linjc16/ctgov huggingface dataset:
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.

Official Title
-----------------
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed the informed consent Meet criteria for major depressive disorder without psychotic features. Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel. Have had at least one other major depressive episode prior to the one being experienced at study entry. You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol. Exclusion Criteria: You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. Any women who are pregnant or breast feeding. If you have any serious medical illnesses other than major depressive disorder. If you have previously participated in a clinical trial for duloxetine. Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|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
-----------------
Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema

Official Title
-----------------
A Randomized, Double-masked, Placebo-controlled, add-on Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily for Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 1 or type 2 diabetes Diabetic macular edema Exclusion criteria: Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months) Recent laser photocoagulation in the study eye Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye Other protocol-defined inclusion/exclusion criteria applied

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren 300 mg<br>Aliskiren 300 mg once daily for 12 weeks | Drug: Aliskiren<br>* 300 mg once daily<br>* Other names: SPP100;|
| Placebo Comparator: Placebo<br>Matching placebo once daily for 12 weeks | Drug: Placebo<br>* Matching placebo once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment | The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor | Baseline to week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Macular edema, Aliskiren, Diabetic retinopathy, Diabetes mellitus type 1, Diabetes mellitus type 2
Study of Incidence, of Mechanisms and Prognosis of the Thrombopenia From Patients of Reanimation.

Study Overview
=================
Brief Summary
-----------------
About 40 % of the patients in reanimation are thrombopenics and the causes are not well known (reduction in platelet's production, increase in their destruction...). This protocol studies the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in order to bring patients best medical cares.

Detailed Description
-----------------
About 40 % of the patients in reanimation are thrombopenics and the causes are not well known (reduction in platelet's production, increase in their destruction...). This protocol studies the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in order to bring patients best medical cares.

Official Title
-----------------
Study of Incidence, of Mechanisms and Prognosis of the Thrombopenia From Patients of Reanimation.

Conditions
-----------------
Thrombopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thrombopenia in reanimation Exclusion Criteria: Pregnancy Contraindication of myelogram

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 |
| --- | --- | --- |
| Epidemiology of Thrombopenia and its consequences. |  | in reanimation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of cost and mortality of Thrombopenia in reanimation. |  | in reanimation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombopenia, Reanimation, Thrombopenia in reanimation
Rivastigmine in Mild Alzheimer's Disease, FMRI Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effect of rivastigmine given as an acute dose compared to placebo and after 1 month chronic dosing on fMRI response during a face recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated with long term treatment effect at 6 months and 12 months.

Official Title
-----------------
Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease

Conditions
-----------------
Alzheimer' Disease

Intervention / Treatment
-----------------
* Drug: rivastigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Probable Alzheimer's disease according to the NINCDS-ADRDA criteria mild disease, CDR 1 the clinician is planning to start anticholinesterase treatment Exclusion Criteria: cognitive impairment for other reason than Alzheimer's disease severe depression other unstable physical disease medal in body prevention MRI examination, claustrophobia cardiac pacemaker other significant neurologic or psychiatric disease contraindication for anticholinesterase treatment

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rivastigmine|Acute dose 3 mg or placebo. Thereafter 1.5 mg x 2 ad 30 days and thereafter increasing the dose upto 4.5 mg x 2 according to instructions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMRI response in face recognition task |  | at baseline and at 1 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment response measured by ADAS-cog |  | at 6 month and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, fmri, face recognition, rivastigmine
Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and quality of life

Conditions
-----------------
HIV-positive Diagnosis

Intervention / Treatment
-----------------
* Other: massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-positive diagnosis Exclusion Criteria: musculoskeletal disorders

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: massage<br>massage | Other: massage<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety measured by Hospital anxiety and depression scale |  | 5 minutes | 
| Depression measured by Hospital anxiety and depression scale |  | 5 minutes | 
| Hyperventilation measured by NIJMEGEN questionnaire |  | 5 minutes | 
| quality of life measured by World Health Organization Quality of Life Questionnaire |  | 10 minutes |
Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)

Study Overview
=================
Brief Summary
-----------------
Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods. The purpose of this study is to evaluate the validity and reliability of the Turkish version of the Caregiver Functional Use Survey (CFUS)

Detailed Description
-----------------
CFUS was designed to assess caregivers' perceptions of how much and how well their child used the involved upper extremity. Children's upper extremity functions will be assessed with a Jebsen Taylor Hand Function Test. Their family will be asked to fill the CFUS. Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS. Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.

