linjc16/ctgov huggingface dataset:
Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to summarize our experience with and to evaluate the feasibility of transvaginal four-dimensional hysterosalpingo-contrast sonography using SonoVue (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility clinic are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of who undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are compared. All of the patients will be followed up. The complications of 4D-HyCoSy will be evaluated and the pregnancy outcomes will be recorded.

Official Title
-----------------
Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency

Conditions
-----------------
Four Dimensional Hysterosalpingo-contrast Sonography, Tubal Patency

Intervention / Treatment
-----------------
* Device: four dimensional hysterosalpingo-contrast sonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have infertility and need to evaluate tubal patency. Exclusion Criteria: vaginal bleeding; acute or subacute inflammation of the reproductive system; uterine malignancies; allergies to the medications used in the examination, such as lidocaine, atropine, and sulfur hexafluoride
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: four dimensional hysterosalpingo-contrast sonography|compare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue | Sensitivity, specificity, accuracy, positive predictive value, negative predictive value | at least one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects and complications of four-dimensional hysterosalpingo-contrast sonography | the intensity of pain perception, vaginal bleeding, fever, pelvic inflammatory diseases，peritonitis，and the pregnancy outcomes | at least one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
feasibility, accuracy, tolerability, four dimensional hysterosalpingo-contrast sonography
Study Evaluating the Nasopharyngeal Carriage in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time.

Official Title
-----------------
Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany

Conditions
-----------------
Healthy Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Main inclusion criteria: Age at enrolment 3 to 4 month Main Exclusion Criteria: Malformation or injury of the nasopharynx Known or suspected immunodeficiency Relevant immunosuppression Use of antibiotics up to 10 days prior to study inclusion

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 4 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and frequency of S. pneumonia positive serotypes |  | 57 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in number and frequency of S. pneumonia positive children at different ages over time |  | 57 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
S.pneumoniae healthy subjects, Healthy subjects
Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease activity in women with systemic lupus erythematosus. II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a case-controlled study. Intensive data collection begins when a patient becomes pregnant. Pregnant women are evaluated with interval pregnancy/exposure history and a clinical exam, including the Systemic Lupus Activity Measure (SLAM). Assessments are scheduled every 3 months as follows: visit 1 when the pregnancy is confirmed, visit 2 during the second trimester, visit 3 during the third trimester, visit 4 at 3 months postpartum, and visit 5 at 6 months postpartum. Visits 4 and 5 include an infant exam for growth and morphologic parameters; these visits occur on the same schedule if there is a miscarriage or stillbirth. Patients not currently pregnant are randomly chosen to be followed as controls. These patients undergo a review of current pregnancy status and measures of disease activity, including SLAM, every 3 months for 5 visits.

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
-----------------
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Relationship Between Hyperventilation Syndrome and SARS-CoV-2 Infection

Study Overview
=================
Brief Summary
-----------------
Following an acute COVID-19 infection, many patients suffer from long lasting physical symptoms that may greatly impair quality of life. Persisting dyspnea and other functional respiratory complaints could evoke Hyperventilation Syndrome (HVS) as a putative contributor of the long-COVID presentation in COVID-19 survivors. We aimed to assess the possible relationship between a HVS and previous acute SARS-CoV-2 infection.

Official Title
-----------------
A Cross-sectional Study : Is There a Relationship Between Hyperventilation Syndrome and History of Acute SARS-CoV-2 Infection?

Conditions
-----------------
COVID-19, Hyperventilation Syndrome

Intervention / Treatment
-----------------
* Other: Nijmegen questionnaire score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Read and speak French Perform a pulmonary function test Exclusion Criteria: - incomplete questionnaire or inability to obtain an interpretable lung function assessment

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 |
| --- | --- |
| Presence of Hyperventilation Syndrome (HVS+)<br>Study population was divided into two groups according to the diagnosis of Hyperventilation Syndrome HVS +- : Nijmegen questionnaire score > 23/64 | Other: Nijmegen questionnaire score<br>* We collected the Nijmegen Questionnaire in order to diagnosis of Hyperventilation Syndrome<br>|
| No presence of Hyperventilation Syndrome (HVS-).<br>Study population was divided into two groups according to the diagnosis of Hyperventilation Syndrome HVS - : Nijmegen questionnaire score < 24/64 | Other: Nijmegen questionnaire score<br>* We collected the Nijmegen Questionnaire in order to diagnosis of Hyperventilation Syndrome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the relationship between a hyperventilation syndrome and previous acute SARS-CoV-2 infection. |  | Nijmegen questionnaire during 15 minutes (cross-sectional monocentric study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the relationship between a hyperventilation syndrome and dyspnea |  | Nijmegen questionnaire during 15 minutes (cross-sectional monocentric study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid-19, dyspnea, Hyperventilation Syndrome
Integrated Care for Frail Older People

Study Overview
=================
Brief Summary
-----------------
This is a qualitative interview study investigating patients', carers' and providers' perspectives on integrated care and integrated care pathways for frail older people in Lambeth and Southwark, south London.

Official Title
-----------------
A Qualitative Study to Investigate Patients', Carers' and Providers' Perspectives on Integrated Care and Integrated Care Pathways for Frail Older People in Lambeth and Southwark, South London

Conditions
-----------------
Frail Elderly Syndrome

Intervention / Treatment
-----------------
* Other: No intervention given. This is a qualitative interview study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frail older people aged 65 years and over, including men and women with different levels of frailty. Carers (family member, friend or neighbor) identified by the frail older participant as a main carer. Health and social care professionals, care workers, service managers and commissioners working in different parts of the local health and care system (primary, secondary, community, social and voluntary care), reflecting a range of roles. Exclusion Criteria: Older people not identified as frail. Frail older people who are unable to provide their informed consent to take part in the study, for example due to significant cognitive impairment.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention given. This is a qualitative interview study|This is a qualitative interview study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stakeholders perspectives as assessed by interview survey | Stakeholders perspectives as assessed by interview survey | Day 1 |
Bariatric Surgery and Pharmacokinetics of Candesartan

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on candesartan are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Candesartan: BAR-MEDS Candesartan

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Candesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Candesartan|Patients are tested for their normal prescription candesartan medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candesartan concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Candesartan
Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?

