linjc16/ctgov huggingface dataset:
Comparison Between Two Operational Techniques for Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%. There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts. The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.

Official Title
-----------------
Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study

Conditions
-----------------
Gait, Unsteady, Knee Arthropathy, Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: REHAGAIT ANYLIZER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients after total knee replacement which was performed in our ward. Exclusion Criteria: Less than 6 months have passed after the procedure Inability to understand and fill out PROMS questionnaires. Inability to walk without aids for at least 20 meters.

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanically aligned TKR<br>patients were operated using the standard mechanically aligned technique | Diagnostic Test: REHAGAIT ANYLIZER<br>* Gait analysis instrumentation<br>|
| Experimental: Kinematically aligned TKR<br>patients were operated using the newer mechanically aligned technique | Diagnostic Test: REHAGAIT ANYLIZER<br>* Gait analysis instrumentation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMS | The patients will fill out functionala and quality of life assessment questionnaires | At least 6 months post operatively | 
| Gait analysis | The patients will perform a gait analysis using the REHAGAIT system. | At least 6 months post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee replacement, gait analysis, PROMS, mechanical aligment, kinematic alignment
Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the historic and reference exam, and commonly systematically the lung ultrasound. However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department. On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator. We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.

Official Title
-----------------
Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit

Conditions
-----------------
Pediatric Lung Ultrasound, Pediatric Chest Radiography, Pediatric Lung Diagnosis

Intervention / Treatment
-----------------
* Radiation: Chest radiography and lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age under 18 years Patient in pediatric intensive care unit Patient registered with a social security scheme Agreement of the persons entitled to give parental authority over minor Patient which has, during his stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval. Exclusion criteria: - Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Chest radiography and lung ultrasound<br>All patients will be enrolled, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval. | Radiation: Chest radiography and lung ultrasound<br>* We'll include all patients which have, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kappa-measure | Kappa-measure of concordance between diagnosis obtained by lung ultrasound and chest radiography | 12 months |
Towards an Objectivation of the Therapeutic Effect of a Rocking Movement

Study Overview
=================
Brief Summary
-----------------
The study evaluates the benefits of a rocking movement on well-being and attention, through high-density electroencephalography recordings. The effect of the rocking movement is compared to a seated position and a lying position.

Official Title
-----------------
Objectivating the Therapeutic Effect of a Rocking Movement by High Density Electroencephalography

Conditions
-----------------
Rocking Movement

Intervention / Treatment
-----------------
* Device: high-density electroencephalography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handed Informed consent Exclusion Criteria: Pregnancy subjects with analgesic treatment subjects dependent on psychotropic substances

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocking movement<br>Participant is lying in a hammock with a rocking motion. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant. | Device: high-density electroencephalography<br>* Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.<br>|
| Active Comparator: Lying position<br>Participant is lying in a hammock with no rocking motion. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant. | Device: high-density electroencephalography<br>* Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.<br>|
| Active Comparator: Seated position<br>Participant is sitting on a chair. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant. | Device: high-density electroencephalography<br>* Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of amplitude between standard and deviant sounds | The amplitude of the mismatch negativity (corresponding to the difference between standard and deviant sounds) will be measured by electroencephalography. | 20 minutes |
Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women

Study Overview
=================
Brief Summary
-----------------
This study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. Women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (>70 yrs. of age) will take estrogen or placebo for three months. At the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). Previous research has shown that these dietary manipulations can briefly produce negative changes in mood. The investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. The investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. The proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: Estrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Non-smoker BMI <30 Healthy Without surgically-induced menopause Not on HRT or >1 year post HRT Normal mammogram within last year No cardiovascular disease other than mild hypertension

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project

Study Overview
=================
Brief Summary
-----------------
Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care.

