linjc16/ctgov huggingface dataset:
Endoscopic Interventions in Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
This is a combined study including a descriptive part about the preparations for COVID-19 and the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who required endoscopic intervention. Results are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3. Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2 infection.

Detailed Description
-----------------
This article is intended to provide an overview of the impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit (IEU, gastroenterological endoscopy, surgical endoscopy, and bronchoscopy) at the University Hospital Tübingen, a center for tertiary care in South-western Germany. First, preparations for COVID-19 pandemic with respect to the IEU are presented, and compared with those of other endoscopy units (7, 8). Additionally, the direct impact of SARS-CoV-2 on the staff of the IEU will be shown, together with a point-prevalence analysis of SARS-CoV-2 of the staff at the end of the SARS-CoV-2 wave in Tübingen. Finally, to our knowledge for the first time, we conducted a prospective single center analysis of the patients infected with SARS-CoV-2, which required a diagnostic or therapeutic endoscopic intervention.

Official Title
-----------------
Impact of the COVID-19 Pandemic on an Interdisciplinary Endoscopy Unit in a German Hotspot Area: a Single Center Experience

Conditions
-----------------
Change; Endoscopy, COVID-19

Intervention / Treatment
-----------------
* Procedure: Endoscopic intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with proven or suspected infections with SARS-CoV-2 infection, who required endoscopic interventions Exclusion Criteria: all other patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic intervention|All endoscopic interventions in COVID-19 positive tested patients were included|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death in time of observation | death in time of observation | 01.March 2020 to 5. May 2020 |
Somatuline Autogel: Acromegaly Self/Partner Injection Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.

Official Title
-----------------
A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Lanreotide (Autogel formulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have a clinical diagnosis of acromegaly The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening The patient must be able to store study medication in a refrigerator in their own home Exclusion Criteria: The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening The patient has received pituitary radiotherapy within one year prior to screening The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lanreotide (Autogel formulation)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels. |  |  | 
| To assess patient/partner and healthcare professional experience with unsupervised injections. |  |  | 
| To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth Hormone
Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.

Official Title
-----------------
Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Radiation: Image-guided radiotherapy
* Radiation: Image-guided radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low or intermediate risk prostate cancer patients as defined by: Clinical stage T1-2b, Gleason Score <=7, and PSA <=20 ng/mL Age >= 18 years Exclusion Criteria: Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months Prior pelvic radiotherapy Anticoagulation medication (if unsafe to discontinue for gold seed insertion) Diagnosis of bleeding diathesis Large prostate (>90cm3) on imaging Immunosuppressive medications Inflammatory bowel disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short treatment time (11 days)<br> | Radiation: Image-guided radiotherapy<br>* 40 Gy / 5 fractions / 11 days<br>|
| Experimental: Long treatment time (29 days)<br> | Radiation: Image-guided radiotherapy<br>* 40 Gy / 5 fractions / 29 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel related quality-of-life |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal toxicity | Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema | During radiotherapy, at 3 and 6 months, then every 6 months after | 
| Genitourinary toxicity | Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema | During radiotherapy, at 3 and 6 months, then every 6 months after | 
| PSA relapse rate |  | 3 and 5 years | 
| Patient Overall Quality of life |  | During radiotherapy, at 3 and 6 months, then every 6 months after | 
| Salvage androgen deprivation therapy rate |  | 3 and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Hypofractionation
EZETROL® Re-examination Study (MK0653-175)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs.

Official Title
-----------------
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants Who Receives EZETROL® In Usual Medical Practice

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| EZETROL® 10 mg<br>Participants with Hypercholesterolemia treated with EZETROL® | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation | Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment. | Up to 14 days after treatment discontinuation | 
| Mean Percent Change From Baseline to Treatment in Lipid Parameters | The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters. | Baseline to 4 weeks | 
| Overall Efficacy Evaluation of EZETROL® | Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened. | Baseline to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia
Comparison of Soft and Hard Tissue Thickness in the Anterior Regions of the Upper and Lower Jaws Taken From CBCT Versus Clinical Measurements

Study Overview
=================
Brief Summary
-----------------
Hypothesis: there is a positive correlation between tissue thickness measured from CBCT and clinical measurements.

Conditions
-----------------
Soft and Hard Tissue Biotype

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 100 subject who have done a CT Exclusion Criteria: periodontal surgery in anterior regions, medications which effect the gingiva

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Efficacy of Dovitinib for Squamous NSCLC.

