linjc16/ctgov huggingface dataset:
Comparison of PRISM III, PIM2 and PELOD Scoring Systems

Study Overview
=================
Brief Summary
-----------------
PRISMIII(Pediatric Risk of Mortality III), PIM2(Pediatric Index of Mortality 2) and PELOD(Pediatric Logistic Organ Dysfunction) are frequently used for predicting mortality and morbidity in general pediatric ICUs(Intensive Care Units). However, the effectiveness of these scoring sistems in a specific group patients undergoing congenital heart surgery(CHS) is unknown. In this study, the investigators aimed primarily to evaluate the success of these scoring systems in predicting mortality and morbiditiy in this specific group and to compare the scoring systems with eachother, and secondly to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category

Official Title
-----------------
Comparison Of PRISM III, PIM2 And PELOD Scoring Systems In Predicting Mortality For Patients Undergoing Congenital Cardiac Surgery In Pediatric Intensive Care Unit

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients younger than 18 years of age who had undergone congenital heart surgery Exclusion Criteria: emergency operations Patients staying in intensive care unit for less than 24 hours

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 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 |
| --- | --- | --- |
| evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity | Patients younger than 18 years of age who had undergone congenital heart surgery were evaluated on the first postoperative day in the ICU and parameters were recorded. PRISMIII and PELOD scores were calculated using the most abnormal values in the first 24 hours, and PIM2 score was calculated using the data within the first hour. | 3 months | 
| morbidity indicators | Morbidity indicators were determined as the length of ICU stay, total hospital stay, re-intubation, surgical revision, complications and re-admission to the ICU. | 3 months | 
| clinical outcomes | Clinical outcomes were determined as 7-day mortality and 30-day mortality. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category | STAT category was determined according to the surgical procedure. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRISM III, PIM2, PELOD, STAT, mortality, congenital heart disease
Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how accurately a pseudo-telehealth shoulder examination diagnoses rotator cuff tears compared to a regular clinical examination. MRI is used as the gold standard.

Official Title
-----------------
Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Diagnostic Test: Telehealth clinical exam
* Diagnostic Test: Standard clinical exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years of age or older, presenting with shoulder pain, and seen in the Duke Sports Medicine clinic by Dr. Wittstein or Dr. Lassiter Exclusion Criteria: Patient cannot have had prior shoulder arthroplasty, instability or history of fracture/dislocation. Pregnant women will be excluded from the study because there will be an MRI. Anyone unable or unwilling to have an MRI will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Shoulder patients<br> | Diagnostic Test: Telehealth clinical exam<br>* This is a pseudo telehealth clinical exam for patients presenting with shoulder pain<br>Diagnostic Test: Standard clinical exam<br>* This is a standard in-person clinical exam for patients presenting with shoulder pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement with MRI findings as they pertain to presence or absence of a rotator cuff tear | % of exams that agreed with the MRI findings | Within 1 month of exam |
Combined Effect Of Cranial And Cervical Mobilization In Patients With CGH

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To investigate the combined effect of cranial and cervical mobilization in patient with cervicogenic headache and there effect on : Perceptive neck pain intensity Perceptive headache intensity pain by pressure frequency of headache episodes duration of headache episodes Medications uptakes

Official Title
-----------------
Combined Effect Of Cranial And Cervical Mobilization In Patients With Cervicogenic Headache

