linjc16/ctgov huggingface dataset:
Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).

Official Title
-----------------
A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

Conditions
-----------------
Heterogeneous Emphysema

Intervention / Treatment
-----------------
* Device: Chartis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heterogeneous emphysema as determined by high-resolution CT scan Scheduled for clinically indicated ELVR procedure Exclusion Criteria: Hyperexcretive chronic bronchitis or excessive sputum secretion Active pulmonary infection Active asthma or lung hyper-responsiveness

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Chartis System<br>* Assessment of airway flow and pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Until end of study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | During procedure and up 1 week post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emphysema, Endobronchial Lung Volume Reduction
Accuracy of Intra Ocular Lens CARLEVALE Calculation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new Carlevale sutureless scleral fixation posterior chamber intra ocular lens.

Detailed Description
-----------------
Retrospective comparison of refractive spherical equivalent predicted before surgery and measured after surgery in patient who underwent implantation of an sutureless scleral fixation posterior chamber intra ocular lens between October 2019 and Avril 2022 in the ophthalmology department of Poitiers Hospital and La Rochelle Hospital.

Official Title
-----------------
Carlevale Sutureless Scleral Fixation Intra Ocular Lens : Retrospective Study of Power Calculation Accuracy.

Conditions
-----------------
Lens Diseases

Intervention / Treatment
-----------------
* Procedure: Carlevale implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2022 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital Exclusion Criteria: No data about post surgery refraction.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carlevale implantation<br> | Procedure: Carlevale implantation<br>* Vitrectomy and Carlevale implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction error | Difference between the measured and predicted post-operative refractive spherical equivalent for the intra oculaire lens power implanted | Between Month 1 and Month 6 |
Expanded Access to NanoDoce

Study Overview
=================
Brief Summary
-----------------
NanOlogy may consider offering expanded access to NanoDoce for patients who do not meet the enrollment criteria of clinical trials in progress.

Official Title
-----------------
Expanded Access to NanoDoce

Conditions
-----------------
Urogenital Neoplasms

Intervention / Treatment
-----------------
* Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and [14C]-labeled intravenous microdoses.

Official Title
-----------------
A Study to Determine the Absolute Bioavailability of YH4808 Using Simultaneous Oral Therapeutic- and [14C]-Labeled Intravenous Microdoses

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: YH4808 PO and [14C]-YH4808 IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male subject aged 20 to 45 at screening subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0 subjects who decide to participate voluntarily and write a informed consent form Exclusion Criteria: subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor clinically significant allergic disease (except for mild allergic rhinitis) subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start subjects considered unsuitable for inclusion by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microdose<br> | Drug: YH4808 PO and [14C]-YH4808 IV<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute bioavailability (Fpo) |  | predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48, 96, 144, 216 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
absolute bioavailability,, microdose,, AMS
Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry

Study Overview
=================
Brief Summary
-----------------
Recent trials have demonstrated that a reduction in low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular adverse events following acute coronary syndrome (ACS). However, the data coming from the real-world setting are limited. Therefore, the aim of the study is to assess the association between LDL-C changes with prognosis in patients who survive ACS. Patients with ACS will be followed for mortality and major events for at least 1 year. Changes in LDL-C between the ACS and a 6- to 10-week follow-up visit will be analysed. The associations between quartiles of LDL-C change and therapy intensity with outcomes will be investigated using adjusted Cox regression analyses.

Official Title
-----------------
Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry

Conditions
-----------------
Acute Coronary Syndrome, Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome Exclusion Criteria: -

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 |
| --- | --- |
| High-intensity statin<br> | Drug: Statin<br>* Statin +/- ezetimib +/- Alirocumab<br>* Other names: Alirocumab;|
| High-intensity statin plus ezetimib<br> | Drug: Statin<br>* Statin +/- ezetimib +/- Alirocumab<br>* Other names: Alirocumab;|
| High-intensity statin plus ezetimib plus PCSK9 inhibitor<br> | Drug: Statin<br>* Statin +/- ezetimib +/- Alirocumab<br>* Other names: Alirocumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiovascular Adverse Events | All-cause death, Acute Coronary Syndrom, Need for Myocardial Revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL reduction |  | 1 year |
Quality of Sleep in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. The investigators hypothesized that this unique character might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. The investigators test (1) the sleep quality of the patients and draw some characteristic features, and (2) investigated the connection between unique biochemical changes such as the increase of c-fos or wee-1.

Detailed Description
-----------------
Under the hypothesis the unique character of patients might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. We do following studies; The study of sleep quality of the patients; The number of patients expected to be included in the study is 1,000. Inclusion criteria is the ACR criteria, and exclusion criteria is any defined disease conditions of sleep disorders in ICSD. The method includes questionnaire using the Pittsburgh Sleep Quality Index (PSQI) scoring and Epworth scoring, and actigraphy measurement for more than 3 days. In a portion of the patients, we measure clinical arthritis activities in conjunction with western blot for c-fos and wee-1 as well as routine clinical laboratory tests. Also in a portion of the patients, we do the polysomnography study; expected number of participants would be 100. We also plan to test the effect of good sloop on arthritis in a portion of the patients.

