linjc16/ctgov huggingface dataset:
Pelvic Floor Disorders Among Sexual Minoritized Women

Study Overview
=================
Brief Summary
-----------------
The investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) in WSW.

Detailed Description
-----------------
There is a paucity of data regarding care of women who have sex with women (WSW). While some cohort studies are being performed in general gynecology, no studies document the reasons as to why WSW seek urogynecological care, or how pelvic floor disorders (PFDs) affect sexual function in this population. Another detrimental gap in current knowledge and a barrier to care for WSW is the lack of understanding of what would drive WSW to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. The Investigators aim to perform qualitative interviews to understand how PFDs affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to WSW.

Official Title
-----------------
Pelvic Floor Disorders Among Sexual Minoritized Women

Conditions
-----------------
Sexual Function Disturbances, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence

Intervention / Treatment
-----------------
* Other: None, this is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence) Age >18 Able to provide consent Able to read/write in English Exclusion Criteria: WSW who have not been sexually active in the past 6 months Incarcerated patients Pregnant or lactating patients Unable to consent with study procedures or guided discussions Unable to speak English No sexual activity in the past 6 months

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None, this is an observational study|This is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative impact of pelvic floor disorders on sexual function | We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative inclusivity of sexual function questionnaires | We will examine this with guided focus groups | 6 months |
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

Study Overview
=================
Brief Summary
-----------------
This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.

Official Title
-----------------
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: raloxifene
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy. Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent). Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0. Exclusion Criteria: Patients with a history of thromboembolism. Patients with positive antiphospholipid antibodies. History of allergic reactions or intolerance to raloxifene or other SERMs. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism. Patients with abnormal uterine bleeding of unknown etiology. Patients with serum creatinine level of >= 200 umol/L.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>raloxifene | Drug: raloxifene<br>* 60mg/day<br>|
| Placebo Comparator: 2<br>placebo arm | Drug: placebo<br>* tab 1 daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover and bone mineral density |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture, safety |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
raloxifene, estrogen, receptor, modulation, osteoporosis, steroid, Steroids
Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

Study Overview
=================
Brief Summary
-----------------
In this study patients who are intubated and on ventilator for more than 24h will be ventilated at three different level of support in Pressure Support and Neural Pressure Support to study patient-ventilator synchrony and muscle unloading.

Detailed Description
-----------------
This study is an interventional randomized crossover study in intubated and mechanically ventilated patients for more than 24h. Eligible patients from whom informed consent is obtained and Pes and Edi catheter are successfully positioned are enrolled in the study. Patients will be ventilated in Pressure Support and Neural Pressure Support at three different level of assist (baseline, 50% and 150% of baseline respectively) in randomized order. Ventilator curves will be recorded and bloodgas obtained at the end of each study step, each lasting 20min.

Official Title
-----------------
Neural Pressure Support, a Randomized Crossover Trial

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Device: Neural Pressure Support (mode of mechanical ventilation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients intubated for more than 24 hours in the weaning phase from the ventilator. Exclusion Criteria: bleeding disorders (PK INR>1,5 or APTT>50s or platelet count <50000/µL) unstable circulation (requiring high vasopressor dose, for example Noradrenalin >0,2µg/kg/min) severe lung disease (PFI ≤ 13,3 kPa) fever> 38,5°C pregnancy.

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
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neural Pressure Support<br>Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order | Device: Neural Pressure Support (mode of mechanical ventilation)<br>* Nasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-ventilator asynchronies | quantification of asynchronies by the use of the Edi catheter | 20 minutes ventilatory traces recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory muscle unloading | quantification of muscle unloading by use of Pes | 20 minutes ventilatory traces recording |
Bolus Insulin Card Calculator Randomised Controlled Study

Study Overview
=================
Brief Summary
-----------------
In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.

