linjc16/ctgov huggingface dataset:
COVID-19 and Hereditary Metabolic Diseases

Study Overview
=================
Brief Summary
-----------------
No additional risk factors have been identified in patients with Inherited Metabolic Diseases (IMD) for contracting or presenting complications of COVID-19 compared to the general population. Yet, IMD patients have cell/tissue alterations that could constitute a potential direct or indirect target for the virus. We do not know the impact of this infection on patients suffering from MHM, nor the possible effect of specific treatment of MHM on the evolution of COVID-19. This study will collect French IMD patients having or having had COVID-19 infection. The main objective is to estimate among IMD patients contracting COVID-19 the frequency of disease aggravation or metabolic decompensation. The secondary objectives will be : a. to evaluate the incidence of COVID-19 diagnosed in a given group of IMD when the number of patients with this IMD is known (Urea Cycle Deficiency, Gaucher Disease). b. to evaluate the impact of IMD on the and severity of COVID-19 infection

Official Title
-----------------
Prospective Study on the Impact of COVID-19 on the Equilibrium of Hereditary Metabolic Disease (MHM) in Patients With or Who Have Contracted COVID-19

Conditions
-----------------
Covid19, Metabolism, Inborn Errors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child or adult patient with a diagnosis of IMD Symptomatic or asymptomatic patient tested positive for COVID-19 (PCR and/or serology) Symptomatic patient non tested but with strong clinical suspicion for COVID-19 Patient affiliated with the health insurance Exclusion Criteria: inability to receive informed information Persons deprived of liberty
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metabolism, Inborn Errors<br>Patient affected by an inherited metabolic disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of MHM imbalance triggered by COVID-19 | disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19. | at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of COVID-19 patients in Gaucher's disease |  | at 24 months | 
| Number of COVID-19 patients in Urea Cycle Disorder |  | at 24 months | 
| Severity of COVID-19 infection | severity of COVID-19 infection as assessed by hospitalization; Intensive Care Unit, death | at 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Inherited metabolic diseases
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Official Title
-----------------
Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable Prepubertal stage Good health with the exception of asthma History of asthma for at least 6 months Currently using rescue medication only Main Exclusion Criteria: Childbearing potential (beyond menarche) Concurrent diseases or conditions which may subsequently affect growth COPD or relevant lung diseases causing alternating impairment in lung function Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids History of life-threatening asthma Current smoking

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth velocity of the right lower leg as measured by knemometry. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPA-axis function |  |  | 
| weight and height |  |  | 
| lung function from spirometry |  |  | 
| asthma symptom score, use of rescue medication from diary |  |  | 
| adverse events |  |  | 
| vital signs, including blood pressure, pulse rate |  |  | 
| physical examination |  |  | 
| laboratory investigation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Ciclesonide, Child, Fluticasone propionate, HPA-axis, Pediatric, Linear growth rate
The Efficacy of Using Far Infrared Radiation to Manage Muscular Dystrophies

Study Overview
=================
Brief Summary
-----------------
The muscular dystrophies (MD) are a group of more than 30 neuromuscular disorders that are characterized by progressive skeletal muscle weakness, defects in muscle proteins and the death of muscle cells and tissue. This study will investigate the use of far infrared radiation for managing muscular dystrophies.

Detailed Description
-----------------
Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells. It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly cure these neuromuscular disorders.

Official Title
-----------------
Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation to Manage or Treat Muscular Dystrophies.

Conditions
-----------------
Muscular Dystrophies

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with muscular dystrophies Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Radiation: Far Infrared Radiation (5μm to 20μm wavelength) | Radiation: Far Infrared Radiation<br>* Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management and Cure of muscular dystrophies |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation of people with muscular dystrophies |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MYOTONIC DYSTROPHY, MYOPATHIES, Distal Myopathies, Muscular Dystrophy, Duchenne, Phosphorylase Deficiency (McArdle Disease)
S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain

Study Overview
=================
Brief Summary
-----------------
For each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment.

Detailed Description
-----------------
The study is investigator-initiated, prospective, study. There will be no change in care. Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have pain will be recruited for this study. Patients will have blood samples taken at the visit they sign the consent form and 6 months later. The study staff will call and remind the patient of their 6 month visit.

