linjc16/ctgov huggingface dataset:
Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT

Study Overview
=================
Brief Summary
-----------------
Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women. The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown. The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.

Detailed Description
-----------------
The aims of the study were : Analyze the consequences on clinical decisions of this wide choice of methodologies for measurement of abdominal aortic aneurysm maximum diameter when using angio-CT; Identify the method of measurement that yields the best agreement for patient management.

Official Title
-----------------
Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Other: Angio-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with abdominal aortic aneurysm Exclusion Criteria: inflammatory aneurysm false aneurysm aneurysm after open repair or stent graft

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 |
| --- | --- |
| group abdominal aortic aneurysm<br>Patients with non-operated abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012 | Other: Angio-CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum diameter of abdominal aortic aneurysm | Maximum abdominal aortic aneurysm measured using 11 measurement methods | Day 0 |
To Investigate the Effect of Early Community-care Program on Fracture Hip Patient

Study Overview
=================
Brief Summary
-----------------
The early community-care program is well-known rehabiliation for the fracture hip patient. For the discharged fracture hip patient from hospital, it is worth to investigate the effect of early mobilization program to improve their physical and psychological aspects.

Detailed Description
-----------------
60 fractured hip patient will randomized allocated into intervention group and control group. The community-care include nursing care, physiotherapy and home modification according to the condition of the patient. The intervention will received community-care program for 12 weeks. Two sessions per week and total 24 sessions. The control group will receive the traditional medication. The outcome measure include elderly mobility scale and happiness scale. The measurement will take at initial and completion of the program. SPSS will be used for data analysis.

Official Title
-----------------
To Investigate the Effect of Early Community-care Program on Physical and Depressive Aspects for Discharged Hospital Patient Suffered From Hip Fracture.

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Procedure: community-care program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fracture hip patients discharged from queen mary hospital Exclusion Criteria: cognitive impairment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: community-care program<br>receive intervention for 12 weeks | Procedure: community-care program<br>* community nurse care, physiotherapy<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elderly Mobility Scale |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical, psychological, fracture hip
Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.

Official Title
-----------------
Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Conditions
-----------------
Muscular Dystrophy, Facioscapulohumeral

Intervention / Treatment
-----------------
* Behavioral: Psychiatric test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years and <75 years FSHD patients 1 or 2 with genetic confirmation Exclusion Criteria: Phosphokinase creatine level > 5 time of the normal Patient as medical history : A history or active neurological disease likely to interfere with the interpretation of results a history of head trauma an infectious disease, hormonal, inflammatory or some deficiency may induce cognitive and / or psychiatric troubles Patient with cons-indication for performing a brain MRI Pregnant, parturient and lactating (producing a serum pregnancy test)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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: FSHD patient<br> | Behavioral: Psychiatric test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery and Asberg Depression Rating Scale |  | One time at the inclusion | 
| Hamilton Depression Rating Scale |  | One time at the inclusion | 
| Hamilton Anxiety Rating Scale |  | One time at the inclusion | 
| Quick inventory of depressive symptomatology Self report |  | One time at the inclusion | 
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form |  | One time at the inclusion | 
| Mini Mental Status Evaluation |  | One time at the inclusion | 
| Wechsler Adult Intelligence Scale |  | One time at the inclusion |
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.

Conditions
-----------------
Hemorrhage, Hypocalcemia, Vocal Cord Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with total thyroidectomy plus central neck dissection if primary tumor size was more than 1 cm in papillary thyroid cancer there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer Exclusion Criteria: patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis patients had clinical or laboratory indicators of coagulation disorders patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve patients with massive extracapsular extension to the surrounding soft tissues.
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
-----------------
Harmonic scalpel, Thyroidectomy, Central neck dissection, Perioperative complications
Metformin in Postmenopausal Women With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.

