linjc16/ctgov huggingface dataset:
Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion

Study Overview
=================
Brief Summary
-----------------
This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center & East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.

Official Title
-----------------
Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia: a Prospective Randomized, Double-blinded, Placebo-controlled Study

Conditions
-----------------
Postoperative Pain Management After Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Other: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking Exclusion Criteria: Age > 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline. | Other: Normal Saline<br>* Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.<br>|
| Experimental: Lidocaine Group<br>Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion. | Drug: Lidocaine<br>* Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain management
Non-invasive Cardiac Output Monitor in Young Adults

Study Overview
=================
Brief Summary
-----------------
The investigators would like to study cardiac output, stroke volume, and fluid responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with routine monitoring will provide a better assessment of intra-operative status.

Detailed Description
-----------------
This study will involve measurements of cardiac output, stroke volume, and fluid responsiveness (change in stroke volume of ≥ 10%) obtained via passive leg raise (PLR) before and after anesthesia induction.

Official Title
-----------------
A Trial of a Non-Invasive Cardiac Output in Young Adults

Conditions
-----------------
Fluid Overload, Hypovolemia

Intervention / Treatment
-----------------
* Device: NICOM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 -30 years of age presenting for surgery at Riley or University Hospital Exclusion Criteria: younger than 18 severely mentally handicapped orthopedic cases with leg injuries any other contraindications that would prevent or discourage passive leg raises if deemed ineligible by an investigator for any other reason.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| Use of Cheetah medical NICOM<br>For those who consent to the study, the Cheetah NICOM will be used to obtain cardiac output, stroke volume, and fluid responsiveness. | Device: NICOM<br>* Use of NICOM and PLR to obtain patient fluid status<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Fluid responsiveness | If patient is fluid responsive, Stroke Volume Index (SVI) will increase by 10% or greater compared to its baseline | within 30 minutes post-anesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac monitoring, Cheetah Medical, passive leg raises
Anovaginal Distance, Interobserver Agreement

Study Overview
=================
Brief Summary
-----------------
Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound

Detailed Description
-----------------
Aims: This study describes perineal ultrasound measurement of the AVD in regard to ease of learning and interobserver agreement, in order to establish if the method is reliable to use in further research about objective postpartum description of perineal tears. Methods: To educate the examiners, the method was shown and described by an experienced examiner. The examiners then measured the anovaginal distance in one woman repeatedly with until similar results (+/- 5 mm ) were achieved. The woman was in the lithotomy position and a vaginal ultrasound probe was used. The AVD in another 40 women was then measured and documented by two examiners, right after the other, who were blinded to the other´s results. The distance was measured between the mucosal margin of the internal anal sphincter and the vaginal probe. Interobserver agreement was calculated using Kappa-score.

Official Title
-----------------
Interobserver Agreement in Perineal Ultrasound of the Anovaginal Distance- a Methodology-study

Conditions
-----------------
Pelvic Floor Disorders

Intervention / Treatment
-----------------
* Other: anovaginal distance variation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Examiners; the gynecologists authoring the study Patients: any women visiting the gynaecological outpatient clinic of Linköping University Hospital where a vaginal ultrasound examination was performed Exclusion Criteria: Examiners: n/a Patients: inability to understand spoken or written Swedish

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| anovaginal distance variation<br>3 measurements | Other: anovaginal distance variation<br>* Kappa calculation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interobserver variation in measurements of the anovaginal distance with perineal ultrasound | 3 measurements per investigator and patient, comparing variation, using kappa value | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of learning the technique of perineal ultrasound to measure the anovaginal distance | how many measurements did the investigator learning the procedure need to perform produce a measurement that was within 5 mm of the measurements of the teacher | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound anovaginal distance, observer variation
Domperidone in Refractory Gastroparesis

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

Official Title
-----------------
Domperidone in Refractory Gastroparesis

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Drug: Domperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 18 and older Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including: Increased prolactin levels Breast changes Extrapyramidal side effects Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix) Exclusion Criteria: History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females) Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities. Gastrointestinal hemorrhage or obstruction. Presence of a prolactinoma (prolactin-releasing pituitary tumor). Pregnant or breast feedings female. Known allergy to domperidone

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 |
| --- | --- |
| Other: Domperidone<br> | Drug: Domperidone<br>* 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroparesis Cardinal Symptom Index |  | upon study completion |
HER2 Circulating Tumor Cells in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer.