Official Title
-----------------
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain : Identification of Potential Relevant Biomarkers

Conditions
-----------------
Interstitial Cystitis

Intervention / Treatment
-----------------
* Other: Questionnaires
* Other: Collection of Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years of age Patients must be able to provide written informed consent. Diagnosis of Interstitial Cystitis documented by provider Exclusion Criteria: age <18 or >70 years of age pregnant

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interstitial Cystitis<br>Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months | Other: Questionnaires<br>* QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery<br>Other: Collection of Blood samples<br>* Blood for PBLs will be collected at 3, 6, and 12 months post surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months | S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain. | 3 months |
Major Depression and Inflammatory Risk Markers for Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this research is to examine whether depression influences immune system function. Studies indicate that individuals who are depressed experience coronary heart disease at a higher rate than expected. This study's goal is to begin identifying mechanisms that might be responsible for this process. This research also examines whether behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are responsible for immune system differences between depressed and nondepressed people

Detailed Description
-----------------
To qualify for participation, subjects are to be between the ages of 18-55, medically healthy and free of all medication three months prior to enrollment. Half of them will be clinically depressed; the remaining one half will be healthy controls without a history of psychiatric illness. All subjects who qualify for the study will attend two laboratory sessions. During the first visit, participants will undergo a structured psychological interview, complete questionnaires about their mood, personality, and behavior, and have blood drawn to assess their immune system function. During the second visit, participants will complete additional questionnaires about their mood, personality, and behavior. The subjects will also participate in a mock job interview to look at their body's response to stress. Before and after the interview, the subjects will have blood drawn and be asked to collect saliva samples to assess their immune system function. In addition to the two laboratory visits, participants will be asked to collect additional information while going about their normal activities. In order to accomplish this, they will be given a small hand held portable computer. Four times each day for four days, the computer will signal them to collect a saliva sample. This will be used later to measure hormone levels. This study will explore changes in the immune system and metabolic system that might predispose depressed individuals to develop heart disease

Official Title
-----------------
Major Depression and Inflammatory Risk Markers for Coronary Heart Disease

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
For eligibility, potential subjects will be 18-55 years of age, free of all medication during the past three months, and have no history of chronic illness involving the cardiovascular, endocrine, immune systems

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.

Detailed Description
-----------------
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). Letters were sent to the 343 children who were examined in phase 1. One hundred and thirty nine individuals returned for the oral examination - experimental group (40.5%). The control group consisted of 139 individuals who did not receive dental care from the PPPWB. These individuals were paired to the experimental group according to their age and socio-demographic characteristics. Gingival bleeding (GBI) and DMFT indices were used in order to determine the children's oral health status. The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.

Official Title
-----------------
Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study

Conditions
-----------------
Health Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who participated to the program Exclusion Criteria: children who did not participate

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 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 |
| --- | --- |
| participation in a dental health program<br>Group 1 - children who participated to a dental health program Group 2 - children who did not participate to dental health program | |
| participation in a preventive program<br>Group 1 - children who participated to the preventive program Group 2 - children who did not participate | |

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
-----------------
Dental caries, Epidemiology, Gingivitis, Oral health
Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery

Study Overview
=================
Brief Summary
-----------------
This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.

Detailed Description
-----------------
Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).

Official Title
-----------------
Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Stimulation of the diaphragm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients following open heart surgery who need permanent pacing Exclusion Criteria: Patients with fast changing need of vasopressors

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stimulation of diaphragm<br> | Device: Stimulation of the diaphragm<br>* Stimulation of the diaphragm using an electrode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction |  | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain natriuretic peptide (BNP) |  | One day | 
| 6-minutes walking distance |  | One day | 
| NYHA functional class |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biventricular Pacing
Changes in Aortic Diameter During Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Various haemodynamic changes are observed during laparoscopic surgery, relating to insufflation of CO2 & patient position. Cardiac output calculations using oesophageal doppler monitoring are based on the assumption that the aortic diameter is fixed. This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.

Detailed Description
-----------------
Purpose and design:This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital. Recruitment: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study. Inclusion / exclusion: Patient refusal, Surgical refusal, Conversion to an open procedure. Consent: Informed consent will be gained from each participant. Risks, burdens and benefits: This is an observational study using a non invasive technique in patients undergoing elective surgery. There is very little in the way of risks, burdens and benefits to the patient. Confidentiality: Caldicott principles will be adhered to. Conflict of interest: None. Use of tissue samples in future research: None.

Official Title
-----------------
Ultrasonic Assessment of Changes in Aortic Diameter During Laparoscopic Surgery

Conditions
-----------------
Abdominal Aortic Diameter During Laparoscopic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients undergoing elective laparoscopic surgery at the Royal Surrey County Hospital Exclusion Criteria: Patient refusal Surgical refusal Conversion to an open procedure

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |