linjc16/ctgov huggingface dataset:
Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers

Study Overview
=================
Brief Summary
-----------------
Despite the prominence of diabetes prevalence (more than 8% of the world population in 2012) and its expected increase in the next 15 years, Charcot foot remains a widely unknown diabetes complication. At this day, there is no national guidelines about diagnosis and treatment of this complication, which is known to alter life quality and to increase risk of foot ulceration and mortality in diabetics. Through this descriptive multicentric study, we will investigate the Charcot foot cares in diabetic-foot centers in France and Belgium.

Official Title
-----------------
Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers.

Conditions
-----------------
Diabetic Foot Neuroarthropathy Charcot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has received written information about the study and did not oppose to participate The patient is affiliated to a health insurance programme The patient is at least 18 years old The patient is admitted to hospitalization or consultation The patient is diagnosed with type 1 or type 2 diabetes mellitus The patient is diagnosed with acute or chronic osteo-neuroarthropathy Exclusion Criteria: The patient participates in another interventional study The patient refuses 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Charcot foot's diagnostic criteria | triggering factors : yes/no acute symptoms : : yes/no chronic symptoms : yes/no Presence of associated soft tissue infection : yes/no Presence of an associated bone infection : yes/no examinations performed to confirm the diagnosis of Charcot : yes/no | inclusion visit | 
| Description Charcot foot's treatment | Discharge used in acute phase and/or in case of wound : yes/no Shoes used in chronic phase : yes/no | inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Charcot foot | To determine diabetic patients' number with acute or chronic Charcot foot cared in diabetic-foot center in France and Belgium over a year (estimation of Charcot foot's incidence in diabetic-foot centers). | inclusion visit | 
| Surgery of Charcot foot | To identify which diabetic-foot centers propose surgical management in Charcot foot, to describe the type of surgery and the indications of surgical treatment. | inclusion visit | 
| Register of Charcot foot | participation to a register of Charcot foot : yes/no | inclusion visit |
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women

Study Overview
=================
Brief Summary
-----------------
The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.

Official Title
-----------------
Soy Isoflavone Tablets: Effects on Questionnaire and Actigraphic Measures of Sleep, Symptoms as Measured by the Women's Health Questionnaire and Cognitive Function as Measured by Computerized Cognitive Performance Tests in Menopausal Women

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: soy isoflavones
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: At least 5 hot flash episodes and/or night sweats per 24 hours Exclusion Criteria: Body mass index (BMI) more than 34 kg/m2 Hypertension Shift work Psychiatric or medical conditions that would affect outcome measures More than 4 caffeine drinks per day More than 10 cigarettes per day More than than 7 alcohol drinks per week
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: soy isoflavones<br> | Drug: soy isoflavones<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women | Hot flashes recorded by means of 5 global estimation and daily diary measures of hot flashes and night sweats. | Nine weeks | 
| Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women | Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions | 9 weeks | 
| Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women | Subjective sleep measured by average questionnaire item scores recorded each morning for a week, repeated at baseline and 4 subsequent times | 9 weeks | 
| Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women | Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests. | 9 weeks |
The Blood Glucose Control in Patients With Type 2 Diabetes Treated With Glargine

Study Overview
=================
Brief Summary
-----------------
Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. This study aims to investigate the current status of blood glucose control in patients with T2D treated with glargine. Glycated hemoglobin(HbA1c) will be tested in these patients to assess the blood glucose control and Continuous Glucose Monitoring System (CGMS) will be used to investigate the glucose variability. Islet function, duration of diabetes, complications, exercise, insulin dose, oral medication regimen and insulin antibodies will be recorded in detail. This study will analysis the association between these clinical characteristics and blood glucose control.

Official Title
-----------------
The Current Situation and Influence Factors of Blood Glucose Control in Patients With Type 2 Diabetes Treated With Glargine in China

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999; Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study; Patients had relatively constant diet and exercise in 2 month before the study; Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L. Exclusion Criteria: Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure; Patients with severe infectious diseases; Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis; Patients with history of psychiatric disorders and were unsuitable to use CGMS; Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Continuous Glucose Monitoring System|Continuous Glucose Monitoring System for 72 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Blood glycated hemoglobin | Day 1 | 
| MBG | 24 h mean blood glucose | Day 1 to Day 4 | 
| MAGE | 24 h mean amplitude of glycemic excursions | Day 1 to Day 4 | 
| SDBG | the standard deviation of the MBG | Day 1 to Day 4 |
Vitamin D Zinc Fever

Study Overview
=================
Brief Summary
-----------------
Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis. There are studies demonstrating an association between vitamin d deficiency and respiratory illnesses. Both zinc and vitamin d are associated with oxidative stress and inflammation.

