linjc16/ctgov huggingface dataset:
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC

Detailed Description
-----------------
Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment. The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort

Official Title
-----------------
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma, Glottic T1

Intervention / Treatment
-----------------
* Procedure: Transoral Laser Microsurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC) Exclusion Criteria: Unable to complete curative intended protocol treatment and/or planned follow up informed concent

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transoral Laser Microsurgery<br>Transoral Laser Microsurgery | Procedure: Transoral Laser Microsurgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laryncegtomy free survival | Alive with larynx | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | Free from disease after primary treatment | 5 years | 
| Ultimate tumor control | Free from disease after primary treatment including salvage RT or surgery | 5 years | 
| Overall survival | Death of any cause | 5 years | 
| Voice quality | Voice Handicap Index score | 3 years | 
| Radiation free survival | survival without being treated with RT | 5 years | 
| any other treatment related morbidity | Dahanca morbidity recording | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transoral laser microsurgery, Accelerated radiotherapy
Clinical Study to Assess the Effectiveness of the Device Patello

Study Overview
=================
Brief Summary
-----------------
The device Patello was designed to passively mobilize the Patella in cranial-caudal direction. Its application field lays in the rehabilitation of any knee pathology where knee range of motion may be restricted due to the Patella mobility.

Detailed Description
-----------------
The effectiveness of the device Patello has not been tested so far. This clinical study aims to assess and proof the effectiveness of this device. The aim is to objectify the movement of the Patella induced by the device Patello in cranial / caudal direction. As outcome parameter serve ultrasound measurements of a bony reference point of the femur and the Patella and its displacement / distance after mobilization.

Official Title
-----------------
Clinical Study to Assess the Effectiveness of the Device Patello

Conditions
-----------------
Passiv Continuous Patella Mobilisation

Intervention / Treatment
-----------------
* Device: Patello


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities closed and intact skin conditions in the area of the knees and thighs no fear of the intervention willingness to participate on all 2 measurement days Exclusion Criteria: operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities open skin conditions in the area of the knees and thighs fear of the intervention no willingness to participate on all 2 measurement days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: One randomly selected knee is treated by the intervention device Patello
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patello<br> | Device: Patello<br>* The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | The cranial-caudal mobilisation of the Patella is assessed during the mobilisation by means of the Patello. | 1 hour |
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .

Official Title
-----------------
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥16 years at index date. Patients with records of receiving high dose ICS or high dose ICS/LABA and diagnosed as asthma (ICD-10 code: J45 or J46 ) during baseline period. High dose ICS and high dose ICS/LABA will be defined in the appendices (Table 6-9). Patients who had visit histories at least one visit during baseline period, at least two visits during outcome period and at least one visit after outcome period. Patients who had a total of 12 weeks of OCS prescribed during the baseline period including the index date. Exclusion Criteria: 1. Patients diagnosed with selected autoimmune diseases during the baseline period because OCS is used as a therapeutic agent for these disease. Autoimmune disease will be identified by following ICD-10 code (M30, M05, M06, L93, M32, K50, K51, K52, N04).

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 130 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 |
| --- | --- | --- |
| Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 |  | from week-0 to week-24 | 
| Percentage of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose from week-0 to week-24 respectively. | (the number of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose) / (number of total patients ) x 100 | from week-0 to week-24 | 
| Total amount of maintenance OCS prescribed during outcome period. |  | from index date to 24 weeks later | 
| Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 with two groups. | Two groups are amount of regular OCS use at index date is ①5mg/day or more and ②10mg/day or more respectively. | from week-0 to week-24 | 
| Total amount of SCS during outcome period. |  | from index date to 24 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8. |  | from week-0 to week-8. | 
| Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16. |  | from week-0 to week-16 |
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)

Study Overview
=================
Brief Summary
-----------------
Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation. Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves). Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver. Proof of hypothesis: Pilot study with n=20 patients with PSC Explorative, open-label, mono-centric study Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

Official Title
-----------------
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study

Conditions
-----------------
Reduction of Intestinal Inflammatory Activity

Intervention / Treatment
-----------------
* Dietary Supplement: Gluten-free diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy. Exclusion Criteria: patients with coeliac disease or wheat allergy patients with active colitis patients already on gluten-free diet liver transplanted patients patients also diagnosed with autoimmune hepatites (PSC-AIH overlap) coloscopy within 2 months before study Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study antibiotics within 3 month before study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Gluten-free diet|After run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of intestinal inflammatory activity | Expression of pro-inflammatory cytokines in gut mucosa (Sigma) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory activity of the liver | alkaline phosphatase (AP) | 2 months | 
| Reduction of inflammatory cells/markers in the blood | stored blood samples, Pax-Gene | 2 months | 
| Quality of life | questionnaire | 2 months | 
| Change of symptoms with change of diet. | questionnaire | 2 months | 
| Changes in patients microbiota | stool samples | 2 months (5 months with follow-up) |
Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome

Study Overview
=================
Brief Summary
-----------------
To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope.

