linjc16/ctgov huggingface dataset:
Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS

Study Overview
=================
Brief Summary
-----------------
To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).

Official Title
-----------------
Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Procedure: Retrograde Intrarenal Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are between 18-90 years old Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones Exclusion Criteria: Patients who have congenital urogenital abnormalities Patients who have previous stone surgery history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: first group<br>Patients undergoing Retrograde Intrarenal Surgery with 20w holmium laser device who have 1-2 cm diameter kidney stones | Procedure: Retrograde Intrarenal Surgery<br>* Endoscopic treatment of Kidney Stones<br>|
| Active Comparator: second group<br>Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser device (working over 20w power) who have 1-2 cm diameter kidney stones | Procedure: Retrograde Intrarenal Surgery<br>* Endoscopic treatment of Kidney Stones<br>|
| Active Comparator: third group<br>Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser(working under 20w power) device who have 1-2 cm diameter kidney stones | Procedure: Retrograde Intrarenal Surgery<br>* Endoscopic treatment of Kidney Stones<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - complications according to clavien system | complications according to clavien system | postoperative 24 hours | 
| safety - visual analog score | visual analog score | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficiency - stone free rate | stone free rate post operative first day | postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RIRS, holmium, 1-2 cm,stones,kidney
The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.

Official Title
-----------------
Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Drug: Cunox
* Drug: Botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 65 Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown Subjects who voluntarily sign the informed consent Exclusion Criteria: Subjects with allergy or hypersensitivity to the investigational drugs or their components Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening Subjects who are not eligible for this study at the discretion of the investigator

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cunox<br>Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once. | Drug: Cunox<br>* Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.<br>|
| Active Comparator: Botox<br>Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once. | Drug: Botox<br>* Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity | An investigator makes a live assessment of subject's glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as improved and glabellar line improvement rate is calculated. | at 4 weeks after the injection. |
Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals

Official Title
-----------------
Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals

Conditions
-----------------
Lipidemia, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Viscous Fibre Blend
* Dietary Supplement: Psyllium
* Dietary Supplement: Wheat Bran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -healthy individuals Exclusion Criteria: regular alcohol consumption regular smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Viscosity<br>viscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration | Dietary Supplement: Viscous Fibre Blend<br>* High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)<br>|
| Experimental: Medium Viscosity<br>Kellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration | Dietary Supplement: Psyllium<br>* Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)<br>|
| Experimental: Low Viscosity<br>Kellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration | Dietary Supplement: Wheat Bran<br>* All Bran cereal (All Bran®; Kellogg Company)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in LDL cholesterol |  | change from baseline after 21 days, relative to control | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in total cholesterol |  | change from baseline after 21 days, relative to control | 
| change in triglycerides |  | change from baseline after 21 days, relative to control | 
| change in HDL cholesterol |  | change from baseline after 21 days, relative to control | 
| change in apolipoprotein B |  | change from baseline after 21 days, relative to control | 
| change in apolipoprotein A-1 |  | change from baseline after 21 days, relative to control | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary fibre, Viscosity, lipids, Healthy
HRQOL of Life After ECMO Due to COVID-19.

Study Overview
=================
Brief Summary
-----------------
We intend to prospectively investigate physical and mental state (HRQOL) by means of quantitative telephone interviews after hospital discharge in patients surviving COVID-19 ARDS and ECMO therapy.

Official Title
-----------------
Health-related Quality of Life Following Extracorporeal Membrane Oxygenation Due to Coronavirus Disease 2019.

Conditions
-----------------
ARDS, COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients surviving COVID-19 ARDS and ECMO therapy Exclusion Criteria: no 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
Interventional Model Description: Phone Interview
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Phone Interview|Phone interview questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQOL after COVID-19 ARDS and ECMO therapy | Health-related quality of life will be delineated by means of a quantitative questionnaire. | 1 year |
Effect of Implementation of Enhanced Recovery After Surgery on 3-year Survival After Colorectal Surgery for Cancer

Study Overview
=================
Brief Summary
-----------------
Several recent studies have shown that the Enhanced Recovery After Surgery (ERAS) protocol reduces morbidity and mortality and shortens the length of stay compared to conventional recovery strategy (pre-ERAS). The aim of this study was to evaluate the effect of the implementation of this protocol on 3-year overall survival and postoperative outcome in patients undergoing colorectal resection for cancer.

Official Title
-----------------
Effect of Implementation of Enhanced Recovery After Surgery (ERAS) Protocol on 3-year Survival After Colorectal Surgery for Cancer - a Retrospective Cohort of 1001 Patients

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

Intervention / Treatment
-----------------
* Other: Enhanced Recovery After Surgery (ERAS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aadult patients, who had undergone resection for colorectal cancer or a precancerous lesion and were cared for using the ERAS protocol or received conventional care (pre-ERAS). Informed patients Exclusion Criteria: Patients presenting or developing peritoneal cancer, Patients having resection for palliative reasons, Patients those under curatorship or tutelage Opposed patients

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enhanced Recovery After Surgery (ERAS)<br> | Other: Enhanced Recovery After Surgery (ERAS)<br>* Multidisciplinary approach to perioperative care.<br>|
| Conventional Recovery Strategy (pre-ERAS)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of the implementation of this protocol on 3-year overall survival. | 3-year overall survival rate | 3 years |
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study longitudinal changes in maternal metabolism and pregnancy outcomes in obese pregnant women.

