linjc16/ctgov huggingface dataset:
Delphi Study to Identify Crucial Steps and Errors in the Placement of Chest Tubes

Study Overview
=================
Brief Summary
-----------------
The goal of this Delphi study is to identify the crucial steps and the errors in Chest Tube Insertion (CTI). These steps and errors will be used for the development of a new assessment tool based on international consensus.

Official Title
-----------------
Delphi Study to Identif Crucial Steps and Errors in the Placement of Chest Tubes

Conditions
-----------------
Thoracic Injury

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be experts in their respective fields. Must hold a degree of Master in Medicine Must have finished the residency training specific to their field (be an attending physician) Must have 5 years post-residency experience Must have performed at least 50 CTIs independently in their career Must have an interest in educating and guiding junior residents in their training. Exclusion Criteria: Insufficient experience in CTI Insufficient experience as an attending physician
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Delphi study<br>Participants were asked to complete three rounds of surveys. These surveys collected information on which steps and errors can occur during CTI, and which of these should be included in an assessment tool. | Other: Survey<br>* Surveys were distributed using REDCap, and participants were asked to complete these within 5 weeks of receiving the invitation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps and errors presented in round 1 | The number of experts who propose a certain step or error | one year | 
| Number of steps and errors passing round 2 | The number of experts who agree on the inclusion of each step or error in the assessment tool on a 5-point Likert scale (Strongly disagree - Disagree - Neutral - Agree - Strongly Agree). | one year | 
| Inclusion of steps with their descriptive anchors | The number of experts who agree on the inclusion of each step with their descriptive anchors in the assessment tool on a 5-point Likert scale (Strongly disagree - Disagree - Neutral - Agree - Strongly Agree). | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment, Chest Tube Insertion, Rating Scale
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that different types of starch vary in their effects on appetite, blood sugar and food intake. In this study, subjects consumed five soups containing 50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added starch at one week intervals. The investigators measured food intake at 120 minutes, appetite and blood sugar.

Official Title
-----------------
The Effect of Different Types of Starch on Glycemic Response, Subjective Appetite and Short-term Food Intake in Young Men

Conditions
-----------------
Obesity Prevention, Diabetes Prevention

Intervention / Treatment
-----------------
* Other: Dietary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males with a BMI of 20-24.9 kg/m2 Exclusion Criteria: Females Smokers Breakfast skippers Individuals with diabetes or other metabolic diseases

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soup with no added starch<br> | Other: Dietary Intervention<br>* soup with or without starch<br>|
| Experimental: Soup + 50 g of whole grain starch<br> | Other: Dietary Intervention<br>* soup with or without starch<br>|
| Experimental: Soup + 50 g of high amylose corn starch<br> | Other: Dietary Intervention<br>* soup with or without starch<br>|
| Experimental: Soup + 50 g of regular corn starch<br> | Other: Dietary Intervention<br>* soup with or without starch<br>|
| Experimental: Soup + 50 g maltodextrin starch<br> | Other: Dietary Intervention<br>* soup with or without starch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | 0-200 min | 
| Food Intake |  | at 120 min | 
| Appetite |  | 0-200 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of treatments |  | 0-200 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
starch, carbohydrates, blood glucose, food intake, satiety, appetite
Post-operative Sore Throat and Gum Chewing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA (laryngeal mask airway) placed for procedures with duration greater than 1 hour.

Detailed Description
-----------------
Patients will be randomized into two groups. Group 1 will receive a piece of gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage. Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.

Official Title
-----------------
Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial

Conditions
-----------------
Anesthesia, Surgery

Intervention / Treatment
-----------------
* Other: Gum
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient ambulatory surgery General anesthesia utilizing a laryngeal mask airway Greater than 1 hour duration Exclusion Criteria: Chronic laryngitis Chronic bronchitis Asthma Gastroesophageal reflux disease Smoking within the last week Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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: Gum<br>Group 1 will receive gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage. | Other: Gum<br>* 2 minutes of gum chewing prior to procedure<br>|
| Other: Control<br>Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention. | Other: Control<br>* 2 swallows prior to procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate to severe Post-operative Sore Throat within 24 hours | Moderate to severe post-operative sore throat defined as greater than 3 on an 11-point Numeric Rating Scale; 0 being no sore throat, 10 being maximum imaginable sore throat | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Anesthesia | 5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied | 24 hour |
Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.

Detailed Description
-----------------
This study is a prospective multicenter single-arm phase II clinical trial. Rectal cancer patients with cT3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. For those who have good response (ycT0-1) will underwent transanal local excision under the patients' agree.

