linjc16/ctgov huggingface dataset:
A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.

Official Title
-----------------
A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent/legally authorized representative (LAR) can speak and read English fluently, have provided informed consent and agree to be contacted for an interventional study prior to being genotyped. Subject is 6 to 17 years of age (inclusive) at the time of informed consent. Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD. Parent/LAR confirms that the subject is not pregnant and/or breastfeeding. Exclusion Criteria: Parent/LAR confirms that the subject has been diagnosed with any of the following conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression, autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure disorder, syncope, or other serious cardiac problems. Aside from your child's current ADHD medication (if applicable), parent/LAR confirms that the subject is currently taking any of the following medications: antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers. Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity |  | Day 1 |
Modulating the Vaginal Microbiome After Implantation Failure

Study Overview
=================
Brief Summary
-----------------
Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal supplements.

Official Title
-----------------
Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements

Conditions
-----------------
Implantation Failure, Infertility, Female, Vaginal Flora Imbalance

Intervention / Treatment
-----------------
* Drug: Vivag Plus
* Drug: Placebo - Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unfavorable vaginal microbiome using ARTPreds test non-smoker Exclusion Criteria: use of oral antibiotics oral probiotics between diagnosis and inclusion in the study pregnancy at inclusion allergy towards study drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised placebo controlled, double blinded study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vivag Plus<br>Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7. | Drug: Vivag Plus<br>* Contains two lactobacilli strains; l. gasseri and l. rhamnosus<br>|
| Placebo Comparator: Placebo<br>Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7. | Drug: Placebo - Cap<br>* Vaginal supplements<br>* Other names: Placebo vaginal capsule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vaginal microbiome after intervention | The investigators wish to determine if the vaginal microbiome will stay changed one month after intervention. The change in vaginal microbiome will be measured with ARTPreds diagnostic test, after intervention and again one month later. The test divides the vaginal microbiome into three categories, low, medium and high. A change in vaginal microbiome is defined by a shift from low to medium or high, or a shift from medium to high. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, female, Vaginal microbiome
Body Image Disorder in Anorexia Nervosa and Virtual Reality

Study Overview
=================
Brief Summary
-----------------
Evaluation of the tolerance and acceptability of the virtual representation of its body image.

Official Title
-----------------
Body Image Disorder in Anorexia Nervosa and Virtual Reality

Conditions
-----------------
Anorexia

Intervention / Treatment
-----------------
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, aged between 16 and 40 Post-puberty Pure restrictive anorexia nervosa, diagnosis by the DSM-V BMI <17.5 Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France Having signed the Informed Consent Form For minor patients, signing the form of informed consent of both parents Exclusion Criteria: Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa), Psychiatric disorders (characterized depressed, anxiety disorder) Neurological Disorders Mental retardation Abuse or addiction to alcohol Abuse or dependence on psychoactive substances in the previous year. Patient with a protective justice measure

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software | Device: Virtual reality<br>* The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-questionnaire assessing tolerance | Patients will have to respond to a self-administered questionnaire assessing tolerance | Day 15 | 
| Self-questionnaire assessing acceptability | Patients will have to respond to a self-administered questionnaire assessing acceptability | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeling of presence | Patients will respond to a self-questionnaire of feeling of presence | Day 15 | 
| Subjective experience by EDI-2 questionnaire | Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire. | Day 15 | 
| Subjective experience by BSQ questionnaire | Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire. | Day 15 |
Comparison the Value of Several Biomarkers of Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the value of serum sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical informative value in predicting outcome.

Detailed Description
-----------------
The investigators enrolled 130 subjects admitted to an ICU: 30 cases with systemic inflammatory response syndrome (SIRS), 36 cases with sepsis, 35 cases with and 29 with septic shock. Results for sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score were recorded on days 1, 3, 5, 7, 10, and 14.

Official Title
-----------------
Comparison of the Value of Serum sTREM-1, sCD163, PCT, CRP Concentrations, WBC Count and SOFA Score During Sepsis and Their Clinical Informative Value in Predicting Outcome

Conditions
-----------------
Systemic Inflammatory Response Syndrome, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female aged 18 years old and over; Clinically suspected infection; Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands. Exclusion Criteria: Those who fulfilled one below: neutropenia (≤ 500 neutrophils/mm3) HIV infection, and patients or their relatives refused

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 |
| --- | --- |
| SIRS<br>(1) temperature > 38oC or < 36oC; (2) pulse rate > 90 beats/min; (3) ventilation rate > 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) < 32 mmHg; (4) white blood cell (WBC) count >1 2,000μL-1 or < 4000 μL-1 , or > 10% immature cells. | |
| Sepsis<br>SIRS + infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Outcome | The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCT, sTREM-1, sCD163, CRP, WBC count, SOFA score, SIRS, sepsis, severity, prognosis
Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure

Study Overview
=================
Brief Summary
-----------------
High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.