Detailed Description
-----------------
In a prospective interventional case-control study, 20 eyes with cataract and PEX and 20 control eyes with cataract without PXE were subjected to phacoemulsification and posterior chamber foldable intraocular lens implantation in Minia University Hospital and Genaidy Eye Center between March 2019 and December 2020. Specular microscopy was done preoperatively, 3 and 6 months postoperatively. Endothelium cell density (ECD), coefficient variation (CV), hexagonality, pleomorphism and corneal thickness were evaluated and compares between PXE and control eyes.

Official Title
-----------------
Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome

Conditions
-----------------
Corneal Endothelial Cell Loss, Pseudoexfoliation Syndrome

Intervention / Treatment
-----------------
* Procedure: phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: senile cataract age more than 55 years Exclusion Criteria: PEX with glaucoma, eyes with cornea guttata or any corneal dystrophy, zonular dehiscence, very dense nuclear cataract (cataracta nigra) history of previous ocular surgery.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome<br> | Procedure: phacoemulsification<br>* phacoemulsification with corneal endothelial evaluation by specular microscopy<br>|
| Experimental: Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation<br> | Procedure: phacoemulsification<br>* phacoemulsification with corneal endothelial evaluation by specular microscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal endothelial cell loss | corneal endothelial cell loss | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
BlueWind RENOVA iStim™ System for the Treatment of OAB

Study Overview
=================
Brief Summary
-----------------
The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

Official Title
-----------------
A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)

Conditions
-----------------
Treatment of Patients Suffering From Overactive Bladder (OAB)

Intervention / Treatment
-----------------
* Device: RENOVA iStim™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 18 or greater (21 in the US) More than or equal to 6 months history of UUI diagnosis Patient who is mentally competent with the ability to understand and comply with the requirements of the study Exclusion Criteria: Any significant medical condition that is likely to interfere with study procedures Patients who are breastfeeding Predominant stress incontinence Have a life expectancy of less than 1 year Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: Treatment arm<br>RENOVA iStim™ System implanted patients | Device: RENOVA iStim™ System<br>* Tibial implantable neuromodulation device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary |  | 6 months | 
| Safety - incidence of adverse events |  | 12 months |
Membrane Shedding During Septic Shock

Study Overview
=================
Brief Summary
-----------------
Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This is a prospective observational study of circulating MPs and blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU at baseline (D1), D2, D3, D4 and D7.

Official Title
-----------------
Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic shock Informed consent Exclusion Criteria: Class IV heart failure Child-Plugh grade C cirrhosis Cancer under active treatment BMI>35 kg/m² Moribund patient DNR decision

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Study Overview
=================
Brief Summary
-----------------
The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies. Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable. Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.

Conditions
-----------------
Feeling Anxious

Intervention / Treatment
-----------------
* Drug: hydroxyzine
* Drug: Pregabalin
* Drug: Lactose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 18 to 75 years Patient schedules for insertion of long-lasting intravenous device Exclusion Criteria: History of previous insertion of long-lasting intravenous device or central intravenous catheter long term treatment of gabapentin or pregabalin Hypersensitivity to pregabalin or any of the excipients Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine. Patient at risk of glaucoma e Patient at risk for urinary retention Patient severe respiratory failure Patient at the general condition not too corrupted (ASA IV) Renal failure with creatinin clearance < 30 ml / min Patient not affiliated to Social Security Pregnant or lactating Patients in emergency situations Inpatient without consent

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabaline<br>Groups PREGABALINE : 150 mg de LYRICA® | Drug: Pregabalin<br>* 150 mg<br>|
| Experimental: Hydroxyzine<br>Groups HYDROXYZINE : 75 mg d'ATARAX® | Drug: hydroxyzine<br>* 75 mg<br>|
| Placebo Comparator: Lactose<br>Groups placebo : 4 g de lactose | Drug: Lactose<br>* 4 g<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy treatment | anxiety score VAS: 0 to 100 |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of pregabaldin | anxiety score VAS:0 to 100 |  |