Official Title
-----------------
Local Excision of Clinical T3 Mid- or Low-Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy: Prospective Multicenter Single-arm Phase II Clinical Trial

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Local excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: more than 20 years biopsy-proven adenocarcinoma of the rectum clinical staging, cT3NxM0 Rectal cancer located 8 cm from the anal verge Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0 ECOG performance status 2 or less Exclusion Criteria: Synchronous colon cancer or other malignancy Obstructing rectal cancer Pregnant or breast-feeding Receiving any other study agents History of prior colorectal cancer or inflammatory bowel disease Hereditary colorectal cancer (FAP, HNPCC)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Local excision<br>Local excision for rectal cancer with good response | Procedure: Local excision<br>* Local excision for rectal cancer with good response<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival | Death or recurrence as an event | 1-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | The rate of complete response of the tumor after neoadjuvant chemoradiotherapy | 1-5 years | 
| Overall survival rate | Death as an event | 1-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal neoplasms, Colorectal neoplasms, Local excision
Automated Telephone Reminder for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
This is a quality improvement study to determine the impact of an automated telephone reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.

Detailed Description
-----------------
Randomized trial of automated reminders with bowel prep instructions and encouraging clear fluid ingestion. The phone calls will occur 48-96 hours prior to the scheduled colonoscopy. All patients undergoing outpatient colonoscopy and prescribed sodium picosulfate plus magnesium citrate will be eligible for enrollment.

Official Title
-----------------
Automated Telephone Reminder Prior to Outpatient Colonoscopy and the Effect on Bowel Preparation Quality

Conditions
-----------------
Polyps

Intervention / Treatment
-----------------
* Other: Phone call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Scheduled for outpatient colonoscopy at a later date Prescribed evening-before or split-dose low volume preparation regimens Exclusion Criteria: Refusal to receive automated telephone reminder No access to telephone Urgent/emergent indication for colonoscopy Prescribed a bowel prep other than Pico-Salax/Purgodan Receiving upper and lower combined procedure

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving reminder phone call<br>Will receive phone call to remind colonoscopy date and bowel prep | Other: Phone call<br>* Automated phone call reminder<br>|
| No Intervention: Not receiving reminder phone call<br>Will not receive phone call to remind colonoscopy date and bowel prep | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ottawa preparation scale score | measures the cleanliness of each part of the colon and the overall fluid volume as assessed by the endoscopist | Immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of glasses of fluid consumed pre-colonoscopy |  | 24 hours |
BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: ibandronate [Bonviva/Boniva]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women or men >30 years of age; osteoporosis; vertebral osteoporotic fracture in past 4 weeks; fracture-related pain requiring analgesic treatment. Exclusion Criteria: non-menopausal women; current treatment with another bisphosphonate; current treatment with class III analgesics.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 3mg i.v. single dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo i.v. single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7). |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with >=50% diminution of pain between day 0 and 7 |  | Day 7 | 
| Pain control |  | Day 7 and 1 month | 
| Analgesic medication |  | 1 month | 
| Hospitalization |  | 1 month | 
| AEs and laboratory parameters |  | Throughout study |
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.

Official Title
-----------------
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: Eszopiclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Participants who have completed LUN01S and need to continue eszopiclone
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with insomnia<br>Participants with insomnia who will receive eszopiclone per approved label. | Drug: Eszopiclone<br>* The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.<br>* Other names: EZOP; Lunesta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of overall improvement | Participants will be interviewed regarding sleep improvement at 3 months after first dose or discontinuation, relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible | At month 3 | 
| Assessment of overall improvement | Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible | At month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia
Haptoglobin and Diabetes Complications in Pregnancy

Study Overview
=================
Brief Summary
-----------------
Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome . The risk for vascular complications including: Intra uterine growth restriction (20%), hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly greater than those in background populations. The risk of developing vascular complications in diabetes pregnancies although is correlated with the severity and length of the disease is not fully understood. Enhanced oxidation has been suggested to be the underlying abnormality responsible for some of the complications of diabetes. Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells. Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the release of heme iron. The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%, 48% and 36%, respectively. In the western world. A total of five independent longitudinal studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to determine whether HP genotype plays important role in development of vascular complications in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing gestational diabetes (GDM)

Official Title
-----------------
Haptoglobin and Diabetes Complications in Pregnancy

Conditions
-----------------
Diabetes in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes in pregnancy Exclusion Criteria: Not willing to participate
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| vascular complications in pregnancy |  | 9 months |
Urine Sample Collection From FOP Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.

Official Title
-----------------
Urine Sample Collection From Patients With Fibrodysplasia Ossificans Progressiva (FOP) for Biomarker Analysis

Conditions
-----------------
Fibrodysplasia Ossificans Progressiva

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP. Physically able to provide first-morning urine sample of at least 30 mL Able to communicate well with the investigator, to understand and comply with the requirements of the study About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function Exclusion Criteria: Diagnosis of diabetes Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.) Diagnosis of cancer other than nonmelanomatous skin cancer.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| Analysis of pre-defined biomarker FGF2 | The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis | 3 months | 
| Analysis of pre-defined biomarker WEGF | The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis | 3 months | 
| Analysis of microRNAs | The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis | 3 months |