linjc16/ctgov huggingface dataset:
Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Study Overview
=================
Brief Summary
-----------------
The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients

Official Title
-----------------
Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.

Conditions
-----------------
Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: Carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes patients with Diabetes neuropathy DN4 > or equal to 4 Male or female aged from 21 to 65 years Informed consent HbA1C < 11% Exclusion Criteria: Prior Hospitalization for Acido- cetosis Prior hospitalization for severe hypoglycemia Pregnancy Hepatitis Diabetes foot AVB (auriculo-ventricular conduction disturbance) Patient treated by antidepressant drugs Patient treated with other antiepileptic drug Patients with blood ion disturbance Patient with neutropenia Glaucoma Bladder Adenoma Alcohol abuse Creatinin clearance < 60 ml/ minute Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbamazepine<br> | Drug: Carbamazepine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding) |  | 12 weeks | 
| Evaluate the quality of life |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuropathic Pain, Brief Pain Inventory, DN4 questionnaire, ElectroCardioGram
Management of Distal Ulna Fractures Using Hook Plate

Study Overview
=================
Brief Summary
-----------------
The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult  without concomitant distal radius fractures.

Detailed Description
-----------------
The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion

Official Title
-----------------
Prospective Study of the Management of Distal Ulna Fractures Using Hook Plate in Adult

Conditions
-----------------
Distal Ulna Fractures

Intervention / Treatment
-----------------
* Procedure: Hook plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature distal ulna fracture with or without radius fracture. Exclusion Criteria: Pathological fracture Skeletally immaturity Neurovascular problems

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adult patients with distal ulna fractures<br>adult patients with distal ulna fractures | Procedure: Hook plate<br>* We used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured<br>* Other names: Distal ulna anatomical plate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of Distal Ulna Fractures Using Hook Plate | surgery | 6 months |
Effect of Upper Third Molar Extraction on Distalization Carriere Motion Appliance :A Prospective Clinical Study

Study Overview
=================
Brief Summary
-----------------
This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance

Official Title
-----------------
Effect of Upper Third Molar Extraction on Distalization Using Carriere Motion Appliance :A Prospective Clinical Study

Conditions
-----------------
Class II Malocclusion

Intervention / Treatment
-----------------
* Device: carriere motion appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angle´s Class II canine relationship, at least half-unit. Skeletal Class I or mild Class II relationship. Upper second molars were fully erupted before starting distalization. Normal or horizontal growth pattern. Good oral hygiene. Absence of any systemic diseases Exclusion Criteria: Previous orthodontic treatment. 2. Patients who required surgery to correct skeletal discrepancies (sever skeletal class11). 3. Patients with hyperdontia, hypodontia, or syndromic diseases. 4. Extraction or badly destructed teeth in upper arch -

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 22 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1: control group<br>will be treated using carriere motion appliance for distalization of upper buccal segment in the presence of upper third molar | Device: carriere motion appliance<br>* after finished treatment with carrirere motion appliance in the two group (group 1 have upper wisdom teeth ,group 2 have not upper wisdom teeth ) the pre and post casts will be scanned and superimposed to determine amount upper molar distalization<br>|
| Active Comparator: group2: teste group<br>will be treated with using carriere motion appliance for distalization of upper buccal segment with upper third molar extraction or have congenital missing upper third molar | Device: carriere motion appliance<br>* after finished treatment with carrirere motion appliance in the two group (group 1 have upper wisdom teeth ,group 2 have not upper wisdom teeth ) the pre and post casts will be scanned and superimposed to determine amount upper molar distalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in upper first molar position | using 3d cast superimposition | Baseline to 6 months |
Strong Heart Study Analyses Obesity and Lipoproteins

Study Overview
=================
Brief Summary
-----------------
To examine the relationship of obesity and body fat distribution to lipoprotein concentrations in members of the Strong Heart Study.

Detailed Description
-----------------
BACKGROUND: The Strong Heart Study is a longitudinal cohort study of several American Indian groups in three participating centers. The overall aim of the main study is to determine the role of various risk factors in the development of cardiovascular disease in this native American population. DESIGN NARRATIVE: Data from the first and second clinical exams of the Strong Heart Study were analyzed to determine if body fat distribution as measured by waist-to-hip circumference was a better correlate of lipoproteins than was body mass index. In addition, change in body mass index (BMI) and waist-to-hip ratio (WHR) were correlated with change in lipoproteins. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Modified Triple Osteotomy for Acetabular Dysplasia

Study Overview
=================
Brief Summary
-----------------
Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. The investigators modified the technique with two anterior incisions and ramus cuts close to inferior acetabulum. The purpose of this study is to compare these two techniques in femoral head coverage

Official Title
-----------------
Modified Triple Osteotomy for Acetabular Dysplasia - A Modified Technique for Better Femoral Head Medialization and Coverage

Conditions
-----------------
Sharp Angle, Center Edge Angle, Femoral Head Extrusion Index, Center Head Distance Discrepancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic acetabular dysplasia in adolescent or young adult Closed triradiate cartilage Minor coxarthrosis with Tonnis grades at 1 or 2 Exclusion Criteria: High subluxation or complete dislocation of the hip joint Severe osteoarthrosis Combined with proximal femoral osteotomy that changed the femoral neck shaft angle (such as varus or valgus osteotomy)

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Traditional Steel Triple Osteotomy<br>Traditional technique | |
| Modified Triple Osteotomy<br>Modified technique | |

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
-----------------
Hip dysplasia, Triple Osteotomy, Femoral Head Coverage, Femoral Head Medialization
Study on the Relationship Between Physical Constitution and Diseases

Study Overview
=================
Brief Summary
-----------------
Physical constitution is an important factor for the development and outcome of diseases according to the theory in traditional Chinese medicine. The purpose of the study is to find the correlation between physical constitution and clinical characteristics (age, sex, symptoms, physical signs, life style, laboratory results and image findings) through the questionnaire and results of health examination.

