linjc16/ctgov huggingface dataset:
Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

Detailed Description
-----------------
This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Official Title
-----------------
Efficacy and Safety of Intra-articular Multiple Doses of 500 µg Icatibant Including 40 mg Triamcinolone as Calibrator in a Randomized, Double-blind, Parallel-group, Placebo-controlled 13-week Multi-centre Study in Patients With Symptomatic Knee Osteoarthritis

Conditions
-----------------
Joint Disease

Intervention / Treatment
-----------------
* Drug: HOE140 Icatibant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with painful osteoarthritis of the knee. Exclusion Criteria: Subjects presenting with diagnosis of OA < 3 months and an OA grading < K&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the CSP).

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HOE140 Icatibant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global assessment assessed daily as well as WOMAC scores at each visit and intake of rescue medication daily via EPD recording. Safety assessed at each visit and pharmacokinetics at visits 2, 3 & 4. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, knee
Feasibility - Infinitome

Study Overview
=================
Brief Summary
-----------------
The Infinitome Program from Omniscient has the ability to identify abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI). This technology, which visualizes brain networks in three dimensions, was originally developed to ensure neurosurgeons avoid inadvertently lesioning cognitively eloquent brain regions during surgical operations. The potential of Infinitome in identifying connectome dysfunction for neurodegenerative diseases such as Alzheimer's disease has yet to be explored. This diagnostic technique may play a critical role for identifying disease brain networks that may benefit from targeted interventions in clinical trials.

Official Title
-----------------
Feasibility of Utilizing the Infinitome Program to Evaluate Abnormal Large Scale Brain Networks in Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Procedure: Infinitome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of mild, moderate, or severe Alzheimer's disease Age: 40 - 90 Years Patients who are clinically indicated for an MRI Exclusion Criteria: fMRI contraindicated (eg. Implantable device, pacemaker, metallic implants, etc.) Subject unable to tolerate sitting for a one hour fMRI Other concerns as determined by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Infinitome<br>All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed. | Procedure: Infinitome<br>* Added sequence of rs-fMRI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed Rs-fMRI | Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion. | 4 months | 
| Number of Subjects Whose Images Completed Analysis | Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion. | 4 months |
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

Study Overview
=================
Brief Summary
-----------------
Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.

Detailed Description
-----------------
Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.

Official Title
-----------------
Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Conditions
-----------------
Antibiotic-Associated Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: Inulin and fructo-oligosaccharides.
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children with acute infection. Exclusion Criteria: Hypersensitivity to antibiotics, chronic illness.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 14 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 |
| --- | --- |
| Experimental: A<br>Treated with prebiotics. | Dietary Supplement: Inulin and fructo-oligosaccharides.<br>* Supplement during antibiotic treatment+14 days.<br>* Other names: Placebo is base powder of product with no oligosaccharides.;|
| Placebo Comparator: B<br>Placebo treated. | Dietary Supplement: Placebo<br>* Placebo is base powder of product with no oligosaccharides.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of diarrhea. |  | During antibiotic treatment+14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea. |  | During antibiotic treatment+14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prebiotics, Antibiotic-associated diarrhea
Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients

Study Overview
=================
Brief Summary
-----------------
Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.

Official Title
-----------------
Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Behavioral: Repeated intervention
* Behavioral: Single session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Either diabetic neuropathy or previous foot ulcer Exclusion Criteria: Arteriopathy of lower limbs, with ABI<0.8 or needing revascularization

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated educational intervention<br>Repetition every 6 months of a group educational session | Behavioral: Repeated intervention<br>* Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention<br>|
| Active Comparator: Control group<br>Initial single group educational session, with no repetition | Behavioral: Single session<br>* Single 2-h group session educating patients at foot hygiene and ulcer prevention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of foot ulcers |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of foot ulcers |  | 6 months | 
| incidence of foot ulcers |  | 12 months |
Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection

Study Overview
=================
Brief Summary
-----------------
Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.

Detailed Description
-----------------
Assessment of hospital course and health status during 3, 6, 12 months after discharge in COVID-19 patients in cohorts with comorbidities and without comorbidities. Evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.

Official Title
-----------------
Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)

Conditions
-----------------
Atrial Fibrillation, DVT, Pulmonary Embolism, Anemia, Myocarditis, COVID-19, Chronic Heart Failure, Diabetes Mellitus, Chronic Kidney Diseases, Ischemic Heart Disease, Arrythmia, Hypertensive Heart Disease, Overweight and Obesity, Oncology, Ischemic Stroke, Myocardial Infarction, Stroke, Copd, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or confirmed COVID-19 Exclusion Criteria: Age under 18 years. Refusal to be involved in 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 |
| --- | --- | --- |
| death for any cause | rate of lethal outcomes | From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months | 
| hospitalization for any cause | rate of hospitalization for any cause | 12 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of any disease diagnosed 1 year after discharge | rate of patients with onset of any disease diagnosed 1 year after discharge | 1 year after discharge | 
| rate of demand for medical care | number of patients seeking for health care after discharge | 1 year after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, covid-19, ACTIV, Chronic Heart Failure, Ischemic Heart Disease, Hypertensive Heart Disease, Chronic Kidney Diseases, Myocarditis
Attitudes Associated to Prescription of ADHD Drugs Among Child and Adolescent Psychiatrists in Region Skåne.

