linjc16/ctgov huggingface dataset:
Two Warming Methods in Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the operating room warming will be continued with the same warming method. Primary end point is core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia. Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is used in this study. During the study we will test the accuracy of the 3M BairHugger Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head. After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M BairHugger Temperature Monitoring System. So the patients (n=30) have both these different core temperature monitoring systems on their foreheads. This observational monitoring study is performed from the patient number 80 until the end.

Official Title
-----------------
Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.

Conditions
-----------------
Hypothermia, Accidental

Intervention / Treatment
-----------------
* Device: EasyWarm
* Device: BairHugger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25-40 ASA class I-III elective primary unilateral kneearthroplasty spinal anaesthesia Exclusion Criteria: ASA class > III unstable coronary artery disease revision surgery, bilateral arthroplasty general anaesthesia decreased mental status

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: EasyWarm<br> | Device: EasyWarm<br>* Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia<br>|
| Active Comparator: BairHugger<br> | Device: BairHugger<br>* Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature after arriving to the post-anaesthesia care unit |  | one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inadvertent, intraoperative hypothermia, prewarming, core temperature monitoring
Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

Study Overview
=================
Brief Summary
-----------------
Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.

Detailed Description
-----------------
Outcome measures Post-operative emergence delirium, observed with an average duration up to 24 hours Sedatives used in recovery unit

Official Title
-----------------
Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

Conditions
-----------------
Children, Post-operative Delirium, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: American Society Anesthesia (ASA) risks classification I or II Exclusion criteria: Parents who have cognitive problems Parents who have difficulty finishing questionnaire

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |
| degree of emergence delirium |  | after operation, with an average duration up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery room stay time |  | after operation, with an average duration up to 24 hours | 
| Sedatives used in recovery room |  | after operation, with an average duration up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia
Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors

Study Overview
=================
Brief Summary
-----------------
Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially. Design: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45% alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours postprandially. Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.

Official Title
-----------------
Phase I Study of Chinese Tea Flavor Liquor on Human Health

Conditions
-----------------
Alcohols, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Chinese tea flavor liquor
* Dietary Supplement: Chinese Meijiao liquor
* Dietary Supplement: Water control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no CVD history or liver disease, healthy young men Exclusion Criteria: smokers

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese tea flavor liquor<br> | Dietary Supplement: Chinese tea flavor liquor<br>* 60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.<br>|
| Placebo Comparator: Water<br>Water combined with meal as control. | Dietary Supplement: Water control<br> <br> |
| Placebo Comparator: Chinese Meijiao Liquor<br> | Dietary Supplement: Chinese Meijiao liquor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum sample | blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample. | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese tea flavor liquor, postprandial, uric acid, high-sensitive C-reactive protein
POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES

Study Overview
=================
Brief Summary
-----------------
Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.

Official Title
-----------------
ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK USING BUPIVACAINE ALONE OR COMBINED WITH MAGNESIUM SULFATE FOR DIABETIC FOOT SURGERIES

Conditions
-----------------
Diabetic Patient

Intervention / Treatment
-----------------
* Drug: bupivacaine
* Drug: magnesium sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (ASA) II or III scheduled for diabetic foot surgeries. Exclusion Criteria: Patients who refused the anaesthetic technique, whose BMI ≥ 35 kg/ m2, unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders), patients with coagulopathy, skin infection at the site of injection, preoperative use of opioid or non-steroidal anti-inflammatory drugs, allergy or contraindication to studied medication

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group B<br>28ml of 0.25% bupivacaine and 2ml normal saline | Drug: bupivacaine<br>* group B received 28ml of 0.25% bupivacaine and 2ml normal saline<br>|
| Active Comparator: group BM<br>received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%. | Drug: bupivacaine<br>* group B received 28ml of 0.25% bupivacaine and 2ml normal saline<br>Drug: magnesium sulfate<br>* group BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of postoperative analgesia | evaluate the effects of adding magnesium sulfate to bupivacaine versus bupivacaine alone in popliteal sciatic nerve block with ultrasound guidance for diabetic foot surgeries as regards the duration of postoperative analgesia | 24 hours |
Study to Evaluate the Efficacy of Bite's Natural Deodorant

Study Overview
=================
Brief Summary
-----------------
This is an open-label observational single-arm clinical trial to study the efficacy of a commercial deodorant and its effect on odor, clothing (stains), and quality of life. It is hypothesized that the deodorant marketed as Bite deodorant will mask bodily odor in participants, will not stain clothes, and improve the quality of life in trial participants.

