linjc16/ctgov huggingface dataset:
Randomised Comparison of 2 Cold Snare Polypectomy Techniques

Study Overview
=================
Brief Summary
-----------------
Different modalities are employed to remove small colonic polyps which potentially harbour a cancer risk. But, they can all vary in their completeness of removal, safety and the histological quality and the gold standard technique has yet to be defined. A novel suction pseudopolyp technique has been described by Patullo et al and in their prospective study, 126 polyps measuring less than 10mm flat or sessile were removed by this method with 100% complete endoscopic resection and without any immediate or delayed complications. The aim of the investigators study is to compare this technique with the standard cold snare technique. Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size will be eligible and they will be randomised to the polypectomy technique. Patient demographics and polyp characteristics will be recorded. The primary outcome measured will be the macroscopic resection rate. The secondary outcome measures are abdominal pain, tenderness, bleeding and fever.

Official Title
-----------------
A Prospective Randomised Comparison of Cold Snare Polypectomy Versus Cold Snare Pseudosuction Technique

Conditions
-----------------
Bowel Cancer

Intervention / Treatment
-----------------
* Procedure: conventional cold snare polypectomy
* Procedure: Cold snare polypectomy with suction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with small polyps 3-7 mm in size, flat or sessile found during colonoscopy Exclusion Criteria: Patients are less than 18 years old Pregnant Inadequate bowel preparation On anticoagulants or clopidogrel

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: conventional cold snare polypectomy<br>conventional cold snare polypectomy | Procedure: conventional cold snare polypectomy<br>* conventional cold snare polypectomy<br>|
| Experimental: Cold snare polypectomy with suction<br>Cold snare polypectomy with suction | Procedure: Cold snare polypectomy with suction<br>* Cold snare polypectomy with suction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete macroscopic polyp eradication rate | The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data. | At time of polypectomy intervention |
Initiation of Hydrocortisone for the Treatment of Septic Shock

Study Overview
=================
Brief Summary
-----------------
The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.

Official Title
-----------------
Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: Hydrocortisone
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years old or older; onset of septic shock within 6 h Exclusion Criteria: Systemic corticosteroid therapy within the last 3 months before septic shock; high-dose steroid therapy; immunosuppression; refusal of the attending staff or patient family.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. | Drug: saline<br>* Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.<br>* Other names: Normal saline;|
| Experimental: hydrocortisone<br>Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). | Drug: Hydrocortisone<br>* Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).<br>* Other names: cortisol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day Mortality | Death from any cause at 28 days after the onset of septic shock | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality | Death from any cause at 90 days after the onset of septic shock | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, hydrocortisone, mortality
Red Wine and Ageing and Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from 50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow mediate dilatation, coronary tomographic angiography and leucocyte telomere length. The sample size has been calculated expecting that regular red wine ingestion would lead to a five year old younger vascular ageing indexes measured by carotid intimal media thickness, coronary artery calcium scores and leucocyte telomere length longer than those abstainers subjects at same age. The investigators hypothesized that regular wine consumers present less coronary lesion and coronary calcium score on coronary tomographic angiography, lower carotid intimal media thickness and higher mean telomere length due the benefice of wine.

Official Title
-----------------
The Red Wine Project: a Study of Ageing Indexes and Prevalence of Atherosclerosis in Regular Red Wine Consumers Versus Abstainers

Conditions
-----------------
Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, from 50 years-old to 70 years-old. Exclusion Criteria: asiatic or with manifest atherosclerosis disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| red wine<br>red wine usual consumer versus abstemious | |

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
-----------------
wine, aging, atherosclerosis, telomere, tomography, coronary vessels
Hyaluronan in Embryo Transfer Media

Study Overview
=================
Brief Summary
-----------------
Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan. Primary outcome: implantation and pregnancy rates

Official Title
-----------------
Effect of Hyaluronan Enriched Embryo Transfer Media on IVF Outcome

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile patients entering in vitro fertilization treatment at least 1 embryo transferred Exclusion Criteria: IVF treatment with donated oocytes No embryo available for transfer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyaluronan enriched transfer media<br>Embryos are incubated at least 10 minutes in hyaluronan enriched embryo transfer media before transfer | |
| Control group<br>Embryos are incubated in embryo transfer media containing low concentration of hyaluronan for at least 10 minutes before transfer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Number of clinical pregnancies (gestational sacs visible by ultrasound examination) divided by the number of embryotransfers | 5 weeks after embryo transfer | 
| Implantation rate | Number of embryos implanted (No. of gestational sacs) divided by the number of embryos implanted | 5 weeks after embryotransfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple pregnancy rate | Number of multiple pregnancies divided by the number of embryotransfers | 5 weeks after embryotransfer | 
| Delivery rate | Number of delivery divided by the number of embryo transfers | 40 weeks after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization, Embryotransfer, Hyaluronan, Pregnancy rate, Implantation rate
KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis seems to be different according to the respiratory causative virus. The investigators propose to study, during an epidemic season, the correlation between KL-6 levels and clinical severity, and the type of viral infection.

Detailed Description
-----------------
Prospective, monocentric, case-control and transversal study Primary end-point: correlation between serum KL-6 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit Secondary end-points: respiratory virus detected by EIA and RT-PCR, phylogenetic study of rhinovirus, length of hospitalisation, immediate morbidity and mortality, risk of asthma at the age of three years old.

