linjc16/ctgov huggingface dataset:
Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

Study Overview
=================
Brief Summary
-----------------
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Official Title
-----------------
Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations

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

Intervention / Treatment
-----------------
* Drug: Methacholine (Provocholine)
* Drug: Mannitol (Aridol)
* Drug: Methacholine (Provocholine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable controlled asthma Exclusion Criteria: pregnancy use of asthma therapies other than bronchodilator therapy

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methacholine (Provocholine) with deep inhalation<br> | Drug: Methacholine (Provocholine)<br>* two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL<br>|
| Experimental: Mannitol (Aridol)<br> | Drug: Mannitol (Aridol)<br>* single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).<br>|
| Active Comparator: Methacholine (Provocholine) tidal breathing<br> | Drug: Methacholine (Provocholine)<br>* two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing | The two minute tidal breathing PC20 with be captured once at visit 1. | Visit 1 (Day 1) | 
| airway responsiveness (PD15) to inhaled mannitol | The PD15 to mannitol will be captured once at either visit 2 or visit 3. | Visit 2 = up to 13 days | 
| Airway responsiveness (PC20) to deep inhalation methacholine | The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3. | Visit 3 = up to 14 days |
Management of Infectious Endocarditis as Part of a Multidisciplinary Consensus Meeting

Study Overview
=================
Brief Summary
-----------------
New ESC 2015 recommendations with encouragement to set up a Multidisciplinary Consultation Meeting to discuss the medical and surgical management of endocarditis, set up at Strasbourg University Hospital in October 2016: Impact and benefits

Official Title
-----------------
Impact of Setting up a Multidisciplinary Consensus Meeting in the Prognosis and Management of Infectious Endocarditis at Strasbourg University Hospital.

Conditions
-----------------
Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 18 years at diagnosis Diagnosis of confirmed Infectious Endocarditis Medical and / or surgical care at Strasbourg University Hospital between January 2007 and June 2018 Exclusion Criteria: - Refusal to participate in 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 |
| --- | --- | --- |
| Mortality rate |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endocarditis
Almond Intervention in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study of an almond-enriched diet (within the overall context of Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.

Official Title
-----------------
Effect of Almond Supplementation on Glycemic and Cardiovascular Risk Factors in Asian Indians in North India With Type 2 Diabetes Mellitus: A 24-week Prospective Cohort Study

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: almond


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the age range of 25-65 years on stable doses of metformin from past 3 months having HbA1C less than 9% LDL-c ≥100 mg/dl were recruited Exclusion Criteria: Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years having high uric acid levels (≥ 8 mg/dl), with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure, appreciable weight loss (more than 10%) during past 6 months Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: almond<br>almonds are substituted for visible fat and carbohydrates | Dietary Supplement: almond<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-c |  | baseline, after six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | baseline, after six months of intervention |
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to evaluate the diagnostic performance of the XL probe for estimating degree of liver fibrosis/cirrhosis in obese patients > 28 kg/m² with various liver diseases in patients with chronic liver disease scheduled for a liver biopsy.

Official Title
-----------------
Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

Conditions
-----------------
Liver Fibrosis, Cirrhosis

Intervention / Treatment
-----------------
* Device: FibroScan M and XL probes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of at least 18 years of age Patient able to give written informed consent form Patient with a BMI superior or equal to 28kg/m² Patient scheduled to have a liver biopsy within 1 month after the enrollment or with a liver biopsy performed within 6 months before the enrollment. Patient for which abdominal ultrasound is technically possible Exclusion Criteria: Unable or unwilling to provide written informed consent Confirmed diagnosis and/or history of malignancy, or other terminal disease Patients with clinical ascites Pregnant women Patient with a BMI < 28 kg/m² Patients with any active implantable medical device (such as pacemaker or defibrillator) Transplanted patient and patient with heart disease Refusal to undergo a liver biopsy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FibroScan M and XL probes|Each patient undergo two liver stiffness measurements with the FibroScan: once with the M probe and once with the XL probe|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis accuracy for the assement of significant fibrosis and cirrhosis |  | at enrollement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²
Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Study Overview
=================
Brief Summary
-----------------
This study will compare the effect of constant low-level energy [150 joules] to an escalating energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient outcomes.

Detailed Description
-----------------
This pilot, which will enroll 200 subjects, will allow a reasonable estimate of effect size and this will, in turn, allow for the accurate design and planning of a definitive randomized controlled trial. The following outcomes will be evaluated: Important Clinical Outcomes: Successful conversion, Resuscitation to one hour, Survival to hospital discharge, Neurological function, and Quality of life. Process Outcomes: Number of shocks required, Recurrences of VF, and Responsiveness to varying periods of pulselessness. Adverse Outcomes: Myocardial damage.

