linjc16/ctgov huggingface dataset:
A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.

Study Overview
=================
Brief Summary
-----------------
The study of extended total mesopancreas excision(eTME) for pancreatic head adenocarcinoma is a retrospective multicenter cohort, collecting medical records and follow-up data of patients who underwent radical resection with pancreatic head adenocarcinoma.

Detailed Description
-----------------
The objectives of the study are as follows: To evaluate the perioperative safety of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma. To demonstrate the prognosis of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.

Official Title
-----------------
Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine

Conditions
-----------------
Pancreas Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pancreatic head adenocarcinoma who underwent curative-intent resection. Patients with accessible medical records Exclusion Criteria: Patients with unknown chemotherapy sequence or status Patients with history of previous malignant tumors Patients with distant metastases
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 |
| --- | --- | --- |
| Overall survival | The overall survival data were defined by (date of death)-(date of first diagnosis).The survival status of patients were retrieved from follow-up. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The overall survival data were defined by (date of recurrence/progression)-(date of surgery).During follow-up period, abdominal enhanced CT, chest X-ray, tumor markers and routine blood tests were carried out to evaluate recurrence/progression. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy
Movement Disorder Quantification Algorithm Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living.

Conditions
-----------------
Parkinson's Disease, Essential Tremor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Clinical diagnosis of idiopathic Parkinson's disease or essential tremor Able to provide informed consent Exclusion Criteria: Significant medical or psychiatric illness Not capable of following the required clinical instructions Serious medical conditions that compromise safety

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 |
| --- | --- | --- |
| Processed kinematics | Motion data collected during various motor tasks will be processed and compared to video review. | During assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motion sensors, tremor, bradykinesia, gait, balance, dyskinesia
Mask-associated Dry Eye Symptoms in China

Study Overview
=================
Brief Summary
-----------------
To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.

Official Title
-----------------
Mask-associated Dry Eye Symptoms: an Online Survey of 6262 Chinese Persons

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Other: face mask or not


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >=8 years mental health Exclusion Criteria: eye diseases mental or systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 80 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 |
| --- | --- |
| mask wear<br> | Other: face mask or not<br>* long term face mask wear<br>|
| dry eye<br> | Other: face mask or not<br>* long term face mask wear<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of face mask wear |  | 3 months |
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.

Official Title
-----------------
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

Conditions
-----------------
Overweight and Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Procedure: Cardiopulmonary exercise test (CPET)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing) Exclusion Criteria: Unstable heart or lung disease Exercise >150 minutes/week Participation in college sports

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiopulmonary exercise testing<br> | Procedure: Cardiopulmonary exercise test (CPET)<br>* CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myostatin | Change in serum myostatin levels | Pre- to 3-hours post-exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irisin | Change in serum irisin levels | Pre- to 3-hours post-exercise | 
| IL-6 | Change in serum IL-6 levels | Pre- to 3-hours post-exercise |
Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Study Overview
=================
Brief Summary
-----------------
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.

Official Title
-----------------
A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: diquafosol ophthalmic solution
* Drug: 0.1% sodium hyaluronate ophthalmic solution.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who show: Keratoconjunctival disorder confirmed with vital dye staining Abnormal Schirmer score results Exclusion Criteria: Eye disease that needs therapy other than that for dry eye Those who need to wear contact lenses during the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 69 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 |
| --- | --- |
| Experimental: DE-089<br>DE-089 ophthalmic solution | Drug: diquafosol ophthalmic solution<br>* DE-089 topical ocular application, 6 times daily for 4 weeks.<br>* Other names: HA;Drug: 0.1% sodium hyaluronate ophthalmic solution.<br>* 0.1% HA topical ocular application, 6 times daily for 4 weeks.<br>|
| Active Comparator: HA<br>0.1% sodium hyaluronate ophthalmic solution | Drug: 0.1% sodium hyaluronate ophthalmic solution.<br>* 0.1% HA topical ocular application, 6 times daily for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the fluorescein and rose bengal staining score | Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority) | 2 weeks and 4 weeks from baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tear film breakup time (second) | Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation | 2 weeks and 4 weeks from baseline. |
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Study Overview
=================
Brief Summary
-----------------
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.

