linjc16/ctgov huggingface dataset:
Variation in Fluids Administered in Shock

Study Overview
=================
Brief Summary
-----------------
To conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas.

Official Title
-----------------
Observation of Variation in Fluids Administered and Characterization of Vasopressor Requirements in Shock

Conditions
-----------------
Shock

Intervention / Treatment
-----------------
* Other: Fluids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years admitted to the participating hospital. Patients in the emergency department, intensive care unit, PACU, or any hospital floor. For patients not in the ICU, there must be plans to transfer to an intensive care unit when an ICU bed is available for patient. Patients with shock as defined by: Need for vasopressor (dopamine, norepinephrine, or epinephrine at any dose) to keep MAP > 65 mmHg Or Systolic BP < 90 mmHg Exclusion Criteria: Patients previously enrolled into this study. Patients who were in the operating room at time of shock and fluid bolus. Patients admitted to an ICU after cardiac surgery Patients with primarily cardiogenic shock as etiology for their shock Patients transferred from another hospital or emergency room to the study hospital.

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 |
| --- | --- |
| Shock<br> | Other: Fluids<br>* Fluids Administered in Shock<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method used to guide volume resuscitation | Characterize the method used to guide volume resuscitation and vasopressor use in patients with shock | 7 days |
Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy

Study Overview
=================
Brief Summary
-----------------
This single arm pilot study will evaluate the feasibility and acceptability for perioperative Comprehensive Geriatric Assessment (CGA) and CGA-directed supportive and restorative care for patients with muscle-invasive bladder cancer who are planned to undergo preoperative chemotherapy.

Official Title
-----------------
Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy: A Pilot Trial

Conditions
-----------------
Urinary Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent Males and females age ≥ 65 years Diagnosis/disease status Histologically proven muscle-invasive bladder cancer (MIBC) without metastatic disease. Patients planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC. Treatment with investigational systemic therapy is permitted if participants will be receiving chemotherapy as part of their treatment plan Exclusion Criteria: Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements Any other known invasive malignancy within previous 2 years with the following EXCEPT: low grade prostate cancer on active surveillance, chronic lymphocytic leukemia CLL on surveillance / observation, non-melanoma skin cancers

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Develop a geriatric oncology assessment clinic and workflows | Develop a geriatric oncology assessment clinic and workflows for the University of Kansas Health System, including University of Kansas Cancer Center St. Francis and Great Bend practices. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test feasibility, acceptability, and preliminary impact | Test feasibility, acceptability, and preliminary impact of the Comprehensive Geriatric Assessment (CGA) and CGA-directed care. Note: The results of the CGA will be used by clinicians to guide patients' medical care. | 12 months |
Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

Study Overview
=================
Brief Summary
-----------------
This observational study is conducted in Europe. The objective of this retrospective observational cohort analysis is to assess the changes of glycaemic control and quality of care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.

Official Title
-----------------
Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with type 2 diabetes previously treated with BHI for at least 12 months Analogue premix administration for the last 6 months Exclusion Criteria: Known or suspected allergy to insulin aspart Newly diagnosed diabetes

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 |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features. Physicians are allowed to decide the treatment regimen according to the medical standards.<br>* Other names: NovoMix® 30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General conditions (reason of switch, BMI, selected laboratory parameters, quality of care) |  | 6 months |
Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study has been designed to conduct as Randomized comparative clinical study.

Detailed Description
-----------------
Two groups, group B received Qurse Mafasil tablet orally two tablets two times daily for 8 weeks while group A received Leech therapy once weekly for 8 weeks along with Qurse mafasil.

Official Title
-----------------
Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Biological: Hirudinaria granulosa, qurse mafasil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee osteoarthritis Exclusion Criteria: pregnancy, lactation, anaemia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Hirudinaria granulosa and Qurse mafasil are given | Biological: Hirudinaria granulosa, qurse mafasil<br>* compare the efficacy of both groups<br>* Other names: leech and drug;|
| Active Comparator: Group B<br>Qurse mafasil only given | Biological: Hirudinaria granulosa, qurse mafasil<br>* compare the efficacy of both groups<br>* Other names: leech and drug;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Score |  | end of 6 weeks | 
| VAS |  | end of 6 weeks | 
| Active Range of Motion |  | end of 6 weeks | 
| Knee circumference |  | end of 6 weeks | 
| 15 m walking time test |  | end of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS subscores |  | end of 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Qurse mafasil, leech therapy, Hirudinaria granulosa
Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma

Study Overview
=================
Brief Summary
-----------------
Correct measurement of the intraocular pressure of children with glaucoma or suspected glaucoma is essential for diagnosis and therapy. Despite new non-invasive measurement methods most of the children are uncooperative during the ophthalmological examination. Therefore examination under anaesthesia is needed. A lot of perioperative factors influence the measurement of intraocular pressure. Established and safe anaesthetic regimes have been modified regarding these factors. Aim of the study is to evaluate, if a standardized anaesthetic protocol generates reliable and reproducible measured values.

