linjc16/ctgov huggingface dataset:
Outcome of Patients After a Negative Oral Challenge to Amoxicillin

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin

Detailed Description
-----------------
This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed at Angers University Hospital between 2017 and 2019. An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.

Official Title
-----------------
Study of Patient's Outcomes After a Negative Reintroduction Test for Amoxicillin

Conditions
-----------------
Negative Challenge to Amoxicillin

Intervention / Treatment
-----------------
* Drug: Amoxicillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019. Major patients. Exclusion Criteria: Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire Person objecting to participate in this research and to the processing of their medical data

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 |
| --- |
|Drug: Amoxicillin|Outcome of patients with negative oral challenge to amoxicillin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of Amoxicillin after a negative oral challenge to Amoxicillin | The main objective is to know if patients who had a negative test for reintroduction of Amoxicillin, have resumed this molecule afterwards. | Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
penicillins, reintroduction
Hemophagocytosis in Critically Ill Adult Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find out whether non-responsiveness to therapeutic recombinant human granulocyte colony-stimulation factor (rhG-CSF) is associated with hemophagocytosis in critically ill adult patients with cytopenias.

Detailed Description
-----------------
In children with bi- or pancytopenia, hemophagocytosis is known as life-threatening hemophagocytic lymphohistiocytosis (HLH). The purpose of the study is to find out whether adult patients with bicytopenia or pancytopenia fulfilling the clinical HLH criteria used in children reflect life-threatening hemophagocytosis and whether hemophagocytosis is associated with responsiveness to recombinant human granulocyte colony-stimulation factor (rhG-CSF) or not.

Official Title
-----------------
Hemophagocytosis in Critically Ill Adult Patients With Cytopenias

Conditions
-----------------
Hemophagocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years critically ill adult patients leukopenia and thrombocytopenia rhG-CSF therapy Exclusion Criteria: life expectancy < 24 hours inclusion in other studies trauma patients with reanimation on scene or immediately dying on hospital admission pregnancy hematologic disorder, malignancy high dose corticosteroid treatment or chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| patients with cytopenias<br>Patients with sepsis and concomitant cytopenias (leukopenia with thrombocytopenia and anemia) who are routinely treated with rhG-CSF will be followed for reconstitution of peripheral blood cell counts. In cooperation with the Department of Hematology, patients are examined for bone marrow cellularity and hemophagocytosis if G-CSF treatment does not result in leukocyte increase. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF) | increase in leukocytes | within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8 clinical HLH criteria | degree of fulfillment x out of 8 clinical HLH criteria | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophagocytosis, adults, rhG-CSF
Early Detection of Epidural Onset by Temperature Change

Study Overview
=================
Brief Summary
-----------------
Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as loss of resistance while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.

Detailed Description
-----------------
Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine

Official Title
-----------------
Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe

Conditions
-----------------
Early Confirmation of Epidural Catheterization

Intervention / Treatment
-----------------
* Drug: epidural injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight:50-90kg, American Society of Anesthesiologists physical status classification I-II, Under epidural anesthesia for surgery Exclusion Criteria: History of receiving lumbar surgery Allergy to alfentanil ,xylocaine, bicarbonate Trauma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epidural injection<br>epidural injection of 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000) | Drug: epidural injection<br>* drug combination: 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of skin temperature change over big toe after epidural local anesthetic injection | SPECTRUM 9000MB to detect lower limb color changes | within 10 mins after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of skin sensation change between inguinal area to umbilicus | tested by alcohol sponge | within 15 mins after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia, epidural, skin temperature
Environmental Contaminants and Infant Development

Study Overview
=================
Brief Summary
-----------------
This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland.

Detailed Description
-----------------
Due to prevailing weather patterns and ocean currents, certain environmental contaminants are transported to the Arctic region. The Inuit are among the most heavily exposed populations on earth due to the prevalence of these contaminants in traditional foods that comprise a large portion of their diet. The contaminants assessed in this study include polychlorinated biphenyls (PCBs), methylmercury, selenium, organochlorine pesticides, and lead. These contaminants are measured in umbilical cord blood samples obtained at birth, milk samples obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from the mothers. Omega-3 and omega-6 fatty acids are also assessed in these samples to examine the degree to which these nutrients may protect against adverse effects attributable to these contaminants.

