linjc16/ctgov huggingface dataset:
Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.

Official Title
-----------------
Accuracy of Pulse Pressure Variation (Nexfin) and of Pleth Variability Index (Radical 7) to Predict the Response to a Fluid Challenge: Comparison With the Reference Method (Measurement of Stroke Volume by Esophageal Doppler)

Conditions
-----------------
Fluid Responsiveness

Intervention / Treatment
-----------------
* Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing major abdominal surgical procedures performed by laparotomy patients undergoing major urological surgical procedures performed by laparotomy patients undergoing major gynecological surgical procedures performed by laparotomy age ≥ 18 years signed informed consent Exclusion Criteria: pregnant women esophageal disease aortic valve disease allergy to gelatin BMI > 35 beta blocker treatment, antiarrhythmic treatment, arrhythmia, pace-maker, presence of an arterio-venous shunt or of any other vascular disease on upper limb

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical patients<br>Nexfin (Pulse Pressure Variation) Radical 7 (Pleth Variability Index) CardioQ (stroke volume) | Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge | Three fluid challenges, 250 mL of a gelatine solution, are planned. Pleth Variability Index and Pulse Pressure Variation are compared to the measurement of stroke volume by Esophageal Doppler (the reference method) | during the intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices |  | during the intraoperative period |
Outpatient Care for Multiparas After Elective Cesarean Section: an Observational Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate whether outpatient cesarean section can be performed in multiparous women without significant decrease in the parents' sense of security .

Conditions
-----------------
Outpatient Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned elective cesarean section of multiparous women Singleton pregnancy Age of at least 18 Gestational age between 37 and 42 weeks Internet access at home Exclusion Criteria: Lack of consent Women with no or little understanding of Danish and ability to speak Danish. Allergies to medicine included in the pain management regimes Expected maternal or neonatal complications after delivery Birth weight of less than 2500 grams

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| multiparas having a planned cesarean section<br>elective cesarean section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the parents' postnatal sense of security (PPSS) | measured by a questionnaire sent to the parents' in the second week after delivery. | the PPSS is measured the second week after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambulation time | ambulation time measured during the first three days after delivery by an accelerometer | three days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outpatient care, videoconferencing, elective cesarean section
Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI.

Official Title
-----------------
Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Other: None, just observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with SCI Exclusion Criteria: had neurologic impairments unrelated to SCI, such as peripheral nerve injury, brain injury and cognitive deficits, or if they were unable to complete the questionnaire.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None, just observation|None ,just observation test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sacral sparing self-report questionnaire | sacral sparing self-report questionnaire | 12months |
SCOOT: Sample Collection for DART

Study Overview
=================
Brief Summary
-----------------
The study will use a blood sample collected from participants to: Develop new ways of finding and diagnosing lung health problems, such as lung cancer. Develop tools which make it easier to screen people with possible lung health problems, diagnose problems earlier and with fewer tests, and start the best treatment faster. Help improve the early diagnosis of lung cancer, as finding lung cancer early means that it can be treated more easily and successfully.

Detailed Description
-----------------
The results from this study will be linked with the data from the DART study (also collecting data through the Lung Health Check programme) to develop new ways of using computer technology (artificial intelligence) to improve lung health care. The studies use computer programs (called 'algorithms') which can be trained to analyse medical samples. Once developed, these algorithms can be used to support doctors by increasing their speed and accuracy of diagnosing issues.

Official Title
-----------------
Sample Collection for The Integration and Analysis of Data Using Artificial Intelligence to Improve Patient Outcomes With Thoracic Diseases

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Patient suitability will be assessed against the below criteria by the clinical teams managing the patients. Inclusion Criteria: Patients with a pulmonary nodule or nodule(s) detected on a CT scan performed as part of Lung Cancer Screening from the Lung Health Check centres, that require further investigation with a PET-CT scan, and / or biopsy, and / or resection Willing and able to give informed consent Exclusion Criteria: None -

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop an algorithm that gives a greater than chance improved ability to diagnose lung cancer using the blood biomarkers with or without the AI CT algorithm compared to not using them |  | by July 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop an algorithm that gives a greater than chance improved ability to diagnose lung cancer using the blood biomarkers with or without the AI CT and blood markers algorithm compared to not using them |  | by July 2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, lung health check, artificial intelligence, algorithm, diagnosis, detection
Recovery Therapy Trial

Study Overview
=================
Brief Summary
-----------------
This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.

