linjc16/ctgov huggingface dataset:
Hemodynamic Changes of Upper and Lower Extremities After Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy.

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

Intervention / Treatment
-----------------
* Procedure: spinal anesthesia for surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 65yr men who undergoes spinal anesthesia for elective TURP normotensive/hypertensive Exclusion Criteria: vascular disease contraindications for spinal anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasonographic exam<br> | Procedure: spinal anesthesia for surgery<br>* spinal anesthesia (T10) for elective TURP surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow |  | during 30 min after spinal anesthesia | 
| Blood volume |  | during 30 min after spinal anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasonographic exam on upper and lower extremities
The Impact of Post Discharge One-Time Home Visit: Bridging the Gap Between Hospital and Home.

Study Overview
=================
Brief Summary
-----------------
A single post-hospital discharge home visit by a geriatric nurse practitioner or geriatric fellow can bridge the gap and ease the transition for elderly frail patients returning home after hospital admission. We believe this intervention will reduce medication errors, ensure follow-up discharge plans, decrease re-hospitalization rates, and decrease morbidity and mortality.

Conditions
-----------------
COPD, Coronary Artery Disease, Diabetes Mellitus, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the ACE unit during the study time frame, age 65 and over, and residing in the community before and after discharge from the hospital. Selected patients will have complex discharge plans including referrals to home care agencies, poly-pharmacy, multiple co-morbidities, history of repeated hospitalizations, and poor social support systems in the community. In addition, eligible patients will have at least one of eight admitting diagnoses, chosen for their high likelihood of requiring post-discharge home care needs. These diagnosis include: CHF, COPD, coronary artery disease, diabetes mellitus, stroke, hip fracture, peripheral vascular disease or cardiac arrhythmia. The GNP or fellow will then request permission from the patient's primary physician to do a one-time post-discharge home visit. Exclusion Criteria: Patients discharged to settings other than their homes (i.e. nursing home, sub-acute rehabilitation, etc.)Patients discharged to settings other than their homes (i.e. nursing home, sub-acute rehabilitation, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.

Official Title
-----------------
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Ischemia-reperfusion Injury.

Intervention / Treatment
-----------------
* Drug: Vardenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing cardiac surgery Exclusion Criteria: emergent surgery recent MI in past 7 days prior to surgery ejection fraction < 35% creatinine > 2.0 prior CVA severe COPD recent use of nitrates (within past 48 hours prior to surgery) prior CABG pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vardenafil<br> | Drug: Vardenafil<br>* 10 mg PO once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension |  | approximately 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection Fraction |  | approximately 5-7 days postop |
Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.

Official Title
-----------------
Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

Conditions
-----------------
Acquired Bleeding Disorder, Acquired Haemophilia

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with acquired haemophilia Treated with activated recombinant human factor VII as first line treatment Treated with activated recombinant human factor VII after January 2011 Exclusion Criteria: Patients with first diagnosis before january 2010 and having a relapse after january 2011 Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: activated recombinant human factor VII<br>* Data collection of the use of activated recombinant human factor VII observed through real-world treatment practices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of decision criteria to treat patient with activated recombinant human factor VII |  | Year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a control of bleeding |  | Year 3 |
Satisfaction With Placement of Implantable Venous Access Devices in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about patients with solid tumors who have implantable venous access devices may help doctors learn more about patient satisfaction. PURPOSE: This phase I trial is studying satisfaction with placement of implantable venous access devices in patients with solid tumors.

Detailed Description
-----------------
OBJECTIVES: To determine patient satisfaction with subcutaneous venous-access device placement in oncology patients. OUTLINE: Patients complete a computer-based survey while in the treatment area of the Vanderbilt Oncology Clinic. Basic demographic information and basic information regarding the placement of the device and complications are collected from the patient's medical record.

Official Title
-----------------
Patient Satisfaction With Placement of Implantable Venous Access Devices

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Other: computer-assisted intervention
* Other: medical chart review
* Other: questionnaire administration
* Other: survey administration


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of a solid tumor malignancy No hematological malignancy Patient at the Vanderbilt Oncology Clinic Has undergone placement of a subcutaneous, single-lumen venous-access device within the past 6 months No patients who have had ≥ 2 venous-access devices placed by ≥ 1 department PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics Not currently undergoing preparation for or process of stem cell transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: computer-assisted intervention|nan|
|Other: medical chart review|nan|
|Other: questionnaire administration|nan|
|Other: survey administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with port placement |  | n/a - study closed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of complications |  |  | 
| Frequency of port failure |  |  | 
| Need for removal of device |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific
Comparison on the Efficacy of a Monophasic

Study Overview
=================
Brief Summary
-----------------
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.

Detailed Description
-----------------
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001. This study will retrospectively collect and analyze clinical data related to the Atlanta VA Medical Center, a member of the National Registry of Cardiopulmonary Resuscitation, to assess clinical parameters in cardiac arrest survivors. This study focuses on collecting data retrospectively in regard to cardiac arrest patients to discern what factors are playing a role in patient survival after cardiac arrest. Such data will help hospitals and physicians to improve quality of care in patients at risk for cardiac arrest as well as to implement strategies to reduce such events or improve management of these high-risk patients in order to save lives.

