linjc16/ctgov huggingface dataset:
Personalized Prediction of Persistent Postsurgical Pain

Study Overview
=================
Brief Summary
-----------------
P5 is planned as a prospective observational study, collecting evidence-based perioperative data on patient history and demographics, physical function, cognitive measures, psychological, and biological markers associated with increased pain susceptibility, and psychophysical measures of pain processing. The study will use daily ecologic momentary assessment (EMA) of physical and emotional parameters, and collect data on perioperative events. Follow up will occur 3 months and 6 months postoperatively.

Official Title
-----------------
Personalized Prediction of Persistent Postsurgical Pain

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18-75 who are candidates for major surgery (expected surgery duration >1 hour, and expected overnight admission to the hospital) Access to a smartphone Exclusion Criteria: Participants who do not speak English

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Postsurgical Pain (PPSP) | Clinically meaningful PPSP will be defined as pain in the surgical area present 3 months after surgery which fulfils one of the following criteria: 1) pain intensity on rest or movement ≥3 on 0-10 numerical rating scale (NRS), or 2) pain interference with any of the seven Brief Pain Inventory items (general activity, mood, walking ability, normal work [including housework], relations with other people, sleep, and enjoyment of life) ≥3 on 0-10 scale. | up to 7 months following consent |
Acupuncture and Laser Acupoint Treatment on Hypertension

Study Overview
=================
Brief Summary
-----------------
To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive subjects.

Detailed Description
-----------------
The specific aims of the study are to test the effectiveness of acupuncture and laser acupoint on hypertension. The hypothesis is: the stimulation of a pattern of acupoints with acupuncture and laser will result in significant reductions in blood pressure. The points that are going to be used for the study are: Zusanli (St36), Tianshu (St25), Quchi (LI11).

Official Title
-----------------
Acupuncture and Laser Acupoint Treatment on Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Laser acupoint treatment
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over 18 and under 70 years of age with hypertension (blood pressure over 140/90 mmhg). Exclusion Criteria: Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, and currently taking drugs or medications will not be recruited in the study. A health history questionnaire will be used to screen the subjects.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Procedure: Acupuncture<br>* Needle acupuncture on ST36 and LI11.<br>|
| Experimental: Laser Acupoint<br> | Device: Laser acupoint treatment<br>* Laser<br>* Other names: Laser;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Pretreatment then at 2 and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, acupuncture, laser
Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

Detailed Description
-----------------
Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures >40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.

Official Title
-----------------
Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care

Conditions
-----------------
Sphincter of Oddi Dysfunction, Abdominal Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over age 18 suspected history and clinical features suggestive of sphincter of oddi dysfunction Exclusion Criteria: prior history of endoscopic therapy for sphincter of oddi dysfunction no proven sphincter of oddi dysfunction on manometry

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| sphincter of oddi dysfunction<br>endoscopic therapy vs conservative care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom improvement |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved quality of life |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sphincter of Oddi Dysfunction
Analysis of Respiratory Variations of the Right Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . The aim of the study was to test the hypothesis that respiratory changes in right internal jugular vein diameter are similar to respiratory changes in superior and inferior vena cava in mechanically ventilated patients and therefore help to predict fluid responsiveness.

Official Title
-----------------
Analysis of Respiratory Variations of the Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation

Conditions
-----------------
Jugular Veins, Ultrasonography

Intervention / Treatment
-----------------
* Diagnostic Test: respiratory variation of the right internal jugular vein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years Mechanical Ventilation Exclusion Criteria: no exclusion Criteria

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: respiratory variation of the right internal jugular vein<br> | Diagnostic Test: respiratory variation of the right internal jugular vein<br>* respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV | Difference (Δ) between the maximum and the minimum diameter value/maximum diameter . | through study completion, an average of 1 year | 
| Respiratory Variation of the superior vena cava ∆DSVC | Difference (Δ) between the maximum and the minimum diameter value/maximum diameter . | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Variation of the inferior vena cava ∆DIVC | Difference (Δ) between the maximum and the minimum diameter value/minimum diameter . | through study completion, an average of 1 year |
Predictors of Scar Dehiscence in Patients With Previous Caesarean Section

Study Overview
=================
Brief Summary
-----------------
In recent decades, the percentage of Cesarean section deliveries has dramatically increased in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased steadily. The pregnant women with previous Cesarean section face a difficult choice for their next delivery between a trial of labor after Cesarean or repeat caesarean section delivery. The performance of multiple Cesarean section exposes women to greater risks of complications; furthermore, the risk of complications increases with each subsequent Cesarean section. In fact, women with previous Cesarean section are more likely to experience short and long-term maternal complications in future pregnancies, or a trial of labor after Cesarean, with the risk of [uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and difficulties during surgery

