linjc16/ctgov huggingface dataset:
Vitamin D in Periodontal and Cardiovascular Disease Progression

Study Overview
=================
Brief Summary
-----------------
Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Detailed Description
-----------------
Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.

Official Title
-----------------
Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Other: Evaluation of periodontal status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least twenty teeth CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm; Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs Presence of ≥40% sites with bleeding on probing (BOP) Exclusion Criteria: Intake of contraceptives Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study Status of pregnancy or lactation Previous history of excessive drinking Allergy to local anaesthetic Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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 |
| --- | --- |
| Control<br>Healthy subjects | Other: Evaluation of periodontal status<br>* Clinical examination<br>|
| Periodontitis<br>Patients with periodontal disease | Other: Evaluation of periodontal status<br>* Clinical examination<br>|
| Cardiovascular<br>Patients with cardiovascular disease | Other: Evaluation of periodontal status<br>* Clinical examination<br>|
| Periodontitis+Cardiovascular<br>People with both cardiovascular and periodontitis | Other: Evaluation of periodontal status<br>* Clinical examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment level | Clinical Analysis | 1 year |
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance of Rosuvastatin/Ezetimibe

Detailed Description
-----------------
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Official Title
-----------------
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe

Conditions
-----------------
Mixed Dyslipidemia

Intervention / Treatment
-----------------
* Other: NA (Observation study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient who is first prescribed and administered Rosuvastatin/Ezetimibe Exclusion Criteria: The patients who are overreacting to this drug or its components The patients with severe renal impairment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: NA (Observation study)|NA (Observation study)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event after this drug administration in general medical practice | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 24 weeks | 
| Incidence of serious adverse event after this drug administration in general medical practice | Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events. | 24 weeks |
Determinants of Thyroid Surgery Outcomes

Study Overview
=================
Brief Summary
-----------------
In a large prospective cross-sectional study, the investigators aimed to identify the determinants of thyroid surgery outcomes and quantify the relative influence of preoperative and intraoperative factors. For this purpose, the investigators considered the interplay of several characteristics specific to surgeons, patients, and surgical procedures.

Official Title
-----------------
Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes

Conditions
-----------------
Thyroid Disease

Intervention / Treatment
-----------------
* Procedure: Thyroid surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients who underwent a thyroid procedure between April 2008 and July 2008. Exclusion Criteria: - Participation refusal
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thyroid surgery<br>All patients who underwent a thyroid procedure in 5 high volume referral centers in France were eligible for inclusion. | Procedure: Thyroid surgery<br>* Thyroidectomies performed by all surgeons in 5 academic hospitals in France.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent laryngeal nerve palsy | Systematic postoperative screening by laryngoscopy | During inpatient stay and at 6 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary hypoparathyroidism | Systematic postoperative screening based on hypocalcaemia < 2 mmoL/l or vitaminocalcic substitution | During inpatient stay and at 6 months following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid surgery, surgical outcomes, patient safety, healthcare quality, surgeons performance
Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients

Study Overview
=================
Brief Summary
-----------------
This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary hypertension (PH) in patients with end-stage kidney disease (ESKD).

Detailed Description
-----------------
Pulmonary hypertension (PH) is a rare cardiovascular disease with progressive and fatal features. PH is classified into the 5 groups, and the prevalence of group 1 pulmonary arterial hypertension, including idiopathic and heritable, is 5 to 15 cases per one million adults and a median survival was reportedly three years. PH found in patients with end-stage kidney disease (ESKD) is classified into group 5, because the pathogenesis and clinical characteristics have not been clarified. The prevalence of PH in patients with ESKD was reportedly around 17 56% based on echocardiographic studies. In this study, we evaluated the incidence of idiopathic pre-capillary PH of ESKD patients by right heart catheterization, and examined the prognosis by following the occurrence of heart failure death.

Official Title
-----------------
Idiopathic Pre-capillary Pulmonary Hypertension in Patients With End-stage Kidney Disease

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of dyspnea, hypotension (systolic blood pressure <90mmHg, or syncope. Systolic pressure gradients in tricuspid valve of 40 mmHg or more. In right heart catheterization, precapillary PH was defined as mean pulmonary arterial pressure (PAP) ≥25 mmHg, pulmonary vascular resistance (PVR) ≥3 wood unit, and pulmonary artery wedge pressure (PAWP) ≤15 mmHg. Exclusion Criteria: Patients with systolic left ventricular dysfunction (left ventricular ejection fraction [LVEF] <50%), mitral or aortic regurgitation of grade 2 or more, aortic or mitral surface <1.5 cm2, severe anemia (blood hemoglobin <9 g/dl), severe chronic obstructive pulmonary disease defined by percent predicted forced expiratory volume in one second <60%, or lung fibrosis were not enrolled in this study. In right hear catheterization, PAP ≥25 mmHg and PAWP >15 mmHg were diagnosed as post capillary PH.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Number of patients of idiopathic pre-capillary hypertension |  | 14 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who died of heart failure |  | 14 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, survival, end-stage kidney disease
Movement Disorder Survey in East China

