linjc16/ctgov huggingface dataset:
A Registry Study of Biomarkers in Mitral Valve Disease (BIOMS-MVD)

Study Overview
=================
Brief Summary
-----------------
The registry study aims to discover the prognostic value of bio-markers in mitral valve disease

Detailed Description
-----------------
The purpose of this study is to investigate the prognostic value of biomarkers in mitral valve disease.Patients with confirmed diagnosis of mitral valve disease are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Official Title
-----------------
A Registry Study of Biomarkers in Mitral Valve Disease

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients clinically diagnosed with mitral valve disease in Beijing Anzhen Hospital from April 2016 to December 2019 The operator performs more than 25 mitral valve operations per year / the operator unit has surgeons who complete 50 operations per year Exclusion Criteria: Age ≤ 18 years Failure to obtain medical records and ultrasound data Refuse follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Number of death (all cause) | Number of death within 2 years of discharge | 1 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rehospitalizations | Number of heart failure related hospitalization within 1 years of discharge | 1 years of follow-up |
Morbidity and Mortality Follow Up for the Scleroderma Lung Study

Study Overview
=================
Brief Summary
-----------------
The primary intent of this study is to add to the body of knowledge on scleroderma patients with interstitial lung disease. While lung disease is recognized as the leading cause of death amongst patients with scleroderma, there is not a large body of literature describing the long-term morbidity and mortality rate of these scleroderma patients. For this reason, the investigators are following participants of the Scleroderma Lung Study (NCT00004563) after their participation in that study was concluded. In addition, the investigators will assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung Study experienced progression of their scleroderma-related lung disease following the end of the study.

Detailed Description
-----------------
Retrospective and prospective data will be collected about patients who participated in the Scleroderma Lung Study (SLS). An attempt will be made to include all of the participants of the Scleroderma Lung Study, who were reported as alive at the end of that study. A total of 158 subjects (79 per treatment arm) were randomized on the original Scleroderma Lung Study. Of those, 109 subjects completed the study. A single telephone interview with the participants to assess the occurrence of severe events and a review of the participant's medical records may be conducted. The outcome information will be combined with information collected about all participants in the SLS study. The data being collected includes information on mortality, development of cancers, development of organ failure, and performance status.

Official Title
-----------------
Morbidity and Mortality Follow Up of Participants of the Scleroderma Lung Study 1

Conditions
-----------------
Scleroderma

Intervention / Treatment
-----------------
* Other: Followup survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the Scleroderma Lung 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who received cyclophosphamide<br>Patients who received cyclophosphamide on the Scleroderma Lung Study | Other: Followup survey<br> <br> |
| Patients who received placebo<br>Patients who received placebo on the Scleroderma Lung Study | Other: Followup survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death or first organ failure |  | 9-12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleroderma, interstitial lung disease
Symbolic Representation in Young Children With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to characterize the process of constitution of symbolic representation in infants with Down syndrome, as well as to investigate the relationship between gestures and the emergence of oral language. The investigators hypothesis is that children with Down syndrome could present difficulties during the constitution of symbolic representation that may be related to later deficits on expressive language, generally observed in these children.

Detailed Description
-----------------
According to the Genetic Epistemology, language development is directly related to cognitive construction. Such relationship is clearly observed after the constitution of representation that allows one individual to express his or her thinking through language.

Official Title
-----------------
The Constitution of Symbolic Representation in Young Children With Down Syndrome

Conditions
-----------------
Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Study Group: genetic diagnosis of Down Syndrome be at the 4th stage of sensorimotor period at the initial assessment good health conditions good results on audiologic evaluation pediatric and ear, nose and throat periodic check ups. Inclusion Criteria for Control Group: good health conditions be at the 4th stage of sensorimotor period at the initial assessment pediatric and ear, nose and throat periodic check ups. Exclusion Criteria for all groups: submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development presence of visual or auditory important deficits historic of prematurely and/or low birth weight
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>20 infants with Down syndrome | |
| Control Group<br>15 typically developing children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on monthly assessments administered after the initial evaluation |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down syndrome, symbolic representation, gestures, expressive language development
Interactive Computer Treatment for Panic Disorder

Study Overview
=================
Brief Summary
-----------------
This study will develop an interactive computer-based version of cognitive behavioral therapy (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.

Detailed Description
-----------------
Panic disorder (PD) is a highly prevalent and debilitating condition. Unfortunately, many people with PD go untreated because of the high cost and low availability of treatment. Research shows that CBT is an effective treatment for PD. When administered as a self-help, computer based treatment, CBT may provide a less expensive, more engaging treatment for PD. Participants in this study will be randomly assigned to receive computer based treatment, book based treatment, or no treatment for 10 weeks. After these 10 weeks, symptoms of anxiety and depression will be measured with patient interviews, scales, and questionnaires.