Study Overview
=================
Brief Summary
-----------------
Children are typically inadequately prepared for the sexual abuse medical examination. Caregivers report lack of examination knowledge as a barrier to preparing their children. The purpose of this study was to determine if informational leaflets provided prior to the examination are helpful to caregivers in preparing their children.

Official Title
-----------------
Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?

Conditions
-----------------
Child Sexual Abuse, Suspected

Intervention / Treatment
-----------------
* Behavioral: Education Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive caregivers accompanying children for scheduled sexual abuse medical examination Exclusion Criteria: Lack of consent Failure to complete study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Education Counseling<br>Education of caregivers to counter lack of Preparedness for Children Undergoing Sexual Abuse Medical Examination | Behavioral: Education Counseling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the helpfulness of informational leaflets in preparing caregivers for the child sex abuse examination | [The study] undertook a prospective study of consecutive caregivers accompanying children for a scheduled sexual abuse medical examination. Prior to the appointment, caregivers were mailed information leaflets (in English and Spanish) about how to prepare their children for the exam. Caregivers completed pre and post exam surveys and the State-Trait Anxiety Inventory. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lack of Preparation for Abused Children during Medical Examination
Livalo Acute Myocardial Infarction Study (LAMIS)

Study Overview
=================
Brief Summary
-----------------
This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.

Official Title
-----------------
1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI)

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with STEMI, NSTEMI Patients satisfying at least one of the followings Patients with LDL-C ≥ 130 mg/dL Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator Patients taking statin are required continuous cholesterol lowering therapy Patients satisfying at least two of the followings The change of Ischemic ECG CK, CK-MB, Troponin-I increased more than two times The symptom of ACS Exclusion Criteria: Patients with in-stent restenosis after PCI or coronary artery bypass Patients with cardiogenic shock Patients with severe heart failure (Left ventricular ejection fraction is less than 30%) Patients who are taking cyclosporine Patients who experienced hypersensitivity to pitavastatin Patients under dialysis treatment Patients who are participating other clinical trials Patients who can not stop taking concomitant drugs Pregnant or lactating women or suspected pregnancy Patients who are regarded as ineligible for this study by the investigator
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 |
| --- | --- | --- |
| Incidence of TLR-MACE for 1 year after enrollment |  | 1 year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TVR-MACE for 1 year after enrollment |  | 1 year after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydroxymethylglutaryl-CoA Reductase Inhibitors
The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning

Study Overview
=================
Brief Summary
-----------------
To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors.

Detailed Description
-----------------
108 patients who passed the spontaneous breathing test (SBT) were included in this study,every patient were performed 30-60 minutes SBT after enrollment.Patients were divided into succeed weaning and difficult weaning group according the results of SBT, the difficult weaning group were futher divided into A(Airway and Lung dysfunction),B（Brain dysfunction）,C（Cardic dysfunction）,D（Diaphragm dysfunction）,E（Endocrine and metabolic dysfunction）five different groups according to the causes of difficult weaning. The respiratory mechanical parameters,the diameter of inferior vena cava and the diaphgram excursion were recorded before SBT and 30 minutes after SBT.

Official Title
-----------------
The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning

Conditions
-----------------
Intensive Care Medicine, Mechanical Ventilation, Weaning

Intervention / Treatment
-----------------
* Behavioral: weaning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanical ventilation patients prepared to weaning sign on the acknowledged Exclusion Criteria: endotracheotomy single lung pregnant heart,liver,renal failure

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| Weaning success<br>patients pass SBT and weaning without any ventilation in 48 hours | Behavioral: weaning<br>* T piece<br>|
| weaning failure<br>patients do not pass SBT or ventilation with any ventilation in 48 hours | Behavioral: weaning<br>* T piece<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the reasons of difficult weaning |  | 30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The predictive value of diaphragm associated values in weaning |  | 30mins |
Device to Assist With Abdominal Access During Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.

Official Title
-----------------
Pilot Study to Establish Safety and Ease of Use of a Trocar Placement Access Device (TPAD) for Laparoscopic Surgery

Conditions
-----------------
Laparoscopic Surgery

Intervention / Treatment
-----------------
* Device: Trocar Placement Assist Device (TPAD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 Scheduled for laparoscopic surgery Able to understand and willing to sign a written informed consent form Exclusion Criteria: Age < 18 Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated. Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall. Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia. Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trocar Placement Assist Device (TPAD)<br>Participants will receive investigational TPAD device during laparoscopic surgery | Device: Trocar Placement Assist Device (TPAD)<br>* The TPAD is an experimental device used to assist with placement of Veress needle and trocar during laparoscopic surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon satisfaction survey | The surgeon will complete a LIKERT scale satisfaction survey related to the TPAD to assess its ease of use. Scale range 1-5 (higher scores correspond to higher satisfaction) | up to 1 minute on day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery | Time from incision to successful placement of primary trocar will be measured and reported | Up to 10 minutes | 
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Adverse events related to the surgery itself, or to the incision and skin around the incision where the TPAD is placed | Continuous from start of surgery through postoperative day 7 |