Official Title
-----------------
Applicability of CBT to Unselected Mental Health Service Clients With Psychotic Disorders

Conditions
-----------------
Schizophrenia, Psychotic Disorders, Mood Disorders

Intervention / Treatment
-----------------
* Behavioral: Recovery Therapy (Cognitive Behaviour Therapy for psychosis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acceptance by the participating Community Mental Health Services for case management a preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder a recovery need in one of the areas addressed by the therapy Exclusion Criteria: a preliminary DSM-IV diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder, PTSD) even where psychotic features are/have been present non-English speaking comorbid intellectual disability

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Recovery Therapy (Cognitive Behaviour Therapy for psychosis)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the applicability of cognitive behaviour therapy for psychosis in the real world setting of ordinary mental health services |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish rates of uptake of Recovery Therapy amongst clients at a community mental health service |  |  | 
| To establish effectiveness of therapy in clients who received a defined length of therapeutic contact (12-24 sessions) |  |  | 
| To identify factors predicting uptake and effectiveness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Therapy, Psychotic Disorders, Treatment Outcome
A Validation Study of The Relationship Between ALDH2 and Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.

Official Title
-----------------
A Validation Study of The Relationship Between ALDH2 and Aortic Dissection

Conditions
-----------------
Aortic Dissection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital Exclusion Criteria: Aortic dissection based on trauma, connective tissue diseases and pregnancy Patients with tumor Patients with no written consensus
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Chinese Han people to do physical examination in physical examination center of Guangdong Provincial People's Hospital | |
| Aortic dissection<br>Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with different ALDH2 genotype | DNA was extracted from venous blood;genomic DNA underwent PCR amplification; finally, PCR products were purified and directly sequenced by Invitrogen Corp or Biosune Corp.Then ALDH2 genotype was distinguished depend on a G-to-A missense mutation on exon 12 of ALDH2 gene. | 1-30 days after samples collected | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic dissection, Aldehyde dehydrogenase 2 polymorphism
Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Study Overview
=================
Brief Summary
-----------------
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.03% eye drops
* Drug: travoprost 0.004% eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma or ocular hypertension in both eyes Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering Best-corrected visual acuity of 20/100 or better in each eye Visual field within 6 months of study entry Exclusion Criteria: Secondary glaucoma Active intraocular inflammation or macular edema Intraocular surgery or laser surgery within the past 3 months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bimatoprost 0.03% eye drops<br>* bimatoprost 0.03% 1 drop nightly for 3 months<br>* Other names: Lumigan®;|
| Active Comparator: 2<br> | Drug: travoprost 0.004% eye drops<br>* travoprost 0.004% 1 drop nightly for 3 months<br>* Other names: Travatan®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Intraocular Pressure | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability - Conjunctival Hyperemia | Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe) | Month 3 |
Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients

Official Title
-----------------
An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.

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

Intervention / Treatment
-----------------
* Drug: Letrozole
* Drug: Trastuzumab plus Letrozole
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Her-2 overexpression and ER and/or PgR positive Metastatic Breast Cancer Exclusion Criteria: Previous treatment with trastuzumab Significant Liver or renal impairment Erbb2 negative and/or ER and PgR negative Other protocol-defined inclusion / exclusion criteria may apply.

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

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

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 |
| --- | --- |
| Experimental: A - HER-2 +ve patients with Femara alone<br> | Drug: Letrozole<br> <br> |
| Experimental: B - HER-2 +ve patients with Femara + Herceptin<br> | Drug: Trastuzumab plus Letrozole<br> <br> |
| Experimental: C - HER-2 -ve patients with Femara alone<br> | Drug: Letrozole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression as assessed by clinical palpation and radiologic imaging every 3 months |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate/Clinical Benefit rate |  | 3 months | 
| Time to treatment failure |  | 3 months | 
| Duration of response/clinical benefit during treatment |  | 3 months | 
| Overall survival |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Metastatic, Trastuzumab, Letrozole
Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.

Detailed Description
-----------------
The investigators will enroll 60 patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping from January 2006 to June 2011. All the patients (40 men, 20 women) were immunocompetent and diagnosed as symptomatic CMV infection. Their medical records will be reviewed, including demographic data as well as their ophthalmic and medical histories. The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in CMV anterior uveitis.

Official Title
-----------------
Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

Conditions
-----------------
Anterior Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping. All the patients were immunocompetent and diagnosed as symptomatic CMV infection. Exclusion Criteria: Patients without positive results of the CMV PCR Immunocompromised patients with positive results of the CMV PCR

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Anterior chamber inflammation | anterior chamber cell grading based on slit lamp microscopy | 4 weeks after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probability of relapse-free | Kaplan-Meier curve of relapse-free probability | 2 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytomegalovirus, uveitis
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).

Official Title
-----------------
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety of GABITRIL at Dosages up to 16mg/Day in Adults With Generalized Anxiety Disorder

Conditions
-----------------
General Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: GABITRIL (tiagabine hydrochloride; CEP-6671)


Participation Criteria
=================
Eligibility Criteria
-----------------
Not available at time of registration

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GABITRIL (tiagabine hydrochloride; CEP-6671)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |