linjc16/ctgov huggingface dataset:
Risk Factors for Long-term Opioid Use

Study Overview
=================
Brief Summary
-----------------
Surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. We examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making. Using the IBM MarketScan® Research Database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (January 2007-September 2015). Multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year.

Official Title
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Opioid Use Among Patients With Pain Syndromes Commonly Seeking Surgical Consultation

Conditions
-----------------
Pain Syndrome

Intervention / Treatment
-----------------
* Other: No intervention - retrospective observational cohort study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-64 years old at least one encounter for anorectal, foot/ankle, or TMJ pain Marketscan continuous enrollment for 1 year prior and 1 year after the index pain encounter

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anorectal<br>Patients presenting with anorectal pain. | Other: No intervention - retrospective observational cohort study<br> <br> |
| TMJ<br>Patients presenting with temporomandibular joint pain. | Other: No intervention - retrospective observational cohort study<br> <br> |
| Foot/Ankle<br>Patients presenting with foot and ankle pain. | Other: No intervention - retrospective observational cohort study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term opioid use | opioid prescriptions for 3 months. | >90 days of opioid supply | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new long-term opioid use | Opioid prescriptions for over 3 months in patients who have not had prior opioid prescriptions. | >90 days of opioid supply |
Qualitative Interviews With Healthcare Professionals

Study Overview
=================
Brief Summary
-----------------
PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement (TKR) surgery for the treatment of knee arthritis.

Detailed Description
-----------------
The interviews for the SYNC01-PP-USA project will be conducted in person at the American Association of Hip and Knee Surgeons (AAHKS) annual conference in Dallas, Texas, USA during the 3rd, 4th, and 5th November 2022. The interviews will take approximately 30 minutes.

Official Title
-----------------
PLANNING PHASE- Qualitative Interviews With Healthcare Professionals to Assist in the Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement (TKR) Surgery for the Treatment of Knee Arthritis.

Conditions
-----------------
Total Knee Replacement

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthcare Professionals who currently care for patients who have undergone Total Knee Replacement surgery. Healthcare Professionals who, in the opinion of the Investigator, can understand the project, co-operate with the interview process and are willing to be interviewed in person. Healthcare Professionals who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare Professionals<br>Planning Phase Interviews | Other: Interview<br>* Interviews<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview | The interview carried out with the HCPs will ascertain their opinions of the issues that patients report after undergoing TKR. The replies (data) collected could be different for each HCP so there is no outcome measure as such for this data. This information collected will be structured around a set number of questions asked in the interview and will be used to form the potential structure and layout of a Patient Reported Outcome Measure (PROM) and to provide background information for the subsequent Phase One of the project which will take place in the UK. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKR
Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is an open label, prospective, test of superiority efficacy trial of Ipomea pes-caprae ointment as an add-on therapy in patient with jellyfish dermatitis. Each patient will receive standard medical treatment depend on the severity of the disease. The doctor will divide the dermatitis area of each patient into two parts. Ipomea pes-caprae ointment will be applied as an add-on therapy to the test area, while the ointment will not be applied to the control area. Patients will be asked to come for follow up 6 times in the 28-days study period. Primary objective is to compare the healing time of dermatitis in both areas.

Detailed Description
-----------------
The Test area and Control area are allocated in each participant. We use the Internal Control fashion. The healing time of each area will be collected as an outcome measure.

Official Title
-----------------
Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis

Conditions
-----------------
Jellyfish Dermatitis, Jellyfish Venoms

Intervention / Treatment
-----------------
* Drug: Ipomea pes-caprae ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of jellyfish dermatitis total lesion area is more than 4 square centimeter Exclusion Criteria: expose to jellyfish more than 7 days severe systemic reaction to jellyfish allergy to Ipomea pes-caprae or the component of the ointments

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Area<br>Test Area = Standard Treatment plus Ipomea pes-caprae oinment | Drug: Ipomea pes-caprae ointment<br>* Ipomea pes-caprae ointment will be applied twice a day as an add-on therapy.<br>|
| No Intervention: Control Area<br>Control = Standard Treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time of the Jellyfish dermatitis lesion (days) |  | Follow up to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
jellyfish, jellyfish venom, jellyfish dermatitis, jellyfish stings, Ipomea pes-caprae
Expression Profiling of microRNA Following Administration of Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find out the differential expression profiling of microRNA before and after adiministration of dexmedetomidine in patients undergoing procedures, and then investigators will do some in vitro studies to validate the functions of the microRNA.

Detailed Description
-----------------
Background and objective: The use of dexmedetomidine may have benefits on the clinical outcomes of cardiac surgery. MicroRNAs are non-coding RNA sequences that act as regulators of gene expression. Investigators conduct a study to determine the role of microRNAs in cardioprotection mediated by dexmedetomidine. Methods: In this study 3 patients were selected. The blood sample were taken before administration of dexmedetomidine.Investigators infused loading dose of dexmedetomidine for 10 minutes and maintaining dese of dexmedetomidine for 20 minutes.Thirty minutes after the administration, another blood samples were taken and stored in the liquid nitrogen and both the samples were marked. Those sample were analyzed for differentially expressed microRNA with Exiqon miRNA Array.