Official Title
-----------------
A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Procedure: fixed versus escalating biphasic defibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator Exclusion Criteria: Terminal illness or do-not-resuscitate (DNR) status No cardiopulmonary resuscitation (CPR) x 10 minutes Acute trauma Exsanguination Cardiac arrest experienced while in hospital

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: fixed versus escalating biphasic defibrillation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful conversion to an organized heart rhythm |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to hospital discharge |  |  | 
| Resuscitation for survival to one hour |  |  | 
| Neurologic function |  |  | 
| Removal of ventricular fibrillation (VF) in 5 seconds |  |  | 
| Return of spontaneous circulation |  |  | 
| Survival to 24 hours |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
defibrillation, ventricular fibrillation, heart arrest
Complications Associated With Arterial Line Placement in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.

Detailed Description
-----------------
artery observation with ultrasound

Official Title
-----------------
Study on Complications After Arterial Line Placement and the Risk Factors in Children

Conditions
-----------------
Complications After Arterial Catheterization

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients under 5 years of age who require invasive arterial pressure monitoring Exclusion Criteria: Patients who do not need invasive arterial pressure monitoring

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children<br>Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography | Diagnostic Test: Ultrasonography<br>* Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications associated with arterial catheterization | Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred. | within 5 days after arterial catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age as a risk factor | To evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis. | within 5 days after arterial catheterization | 
| Number of attempts as a risk factor | To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications | within 5 days after arterial catheterization | 
| Duration of catheterization as a risk factor | To evaluate the duration of catheterization as one of the risk factors for complications | within 5 days after arterial catheterization |
Thermal Analgesia in Newborns

Study Overview
=================
Brief Summary
-----------------
Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.

Official Title
-----------------
Thermal Analgesia in Newborns

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: sucrose
* Other: warmth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy infants Exclusion Criteria: unhealthy infants

Ages Eligible for Study
-----------------
Maximum Age: 2 Days

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

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

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 |
| --- | --- |
| Active Comparator: 1<br>Sweet Taste | Other: sucrose<br>* sweet taste<br>|
| Active Comparator: 2<br>warmth | Other: warmth<br>* warmth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased behavioral and physiologic indicators of pain |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infants, undergoing, vaccinations
Plasma Pharmacokinetics of Alkylresorcinol Metabolites; New Candidate Biomarkers for Whole Grain Rye and Wheat Intake

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the kinetics of two known alkylresorcinol metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the most abundant source of alkylresorcinols.

Official Title
-----------------
Kinetic Study of Two Known Alkylresorcinol Metabolites in Human Subjects After the Intake of Rye Fiber, the Most Abundant Source of Alkylresorcinols in Diet.

Conditions
-----------------
Kinetics of Alkylresorcinol Metabolites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, volunteer Exclusion Criteria: Hemoglobin below 125 mmol/L in females and below 135 mmol/L in males use of antibiotics within 3 months before entering the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kinetics, alkylresorcinol metabolites, rye fiber
CAFE Comparison of Atypicals in First Episode of Psychosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder who are experiencing their first psychotic episode.

Official Title
-----------------
Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison

Conditions
-----------------
Schizophrenia, Psychotic Disorders, Mental Health, Mental Disorders

Intervention / Treatment
-----------------
* Drug: Olanzapine, risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder with psychotic symptoms lasting 1-60 months Psychotic symptoms must have persisted at least one month, and not more thn 5 years (60 months) Patients must have no previous history of drug treatment (greater than a total of 16 weeks) with antipsychotics Exclusion Criteria: Patients with history of psychotic disorder with recovery period of at least 3 months Female patients who are pregnant or nursing Patients with a known history of mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 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: Olanzapine, risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria in patients with chronic kidney disease regardless the ethiology.

Detailed Description
-----------------
Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa L. Different studies have demonstrated that curcumin has potent biological activity and therefore is an effective therapeutic agent for the treatment of various ailments. This compound acts as a bifunctional antioxidant: ه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by its ability to induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway. Although RAAS blockade is the cornerstone to prevent the progression of proteinuric nephropathy, a significant number of patients remained with proteinuria and progress to end-stage renal disease. Due to the low cost and few side effects of curcumin, this could become an adjuvant treatment of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.

Official Title
-----------------
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

Conditions
-----------------
Proteinuria

Intervention / Treatment
-----------------
* Drug: Curcumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection. Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination. Exclusion Criteria: Hepatic damage. Malignancy. Pregnancy. Peritoneal or hemodialysis. Organ transplantation. Heart failure classification III or IV (New York Heart Association). History of chemotherapy within 2 years prior to screening.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetic<br> | Drug: Curcumin<br> <br> * Other names: Turmeric;|
| Active Comparator: Non-diabetic<br> | Drug: Curcumin<br> <br> * Other names: Turmeric;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proteinuria |  | 8 weeks |