linjc16/ctgov huggingface dataset:
Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze how common stress hyperglycaemia (abnormally high blood glucose) is in primary hip and knee replacement surgeries and which factors predispose to hyperglycaemia.

Detailed Description
-----------------
Postoperative infections remain one of the most frequent reasons of failure of hip and knee prostheses. Diabetes increases the risk of infections. In other fields of surgery, hyperglycemia induced by surgical stress (stress/perioperative hyperglycemia) has been associated with higher rates of postoperative infections and complications. Such studies have not yet been performed in the field of joint replacement surgery. Unlike several other risk factors of infected joint replacements, hyperglycemia is potentially modifiable and therefore its prevalence, predisposing factors and association with postoperative infections are of interest.

Official Title
-----------------
Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement

Conditions
-----------------
Knee Replacement, Hip Replacement, Hyperglycemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of osteoarthritis Scheduled for primary hip or knee replacement Exclusion Criteria: Arthritis other than osteoarthritis Medication affecting glucose metabolism (excl. antidiabetic agents) Not undergoing hip or knee replacement

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 |
| --- | --- |
| Hip and knee replacements recipients<br>Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence (and severity) of hyperglycemia following primary hip or knee replacement | Follow-up covers postoperative hospital stay at the operating hospital, that lasts typically 2-5 days. | 3 days (average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical-site infections |  | 1 year | 
| Prevalence of glucose metabolism disorders and metabolic syndrome |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee replacement, hip replacement, hyperglycemia, diabetes, osteoarthritis
The Effects of Hesperidin on Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
To study the effects of Hesperidin supplement in patients with metabolic syndrome, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.

Official Title
-----------------
Evaluation of the Effects of Hesperidin Supplementation in Patients With Metabolic Syndrome

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

Intervention / Treatment
-----------------
* Dietary Supplement: hesperidin
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 to 70 years having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HDL Exclusion Criteria: pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis Following program to lose weight in recent 3 mo

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hesperidin<br> | Dietary Supplement: hesperidin<br>* 500 mg hesperidin as two capsuls<br>|
| Placebo Comparator: control<br> | Other: control<br>* no supplementation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome: Number of participants with treated metabolic syndrome | number of participants with treated metabolic syndrome | 12 weeks |
Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation. determine changes in patient pain level determine changes in patient functionality determine changes in patient life quality

Conditions
-----------------
Hip Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male that is not younger than 60 years old. Patient suffers from hip fracture that will need hip arthroplasty. Patient that weight less than 150Kg Patient femur head diameter between 40mm - 50mm Mentally normal Patient that could walk before suffering from hip fracture Patient that willing to cooperate with the doctor Patient that signed on the acceptance form Exclusion Criteria: Patient that does not willing to cooperate with the doctor Patient that is legally rejected Patient that suffer from cancer Patient that had passed amputation in is limbs Patient that is paralysis Patient that passed CVA or TIA Patient that still recovering from hard wounds or surgery Patient that suffer from infection in the hip joint

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| A<br> | |

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
-----------------
determine changes in patient pain level, determine changes in patient functionality, determine changes in patient life quality
Halitosis and Mouth Breathing in Children

Study Overview
=================
Brief Summary
-----------------
Objective: determine whether there is a correlation between halitosis and mouth breathing in children. Study design: Fifty-five children between three and 14 years of age were divided into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive analysis was carried out regarding the degree of halitosis in each group. The chi-square test was used for the comparison between groups, with 5% level of significance.

Official Title
-----------------
Halitosis and Mouth Breathing in Children

Conditions
-----------------
Mouth Breathing, Halitosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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 |
| --- | --- |
| Mouth breathing<br> | |
| Nasal breathing<br> | |

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
-----------------
halitosis, pediatric dentistry, mouth breathing
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Study Overview
=================
Brief Summary
-----------------
Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Detailed Description
-----------------
Study Design:

Official Title
-----------------
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Conditions
-----------------
Restless Legs Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Moderate to severe Primary Restless Legs Syndrome Male or female patients aged at least 18 years Exclusion criteria: Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients. Ongoing treatment with Mirapex Pregnant and breastfeeding women Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa) Secondary RLS

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 |
| --- | --- |
| Pramipexole<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Reported Adverse Events | If there is a dose titration, another 4 weeks should be followed up | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment | a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40 | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) | 
| Patient-Global Impressions (PGI-I) | PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse. | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) | 
| Clinical Global Impressions-Global Improvement (CGI-I) | CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse. | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
What is the Knowledge and Use of Emergency Contraception

Study Overview
=================
Brief Summary
-----------------
The main objective is to assess the knowledge of women seeking abortion about emergency contraception. The secondary objectives are to evaluate the use of emergency contraception among women seeking abortion and to identify barriers to the efficacy and use of emergency contraception in these women.