Detailed Description
-----------------
Both vit. d and zinc share anti inflammatory and anti oxidative actions. vit. d deficiency is associated with an increase in serum levels of proinflammatory cytokines and decreased levels of anti inflammatory cytokines. there are reports concerning the association of vit. d deficiency with infections.

Official Title
-----------------
Vitamin d and Zinc Levels in Patients With Fever

Conditions
-----------------
Sepsis, Fever, Vitamin D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years Exclusion Criteria: CCT<90 taking calcium hyper/hypoparathyroidism active malignancy.

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 |
| --- | --- |
| fever zinc vit. d<br>patients with fever but without sepsis | |
| sepsis zinc vit. d<br>patients with sepsis | |

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
-----------------
zinc, sepsis, fever, vitamin d
Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.

Official Title
-----------------
Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1. Exclusion Criteria: any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding

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

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

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: gefitinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the complete pathological response rate in the two study groups at trial closure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population |  |  |
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.

Detailed Description
-----------------
Ocular Rigidity (corneal hysteresis and corneal resistance factor) is measured with the Ocular Response Analyzer (Reichert) before and 4 weeks after SLT (Q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). The trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mJ. The purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.

Official Title
-----------------
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Selective Laser Trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma Exclusion Criteria: other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: glaucoma patients<br>All of the patients treated with SLT need further IOP reduction for control of their glaucoma. | Procedure: Selective Laser Trabeculoplasty<br>* 100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser.<br>* Other names: ORA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in ocular rigidity | Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty? | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP reduction | Is there an effective IOP drop after SLT? | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, selective laser trabeculoplasty, ocular rigidity
Symbicort in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.

Official Title
-----------------
Symbicort in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD treated with budesonide/formoterol Exclusion Criteria: limitations; possible risks; warnings; contraindications mentioned in the SPC.
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>Patients with COPD treated with budesonide/formoterol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment of COPD, related to the budesonide/formoterole therapy in patients with COPD.
Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Open label study of sorafenib

Detailed Description
-----------------
Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than < 100 cigarettes lifetime).

Official Title
-----------------
A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: sorafenib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Life expectancy > 12 weeks Biopsy-proven BAC or adenocarcinoma Willing to provide smoking status Selected IIIB or stage IV cancer that is incompletely resected or unresectable Exclusion Criteria: O2 saturation < 88% on room air Pregnant or nursing women Surgery or radiation therapy within 4 weeks of starting study Major heart condition within 6 months of starting therapy Certain concomitant medications prohibited

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sorafenib|400mg po bid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | January 2009 | 
| One-year survival |  | January 2009 | 
| Median survival |  | January 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression-free survival |  | January 2009 | 
| Toxicities |  | January 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAC lung cancer, adenocarcinoma of the lung
Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning HD

Study Overview
=================
Brief Summary
-----------------
Responsiveness of recombinant human erythropoietin (rHuEPO) is known to be related with body fatness in hemodialysis (HD) patients. Adiponectin (ADPN) is inversely associated with body fat mass, and in healthy subjects, low ADPN is a predictor of mortality. Recently, higher rHuEPO dose itself is demonstrated to be associated with poor prognosis. So, in this study, we prospectively examined the relationship between rHuEPO dose, serum ADPN, and mortality in patients beginning HD.

Detailed Description
-----------------
We selected 85 patients (51 men/34 women, age; 64±15 years) who survived for more than 3 months after the start of HD. After determining initial rHuEPO dosage, we followed the patients for 3 years, and examined an association between rHuEPO dose, serum ADPN, and all-cause mortality. We could follow totally 74 out of 85 patients for 3 years; 59 patients were survived, but 15 patients expired. Dosage of rHuEPO was significantly and negatively correlated with body mass index (BMI) (r=-0.44, p<0.01) and positively with serum ADPN (r=0.29, p<0.02), but not with leptin. Cox-hazards regression analysis adjusted by age, sex and underlying kidney disease revealed that rHuEPO dose and serum ADPN, as well as nutritional parameter such as protein catabolic rate became significant determinants of 3-year mortality. There was a 12.7% risk increase for 10U/kg/week increase in rHuEPO dose and 1.3% increase for 1µg/ml increment of serum ADPN for the 3-year of follow-up.

Official Title
-----------------
Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Conditions
-----------------
Renal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had first started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in Shizuoka prefecture area. Exclusion Criteria: nothing particular
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
-----------------
adiponectin, recombinant human erythropoietin, mortality