linjc16/ctgov huggingface dataset:
The Effect of Patient's Position After Intra-tympanic Injection

Study Overview
=================
Brief Summary
-----------------
The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.

Official Title
-----------------
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

Conditions
-----------------
Sudden Hearing Loss

Intervention / Treatment
-----------------
* Other: Change of posture after Intra Tympanic injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids Patients who signed an informed consent form Exclusion Criteria: Dysgeusia Inner or middle ear malfomation Eustachian tube dysfunction

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 |
| --- | --- |
| Patients seated after Intra-Tympanic injection<br> | Other: Change of posture after Intra Tympanic injection<br>* Seating position after Intra Tympanic injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of taste | The patients will rate the degree of change of taste in their throat | 0 Minutes, and then 10, 20, 30 minutes after the injection |
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b

Study Overview
=================
Brief Summary
-----------------
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. When mothers of hospitalized infants are unable to supply their milk, the recommended supplement is human donor milk. The impact of a pandemic on human milk banking is unknown. This study seeks to address this public health issue. Donor milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System in Toronto. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding donor milk banking to protect the health of infants.

Official Title
-----------------
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b

Conditions
-----------------
Sars-CoV2, Breastmilk

Intervention / Treatment
-----------------
* Other: Human milk donors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Human milk donor for the Rogers Hixon Ontario Human Milk Bank Exclusion Criteria: - None
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 |
| --- | --- |
| Human milk donors<br> | Other: Human milk donors<br>* Human milk donors for the Rogers Hixon Ontario Human Milk Bank<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of SARS-CoV-2 in breastmilk | To describe the prevalence of human milk donations received at the Ontario Human Milk Bank that test positive for SARS-CoV-2 | 2 months | 
| Prevalence of SARS-CoV-2 antibody in breastmilk | To describe the prevalence of human milk donations received at the Ontario Human Milk Bank with antibodies for SARS-CoV-2 | 2 months |
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase

Study Overview
=================
Brief Summary
-----------------
This extension trial of SP668 consists of two phases: double-blind treatment and open-label extension. The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy. Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg. Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg. The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ECG, physical and urological examinations and subject's assessment of treatment tolerance. Secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.

Official Title
-----------------
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder(OAB): a Double-Blind Phase Followed by an Open-Label Extension Phase

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: SPM 907


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactive bladder

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 907|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Study Overview
=================
Brief Summary
-----------------
Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States. The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about five months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, electrocardiogram (ECG), blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: SPM 927


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy with partial seizures Exclusion Criteria: Subject received SPM 927 in a previous trial

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 927|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy with partial seizures
Reliability and Validity of the Taiwan-version of Multidimensional Fatigue Inventory and Fatigue Severity Scale

Study Overview
=================
Brief Summary
-----------------
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and -FSS- to Taiwan-version, and to examine the reliability and validity of the scales. A hundred adult people without diagnosed physical nor mental disabilities will be recruited. Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later to evaluate the test-retest reliability. Another twenty people who are familiar with both English and Chinese will be recruited to evaluate the translation reliability. Subjects will fill out the English version of MFI and FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes apart. The translation reliability will be evaluated by paired t test and the intraclass correlation coefficient.

Conditions
-----------------
Fatigue, Taiwan-version Questionnaire

Intervention / Treatment
-----------------
* Other: No Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No cognition or mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Healthy people<br> | Other: No Interventions<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the reliability and validity of Taiwan-version Multidimensional Fatigue Inventory questionnaire |  | 1 week | 
| Assessing the reliability and validity of Taiwan-version Fatigue Severity Scale questionnaire |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 questionnaire | To establish the criterion validity | Baseline | 
| Pittsburg Sleep Quality Index questionnaire | To establish the criterion validity | Baseline |
Total Hip Arthroplasty: Fluoroscopy vs Freehand

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare total hip arthroplasty intervention executed with or without the use of intraoperative fluoroscopy in terms of positioning of the hip prosthesis. The comparison will be made on post-operative follow-up X-ray performed as per clinical practice, in order to verify if intraoperative fluoroscopy provides better prosthesis components positioning or not.

Official Title
-----------------
A Randomized, Monocentric Investigator-initiated Clinical Investigation Comparing Fluoroscopy Versus Freehand in Total Hip Arthroplasty

