linjc16/ctgov huggingface dataset:
The Point of View of Adolescents Who Have Undergone a Suicidal Act: What do They Expect From Their Relationship With Their Doctor?

Study Overview
=================
Brief Summary
-----------------
Evaluate the expectations of adolescents who have performed a suicidal act with regard to their relationship with their doctor

Official Title
-----------------
The Point of View of Adolescents Who Have Undergone a Suicidal Act: What do They Expect From Their Relationship With Their Doctor?

Conditions
-----------------
Suicidal Act

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents who have undergone a suicidal act and who were initially treated by the paediatric emergency department of the University Hospital of Nîmes. Teenagers with an attending physician. Adolescents who do not object to participating in the study Parents (holder of parental authority) who do not object to their child participating in the study Preliminary agreement to participate in the research project of the child psychiatrist treating the child. Exclusion Criteria: - Patient who has objected to the use of his data. Refusal by the child psychiatrist to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
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 |
| --- | --- | --- |
| percentage of adolescents with poor relationship with the doctor |  | 2019 |
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Study Overview
=================
Brief Summary
-----------------
Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients. Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban

Detailed Description
-----------------
Study Population Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients, Samsung Medical Center is aim to enroll about 200 patients

Official Title
-----------------
A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Conditions
-----------------
Atrial Fibrillation, Rivaroxaban, Elderly, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: Rivaroxaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with consent given Elderly patients with age 65 ≥ years old NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months Exclusion Criteria: Refusal to participate in this study or to give an informed consent Patients with moderate to severe mitral stenosis Patients with mechanical valve Contraindication from rivaroxaban Korea SmPC

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rivaroxaban|rivaroxaban for stroke prevention of atrial fibrillation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite incidence of stroke/ non-CNS SE | incidence of stroke/ non-CNS SE | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding incidence | Bleeding incidence | 1 year |
Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock

Study Overview
=================
Brief Summary
-----------------
The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.

Detailed Description
-----------------
Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) with cardiogenic shock (CS) are often treated with Intra-aortic balloon pump counterpulsation (IABP) although the evidence to support this is limited. We conducted a prospective, randomised clinical trial, of IABP as an addition to PCI centred therapy, in patients with AMI complicated by CS. 45 patients with AMI and CS undergoing PCI were randomised to care with or without IABP. Over 4 days, APACHE II scores, haemodynamic parameters, inflammatory markers and BNP levels were collected to assess the impact of IABP treatment on CS triggered multi organ dysfunction syndrome (MODS).

Official Title
-----------------
Intra-Aortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock - The Prospective, Randomised IABP SHOCK Trial for Attenuation of Multi-Organ Dysfunction Syndrome

Conditions
-----------------
Myocardial Infarction, Cardiogenic Shock

Intervention / Treatment
-----------------
* Device: Intra-aortic balloon pump counterpulsation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction Cardiogenic shock Exclusion Criteria: Absent peripheral pulses Mechanical complications of myocardial infarction
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

| Intervention/Treatment |
| --- |
|Device: Intra-aortic balloon pump counterpulsation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APACHE II SCORE |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic state |  | 4 days | 
| BNP levels |  | 4 days | 
| Inflammatory activation |  | 4 days | 
| Mortality |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Cardiogenic shock, Systemic inflammatory response syndrome, Percutaneous coronary intervention, aortic balloon counterpulsation
HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers

Study Overview
=================
Brief Summary
-----------------
Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis

Detailed Description
-----------------
Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals. The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8

Official Title
-----------------
HIF-1 Alpha, VEGF and MMP-8 Levels in Peri-implant Crevicular Fluid of Smokers Versus Non Smokers

Conditions
-----------------
Peri-Implantitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically free patients Individuals with restored implants placed one year or more before study enrollment Both genders Age range 20-50 years old Exclusion Criteria: Pregnant Females Lactating females

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid | Markers collected using periopaper strips | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gingival crevicular fluid, Smoking, inflammation
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.

Official Title
-----------------
A Phase I, Single-centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics After Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD2516
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2 Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly) Exclusion Criteria: History of previous or ongoing somatic or psychiatric disease/condition Abnormalities in ECG that may interfere with interpretation of data.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Capsule administered once orally | Drug: AZD2516<br>* Capsule administered once orally. Specific dose depends on dose panel.<br>|
| Placebo Comparator: 2<br>Capsule administered once orally | Drug: Placebo<br>* Capsule administered once orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG |  | Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects |  | Blood sampling at defined timepoints during residential period and follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, tolerability, AZD2516, pain, Japanese
Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a particular patient's immune cells possess influences how they respond to rituximab and other monoclonal antibodies.

