linjc16/ctgov huggingface dataset:
Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents

Detailed Description
-----------------
The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups.

Official Title
-----------------
A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Device: Antimicrobeal coated stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will undergo ureteral stent placement Exclusion Criteria: Patients allergic to sulpha containing medications Ureteral stent insertion for infected hydronephrosis Patients who developed septic complications requiring antibiotic treatment after stent placement Patients who need bilateral stents Patients with chronic kidney disease grade IV and V (GFR <30ml/min) Immunocompromised patients as those with malignancy or organ transplantation.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>This arm will include patients with non-coated stents | |
| Active Comparator: Antimicrobeal group<br>This arm will include patients with antimicrobeal coated stents | Device: Antimicrobeal coated stents<br>* Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of urinary tract infection (UTI) | UTI will be diagnosed with urine and stent culture of stent removal | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ) | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ureteral stents, Double J stent, Antimicoreal coated stent, USSQ, UTI
VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators

Study Overview
=================
Brief Summary
-----------------
ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. The aim is to test whether a novel adaptation to a handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment and has implications in the prevention of infection. The lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.

Official Title
-----------------
VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: Kardia 6L


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part Exclusion Criteria: Patients who are unable or refuse to consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 Lead ECG<br>Application of hand held electrocardio gram | Device: Kardia 6L<br>* The Kardia 6L has CE marking. The purpose of this study is to extend the use of this device by a simple modification using existing equipment in the department. The device will be connected to the left leg electrodes using standard clinical crocodile clips and the other electrode applied to the chest in V1 and V6 positions to acquire the modified V1 and V6 leads<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of adaptation to handheld 6Lead | Sensitivity and specificity of adaptation to handheld 6Lead compared to 12 lead for leads V1 and V6 for the measurement of PR, QRS duration and QT interval | 10 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of other ECG parameters | Assessment of other ECG parameters e.g. ST segment change in the ECG wave | 10 Minutes |
Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine STD test.

Detailed Description
-----------------
This study has three primary objectives: 1) to determine the prevalence of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring STDs; 2) to determine the rate of successful treatment in women diagnosed with STDs in this venue.

Official Title
-----------------
Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population

Conditions
-----------------
Trichomonas Vaginitis, Chlamydia Trachomatis, Neisseria Gonorrhoeae Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing. Ability to provide written informed consent. Exclusion Criteria: Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women seeking emergency contraception<br>Women seeking emergency contraception | |
| Women seeking urine pregnancy testing<br>Women seeking urine pregnancy testing | |

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
-----------------
trichomonas, chlamydia, gonorrhea, emergency contraception, emergency contraception use
Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

Study Overview
=================
Brief Summary
-----------------
This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.

Official Title
-----------------
A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy

Conditions
-----------------
Cancer, Dysplasia

Intervention / Treatment
-----------------
* Device: Luma Cervical Imaging System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented abnormal pap test

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Luma Cervical Imaging System|Colposcopy using LUMA Cervical Imaging System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed. |  | ongoing - estimated at 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high-grade disease, Cervical examination, targeting biopsies, dysplasia, cancer
Outcome of Embryo Culture at Two Oxygen Tensions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome.

Official Title
-----------------
Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial

Conditions
-----------------
Embryo Development

Intervention / Treatment
-----------------
* Other: oxygen concentration in the culture atmosphere


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle Exclusion Criteria: less than one mature (metaphase II) oocyte at the time of denudation

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 44 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: I<br>5% oxygen concentration in the culture atmosphere | Other: oxygen concentration in the culture atmosphere<br> <br> |
| Experimental: II<br>20% oxygen concentration in the culture atmosphere | Other: oxygen concentration in the culture atmosphere<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate per cycle |  | 10-11 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical outcome, ICSI cycles, low oxygen, poor responders, pregnancy rate, prospective randomized study
Anthropological Survey on the Use of Essential Oils (EOs) by Cystic Fibrosis Patients: a Quantitative and Qualitative Approach

Study Overview
=================
Brief Summary
-----------------
Patients and parents of patients will be asked to answer a questionnaire on paper or online, by the CRCMs and through communication campaigns distributed by the association Vaincre La Mucoviscidose (VLM). This questionnaire includes about fifty items that will take 5 to 12 minutes to complete. The study aims to interview 250 patients / parents of patients, users and non-users of essential oils. Thirty patients or volunteer parents will then meet with a health anthropologist for qualitative interviews to document very precisely the modalities of use of essential oils: which ones, at what dose, advised by whom, the dedicated budget. Relationships with CRCM doctors, the effects felt, the side effects will also be explored. The global data of the two phases will be integrated and put into perspective with the scientific data currently available on essential oils.

