linjc16/ctgov huggingface dataset:
Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The study is aimed at comparing peripherial venous pressure as an indicator of central venous pressure in post operative surgical patients.

Official Title
-----------------
Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial

Conditions
-----------------
Peripherial Venous Pressure, Central Venous Pressure, Fluid/Volume Status Monitoring of Patient

Intervention / Treatment
-----------------
* Procedure: Peripherial and central venous access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I/II/III surgical patients who require central venous access as part of their surgical treatment plan with no organ support in post operative period. Age between 18 and 75 years Who have atleast 1 x 18 gauge peripherial venous cannula in the upper limb from elbow below to the hand Who have given consent Exclusion Criteria: Not meeting the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Pressures measured<br>Venous pressure measured through a peripherial and a central venous catheter/cannula | Procedure: Peripherial and central venous access<br>* Passing a peripherial and a central venous catheter/cannula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripherial venous pressure as an indicator of central venous pressure |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripherial venous pressure, Central venous pressure
The Effects of Miminal Stimulation Protocol on Preimplantation Genetic Screening

Study Overview
=================
Brief Summary
-----------------
PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) for controlled ovarian hyperstimulation is defined for poor ovarian response women. The aim of this study is to show minimal stimulation protocol affect euploidy and pregnancy rates in preimplatation genetic screening (PGS) cycles with single embryo transfer.

Official Title
-----------------
The Effects of Miminal Stimulation Protocol on Clinical Outcomes of Advanced Maternal Aged Women With Preimplantation Genetic Screening

Conditions
-----------------
Preimplantation Genetic Screening

Intervention / Treatment
-----------------
* Genetic: protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced maternal aged - Exclusion Criteria: Severe male factor, endometriosis, and absolute tubal factor were excluded in this study. -

Ages Eligible for Study
-----------------
Minimum Age: 38 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 |
| --- | --- |
| 100 patients with minimal<br>In advancing maternal age (AMA) women, minimal stimulation protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women. | Genetic: protocol<br>* ovarian stimulation protocols on euploid rates were compared.<br>|
| 100 patients with recombinant FSH antagonist protocol<br>In advancing maternal age (AMA) women, flexible antagonist protocol with recombinant FSH were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women. | Genetic: protocol<br>* ovarian stimulation protocols on euploid rates were compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| euploid rates | the effects of different stimulation protocols on euploid rates | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rates | the effects of different stimulation protocols on pregnancy rates | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preimplantation genetic screening, gonadotropin dosage, euploidy rates
Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Study Overview
=================
Brief Summary
-----------------
Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).

Official Title
-----------------
Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Binocular CP1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spherical equivalent -0.50 to -5.50 diopters visual acuity of at least 20/25 in each eye Exclusion Criteria: history of ocular trauma or major eye surgery active ocular infection any prior history or participation in myopia control treatments within the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 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 |
| --- | --- |
| Active Comparator: CP1 device<br> | Device: Binocular CP1<br>* Binocular active projection of defocused image in the peripheral visual field<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central axial length |  | 12 months | 
| Cycloplegic refraction |  | 12 months |
Prognostic Value Cardiac Dysfunction Assessed by Bedside Echocardiography in Critically Ill COPD Patients Requiring Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is a major reason for ICU admission. Cardiac function is often impaired in this disease but its association with clinical outcome has not been fully established. The study aims to investigate the association between cardiac dysfunction and clinclial outcomes.

Detailed Description
-----------------
This is a prospective observational study conducted in a 47-bed mixed ICU of tertiary academic teaching hospital. The study will be performed between January 2014 to December 2015. All patients meeting the diagnostic criteria of AECOPD and admitted to ICU are potentially eligible for the present study. Relevant demographics and laboratory measurements are obtained. Transthoracic echocardiography (TTE) is performed immediately after ICU admission by experienced intensivists. Cox proportional hazard regression model is fitted by using stepwise forward selection and backward elimination technique. If linear assumption is not satisfied, the linear spline function will be used.

Conditions
-----------------
COPD Patients, Mechanical Ventilation

Intervention / Treatment
-----------------
* Device: echocardiography examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients experiencing episode of exacerbation and require mechanical ventilation were admitted to ICU Exclusion Criteria: COPD patients admitted to ICU due to other reasons (major surgery, ischemic heart disease, and renal failure) moribund and expected to die within 48 hours with Do-Not-Resuscitation order

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 |
| --- | --- |
| echocardiography examination<br> | Device: echocardiography examination<br>* patients underwent echocardiography examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | 28 days after ICU admission; if a patient leave ICU before 28-days, it is considered as censored. | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation |  | from ICU admission to extubation, an expected average of 8 days |
Glucose Control In Hematopoetic Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)

Detailed Description
-----------------
TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.

