linjc16/ctgov huggingface dataset:
Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.

Official Title
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Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer

Conditions
-----------------
Recurrent Oropharynx Carcinoma

Intervention / Treatment
-----------------
* Other: Treatment for recurrent oropharyngeal cancer (curative/ palliative)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (aged 18 years or over) competent to provide consent Have a diagnosis of recurrent OPC Have adequate linguistic and cognitive function to participate in interview English speaking Exclusion Criteria: Any previous medical condition, other than HNC, which has a known impact on communication/ swallowing (Parkinson's Disease, Multiple Sclerosis, cerebral vascular accident (CVA)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Treatment for recurrent oropharyngeal cancer (curative/ palliative)|Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported swallowing related quality of life | MD Anderson Dysphagia Inventory | 6 months |
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Efficacy study of ecabet ophthalmic solution in dry eye disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: ecabet ophthalmic solution
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with dry eye disease Exclusion Criteria: Dry eye disease secondary to surgery

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ecabet ophthalmic solution | Drug: ecabet ophthalmic solution<br>* sterile ophthalmic solution<br>|
| Placebo Comparator: 2<br>Placebo comparator | Drug: placebo<br>* sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured. | 43 days |
Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography. Some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection. To determine the concentration of Cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (BMI).

Official Title
-----------------
Antibiotic Prophylaxis in Bariatric Surgery With Continuous Infusion of Cefazolin: Determination of Concentration in Adipose Tissue

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Cefazolin used in antimicrobial prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index greater than 35 and less than 50kg/m2 Exclusion Criteria: Hypotension during surgery with use of vasoactive drugs renal disfunction (creatinine >1.5 mg/dL)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cefazolin<br>Cefazolin used in antimicrobial prophylaxis Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours. Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis. The samples were processed by High Pressure Liquid Chromatography (HPLC). | Drug: Cefazolin used in antimicrobial prophylaxis<br>* Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours. Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis. The samples were processed by HPLC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage of Cefazolin in adipose tissue during bariatric surgery |  | eight months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Cefazolin, Obesity, antimicrobial prophylaxis, administration and dosage
A Multicenter Survey Study Into Patient Experience With Mobile Apps

Study Overview
=================
Brief Summary
-----------------
This multicenter prospective survey study is designed to evaluate a newly developed mobile app that will support patients with malignant pleural effusion (MPE) treated with an indwelling pleural catheter (IPC). The aim is to test the mobile app with patients with MPE and get user feedback during and at the end of the study period.

Official Title
-----------------
A Multicenter Survey Study Into Patient Experience With Mobile Apps

Conditions
-----------------
Malignant Pleural Effusion

Intervention / Treatment
-----------------
* Other: eMPowEr App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with MPE and, scheduled for an indwelling pleural catheter (IPC) procedure, Age 18 or older Exclusion Criteria: Patients without an iOS smartphone or email account Patients who refuse participation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: eMPowEr App|A mobile app to support participants in the management of malignant pleural effusions at home|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % positive usability rating rated via an mHealth App Usability Questionnaire (MAUQ) | The % positive usability rating rated via an mHealth App Usability Questionnaire (MAUQ) | 2 weeks |
Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The relationship between immune inflammation-related protein complexes in blood of triple negative breast cancer patients and recurrence or metastasis of breast cancer will be studied.

Detailed Description
-----------------
200 patients with triple negative breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Official Title
-----------------
Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients Via Analysis of Immunoinflammation-related Protein Complexes in Blood

Conditions
-----------------
Triple Negative Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Postoperative pathology confirmed invasive breast cancer after surgery for breast lump Breast cancer-related chemotherapy and radiotherapy completed triple negative breast cancer patients age ≤ 60 years old Exclusion Criteria: Male Aged above 60 Breast Carcinoma in situ Women in pregnancy or breastfeeding Suffering from other malignant tumors Non-compliant patient

Ages Eligible for Study
-----------------
Minimum Age: 36 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| triple negative breast cancer<br>triple negative breast cancer patients with age ≤ 60 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune inflammation-related protein complexes | The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography. | 2 years | 
| blood markers | The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay. | 2 years |
Silicone Earplugs for VLBW Newborns in Intensive Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.