Official Title
-----------------
Anthropological Survey on the Use of Essential Oils (EOs) by Cystic Fibrosis Patients: a Quantitative and Qualitative Approach

Conditions
-----------------
Mucoviscidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cystic fibrosis patient or parent of a child with cystic fibrosis Exclusion Criteria: patient who refused

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 |
| --- | --- | --- |
| Frequency of use of the different EO by the patients who answered the questionnaire | Frequency of use of the different EO by the patients who answered the questionnaire | through study completion, an average of 1 year |
Screening of Malignant Hyperthermia Susceptible Individuals

Study Overview
=================
Brief Summary
-----------------
This study intends to target patients who underwent surgery under general anesthesia during the study period and developed malignant hyperthermia during or after surgery. Therefore, the total sample size was estimated to be about 50 people based on the past incidence of this rare disease. Every year, about 20 patients and their families who developed malignant hyperthermia during or after surgery will participate in this nationwide study (estimated by the current incidence of malignant hyperthermia), and about 1-5 patients will be admitted to Peking University Third Hospital participate in this research. Relevant specimens were collected from malignant hyperthermia (MH) patients and their family members for genetic analysis to determine the mutation of MH-related pathogenic gene loci.

Official Title
-----------------
Molecular Genetics Study on Screening of Malignant Hyperthermia Susceptible Individuals

Conditions
-----------------
Malignant Hyperthermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery under general anesthesia during the study period developed malignant hyperthermia during or after surgery. Exclusion Criteria: Malignant hyperthermia was ruled out by later treatment and diagnosis; The patient or family member refuses to be recruited.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
| Whole exome sequencing |  | immediately after MH was diagnosed |
Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport

Study Overview
=================
Brief Summary
-----------------
This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. We will examine and compare first attempt success rates with each method.

Official Title
-----------------
Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport

Conditions
-----------------
Intravenous Access

Intervention / Treatment
-----------------
* Procedure: Butterfly iQ+ Ultrasound
* Procedure: Traditional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients requiring IV access prior to transport by the Angel One Transport Team back to Arkansas Children's Hospital Age group: 2 weeks - 18 years Exclusion Criteria: Adequate IV Access NICU transports Patients not needing IV access

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: POCUS-assisted IV placement<br>using ultrasound to help with placement | Procedure: Butterfly iQ+ Ultrasound<br>* ultrasound will be used in the intervention group for IV access<br>|
| Active Comparator: Traditional IV placement<br>Standard of care | Procedure: Traditional<br>* ultrasound will not be used in the traditional IV placement group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Attempt IV success rates |  | 1 day of transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beside Times during transport | as reported (in minutes) | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, interfacility transport, intravenous access, ultrasound, POCUS
Reinforcing Effects of Brief Exposures to Nitrous Oxide - 8

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.

Official Title
-----------------
Reinforcing Effects of Brief Exposures to Nitrous Oxide

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 20% N2O
* Drug: 40% N2O
* Drug: 60% N2O
* Drug: 80% N2O


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 34 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo + 20% N2O<br>0% N2O inhaled during psychomotor testing, 20% N2O inhaled during psycho motor testing, then subject's choice of the 2. | Drug: 20% N2O<br> <br> |
| Active Comparator: Placebo + 40% N2O<br>0% N2O inhaled during psychomotor testing, 40% N2O inhaled during psycho motor testing, then subject's choice of the 2. | Drug: 40% N2O<br> <br> |
| Active Comparator: Placebo + 60% N2O<br>0% N2O inhaled during psychomotor testing, 60% N2O inhaled during psycho motor testing, then subject's choice of the 2. | Drug: 60% N2O<br> <br> |
| Active Comparator: Placebo + 80% N2O<br>0% N2O inhaled during psychomotor testing, 80% N2O inhaled during psycho motor testing, then subject's choice of the 2. | Drug: 80% N2O<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of nitrous oxide vs placebo | Subjects underwent 4 sessions consisting of 2 sample tests (inhaling placebo and inhaling varying doses of N2O), then choosing which inhalant they wanted for a choice test. The subject & the technician administering the inhalant were blinded. During each intervention and each session, subjects underwent psychomotor testing. | After 1.5 min of inhalation each of nitrous oxide then placebo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, reinforcer, subjective effects, healthy volunteer