Conditions
-----------------
Mercury Poisoning, Lead Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
infant born during recruitment period to a mother who is a resident of Povungnituk, Inukjuak, and Kuujjuarapik, Quebec or Nuuk, Greenland

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Day

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
-----------------
methylmercury, PCBs, lead, fish consumption, breast-feeding
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Official Title
-----------------
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1

Conditions
-----------------
Birch Pollen Allergy

Intervention / Treatment
-----------------
* Biological: Recombinant birch pollen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive Skin Prick Test reaction to birch pollen Positive RAST result to birch pollen Positive Provocation Test result to birch pollen Exclusion Criteria: Serious chronic diseases Other perennial allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- |
|Biological: Recombinant birch pollen|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
-----------------
Allergy, Birch pollen, Recombinant
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.

Official Title
-----------------
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Diet 1
* Other: Diet 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits. Exclusion Criteria: Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study. Food allergies Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm_1<br>Anti-inflammatory diet 1 | Other: Diet 1<br>* Dietary intervention<br>* Other names: anti-inflammatory diet 1;|
| Experimental: Arm_2<br>Anti-Inflammatory diet 2 | Other: Diet 2<br>* Dietary intervention<br>* Other names: anti-inflammatory diet 2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of more than 5 points in Clinical Disease Activity Index |  | 3 months |
Impact of GERD on Daily Life (NIS)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to gather epidemiological data in a population of GERD patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).

Official Title
-----------------
An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life of GERD in Patients With Erosive Gastroesophageal Reflux Disease.

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with erosive esophagitis (endoscopical findings according to the Los Angeles Classification; grade A-D) currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has decided to initiate or change the treatment for GERD

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 |
| --- | --- | --- |
| To gather epidemiological data in a population of GERD patients |  | After collection of all questionnaires | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the added value of a new patient questionnaire (GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment. |  | After collection of all questionnaires | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, esophagitis, PPI
An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

Study Overview
=================
Brief Summary
-----------------
This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

Official Title
-----------------
Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected With Chronic Hepatitis C Receiving a Long Acting Interferon Plus Ribavirin

Conditions
-----------------
Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (according to local legislation) Chronic hepatitis C Treatment with long-acting interferon plus ribavirin Quantifiable HCV RNA before initiation of treatment No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label Exclusion Criteria: End stage renal disease Major organ transplantation Concomitant therapy with telbivudine Pregnant or breast-feeding females Male partners of pregnant females

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin |  | 4 years | 
| Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment) |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of on-treatment factors and dose reduction/treatment discontinuation |  | 4 years | 
| Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR |  | 4 years | 
| Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients |  | 4 years | 
| Safety: Incidence of adverse events |  | 4 years |
Observational Study at the Influence of Malnutrition on Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation.

Official Title
-----------------
Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Other: Laboratory values


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in early neurological rehabilitation informed consent given Exclusion Criteria: none

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients in neurological rehabilitation<br>Patients suffering from a neurological disease | Other: Laboratory values<br>* Laboratory values which represent nutritional status<br>* Other names: Thyroxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nosocomial infections | Survey whether the patient has infections during the observation period | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Infection, Neurological
A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

Study Overview
=================
Brief Summary
-----------------
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.

Official Title
-----------------
A Randomized Double-Blind, Parallel, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil (5 mg QD for 6 Weeks) After Single Dose and Steady State Therapy (2 Weeks and 6 Weeks) in Subjects With Mild Cognitive Impairment

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

Intervention / Treatment
-----------------
* Drug: donezepil (Aricept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females ages 55-90 inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG and clinical laboratory tests) Body Mass Index (BMI) between 18 to 34 kg/m2, inclusive; and a total body weight Subjects with mild cognitive impairment (MCI) must have a reliable informant who has an average of 10 hours per week or more contact with the subject. Memory complaints and memory difficulties, which are verified by an informant Mini-mental status exam (MMSE) score of 24-30 Exclusion Criteria: Subjects with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives Insulin-requiring diabetes or uncontrolled diabetes mellitus Subjects with a current diagnosis of depression or other psychiatric illnesses

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 Years

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

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

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: donezepil (Aricept)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychologic test scores: GMLT, DSST, Cog State TM including PAL test, RAVLT, ADAS-cog at baseline (pre-dose) 5 and 8 hours after the first dose and 2 and 6 weeks. (Continues in next bullet.) |  |  | 
| MRS (Magnetic Resonance Spectroscopy) profile including but not limited to NAA (N-acetyl-aspartate), NAA/Cr (N-acetyl-aspartate/creatinine ratio), MI (Myoinositol) and MI/Cr (Myoinositol/creatinine ratio). |  |  |