linjc16/ctgov huggingface dataset:
Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

Study Overview
=================
Brief Summary
-----------------
This protocol is a request from Masimo to assist in the collection of data to be used to further refine the accuracy of the monitor's algorithm.

Detailed Description
-----------------
The specific aim of this study is to collect data to characterize Masimo's noninvasive Rainbow SpHb technology during surgeries. The purpose is to compare Masimo Rainbow technology to arterial blood samples taken during surgery. Hemoglobin concentrations in the arterial blood samples will be measured using standard blood analyzers on site and/or the sponsor's laboratory.

Official Title
-----------------
Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases

Conditions
-----------------
Surgery, Hemoglobin

Intervention / Treatment
-----------------
* Device: Pulse CO-Oximetry Technology
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective surgery requiring intra-arterial pressure monitoring Exclusion Criteria: Age less than 18 years Pregnancy Prisoners

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 |
| --- |
|Device: Pulse CO-Oximetry Technology|In addition to the standard pulse oximeter used for clinical care, up to six SpHb finger sensors will be applied to the patient. Additional sensors may also be applied to the forehead, neck, chest and ears. Masimo FDA cleared pulse CO-Oximeter devices: Radical-7, Rad-87, Rad-57, Pronto, Pronto-7, for the noninvasive measurement of SpO2, PR, PI, PVI, SpCO, SpMet, and SpHb, total hemoglobin and respiratory rate. No treatment decisions will be made based on the new technology and no extra medical procedures are required for the study.|
|Other: Blood draw|4mL arterial blood samples (up to 1 per hour), outside standard of care, are drawn throughout the surgical procedure and sent to UCDMC lab/Masimo lab for analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery | Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb. | Five year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemoglobin, Non-invasive
A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)

Study Overview
=================
Brief Summary
-----------------
The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.

Official Title
-----------------
A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)

Conditions
-----------------
Hypertension, Diabetes

Intervention / Treatment
-----------------
* Drug: trandolapril
* Drug: trandolapril/verapamil
* Drug: placebo
* Drug: verapamil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Hypertension Exclusion Criteria: Albuminuria (Phase A) Non-diabetic renal disease Subject has a hypersensitivity to ACE inhibitor, CCB

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A-1, B-1<br>A-1 pertains to Phase 1; B-1 pertains to Phase 2 | Drug: trandolapril<br>* 2 mg QD<br>* Other names: Mavik/Gopten;|
| Active Comparator: A-2, B-2<br>A2 pertains to Phase 1; B-2 pertains to Phase 2 | Drug: trandolapril/verapamil<br>* 180/2 mg QD<br>* Other names: Tarka;|
| Placebo Comparator: A-3<br> | Drug: placebo<br>* 1 tablet QD<br>|
| Active Comparator: A-4<br> | Drug: verapamil<br>* SR 240 mg QD<br>* Other names: ABT-150;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of albumin excretion over time, GFR, blood pressure (BP), incidence of major CV events, overall and CV mortality, HbA1c, progression of retinal changes. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, diabetes, trandolapril, verapamil, albuminuria
Caffeine Versus Placebo for Spinal Headaches

Study Overview
=================
Brief Summary
-----------------
Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka spinal headache).

Detailed Description
-----------------
Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.

Official Title
-----------------
A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department

Conditions
-----------------
Post Dural Puncture Headache

Intervention / Treatment
-----------------
* Drug: Caffeine
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with post dural puncture headache Exclusion Criteria: age < 18 pregnant allergic to caffeine cardiac or peripheral vascular disease uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IV caffeine with saline and opiate | Drug: Caffeine<br>* Caffeine 500 mg IV<br>* Other names: Treatment group;|
| Placebo Comparator: 2<br>IV saline with opiate | Drug: saline<br>* Normal saline<br>* Other names: Placebo control group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by Visual Analog Scale |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headache, caffeine, pain
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Procedure: transarterial chemoembolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases; HCC with no previous treatment; age between 18 and 75 years; Life expectancy of at least 8 weeks; main tumor size greater than 5 cm; adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control); adequate renal function (serum creatinine: ≤1.5 × upper limit of normal); Child-Pugh classification A or B grade; Barcelona Clinic Liver Cancer (BCLC) stage B or C; Eastern Co-operative Group performance status of zero or one. Exclusion Criteria: a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans); diffuse-type HCC; evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy; severe underlying cardiac or renal diseases; color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 received single-drug (doxorubicin)transarterial chemoembolization. | Procedure: transarterial chemoembolization<br> <br> |
| Experimental: Group 2<br>Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization | Procedure: transarterial chemoembolization<br> <br> |
| Experimental: Group 3<br>Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization. | Procedure: transarterial chemoembolization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1-2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma, Transarterial chemoembolization, Gemcitabine
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

Official Title
-----------------
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

Conditions
-----------------
Cisplatin Adverse Reaction, Hearing Loss Ototoxic

Intervention / Treatment
-----------------
* Drug: N Acetylcysteine
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin. Exclusion Criteria: Conductive Hearing Loss SNHL with >= 40db PTA

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcisteine group<br> | Drug: N Acetylcysteine<br>* Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.<br>|
| Placebo Comparator: Control group<br> | Drug: Placebo Oral Tablet<br>* Placebo treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing threshold | High frequencies pure tone average | Baseline. | 
| Hearing threshold | High frequencies pure tone average | up to 4th week of chemoradiotherapy | 
| Hearing threshold | High frequencies pure tone average | through study completion, an average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cisplatin, Ototoxicity, N-acetylcisteine
Outcome of Idiopathic Macular Hole

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).

Official Title
-----------------
Long-term Outcome of Idiopathic Macular Hole Surgery

Conditions
-----------------
Idiopathic Macular Hole

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair Exclusion Criteria: All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vitrectomy in pseudophakic eyes<br> | |
| vitrectomy and cataract:combined procedure<br> | |
| vitrectomy followed by cataract extraction<br> | |
| vitrectomy on phakic eyes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term outcome of idiopathic macular hole surgery |  | 37 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic macular hole, cataract, edema, Reopening
Echocardiographic Characteristics of High Endurance Israeli Athletes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography.

Detailed Description
-----------------
Adaptive cardiac changes, such as enlargement of left ventricle mass and enlargement of left ventricular wall was observed in athletes. The physiological limit of remodeling changes in accordance to sex, type of activity, intensity of activity, genetics and race. Although many studies were conducted on this subject, it is still impossible to predict if an athlete from a certain sport will develop cardiac changes and their what will those changes characteristics will be. Sudden cardiac death is the leading cause of death among young athletes, this is because of high physical activity in the presence of a hidden heart disease, therefore there is much debate about the needed screening tests for athletes. In Israel, there is only one study in this subject that showed no significant cardiac changes in Olympic athletes of various types of sports. the study didn't focused on high endurance sport athletes such as professional bicyclists although cardiac endurance is a main factor in cardiac changes.

Official Title
-----------------
Echocardiographic Characteristics of High Endurance Israeli Athletes

Conditions
-----------------
Athlete's Heart

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known athletes of the bicyclists organization of Israel or any other known organization for 2 year at least. Participated in at least one contest recognized by the bicyclists organization of Israel. Had been in training for the last 3 months at least, which included minimum of 8 hours a week in average Exclusion Criteria: Do not suffer any known cardiac disease Had declared that they are not using drugs which are forbidden by the Olympic committee

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sk<br>professional Israeli bicyclists | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Disease.

Study Overview
=================
Brief Summary
-----------------
To assess the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting diseases, the investigators designed a prospective cohort study. The investigators will recruit 250 patients preparing to undergo a selective epigastrium surgery with coexisting medical diseases which need an anesthetic consultation. The patients will be randomly assigned into two groups. The intervention group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery. The length of stay, hospitalization expense, postoperative complication rate and mortality rate of the two groups will be compared. The investigator assume that consultation in preoperative assessment clinic will improve the prognosis and decrease the hospitalization expenses.

Official Title
-----------------
The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Diseases.

Conditions
-----------------
Length of Stay, Postoperative Complications, Morality

Intervention / Treatment
-----------------
* Behavioral: consultation in preoperative assessment clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients preparing to undergo a selective epigastrium surgery patients with coexisting medical diseases needing an anesthetic consultation over 60 years old ASA II-III patients with good compliance Exclusion Criteria: patients ubdergoing emergency operation ASA I, IV patients under 60 years old patients with bad compliance

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| properative assessment clinic group<br>The treatment group will be seen in the preoperative clinic before hospitalization. | Behavioral: consultation in preoperative assessment clinic<br>* The treatment group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery.<br>|
| Control group<br>The control group will get anesthetic consultation after hospitalization without clinic service. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay |  | an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization expense | The expense patients cost during hospitalization | an average of 5 days |
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life

Study Overview
=================
Brief Summary
-----------------
The prevalence of chewing dysphagia in the domestic rehabilitation department ward was about 53.61%.Nasal tube retention of about 31%, due to nasogastric tube feeding, often overlooked oral hygiene, easy to cause respiratory tract infection. At the same time, oral hygiene will also affect the effectiveness of swallowing treatment, is worthy of attention to health problems.

Official Title
-----------------
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life

Conditions
-----------------
Swallowing Disorders, Stroke

Intervention / Treatment
-----------------
* Other: oral care program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of first stroke with nasal tube retention Language therapist providing swallowing treatment Caregiver providing oral care to patients Exclusion Criteria: Oral cancer head and neck cancer
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral hygiene<br> | Other: oral care program<br>* Oral care (sputum and special needs of people cleaning teeth) time for three days a week (with swallowing treatment time before), once a day, each about 10 minutes of oral care program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional oral intake scale | Seven different grades,Normal for 7 points;Total score of 1-7 | before the first swallowing treatment (one day before treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional oral intake scale | Seven different grades,Normal for 7 points;Total score of 1-7 | two weeks after the swallowing treatment (14 days) | 
| Functional oral intake scale | Seven different grades,Normal for 7 points;Total score of 1-7 | three weeks after the swallowing treatment (21 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke , swallowing function ,oral health quality of life