Official Title
-----------------
Study on the Quality of Sleep in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: diazepam, melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis Exclusion Criteria: Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: diazepam, melatonin|Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.|

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
-----------------
rheumatoid arthritis, sleep disturbance
Physical Activity Recommendation Behaviour in German Psychologists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychologists working with patients with mental disorders.

Detailed Description
-----------------
Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations. Clinical psychologists play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German psychologists. The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychologists working with patients with mental disorders.

Official Title
-----------------
Physical Activity Recommendation Behaviour in German Psychologists

Conditions
-----------------
Mental Disorder, Physical Activity

Intervention / Treatment
-----------------
* Diagnostic Test: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical psychologist Currently working with patients with mental disorders At least 18 years old Sufficient German skills for answering the questionnaire Exclusion Criteria: None

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 |
| --- | --- |
| Clinical psychologists in Germany<br>Clinical psychologists in Germany currently working with patients with mental disorders | Diagnostic Test: Online questionnaire<br>* Online questionnaire via SoSciSurvey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise in Mental Illness Questionnaire (EMIQ) - German Version | Questionnaire assessing the following areas: knowledge, beliefs, behaviours regarding and participation in physical activity in mental health professionals. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Mental disorder, Recommendation behaviour, Prescription Behaviour, Mental health, Exercise
Follow up by US Following Hospitalization With Periappendicular Abscess Refusing to be Operated on Within a Few Weeks.

Study Overview
=================
Brief Summary
-----------------
Follow up via ultrasonic abdoman after patients who were giagnosed and treated as periappendicular abcess and refused to be operated later on in the interval period . To ass what occured to their appendics ?

Detailed Description
-----------------
During the last 10 years patients were hospitalized and treated with antibiotics due to the diagnosis of periappendicular abcess. they were invited to be operate after wards -appendectomy, electively few weeks later on. All these patients refused to be operated. What happend to their appendics few months or years later on via ultrasonic abdomen view??

Official Title
-----------------
US Follow-up After Appendicitis Attack.

Conditions
-----------------
Disorder of Appendix

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed in the last 10 years suffering from periappendicular abcess. Exclusion Criteria: after appendectomy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size and Condition of the Appendix. |  | 6 months to 12 years following Appendicitis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periappendicular abscess, Ultrasound
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized crossover study to compare the NFT sleep patches to sham device to assess sleep via home sleep testing device in the home environment

Official Title
-----------------
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment

Conditions
-----------------
Sleep Disturbance

Intervention / Treatment
-----------------
* Other: Natural Frequency Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: capacity to provide informed consent BMI <30 between 30 and 65 years old in overall good health as determined by history and physical assessment subjects pre-screened to ensure they are drug free work a typical day job/work week. not traveled > 3 time zones in the last month typical bedtime between 9-12 PM estimated on average 6 hours per night negative urine drug screen have self-reported unrefreshing sleep for the past month agree to limit alcohol use to no more than two drinks a night during the testing period and four hours prior to bedtime agree to limit caffeine consumption to four hours prior to bedtime ≤ 2 on the depression scale ≤ 3 on the anxiety scale Exclusion Criteria: pregnant or nursing a child self-induced short sleep habits (<6 hours per night) unstable medical conditions as determined by the clinician current sleep disorder (sleep apnea AHI/REI<5, restless legs, periodic limb movements, narcolepsy) self-reported sleep latency of >30 minutes or early (3-4 AM) awakenings on a regular basis contact dermatitis to adhesives excluded Medications: over the counter sleep aids, prescribed sleep aids, central nervous system stimulants, antidepressants, sedating antihistamines, over the counter decongestants and opioids

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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 |
| --- | --- |
| Sham Comparator: Sham Natural Frequency Patch<br> | Other: Natural Frequency Patch<br>* Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights<br>|
| Active Comparator: Active Natural Frequency Patch<br> | Other: Natural Frequency Patch<br>* Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Assess sleep via home EEG recording | three nights |
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Study Overview
=================
Brief Summary
-----------------
Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection. New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument. The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.

Official Title
-----------------
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Conditions
-----------------
Endoscopy, Digestive System, Esophageal Neoplasms, Stomach Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Submucosal tumor (< 4 cm) Mucosal tumor (T1) in patients unsuitable for surgery Exclusion Criteria: Endoscopic ultrasound (EUS) or CT signs of metastasis Insufficient access to tumor

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic submucosal dissection, Submucosal tumor, Minimal invasive, Gastroscopy