Official Title
-----------------
Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation

Conditions
-----------------
Acute Viral Bronchiolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: Inaugural acute bronchiolitis in infant aged under 1 year; bronchiolitis is defined by rhinorrhea and/or cough, dyspnea, associated with clinical or radiological distension, wheezing or crackling or brake expiratory. Controls: Infant aged under 1 year with blood sample test performed for a non-infectious disease (preoperative assessment) Exclusion Criteria: Cases: bronchopulmonary dysplasia, prematurity, cystic fibrosis, immunodeficiency, primary ciliary dyskinesia, congenital cardiopathy, use of corticotherapy the week between inclusion Controls: infectious documented disease, respiratory symptoms

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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 |
| --- | --- | --- |
| KL-6 rate |  | At day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcineurin, Bronchiolitis, Epithelial lung injury, Rhinovirus, Respiratory Syncytial Virus, Asthma
Physician Reimbursement Home Patients

Study Overview
=================
Brief Summary
-----------------
This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients.

Detailed Description
-----------------
Physician reimbursement today for care of a home dialysis patient is a capitated reimbursement, defined by the age of the patient and their days on home dialysis. Due to the multiple advantages of home therapy, CMS is working on increasing home dialysis uptake; however, there is little to no data on the time and effort involved in providing care to home dialysis patients. In this study, we will develop and distribute a survey to capture the components of home dialysis patient care and the perceived time and effort of nephrologists across the US to do so. This will provide data for CMS as they consider the adjustment of their policy values in physician reimbursement for home dialysis patient care, which is currently labeled as misvalued (Centers for Medicare and Medicaid Services, 2021).

Official Title
-----------------
Physician Reimbursement for Home Dialysis: Assessment of Validity of CMS Compensation for Nephrologists

Conditions
-----------------
ESRD

Intervention / Treatment
-----------------
* Other: No intervention. This is a qualitative study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All nephrologists in the US who care for dialysis patients. Exclusion Criteria: Nephrologists who have not cared for dialysis patients in the last year.

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

| Intervention/Treatment |
| --- |
|Other: No intervention. This is a qualitative study|US nephrologists who care for dialysis patients will be asked to complete an internet based survey evaluating the time and effort required for home dialysis patient care.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide data to facilitate a data-driven adjustment of the capitated physician payment for caring for home dialysis patients. | Compilation of survey data from US nephrologists with dialysis patients. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESRD, Home Dialysis, Compensation
Addressing Diabetes Together

Study Overview
=================
Brief Summary
-----------------
Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.

Official Title
-----------------
Addressing Diabetes Together: Implementation of a Regional Partnership for Population Health Management in Southeast Minnesota

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: Evidence-Based Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years or older Diagnosis of diabetes enrolled in the DSMP or DPP Exclusion Criteria: unable to provide consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program participants<br>Patients enrolled in the DSMP and DPP who provide consent. | Behavioral: Evidence-Based Program<br>* DSMP and DPP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure change in number of program offerings implemented in the community |  | Change from Baseline to 1 year |
Trunk Forward Ability in Patients With Lumbar Fusion

Study Overview
=================
Brief Summary
-----------------
The hypotheses of this study are as follows: There is no significant muscle activity difference of each muscle in patients between pre and post operation. There is no significant forward reach distance/average velocity difference in patients between pre and post operation. There is no significant standard deviation of center of pressure (COP) along x axis, speed of COP along y axis during the task and COP path during the 3-sec holding phase difference in patients between pre and post operation. There is no significant muscle activity difference between muscles on both sides at post operation.

Detailed Description
-----------------
30 healthy adults and 30 patients is going to undergo lumbar fusion surgery will be recruited in this study. The assessment will be held before surgery, two months, three months and six months after surgery. Visual pain scale and passive range of motion over lumbar, hip, knee, ankle joint of each subjects will be recorded. Then the maximum voluntary contraction at lower extremity will be measured by electromyography. Finally, the subjects will be asked to do forward reach by dominant upper limb/bilateral upper limbs/arm crossed in the front of chest for three times in standing and sitting position after five practices. The motion data will be collected by 3-dimension video and the muscle activity by electromyography.

Official Title
-----------------
Joint Coordination Changes During Functional Activities After Lumbar Fusion

Conditions
-----------------
Fusion of Spine, Lumbar Region

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: specific low back pain with MRI finding by the radiologist and the surgeon; patient who is scheduled for MISS in one week. Exclusion Criteria: scoliosis; neurological disorder; Self-reported impairment in daily activities; leg length deficiency over 2 cm; body mass index over 30.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| patients with lumbar fusion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG |  | one months post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forward reach distance |  | one month post operation |
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

Study Overview
=================
Brief Summary
-----------------
The use of MDS to access the presence of melanoma in the skin.

Detailed Description
-----------------
A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Official Title
-----------------
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)

Conditions
-----------------
Skin Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy. The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS. Male and female ≥ 21 years old. Subject is capable of giving written informed consent. Primary excision. Exclusion Criteria: The lesion is less than 1 cm from the eyes. The lesion is on the palms of hands or soles of the feet. Mucosal lesion. Pregnant females. Low study procedure compliance. Patients who are mentally or physically unable to comply with all aspects of the study. Undergoing chemotherapy. Minor or legally incompetent and not able to sign the consent form. Patient previously tested by MDS and was diagnosed with melanoma during the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 97 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 |
| --- | --- |
| Suspicious skin lesions.<br>No intervention is administered. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the performance of MDS |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination. |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Skin Cancer