Official Title
-----------------
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases

Conditions
-----------------
Neonatal Hypotonia, Antidepressant Drug Adverse Reaction, Pregnancy Related

Intervention / Treatment
-----------------
* Drug: Antidepressant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs Exclusion Criteria: Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Antidepressant|Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of neonatal hypotonia newborns following in utero exposure to antidepressant drugs, with a chronology compatible with the drug toxicity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal hypotonia | Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs | Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021 |
Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. This study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.

Official Title
-----------------
Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go

Conditions
-----------------
Gonorrhoea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or female, aged 18 years or above. Participant is literate in German, French, English or Hungarian. Participant is at risk for a N. gonorrhoeae infection. This is defined as: exhibiting signs/symptoms of a N. gonorrhoeae infection. having a sexual partner who has been diagnosed with a N. gonorrhoeae infection. participating in high-risk activities for a N. gonorrhoeae infection. Exclusion Criteria: Subject does not agree to undergo diagnostic test for gonorrhoea.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens |  | Day of specimen sampling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimicrobial resistance, point-of-care testing, Neisseria gonorrhoeae
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

Study Overview
=================
Brief Summary
-----------------
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

Detailed Description
-----------------
Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft. Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland & Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.

Official Title
-----------------
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: A 2 Year Prospective Randomised Study on Distal Radius Osteotomies

Conditions
-----------------
Dorsal Malunion of the Distal Radius

Intervention / Treatment
-----------------
* Procedure: corrective osteotomy distal radius


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: distal radius malunion with dorsal deformity, disability and pain. Exclusion Criteria: age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bone graft<br>Bone graft from iliac crest as gapfiller | Procedure: corrective osteotomy distal radius<br>* Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.<br>|
| Experimental: Calcium phosphate bone cement<br>CaP bone cement as gapfiller | Procedure: corrective osteotomy distal radius<br>* Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volar angulation distal radius, x-ray |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone graft, Calcium phosphate bone cement, RCT, Xray, CT
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and tolerability of the modified Diprobase formulation over 14 days in infants and children with a history of Atopic Dermatitis (AD).

Official Title
-----------------
In-home Use Test of the New Modified Diprobase® Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Device: Modified Diprobase formulation (BAY987534)


Participation Criteria
=================
Eligibility Criteria
-----------------
Children with normal or dry skin and a history of mild to moderate AD, but without any signs or symptoms within the last month prior to enrollment Skin type I - VI according to Fitzpatrick skin classification Aged 6 months to 48 months

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 48 Months

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

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

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: BAY987534<br>Infants and children with quiescent atopic dermatitis | Device: Modified Diprobase formulation (BAY987534)<br>* The modified Diprobase formulation will be applied topically twice daily over 14 days on the whole body and face.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse event (AE) |  | Up to 14 days | 
| Severity of adverse event | The intensity of an AE is classified according to the following categories: Mild Moderate Severe | Up to 14 days |
Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.

Official Title
-----------------
Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study

Conditions
-----------------
Thoracic Aortic Aneurysm, Bicuspid Cardiac Valve

Intervention / Treatment
-----------------
* Procedure: Aortic surgery +/- aortic valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years First-time surgery Bicuspid aortic valve confirmed Thoracic aortic aneurysm involving aortic root or ascending aorta Exclusion Criteria: No available pre-operative cross-sectional imaging Re-do surgery

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 |
| --- |
|Procedure: Aortic surgery +/- aortic valve replacement|Replacement of aneurysmal proximal thoracic aorta +/- replacement of diseased bicuspid aortic valve|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median aortic diameters in aneurysms | As above | Data collection period from 27th January 2017 - 15th May 2017 | 
| Cross-sectional aortic area/patient height ratio in aneurysms | Calculation of indexed aortic area in aneurysms | Data collection period from 27th January 2017 - 15th May 2017 | 
| Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/m | Proportion of aneurysms with an abnormal indexed aortic area | Data collection period from 27th January 2017 - 15th May 2017 | 
| Median cross-sectional aortic area/patient height ratio for aneurysms with diameter <4.0 cm, 4.0-4.5 cm, 4.5-5.0 cm, 5.0-5.5 cm and >5.5 cm |  | Data collection period from 27th January 2017 - 15th May 2017 | 
| Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m |  | Data collection period from 27th January 2017 - 15th May 2017 |