linjc16/ctgov huggingface dataset:
Colorectal Cancer Screening Validation Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.

Official Title
-----------------
Altered Gene Expression in Colorectal Smears of Individuals With Colon Cancer

Conditions
-----------------
Colorectal Cancer Screening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to provide informed consent greater than or equal to 50 years of age patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery subject is willing to provide colorectal mucosal sample for gene expression testing Exclusion Criteria: recent radiation or treatment for gynecologic, prostate or rectal cancer recent surgery for anal rectal disease polys, family or self history of cancer (control group only) GI disease any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions. | |
| 2<br>Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data |  | Mai 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates |  | Mai 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer screening, Gene expression, RTPCR
Application and Generalization of Flutter Mucus Clearance Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.

Detailed Description
-----------------
Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.

Official Title
-----------------
Application and Generalization of Flutter Mucus Clearance Device

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Device: flutter mucus clearance device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary department: available to perform the device, in-hospital patients Male and female Age: 45 - 85 years Chronic bronchitis, COPD Thoracic surgery department and surgical department (upper abdomen): Patients with endotracheal intubation of general anesthesia Age: 40-75 years Exclusion Criteria: Not available to perform the procedure Untreated pneumothorax Diffusion interstitial lung disease Acute coronary syndrome Third stage hypertension Advanced cancer Severe heart, liver, renal , blood system and endocrine system dysfunction Noninvasive mechanical ventilation more than 6 hrs per day Patients with invasive ventilation and cannot weaning and extubation within 48 hours Active hemoptysis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>flutter mucus clearance device | Device: flutter mucus clearance device<br>* five minutes every session, four sessions per day<br>|
| No Intervention: 2<br>Observation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Disease, Chronic Obstructive, flutter, airway clearance, sputum, Physical Therapy Techniques
Transition of Diabetes Care From Pediatric to Adult Healthcare Providers.

Study Overview
=================
Brief Summary
-----------------
A dedicated pre-transition class, as proposed in this study, could help facilitate a smooth transition between pediatric and adult diabetes care. The innovation in this study is that these classes are an opportunity for the patients and their families to meet with the Adult Diabetes Team consisting of a diabetologist, RD and CDE, prior to the transition of care. Having met them would then increase the likelihood of compliance with the Adult clinic visits.

Official Title
-----------------
Adolescents With Type 1 Diabetes Who Attend Pre-transition Classes, Are Better Prepared to Transition Their Care From Pediatric to Adult Providers

Conditions
-----------------
Transition

Intervention / Treatment
-----------------
* Other: Transition classes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents with Type 1 Diabetes Exclusion Criteria: Not wanting to participate in the classes

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients attending the classes<br>The patients attending the transition classes will receive a survey to assess transition preparedness before and after attending the class. | Other: Transition classes<br>* 90 minutes spent with patients and their families (separately) to review the changes and challenges associated with healthcare transition and help alleviate some of the barriers traditionally associated with this process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition preparedness | Patients with be given the modified TRAQ questionnaire before and after the program. A team consisting of an adult diabetes provider, diabetes nurse educator and dietitian will meet in small groups with adolescents between ages 16-18 years to provide them with 'adult specific' goals and discuss various topics like college preparedness, expectations from adult providers, potential changes in dynamics of diabetes management etc. | 1 month |
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient

Study Overview
=================
Brief Summary
-----------------
Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.

Official Title
-----------------
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient

Conditions
-----------------
Intubation; Difficult or Failed, Obesity

Intervention / Treatment
-----------------
* Device: McGrath MAC
* Device: Trachway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery needs intubation ASA I to III BMI>30kg/m2 Exclusion Criteria: Head and neck cancer Skull, neck fracture Tracheal trauma NPO< 8hr Lung disease with hypoxemia Mental Disorders Patient wouldn't be extubated after operation immediately Contraindicated to muscle relaxant

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Laryngoscope<br>Intubation with traditional laryngoscope | |
| Active Comparator: McGrath MAC<br>Intubation with video laryngoscope | Device: McGrath MAC<br>* Intubaion with McGrath MAC<br>|
| Active Comparator: Trachway<br>Intubation with video stylet | Device: Trachway<br>* Intubaion with Trachway<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | Total intubation duration | 10 minute | 
| Intubation difficulty | Including Intubation difficulty scale, inubation attempt times, number of operator | 10 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any injury during intubation | Including sore throat, hoarseness, trauma | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, Intubation
Post-operative Mobilization for Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of one week of immobilization following carpal tunnel release surgery versus no immobilization.