Official Title
-----------------
Establishment of an Anaesthetic Protocol for Examinations Under Anaesthesia for Children With Glaucoma or Suspected Glaucoma - Correlation of Bispectral Index (BIS) and Intraocular Pressure (IOP)

Conditions
-----------------
Anesthesia, Intraocular Pressure, Glaucoma, Suspect, Pediatric Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for a general anesthesia (laryngeal mask) and ophthalmological examination and probably surgery Children with glaucoma or suspected glaucoma ASA classification I-III written informed consent of the legal representatives Exclusion Criteria: Contraindication for a laryngeal mask airway Known allergy to propofol or remifentanil

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 10 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 |
| --- | --- | --- |
| Correlation of depth of anesthesia an intraocular pressure | The primary outcome measure is the association between intraocular pressure and bispectral index. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bland Altmann Correlation of Applanation tonometry and rebound tonometry | Comparison of two different examination tools | 1 day | 
| Normal range of pediatric intraocular pressure | Defining the normal range of pediatric intraocular pressure | 1 day | 
| Correlation of the corneal thickness and the intraocular pressure | Regression | 1 day |
Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital

Study Overview
=================
Brief Summary
-----------------
In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs. The primary objective of this study was to demonstrate the incidence of packed red blood cell (PRBC) transfusion in elective CABGs.

Detailed Description
-----------------
Three hundred patients undergoing isolated, first time CABGs during November 2011-September 2013 were prospective enrolled in this observational study. Patients' preoperative variables and postoperative outcomes, as well as perioperative transfusion characteristics were recorded.

Official Title
-----------------
Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital

Conditions
-----------------
PRBC Transfusion, CABGs

Intervention / Treatment
-----------------
* Other: Packed red blood cell transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing first-time isolated elective coronary artery bypass graft surgery Exclusion Criteria: None

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

| Intervention/Treatment |
| --- |
|Other: Packed red blood cell transfusion|Record number of PRBC transfusion during perioperative period.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of PRBC transfusion in elective CABG surgery |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors of PRBC transfusion in elective CABG surgery |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRBC transfusion, CABGs
Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation.

Study Overview
=================
Brief Summary
-----------------
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea. This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.

Detailed Description
-----------------
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea. This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult mask ventilation of tracheal intubation.

Official Title
-----------------
Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation Among Patients Scheduled for Bariatric Surgery.

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Other: Mass Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 kg m-2 Preoperative Polysomnography Exclusion Criteria: Pregnant women ENT Cancer

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 |
| --- | --- |
| Study Group<br>Mass Screening | Other: Mass Screening<br>* Preoperative screening with STOP-BANG and DES-OSA scores and postoperative comparison with difficult intubation / ventilation scores.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perioperative Period, Sleep Apnea Syndromes, Mass Screening
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bonviva/Boniva]
* Drug: ibandronate [Bonviva/Boniva]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory post-menopausal women with osteoporosis; 55-85 years of age; eligible for bisphosphonate treatment; naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago). Exclusion Criteria: inability to stand or sit in an upright position for at least 60 minutes; inability to swallow a tablet whole; hypersensitivity to bisphosphonates; administration of any drug, or presence of active disease, known to influence bone metabolism; uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism; history of major upper gastrointestinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 150mg po monthly for 6 months (+ feedback)<br>|
| Active Comparator: 2<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 150mg po monthly for 6 months (- feedback)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction by OPSAT-Q and OPPS. |  | 6 months | 
| Tolerability; SAEs. |  | Throughout study |
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease.

Detailed Description
-----------------
Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing, and immunohistochemistry techniques. Differences between patient groups are statistically evaluated.

Official Title
-----------------
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

Conditions
-----------------
Bladder Pain Syndrome, Interstitial Cystitis, Overactive Bladder

Intervention / Treatment
-----------------
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with diagnosed BPS/IC, OAB or healthy controls included healthy controls must have another pelvic surgery planned (e.g. hysterectomy) being able to act and judge Exclusion Criteria: unstable endocrinological situation severe illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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: all study patients<br>Same intervention for all subjects: anamnesis, questionnaires and biological samples (bladder biopsy, bladder washing, blood and urine) are collected at one single visit. | Procedure: biopsy<br>* cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of new diagnostic markers for BPS/IC |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of molecular details that lead to BPS/IC (pathogenesis). |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPS/IC, OAB