linjc16/ctgov huggingface dataset:
Culture System for Isolating Circulating Tumor Cells

Study Overview
=================
Brief Summary
-----------------
This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating cancer cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.

Official Title
-----------------
Culture System for Isolating Circulating Tumor Cells

Conditions
-----------------
Early Detection of Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polycythemia patients are between the ages of 20 and 70. Willing to sign the consent form under the informed consent. Inclusion Criteria: Exclusion Criteria: 1. Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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 |
| --- | --- | --- |
| Cancer Cell Isolation Efficiency of The Isolation System | The percentage isolation of fluorescently-labeled A549 cell lines will be spiked into the whole blood, and the put into the system. The supernatant of the system will be collected to re-culture on the culture dishes and analyzed by fluorescence microscope. | 1 day | 
| WBCs adhesion ratio | The whole blood will be diluted and put into the system. And the supernatant will be collected to count the number of blood cell number by the automatic blood cell count. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulating tumor cells,WBCs adhesion, biomedical materials
Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of three interventions on CPAP adherence.

Detailed Description
-----------------
To determine whether there is a need for a more intensive one on one interaction with the patient in order to improve CPAP usage. And also to try to identify in general which population of patients may require a more intensive intervention.

Official Title
-----------------
Weekly Phone Calls vs. Brief Patient Education to Improve CPAP Compliance: A Randomized Controlled Trial

Conditions
-----------------
Obstructive Sleep Apnea (OSA)

Intervention / Treatment
-----------------
* Behavioral: Weekly phone calls
* Behavioral: Frequently asked questions
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All new patients undergoing of the Sleep Center suspected of having sleep apnea and undergoing sleep studies Exclusion Criteria: Refusal to participate, or not suspected of having sleep apnea prior to 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly phone calls<br>Will be called weekly to answer questions regarding usage. | Behavioral: Weekly phone calls<br>* Calling weekly to answer questions regarding CPAP usage.<br>|
| Active Comparator: Frequently asked questions<br>Providing written general answers to commonly asked questions. | Behavioral: Frequently asked questions<br>* Answers to frequently asked questions in pre-printed form.<br>|
| Active Comparator: Usual care<br> | Behavioral: Usual care<br>* Answers will be provided by the renter of the equipment, and the sleep center if asked in addition to explanations by the sleep specialist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which intervention will improve CPAP compliance in sleep apnea |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To try to identify which individual characteristics within a group may require a specific intervention |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA, CPAP
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects MR Perfusion Imaging will be assess in both cochlea as well Primary auditory brain pathways will be evaluated through MR diffusion imaging

Official Title
-----------------
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

Conditions
-----------------
Meniere Disease

Intervention / Treatment
-----------------
* Drug: Gadoteric acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years) Informed consent signed Medical examination performed prior to participation in research Patients without history of inner ear disease Recipient of a French social security scheme Exclusion Criteria: Patients minors Patients on a legal protection regime type guardianship Respiratory pathologies, cardiovascular, renal, diabetes Claustrophobia Contraindications to exposure to a magnetic field Contraindications to injecting Dotarem ®

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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: Gadoteric acid<br>Gadoteric acid 0.2 mmol/kg | Drug: Gadoteric acid<br>* Comparison with patients with Meniere's disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging |  | One MR scan (4 hours) |
CSF Cholinergic Biomarkers and Postoperative Cognitive Change

Study Overview
=================
Brief Summary
-----------------
Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.

Official Title
-----------------
Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients

Conditions
-----------------
Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Lower Limb

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elder than 60 years old Spoke proficient Mandarin Chinese Agree to undergoing spinal plus general anesthesia Selected total knee replacement surgery Exclusion Criteria: Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 Several audition or vision disorder Unwillingness to comply with the protocol or procedures.

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

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 |
| --- | --- | --- |
| Short-term postoperative cognitive dysfunction rate |  | The day before surgery and 7 days after surgery (or before leave hospital) | 
| Concentration of Acetylcholine in CSF |  | During spinal anesthesia | 
| Concentration of choline acetyltransferase in CSF |  | During spinal anesthesia | 
| Concentration of acetylcholinesterase in CSF |  | During spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term postoperative cognitive dysfunction rate |  | Two months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Postoperative cognitive changes, Acetylcholine in CSF
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Detailed Description
-----------------
This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant. Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician. Primary Objective: -To treat a single patient with gastroparesis who has requested expanded access with tradipitant Secondary Objectives: To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient

Official Title
-----------------
VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

Conditions
-----------------
Gastroparesis, Diabetic Gastroparesis

Intervention / Treatment
-----------------
* Drug: Tradipitant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identified subject who requested expanded access Diagnosed with gastroparesis Demonstrated delayed gastric emptying Presence of moderate to severe nausea Patient does not qualify for or does not have access to other clinical trials with tradipitant; Exclusion Criteria: Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis A positive test for drugs of abuse at the screening or evaluation visits; Exposure to any investigational medication in the past 60 days other than tradipitant Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tradipitant|NK-1 Receptor antagonist|

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
-----------------
tradipitant, gastroparesis, idiopathic, diabetic, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p, expanded access
Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.

Detailed Description
-----------------
Research question: Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers? Research hypothesis: The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.

Official Title
-----------------
Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study

Conditions
-----------------
Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: Three-dimensional (3D) ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications Exclusion Criteria: Twins. Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc). Autoimmune disorders. Congenital fetal anomalies. Macrosomia and intrauterine growth restriction (IUGR). Intrauterine fetal death (IUFD). Amniotic fluid index <5cm or >20cm. Patients taking steroids within one week of measurement of lung volume.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Three-dimensional (3D) ultrasonography|A longitudinal section of fetal chest will be obtained that clearly depicts the lung. A 3D window will be activated . After complete electronic sweep and assurance of absence of fetal or maternal movements to avoid motion artifacts, 3D multi-planar view will be then obtained|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal respiratory distress | Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers | immediately after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Neonatal mortality rate | - Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission | One week after delivery |
Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months

Study Overview
=================
Brief Summary
-----------------
The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants. 2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection. Evaluation of the area under the ROC for Procalcitonin concentration.

Detailed Description
-----------------
Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

Official Title
-----------------
Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months

Conditions
-----------------
Fever, Bacterial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant older than 7 days old and less than 3 months old. Fever (defined by a rectal temperature greater than or equal to 38°C) Emergency consultation Exclusion Criteria: Infants with a previously identified immunodeficiency or chronic disease, Antibiotic treatment within the previous 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 3 Months

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 |
| --- | --- | --- |
| Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections |  | At the day of emergency consultation for fever | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin |  | At the day of emergency consultation for fever | 
| Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin |  | At the day of emergency consultation for fever | 
| Diagnostic value (sensibility and specificity) of CRP versus procalcitonin |  | At the day of emergency consultation for fever | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fever, Infant, Procalcitonin, Serious Bacterial Infection
A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, and potential efficacy of IMB-1018972 in patients with non-obstructive HCM.

Official Title
-----------------
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy

Conditions
-----------------
Non-obstructive Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: IMB-1018972
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European guidelines Ability to perform an upright treadmill cardiopulmonary exercise test Agreement to abide by contraceptive requirements Exclusion Criteria: Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability Women who are pregnant, planning to become pregnant or lactating Participation in another clinical study involving a test product or invasive medical device within 28 days (or within 5 elimination half-lives of the respective test product, whichever is longer), prior to first dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: IMB-1018972 200mg<br> | Drug: IMB-1018972<br>* Modified release (MR) oral tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching oral tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs |  | Baseline through Week 14 Safety Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET) |  | Baseline, Week 12 |