Official Title
-----------------
Expression Profiling of microRNA Following Administration of Dexmedetomidine in Patients Undergoing Procedures

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients without arrithmia will undergo procedure. Exclusion Criteria: The patients have bradycardia (hear rate is less than 60 beats per minute) or conduction block.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: before dexmedetomidine<br>We took blood samples before the administration of dexmedetomidine to determine exression level of microRNA in the subjects. | Drug: Dexmedetomidine Injection<br>* Investigators gave the patients loading dose of dexmedetomidine for 10 minutes and maintaining dose of dexmedetomidine for 20 minutes. Investigators took blood samples before and after the administration of dexmedetomidine.<br>* Other names: Dex group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microRNA differential expression | microRNA differential expression exerts cardioprotection effect on patients undergoing procedures. | 30 minutes |
Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Two doses of metformin with 12 hour interval low dose group (375/250 mg) high dose group (1000/1000mg)

Detailed Description
-----------------
A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.

Official Title
-----------------
An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 45 Body weight 50 to 100 kg fasting serum glucose 70 to 125 mg/dL who provide informed consent voluntarily Exclusion Criteria: any significant renal, gastrointestinal, hepatic, and metabolic condition any co/prior medication within 14 days of study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin 250mg<br>metformin 375/250 mg | Drug: Metformin<br> <br> |
| Experimental: metformin 1000mg<br>metformin 1000/1000 mg | Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration |  | 0-12 hour | 
| Area under the metformin concentration curve |  | 0-12 hour | 
| Area under the glucose curve |  | 2-5 hour |
Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers. The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT. The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured. The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement. The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.

Official Title
-----------------
Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit

Conditions
-----------------
Gastrointestinal Motility, Total Gastrointestinal Transit Time, Segmental Transit Time, Gastric Emptying

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteer Signed informed consent obtained Fasted since midnight Exclusion Criteria: Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders Subject has cancer or other life threatening diseases or conditions Subject is pregnant Subject has undergone abdominal surgery Subject has abdominal diameter >140cm? Drug abuse or alcoholism Subject's bowel movements are irregular Subject has known cardiovascular or pulmonary diseases Participation in any clinical study within the last 30 days Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device. Subject takes any medication affecting GI motility Subject having MRI within the next four weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Total gastrointestinal transit time in healthy subjects. |  | Three days from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segmental transit times in healthy subjects |  | Three days from Baseline visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal Motility, Transit time
Evaluation of Different Etiologies of Obscure Ascites

Study Overview
=================
Brief Summary
-----------------
Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is most commonly observed in patients with cirrhosis and resulting portal hypertension (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a malignancy

Official Title
-----------------
Evaluation of Different Etiologies of Obscure Ascites: Clinical, Laboratory, and Laparoscopic Study.

Conditions
-----------------
Ascites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ascites serum ascites albumin gradient >1.1. Exclusion Criteria: ascitic fluid serum ascites albumin gradient <1.1. Haemorrgaic ascites; chylous ascites
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 |
| --- | --- | --- |
| The percentage of patients with malignant ascites | according to laboratory and clinical criteria | 1 month |
Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15

Study Overview
=================
Brief Summary
-----------------
After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, […], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.

Official Title
-----------------
Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15

Conditions
-----------------
Recovery of Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery Patient agreeing to use his data for research purposes Exclusion Criteria: Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire Patient unable to express non-opposition to participation in the study Patient expressing opposition to participating in the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery | the score is calculated from the questionnaire 24 hours after the surgery | 24h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Recovery, Postoperative, Surgery, French, Translation, Validation
Clinical Presentation of Melioidosis in Head and Neck Region

Study Overview
=================
Brief Summary
-----------------
Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.

Detailed Description
-----------------
This research is retrospective study about five years ( Jan 2011- Oct 2016).

Official Title
-----------------
Clinical Presentation of Melioidosis in Head and Neck Region

Conditions
-----------------
Melioidosis, Head and Neck Infection

Intervention / Treatment
-----------------
* Other: Patient who presented with melioidosis in head and neck


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei Exclusion Criteria: No
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patient who presented with melioidosis in head and neck|Investigators assess the patients who had the pus culture positive with Burkholderia pseudomallei.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of infection in head and neck as assess by clinical diagnosis | These results will be reported as single or multiple site infection in head and neck region. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis as confirm with pus culture | Assessing the correlation of melioid titer and culture by Pearson statistic | 5 years | 
| Number of participants with successful treatment as assess by clinical presentation | These results will be evaluated as remission or recurrent. The remission mean that fever or pus collection is subside and no presentation with melioidosis again in 5 years. The recurrent mean that participants will present with clinical melioidosis again in 5 years | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melioidosis, Head and Neck, Clinical