Conditions
-----------------
Cervicogenic Headache

Intervention / Treatment
-----------------
* Other: Mobilization Techniques
* Other: Conventional Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pain originating at the neck and radiating to oculo-frontal-temporal regions. symptom unilaterally. symptom provocation through cervical movement and/or awkward cervical postural. symptom provocation through external pressure application through palpation to associated posterior cervical spine segments with resultant symptom reproduction. possible ipsilateral shoulder and/or arm pain of vague reference. 15 or more headache episodes per month No history of cervical operation or any disease that result in headache as colities -All patients will sign the informed consent before joining the study. Exclusion Criteria: Headache not of cervical origin Headache with autonomic involvement, dizziness, or visual disturbance Congenital conditions of the cervical spine It is of primary concern to exclude serious or life-threatening pathology such as : cranial tumors. Meningitis. sub-arachnoid hemorrhage. carotid artery,vertebral artery dissection. History of cervical operation or any disease that result in headache as colitis Age less than 18 or more than 40 years chronic maxillary sinusitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranial Mobilization and Exercises Group<br> | Other: Mobilization Techniques<br>* Combination of Cranial and Cervical Mobilization for Cervicogenic headache Patients treatment<br>Other: Conventional Treatment<br>* Cervicogenic headache exercises<br>|
| Active Comparator: Exercises Group<br> | Other: Conventional Treatment<br>* Cervicogenic headache exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assis Headache Perceptive intensity | By visual analog scale , Minimum value zero mean No pain Maximum value 10 mean Worst pain . | 2 weeks |
Human Breast Tissue Bioavailability of Topically Applied Limonene

Study Overview
=================
Brief Summary
-----------------
The overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.

Official Title
-----------------
Human Breast Tissue Bioavailability of Topically Applied Limonene

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

Intervention / Treatment
-----------------
* Other: limonene containing massage oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are 18-65 years of age ECOG performance status 0-1 Normal organ and marrow function Women of child-bearing potential must agree to use adequate contraception Willing to avoid consumption and use of citrus or citrus containing products throughout the study Have both breasts intact Exclusion Criteria: Have had cancer(s) within the past 5 years Participated in another clinical interventional trial within the past 3 months Uncontrolled intercurrent illness Pregnant or breast feeding Unable to produce nipple aspirate fluid Have known allergic or sensitive reactions to skin care products, citrus or coconut oil Have ongoing skin disorders such as eczema and psoriasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limonene intervention<br> | Other: limonene containing massage oil<br>* daily massage application to the breast for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast tissue bioavailability | limonene levels in nipple aspirate fluid after 4 weeks of intervention | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | number of participants with adverse events | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer prevention
Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT

Study Overview
=================
Brief Summary
-----------------
Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.

Detailed Description
-----------------
In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures. The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.

Official Title
-----------------
Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.

Conditions
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Myeloid Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders Chronic Myeloid Leukemia Exclusion Criteria: Performance status ECOG>2 Cardiomyopathy (LVEF <39%) Pulmonary dysfunction (DLCO<39%) Hepatic dysfunction Grade >1 Renal dysfunction Grade >1 (Creatinine > 1.6 mg/dl) HIV infection Other active neoplasm
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allogeneic HSCT, Busulfan, Fludarabina
Immediate Effects of Eurythmy Therapy on Psychophysiological Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate different effects of Eurythmy Therapy on psychological and physiological parameters of circulation and thermoregulation

Conditions
-----------------
Eurythmy Therapy

Intervention / Treatment
-----------------
* Other: Eurythmy Therapy Movement R
* Other: Eurythmy Therapy Movement L
* Other: Eurythmy Therapy Movement B
* Other: Normal movements during walking or standing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 18-55 Years old, signed informed consent available Exclusion Criteria: Any known diseases of the cardiovascular system, allergic reactions to electrode patches in the past, coffee, alcohol or smoking less than 3 hours prior to the study, insufficient knowledge of the German language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eurythmy Therapy Movement R<br>EYT exercise R: Positioned between two steps and forearms parallel to the ground, the patient performs a rolling movement like wheels on a wagon. The movement is positioned below shoulder height and is initiated from the shoulder blade. | Other: Eurythmy Therapy Movement R<br> <br> |
| Experimental: Eurythmy Therapy Movement L<br>EYT exercise L: In a circular and flowing movement the patient leads his hands upwards in front of his body and down again laterally. During elevation of the arms, the patient performs a small hop onto the toes and into knock knees. Lowering his arms, he releases the legs and straightens up again. | Other: Eurythmy Therapy Movement L<br> <br> |
| Experimental: Eurythmy Therapy Movement B<br>EYT exercise B: The patient describes an embracing movement with both arms and the left leg while balancing on one foot. He then returns to the initial position and repeats the movement using the other leg. | Other: Eurythmy Therapy Movement B<br> <br> |
| Active Comparator: Normal movements during walking or standing<br>Control exercise: Participants slowly walk across the room, their arms swinging in a natural way. This was designed to control for the most basic upright movement, shifting thermoregulation from resting conditions to exercise conditions, triggering non-thermal factors. | Other: Normal movements during walking or standing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave Velocity |  | 10 minutes after the movement exercises |
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic screening with electrocardiogram could improve atrial fibrillation detection. No studies are available in nursing home. The goal of this study is to screen atrial fibrillation in patients who live in nursing home.