Official Title
-----------------
What is the Knowledge and Use of Emergency Contraception for Women Who Are Seeking Abortion in University Hospitals of Strasbourg

Conditions
-----------------
Abortion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged over eighteen years old the patient agreed that her questionnaire data should be collected and analyzed for this research. women who are able to read and write French woman seeking an abortion at the Orthogeny Center in University Hospitals of Strasbourg Exclusion Criteria: refusal to participate in the study

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of women's knowledge of contraceptive methods through a questionnaire |  | 1 hour after consultation for abortion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perception of pregnancy risk, Contraceptive failure, Abortion, Emergency contraception, Emergency pill
CGM Use in Children With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

Detailed Description
-----------------
The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

Official Title
-----------------
IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Continuous glucose monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, diabetes duration >3 months Exclusion Criteria: Prior use of CGM

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CGM Arm<br>Children with type 2 diabetes will wear a continuous glucose monitor for 10 days. | Device: Continuous glucose monitor<br>* Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.<br>* Other names: Dexcom G6 CGM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time in Range Glucose Control | The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL | 5 days, 10 days | 
| Hemoglobin A1c | HbA1c at baseline and 3-6 month follow-up. | Baseline, 3 - 6 months | 
| More Frequent Insulin Administration | Response to Did you take your insulin more often than before? | 10 days from CGM placement | 
| More Frequent Glycemic Control Monitoring | Response to Do you look at or check your blood sugar more often than before? | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous glucose monitoring (CGM), Hemoglobin A1c
Observational Study on a Chinese Population

Study Overview
=================
Brief Summary
-----------------
An observational study was conducted in a health examination center to distinguish risk factors for health in a randomly recruited volunteers of Chinese population.

Official Title
-----------------
Observational Study on the Risk Factors for Health in a Chinese Population

Conditions
-----------------
Metabolic Disease, Nutrition Disorders, Genetic Predisposition to Disease

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Han population, living in Shenzhen City for > 2 y, not in pregnancy, without hepatic diseases and renal diseases Exclusion Criteria: caught by organic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| A group of participants<br> | Other: No intervention.<br>* Cross-sectional observation without interventions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating 25OHD concentration. |  | Jan., 2014 - May., 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | Jan.-Dec., 2013 | 
| Plasma glucose |  | Jan.-Dec., 2013 | 
| DNA polymorphisms |  | Jan., 2014 - Dec., 2017 | 
| Plasma lipids |  | Jan.-Dec., 2013 | 
| Blood pressure |  | Jan.-Dec., 2013 |
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Detailed Description
-----------------
Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment. Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Official Title
-----------------
Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

Conditions
-----------------
Hand Dermatoses

Intervention / Treatment
-----------------
* Drug: alitretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis Lasting for 6 months since initial diagnosis Rated severe Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens Refractory to topical steroids Exclusion Criteria: Female patients who are pregnant or want to become pregnant Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alitretinoin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians global assessment |  |  | 
| at week 12 or 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate per treatment group |  |  | 
| Modified total lesion symptom score |  |  | 
| Patients global assessment |  |  | 
| at week 12 or 24 |  |  | 
| Time to relapse |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hand Dermatitis
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.

Official Title
-----------------
Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Deep brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient over 18 yo patient with Parkinson's disease implanted for deep brain stimulation patient responders to deep brain stimulation (UPDRS improved by at least 40%) patient covered by the french health care system patient not taking anti-parkinsonian medication the day before evaluation French speaking Exclusion Criteria: patient below 18 yo pregnancy Severe psychiatric or cognitive disorders diabetes mellitus morbid obesity compulsive eating disorders diffuse GI motility impairment (except Parkinson's disease) other evolutive neurologic disorders previous history of significant GI resection inability to swallow or defecate when asked

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ON<br>Stimulator switched ON | Device: Deep brain stimulation<br>* Comparison ON vs OFF<br>|
| Sham Comparator: OFF<br>Stimulator switched OFF | Device: Deep brain stimulation<br>* Comparison ON vs OFF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal pressure |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, deep brain stimulation, GI motility