Study Overview
=================
Brief Summary
-----------------
Movement disorder involve recurring or constant muscle contractions causing squeezing or twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most common focal dystonia was cervical dystonia in western countries according to previous studies, which is different from China in Chinese neurologists' opinion. And there is no such survey. So the investigators are conducting a movement disorder survey in east China to confirm it.

Official Title
-----------------
Movement Disorder Survey in East China

Conditions
-----------------
Primary Dystonia, Hemifacial Spasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seeking treatment in movement disorder clinics(include naive or may have previously been to clinics) Exclusion Criteria: Patients who have received this movement disorder survey
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Movement disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with primary dystonia | It is Cross-Sectional, service-based survey to study the primary dystonina prevalence in east China. | half year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hemifacial spasm | It is a Cross-Sectional survey to study the prevalence of hemifacial spasm in movement disorder of east China. | half year | 
| Number of participants with blepharospasm | It is a Cross-Sectional survey to study the prevalence of blepharospasm in movement disorder of east China. | half year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dystonia, Hemifacial spasm, Cervical dystonia, Blepharospasm
Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

Study Overview
=================
Brief Summary
-----------------
Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies. All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.

Official Title
-----------------
Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

Conditions
-----------------
Hemodynamic Instability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric critically ill ventilated patients admitted to PICU & PCICU Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made parental concent Exclusion Criteria: Cardiac shunt Aortal anomaly \ Repair Tracheostomy Parental refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum 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 |
| --- | --- | --- |
| Raise>10% in cardiac index following therapy |  | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cardiac output, fluid responsiveness, critically ill, hemodynamic monitoring
Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

Study Overview
=================
Brief Summary
-----------------
This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.

Detailed Description
-----------------
Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.

Official Title
-----------------
A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)
* Drug: low dose cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myeloid leukemia except APL ECOG PS：0-3 Unfit or unwilling to receive intensive therapy Exclusion Criteria: The one who has already received induction therapy no matter what the outcome is. Active cancer patients who are needed to receive treatment; Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）； Active heart disease

Ages Eligible for Study
-----------------
Minimum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAG regimen<br>Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy. | Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)<br>* Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.<br>|
| Active Comparator: Low dose cytarabine<br>cytarabine 20mg bid for 10 days. | Drug: low dose cytarabine<br>* cytarabine 20mg bid for 10 days.<br>* Other names: cytarabine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate |  | 4 months | 
| relapse free survival |  | 3 years | 
| treatment-related mortality |  | 2 months |
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.

Detailed Description
-----------------
30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of >35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline. Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

Official Title
-----------------
A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Truncal Vagotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female age 25-55 BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity Stable weight for the last 3 months willing to use contraceptives motivated to lose weight a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight fully ambulatory Exclusion Criteria: sign of prior major abdominal surgery history of or signs and /or symptoms of gastro-duodenal ulcer disease abnormal vagus nerve testing current use of a list of medication

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- |
|Procedure: Laparoscopic Truncal Vagotomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Excess Weight Loss |  |  | 
| Absolute Weight Loss |  |  | 
| Change in BMI |  |  | 
| Change in Percent Body Fat (DEXA) |  |  | 
| Change in Percent Body Fat (Impedence) |  |  | 
| Change in Lipid Panel (chol, triglycerides, LDL, HDL |  |  | 
| Urinary pH |  |  | 
| 3 day dietary diary |  |  | 
| fasting glucose |  |  | 
| OGGT with insulin |  |  | 
| OGGT with FFA and gut peptides |  |  | 
| gastric emptying |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  |  |
an Istitution Experience on Parosteal OsTeosarcoma

Study Overview
=================
Brief Summary
-----------------
single institution cases series review of histological and clinical data

Detailed Description
-----------------
Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.

Official Title
-----------------
Parosteal OsTeosarcoma: a Single Istitution Experience

Conditions
-----------------
Parosteal Osteosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018 Diagnosis of parosteal osteosarcoma Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: • Patients with histological diagnosis different from parosteal osteosarcoma
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retrospective analysis of cases of Parosteal osteosarcoma | Investigators will exam the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome. | at baseline (Day0) |