Conditions
-----------------
Intraoperative Fluoroscopy

Intervention / Treatment
-----------------
* Device: Intraoperative fluoroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing unilateral primary THA through DAA Patients aged 18-90 years old. Patients with a BMI >18 and <35. Patients able to provide informed consent. Informed consent as documented by signature. Exclusion Criteria: Revision THA. Women who are pregnant or breast feeding. Presence of other clinically significant concomitant disease states (ASA IV). Previous enrolment into the current study. Enrolment of the investigator, his/her family members, employees and other dependent persons.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoroscopy<br> | Device: Intraoperative fluoroscopy<br>* Fluoroscopy is a medical procedure that makes a real-time video of the movements inside a part of the body by passing x-rays through the body over a period of time.<br>|
| No Intervention: Freehand<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetabular component anteversion | Acetabular component anteversion will be measured on post-operative control antero-posterior pelvis view X-ray performed as per clinical practice using the PACS software according to the method described by Lewinnek et al. This method is based on the following equation to measure radiographic anteversion β. β = arcsin(S/L) Where S is the length of the short axis and L is the length of long axis of the ellipse. The ellipse is formed by the outer ring of the acetabulum component on the anteroposterior pelvis view X-ray. | 2 months post-operative |
Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD

Study Overview
=================
Brief Summary
-----------------
Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.

Official Title
-----------------
Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD stage 3 or 4 Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course; Exclusion Criteria: FEV ≥ 50% Pneumonectomy, Lobectomy less than 6 months Patient with risk of spontaneous pneumothorax or rib fracture

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>conventional pulmonary rehabilitation | |
| Experimental: Inspiratory muscle training<br>Inspiratory muscle training associated with a conventional pulmonary rehabilitation | Other: Inspiratory muscle training<br>* Inspiratory muscle training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea measure | Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire. | 21 - 4 days / +7 jours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PI max variation | Measure of PI max variation with MicroRPM | 21 - 4 days / +7 days | 
| CI variation | Measure of CI variation with spirobank II | 21 - 4 days / +7 days | 
| Dyspnea measure | Meausre of dyspnea with London Chest of Activity Daily Living (LCADL) | 21 - 4 days / +7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inspiratory muscle training, COPD, dyspnea, Multidimensional Dyspnea Profile questionnaire (MDP)., pulmonary rehabilitation
Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section

Study Overview
=================
Brief Summary
-----------------
The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is concerning, as repeat CS are associated with increased maternal morbidity and mortality, and neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth complications. However, there is limited information about Taiwanese women's decision regarding VBAC and their participation in decision-making. There is also a gap in literature about information for women about CS and VBAC.

Detailed Description
-----------------
Ajzen's Theory of Planned Behaviour will theoretically underpin the study. A qualitative descriptive design using purposive sampling of 20 Taiwanese pregnant women who have previously had a CS with a live baby will be recruited from Chang Gung Memorial Hospital in Taiwan. In-depth interviews will be carried out in three phases: (1) between 34 weeks to 38 weeks of women's pregnancy; (2) on the third day after childbirth; and (3) at the fourth week after birth, the end of confinement. Boyatzis' Data Driven approach will be adopted to thematically analyze the data.

Official Title
-----------------
Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section

Conditions
-----------------
Caesarean Section

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had a previous CS with a live baby Currently at 34 to 38 weeks of pregnancy Medically eligible for a VBAC Have chosen to have a natural birth 20 years old and over Able to converse in Mandarin and/or Taiwanese Exclusion Criteria: Previous myomectomy Previous classical caesarean section Two previous caesarean section Pregnant with complications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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
-----------------
caesarean section, vaginal birth after caesarean section, repeat caesarean section, childbirth expectation, childbirth experience
Studying the Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature

Study Overview
=================
Brief Summary
-----------------
Patients complaining of congenital penile curvature were subject to Penile duplex study to assess their curvature. Their penile duplex data including Peak Systolic velocity, End Diastolic velocity and Resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection using the erection hardness grading scale.

Official Title
-----------------
Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature

Conditions
-----------------
To Assess Erectile Function in Patients Complaining of Congenital Penile Curvature

Intervention / Treatment
-----------------
* Diagnostic Test: Penile Duplex Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complaining of congenital curvature Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal erectile response<br>Peak systolic velocity above 35cm/s, EDV below 5cm/s, Erectile score 4 or 3 | Diagnostic Test: Penile Duplex Study<br>* A penile duplex study will be done to assess PSV, EDV, RI, angle and degree of curvature and Erection quality using the erection hardness grading scale<br>|
| Abnormal erectile response<br>Peak systolic velocity below 35cm/s, EDV above 5cm/s, Erectile score 2 or 1 | Diagnostic Test: Penile Duplex Study<br>* A penile duplex study will be done to assess PSV, EDV, RI, angle and degree of curvature and Erection quality using the erection hardness grading scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile duplex study parameters | A penile duplex study will be done to assess peak systolic velocity, end diastolic velocity, Resistivity index | 3 years | 
| Degree of curvature | Angle and degree of penile curvature using a compass | 3 years | 
| Erection quality using the erection hardness grading scale | A score of 1 indicates that the penis is larger than normal, but not hard; 2 means the penis is hard, but not hard enough for penetration, 3 means the penis is hard enough for penetration but not completely hard, and 4 indicates that the penis is completely hard and fully rigid | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital penile curvature, Erectile dysfunction