Official Title
-----------------
Glucose Control In Hematopoetic Stem Cell Transplant

Conditions
-----------------
Hyperglycemia, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Regular Insulin
* Device: Deployment of the MiniMed Paradigm monitoring device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 Must meet standard criteria for HSCT If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm Exclusion Criteria: If on intensive arm patient must stop all oral hyperglycemic meds

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Regular Sliding Scale Insulin administration for hyperglycemia | Drug: Regular Insulin<br>* Use of sliding scale insulin as per Appendix 1<br>|
| Experimental: Arm 2<br>MiniMed Paradigm monitoring device for hyperglycemia | Device: Deployment of the MiniMed Paradigm monitoring device<br>* Automated insulin delivery system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) |  | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Infection |  | About 100 days | 
| Reduced Length of In-hospital Stay |  | About 100 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperglycemia, Hematopoietic stem cell transplantation, Bone marrow transplant, High blood sugar
The Suicide Guard Rail: A Structural Intervention for Hospitals Avoid Suicides by Jumping From Heights Buildings

Study Overview
=================
Brief Summary
-----------------
Background: Suicides by jumping from the high buildings of acute hospitals are dramatic events which are highly traumatizing to families, staff and fellow pts. In the 10 years from1995 to 2010 the investigators have counted 10 suicide cases despite extensive measures taken to predict and avoid them. The investigators hypothesized that constructive measures at the windows that would render access more difficult could discourage spontaneous suicidal behaviour and would reduce the suicide rates. Intervention: Starting in 6/2004, a 20 mm diameter metal guard-rail (which resists 250kg) was installed at each window of a 360 bed acute hospital at a height of 113cm, 18cm above the window parapet with the aim to visually, psychologically and physically discourage potential suicidal impulses.

Conditions
-----------------
Suicide Jumps, Psychiatry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person at risk for suicide Exclusion Criteria: no
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 |
| --- | --- | --- |
| Number of Suicide Jumps over ten years | Suicide jumps from the heights of acute hospitals are dramatic events which are highly traumatizing to families, staff, and fellow patients. From 1995 to 2004, 10 suicide jumps occurred at the investigators institution despite extensive measures taken to predict and avoid them. The investigators hypothesized that specific barriers rendering access to windows more difficult could discourage spontaneous suicidal behaviour and reduce the suicide rates. Starting in 6/2004, a 20 mm diameter metal guard-rail with a tension strength of 250kg/in2 was installed at each window of the investigators 360 bed acute hospital at a height of 113cm, 18cm above the window sill with the aim to psychologically and physically deter potential suicidal impulses. | Between 1995 and 2010, measurement 180 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicide, Heights, Suicide hot spots, Bridges
Preoperative Massage in Breast Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.

Official Title
-----------------
Utility of Preoperative Massage in Breast Surgery Patients

Conditions
-----------------
Anxiety, Presurgical Anxiety, Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Massage therapy
* Procedure: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Must speak English Able to give consent 18 years of age or older Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers Medical Center Exclusion Criteria: Anxiolytics or antidepressants medications during the previous 24 hours Any condition that would prohibit receiving a massage IV medications prior to presurgical holding VAS assessment

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage therapy<br>This group will received presurgical massage | Procedure: Massage therapy<br>* Presurgical 15 minute massage performed by a licensed massage therapist<br>|
| Placebo Comparator: Control<br>Standard of care with no massage | Procedure: Standard of care<br>* Control group will receive standard of care with no massage therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Assessments will be done immediately post registration and immediately prior to surgery | Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Presurgical anxiety, Breast Cancer
Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

Official Title
-----------------
Observational Program for Evaluation of Ribomustin and Rituximab Combined Therapy With Following Rituximab Maintenance of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Other: Ribomustin
* Other: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL) Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee Eastern Cooperative Oncology Group (ECOG) status < 2. Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy Exclusion Criteria: Indolent Non-Hodgkin's Lymphoma transformation Lymphoma with central nervous system (CNS) involvement Presence of second malignant tumor. Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment. Contraindications for Ribomustin usage in accordance with product label Contradictions for rituximab usage in accordance with product label

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 |
| --- | --- |
| Ribomustin and rituximab<br> | Other: Ribomustin<br>* Routine practice<br>* Other names: bendamustine;Other: rituximab<br>* Routine practice<br>* Other names: Mabthera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed, Refractory, Non-Hodgkin Lymphoma, Bendamustine
Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
A retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment

Official Title
-----------------
A Retrospective Observational Study of the Effectiveness of Gemcitabine -Docetaxel in Patients With Relapsed Osteosarcoma Who Have Been Treated With HD-IFO in First Line Treatment

Conditions
-----------------
Osteosarcoma Recurrent, Osteosarcoma Metastatic

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at diagnosis of high grade osteosarcoma >= 4 Received first line treatment with HD IFO Following HD IFO treatment, they have been diagnosed refractory disease and they satisfy at least one of the following criteria : Relapsed in the first 24 month following the initial diagnosis, regardless of location and resectability Lung relapsed disease with more than 2 nodules diagnosed over 24 months from the initial diagnosis Non resectable relapsed disease diagnosed over 24 months from the initial diagnosis Before or during GEMDOX treatment, eligible patients may have been subject to metastasectomy Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observation|not applicable, observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Gemcitabina - Docetaxel Treatment | assessed as overall survival (12 months) | 12 months |