Detailed Description
-----------------
A prospective observational cross sectional multicenter study. The goal of this study is to detect atrial fibrillation in nursing home people aged 65 years old and above, with systematic electrocardiogram. Participants agreement will be collected. Participants characteristics data will be collected in all nursing home. For all participants, one visit were realised with electrocardiogram, and symptoms survey. Data were anonymised on each center before analysed.

Official Title
-----------------
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: electrocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Being in nursing home since 1 month and above Aged > 65 years old Subjects agree to participate at this project Exclusion criteria : Antecedent of atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrocardiogram<br>Patient will take an electrocardiogram in order to detect atrial fibrillation | Other: electrocardiogram<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of atrial fibrillation on electrocardiogram | detection of atrial fibrillation during the electrocardiogram | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of irregular pulse |  | up to 1 hour |
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia

Study Overview
=================
Brief Summary
-----------------
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of intolerance to statins Patients currently receiving ezetimibe Patients willing and able to provide signed informed consent Exclusion Criteria: Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol) Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months Cancer undergoing active treatment Creatinine clearance < 40 ml/minute Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level Participation in any clinical study within the last 30 days Drug addition or alcohol abuse within the past 6 months Use of cyclosporine within the last 3 months Use of gemfibrozil within the last month Patients unwilling or unable to provide informed consent Patients with poor compliance Women of childbearing potential History of rhabdomyolysis due to statins

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crestor<br>Crestor 10 or 20 milligrams | Drug: Rosuvastatin<br>* Rosuvastatin 10 or 20 milligrams once or twice a week<br>* Other names: Crestor;|
| Active Comparator: Ezetimibe<br>Ezetimibe 5 or 10 milligrams | Drug: Ezetimibe<br>* Ezetimibe 5 or 10 milligrams<br>* Other names: Zetia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density lipoprotein (LDL) cholesterol |  | 6 weeks | 
| Low-density lipoprotein (LDL) cholesterol |  | 3-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to remain on Crestor for the study period |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia
Establishment of an Artificial Larynx After Total Laryngectomy

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

Official Title
-----------------
Establishment of an Artificial Larynx After Total Laryngectomy

Conditions
-----------------
Carcinomatous Disease

Intervention / Treatment
-----------------
* Device: PROTIP MEDICAL ( Artificial larynx prosthesis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy Exclusion Criteria: Less than 18 years Contraindications to general anesthesia Any situation considered by the physician operator as an exclusion Pregnant women Lactating women Subglottic or basi-lingual tumor extension more than 1 cm Prior radiotherapy Severe coagulation disorders

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PROTIP MEDICAL ( Artificial larynx prosthesis)|establishment of an artificial larynx prosthesis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the restoration of respiratory functions | 4 items will be used: 0: no dyspnea 1: moderate dyspnea 2: significant dyspnea 3: major dyspnea | one year | 
| Evaluation of the restoration of the ability to swallow by nasofibroscopy | 3 items will be used: 1: no aspiration 2: moderate aspiration 3: massive aspiration | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngectomy, artificial larynx, breathing, swallowing, upper airway