Official Title
-----------------
Bolus Insulin Card Calculator Randomised Controlled Study

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: ezy-BICC dose calculation card
* Other: Fixed dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 11 - 18 years old Currently using indvidual subcutaneous injections (not CSII) Exclusion Criteria: HbA1c > 9.5% Serious illness

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed dose<br>Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin. | Other: Fixed dose<br>* Approach where study subject is prescribed a set amount of carbohydrate to eat each meal and set dose of rapid acting insulin. Minor modifications may be made if the measured BGL is out of target<br>|
| Experimental: ezy-BICC dose calculation card<br>variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin. | Device: ezy-BICC dose calculation card<br>* small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours BGL > 8.3mmol/l (CGMS) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Youth, Insulin dose
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: Bromfenac Ophthalmic Solution A
* Drug: Bromfenac Ophthalmic Solution B
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be of either gender and any race 18 years or older Exclusion Criteria: Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

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: Bromfenac Ophthalmic Solution A<br>Bromfenac ophthalmic solution A | Drug: Bromfenac Ophthalmic Solution A<br>* sterile ophthalmic solution<br>|
| Experimental: Bromfenac Ophthalmic Solution B<br>Bromfenac ophthalmic solution B | Drug: Bromfenac Ophthalmic Solution B<br>* sterile ophthalmic solution<br>|
| Placebo Comparator: Placebo Comparator<br>Placebo Comparator | Drug: Placebo Comparator<br>* sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Surface Disease Index (OSDI) Total Score | The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes. | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sign and symptoms of dry eye disease
Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment

Study Overview
=================
Brief Summary
-----------------
Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.

Detailed Description
-----------------
The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement

Official Title
-----------------
Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in ICSI Treatment Cycles

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: measuring cell freeDNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: third day embryos Exclusion Criteria: less than third day embryos
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Third day embryos<br>embryos culture media during third day after fertilization | Other: measuring cell freeDNA<br>* measuring cell free DNA using PCR<br>|
| Fifth day embryos<br>embryos culture media during fifth day after fertilization | Other: measuring cell freeDNA<br>* measuring cell free DNA using PCR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlations between levels of measured cell free DNA and embryo quality. |  | 12 months |
Study of Antibiotic Utilization Measures and Control of ESBLs in China

Study Overview
=================
Brief Summary
-----------------
A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2

Detailed Description
-----------------
To determine the value of using β-lactamases inhibitors in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection after 12 months. To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months

Official Title
-----------------
Association of Antibiotic Utilization Measures and Control of Extended-spectrum β-lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.

Conditions
-----------------
ICU Patient

Intervention / Treatment
-----------------
* Drug: Third generation cephalosporins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted or transferred to the ICU/burn units. Patients of either sex, 18 years of age or older. Exclusion Criteria: Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase inhibitors.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Third generation cephalosporins|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For both MICU1 and MICU2 (acquisition), all culture results will be collected and recorded, then analyzed to determine the ESBL acquisition rate and bacterial isolates (E. coli or K. pneumoniae). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tzh-Chi ESBL study
Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Off-pump Coronary Artery Bypass Graft

Study Overview
=================
Brief Summary
-----------------
High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is released by inflammatory cells actively, or increased during cell death passively and mediates inflammatory response. It has been reported to have association with the prognosis after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.

Conditions
-----------------
Coronary Artery Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 Patients undergoing off-pump coronary artery bypass graft Exclusion Criteria: Age < 20 Patients undergoing off-pump coronary artery bypass graft with other simultaneous surgery Patients participating other study

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| HMGB1 group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum value of HMGB1 | Measure the maximum value of HMGB1 in all patients and calculate median value. And device into upper median value group and under median value group and compare frequency of composite morbidity/mortality rate between two groups. composite morbidity/mortality is as follows: Stroke Renal failure Prolonged ventilation more than 24 hours Deep sternal wound infection Reoperation for any reason Mortality during the hospitalization for surgery, even if over 30 days | Change from induction of anesthesia to 2hrs after transfer to intensive care unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high mobility group box 1, prognostic biomarker, off-pump coronary artery bypass graft, patients
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

Detailed Description
-----------------
This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose

Official Title
-----------------
A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis

Conditions
-----------------
Secondary Progressive Multiple Sclerosis

Intervention / Treatment
-----------------
* Biological: Placebo
* Biological: Baminercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of Secondary Progressive Multiple Sclerosis Aged 18 to 57 years old, at the time of informed consent Exclusion Criteria: History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis) Inability in the opinion of the Investigator to comply with study requirements Other protocol-defined criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 57 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Placebo|nan|
|Biological: Baminercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo |  | after 4 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo |  | 8 months (4 months on drug, 4 months post-drug) |