Official Title
-----------------
Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial

Conditions
-----------------
Postnatal Growth

Intervention / Treatment
-----------------
* Device: Silicone Earplugs
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birthweight between 401 and 1500 grams less than 1 week of age parental informed consent availability of research personnel Exclusion Criteria: terminal illness congenital anomalies syndromes associated with hearing loss

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br> | Device: Silicone Earplugs<br>* Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first<br>|
| No Intervention: C<br> | Other: Control<br>* Standard care in the neonatal intensive care unit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 34 weeks post-menstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in neonatal intensive care |  | hospital discharge | 
| Time on mechanical ventilator |  | hospital discharge | 
| Weight |  | 18 - 22 months of age | 
| Length |  | 18 - 22 months of age | 
| Frontal-occipital circumference |  | 18 - 22 months of age | 
| Bayley Mental Developmental Index |  | 18 - 22 months of age | 
| Bayley Psychomotor Developmental Index |  | 18 - 22 months of age | 
| ABR Hearing Screen |  | hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postnatal Growth, Postnatal Development, Noise, Neonatal Intensive Care Unit
Comparison of RIRS Versus PCNL Methods, According to Postoperative Pain and Analgesic Demand in 2 to 4 cm Renal Stones

Study Overview
=================
Brief Summary
-----------------
Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Procedure: Percutaneous nephrolithotomy
* Procedure: Retrograde intrarenal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who have 2 to 4 cm kidney stones ASA score within 1 to 3 Exclusion Criteria: Previous surgical treatment including SWL Congenital abnormalities
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIRS<br>Retrograde intrarenal surgery | Procedure: Retrograde intrarenal surgery<br> <br> * Other names: RIRS;|
| Active Comparator: PCNL<br>Percutaneous nephrolithotomy | Procedure: Percutaneous nephrolithotomy<br> <br> * Other names: PCNL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic demand |  | Postoperative 24 hours | 
| Stone clearance |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stone, RIRs, PCNL, Pain
Investigation on Home Care Needs of ALS Patients and Their Caregivers

Study Overview
=================
Brief Summary
-----------------
The research target To investigate the home nursing knowledge needs of ALS patients; Investigate the needs of ALS caregivers for home nursing knowledge; To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

Detailed Description
-----------------
The research target To investigate the home nursing knowledge needs of ALS patients; Investigate the needs of ALS caregivers for home nursing knowledge; To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period. Assessment indicators Scale: Self-designed questionnaire Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Families; Amyotrophic lateral sclerosis function rating scale (ALS FRS)

Official Title
-----------------
Investigation on the Knowledge Needs of ALS Patients and Their Caregivers at Home

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: The questionnaire survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed and suspected patients of ALS diagnostic criteria revised by E1 Escorial in 1998;Conscious and stable vital signs;Signing the informed consent; Exclusion Criteria: patients with severe medical diseases, such as severe cardiovascular and cerebrovascular diseases, liver and kidney failure, etc.The existing resources cannot complete the questionnaire to fill in the exclusion of patients, but the caregivers can fill in the questionnaire;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The questionnaire survey|Questionnaires were issued and collected by 6 competent nurses with strict training, data entry by 2 researchers, statistical analysis by 1 researcher, and quality control by the other 2 researchers throughout the process.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale | Scale: Self-designed questionnaire Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Family Members; | 1 year after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (ALS FRS) | Amyotrophic Lateral Sclerosis Function Scale (ALS FRS) | 1 year after recruitment |
Correlation of Albuminuria With Arterial Stiffness

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the relationship between albuminuria and arterial stiffness in diabetic patients, hypertensive patients and healthy subjects.

Detailed Description
-----------------
CONTEXT: Albuminuria is an important cardiovascular risk factor. Arterial stiffness also gives important information about atherosclerosis. Oscillometric methods may be useful in assessing arterial stiffness in a mainly operator independent way. OBJECTIVE: We aim to investigate the relationship between albuminuria and arterial stiffness measured with an oscillometric device in diabetic patients, hypertensive patients and healthy subjects. METHODS: 152 diabetic patients, 152 hypertensive patients and 152 healthy subjects are planned to be enrolled in this study. The measurements will be done between 9:00 and 13:00. After the measurements, blood and urine samples will be obtained, centrifugated and kept in -80°C until assayed. Afterwards, echocardiographic left ventricle mass index will be calculated. The correlation between albuminuria and arterial stiffness will be assessed as the primary outcome measure.

Official Title
-----------------
Assessment of the Association Between Albuminuria and Arterial Stiffness in Diabetic Patients, Hypertensive Patients and Healthy Controls

Conditions
-----------------
Diabetes Mellitus, Hypertension, Albuminuria, Vascular Stiffness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus Hypertension Healthy subjects Exclusion Criteria: Symptomatic cardiovascular diseases (heart failure, history of myocardial infarction, etc.) Renal failure Pregnancy Diseases of the aorta

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Diabetic patients<br>Hypertensive and normotensive patients with type 2 diabetes mellitus | |
| Hypertensive patients<br>Patients with essential hypertension | |
| Healthy subjects<br>Healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between albuminuria and arterial stiffness |  | Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Hypertension, Albuminuria, vascular stiffness