linjc16/ctgov huggingface dataset:
Clinical Test Report for Blood Pressure Meter CH-609

Study Overview
=================
Brief Summary
-----------------
Blood pressure meter model CH-609 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 85 subjects with a wide range of blood pressure were selected. Exclusion Criteria: Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Measure the accuracy of blood pressure meter model CH-609 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10. |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure
A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.

Official Title
-----------------
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-period Cross-over Study to Evaluate the Scopolamine Cognition Model in Healthy Male Subjects Using AZD1446 and Donepezil Versus Placebo

Conditions
-----------------
Cognition

Intervention / Treatment
-----------------
* Drug: AZD1446
* Drug: AZD1446
* Drug: donepezil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-30 Non-smoker for at least 4 weeks Exclusion Criteria: Any clinically relevant acute or chronic disease Hypersensitivity to scopolamine History of substance abuse

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

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Single dose of AZD1446 10 mg | Drug: AZD1446<br>* capsule; single oral dose<br>|
| Experimental: B<br>Single dose of AZD1446 80 mg | Drug: AZD1446<br>* capsule, single oral dose<br>|
| Active Comparator: C<br>Single Dose of Donepezil 5 mg | Drug: donepezil<br>* capsule, single oral dose<br>* Other names: Aricept;|
| Placebo Comparator: D<br>Single dose of placebo to match AZD1446 | Drug: Placebo<br>* capsule, single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qEEG assessed through the absolutes alpha-power of the two occipital leads |  | In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qEEGs/ERPs assessed by mismatch negativity and p300 |  | In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, EEG
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol

Detailed Description
-----------------
Inhibin A could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.

Official Title
-----------------
Role of Inhibin A as Biomarker for Ovarian Response to Stimulation With Gonadotropins for IVF Treatment

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility. Exclusion Criteria: Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Number of mature oocytes | Patients undergoing ovarian stimulation with gonadotropins | 1 year |
Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of the study is to establish normal HyperQ values in these populations and compare HyperQ values of age-matched athletic vs. non-athletic individuals of similar health status.

Official Title
-----------------
Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes

Conditions
-----------------
Healthy, Asymptomatic, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An asymptomatic, apparently healthy patient performing a maximal exercise stress test Exclusion Criteria: Contraindications for an exercise test Wolff-Parkinson-White (pre-excitation) syndrome Atrial Fibrillation or significant ventricular arrhythmia Treatment with Digoxin Pacemaker Pregnancy or suspected pregnancy QRS duration>120ms or other conduction delays

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Normal values for depolarization characteristics will be established for study groups |  | end of data collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high frequency ECG, normal values, asymptomatic, obese
Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Study Overview
=================
Brief Summary
-----------------
Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.

Official Title
-----------------
Zekai Tahir Burak Maternity Teaching Hospital

Conditions
-----------------
Meconium Aspiration Syndrome

Intervention / Treatment
-----------------
* Drug: Lung lavage with surfactant
* Drug: Bolus surfactant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled. Exclusion Criteria: Congenital cardiac anomalies Major congenital anomalies Hemodynamically unstable infants

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bolus surfactant<br>Bolus surfactant 100 mg/kg proctant alfa | Drug: Bolus surfactant<br> <br> * Other names: Poractant alfa;|
| Active Comparator: Lung lavage with surfactant<br>Lung lavage with surfactant | Drug: Lung lavage with surfactant<br> <br> * Other names: Poractant alfa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation. | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray. | up to 4 weeks | 
| Duration of Hospital Stay | We will record length of stay in a level III neonatal intensive care unit. | Up to 8 weeks or till discharge | 
| Mortality | We will record who died until discharge. | Up to 3 months or till discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung lavage,, Surfactant,, Duration of mechanical, ventilation
Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

Study Overview
=================
Brief Summary
-----------------
Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.

Detailed Description
-----------------
Different definitions of nocturnal hypoventilation are used in the recent literature. Basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature.

Official Title
-----------------
Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

Conditions
-----------------
Neuromuscular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neuromuscular disease Age ≥18 years Non mechanically ventilated Exclusion Criteria: Long-term oxygen therapy

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 |
| --- | --- | --- |
| Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions | The prevalence of nocturnal hypoventilation (percentage of patients diagnosed as having hypoventilation over the total population) according to the different definition available in the literature will be described | Baseline (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between the diagnostic criteria | Concordance between the different diagnostic criteria of hypoventilation | Baseline (Day 1) | 
| sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis) | sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis) | Baseine (Day 1) | 
| Prognostic value of the different definitions of nocturnal hypoventilation | The ability of the examined definition to predict the need for mechanical ventilation will be investigated, defined as appearance of daytime hypercapnia or beginning of mechanical ventilation and/or mortality. | 5 years |
Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5 genotype carries a higher risk of post-operative cognitive dysfunction.

