linjc16/ctgov huggingface dataset:
Retinal Fundus Camera Evaluation

Study Overview
=================
Brief Summary
-----------------
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera.

Detailed Description
-----------------
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera. While also comparing the images to other manufacturer's retinal cameras

Official Title
-----------------
TRC-NW400 Retinal Fundus Camera Image Evaluation and Instrument Comparison Protocol

Conditions
-----------------
Normal Healthy Subjects With no Known Ocular Diseases

Intervention / Treatment
-----------------
* Device: Topcon TRC-NW400
* Device: TRC-NW8
* Device: TRC-NW400
* Device: Canon-CR2
* Device: Zeiss Visucam PRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with no known ocular diseases Exclusion Criteria: Subjects with known ocular diseases

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

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 |
| --- | --- |
| Normal Healthy Eyes<br>Willing and able subjects with normal and healthy eyes | Device: Topcon TRC-NW400<br>* Retinal Fundus Camera<br>Device: TRC-NW8<br>* Retinal Fundus Camera<br>Device: TRC-NW400<br>* Retinal Fundus Camera<br>Device: Canon-CR2<br>* Retinal Fundus Camera<br>Device: Zeiss Visucam PRO<br>* Retinal Fundus Camera<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundus Image Grading | Determining the best display to reflect the real color of the retina | 1 Hour |
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.

Official Title
-----------------
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Melatonin
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of burn injury Scheduled for an elective surgical procedure 5 - 22 years of age, inclusive Exclusion Criteria: History of anoxic brain injury History of head injury within the last year Pre-existing seizure disorder Pre-existing neurological disorder Pre-existing blindness Known hypersensitivity to melatonin Anticoagulant use or aspirin therapy Antihypertensive medication use Diabetes mellitus or other endocrine disorders Autoimmune disorders Schizophrenia Inability to access internet Intellectual disability or inability to follow directions

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 22 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melatonin<br>Subjects will receive melatonin | Drug: Melatonin<br>* po 1 hour before bedtime<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* po, 1 hour before bed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep | Measure sleep parameters via polysomnography, actigraphy and urinary melatonin | 3 years |
Development of a Fall Prevention and Fall Detection System for Ambulatory Rehabilitation of Parkinson's Patients

Study Overview
=================
Brief Summary
-----------------
The investigators plan to conduct a first-stage experiment by recruiting ten subjects, including five PD patients and five non-PD patients. In the beginning, the information collected by the portable motion detector is used to compare the difference in the activities performed by PD and non-PD patients. Besides, the algorithm will be developed to identify the gait patterns of PD patients. Once the system detects the abnormal gaits, such as shuffling and festinating steps or freezing of gait, auditory cues will be given to the PD patients and caregivers by their sides. It can help the patient to maintain normal gait and improve the effectiveness of rehabilitation, as well as preventing falls in daily activities. Moreover, in case of accident falls, the real-time fall detection mechanism alerts the nearest caregiver for instant support and delivers this information to the remote family members and medical personnel. After that, a second-stage experiment will be carried out by recruiting another five PD patients. By comparing the gait patterns identified by the system against those identified manually by the staff, the performance of the proposed system on fall prevention will be examined. For the patients and their family members, the developed system enhances the patients' safety in their daily activities. As for the medical personnel, it serves as an affordable tool that benefits the rehabilitation of PD patients in an easy manner.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: portable motion detector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's Disease Exclusion Criteria: Cardiac disease Mobility disability
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: portable motion detector|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Speech Perception in Noise in Children With ADHD

Study Overview
=================
Brief Summary
-----------------
We are going to assess an ability of speech perception in voice in children diagnosed with ADHD (Attention Deficit Hyperactivity Disorder), comparing to normal control group. This is an attempt to understand the factors influencing on this ability.

Detailed Description
-----------------
Participants will undergo a battery of hearing tests -Standard Hearing Test; Speech Perception in Noise - Hebrew Matrix; Transient Evoked Otoacoustic Emission (TEOAE) and cognitive tests - Working Memory Test (from (Wechsler Intelligence Scale for Children, WISC); Visual Attention Test (TMT (Trail Making Test)); Non-Verbal Intelligence Test (RAVEN)

Official Title
-----------------
Speech Perception in Noise in Children With ADHD

Conditions
-----------------
no Conditions

Intervention / Treatment
-----------------
* Diagnostic Test: hearing and cognitive assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Research group: Kids diagnosed with ADHD, without previous hearing problems. Control group: Kids with regular development without previous hearing problems. Exclusion Criteria: For both groups: Having previous hearing problems or disorders Other psychiatric disorders Treatment with psychiatric medications other than stimulants Having autism Having severe learning disabilities.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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 |
| --- | --- |
| Investigator<br>Child and Adolescent Psychiatrists, Speech Therapists | |
| Participant<br>Kids aged 4-18 diagnosed with ADHD | Diagnostic Test: hearing and cognitive assessment<br>* psychiatric assessment, hearing assessment and brief cognitive assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech perception in noise | Hebrew Matrix | 1 day |
Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric.

Study Overview
=================
Brief Summary
-----------------
Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.

Official Title
-----------------
Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind

Conditions
-----------------
Quality of Life, Drug Use

Intervention / Treatment
-----------------
* Procedure: STOPP/START criteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with more than 75 years old Hospitalized in geriatrics short-stay Patient with a written informed consent Patient with a social security scheme Exclusion Criteria: Severe dementia Not able to respond to SF-12 Disease at final stage Patient under legal protection (maintenance of justice, tutelage, legal guardianship)

Ages Eligible for Study
-----------------
Minimum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STOPP/START<br>Use of STOPP/START criteria during medication reconciliation | Procedure: STOPP/START criteria<br>* software which helps to do the drug reconciliation<br>|
| No Intervention: CONTROL<br>Medication reconciliation done as usual, without the consideration of the STOPP/START criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 Quality of life scale | The evolution of the hospitalised elderly people's quality of life at 2 months will be measured by the SF-12 scale. | at inclusion and at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls | The number of falls during the two months following the inclusion will be collected for each patient. | at 2 months | 
| Proportion of patients rehospitalized | The proportion of patients that have been rehospitalized (unscheduled hospitalization) during the two months following inclusion will be measured. | at 2 months | 
| Mortality | The mortality during the two months following inclusion will be measured. | at 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly people, geriatric short-stay, STOPP/START criteria
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

Official Title
-----------------
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin glargine
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for at least 12 months Current daily insulin dose of more than 1.4 IU/kg BMI lesser than or equal to 35 kg/m2 HbA1c greater than 7.5% and less than or equal to 12.0% In Austria, age more than 19 years Exclusion Criteria: Proliferate retinopathy or maculopathy Recurrent major hypoglycaemia Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin glargine|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Body weight |  |  | 
| Blood glucose |  |  | 
| Hypoglycaemia |  |  |
Value on Survival of Liver Volume After an Acute Decompensation of an Alcoholic Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a small liver have a lower survival compared to patients having a normal sized liver.

Detailed Description
-----------------
In this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. Investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. Liver volume will be evaluated using CT-scan or MRI reconstructions.