Official Title
-----------------
Interactive Computer Treatment for Panic Disorder

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Behavioral: Computer Based Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of panic disorder, with or without agoraphobia Exclusion Criteria: Change in medication type or dose 12 weeks prior to study entry Suicidal Current substance abuse Current or past schizophrenia, bipolar disorder, or organic mental disorder. Patients on medications must meet stability requirements such that initial administration of the medication and dose has been maintained for at least 3 months prior to treatment and will be maintained until post-treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Behavioral: Computer Based Cognitive Behavioral Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

Study Overview
=================
Brief Summary
-----------------
Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch. In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.

Official Title
-----------------
LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Vardenafil (Levitra, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >/= 18 years Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers Exclusion Criteria:

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 |
| --- | --- |
| Group 1<br> | Drug: Vardenafil (Levitra, BAY38-9456)<br>* Patients under daily life treatment receiving Levitra according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied |  | 2 months | 
| Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vardenafil, Erectile dysfunction, Phosphodiesterase Inhibitors, Combination use with alpha-blockers
Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.

Official Title
-----------------
Evaluation of Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation

Conditions
-----------------
Liver Transplant Disorder, Reperfusion Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Undergoing primary orthotopic liver transplantation Exclusion Criteria: Redo orthotopic transplantation Acute or fulminant liver failure Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy Patients with an abnormal preoperative stress test (EF <55%, areas of prior infarct, ongoing ischemia)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Degree of change in cardiac strain | Evaluate the degree of change to cardiac strain using speckle tracking echocardiography | Up to 1 hour after graft reperfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of right and left ventricular strain | Describe the pattern of right and left ventricular strain throughout the course of orthotopic liver transplantion. | Up to 5 hours from the time of surgery start |
Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

Study Overview
=================
Brief Summary
-----------------
Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.

Detailed Description
-----------------
The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

Official Title
-----------------
Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: NightOwl HSAT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for a sleep study Exclusion Criteria: Mentally disabled people Known allergy to Plexiglas (PMMA) or other acrylates

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NightOwl HSAT<br>Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a Type IV sleep monitor. | Device: NightOwl HSAT<br>* Patient wears the NightOwl sensor device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors | At the time of the diagnostic night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep-wake discrimination | Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors | At time of the diagnostic night |
Drug-Drug Interaction Study of TRK-100STP

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Detailed Description
-----------------
Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

Official Title
-----------------
TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: TRK-100STP (BERASUS LA)
* Drug: AST-120 (Kremezin®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg Exclusion Criteria: Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments Receives any investigational medicine within 120 days before screening Recent blood donor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cross-over study | Drug: TRK-100STP (BERASUS LA)<br>* oral<br>* Other names: BERASUS LA;Drug: AST-120 (Kremezin®)<br>* oral<br>* Other names: sopherical carbon adsorbent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters (vital signs, ECG, laboratory tests) |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRK-100STP,, beraprost sodium,, Careload LA, AST-120, Spherical carbon adsorbent, Drug-drug interaction
Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

Study Overview
=================
Brief Summary
-----------------
A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.

Official Title
-----------------
A Retrospective Study for Collecting Data on the Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Device: EndoFast Reliant SCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Female subjects >18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP Exclusion Criteria: 1. Patients without follow-up

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 |
| --- |
|Device: EndoFast Reliant SCP|POP repair procedure with the EndoFast Reliant SCP system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- procedure and device related complication rate | Percentage of device and procedure related complications. | Up to 4 years |
Study of the Proteome and Cytokines During Inflammatory Syndromes of Different Etiologies.

Study Overview
=================
Brief Summary
-----------------
The hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. The identification of biological markers specific to an etiology would therefore allow a faster diagnosis and improve care for patients. We thus took an interest in the three groups of diseases most frequently responsible for an inflammatory syndrome, infections, cancers and auto-immune diseases. To achieve this, various methods will be used.

Conditions
-----------------
Inflammatory Disease

Intervention / Treatment
-----------------
* Other: proteomic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting an inflammatory syndrome, defined by elevated C-reactive protein (CRP>50mg/L), whose etiology is related to infection, cancer or an inflammatory disease. Patients not on treatment (corticoids, immunosuppressive drugs) during the 7 days preceding inclusion Age: 18-90 years Patients covered by the National Health Insurance Agency signed written informed consent form Exclusion Criteria: - Any patient not meeting the inclusion criteria Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with inflammatory syndrome<br> | Other: proteomic analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of usual parameters of inflammation |  | at baseline |