Official Title
-----------------
Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive

Conditions
-----------------
Prehypertension, Gout, Pulse Wave Velocity, Hypertension, 24 Hour Blood Pressure

Intervention / Treatment
-----------------
* Drug: Febuxostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP). Plasma uric acid level ≥5 mg/dl Ages 18-50 non-smokers Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email. Exclusion Criteria: no current smoking in the prior 6 months. Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study. Any history of gout, hypertension, hypercholesterolemia, morbid obesity. Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications any history of illicit drug use within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Febuxostat<br> | Drug: Febuxostat<br>* 80mg PO daily for 8 weeks<br>* Other names: Uloric;|
| Placebo Comparator: Placebo<br> | Drug: Febuxostat<br>* 80mg PO daily for 8 weeks<br>* Other names: Uloric;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 24 Hour Blood Pressure |  | 8 weeks | 
| Changes in Pulse Wave Velocity |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prehypertension, Gout, Puls Wave Velocity, Hypertension, 24 hour blood pressure
The Role of Visceral Hyperalgesia, Gastroesophageal Reflux Disease (GERD) and Esophageal Motility Disorder (EMD) in NCCP Patients

Study Overview
=================
Brief Summary
-----------------
Noncardiac chest pain (NCCP) is a common clinical problem worldwide. In Hong Kong, it has been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary heart disease. Despite its benign nature, this condition causes anxiety, impairs quality of life and consumes a substantial amount of healthcare resources. While acid reflux and motility disorder in the esophagus are often attributed as the cause of NCCP, visceral hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of this condition. This research project aims to evaluate the role of visceral hyperalgesia in Chinese patients with NCCP. NCCP patients will be evaluated for the prevalence of gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and pH study. The visceral sensory and pain thresholds of these patients will be compared with asymptomatic controls.

Official Title
-----------------
Is Visceral Hyperalgesia the Culprit of Noncardiac Chest Pian in Chinese? Part I: The Role of Visceral Hyperalgesia, Gastroesophageal Reflux Disease (GERD) and Esophageal Motility Disorder (EMD) in NCCP Patients

Conditions
-----------------
Non-Cardiac Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy Age between 18-70 Exclusion Criteria: Gastroesophageal reflux disease Psychiatric illness Cerebrovascular accident Active peptic ulceration Heart failure or cardiac bradyarrhythmia Epilepsy Pregnancy or lactating female Previous hypersensitivity to muscle relaxant

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic Studies of Strabismus, Nystagmus, and Associated Disorders

Study Overview
=================
Brief Summary
-----------------
Strabismus (misalignment of the eyes) often runs in families. In this study, the investigators are looking for genetic variants associated with strabismus and nystagmus. Three types of subects will be enrolled: (1) Families with at least 3 members with strabismus, (2) individuals with infantile esotropia and their parents and siblings, and (3) individuals with infantile nystagmus and their parents. Whole exome and/or whole genome sequencing will be used to identify genetic variants shared by family members with strabismus and to identify genetic causes of nystagmus.

Official Title
-----------------
Genetic Studies of Strabismus, Nystagmus, and Associated Disorders

Conditions
-----------------
Strabismus, Nystagmus, Congenital

Intervention / Treatment
-----------------
* Genetic: whole genome sequencing or whole exome sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of a family with at least 3 biological relatives with strabismus. (Both affected and non-affected family members will be enrolled). OR Member of a family with at least 1 individual with infantile esotropia. (Both affected and non-affected family members will be enrolled). OR Member of a family with at least 1 individual with nystagmus. (Both affected and non-affected family members will be enrolled). - Exclusion Criteria: paralytic strabismus in affected family members -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: whole genome sequencing or whole exome sequencing|Whole genome sequencing or whole exome sequencing will be performed for all enrolled participants.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variants | genetic variants shared by family members with strabismus | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
strabismus, esotropia, exotropia, nystagmus
Left Atrial Appendage Exclusion Study

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.

Detailed Description
-----------------
The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.

Official Title
-----------------
Left Atrial Appendage Exclusion Study II

Conditions
-----------------
Atrial Appendage

Intervention / Treatment
-----------------
* Device: LARIAT Suture Delivery Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is greater than or equal to 18 years of age Subject has atrial fibrillation (paroxysmal or persistent) Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant) Subject is willing and able to provide written informed consent Subject has a life expectancy of at least 1 year Subject is willing and able to return for scheduled follow up visits Exclusion Criteria: Previous cardiac surgery Thrombus in the left atrial appendage or left atrium NYHA Class IV heart failure symptoms Need for emergent cardiac surgery (i.e. cardiogenic shock) LAA is not appropriate for exclusion based upon intraoperative evaluations Current diagnosis of active systemic infection Renal failure requiring dialysis or hepatic failure A known drug and/or alcohol addiction Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study Pregnancy or desire to get pregnant within 12 months of the study treatment Preoperative need for an intra-aortic balloon pump or intravenous inotropes Patients who have been treated with thoracic radiation Patients in current chemotherapy Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases. Patients with known connective tissue disorders, i.e. Lupus Previous history of pericarditis Presence of a PFO/ASD or valve implant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>LAA exclusion with the LARIAT Suture Delivery Device | Device: LARIAT Suture Delivery Device<br>* LAA exclusion procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device related serious adverse events |  | 30 days | 
| Percent of patients with complete exclusion of the LAA measured with TEE |  | 90 days |