Official Title
-----------------
Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study

Conditions
-----------------
Alcoholic Cirrhosis, Alcoholic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Patient suffering from alcoholic cirrhosis (withdrawn or not) Patient admitted in emergency for an alcoholic cirrhosis decompensation only Prescription for a cutting imaging (CT scan or MRI) during hospitalisation Alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis Patient suffering from decompensated cirrhosis defined by at least one of the following criteria : Model For End-Stage Liver Disease (MELD) score above or equal to 15, ascites needing iterative punctures, symptomatic bacterial ou fungal infections, acute digestive bleeding due to portal hypertension, hepatic encephalopathy defined by a West Haven score above or equal to 2 Exclusion Criteria: Nodule with typical criteria of hepatocellular carcinoma B or C viral infections actives Presence of transjugular intrahepatic portosystemic shunt (TIPS) Presence of an occlusive thrombosis of the porta or one of the principal branches Presence of a thrombosis of the sus-hepatic vein Active extra-hepatic malignant tumor Decompensated cardio-vascular disease Patient unwilling to participate to 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 |
| --- | --- | --- |
| All cause mortality or liver transplantation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver volume, Alcoholic cirrhosis, Liver transplantation
TCM Etiological Study on the Theory of XuSunShengJi in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
To Elucidate and Confirm the Theory of XuSunShengJi in the Traditional Chinese Medicine Etiological Pathogenesis of Liver Cirrhosis.

Official Title
-----------------
Traditional Chinese Medicine Etiological Study on the Theory of XuSunShengJi in Liver Cirrhosis

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Fuzhenghuayu Tablet, Huangqi Decoction Granule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With 6 month of chronic liver disease history, and positive serum HBsAg Exclusion Criteria: Other chronic hepatitis and liver cirrhosis of non-hepatitis B

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Fuzhenghuayu Tablet, Huangqi Decoction Granule|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study

Study Overview
=================
Brief Summary
-----------------
This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer.

Detailed Description
-----------------
Subjects will be given an informed consent to read and sign The medical chart will be reviewed for diagnosis and treatment history Blood (about 4 tablespoons) will be drawn at a clinically available time. The lymph node and breast tumor tissue in the University of Michigan pathology repository will be used for research purposes

Official Title
-----------------
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years of age Able to read and sign the informed consent Able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.

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

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

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 |
| --- | --- | --- |
| Single nucleotide polymorphisms | Determine single nucleotide polymorphism concordances between the three DNA specimen sources | time-independent | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone metastasis, SNP concordance
Study to Evaluate Blood Cell Lines From Patients With Gaucher Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about Gaucher disease. The information we collect from medical histories and a blood sample from people with Gaucher disease may help us pinpoint certain things that are different between people who have Gaucher disease and people who do not have Gaucher disease. This information may be useful in the future to help find new treatments for Gaucher disease.

Detailed Description
-----------------
This study is designed to evaluate the ex vivo response to pharmacological chaperone therapy by testing blood samples from previously treated and untreated patients with Gaucher disease. The study will include patients with non-neuropathic Gaucher disease (type I) and neuropathic Gaucher disease (types II and/or III). All subjects will participate in one study visit. Clinical information will be collected retrospectively from medical records. Information collected will include Gaucher disease diagnosis and history, medical history, family history, assessments of clinical severity, and genotype. A blood sample will be collected and various cells will be isolated for laboratory testing and research.

Official Title
-----------------
A Multicenter Study to Evaluate and Characterize the Ex Vivo Effect of Pharmacological Chaperone Therapy in Blood Cell Lines Derived From Patients With Gaucher Disease

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

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written informed consent by subject or legal guardian Male or female of any age Confirmed diagnosis of Gaucher disease with known genotype Clinically stable and either treatment naïve or on a stable dose of enzyme replacement therapy and/or substrate reduction therapy for at least 6 months prior to study entry Available medical records for collection of retrospective clinical information Exclusion Criteria: Received any investigational product within 30 days prior to study entry Other significant disease or be otherwise unsuitable for the study, as determined by the investigator
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sample|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
-----------------
Gaucher Disease, Gaucher Disease, Type 1, Gaucher Disease, Type 2, Gaucher Disease, Type 3, Neuronopathic Gaucher Disease, Non-Neuronopathic Gaucher Disease, Lysosomal Storage Disease, Metabolism, Inborn Errors, Metabolic Diseases, Sphingolipidoses, Genetic Diseases, Inborn