Conditions
-----------------
Squamous NSCLC

Intervention / Treatment
-----------------
* Drug: Dovitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed squamous NSCLC Previously treated with one or two lines of chemotherapy FGFR amplification (FISH > 5 copies of genes) 20 years or older ECOG PS 0-2 Exclusion Criteria: active infection uncontrolled brain metastasis unstable angina or MI

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dovitinib monotherapy<br> | Drug: Dovitinib<br>* Dovitinib 500mg daily for 5 days on/ 2 day off until progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy, Dovitinib, Squamous NSCLC
Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring

Study Overview
=================
Brief Summary
-----------------
To investigate intervention with early application of non-ablative laser to prevent scarring in the skin

Detailed Description
-----------------
To intervene in scar formation at three different time-points

Official Title
-----------------
Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Device: non-ablative laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good health men Skin type 2-3 non-smokers presenting full medical record Exclusion Criteria: active skin disease in test area resent UV-exposure in test area history of keloid current or resent cancer uncontrolled systemical disease

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-laser<br>non-ablative laser Laser Pre-wounding low dose laser Pre-wounding medium dose laser Pre-wounding high dose | Device: non-ablative laser<br>* non-abaltive laser pre, immediate and post wounding<br>* Other names: 1540 nm laser;|
| Experimental: Immediate-laser<br>non-ablative laser Laser low dose - immediate after wounding Laser medium dose - immediate after wounding Laser high dose - immediate after wounding | Device: non-ablative laser<br>* non-abaltive laser pre, immediate and post wounding<br>* Other names: 1540 nm laser;|
| Experimental: Post-laser<br>non-ablative laser Laser low dose - post wounding Laser medium dose - post wounding Laser medium dose - post wounding | Device: non-ablative laser<br>* non-abaltive laser pre, immediate and post wounding<br>* Other names: 1540 nm laser;|
| No Intervention: Control<br>Untreated control wound | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points | Clinical evaluation by scar scales | 3 months after |
Monitoring of NOAC Therapy: Standardizing Reference Intervals

Study Overview
=================
Brief Summary
-----------------
This study is aimed to establish reference intervals of NOAC (dabigatran, apixaban and rivaroxaban) in ethnic Chinese patients.

Detailed Description
-----------------
360 patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited. After the informed consent, the patient will be needed for blood taking before and 2 hours after the medication (NOAC). The patient's demographic data and medical history will also be retreived from Central Medical Syetem too.

Official Title
-----------------
Monitoring of NOAC Therapy: Standardizing Reference Intervals

Conditions
-----------------
Ischemic Stroke, Stroke, Acute, Stroke Syndrome, Ischemic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ethnic Chinese ONLY 18 years old or above Non-valvular atrial fibrillation Duration of NOAC use at least 3 months No changes in NOAC dosage or type within 3 months Creatinine Clearance (by Cockcroft-Gault formula) >/=30mL/min Exclusion Criteria: Valvular atrial fibrillation or no atrial fibrillation Recent haemorrhage or ischemia within 1 year Active liver disease Abnormal baseline clotting profile Abnormal baseline thrombocytopenia or thrombocytosis Thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein C, S, anti-thrombin III deficiency) Non-compliant patients, defined as missing any doses of NOAC in recent 1 month Anticoagulation for disorders other than AF Pregnancy

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 |
| --- | --- |
| Ischemic stroke patient<br>Ischemic stroke patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited from the Prince of Wales Hospital, either in-patient or out-patient clinic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOAC level in blood | The NOAC level in blood before and after the medication | One week after the recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, ischemic stroke
Association of Proteinuria and Progression of Kidney Dysfunction in Sickle Cell DiseaseDisease

Study Overview
=================
Brief Summary
-----------------
To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality.

Detailed Description
-----------------
This is a retrospective, non-interventional, secondary use of the data coming from the single-center secondary GEN-MOD study cohort at the Henri Mondor Hospital (Creteil, France). The GEN-MOD cohort includes 355 SCD patients. The GEN-MOD data are accessible through the center's clinical and laboratory database and will be extracted and analyzed for the purpose of this study. The enrolment in the GEN-MOD cohort lasted from 01 December 2002 until 01 March 2014. Follow-up occurred every six months and ranged from five to seventeen years and ended on 31 December 2019. The index date (baseline) for this study is the time of inclusion of patients in GEN-MOD cohort study

Official Title
-----------------
ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease

Conditions
-----------------
Change in Albumin to Creatinine Ratio and Glomerular Filtration Rate, Progression of Kidney Failure and or All-cause Mortality

Intervention / Treatment
-----------------
* Other: no intervention study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged ≥ 18 years old. Confirmed diagnosis of SCD by Hb electrophoresis or high performance liquid chromatography. SCD genotypes HbSS, HbSβ0-thal. Availability of ACR and eGFR baseline records. Exclusion Criteria: Patients enrolled in a chronic transfusion program. Patients receiving hydroxyurea treatment at the time of study enrollment.

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 study|no intervention study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| albumin to creatinine(ACR) and glomerular filtration rate(eGFR) | To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of kidney dysfunction | •To assess the association of baseline and change in ACR, and CKD progression category | 10 years | 
| ACR elevation | To assess potential risk factors (at baseline) for ACR elevation during study follow-up | 10 years |