Detailed Description
-----------------
It is difficult to predict the process or outcome of disease for individuals who expose to the same pathogen or condition. But according to the Traditional Chinese Medicine, physical constitution is an important factor for disease pattern, severity and response to the treatment. So it is paid more and more attention in Western Medicine to study the variation of individualized susceptibility to diseases. There have been some researches to investigate the relationship between physical constitution and disease pattern. Before further studies, we need to obtain more information about physical constitution and clinical characteristics. Therefore we design a comprehensive questionnaire to survey the types of physical constitution. And we plan to collect the data from health reports of candidates after their medical tests at Health Examination Center in National Taiwan University Hospital Yu-Lin Branch. We focus on the relationship between clinical characteristics (age, sex, symptoms, physical signs, laboratory results and image findings) of Western Medicine and the physical constitutional types of Chinese Medicine. Then we will try to find the correlation and significance between them. The study will conclude the constitutional characteristics in general population of Taiwan and the distribution tendency of physical constitution for the common diseases. The result can serve as a stepping stone for integration of the Traditional Chinese Medicine and Western Medicine.

Official Title
-----------------
Cross Sectional Study on Relationship Between Physical Constitution and Diseases in the Integrative Chinese Medicine and Western Medicine

Conditions
-----------------
Chronic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: candidates with healthy report on health exam Exclusion Criteria: acute infection chronic disease with acute exacerbation unstable disease status or medication

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Constitution, Disease Pattern, Laboratory Data, Integrative Chinese Medicine and Western Medicine
Perception and Prevalence of Fungal Infections in Berlin - Brandenburg

Study Overview
=================
Brief Summary
-----------------
This is a structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field of invasive mycoses.

Detailed Description
-----------------
Intensive care patients with invasive mycosis require a special clinical expertise especially in light of a high lethality. Early identification of patients at risk to develop a fungal infection is of utmost importance to start effective antifungal therapy. The implementation of current knowledge into clinical practice to fight fungal infection is not clear.

Official Title
-----------------
Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg

Conditions
-----------------
Invasive Mycosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive care units of hospitals in the INABBRA alliance. Patients with invasive mycosis. Exclusion Criteria: Hospitals without intensive care unit.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INABBRA<br>Participating hospitals in the INABBRA alliance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception and prevalence of fungal infections | Perception and prevalence of fungal infections in ICU patients differs from real prevalence and leads to insufficient attribution of importance to this special medical condition. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Practice - Surrogate markers for diagnosis and therapy of fungal infection and retrospective analysis of cases of invasive mycosis in a peer-review setting. | Qualitative and quantitative estimation of surrogate markers for diagnosis and treatment of invasive mycosis Number of bloodcultures per year Rate of bloodcultures positive for fungi ICD-10 diagnosis ICU length of stay for patients with invasive mycosis and/or fungal infection Hospital mortality for patients with invasive mycosis and/or fungal infection Number of patients treated by antimycotics per year Mean duration of antifungal treatment Defined daily doses of antimycotics given by hospital pharmacy | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care, candidemia, fungal infection
Non-specific Response to H1N1 Vaccine

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia. The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.

Official Title
-----------------
Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine

Conditions
-----------------
Influenza H1N1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of H1N1 influenza vaccine. Healthy individuals with no signs of influenza or other infectious disease. Exclusion Criteria: Signs of influenza or other infectious disease in 1 month before study participation.

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 |
| --- | --- |
| Healthy volunteers from recipients of H1N1 vaccine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination |  | At 3 weeks after vaccination | 
| T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination |  | At 11 weeks after vaccination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza H1N1, Vaccine, Adjuvant, T Lymphocytes, Non-specific response, Interleukin-2, Non-specific T cell response
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) 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
-----------------
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study

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

Intervention / Treatment
-----------------
* Dietary Supplement: hesperidin
* Dietary Supplement: hesperidin and flaxseed
* Dietary Supplement: flaxseed
* 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 HD Exclusion Criteria: pregnancy or lactation history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis Following a 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 and flaxseed<br>1000 mg hesperidin as two capsules and 30 grams flaxseed | Dietary Supplement: hesperidin and flaxseed<br>* 1000 mg hesperidin as two capsules and 30 grams flaxseed<br>|
| Placebo Comparator: control<br>no supplementation | Other: control<br>* no supplementation<br>|
| Active Comparator: flaxseed<br>30 grams flaxseed | Dietary Supplement: flaxseed<br>* 30 grams flaxseed<br>|
| Active Comparator: hesperidin<br>1000 mg hesperidin as two capsules | Dietary Supplement: hesperidin<br>* 1000 mg hesperidin as two capsules<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 |