Official Title
-----------------
Study to Evaluate the Efficacy of Bite's Natural Deodorant

Conditions
-----------------
Sweat, Underarm Odor

Intervention / Treatment
-----------------
* Other: BITE Deodorant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agree to refrain from the use of any other deodorant or antiperspirant other than Bite for the study period Must be in good health (does not report any medical conditions asked in the screening questionnaire) Must be willing to comply with the requirements of the protocol Must be willing to add the deodorant to their daily routine Is willing and able to share feedback Shower daily, and put deodorant on the first thing in the morning (before sweating) If used deodorants previously must be a natural version Exclusion Criteria: Unwilling to follow the routine of the protocol Currently participating in another research study Severe chronic conditions including oncological conditions, psychiatric disease, or other Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding Presence of self-reported armpit sensitivity Known to have severe allergic reactions Have known allergies to the trial product ingredients Currently using an antiperspirant

Ages Eligible for Study
-----------------
Minimum Age: 24 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bite Deodorant<br>All 38 participants apply BITE deodorant daily for four weeks. | Other: BITE Deodorant<br>* BITE natural Deodorant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in underarm odor | Survey-based assessment (0-5 scale) of changes in underarm odor | 4 weeks | 
| Changes in clothing staining | survey-based assessment (0-5 scale) of changes in clothing staining | 4 weeks | 
| Changes in reported quality of life | survey-based assessment (0-5 scale) of changes in reported quality of life | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sweat, underarm odor, perspiration
Cornual Wedge Resection Outcome

Study Overview
=================
Brief Summary
-----------------
Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. However, nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial resection. Although this technique can potentially protect the fertility of the patient, it carries a serious risk of bleeding and requires a surgical experience.

Official Title
-----------------
Cornual Wedge Resection for Interstitial Pregnancy and Postoperative Outcome

Conditions
-----------------
Ectopic Pregnancy, Laparoscopic, Cornual Pregnancy

Intervention / Treatment
-----------------
* Procedure: laparoscopic cornual resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cornual ectopic pregnancy Patients undergoing laparoscopic cornual wedge resection Exclusion Criteria: medical treatment area due to cornual pregnancy laparotomy conservatively managed patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic cornual resection|patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | The duration of surgery of patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy | surgery from start to end | 
| amount of bleeding | The amount of hemorrhage in patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy | 48 hours |
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)

Study Overview
=================
Brief Summary
-----------------
To determine accuracy specifications of the Pulse oximeter.

Official Title
-----------------
Controlled Acute Hypoxia Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between the ages of 18 to 50 years (inclusive). Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease All female volunteers must have a negative urine pregnancy test prior to participation. Exclusion Criteria: Pregnancy or lactating women Unexplained syncopal episodes Hypertension (defined as a systolic pressure of >145 mmHg or a diastolic pressure >90 mm Hg on three consecutive readings) Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute History of seizures (except childhood febrile seizures) or epilepsy Routine use of tranquilizers and/or excessive anxiety History of frequent headaches or migraines History of stroke Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors History of altitude sickness defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (> 1 hour) History of significant respiratory disease, such as severe asthma, emphysema, etc. Sickle cell disease or trait. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study. Abnormal ECG finding Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) Prior or known allergies to heparin. History of transient ischemic attacks or carotid artery disease History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy History of chronic renal impairment History of recent arterial cannulation (less than 1 month prior to study) History of complications from previous arterial cannulation Current use of blood thinners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| SpO2 Accuracy (percentage of blood oxygen saturation) |  | Duration of subject visit- approx. 1.5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjects
A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients

Study Overview
=================
Brief Summary
-----------------
This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: LCQ908
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent. Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3). No prior therapy or inadequate response to therapy for hepatitis C. Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2. Exclusion Criteria: Use of other investigational drugs within at least 30 days of enrollment Women of child-bearing potential. Other protocol-defined inclusion/exclusion criteria apply

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCQ908<br> | Drug: LCQ908<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change in hepatitis C viral load as assessed by PCR |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events. |  | 28 days | 
| Measure: LCQ908 concentrations in the blood |  | over 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C virus, Chronically infected, treatment naive, non responders to prior therapy
Study With Fascigel

Study Overview
=================
Brief Summary
-----------------
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.

Official Title
-----------------
Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Device: Fascigel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Back pain (VAS above 4 cm) Limited range of motion Duration of pain for over 3 months Patient willing and able to provide the written consent Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study Exclusion Criteria: State after back surgery BMI > 35 Age < 18 years Pregnant or lactating woman Patient in terminal stage of living Patient with known hypersensitivity or allergy to any of substances contained in Medical Device Patient participating in the intervention clinical study Alcohol or drug abuse Patient undergoing chronic coagulation therapy

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 |
| --- | --- |
| Experimental: Fascigel injection application<br>Device is administered injected interfascially in the concerned place (low back) in multiple places laterally. | Device: Fascigel<br>* The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Pain management | Visual Analogue Scale - 0-100 - higher scores mean a worse outcome | 3 months |