Detailed Description
-----------------
We will study how normal metabolic changes of pregnancy are modified in obesity and investigate the consequences of altered fat and carbohydrate metabolism for pregnancy outcome. The results will aid our understanding of why pregnant obese women and their babies are at higher risk of complications and may highlight potential therapies to reduce these risks. Overall aim and hypothesis: The overall aim is to increase knowledge about the relation between obesity, metabolic profile/risk factors and pregnancy outcome in order to improve antenatal care and the health of the next generation. We hypothesize that obese pregnant women can be differentiated into subgroups according to their metabolic risk profile and their risk of adverse pregnancy outcomes. Specific aims: Establish an outpatient clinic for obese pregnant women at Department of Obstetrics, Drammen, Vestre Viken HF in order to: Provide improved antenatal care for obese pregnant women who have increased risk of pregnancy complications by offering: antenatal care according to national guidelines (Veileder i fødselshjelp 2014) fetal surveillance (ultrasound) planned delivery according to national and local guidelines Conduct an observational study in which clinical and biochemical data will be collected in order to increase knowledge on longitudinal metabolic changes in pregnancies complicated by obesity and how these relate to pregnancy outcomes

Official Title
-----------------
Healthy Mother - Lifelong Health: A Longitudinal Study on Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

Conditions
-----------------
Pregnancy, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with pregestational BMI > 35 Exclusion Criteria: diabetes mellitus type 1
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 |
| --- | --- | --- |
| Mode of delivery |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal metabolic changes during pregnancy |  | 1 year |
Adherence and Quality of Life in People With Schizophrenia and Schizoaffective Disorder

Study Overview
=================
Brief Summary
-----------------
It is the goal of this study adherence and quality of life in a population of people suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are influenced by treatment, support, social services, and residential treatment. The study population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.

Official Title
-----------------
In the Cantons Graubunden and Glarus as Well as in the Principality of Liechtenstein: Influence of Intensive Outpatient Treatment of People With Schizophrenia and Schizoaffective Disorder on Quality of Life and Adherence

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia or schizoaffective disorder 18 - 65 years old treated in the PDGR within the past 19 years Exclusion Criteria: organic brain disorder alcohol or drug dependence low intelligence unable to give consent no legal competency lacking knowledge of German language current psychiatric inpatient treatment

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence
Assessment of Frailty in Elderly Patients With Advanced Cancers

Study Overview
=================
Brief Summary
-----------------
This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers

Detailed Description
-----------------
This study is primarily looking to see if it is feasible to assess frailty in patients age 70 years and above with advanced cancers. it is also evaluating whether there may be any correlation between these assessments and toxicity and treatment and outcome. The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed using timed walk, grip strength and muscle mass measurement from imaging performed as part of routine clinical care. The assessments will be performed at baseline, week 12 and week 24. There is the option for patients to also donate blood samples for research purposes.

Official Title
-----------------
Assessment of Frailty in Elderly Patients With Advanced Cancers

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of advanced carcinoma - not suitable for curative treatment Age 70 years or over seen by an oncologist for consideration of palliative systemic medical therapy and decision regarding management already made WHO Performance Status 0-2 Written informed consent Exclusion Criteria: Hepatocellular cancer Prostate cancer Breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 70 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 patients consenting for assessments out of number approached | Number of patients consenting for the study as a percentage of number of patients approached about the study. | Baseline | 
| Time taken to complete assessments | Length of time participants take to complete study assessments | Baseline, week 12 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty as a predictor of grade 3/4 toxicity | Evaluate whether there is a possible correlation between frailty score at baseline and development of grade 3/4 toxicity during anticancer treatment | baseline | 
| Sarcopenia as a predictor of outcome | sarcopenia at baseline and over time as a predictor of outcome | baseline, week 12 and week 24 | 
| Quality of life EORTC QCQ 30 | Participants complete EORTC QCQ 30 questionnaire | baseline, week 12 and week 24 | 
| Biomarker assessment of frailty and associated factors which may include genetic analysis | Assessment of frailty biomarkers in blood samples | baseline, week 12 and week 24 |
Impact of Nicotine on Retinal Vascularization

Study Overview
=================
Brief Summary
-----------------
The main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization. Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption via cigarette or e-cigarette data will be collected. The objective is to seek an association between retinal vascular density and inhaled nicotine intake.

Official Title
-----------------
Impact of Nicotine on Retinal Vascularization (Tabaret)

Conditions
-----------------
Tabagism

Intervention / Treatment
-----------------
* Diagnostic Test: OCT-A (Optical Coherence Tomography)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria For group of smokers: Patient reporting active smoking for at least 3 months and at least 1 cigarette per day on average over a week For group of vapers : Patient using exclusively the electronic cigarette with a nicotine level of more than 6mg/ml for at least 3 months and at least 1 times per day on average over a week. For group of no-smokers no-vapersNon-smoking and no vaping, for more than 6 months Non-inclusion criteria: Caffeine intake within 2 hours prior to the OCT-A exam ametropia greater than + 3 dioptres of hyperopia or-3 dioptres of myopia astigmatism greater than 2 dioptres Known retinal or retina vascular pathology

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| smokers<br> | Diagnostic Test: OCT-A (Optical Coherence Tomography)<br>* Included patients will have an OCT-A and will be questioned about their nicotine intake, their background and taking an oral conception<br>|
| vapers<br> | Diagnostic Test: OCT-A (Optical Coherence Tomography)<br>* Included patients will have an OCT-A and will be questioned about their nicotine intake, their background and taking an oral conception<br>|
| non smokers/non vapers<br> | Diagnostic Test: OCT-A (Optical Coherence Tomography)<br>* Included patients will have an OCT-A and will be questioned about their nicotine intake, their background and taking an oral conception<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. |  | At the inclusion consultation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT-A, smokers, vapers, non-smokers/non-vapers, nicotine, retinal micro-vascularization