Official Title
-----------------
Comparison on the Efficacy of a Monophasic, Manually Operated Defibrillator to That of a Biphasic Automatic External Defibrillator in the Hospital Setting.

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical outcomes of patients who suffered a cardiac arrest while hospitalized and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001. Exclusion Criteria: Biphasic defibrillators were implemented Cardiac arrest before 2001

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| 1<br>Case: Patients resuscitated after 2001 | |
| 2<br>Control: Patients who suffer cardiac arrests after 2001. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| s who suffered a cardiac arrest while hospitalized at the VA and were resuscitated |  | Information on patients who suffered cardiac arrest before 2001 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study is observational. |  | Comparison before and after 2001 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest, Biphasic Defibrillator
Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies

Study Overview
=================
Brief Summary
-----------------
Based on a clinical multi-center study of the natural course of inherited retinal dystrophies in Chinese population, screening fundus imaging indicators for patients with Chinese inherited retinal dystrophies, describing the clinical features of Chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - Follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in China. The research will further improve and enrich the genotype, phenotypic characteristics and natural course of Chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. It is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment.

Official Title
-----------------
Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies

Conditions
-----------------
Inherited Retinal Dystrophies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with IRDs whose mutations have been identified 4 70 years old Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG Exclusion Criteria: Has participated in other interventional treatment studies; Patients with severe systemic diseases, mental dysplasia, mental illness; Unable to accept eye examination patients; Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis At the initial visit, the patient's binocular vision is displayed as no light. Both eyes have a history of internal eye surgery

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Visual acuity | A typical Snellen chart that if frequently used for visual acuity testing | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inherited retinal dystrophies, Gene screen
Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.

Official Title
-----------------
A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Ropinirole Immediate Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS). Exclusion Criteria: Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropinirole<br>single dose .25mg of IR formulation, .05mg of RLS controlled release | Drug: Ropinirole Immediate Release<br>* Ropinirole Immediate Release<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy). |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy. |  | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLS, PLMS, Adolescent, Periodic Limb Movements of Sleep, Ropinirole
Prevalence of NNSH in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.

Study Overview
=================
Brief Summary
-----------------
Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged 3-8 years old in Giza Governorate. Assessment of factors associated with NNSH.

Detailed Description
-----------------
Several studies have reported on the prevalence of non-nutritive sucking behaviors among infants and young children in different populations. Non-nutritive sucking is regarded as a normal part of development, and early studies of its prevalence generally found that 70-90% of children had some history of a non-nutritive sucking habit. Like these early studies, most recent studies have used retrospective methods to assess the prevalence of non-nutritive sucking habits. Prolonged duration of non-nutritive sucking behaviors may have consequences in regard to the developing orofacial structures and occlusion. Little is known as to why some children have sucking habits beyond the first 2 to 3 years of life. Prevalence of NNSH and associated factors in Egyptian children might be different.

Official Title
-----------------
Prevalence of Non-Nutritive Sucking Habits in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.

Conditions
-----------------
Child Behavior

Intervention / Treatment
-----------------
* Behavioral: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3-8 years old children. Children free of systemic diseases. Positive patient/parents acceptance for participation in the study. Both sexes will be included. Exclusion Criteria: Disabled children. Children with cleft lip & palate. TMJ disorders. Children undergoing orthodontic/orthopedic treatment. Participants who were exposed to thumb sucking prevention programs.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-nutritive sucking habits | child sucking one or more of his/her digits and/or object beyond 36 months old. | 20 mins |
Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

Study Overview
=================
Brief Summary
-----------------
Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

Detailed Description
-----------------
Biliary atresia patients with cholestatic jaundice were noted to have increased incidence of infectious complications. Previous animal models of bile duct ligation with acute jaundice ever demonstrated impairment of both humoral and cellular immune function. We performed the immunity study in biliary atresia patients due to the lack of comprehensive systemic immunity study in pediatric cholestatic model. Systemic humoral immunity (total serum IgG, IgA, IgM, C3 and C4), specific cellular immunity (lymphocyte classification, mitogen response, cytokines level after PHA stimulation test), and non-specific cellular immunity (absolute neutrophil count, PMN CD11b/CD18 expression level, PMN superoxide release function, and PMN phagocytosis function) were tested. Association with serum bilirubin level, nutritional status and blood biochemical values were tested to see the relation between systemic immune function and cholestatic jaundice.

Official Title
-----------------
Impaired T-Lymphocyte Proliferative Function in Biliary Atresia Children With Prolonged Jaundice

Conditions
-----------------
Biliary Atresia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biliary patients older than 1-year-old status post Kasai operation. Exclusion Criteria: Received liver transplantation, immunosuppresant, systemic immunoglobulin (within 6 months) and obvious infectious episode (within 2 weeks).

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |