linjc16/ctgov huggingface dataset:
Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent

Study Overview
=================
Brief Summary
-----------------
Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.

Official Title
-----------------
Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis

Conditions
-----------------
Coronary Angiography, Drug-eluting Stents, Fractional Flow Reserve, Myocardial

Intervention / Treatment
-----------------
* Device: Cypher, Taxus or Endeavor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective PCI Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion) Reference diameter > 2.5mm, lesion length < 60mm (cover by 2 stents) No documented evidence of ischemia by noninvasive tests Exclusion Criteria: Acute ST elevation MI Left main disease Chronic renal failure (cr >2 mg/dL) Expected survival < 2yrs > 1degree AV block

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Fractional flow guided drug-eluting stent implantation arm | Device: Cypher, Taxus or Endeavor<br>* percutaneous drug-eluting stent implantation, FFR group: if FFR<0.75 Routine DES group<br>|
| Other: 2<br>Routine drug-eluting stent implantation | Device: Cypher, Taxus or Endeavor<br>* percutaneous drug-eluting stent implantation, FFR group: if FFR<0.75 Routine DES group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical event: Cardiac death, myocardial infarction, target lesion revascularization |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVUS | IVUS minimum lumen area | at the time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intermediate lesion, drug-eluting stent, fractional flow reserve
Detection and Analysis of MBC With Heterogeneous ER Expression

Study Overview
=================
Brief Summary
-----------------
To investigate the treatment pattern and efficacy of MBC patients with ER heterogeneity using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).

Official Title
-----------------
Chemotherapy Versus Endocrine Therapy in Metastatic Breast Cancer Patients With Heterogeneous Estrogen Receptor Expression

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients received 18F-FES PET/CT in Fudan University Shanghai Cancer Center from 2017-2021. Patients had both FES positive (FES+) and negative (FES-) lesions in FES exam. Patients received further treatment. Exclusion Criteria: Incomplete medical records.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FES+-<br>MBC patients with both FES positive(+) and negative(-) lesions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0 | 6 weeks |
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers

Study Overview
=================
Brief Summary
-----------------
The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.

Detailed Description
-----------------
This project will involve: a) distributing questionnaires to up to 200 participants (100 patients and 100 caregivers) at the Shands Gastrointestinal clinic and b) focus groups including patients, medical provider, and the clinic case manager. The questionnaires will provide information on the relative effect of gastroparesis on the quality of life of the patients and their caregivers. Assessment of this needs assessment will then help identify areas of potential resource improvement and mobilization to provide support for the patients and their family members.

Official Title
-----------------
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida Caregivers to Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida Exclusion Criteria: Inability to fill out the questionnaires by any cause
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 |
| --- | --- |
| Gastroparesis Patients<br> | |
| Gastroparesis Patients' Caregivers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score in a Quality of life assessment Questionnaire |  | During the clinicial visit at the day of enrollment(Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score in a Quality of life assessment Questionnaire |  | 1st follow-up, at 6 months from Date of enrollment | 
| Score in a Quality of life assessment Questionnaire |  | 2nd follow-up, at 12 months from date of enrollment | 
| Score in a Quality of life assessment Questionnaire |  | 3rd follow-up, at 18 months form date of enrollment | 
| Score in a Quality of life assessment Questionnaire |  | 4th(last) follow-up, At 24 months form date of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroparesis, Quality of Life
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication Study hypothesis:Cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent subjects.

Official Title
-----------------
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence

Conditions
-----------------
Opioid Dependence

Intervention / Treatment
-----------------
* Drug: Cortisol 20 mg
* Drug: Mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Opioid dependency Participant in the Janus heroin programme of the UPK Basel Able to control parallel consumption of other drugs Stable i.v. substitution for at least 3 months Exclusion Criteria: co-morbid psychiatric disturbances Current medical conditions excluding participation Recent history of systemic or topic glucocorticoid therapy known hypersensitivity to the IMP under investigation (cor-tisol) pregnancy, breast-feeding inability to read and understand the participant's information

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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Cortisol 20 mg /Placebo Mannitol | Drug: Cortisol 20 mg<br> <br> Drug: Mannitol<br>* Mannitol used as placebo<br>|
| Other: B<br>Placebo Mannitol/Cortisol 20mg | Drug: Cortisol 20 mg<br> <br> Drug: Mannitol<br>* Mannitol used as placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heroin craving | outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours. | baseline, change from baseline during and after presentation of drug stimuli | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours. | baseline, change from baseline during and after presentation of drug stimuli |
Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).

Study Overview
=================
Brief Summary
-----------------
A 26 week maintenance study of CDP870 in Crohn's disease

Official Title
-----------------
A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Certolizumab Pegol (CDP870)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3)*. * Vienna Classification (1998) Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug. Patients aged 18 years or above at screening. Exclusion Criteria: Crohn's Disease Related Fistula abscess present at screening. Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months. Short bowel syndrome. Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study). Positive stool laboratory results for enteric pathogens.

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Certolizumab Pegol (CDP870)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In population with CRP ≥ 10 mg/L at baseline; Time to disease progression up to and including Week 26; Proportion of patients with clinical remission at Week 26; Proportion of patients with IBDQ response at Week 26; F-36 sub-scores and change from basel |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, CDP870, CDAI, clinical response, remission, Certolizumab Pegol, Cimzia
Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicentre prospective trial is to determine the incidence and risk factors for surgical wound infections. Also the investigators will evaluate consequences of wound infections to the patients, and extra costs caused by wound infections.

Official Title
-----------------
Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-emergency infrarenal aortic or lower limb arterial surgery Exclusion Criteria: patient's refusal to participate

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Other: observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection incidence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical wound infection, risk factor
Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.

Conditions
-----------------
Facial Volume

Intervention / Treatment
-----------------
* Device: Perlane-L
* Other: Non-treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Loss of Fullness in Midface Area Other items as identified in the protocol Exclusion Criteria: History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine. Other items as identified in the protocol

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perlane-L<br>Perlane-L treatment | Device: Perlane-L<br>* Perlane-L Injection in the midface<br>|
| Sham Comparator: Non-Treatment<br>Non-Treatment Arm | Other: Non-treatment<br>* Non-treatment Arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial fullness using midface scale | Change in facial fullness using midface scale. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial fullness using the midface scale | Change in facial fullness using midface scale. | Up to 12-months post treatment | 
| Subject satisfaction using the GAIS | Compare treatment satisfaction as compared to no treatment, on the Global Aesthetic Improvement Scale (GAIS) | Up to 12-months post treatment | 
| Aesthetic improvement | A subjective assessment of aesthetic improvement post baseline | Up to 12-months post treatment |
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Official Title
-----------------
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

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

Intervention / Treatment
-----------------
* Other: Emulsion type artificial tear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and over inclusive. Males or females Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. OSDI score >18 OR TBUT <10 seconds Exclusion Criteria: Corneal refractive surgery or contact lens wear within 6 months of this study. Current use of Restasis Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br> | Other: Emulsion type artificial tear<br>* 2 types of artificial tears<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability Questionnaire | Tolerability (comfort) measured with Visual Analog scale (1 to 100) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability Questionnaire | Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree) | 8 weeks | 
| Tear Break Up Time | Tear Break Up Time measured in seconds | 2-3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial tears
A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia.

Detailed Description
-----------------
Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be recruited into the study. They would be observed for two years for analyzed the predicting factors of dyskinesia. At the baseline, demographic information, Clinical information, blood sample, picture of tongure coating would be collected at the baseline. All participants were evaluated every three months for two years. The severity of motor symptoms were evaluated every 6 months.

Official Title
-----------------
A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Dyskinesias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment. 2) Patients have received Levodopa treatment with the daily dosage above 200mg. Exclusion Criteria: 1) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation
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 |
| --- | --- | --- |
| the occurrence of dyskinesia and its related predicting factors | to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia | The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up | to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up | The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson disease, Dyskinesia, follow up