linjc16/ctgov huggingface dataset:
The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.

Conditions
-----------------
Gingival Scaling, Metabolic Control

Intervention / Treatment
-----------------
* Procedure: Gingival scaling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 25- 75 years; Type 2 diabetes; Chronic periodontitis with 2 or more teeth with CAL≥6mm and one site with a PD≥5mm (established periodontitis)16 Exclusion Criteria: Periodontal treatment within the last 3 months The use of antibiotics within the last 4 weeks Pregnancy or the intention to be pregnant in the next 4 months

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Scaling group<br>The experimental group will receive oral hygiene instruction (OHI) and full-mouth scaling using standard rigid Gracey curettes (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA) and ultrasonic instrumentation (EMS piezoelectric system, Electro Medical Systems, Nyon, Switzerland) at week 1-2 and at a second reinforcement visit at 6-8 weeks. Subjects will also be instructed to rinse with 10ml of Chlorhexidine 0.2% mouthrinse twice daily for 30 seconds for the duration of the study. | Procedure: Gingival scaling<br>* Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments.<br>|
| No Intervention: B: Control group<br>The control group will receive no periodontal treatment during the study. After completion of the study, these patients will be given oral hygiene instruction and a full mouth scaling. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control | Blood sample that measures fasting plasma glucose and the HbA1c level. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Blood sample to measure C reactive protein (inflammatory marker). | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
he effect of gingival scaling on Metabolic control
Prognostic Factors of COVID19

Study Overview
=================
Brief Summary
-----------------
COVID-19 is an emerging disease, for which no specific treatment options are currently available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of the number of COVID-19-positive patients in serious condition requiring hospitalization. At the same time, many people develop only mild or moderate symptoms. To date, the prognostic factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the COVID-HUS protocol is to investigate viral and host-related factors to understand the pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and therapeutic strategies against SARS CoV-2 . The secondary objectives are Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in infected patients Monitoring of the humoral and cellular response directed against SARS-CoV-2 Identification of factors leading to significant and / or prolonged viral replication of SARS-CoV-2 in the blood or respiratory samples Evaluation of the benefit of possible treatments implemented following the diagnosis of SARS-CoV-2 infection Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected patients Typing of the HLA system in infected patients

Official Title
-----------------
Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals

Conditions
-----------------
SARS-CoV-2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection Patient who has signed a non-opposition form (or a form signed by a family member or a support person if the seriousness of the patient's condition and the emergency situation do not allow it) or who has given his oral agreement to the doctor Exclusion Criteria: Patient's explicit refusal to participate Subject deprived of liberty or subject to the protection of justice Subject under guardianship or trusteeship

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital |  | From 1st March 2020 to 1st March 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Covid-19, Prognostic factors, Genetic factors, T and B cell immune response
Comparison of Two Methods of Immunization for Intramuscular Injections

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Detailed Description
-----------------
This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Official Title
-----------------
Comparison of Two Methods of Immunization for Intramuscular Injections

Conditions
-----------------
Consequences of Immunization Method

Intervention / Treatment
-----------------
* Procedure: Procedure: Z-track
* Procedure: Procedure: Bunch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults without latex allergy over 18 years of age Exclusion Criteria: latex allergy illness 18 years or less

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-Track immunization<br>Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle. | Procedure: Procedure: Z-track<br>* Subject received immunization by z-track<br>|
| Active Comparator: Bunch immunization<br>Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle. | Procedure: Procedure: Bunch<br>* Subject receives immunization by bunch method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived pain | Subjects will be asked to rate perceived pain on scale of 0-10 | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication leakage | Any medication leakage from either arm within 72 hours | 72 hours | 
| Redness at injection site | Redness, as determined by naive observer at injection site immediately and up to 72 hours after study. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intramuscular injection, bunch, z-track
Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience

Study Overview
=================
Brief Summary
-----------------
Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.

Conditions
-----------------
Treatment Procedure, Mortality

Intervention / Treatment
-----------------
* Procedure: Retroperitoneal hematoma due to cardiac catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retroperitoneal hematoma following cardiac catheterization Exclusion Criteria: Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.

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 1<br>Conservative management | Procedure: Retroperitoneal hematoma due to cardiac catheterization<br> <br> |
| Group 2<br>Angiografic stenting | Procedure: Retroperitoneal hematoma due to cardiac catheterization<br> <br> |
| Group 3<br>Surgery | Procedure: Retroperitoneal hematoma due to cardiac catheterization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 01/01/2010- 31/10/2016 |
Angeliq Regulatory Post Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.