Official Title
-----------------
Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 3-15 years Diagnosed as Cerebral Palsy (Hemiplegia) Literate in Turkish language and can complete the questionnaire by primer caregiver Exclusion Criteria: Cannot understand the questionnaire by themselves. Participants had a botulinum toxin injection within the last 6 months Any surgical correction within the last year

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 15 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 |
| --- | --- | --- |
| Validity of Caregiver Functional Use Survey (CFUS) | Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of CFUS | Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient. | 8 week |
Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)

Study Overview
=================
Brief Summary
-----------------
To investigate the etiology, epidemiology and prognostic factors of acute kidney injury. To find out risk factors that relate with the prognosis of acute kidney injury,focusing on inflammation, oxidative stress and nutritional status. To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

Detailed Description
-----------------
to investigate the relationship between preexisting malnutrition and adverse outcomes in patients with AKI - Several nutritional assessment methods such as anthropometric, clinical and biochemical evaluations have been used; however, no single indicator is considered to be a gold standard. to evaluate the association of serum nutritional variables and prognosis of acute kidney injury Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (<7 days) and late death (>7 days, <28 days) patients.

Official Title
-----------------
The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury

Conditions
-----------------
Renal Failure, Nutrition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >=16 years and <= 88 years clinically diagnosed with acute kidney injury, according RIFLE or KDIGO criteria. Exclusion Criteria: acute Renal Failure occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporin or tacrolimus nephrotoxicity Do Not Resuscitate (DNR) status subjects enrolled in another clinical trial that could affect the outcome of this study protocol

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 88 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 |
| --- | --- | --- |
| renal function survival rate days in the hospital days in the ICU |  | discharg from hospital, 28days,90days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney disease, prognosis, oxidative stress, inflammation, gene polymorphism
Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.

Detailed Description
-----------------
The intoxication by Bupivacaine is considered life threatening. Currently the most safety local anesthetic in substitution to bupivacaine is ropivacaine, however in Brasil there is a bupivacaine mixture of 75% levobupivacaine plus 25% racemic bupivacaine. The research design is: Patients involved: 48; age: 18 to 40 years old; both sex; ASA I and II. Surgery: elective upper extremity orthopedic surgery. Anesthesia technique: brachial plexus block. Primary endpoint: cardiovascular safety; analysis by continuous Holter. Secondary endpoint: anesthetic and analgesic efficacy.

Conditions
-----------------
Injuries, Hand, Anesthesia Conduction, Anesthetics, Local

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients involved: 48; ASA I and II; Surgery: elective upper extremity orthopedic surgery. Exclusion Criteria: Contraindications to anesthesia technique and/or to local anesthetic; Participation in different trials in the last two months; Antiretroviral users; Obesity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>Arm number B corresponds to the Bupivacaine group. | Drug: Bupivacaine<br>* Dosage: 150mg at once for anesthesia induction<br>|
| Active Comparator: R<br>Arm number R corresponds to the Ropivacaine group. | Drug: Ropivacaine<br>* Single dose of ropivacaine, 150mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular safety |  | Two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia Analgesia quality |  | Two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ropivacaine, Bupivacaine, Upper Extremity, Local anesthetic
A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

Official Title
-----------------
A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic

Conditions
-----------------
Nocturia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nocturia Exclusion Criteria: habitual or psychogenic polydipsia, known or suspected cardiac insufficiency other conditions requiring treatment with diuretics moderate and severe renal insufficiency known hyponatremia syndrome of inappropriate ADH secretion

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 |
| --- | --- | --- |
| Number of patients with adverse events |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of changes in dosage regime |  | 24 months |
What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist?

Study Overview
=================
Brief Summary
-----------------
The clinical pharmacists present in the hospitalisation units aim to ensure the daily review of the drug prescriptions of hospitalized patients. In order to optimize their work, the objective of this study would be to provide them with a clinical decision support tool via artificial intelligence in order to improve the patient's medication management. This study will test the Pharmaclass® software.

Official Title
-----------------
What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist? Analysis of These Impacts Within 2 Geriatric Units of the CHU Brugmann Hospital

Conditions
-----------------
Pharmacist-Patient Relations

Intervention / Treatment
-----------------
* Other: Pharmaclass® software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022 Speaking French and/or Dutch With chronic renal failure or taking at least one medicine for diabetes, heart, COPD, asthma, high blood pressure, epilepsy, atrial fibrillation, osteoporosis, high cholesterol, pain, parkinsonism, blood clotting, constipation, thyroid, depression, benign prostatic hypertrophy, gastric ulcer, Alzheimer's disease, cirrhosis as well as for electrolyte disorders (hypo or hypernatremia / potassium / calcium/magnesemia/phosphatemia). Exclusion Criteria: Patient who died or was transferred to another care unit during his/her hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 75 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 of Geriatric Wards SU06 and SU13 of the CHU Brugmann Hospital<br> | Other: Pharmaclass® software<br>* Clinical decision support tool via artificial intelligence in order to improve the patient's medication management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Time required to perform an intervention (pharmacist versus software) | 5 months | 
| Dosage compliance | Dosage compliance with existing recommendations and laboratory results/clinical parameters (pharmacist versus software) | 5 months | 
| Medication error severity | Severity of the medication error that could be avoided (pharmacist versus software) | 5 months | 
| Geriatrician approval | Number of interventions validated/refused by the geriatrician (pharmacist versus software) | 5 months |