linjc16/ctgov huggingface dataset:
Outcome After Non-invasive Ventilation.

Study Overview
=================
Brief Summary
-----------------
The study is an exploratory retrospective observational study with the aim to describe outcome fo the cohort of patients that receive non-invasive ventilation at an intensive care unit. Main research questions are: Characteristics of the cohort. The course for the patients at the ICU. ICU-mortality and 30-day mortality Amount of patients with limitations of care. Factors associated with mortality.

Official Title
-----------------
Outcome After Non-invasive Ventilation - an Observational Study at the Intensive Care Unit at Sundsvall Hospital.

Conditions
-----------------
Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Non invasive ventilation Admitted to Sundsvalls ICU during 2018 Exclusion Criteria: Below 18 years age.

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 |
| --- | --- |
| Patients with non-invasive ventilation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | Age, gender, comorbidities, indications for respiratory support, BMI, limitations of care. | At the day of admission to the ICU - 1 day | 
| ICU-mortality | Death occuring during ICU stay | Patients will be followed during their ICU-stay - estimated to be 1 to 60 days. | 
| 30-day mortality | Death within 30 days after ICU admission | 30 days from admission to ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with mortality | Evaluate patient and ICU-factors and relation to mortality. | 30 days from admission to ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive ventilation, critical care
Home Therapy With VPRIV in Gaucher's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Gaucher's Disease receiving their enzyme replacement therapy with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the infusions at the clinic or at doctor's practice.

Official Title
-----------------
Non Interventional Study of VPRIV® (Velaglucerase Alfa) Home Therapy in Patients With Gaucher's Disease

Conditions
-----------------
Gaucher Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with a confirmed diagnosis of Gaucher disease type 1 Age> 2 years patients who have at least 3 infusions (6 weeks) at least 5-year or 5-6 infusions (10-12 weeks) at 2 - to 4-year patients have received VPRIV ® and tolerate well The patient is compliant, the previous VPRIV ® infusions were / performed approximately every 2 weeks in the center during office visits The patient was already before inclusion in this study for a home infusion therapy and has consented to (or their legal representative) The patient / be lawful. Representative has consented in writing to participate in this study. Exclusion criteria: • The patient is participating in a clinical trial with a medicinal product

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Gaucher's Disease under VPRIV<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction estimated on a 10-ary Likert scale, quality of life estimated by SF-36 questionnaire |  | comparison of baseline to 12 months value | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (per infusion) and severity of infusion-related side effects |  | baseline compared to 12 months |
Change in Brain Metabolism and Cognitive Function by Aripiprazole

Study Overview
=================
Brief Summary
-----------------
Dopamine receptor occupancy and brain metabolism were measured using positron emission tomography after the administration of aripiprazole. Working memory performance was also measured using N-back task. The investigators explored the relationship between changes in brain metabolism and working memory performance.

Official Title
-----------------
The Relationship Between D2 Occupancy and Change in Frontal Metabolism and Working Memory Induced by Aripiprazole

Conditions
-----------------
Antipsychotics, Cognition, Brain Metabolism, Dopamine Receptor Occupancy

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers right-handed Exclusion Criteria: any significant abnormality on routine lab any psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole|single oral administration of aripiprazole|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time of correct response in N-back task |  | 48 hrs after the administration of aripiprazole |
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Study Overview
=================
Brief Summary
-----------------
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study

Official Title
-----------------
An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients currrently participating in Novartis study CAMN107A2109 imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC) males or females ≥18 years of age WHO Performance Status of ≤ 2 patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor Exclusion Criteria: Impaired cardiac function; use of therapeutic coumarin derivatives patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CAMN107A2109 Extension Patients<br> | Drug: Nilotinib<br> <br> |
| Other: AMN107 Naive<br> | Drug: Nilotinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months |  | 3 - 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, adult chronic myeloid leukemia, imatinib, nilotinib
Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.

Official Title
-----------------
Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.

Conditions
-----------------
Peripheral Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Biological: Expanded autologous ASCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe peripheral vascular disease not amenable to bypass or angioplasty Age >40 years old Normal renal function (creatinine < 1.6) Non pregnant female Lifespan > 6 months Exclusion Criteria: Age <40 years old Refusal to give informed consent and/orCognitively disabled Congestive heart failure or stroke in the last 3 months History of cancer or myeloproliferative disorders Proliferative retinopathy Pregnancy Positive screening test for HIV, Hepatitis B or Hepatitis C Buerger patient Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue Pregnancy or lactation Having been non controlled severe pathology