Study Overview
=================
Brief Summary
-----------------
Each year Region Skåne in Sweden gathers information on drug prescriptions within the region. The last ten years a significant pattern of uneven prescription rates of ADHD drugs to people up to 17 years of age are noticed in the different districts. These regional differences are noticed in other regions in Sweden as well and internationally. The convention on the rights of the child became an institutional law in Sweden in 2020 and it emphasises that each child has the right to equal care and treatment. Therefore it is of importance to analyse how the variations in prescriptions rates arise and if we as healthcare providers can influence it. Our study is a collaboration between Region Skåne and the university of Lund and is a part of a larger study of the regional variations of prescriptions of ADHD drugs. Previous research informs us that a complex interplay of multiple factors can be behind variations in prescription rates among medical doctors and not the least subjective experiences and attitudes. Our study performs semistructured interviews of Region Skånes child and adolescent psychiatrists with questions specifically regarding their own experiences and attitudes that might influence their prescription behavior. The intention is to gather information that can guide future research questions.

Official Title
-----------------
Attitudes Associated to Prescription of ADHD Drugs Among Child and Adolescent Psychiatrists in Region Skåne.

Conditions
-----------------
Attitude, ADHD - Combined Type, Physician's Role

Intervention / Treatment
-----------------
* Other: Semi structured interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child and adolescent psychiatrist in Region Skåne Exclusion Criteria: part of the research group
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Child and adolescent psychiatrist<br> | Other: Semi structured interview<br>* Interviews are performed by one research group member and based on beforehand decided questions and sub-questions. The interview material is transcribed and analysed on a theme level.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes and experiences associated with prescription and diagnosis of ADHD | Semistructured interview | 1 day (During the analysis of the transcribed interview) |
Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery.

Detailed Description
-----------------
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, the following results were obtained: Perioperative risk factors of death and complications of different organ systems after cardiac surgery, providing evidence for early prevention and intervention; Risk factors of blood transfusion risk were analyzed to provide ideas for reducing intraoperative blood transfusion; The relationship between hemoglobin and complications after heart surgery was explored to provide a factual basis for the development of blood transfusion indications for such patients

Official Title
-----------------
Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study

Conditions
-----------------
Prognosis, Post-cardiac Surgery, Blood Transfusion Complication

Intervention / Treatment
-----------------
* Procedure: acute normovolemic hemodilution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB) Exclusion Criteria: No

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

| Intervention/Treatment |
| --- |
|Procedure: acute normovolemic hemodilution|acute normovolemic hemodilution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | all-cause death | 28 days after surgery |
Evaluation of Behaviour in Parkinson's Disease. Normal Values in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies. Due to their specificity and the absence of an appropriate evaluation tool, behavioral disorders are rarely searched for. Therefore, investigators developed a scale permitting qualitative and quantitative evaluation of behavior according to the severity of the disorders. This study aims to define reference values for healthy individuals

Detailed Description
-----------------
The application of the scale includes a semi-structured interview The ECMP scale consists of 21 items, each of which may be assessed by use of a 5 point scale (not at all - light trouble - moderate trouble - important trouble - severe trouble)

Official Title
-----------------
Evaluation Comportementale Dans la Maladie de Parkinson. Normes Chez Des Sujets Sains

Conditions
-----------------
Behaviour

Intervention / Treatment
-----------------
* Other: Healthy participants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants without any neurologic disease Men and women from 25 to 75 years old French mother tong without cognitive troubles (MMS ≥ 24) Exclusion Criteria: Subject under legal guardianship Pregnant woman or with childbearing potential without contraceptive device

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy participants<br>Submission of the scale 'Evaluation of behaviour in Parkinson's Disease' to healthy subjects | Other: Healthy participants<br>* Semi-structured interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECMP score | Semi-structured interview | 3 hours |
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study

Official Title
-----------------
Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Z-360


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with unresectable locally advanced or metastatic pancreatic cancer KPS > 70% Life expectancy of at least 3 months Exclusion Criteria: received previous chemotherapy for the current indication received previous radiotherapy for the current indication Currently receiving chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Z-360|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Pharmacokinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour shrinkage, Tumour objective response rate |  |  |