linjc16/ctgov huggingface dataset:
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Official Title
-----------------
Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)

Conditions
-----------------
OSA

Intervention / Treatment
-----------------
* Drug: AD109
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age at the time of informed consent. PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15 PROMIS-Fatigue: raw score ≥17 PAP intolerance or current PAP refusal. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive. Exclusion Criteria: Narcolepsy, restless leg syndrome, REM sleep behavior disorder Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD109<br>AD109 | Drug: AD109<br>* Oral administration at bedtime.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Oral administration at bedtime.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of AD109 on airway obstruction in mild to severe OSA | Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea
A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.

Detailed Description
-----------------
Vaginal invasion is a crucial index participant in cervical cancer tumor staging and prognosis prediction. However, the roles of vaginal invasion are overlooked in the literature, compared with those of lymph node metastasis and parametrial invasion. As far as we know, this study is novel to construct a nomogram to predict the probability of pathologic vaginal invasion occurrence.

Official Title
-----------------
Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients

Conditions
-----------------
Cervix Carcinoma

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed cervical cancer; FIGO2018 stage IB-IIA according to the result of physical examination and images; No preoperative treatment before surgery; Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery. All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection. Exclusion Criteria: Accompanied with other tumors; Accompanied with chronic infectious and immune diseases; Incomplete clinical data.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| cervical cancer treated with surgery<br>The inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data. | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaginal invasion | 100 cervical cancer patients who underwent radical hysterectomy (RH) with bilateral pelvic lymphadenectomy were pathologically assessed for vaginal invasion. The primary outcome is vaginal invasion or no-vaginal invasion. Pathological vaginal invasion is defined as cervix tumor disruption of the vaginal wall. | 7 days after surgery |
Study on AUNIP as a Novel Tumor Marker for Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.

Detailed Description
-----------------
Blood of all study participants of cervical cancer patients are collected to detect the expression of AUNIP, analyze the statistical correlation between the expression of cervical cancer AUNIP and clinicopathological parameters of patients, and preliminarily understand the expression of AUNIP in cervical cancer tumor tissues and its clinical diagnostic and progniostic value.

Official Title
-----------------
Study on AUNIP as a Novel Tumor Marker for Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Detection of serum AUNIP expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study group inclusion criteria: Women aged 20-60 There is a definite pathological diagnosis of cervical cancer Healthy control group: Women aged 20-60 No tumors in the uterus or other parts of the body No inflammatory disease Blood routine and blood biochemical tests are normal Exclusion Criteria: Exclusion criteria of the study group: There are other lesions in the uterus and uterine adnexa Exclusion criteria of healthy control group: Pregnant, lactating or menarche women Women who are undergoing human papillomavirus (HPV) vaccination

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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 |
| --- | --- |
| study group<br>Women aged 20-60; There is a definite pathological diagnosis of cervical cancer | Diagnostic Test: Detection of serum AUNIP expression<br>* The experiment is carried out according to the ELISA kit instructions, and the absorbance optic density (OD) value of the enzyme labeler at 450 nm is read. The protein concentration of AUNIP in the serum sample is calculated according to the standard curve.<br>|
| Healthy control group<br>Women aged 20-60; No tumors in the uterus or other parts of the body; No inflammatory disease; Blood routine and blood biochemical tests are normal. | Diagnostic Test: Detection of serum AUNIP expression<br>* The experiment is carried out according to the ELISA kit instructions, and the absorbance optic density (OD) value of the enzyme labeler at 450 nm is read. The protein concentration of AUNIP in the serum sample is calculated according to the standard curve.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUNIP expression in serum | Serum AUNIP expression is detected by ELISA kit. The results will be recorded seperately. | through study completion, an average of 3 year |
Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)

Study Overview
=================
Brief Summary
-----------------
Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate. The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI

Official Title
-----------------
Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better

Conditions
-----------------
Infertility, Male, Azoospermia, Reproductive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI Exclusion Criteria: Spouse with advanced maternal age (> 40 years) Egg donation cycle

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TESA-ICSI<br>Compare ICSI outcomes with high Sperm DNA fragmentation undergoing TESA (testicular sperm extraction) | |
| Zymot-ICSI<br>Compare ICSI outcomes with high Sperm DNA fragmentation using microfluidic sperm separation device (Zymot) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation | approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of utilizable blastocysts obtained | Compare the number of utilizable embryos obtained in couples using TESA-ICSI vs Zymot-ICSI | Approximately 20 days |
Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults

Study Overview
=================
Brief Summary
-----------------
Semaglutide is a medication approved by the US Food and Drug Administration (FDA) as an antihyperglycemic (a drug that reduces glucoses in those with diabetes) and for weight management. This new study will help find out what effects, semaglutide has on people who take the drug and the drug's effect on physical function, body composition, and aging.

