linjc16/ctgov huggingface dataset:
D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

Official Title
-----------------
Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: D-dimer assay before ablation of atrial fibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years. Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter Patient informed of the study Exclusion Criteria: Age <18 years. Patients under guardianship Pregnant woman Contraindication to transesophageal echocardiography transesophageal echocardiography made in another center as the center of ablation Refusal of the patient to participate in the study Patient participating in another interventional study in which an intervention related to biomedical research is performed before the transesophageal echocardiography

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atrial fibrillation<br>D-dimer assay before ablation of atrial fibrillation | Other: D-dimer assay before ablation of atrial fibrillation<br>* Blood sample collection for D-dimers measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound |  | up to 48 hours before ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHADS2 Score | CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1) | 48 hours before ablation | 
| Risk Factors | variables related to the presence of atrial thrombus | 48 hours before ablation | 
| Atrial Thrombus Exclusion (ATE) Score | The following thromboembolic risk factors mark 1 point if present in patient: hypertension = 1 point cardiac insufficiency = 1 point history of stoke = 1 point d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score | 48 hours before ablation |
Remifentanil for Preventing Propofol Injection Pain in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.

Official Title
-----------------
Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients

Conditions
-----------------
Drug Usage

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I or II undergoing general anesthesia Exclusion Criteria: neurologic disorder psychologic disorder vascular disorder patients with chronic pain difficulty in vascular access

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly<br>Remifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients. | Drug: Remifentanil<br>* Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years)<br>* Other names: Ultiva;|
| Active Comparator: Adult<br>Remifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients. | Drug: Remifentanil<br>* Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years)<br>* Other names: Ultiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of propofol injection pain-4 point scale | 0 = no pain (negative response to questioning), = mild pain (pain reported only in response to questioning without any behavioral signs), = moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontane¬ously without questioning), = severe pain (vocal response accompanied by facial grimacing, arm withdrawal, or tears) | during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, propofol, remifentanil
Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery

Study Overview
=================
Brief Summary
-----------------
The aims of this three-year study are to: explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months. develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Detailed Description
-----------------
Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Official Title
-----------------
Developing and Testing the Effects of Patient-centered Prehabilitation Program on Improving Fatigue, Nutritional Status, and Quality of Life in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery

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

Intervention / Treatment
-----------------
* Behavioral: Physical and nutrition program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pancreatic cancer and are going to receive surgery. Exclusion Criteria: poor functional status

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical and nutrition program<br>6 education programs with physical enhancement and nutrition related information for 12 weeks. | Behavioral: Physical and nutrition program<br>* 6 education programs with physical enhancement and nutrition related information for 12 weeks<br>|
| No Intervention: Control<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report Questionnaire | The questionnaire includes 25 items to assess the physical symptom distresses | Change from baseline physical symptom at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report Questionnaire | The questionnaire includes 14 items to assess fatigue intensity and duration | Change from baseline fatigue at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer, Fatigue, Nutrition, Quality of Life
Energy Turnover in Patients With Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.

Official Title
-----------------
Does Energy Turnover After Short-term Nutritional Recovery Predict Subsequent Weight Course in Patients With Anorexia Nervosa?

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anorexia nervosa anabolic metabolism high compliance end of inpatient treatment Exclusion Criteria: any further disease than eating disorder smokers

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 36 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 |
| --- | --- |
| AN patients<br>Patients with Anorexia Nervosa (AN). No intervention, observation at end of inpatient treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy expenditure (REE; kcal/d); Total Daily Energy Expenditure (TDEE; kcal/d) | REE will be measured in a Respiration chamber and TDEE with isotope dilution | End of inpatient treatment (T0), within 2 weeks before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight 6 months after discharge from inpatient Treatment (T1) | T1 = 6 months after first test (T0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy metabolism
Drug-drug Interaction Study With ASP1941 and Glimepiride

Study Overview
=================
Brief Summary
-----------------
A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Detailed Description
-----------------
Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.

Official Title
-----------------
An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: ASP1941
* Drug: Glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18.5 and 30 kg/m2, inclusive Exclusion Criteria: Any of the liver function tests above the upper limit of normal Pulse <40 or >90 bpm; Systolic Blood Pressure >140 mmHg; Diastolic Blood Pressure > 90 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ASP1941|oral|
|Drug: Glimepiride|oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941 |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-Drug interaction, ASP1941, Glimepiride, Healthy subjects
Antimanic Drug Use in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.