Official Title
-----------------
Predictors of Scar Dehiscence in Patients With Previous Caesarean Section; a Study of Different Variables Tenderness Versus Non-stress Test

Conditions
-----------------
Cesarean Section; Dehiscence

Intervention / Treatment
-----------------
* Device: non-stress test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant full-term 37-42 weeks. Previous one caesarean section Exclusion Criteria: Absolute indication of cesarean section in previous and in current pregnancy Pregnant women with Hemoglobin <9 Pregnant women with bleeding tendency Pregnant women with collagen disease Pregnant women with pre-eclampsia and eclampsia Pregnant women with gestational diabetes Multiple pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: non-stress test|antepartum fetal monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of women with dehisensce scar and Non-stress test abnormalities |  | 6 hours |
Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.

Detailed Description
-----------------
Mosquito-bite symptoms include wheals and pruritic bite papules. Oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials. Subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.

Official Title
-----------------
A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects

Conditions
-----------------
Allergy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent history of suffering from mosquito-bite reactions. At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes Exclusion Criteria: Pregnancy or lactating females Oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (NSAID) use within two weeks before the study. Severe or moderate systemic illness Allergy to rupatadine or other antihistamines Anaphylaxis from mosquito bites

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rupatadine|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bite lesion size (squared mm) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus on a Visual Analog Scale |  |  |
Parent-QoL and Sleep Disordered Breathing

Study Overview
=================
Brief Summary
-----------------
In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who were planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprise the control group.

Detailed Description
-----------------
Parents of children with any chronic illness may experience increased anxiety and reduced health-related quality of life (QoL). In this study, the investigators will analyze QoL parameters among parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment. In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who are planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprisedthe control group. The investigators will translate and validate the PAR-ENT-QoL questionnaire through forward-backward translation method. Main outcome measure: The questionnaire was tested for reliability, consistency, reproducibility, responsiveness, and for its clinical use.

Official Title
-----------------
The Impact of Sleep Disordered Breathing on Parental Quality of Life

Conditions
-----------------
Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Procedure: adenotonsillectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy Exclusion Criteria: We excluded parents of children who required immediate surgery or had any other chronic diseases (such as ADHD, asthma, allergic rhinitis or severe medical or mental impairments).

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Study<br>parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment | Procedure: adenotonsillectomy<br>* adenotonsillectomy surgery<br>|
| Control<br>A group of parents to healthy children comprised the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in the PAR-ENT-QoL questionnaire score | translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method. | Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery |
Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

Study Overview
=================
Brief Summary
-----------------
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Detailed Description
-----------------
The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Dexcom Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 2 or older Diagnosis of Type 1 diabetes or Type 2 diabetes Willing to wear the required number of Systems for the total duration of study wear Willing to participate in Clinic Session(s) during study wear Exclusion Criteria: Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin Known allergy to medical-grade adhesives Pregnancy Hematocrit outside specification ≥ 18 years of age: Male: 36.0%; Female: 33.0%; 13-17 years of age: 35.0%; 7 years - 12 years of age: 32.0%; End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM Users<br>Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement. | Device: Dexcom Continuous Glucose Monitoring System<br>* Dexcom Continuous Glucose Monitoring System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexcom Continuous Glucose Monitoring System Performance | The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Related Adverse Device Effects | The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants | 10 days |
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy

Study Overview
=================
Brief Summary
-----------------
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.

Detailed Description
-----------------
the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days

Official Title
-----------------
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial

Conditions
-----------------
Stomatitis

Intervention / Treatment
-----------------
* Drug: tulsi extract
* Drug: Benzydamine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV) Patient should be able to read and/or understand and sign the consent form. Exclusion Criteria: Patients with HIV infections or hyperthyroidism. Karnofsky performance status (KPS) less than 60% Patients having an allergy to tulsi or benzydamine HCL Patients who are pregnant and/or nursing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Allocation ratio (1:1)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tulsi extract<br>4% tulsi extract as intervention | Drug: tulsi extract<br>* 4% topical oral spray<br>|
| Active Comparator: benzydamine hydrochloride<br>0.15% benzydamine hydrochloride | Drug: Benzydamine Hydrochloride<br>* 0.15% topical oral spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of mucositis | Oral Mucositis Assessment Scale (OMAS) | up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and burning sensation | assess by numerical rating scale (NRS) (10 points scale) | up to 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral mucositis, tulsi extract, benzydamine hydrochloride, radiotherapy