linjc16/ctgov huggingface dataset:
Changes in Unstable Ankles After Balance Training

Study Overview
=================
Brief Summary
-----------------
This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.

Detailed Description
-----------------
Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.

Official Title
-----------------
Modulation of Sensorimotor Measures in Chronically Unstable Ankles

Conditions
-----------------
Ankle Injury

Intervention / Treatment
-----------------
* Procedure: Checking stability of ankle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy Exclusion Criteria: ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Checking stability of ankle|Flexing and walking|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postural control |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle, sensorimotor, reflex, training
An Intervention to Reduce Inappropriate Prescriptions for Elderly Patients in General Practice

Study Overview
=================
Brief Summary
-----------------
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to reduce inappropriate prescription patterns for elderly patients > 70 years.

Official Title
-----------------
A Cluster Randomized Educational Intervention to Reduce Inappropriate Prescription Patterns for Elderly Patients in General Practice

Conditions
-----------------
Aged, Family Practice

Intervention / Treatment
-----------------
* Behavioral: Educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General practitioner Specialist in general practice
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

| Intervention/Treatment |
| --- |
|Behavioral: Educational intervention|We developed a set of explicit criteria for pharmacological inappropriateness for Norwegian GPs' prescribing to elderly patients. The main purpose of the criteria was to serve as quality indicators during an educational intervention: the Prescription Peer Academic Detailing (Rx-PAD) Study, aimed at improving GPs' prescribing for elderly patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients | Prescription data for 1 year were retrospectively retrieved from the Norwegian Prescription Database (NorPD) and assessed in relation to 13 prescription quality indicators. | 1 year |
COVID 19 and Psychological Health: a Cross Sectional Study to Evaluate Anxiety and Depression in Covid-19 Patients

Study Overview
=================
Brief Summary
-----------------
The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety. To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.

Official Title
-----------------
COVID19 and Psychological Health: a Cross Sectional Evaluation of the Risks of Anxiety and Depression Among Patients Diagnosed With Covid 19

Conditions
-----------------
Covid19, Anxiety, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients with COVID19 willing to participate in the study Exclusion Criteria: unwilling unable to read or interact with standardized questionnaire unconscious

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| mild covid<br> | |
| moderate covid<br> | |
| severe covid<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression | Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points | at the time of acute infection, average of 1 month | 
| anxiety | Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points | at the time of acute infection, average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID19, Anxiety, Depression
Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetic (PK) properties of various modified release tablet formulations of Lu AF11167 (Part A) and to investigate the pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a fed and fasted state and following multiple dosing (Part B).

Official Title
-----------------
Interventional, Open-label, Part Fixed Sequence, Part-randomised Study Investigating the Pharmacokinetic Properties of up to 6 Prototype Modified Release Tablet Formulations of Lu AF11167 in Healthy Young Subjects

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Lu AF11167


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women ≥18 and ≤45 years of age with a body mass index (BMI) of >18.5 and <30.0 kg/m2. Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status. Other pre-defined inclusion and exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Period A<br>1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167 | Drug: Lu AF11167<br> <br> |
| Experimental: Treatment Period B<br>Food interaction and multiple dosing of Lu AF11167 | Drug: Lu AF11167<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters for Lu AF11167 estimated from the single dose treatment periods in Part A and B: Cmax, Frel, AUC0-inf, AUC0t, AUC%extr, CL/F, t½, tlag, tmax and Vz/F. | Composite analysis | 0-48 hours | 
| PK parameters for Lu AF11167 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI (accumulation index), Cmax, Cpre, CL/F, t½, tmax and Vz/F. | Composite analysis | Up to 60 hours post dose on day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters for Lu AF36201 estimated from the single dose treatment periods in Part A and B: Cmax, AUC0-inf, AUC0-t, AUC%extr, t½, tlag and tmax, MR (metabolic ratio). | Composite analysis | 0-48 HOurs | 
| PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax. | Composite analysis | Up to 60 hours post dose day 7 |
Is Virtual Reality a Non-pharmacological Premedication?

Study Overview
=================
Brief Summary
-----------------
Preoperative anxiety of patients who will undergo septorhinoplasty surgery will be measured and their hemodynamic parameters will be recorded afterwards. Then, a video will be shown to the patients through virtual reality glasses and the effect of this application on their anxiety will be investigated.