Official Title
-----------------
Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute Exclusion Criteria: Previous cardiovascular diseases Contraindicated to metformin: serum creatinine >1.4 mg/dL, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis Previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment Fasting blood sugar ≥ 200 mg/dL or HbA1c >8% Serum triglyceride ≥500 mg/dL Abnormal EKG

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Metformin (850mg) 1 tab oral twice a day | Drug: Metformin<br>* Metformin(850 mg) 1tab oral twice aday<br>|
| Placebo Comparator: Placebo<br>Placebo 1 tab oral twice a day | Drug: Placebo<br>* Placebo 1 tab oral twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk factors | To compare the cardiovascular risk factors, including blood pressue, fasting blood sugar (FBS), Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR), 75-g oral glucose tolerance test (75-g OGTT), lipid profile, high sensitivity C-reactive protein(hs-CRP), neck circumference and waist circumference, between metformin and plcebo at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-year risk of coronary heart disease | To compare 10-year risk of coronary heart disease, which is calculated from RAMA- Electricity Generating Authority of Thailand (RAMA-EGAT) score, between metformin group and placebo at 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular risk factors
Negative Predictive Value of Drug Provocation Tests to Beta-lactams

Study Overview
=================
Brief Summary
-----------------
Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.

Official Title
-----------------
Negative Predictive Value of Drug Provocation Tests to Beta-lactams

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Other: Evaluation of reexposure to a negatively tested betalactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam The patient or the patient's legal representatives are not their opposition to participate in this study The patient must be affiliated or beneficiary in a health insurance system Exclusion Criteria: The patient is exclusion period determined by a previous study The patient is under judicial protection, guardianship or curatorship The patient or the patient's legal representatives do not read fluently the French language

Ages Eligible for Study
-----------------
Minimum Age: 5 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Evaluation of reexposure to a negatively tested betalactam<br> | Other: Evaluation of reexposure to a negatively tested betalactam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of drug provocation tests to betalactams |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The types of reactions upon reexposure to a negatively tested betalactam |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug hypersensitivity, Betalactam, Drug provocation test
Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate the spanish (from Spain) version of the Nocturia Quality of Life Questionnaire and assess their psychometric properties, using the spanish translation provided by the copyright holder. Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by Intraclass Correlation Coefficient), Convergent Validity (assessed using other already validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be evaluated.

Official Title
-----------------
Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia

Conditions
-----------------
Nocturia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Older than 60 years old One or more voidings overnight Exclusion Criteria: Sleep disturbances Psychiatric diseases Surgical procedures during the time of study Introduction of new pharmacological treatments during the time of study Inability to complete the questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 99 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 |
| --- | --- |
| Men with nocturia<br>Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria | |
| Women with nocturia<br>Women older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score in n-QoL questionnaire |  | two determinations in ten days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score in IPSS spanish validated questionnaire |  | two determinations in ten days (only men) | 
| score in Pittsburgh Sleep Quality Index spanish validated questionnaire |  | two determinations in ten days | 
| score in King's health spanish validated questionnaire |  | two determinations in ten days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOCTURIA, SYMPTOMATIC QUESTIONNAIRE, N-QOL
Evaluation of the Dental Health Condition in Obesity Patients Before and After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions. People who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity related dietary habits could result in an increment of dental caries because both the amount and the frequency of sucrose ingestion are important factors associated with the aetiology of the oral disease.

Conditions
-----------------
Obesity, Periodontitis, Caries, Periapical Lesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese pateints who intended to go bariatric surgery. Exclusion Criteria: Coronary heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

Study Overview
=================
Brief Summary
-----------------
Primary: • To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 To evaluate the immunogenicity of AVP-21D9

Detailed Description
-----------------
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers

Conditions
-----------------
Anthrax

Intervention / Treatment
-----------------
* Drug: AVP-21D9
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy volunteers, between 18 and 45 years of age Normal laboratory (blood test) results Key Exclusion Criteria: Prior immunization with anthrax vaccine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVP-21D9<br> | Drug: AVP-21D9<br>* intravenously, single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo comparator<br>* Other names: Placebo comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments | Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 90 or the early withdrawl visit, if applicable. | 90 days following infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) analysis | PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9. | 90 days following infusion | 
| Immunogenicity analysis | Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation | From day 1 up to day 90 following infusion |