Official Title
-----------------
Post-operative Mobilization for Carpal Tunnel

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: Carpal tunnel release surgery
* Procedure: Carpal tunnel release surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing open carpal tunnel release will be included in this study. Patients must have clinical evidence of carpal tunnel syndrome. Patients must have positive EMG results. English speaking patients only. Patient selection factors include: Ability and willingness to follow instructions. Patients who are able and willing to return for follow-up evaluations. Patients of all races and genders. Patients who are able to follow care instructions. Exclusion Criteria: Patients less than 18 years old. Patients who are pregnant. Patients unwilling or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol. Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: Carpal tunnel release surgery<br>* Patient will have carpal tunnel release surgery and will be put in a splint after surgery.<br>|
| Active Comparator: 2<br> | Procedure: Carpal tunnel release surgery<br>* Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome. |  | 6 months |
Doppler and Biological Second Trimester Placental Insufficiency Screening

Study Overview
=================
Brief Summary
-----------------
To assess the role of uterine artery and maternal serum leptin and lipids and their combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at 20-24 weeks of gestation

Detailed Description
-----------------
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention. Uterine artery Doppler during anomaly scan at 20 to 24 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy. Studies have reported detection rate of 50-70% for a 5% false positive rate in women developing early pre-eclampsia. A variety of proteins and hormones have been studied as potential markers for pre-eclampsia. Among these protein serum placental leptin has demonstrated higher levels in pregnant women who will subsequently develop pre-eclampsia. However, screening performance of leptin detection in early pregnancy has never been assessed. Our study is aimed to evaluate the performance of serum leptin measurement in association with uterine artery Doppler as a screening too for placental insufficiency.

Official Title
-----------------
Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids

Conditions
-----------------
Pre-Eclampsia, Fetal Growth Retardation, Placental Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hypertension under medication Diabetes Thrombophilia Previous history of pre-eclampsia Previous history of unexplained stillbirth Previous history of placental abruption Previous history of SGA (< 10th centile) History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister Obesity (BMI>30) Nulliparous after 40 years Assisted conception with donor Exclusion Criteria: Multiple pregnancy Complicated pregnancy with a high probability of required fetal extraction before term Pregnancy requiring termination Unability to understand the study

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?
-----------------
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
-----------------
Screening, uterine artery Doppler, HELLP syndrome, abruption
Sensory Changes From Chest Drains

Study Overview
=================
Brief Summary
-----------------
Does chest drains contribute to the post thoracotomy pain syndrome

Official Title
-----------------
Late Sensory Changes From Chest Drain Insertion During Thoracotomy

Conditions
-----------------
Thoracotomy, Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Able to cooperate able to speak and read Danish Exclusion Criteria: repeat surgery cognitive dysfunction other nerve injury on the thorax abuse (medicine/ alcohol etc)

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 |
| --- | --- |
| lung cancer surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (NRS) |  | 3 years postoperatively | 
| Sensory thresholds |  | 3 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometrics (HADS) |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracotomy, Chronic Pain, persistent post-surgical pain
Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Lidocaine Spray
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Not pregnant Smear negative Exclusion Criteria: Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline spray application<br>Placebo group | Drug: Placebo<br> <br> |
| Experimental: lidocaine spray application<br>2 puff lidocaine spray applicated before IUD insertion | Drug: Lidocaine Spray<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 10 cm VAS scale | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scores During IUD insertion.
Low Dose St John's Wort for Depression

Study Overview
=================
Brief Summary
-----------------
This observational study observes the routine use of low-dose St John's Wort herbal mother tincture in patients with major depression. It measures intensity of depression at the beginning of St Johns Wort and after 6 weeks and evaluates tolerability and compliance.

Detailed Description
-----------------
Herbal medicine is widely used, and high-quality evidence shows their efficacy and tolerability for specific disorders. Most of the studies, however, is conducted with standardized, relatively high dosed dry extract preparations, while other preparations such as tinctures are widely used as well. The aim of this observational study ist to document real-live use of the use of a low-dose herbal medicine preparation (a mother tincture) of St John's Wort (Hypericum perforatum), to compare depression intensity at the beginning and after 6 weeks of therapy using the Hamilton Depression Scale 17, and to evaluate tolerability and compliance. Finally, the results will be compared with results of randomized controlled trials examining high dosed dry extract preparations of St John's Wort for major depression.

Official Title
-----------------
Observational Study of the Efficacy and Tolerability of Low-dose Phytotherapy Using the Example of St John's Wort (Hypericum Perforatum)

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: St John's Wort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of mild or moderate depression according to ICD-10 or DSM-IV new start of CERES St John's wort mother tincture Exclusion Criteria: - at the same time as St John's wort mother tincture started, other antidepressive therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: St John's Wort|daily intake of CERES St John's Wort mother tincture. Dose according to the treating physician.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale 17 | validated tool to measure depression intensity. Maximum score 51, minimum 0. Higher score means higher intensity of depressive symptoms. | Change at 6 weeks |