linjc16/ctgov huggingface dataset:
Electrogastrography (EGC) in Premature Infants With Feeding Intolerance

Study Overview
=================
Brief Summary
-----------------
Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.

Official Title
-----------------
Electrogastrography (EGC) in Premature Infants With Feeding Intolerance: The Effect of Metoclopramide

Conditions
-----------------
Infant, Newborn, Diseases

Intervention / Treatment
-----------------
* Drug: metoclopramide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Premature infants. Absence of 1) infection, 2) congenital anomalies, 3) growth retardation

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: metoclopramide|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
-----------------
Feeding intolerance, Infant, premature
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.

Official Title
-----------------
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia

Conditions
-----------------
Negative Symptoms of Schizophrenia

Intervention / Treatment
-----------------
* Drug: SPD489 Low-Dose
* Drug: SPD489 High-Dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has diagnosis of schizophrenia for at least 2 years Subject has persistent predominant negative symptoms Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications Subject has been clinically stable and is in the non-acute phase of illness Exclusion Criteria: Subject has clinically notable positive symptoms Subject is considered to be treatment refractory Subject has current history of substance abuse/dependance Subject is considered a suicide risk or risk to harm others

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPD489 Low-Dose<br> | Drug: SPD489 Low-Dose<br>* SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks<br>* Other names: Vyvanse, Lisdexamfetamine dimesylate, LDX;|
| Experimental: SPD489 High-Dose<br> | Drug: SPD489 High-Dose<br>* SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks<br>* Other names: Vyvanse, Lisdexamfetamine dimesylate, LDX;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule taken once-daily for up to 26 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Symptom Assessment (NSA-16) total score |  | up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  | up to 26 weeks |
Psychometric Testing and Cue Utilization During Cued Visual Search

Study Overview
=================
Brief Summary
-----------------
The experimenters will examine the relationship between utilization of positive (target cue) and negative (distractor cue) templates during a cued visual search task with performance on a set of measures related to executive functions associated with attentional control: shifting, updating, and inhibition.

Detailed Description
-----------------
The experimenters will utilize the typical procedures for the cued attentional task, while also deploying the Miyake executive function analysis. Data will also include a working memory capacity measure.

Official Title
-----------------
Psychometric Testing and Cue Utilization During Cued Visual Search

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Behavioral Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal or corrected-to-normal visual acuity, normal color vision Exclusion Criteria: age

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?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Within-subjects measures, individual differences analysis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attentional Tests- Miyake and others<br>All participants will complete a series of behavioral tasks, including cued visual search with positive, negative, and neutral cues, Miyake executive attention tasks, and a visual working memory task. Single Arm. | Behavioral: Behavioral Measurement<br>* Take measurements of behavioral performance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive, Negative, Neutral Attention Task Performance Speed | Reaction times on visual search task with positive, negative, and neutral cues | 1 day | 
| Positive, Negative, Neutral Attention Task Performance Accuracy | Accuracy on visual search task with positive, negative, and neutral cues | 1 day | 
| Miyake Executive Attention task- Updating | Updating Attention | 1 day | 
| Miyake Executive Attention task-Shifting | Shifting Attention | 1 day | 
| Miyake Executive Attention task-Inhibition | Inhibition of attention | 1 day | 
| Working Memory Capacity | Estimate of working memory capacity based on behavioral performance | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attention, visual search
The Discrepancy in Radiologists' Practice of Intravenous Contrast Imaging Studies Among Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
There is a discrepancy between protocols used for intravenous imaging for chronic kidney disease including hemodialysis patients among different hospitals and even, among radiologists same selves. This questionnaire based study aims to quantify that discrepancy and describe the variables associated with the discrepancy.

Detailed Description
-----------------
There is a discrepancy between protocols used for intravenous imaging for chronic kidney disease including hemodialysis patients among different hospitals and even, among radiologists same selves. This questionnaire-based study aims to quantify that discrepancy and describe the variables associated with the discrepancy.

Official Title
-----------------
The Discrepancy in Radiologists' Practice of Intravenous Contrast Imaging Studies Among Chronic Kidney Disease Patients

Conditions
-----------------
Chronic Kidney Diseases, Chronic Kidney Disease 5D

Intervention / Treatment
-----------------
* Other: Questionnare


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Practicing radiologist Exclusion Criteria: retired radiologist

Ages Eligible for Study
-----------------
Minimum Age: 24 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 |
| --- | --- |
| active arm<br>participants responding to the questionnaire emailed. | Other: Questionnare<br>* A questionnaire form is emailed to radiologists to get their response of their practice with hemodialysis and chronic kidney disease patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from IV contrast study and next dialysis session | time from IV contrast study and next dialysis session | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, Hemodialysis, Intrevenous Contrast
Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

Study Overview
=================
Brief Summary
-----------------
To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients >=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main Exclusion Criteria: Pregnant breast-feeding unwilling to use birth control during the study secondary hypertension SBP>=180 mmHg DBP>=120 mmHg severe renal dysfunction hepatic insufficiency stroke within the last 6 months myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months unstable or uncontrolled diabetes history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telmisartan|nan|
|Drug: Ramipril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM |  |  |
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires. The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.

Official Title
-----------------
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia. A Double-Blind, Randomized, Placebo-Controlled,Three Way Cross-Over Study

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Drug: zolpidem-MR (modified release)
* Drug: zolpidem (SL800750)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zolpidem-MR (modified release)|nan|
|Drug: zolpidem (SL800750)|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysommography (PSG) wake time after sleep onset (WASO) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia
Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound

Study Overview
=================
Brief Summary
-----------------
Benefit of MRI in pathological nipple discharge.

Official Title
-----------------
Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single pore nipple discharge neither green nor milky. Mammography (at least 2 shots, +/- centred on retro-areal) normal. Initial ultrasound: normal. Age over 18 years Female Patient affiliated to the social security scheme. Patient information and informed consent signed and dated Exclusion Criteria: Physiological milky or green discharge

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort - MRI<br>Patients with pathological nipple discharge | Device: MRI<br>* The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound. |  | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performances of MRI (sensitivity, specificity, positive predictive value) in pathological nipple discharge with normal mammography / ultrasound. |  | At baseline |
Prospective Evaluation of Bleeding Risk of Anticoagulant and Anti-platelet Therapy

Study Overview
=================
Brief Summary
-----------------
This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy

Detailed Description
-----------------
To evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy. To evaluate differences in outcomes in patients not receiving any anticoagulant or antiplatelet therapy compared to patients receiving various types of drugs with anticoagulant or antiplatelet therapeutic effects. To evaluate and compare the adverse event profiling all patients.

Official Title
-----------------
A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Drug: Antithrombotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing interventional techniques. Subjects who were able to give voluntary, written informed consent. Exclusion Criteria: All those things, patients on heparin, dextran, and low molecular heparin

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 |
| --- | --- |
| no anthithrombotic<br>procedures where there were no antithrombotics | Drug: Antithrombotics<br>* With or without or discontinuted use of Antithrombotics<br>* Other names: anticoagulant or antiplatelet drugs;|
| Antithrombotic - continued<br>patients who are on antithrombotics | Drug: Antithrombotics<br>* With or without or discontinuted use of Antithrombotics<br>* Other names: anticoagulant or antiplatelet drugs;|
| Discontinued Antithrombotic<br>Patients who were on antithrombotics but have been discontinued | Drug: Antithrombotics<br>* With or without or discontinuted use of Antithrombotics<br>* Other names: anticoagulant or antiplatelet drugs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess adverse events in all patients. |  | 24 months |
Systemic Inflammation in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Investigate systemic inflammation in liver cirrhosis patients

Official Title
-----------------
Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices; Adult patients aged 18-75 years; Willing to anticipate and informed consent form obtained Exclusion Criteria: History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy; Non-sinusoidal cirrhosis (e.g. vascular cirrhosis); Coexistence with advanced hepatocellular carcinoma or other malignancies; Coexistence with severe systemic diseases and less than 3 months of expected survival time; Acute infection within 4 weeks before recruitment; Antibiotic use within 4 weeks before recruitment; Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment; Pregnant or lactating women; Patients resistant to long-term follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EGD+NSBB<br>Patients receiving both endoscopic therapy and non-selective beta-blockers for treating high-risk esophagogastric varices | |
| EGD<br>Patients receiving mono endoscopic therapy for treating high-risk esophagogastric varices | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Gastrointestinal Bleeding | Overt upper GI bleeding due to esophagogastric varices, ulcers and other causes; Identified by clinical manifestations, lab tests and endoscopy and measured by number/proportion of patients | One Year | 
| Death | Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New or worsening acute decompensation event other than upper GI bleeding | Ascites, Hepatic encephalopathy, systemic infection, spontaneous bacterial peritonitis, hepatorenal syndrome, etc Identified by clinical manifestations, lab tests and images according to renown practice guidelines and measured by number/proportion of patients | One Year | 
| Liver transplantation/ Transfer to other non-endoscopic therapies | Undergo liver transplantation, or transferred to surgical, radio-interventional, or other non-endoscopic therapies; Measured by number/proportion of patients | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver cirrhosis; Systemic inflammation