Detailed Description
-----------------
A medical data collection survey sheet will be filled out by the patient or doctor with medical information pertaining to how the patient responded to rituximab and other monoclonal antibodies for use in this study. Blood work will be performed to analyze the blood by molecular technology to find the kind of Fc gamna RIIIa receptor the patient possess and correlate these findings with the outcome of treatment with rituximab or other monoclonal antibodies.

Official Title
-----------------
Correlation of Fc Gamma RIIIA Receptor Expression and Response to Rituximab and Other Monoclonal Antibodies in Patients With Waldenstrom's Macroglobulinemia

Conditions
-----------------
Waldenstrom's Macroglobulinemia

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: monoclonal antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|
|Drug: monoclonal antibodies|nan|

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
-----------------
monoclonal antibody, Fc gamma RIII receptor expression, rituximab
Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

Study Overview
=================
Brief Summary
-----------------
In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

Detailed Description
-----------------
Upon determination of eligibility, patients will receive: Paclitaxel + Estramustine + Carboplatin Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

Official Title
-----------------
A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel
* Drug: Estramustine
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adenocarcinoma of the prostate not curable with local treatment Disease progression while receiving hormonal therapy Measurable or evaluable disease Previous treatment with a maximum of one prior chemotherapy regimen ECOG performance status 0, 1, or 2. Adequate bone marrow, liver and kidney function Able to comprehend the nature of this study and give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of treatment for an invasive malignancy within five years Significant heart disease Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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: Paclitaxel|nan|
|Drug: Estramustine|nan|
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Overall survival |  |  |
A Prospective Clinical Study On A Total Hip Resurfacing System

Study Overview
=================
Brief Summary
-----------------
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Official Title
-----------------
A Prospective Clinical Study On A Total Hip Resurfacing System

Conditions
-----------------
Arthritis, Avascular Necrosis

Intervention / Treatment
-----------------
* Device: ReCap Total Hip Resurfacing System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including: Osteoarthritis Avascular necrosis Traumatic arthritis Legg Perthes Rheumatoid arthritis
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: ReCap<br>ReCap Total Hip Resurfacing System | Device: ReCap Total Hip Resurfacing System<br>* This is a hip resurfacing system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score, Device Revision/Removal, Radiographic Evaluation |  | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | Anytime |
Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

Study Overview
=================
Brief Summary
-----------------
A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

Official Title
-----------------
A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.

Conditions
-----------------
Epilepsy, Tonic-clonic

Intervention / Treatment
-----------------
* Drug: LEVETIRACETAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a confirmed diagnosis of epilepsy. Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial. Exclusion Criteria: Need for an additional AED.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monotherapy, epilepsy, Levetiracetam, Keppra
Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

Study Overview
=================
Brief Summary
-----------------
This study is investigating the normal range of maximal diaphragm thickness during a sniff inspiratory manoeuvre using ultrasound in healthy subjects stratified by age and gender.

Detailed Description
-----------------
Diaphragm dysfunction is associated with poor clinical outcomes in critically ill patients but is difficult to diagnose. Traditionally, diaphragm function is measured by evaluating inspiratory muscle strength via maximal inspiratory pressure (MIP). However, this technique relies on a volitional maximal effort and can be challenging for patients to perform. An alternative to measuring inspiratory muscle strength is the sniff inspiratory pressure approach. During short, sharp sniffs, the diaphragm is maximally activated. Currently, there are no reported values of the normal range of maximal diaphragm thickness during a sniff maneuver. This study will define the normal range of values for sniff maximal diaphragm thickening fraction, maximal thickening against an occluded airway, and diaphragm thickening during resting tidal breathing in healthy subjects.

Official Title
-----------------
Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

Conditions
-----------------
Diaphragm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Exclusion Criteria: Antecedent history of neuromuscular or cardiorespiratory disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sniff diaphragm thickening fraction | Thickening of the diaphragm during an inspiratory sniff | Day 1 | 
| Maximal diaphragm thickening fraction | Thickening of the diaphragm during a maximal inspiratory effort | Day 1 | 
| Resting tidal thickening fraction | Thickening of the diaphragm during resting tidal breathing | Day 1 |