Official Title
-----------------
The Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Biomarkers of Aging in Older Overweight/Obese Adults With Insulin Resistance

Conditions
-----------------
Aging, Diabetes Mellitus, Type 2, PreDiabetes, Overweight and Obesity

Intervention / Treatment
-----------------
* Drug: Semaglutide Injectable Product
* Behavioral: Lifestyle Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 65 Have prediabetes or diabetes BMI ≥ 27.0 kg/m2 Living independently (not in assisted living or nursing home) Exclusion Criteria: Have heart disease Have liver disease Smoke

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaglutide and lifestyle intervention<br>Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks. | Drug: Semaglutide Injectable Product<br>* Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.<br>Behavioral: Lifestyle Counseling<br>* Lifestyle Counseling will be provided throughout study intervention<br>|
| Active Comparator: Lifestyle intervention<br>Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program | Behavioral: Lifestyle Counseling<br>* Lifestyle Counseling will be provided throughout study intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking distance | Determine if there is any change in 6 minute walking distance at end of study. Participants are timed to see how far they can walk in 6 minutes. Distance walked will be measured in meters. | 20 weeks |
DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.

Official Title
-----------------
DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study

Conditions
-----------------
Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
-----------------
* Diagnostic Test: DIC markers and Thrombin Generation Parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≧ 18; AND Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support. Exclusion Criteria: Patients who are on central VA-ECMO support; OR Patients with missing clinical data; OR Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR Post-operative admissions

Ages Eligible for Study
-----------------
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 |
| --- | --- |
| Adult Intensive Care Unit, Queen Mary Hospital<br> | Diagnostic Test: DIC markers and Thrombin Generation Parameters<br>* Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications<br>|
| Department of Intensive Care Unit, Tuen Mun Hospital<br> | Diagnostic Test: DIC markers and Thrombin Generation Parameters<br>* Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of thrombotic and hemorrhagic events | Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO. Hemorrhagic events include bleeding at critical sites or requiring interventions. | From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECMO, Thrombosis, Haemorrhage
Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

Study Overview
=================
Brief Summary
-----------------
The precise and noninvasive evaluation of disease activity among patients with Crohn's disease is not easy, especially for children. It deals with clinical, biological, histological and radiological parameters. Bowel sounds (BS) when evaluated by a stethoscope are modified by several factors including surgery, infection, drugs or intestinal inflammation. These factors can interact on intestinal motricity. There is a direct relationship between gastrointestinal motility and characteristics of BW. The study of BS using a stethoscope is a simple method, although operator dependent and subjective,with a wide inter and intraindividual variability. Some studies among adults showed interest in the spectral analysis of BS to assess gastrointestinal motility. This more precise and reproducible method is not operator dependent. To date, no such study has evaluated the correlation between disease activity and the spectral pattern of BS. of this project is to assess the correlation between disease activity and the spectral pattern of BS in pediatric Crohn's disease.

Official Title
-----------------
Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

Conditions
-----------------
Bowel Sounds, Intestinal Inflammation, Crohn Disease

Intervention / Treatment
-----------------
* Other: Abdominal auscultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's Disease Age between 4 and 17 years Follow-up at CHU Amiens-Picardie Exclusion Criteria: Other diseases than Crohn's or treatments affecting the gastrointestinal tract, recent (< 3 months) surgery or refusal to participate (parents or children)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paediatric inflammatory bowel disease<br> | Other: Abdominal auscultation<br>* spectral analysis of Bowel sounds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of frequency of bowel sounds |  | one day | 
| evaluation of wPCDAI | wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX | one day | 
| correlation between wPCDAI and frequency of bowel sounds | wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel sounds, Intestinal Inflammation, Crohn Disease
Imaging the Pathogenesis of Cerebral Small Vessel Disease

Study Overview
=================
Brief Summary
-----------------
Cerebral small vessel disease (CSVD) can lead to vascular cognitive impairment and dementia (VCID). The hallmark of CSVD is the appearance and progression of white matter hyperintensities (WMH) on MRI. The goal of this study it to recruit and follow individuals at risk for WMH progression and use serial MRI scanning to gain insights into the pathogenesis of CSVD.

Detailed Description
-----------------
Vascular Cognitive Impairment and Dementia (VCID) which is attributed in large part to cerebral small vessel disease (CSVD) is prevalent in patients with a history of stroke and vascular risk factors. The hallmark of CSVD is white matter hyperintensities (WMH) seen on T2-weighted MRI. The initial amount, and rate of progression, of WMH is tied closely with the development and progression cognitive deficits. It is hypothesized that one of the early pathologic features in the normal appearing white matter (NAWM), before it progresses to WMH is disruption of the blood-brain barrier (BBB) and loss of micro-structural integrity. The purpose of this study is track the progression of WMH using multiple MRI biomarkers looking at BBB disruption (DCE, DSC, ASL), micro-structural changes (multi-shell DTI), and macrostructural changes (FLAIR, SWI, T1) to better understand the pathogenesis of CSVD. Patients with a history of a stroke, at least one vascular risk factor, and evidence of CSVD on MRI may be eligible for this study. We will follow 50 patients with 3 MRIs performed over 1.25 years

Official Title
-----------------
Imaging the Pathogenesis of Cerebral Small Vessel Disease

Conditions
-----------------
Ischemic Stroke, Hypertension, Hyperlipidemias, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical or radiographic evidence of ischemic stroke One vascular risk factor (hypertension, hyperlipidemia, or diabetes) Evidence of cerebral small vessel disease on MRI Exclusion Criteria: Inability to complete 3 research MRI scans over 1.25 years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of cerebral small vessel disease | Conversion of normal appearing white matter to white matter hyperintensity measured on MRI using 3D FLAIR imaging. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral small vessel disease, Vascular cognitive impairment and dementia, White matter hyperintensities, Blood-brain barrier, Vascular risk factors, Ischemic stroke