Official Title
-----------------
Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Pharmacist-Physician Collaborative Medication Therapy Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or over diagnosis of hypertension with most recent blood pressure >140/90 mmHg or blood pressure >130/80 mmHg if patients also had diabetes mellitus treated with at least one anti-hypertensive medication continuous active patient (at least one visit) of the clinic for at least the past 6 months (1/1/2010-6/31/2010) English speaking Able to complete questionnaires in English. Exclusion Criteria: -do not meet provisions of the clinical collaborative agreement protocol in the judgment of the patient's physician or the clinical pharmacist

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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist-Physician Collaborative Medication Management<br>Pharmacist-Physician Collaborative Medication Management | Other: Pharmacist-Physician Collaborative Medication Therapy Management<br> <br> |
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure |  | 6 months |
Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride

Study Overview
=================
Brief Summary
-----------------
Patients resuscitated with 4% Albumin will have less incidence and reduced severity of pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved intravascular oncotic pressure effected from higher albumin levels.

Detailed Description
-----------------
Pressure ulcers incur multiple risks to the patient. The disruption of the skin is a portal of entry for infection , which may remain localised to the site or become blood borne. A pressure ulcer can lead to protein and fluid losses from the wound exudate. Many authors have theorised the existence of a relationship between the development of pressure ulcers and low serum albumin levels however, there is no strong evidence to prove this correlation. The literature does demonstrate a clear relationship between people with existing pressure ulcers and the presence of low serum albumins. Specifically serum albumin levels <30mg/dl have been associated with the incidence of pressure ulcer development.

Official Title
-----------------
The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)

Conditions
-----------------
Pressure Ulcer, Area, Pressure Ulcer, Grade, Albumin Level, Risk Score, Length of ICU Stay

Intervention / Treatment
-----------------
* Drug: 4% Albumin / 0.9% Sodium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomisation to the SAFE study - Exclusion Criteria: In addition to the SAFE exclusion criteria, pre-existing pressure ulcers (developed prior to ICU admission) will also be excluded-

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 4% Albumin / 0.9% Sodium Chloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a difference in the incidence of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride |  |  | 
| Is there a difference in the severity of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride. |  |  |
Angelman Syndrome Natural History Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to conduct a prospective, longitudinal natural history study of children and adults with Angelman Syndrome using investigator-observed and parent-reported outcome measures to obtain data that will be useful for future clinical trials.

Detailed Description
-----------------
The overall goal is to increase our understanding of the long-term natural history of Angelman syndrome and obtain Angelman-specific norms for outcome measures that can be used in clinical trials, ultimately improving the care of individuals with Angelman syndrome.

Official Title
-----------------
Angelman Syndrome Natural History Study

Conditions
-----------------
Angelman Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molecular diagnosis of Angelman syndrome Exclusion Criteria: Presence of another condition, unrelated to Angelman syndrome, that affects neurodevelopment
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 |
| --- | --- | --- |
| Medical History | Includes various medical complications, including seizure history | Through study completion, an average of 1 year | 
| Vineland Adaptive Behavior Scales, 3rd edition | Developmental and Adaptive skills | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angelman syndrome
Risk Factors for Post-ESWL and Post-ERCP Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.

Official Title
-----------------
Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis

Conditions
-----------------
Chronic Pancreatitis, Risk Factors, ERCP, ESWL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP Exclusion Criteria: Patients with isolated pancreatic tail stone Patients with suspected or established malignancy Patients with pancreatic ascites Patients attending other interventional clinical trials Patients with non-correctable coagulation disorder Patients with pregnancy
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 |
| --- | --- | --- |
| post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis | The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging. | up to 1 months | 
| post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis | The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging. | up to 1 months |
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.

Official Title
-----------------
Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

Conditions
-----------------
Alcoholic Cirrhosis

Intervention / Treatment
-----------------
* Drug: Propranolol - Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication of transjugular hepatic biopsy alcoholic cirrhosis presence of oesophageal varices ≤ stade 2 Exclusion Criteria: renal insufficiency natremia ≤ 135 mmol/l vasoactive treatment in the last month before inclusion hepatocellular carcinoma positive HIV and HCV patients paracentesis in the last week before inclusion digestive bleeding in one last week oesophageal varices stade 3 or 2 with red signs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propranolol - Spironolactone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of spironolactone/propranolol association |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol