linjc16/ctgov huggingface dataset:
Auditory Verbal Hallucinations in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring would cause the verbal thoughts of the patient to be perceived as external voices resulting in AVHs. In order to examine whether AVHs correspond to self-generated inner speech, the present study aims at collecting speech muscle activity during covert AVHs (without articulation), overt speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and control subjects to detect any speech muscle activity during AVH.

Official Title
-----------------
Electromyography Study of Lip Muscles During Auditory Verbal Hallucinations Without Subvocalization in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy controls: must be more than 18 years and less than 60 years old pre-inclusion medical examination must have signed consent form must be able to read stimuli on a screen Schizophrenia patients: must be more than 18 years and less than 60 years old pre-inclusion medical examination must have signed consent form must be able to read stimuli on a screen diagnosed with a schizophrenia disorder according to DSM-IV TR (diagnostic and statistical of mental disorders) (PANSS item P3 greater than 4) prior evaluation of the secondary effects of any medication via Barnes and AIMS scales affiliated with the French social security if under guardianship, must have additional consent form signed by guardian Exclusion Criteria: Healthy controls: if aged less than 18 years or more than 60 years diagnosed with any psychiatric disorder with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.) with auditory impairment pregnant, parturient, breast-feeding Schizophrenia patients: if aged less than 18 years or more than 60 years significant secondary effects of antipsychotic medication, measured with the Barnes and AIMS scales with a neurodegenerative disease with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.) with auditory impairment pregnant, parturient, breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Labial EMG activity during auditory verbal hallucination |  | up to 3 years |
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Study Overview
=================
Brief Summary
-----------------
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Conditions
-----------------
Open Angle or Ocular Hypertension, Glaucoma

Intervention / Treatment
-----------------
* Drug: brinzolamide 1% ophthalmic suspension
* Drug: Azopt 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension. Exclusion Criteria: Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma, ocular hypertension.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azopt 1% ophthalmic suspension<br>Ophthalmic suspension | Drug: Azopt 1%<br>* Azopt 1%, RLD<br>|
| Experimental: Brinzolamide 1% ophthalmic suspension<br>ophthalmic suspension | Drug: brinzolamide 1% ophthalmic suspension<br>* brinzolamide 1% ophthalmic suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at Week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) From Baseline to Week 12 |  | Baseline, Week 12 |
Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

Study Overview
=================
Brief Summary
-----------------
Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is associated with high rates of delirium. The aim of this pilot study is two fold. First, to determine the feasibility and potential challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.

Official Title
-----------------
Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

Conditions
-----------------
Septic Shock, Delirium, Renal Failure

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 Diagnosis of septic shock Require mechanical ventilation and vasopressor therapy Exclusion Criteria: Previous stroke Dementia Recent Craniotomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 Cerebral Desaturation<br>We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not. | Other: Observation<br> <br> |
| Patients without cerebral desaturation<br>We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not. | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Delirium |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 28 Days |
Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.

Detailed Description
-----------------
The purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. In addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. To do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer. Study participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. We would also like to collect optional samples from your follow-up colonoscopy. You may be in the study for up to 5 years.

Official Title
-----------------
Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Conditions
-----------------
Cancer Colon, Gastrointestinal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patients undergoing bowel resection by any standard surgical approach. Exclusion Criteria: Female that are pregnant Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks. Currently receiving or have received chemotherapy in the past 2 weeks.

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 |
| --- | --- |
| Colorectal Cancer Subjects<br>Subjects under going colorectal resection with colorectal cancer will have tissue and stool collected | |
| Benign Colon Resection Subjects<br>Subjects under going colorectal resection without colorectal cancer will have tissue and stool collected | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA/RNA Biomarkers | Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions. | 5 years | 
| Microbial 16S rDNA Biomarkers | The samples will be used to partially (V3-V5 region) amplify the microbial 16S rDNA genes through a polymerase chain reaction (PCR). The PCR product will subsequently be purified and quantified before being sequenced. They will also be used for whole genome sequencing (WGS) and Methylation sequencing (Methyl-Seq). The RNA will be used for RNAseq. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein Measurements | Based on our initial findings protein measurements may also be performed on any extra residual specimens. | 5 years |
SynCardia CardioWest TAH-t Postmarket Surveillance Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.

Official Title
-----------------
The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study

Conditions
-----------------
Biventricular Failure

Intervention / Treatment
-----------------
* Device: CardioWest temporary Total Artificial Heart (TAH-t)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. Exclusion Criteria: Patients who are not cardiac transplant eligible. Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas <1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) < 10 cm. Patients who cannot be adequately anticoagulated on the TAH-t.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CardioWest temporary Total Artificial Heart (TAH-t)|The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject survival at 30-days and one-year post transplant |  | 30-days and one-year post transplant |
Acupuncture - a Treatment for Children With Headache

Study Overview
=================
Brief Summary
-----------------
Acupuncture as a treatment for headache in children

Detailed Description
-----------------
A randomised controlled study in the effect of acupuncture as a treatment for headache in children. The children are randomised for training or for training and acupuncture.

Official Title
-----------------
Acupuncture - a Treatment for Children With Headache

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Other: Acupuncture and training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed by pediatrician- Age-9-17 years Min. headache 8 times within the last month Exclusion Criteria: Mentally illness Fear of needles

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraine_acupuncture and training<br>Migraine acupuncture and training | Other: Acupuncture and training<br>* Acupuncture twice in the week in 3 weeks combined with training in 6 weeks<br>|
| Experimental: Migraine training<br>Migraine training | Other: Acupuncture and training<br>* Acupuncture twice in the week in 3 weeks combined with training in 6 weeks<br>|
| Experimental: Tension_acupuncture and training<br>Tension headache acupuncture and training | Other: Acupuncture and training<br>* Acupuncture twice in the week in 3 weeks combined with training in 6 weeks<br>|
| Experimental: Tension headache training<br>Tension headache training | Other: Acupuncture and training<br>* Acupuncture twice in the week in 3 weeks combined with training in 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with headache | Number of days with headache | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Training, Children, Effect
Retrospective Study in a NSCLC M+ p

Study Overview
=================
Brief Summary
-----------------
This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals. At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Detailed Description
-----------------
Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Official Title
-----------------
Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain

Conditions
-----------------
EGFR Mutated Non-small Cell Lung Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV) Confirmed EGFR mutation by a validated test Availability of medical record Exclusion Criteria: Participating on a blinded randomized clinical trial at any time during the study period Pregnant women (due to they do not reflect daily clinical practice)

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 |
| --- | --- | --- |
| Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain. |  | 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain. |  | 32 months | 
| Evaluation of overall response rate (ORR). |  | 32 months | 
| Evaluation of disease control rate (DCR). |  | 32 months | 
| Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate). |  | 32 months | 
| Evaluation of overall survival (OS: median OS and 1 year OS rate). |  | 32 months | 
| Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics. | TK- Tyrosine Kinase | 32 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR,, lung cancer,, mutated
SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

Study Overview
=================
Brief Summary
-----------------
Primary objective: To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin. Secondary objective: To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).

Official Title
-----------------
Single Centre, Open, Controlled, Randomised (1:1), Parallel Group: Insulin Glargine vs. NPH: FPG (Fasting Plasma Glucose) in Patients With DM Type 1 Who Skip the Morning Meal During Treatment With MDI (Multiple Daily Injection) Basal/Bolus Insulin

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l). Exclusion Criteria: Breast-feeding History of hypersensitivity to the study medication or to drugs with similar chemical structures Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol Treatment with any investigational drug in the last 30 days before study entry Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult History of drug or alcohol abuse No subjects who have previously been treated with Insulin glargine will be enrolled in this study.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of change of blood glucose between patients on Insulin glargine and NPH insulin. |  | between 7:00 am and 11:00 am |