Official Title
-----------------
Antimanic Drug Use in Pregnancy

Conditions
-----------------
Bipolar Disorder, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Bipolar Subjects: Age 18 or older Pregnant at 20 weeks or more Women must receive OB care English-speaking DSM-IV diagnosis of BP, any subtype Inclusion Criteria for non-Bipolar Control Subject: Age 18 or older Pregnant at 20 weeks or more English-speaking Women must receive OB care. Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV. Exclusion Criteria for all: Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance. Women must not take drugs in the FDA categories D or X. Additional Exclusion Criteria for Control Subjects: Women must have no lifetime history of Bipolar Disorder or antimanic drug use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Pregnant women with bipolar disorder | |
| 2<br>Pregnant women without bipolar disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIGH-ADS |  | 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum | 
| Mania Rating Scale |  | 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum | 
| Bayley Scales of Infant Development |  | 12, 28, 52 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain in pregnancy |  | 20,30,36 weeks gestation | 
| Structured Clinical Interview for DSM-IV |  | 20 weeks gestation at enrollment | 
| Nutritional Blood Levels |  | 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum | 
| Maternal Functioning and Gratification |  | 2, 12, 28, 52 weeks postpartum | 
| Infant physical exam |  | 2,12,28,52 weeks post delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Pregnancy, Infant Development
The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients

Study Overview
=================
Brief Summary
-----------------
Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.

Official Title
-----------------
The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokines in COPD Patients

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: simvastatin, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable COPD without an exacerbation within 3 months prior to study entry mild, moderate and severe COPD with or without treatments, regardless of COPD medications Exclusion Criteria: Concomitant other chronic lung diseases including with TB and malignancy HIV Being on immunosuppressive drugs and systemic corticosteroids Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry Cognitive impairment Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin<br>simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks | Drug: simvastatin, placebo<br> <br> * Other names: B1-6-12;|
| Placebo Comparator: B1-6-12<br>B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks | Drug: simvastatin, placebo<br> <br> * Other names: B1-6-12;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum cytokines |  | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | Up to 4 weeks | 
| Sputum neutrophils |  | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Statins, Cytokines
Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old

Study Overview
=================
Brief Summary
-----------------
This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.

Conditions
-----------------
Enterovirus 71 Vaccine

Intervention / Treatment
-----------------
* Biological: two doses enterovirus 71 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense. Exclusion Criteria: History of allergy to any vaccine ingredient or gentamycin; Fever, or acute disease, or acute stage of chronic disease; Having serious chronic diseases, or allergic constitution; Refusal of follow-up for safety concern.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Months

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

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

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: two doses enterovirus 71 vaccine<br>Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval. | Biological: two doses enterovirus 71 vaccine<br>* Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of adverse reactions of enterovirus 71 Vaccine | Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, safety
Effect of Antigens or Therapeutic Agents on in Vitro Human Intestinal Organoids

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effect of nutrient antigens or therapeutic agents on human small intestinal organoids.

Detailed Description
-----------------
Small intestinal biopsies will be taken to establish human intestinal organoids in vitro. The organoids will be propagated and various antigens will be checked for their effects on proliferation, production of inflammatory components or signal cascade.

Official Title
-----------------
Establishment of Small Intestinal Human Organoids to Check the Influence of Nutrient Antigens or Therapeutic Agents

Conditions
-----------------
Intestine Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gastrointestinal disorders and therapeutical indication of gastroduodenoscopy or coloscopy healthy controls for preventive medical check-up Exclusion Criteria: pregnant women

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 |
| --- | --- |
| healthy controls<br>healthy controls | |
| patients with allergy<br>patients with Food intolerances or Food allergy | |
| gastrointestinal disorders<br>patients with inflammatory bowel disease, irritable bowel disease, gluten sensitivity, short bowel syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of proliferation, apoptosis, histology, and cytokine Expression before and after Antigen provocation of organoids with gluten peptides, nutritional Antigens, GLP-antagonist, or TNF antagonists | Determination of effects on organoids after antigen Stimulation with ELISA, histochemistry, RNA or proteome analysis | baseline vs 24h vs 48h vs 72h |