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Autologous ASCs<br>Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells. | Biological: Expanded autologous ASCs<br>* Drug: Expanded autologous adipose-derived adult stroma/stem cells<br>* Other names: Expanded autologous Adipose-derived adult Stroma/Stem cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Nature of Adverse Events : safety and tolerability | To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ] | 15 days, 1, 2, 3, 4,5, 6 months for adverse events record | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical leg ischemia, Adipose derived Stroma/Stem Cells, Autologous, Angiogenesis
Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path

Study Overview
=================
Brief Summary
-----------------
The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.The Investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. This work will ultimately have a real clinical impact on the management of these traumatized patients

Official Title
-----------------
Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path

Conditions
-----------------
Shoulder Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient consulting for acute shoulder dislocation Exclusion Criteria: Patient refusing to participate in the study

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 |
| --- | --- | --- |
| Evaluation of shoulder dislocation |  | Day of consultation of the emergency department |
Target Heart Rate and Aerobic Interval Training

Study Overview
=================
Brief Summary
-----------------
Aerobic interval training is shown to be superior in increasing oxygen uptake in both healthy and patients with coronary artery disease (CAD), compared to moderate continuous training. However, in cardiac rehabilitation exercise groups, exercise intensity is usually controlled with perceived exertion (Borg scale). The investigators will investigate degree of agreement between target heart rate and perceived exertion during interval training in cardiac rehabilitation.

Official Title
-----------------
Exercise Intensity and Target Heart Rate During Aerobic Interval Training in Cardiac Rehabilitation

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Rate of perceived exertion
* Other: Heart rate monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred to cardiac rehabilitation able to perform exercise treadmill test Exclusion Criteria: unstable angina severe arrhythmias heart failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rate of perceived exertion<br>Exercise intensity controlled by Borg | Other: Rate of perceived exertion<br>* Exercise intensity controlled by Borg scale<br>Other: Heart rate monitor<br>* Exercise intensity controlled by heart rate monitors<br>|
| Active Comparator: Heart rate monitor<br>Exercise intensity controlled by heart rate monitors | Other: Heart rate monitor<br>* Exercise intensity controlled by heart rate monitors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of agreement between target heart rate (THR) and perceived exertion | Exercise intensity during one-hour exercise session monitored by Borg, subsequently one-hour exercise session monitored by heart rate monitor | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise intensity, aerobic interval training, cardiac rehabilitation, group exercise
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fed conditions

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|750 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalance based on Cmax |  | 10 days |
Stick Versus Quadricep Exercise for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the efficacy between Boonme stick exercise and quadriceps strengthening exercise in knee osteoarthritis.Patients diagnosed as knee osteoarthritis using Altman criteria will be randomized into 2 groups using simple random technique. Patients will be instructed and trained for both quadriceps or Boonme stick exercise by one-trained physical therapist. All patients will be treated with behavioral modification, NSAIDs and analgesic drugs and regularly follow-up . Assessment included visual analogue scale, exercise compliance, WOMAC and patient satisfaction were done by an assessor in a blinded fashion.

Official Title
-----------------
Boonme Stick Exercise vs. Quadriceps Strengthening Exercise in Knee Osteoarthritis : A Randomized Controlled Trial

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Boonme stick exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee osteoarthritis using Altman criteria Exclusion Criteria: problem of communication ability

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: Quadricep strengthening exercise<br>Quadricep strengthening exercise | Other: Boonme stick exercise<br>* individual exercise daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vas score |  | 1,2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC |  | 1,2 yrs | 
| number of analgesic used |  | 1,2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, exercise
Vitrous Analysis in Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy

Detailed Description
-----------------
To analyse and compare vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy.

Official Title
-----------------
Analysis of Vitreous Proteins in Patients Undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

Conditions
-----------------
Proliferative Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proliferative diabetic retinopathy with vitreous hemorrhage Exclusion Criteria: vitreous hemorrhage of other cause than proliferative diabetic retinopathy previous vitrectomy

Ages Eligible for Study
-----------------
Minimum Age: 12 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
-----------------
PDRP, vitreous, protein, vitrectomy
Evaluation of the Validity of the Prothrombin Time Internation Normalised Ratio (PT/INR) Measured at the point-of Care on the Arterial Bloodline of Haemodialysis Extracorporeal Blood Flow

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation state (prothrombin time) measured inside the therapeutical zone and thanks to a portable monitor. The values obtained at the point of care will be compared to the standard biological assessment.

Conditions
-----------------
Haemodialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Haemodialyzed patient whose INR needs to be monitored Patient not objecting to participate in the study

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 |
| --- | --- | --- |
| correlation ratio between point-of-care PT/INR value and standard laboratory assessement |  | 5 months |