Detailed Description
-----------------
We propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer. Blood samples will be collected from metastatic gastric cancer patients.

Official Title
-----------------
HER2 Circulating Tumor Cells in Gastric Cancer

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years ② Patients with localized, histologically confirmed gastric cancer ③ Informed consent form Exclusion Criteria: No informed consent form

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 |
| --- | --- | --- |
| To survey the frequency of HER2(+) CTC in gastric cancer |  | 24month |
Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion

Study Overview
=================
Brief Summary
-----------------
Percutaneous cryoablation is an alternative to urological surgery for T1a tumours, whose oncological efficacy decreases for the most central tumours due to a cold sink effect.

Official Title
-----------------
Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion

Conditions
-----------------
Kidney Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject (≥18 years) Subject who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the HUS during the period 01/01/2018 to 30/12/2021 Subject who has not expressed his/her opposition, after information, to the re-use of his/her data for the purpose of this research. Exclusion criteria : Subject having expressed his/her opposition to participate in the study Subject under legal protection, guardianship or curatorship

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 |
| --- | --- | --- |
| Description of the technique of percutaneous cryoablation of central renal tumours with temporary balloon obliteration of the renal artery |  | Files analysed retrospectively from January 01, 2018 to December 31, 2021 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Cancer, Central Kidney Tumours, Renal Artery Occlusion, cryoablation, Urological surgery, T1a tumours, Cold sink effect, Endovascular balloon clamping, Renal hilum
A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor

Study Overview
=================
Brief Summary
-----------------
Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its accompanying protease inhibitor. However, ritonavir is unpopular with many patients because of its large size and because of the recommended need for refrigeration. This study will test the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying protease inhibitor in patients receiving such therapy.

Detailed Description
-----------------
The study staff will employ MEMS caps to prospectively measure adherence to ritonavir and its accompanying protease inhibitor over 24 weeks of follow-up. Paired sample t-tests will be employed to compare adherence to the two agents, and secondary analyses will be conducted to evaluate the chronologic concordance of ritonavir and accompanying protease inhibitor dosing.

Official Title
-----------------
A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection, age>18 years, receiving therapy with ritonavir-boosted atazanavir or fosamprenavir, willingness to use MEMS caps, willingness to provide informed consent Exclusion Criteria: Treatment with any medication that is contraindicated in combination with ritonavir or its accompanying protease inhibitor

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, antiretroviral therapy, adherence, ritonavir
Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

Detailed Description
-----------------
The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. This assists in negotiating sharp turns by better anticipation of the direction. Cap-assisted colonoscopy can be tried as a salvage procedure in cases of failed cecal intubation with regular colonoscopy. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

Official Title
-----------------
Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery: A Randomized, Controlled Trial

Conditions
-----------------
Insertion Time

Intervention / Treatment
-----------------
* Device: cap-assisted colonoscopy
* Device: Standard colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of abdominal or pelvic surgery Exclusion Criteria: Previous colorectal resection

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cap-assisted colonoscopy<br>cap-assisted colonoscopy | Device: cap-assisted colonoscopy<br>* cap-assisted colonoscopy<br>|
| Active Comparator: Standard colonoscopy<br>Standard colonoscopy | Device: Standard colonoscopy<br>* Standard colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort | 10-point visual analog scale | Day 1 | 
| Overall technical ease | 10-point visual analog scale | Day 1 |
Bleeding Events After Triple Antithrombotic Therapy Initiation.

Study Overview
=================
Brief Summary
-----------------
The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard. Our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.

Official Title
-----------------
Bleeding Events After Triple Antithrombotic Therapy Initiation: a Prospective Observational Study in Real Life

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Other: Triple antithrombotic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation Exclusion Criteria: history of bleeding patients already under triple antithrombotic therapy patients under vitamin K antagonists

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Triple antithrombotic therapy|patients who are prescribed double antiplatelets agents and oral anticoagulation (except VKA)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events | Bleeding events with clinical significance | within 6 months since the initiation of triple antithrombotic therapy |