Official Title
-----------------
Angeliq Regulatory Post Marketing Surveillance

Conditions
-----------------
Postmenopausal Period, Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: E2/DRSP (Angeliq, BAY86-4891)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis Exclusion Criteria: Undiagnosed genital bleeding Known, past or suspected cancer of the breast Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer) Untreated endometrial hyperplasia Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism) Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal Porphyria Severe renal insufficiency or acute renal failure Known hypersensitivity to the active substances or to any of the excipients
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: E2/DRSP (Angeliq, BAY86-4891)<br>* Take one tablet daily, continuously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | At each visit of patient during observational period (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of menopausal symptoms |  | After 6 months or at discontinuation of Angeliq (At earlier point) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Menopausal symptoms, Prevention of osteoporosis in menopausal women, Estrogen deficiency symptoms, Hormone replacement therapy
Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of an additional distal rectus femoris transfer carried out as a part of single-event multilevel surgery in children with spastic diplegic cerebral palsy.

Official Title
-----------------
Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: Distal rectus femoris transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral palsy spastic diplegia ambulatory stiff knee gait Exclusion Criteria: relevant previous surgery at the legs Botulinum-toxin-injections 6 months prior surgery

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: Distal rectus femoris transfer<br>Single-event multilevel surgery with a concomitant distal rectus femoris transfer | Procedure: Distal rectus femoris transfer<br>* Transfer of the distal rectus femoris tendon to the semitendinosus tendon.<br>* Other names: rectus transposition;|
| No Intervention: No distal rectus femoris transfer<br>Single-event multilevel surgery without distal rectus femoris transfer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of knee flexion in swing phase |  | prior intervention (baseline) and 1 year post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak knee flexion in swing phase |  | prior to intervention (basline) and 1 year post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, distal rectus femoris transfer, stiff knee gait pattern, gait analysis, single event multilevel surgery, randomized trial, crouch gait
Shared Decision Making in Graves Disease - Graves Disease (GD) Choice

Study Overview
=================
Brief Summary
-----------------
The investigators' decision aid for patients with GD, GD Choice, will be the result of a user-centered participatory action research involving) synthesis of the best available evidence from the literature and real-world registry experience, ii) input and involvement of patients, clinicians and other stakeholders, iii) direct observation of encounters and iv) extensive field-testing. The goal is to create a decision aid that will be rigorously evidence-based, clear and complete, able to be used by clinicians with minimal training time, while satisfying extant standards for rigorous high-quality shared decision making tools.

Official Title
-----------------
Shared Decision Making in Graves Disease - Graves Disease (GD) Choice

Conditions
-----------------
Graves' Disease, Thyroid Disease, Hyperthyroidism

Intervention / Treatment
-----------------
* Other: Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years Diagnosis of Graves Disease Appointment with endocrinologist to discuss treatment options for Graves Disease Exclusion Criteria: Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decision Aid<br>Observation of clinical encounter using the decision aid, via video, audio or written notes. | Other: Decision Aid<br>* Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.<br>* Other names: DA;|
| No Intervention: Usual Care<br>Observations in clinical encounters, either video, audio, or observational notes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants | Outcome measure to be assessed through post-visit surveys. | up to 2 weeks post-visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Grave's, Disease, Thyroid, Hyperthyroidism, Thyroidectomy, Radioactive, Iodine, Antithyroid, Shared, Decision, Making, Aid, Evidence, Based, Endocrinology, Mayo, Clinic
A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.

Official Title
-----------------
A 12-Week Multicenter, 2-Arm Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily, in Patients With Stable, Chronic Heart Failure (NYHA Class Ll-lll)

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: valsartan 160 mg
* Drug: valsartan 160 mg BID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males or females aged 18 years or older Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1 Patients must remain on their prior standard care CHF therapy Exclusion Criteria Diagnosis of severe hypertension (SBP>180 and DBP>110 mm Hg) Right heart failure due to pulmonary disease Presence of rapidly deteriorating heart failure MI or cardiac surgery, including PTCA within 3 months of Visit 1 Unstable angina or coronary artery disease likely to require CABG or PTCA Other protocol-defined exclusion criteria may apply.

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

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

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: valsartan 160 mg|nan|
|Drug: valsartan 160 mg BID|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients reaching target dose at 10 weeks |  |  | 
| Change from baseline in systolic blood pressure at each study visit |  |  | 
| Change from baseline in diastolic blood pressure at each study visit |  |  | 
| Change from baseline in blood potassium at each study visit |  |  | 
| Change from baseline in blood creatinine at each study visit |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
valsartan,, chronic heart failure,