Official Title
-----------------
The Correlation Between Certain Clock-gene Genotypes and POCD (Post-operative Cognitive Dysfunction)

Conditions
-----------------
Genotype, Cognitive Impairment

Intervention / Treatment
-----------------
* Genetic: Genotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia Exclusion Criteria: daily use of major tranquilizers or antipsychotic medication known disease of the CNS score less than 24/30 points in MMSE

Ages Eligible for Study
-----------------
Minimum Age: 40 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 POCD - cases<br>Out of the 976 patients included in the ISPOCD2 study (Abildstrom H, Christiansen M et al. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology 2004;101:855-61) the 93 patients with POCD whose blood samples are stored will be included together with 2x93 controls (without POCD), who will be matched by type of surgery, age, education, ASA-score and sex. | Genetic: Genotyping<br>* Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples<br>|
| Patients without POCD - controls<br>Out of the 976 patients included in the ISPOCD2 study (Abildstrom H, Christiansen M et al. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology 2004;101:855-61) the 93 patients with POCD whose blood samples are stored will be included together with 2x93 controls (without POCD), who will be matched by type of surgery, age, education, ASA-score and sex. | Genetic: Genotyping<br>* Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPER3 genotype |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative morbidity |  | ½ year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POCD, clock-gene genotypes, HPER3
Prospective PRO/QoL Registry for Patients With Bone Metastases of Breast or Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life patients with bone metastases treated with osteoprotective agents.

Detailed Description
-----------------
The PRO Bone project will recruit a representative cohort of patients with breast or prostate cancer suffering from bone metastases. The aim of this study is to collect data on Patient Reported Outcomes (PRO)/Quality of Life regarding bone pain and the impact of bone pain on quality of life and daily activities. PROs are assessed by a questionnaire consisting of a visual analog scale for bone pain, two questions regarding bone pain management, the bone pain module of FACT questionnaire (FACT-BP) and four questions addressing the impact of treatment on daily life (overall, social life, ability to work and ability to perform routine tasks)

Official Title
-----------------
Open-labeled, Multicenter, Non-interventional Prospective PRO/QoL Registry for Patients With Osteoprotective Treatment for Bone Metastases of Breast or Prostate Cancer

Conditions
-----------------
Breast Cancer, Prostate Cancer, Bone Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed metastatic breast or prostate cancer Start of first systemic osteoprotective treatment Ability to read and understand German Written informed consent 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes (PRO) regarding bone pain and the impact of bone pain on quality of life and daily activities in patients with bone metastases treated with osteoprotective agents. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes regarding the impact of treatment on daily life |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Reported Outcomes
Artificial Intelligence in Colonic Polyp Detection

Study Overview
=================
Brief Summary
-----------------
A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

Official Title
-----------------
Artificial Intelligence in Colonic Polyp Detection

Conditions
-----------------
Polyp of Colon, Adenoma Colon, Gastrointestinal Neoplasms

Intervention / Treatment
-----------------
* Device: Artificial intelligence
* Device: No Artificial Intelligence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients without IBD referred for colonoscopy Exclusion Criteria: Age < 40 years Not willing to participate

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI<br>Colonoscopy with AI | Device: Artificial intelligence<br>* Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps<br>|
| Placebo Comparator: No AI<br>Colonoscopy without AI | Device: No Artificial Intelligence<br>* Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR | Adenoma detection rate | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APC | Adenomas per colonoscopy | 1 hour | 
| Procedural time | The number of minutes required to complete the colonoscopy withdrawal | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, artificial intelligence
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

Study Overview
=================
Brief Summary
-----------------
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema

Detailed Description
-----------------
Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.

Official Title
-----------------
Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Procedure: Bronchoscopy
* Device: Lung Volume Reduction Coil (HEAT-LVRC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe emphysema (recent CT-scan (< 6 mois) ) Age > 35 ans Modified Medical Research Council Scale (mMRC) > 2 Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45% Residual volume > 175% Total Pulmonary capacity > 100% Exclusion Criteria: Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator Carbon Monoxide Diffusing Capacity (TLCO) < 20% Recurrent respiratory infection Infections with clinics symptoms Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg Impossibility to walk more that 140 meter (6 min test) Surgery history of volume reduction or pulmonary transplantation Broncho-dilatation with clinic symptoms

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with severe emphysema<br>Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy | Procedure: Bronchoscopy<br>* Two sequences of 30 minutes are necessary by patient<br>Device: Lung Volume Reduction Coil (HEAT-LVRC)<br>* Bronchoscopy with Heat-LVRC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperinflation Assessment After Treatment | Assessed by Lung Volume Reduction Coil | 3 months |