Official Title
-----------------
The Effect of Virtual Reality on Preoperative Anxiety in Septorhinoplasty Patients

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: anesthesiologist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II risk group Will be operated under general anesthesia under elective conditions Going to undergo surgery for septoplasty / rhinoplasty Patients whose informed consent was read and approved Exclusion Criteria: Those who do not want to participate in the study ASA III - IV-V patients Psychiatric-Cognitive dysfunction Claustrophobia Patients using sedative and narcotic drugs Alcohol-drug addicts Blind or deaf patients Patients who cannot speak Turkish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: anesthesiologist|non-interventional observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to reduce preoperative anxiety | Investigation of the effect of virtual reality applications on preoperative anxiety | through study completion, an average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, Anxiety, Premedication
PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.

Official Title
-----------------
A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:. Male over the age of 40. Patient is scheduled for prostate biopsy for one or more of the following reasons: PSA > 2.5 ng/ml Rising PSA (>0.5 ng/ml/yr) Lower PSA value with other risk factors for prostate cancer (e.g.; family history) Abnormal DRE Percent free PSA <15% No prior history of prostate cancer or prostate biopsy. Exclusion Criteria: Unable or unwilling to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| men scheduled for prostate biopsy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ability of whole blood gene expression to predict biopsy outcome |  | pre-biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of tumor aggressiveness using whole blood gene expression |  | post-biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer
Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children

Study Overview
=================
Brief Summary
-----------------
Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulating volume, some of the subjects will receive additional fluid.This will be evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.

Official Title
-----------------
Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children

Conditions
-----------------
Urological Surgery

Intervention / Treatment
-----------------
* Drug: Administration of remifentanil and glycopyrrolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II children 1-6 years urological surgery Exclusion Criteria: Cardiac disease Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of remifentanil and glycopyrrolate|2 mg, intravenius use|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index |  | Twice in 16 minutes. | 
| Blood pressure |  | Twice in 16 minutes. |
Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.

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

Intervention / Treatment
-----------------
* Drug: Calcium dobesilate (Doxium)
* Drug: Placebo drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BS 120-200 mg/dl Age 40-70 Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy) type II diabetes no history of doxium consumption Exclusion Criteria: Allergy to doxium incidence of active hepatic disease or rising of hepatic enzymes during the intervention

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo tablets will be administered to the patients in Placebo arms daily for three months. | Drug: Placebo drug<br>* Similar to the that of the Experimental arm, Daily, Three months<br>|
| Experimental: Calcium dobesilate<br>Calcium dobesilate as 500 mg tablets will be administered once to the patients daily. | Drug: Calcium dobesilate (Doxium)<br>* 500 mg, Tablet, Daily, 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high sensitivity CRP and Endothelin-1 serum levels |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelin-1 high sensitivity CRP
Cholecystoduodenal Fistula With and Without Gallstone Ileus

Study Overview
=================
Brief Summary
-----------------
Observative and descriptive study of 10 patients, which were diagnosed with a Cholecystoduodenal fistula, All electronic medical records were retrospectively reviewed.

Detailed Description
-----------------
A cholecystoenteric fistula is an uncommon complication of gallstone disease, although most studies in the English literature concern biliary-enteric fistulas. The aim of this study was to present a case series of patients with a cholecystoduodenal fistula (CDF), with or without gallstone ileus, along with the surgical outcomes. From 2015 to 2018, 3245 consecutive patients underwent cholecystectomy for gallbladder disease at our institution, of whom 10 were diagnosed with a CDF. All electronic medical records were retrospectively reviewed.

Official Title
-----------------
Cholecystoduodenal Fistula With and Without Gallstone Ileus: A Case Series

Conditions
-----------------
Gallbladder Diseases

Intervention / Treatment
-----------------
* Procedure: Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cholecystoduodenal fistula Exclusion Criteria: Patients with cholecystocolonic fistula or cholecystogastric fistula

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cholecystectomy|Cholecystectomy with repair of duodenal wall.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Age | Age in years | Feb 01- 2020 | 
| Median value of white blood count | It will presented in cells/L | Feb 01-2020 | 
| Type of surgery performed | It will described the type of procedure, either conventional or laparoscopic | Feb 01-2020 | 
| Surgical complications | Morbidity will be described as Yes or No | Feb 01-2020 | 
| Recovering time | The median time in days, after the procedure and full recovery of the patients. | Feb 01-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystoduodenal fistula, Gallbladder