prevalence according to tissue affected | Description of the distribution of injuries according to the type of the injury (muscle only) (% of all) | [Time Frame: January 2018-December 2018] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevalence, Multidirectional Sport, Injury prevention, Athletic injuries
Pediatric Epilepsy Database

Study Overview
=================
Brief Summary
-----------------
The purpose of this database is to collect information for clinical purposes on all children being treated for seizure disorders.

Detailed Description
-----------------
At some point this information may be used to retrospectively review trends in seizure types, diagnostic evaluation and treatment (medical or surgical). The potential data recorded will be that of standard of care provided to these patients, including age, gender, seizure type/classification, diagnostic procedures (eg. EEG, MRI Magnetoencephalography {MEG}, Single Photon Emission Computed Tomography {SPECT}, Positron Emission Tomography {PET}, invasive electrocorticography) and various treatments (medications, diet, or neurosurgical interventions for the treatment of epilepsy). Records in the database will have identifiable information (name, date of birth, date of procedure, medical record number), but these identifying data will be removed, and only nonidentifying data will be used in the event of research completed using information from this clinical database.

Official Title
-----------------
Pediatric Epilepsy Database

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NONE Exclusion Criteria: NONE

Ages Eligible for Study
-----------------
Maximum Age: 17 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
-----------------
epilepsy
Retrospective Femoral Nerve Block Study

Study Overview
=================
Brief Summary
-----------------
This is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional anesthesia program. The investigators hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia and facilitates discharge home when compared to intravenous opioid use following reconstructive knee surgery.

Conditions
-----------------
Other Reconstructive Surgery

Intervention / Treatment
-----------------
* Procedure: Femoral nerve block
* Drug: Intravenous opioids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that had reconstructive knee surgery between July 2009 to the present. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intravenous opioids<br> | Drug: Intravenous opioids<br>* Whatever opioids prescribed<br>|
| femoral nerve block<br> | Procedure: Femoral nerve block<br>* Ropivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | duration of hospitalization and need for inpatient admission in patients who received femoral nerve block versus those who received intravenous opioids | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting |  | 1 Week | 
| Total opioid use |  | 1 Week | 
| Postoperative pain score |  | 1 Week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee, reconstructive surgery, femoral nerve block
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

Detailed Description
-----------------
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design. The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.

Official Title
-----------------
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ARQ 197


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must provide written informed consent prior to any study related procedures Subjects must be between the ages of 18 and 65 years Male participants must have been surgically sterilized Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype. Exclusion Criteria: Males who are not surgically sterilized Females of child-bearing potential who are not surgically sterilized Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination Any clinically significant abnormality in the screening laboratory tests or ECG Received any investigational drugs within four weeks Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) 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?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 197|Treatment with ARQ 197|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B. |  | May 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor safety of the three solid states of ARQ 197. |  | May 2008 |
Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

Study Overview
=================
Brief Summary
-----------------
Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.

Detailed Description
-----------------
The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.

Official Title
-----------------
Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Office hysteroscopy and endometrial snip
* Procedure: Office hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18- 38 years old at least one patent tube unexplained infertility, anovulation, mild to moderate male factor infertility previous failed IUI Exclusion Criteria: indicated for ICSI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Office hysteroscopy and endometrial snip<br>Office hysteroscopy and endometrial snip | Procedure: Office hysteroscopy and endometrial snip<br>* Office hysteroscopy with endometrial snip<br>* Other names: Office hysteroscopy combined with endometrial snip;|
| Active Comparator: Office hyteroscopy<br>Office hysteroscopy | Procedure: Office hysteroscopy<br>* Office hysteroscopy<br>* Other names: Outpatient hysteroscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Positive pregnancy test with fetal heart activity | 10 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Pregnancy Continued after 12weeks | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Office hysteroscopy,, intrauterine insemination, endometrial scrap
Influence of Arm Retraction on the Supraclavicular Approach for Subclavian Vein Catheterization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of arm retraction on the supraclavicular approach for subclavian vein catheterization in adults and children.

Official Title
-----------------
Influence of Arm Retraction on the Relative Position of Clavicle and the Subclavian Vein,During Supraclavicular Approach for Central Venous Catheterization in Adults and Children

Conditions
-----------------
Subclavian Venous Catheterization

Intervention / Treatment
-----------------
* Procedure: arm retraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing general anesthesia regardless of subclavian venous catheterization Exclusion Criteria: patients with infection over the puncture site history of thoracic surgery or clavicular fracture vascular malformation anatomical abnormality of subclavian vein

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant<br>patients aged younger than 1year | Procedure: arm retraction<br>* gently pulling through the ipsilateral arm to the knee<br>|
| Experimental: Child<br>patients aged 1year to 5years | Procedure: arm retraction<br>* gently pulling through the ipsilateral arm to the knee<br>|
| Experimental: Adult<br>adult patients | Procedure: arm retraction<br>* gently pulling through the ipsilateral arm to the knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of distance between clavicle and confluence of internal jugular vein and subclavian vein while arm retraction |  | Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction | 
| Change in diameter of suvclavian vein at the confluence of internal jugular vein and subclavian vein |  | Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction |