linjc16/ctgov huggingface dataset:
Genetic Causes of Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
Familial hypercholesterolemia (FH) is a common disease. The genetic background to FH is not yet fully understood. In the present prospective cohort study we aim to study the association between different clinical characteristics, gene mutations and prognosis.

Detailed Description
-----------------
In this prospective observational cohort study of patients with high clinical suspicion of familial hypercholesterolemia (FH) we aim to study the association between different clinical characteristics, gene mutations and prognosis. The included patients will undergo physical examination and extended blood sampling. DNA will be extracted and used for both whole genome sequencing and investigation of both known- , unknown- and suspected mutations associated with FH. The patients will be followed in for 15 years in the Swedish patients registry and the Swedish cause of death registry.

Official Title
-----------------
Genetiska Orsaker Till familjär Hyperkolesterolemi- Mekanism, Prognos Och Individanpassad Behandling

Conditions
-----------------
Familial Hypercholesterolemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 8 years or older. Clinical suspicion of FH Dutch Lipid Clinic Network Score of at least four or a first grade relative with a genetic deviation that may be associated with FH. Exclusion Criteria: 1) Age below 8 years.

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Group 1<br>Patients with high clinical suspicion of familial hypercholesterolemia. No intervention. | Other: No intervention<br>* No intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of mutations. | The prevalence of known and newly discovered mutations associated with FH in the study population. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis, composite endpoint. | Time to death (cardiovascular and total), hospitalization due to acute myocardial infarction, unstable angina, heart failure or stroke. | 10 years | 
| Prognosis, individual endpoint. | Time to the individual endpoints: death (cardiovascular and total), hospitalization due to acute myocardial infarction, unstable angina, heart failure, stroke. | 10 years |
Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: inositol + folic acid
* Dietary Supplement: inositol + folic acid
* Drug: Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 women in their first trimester of pregnancy affected by one or more of the following risk factors: Glycemia levels > 92 mg/dl BMI > 30 At least a parent or a brother (or sister)affected by diabetes Pre-existing pregnancy with gestational diabetes Exclusion Criteria: Pregnant women affected by pregestational diabetes Twin pregnancy Patients affected by pre-existing diseases in pregnancy (diabetes excluded) Patients affected by chronic disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myo-inositol powder<br> | Dietary Supplement: inositol + folic acid<br>* 2000 mg of inositol+200mcg of folic acid; 2 per diem<br>|
| Experimental: Myo-inositol soft gel capsules<br> | Dietary Supplement: inositol + folic acid<br>* 600 mg of inositol + 200mcg of folic acid; 2 cp per diem<br>|
| Placebo Comparator: Folic acid<br> | Drug: Folic Acid<br>* Folic Acid 400mcg; 1 cp/die<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OGTT | The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pregnant women with gestational diabetes |  |  | 
| Number of pregnant women requiring insulin treatment |  |  | 
| Weight gain at the end of pregnancy |  |  | 
| Number of newborn infants whose weight is more than 4000 g |  |  | 
| Number of newborn infants requiring Neonatal Intensive Care (NIC) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, pregnancy, myo-inositol
Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral selegiline.

Detailed Description
-----------------
To determine the safety of the selegiline concurrent with d-methamphetamine challenges of 15mg & 30mg i.v. with the focus being on cardiovascular responses (HR,BP) to the i.v. methamphetamine challenges. This is a randomized, single-blind, placebo-controlled, two-arm study design to evaluate the safety of selegiline treatment, compared to placebo treatment, concurrent with i.v. methamphetamine challenges.

Official Title
-----------------
Assessment of Potential Interactions Between Intravenous Methamphetamine and Oral Selegiline

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Selegiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers who meet DSM-4 criteria for methamphetamine abuse or dependence; non-treatment seeking individuals Be able to verbalize understanding of consent form; provide written informed consent Exclusion Criteria: Please contact site for more information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selegiline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of selegiline |  |  | 
| pharmacokinetic assessment |  |  |
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting

Study Overview
=================
Brief Summary
-----------------
User questionnaire of Eeva System usability and reports of device malfunctions.

Detailed Description
-----------------
This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.

Official Title
-----------------
Eeva Continued Access Study.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs Subject is ≥ 18 and ≤ 40 years of age. Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle. Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm. Subject has ≥ 5 normally fertilized eggs (2 PN) Willing to have all 2PN embryos monitored by Eeva Willing to comply with study protocol and procedures and able to speak English. Willing to provide written informed consent. Exclusion Criteria: Reinseminated eggs. History of cancer. Gestational carriers. Planned preimplantation genetic diagnosis or preimplantation genetic screening. Previously enrolled in this study Concurrent participation in another clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Women undergoing IVF treatment<br>Women undergoing IVF treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User questionnaire of Eeva System usability and reports of device malfunctions. |  | Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in vitro fertilization, assisted reproduction, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocysts, infertility, Genital Diseases, Male, Genital Diseases, Female
Estimation of Glomerular Filtration Rate (GFR) in Patients With Type 2 Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin C and creatinine based equations for GFR estimation compared with 51Cr-EDTA (chromium-51 labeled ethylenediamine tetraacetic acid) measured GFR in patients with diabetes.

Detailed Description
-----------------
The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin C and creatinine based equations for GFR estimation compared with 51Cr-EDTA measured GFR in patients with diabetes. Additional, we will check which equation detects better the reduction of renal function over the time, in patients with diabetes. Finally, we will investigate if cystatin C levels can be influenced by factors other than GFR

Official Title
-----------------
Comparative Study of New Formulae of GFR Estimation Based on Creatinine, Cystatin C and Cr51-EDTA.

Conditions
-----------------
Diabetes Mellitus, Diabetic Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 and type 1 diabetes mellitus Exclusion Criteria: Patients with other type diabetes: gestational, exocrine pancreatic defects, endocrinopathies, drugs Patients with end-stage renal disease, cardiac failure, hepatic failure, malignancies, immunosuppression, pregnant, diabetic ketoacidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
Expression of Optic Atrophy Type 1 (OPA1) Protein in Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial bioenergetics and mitochondrial networks. The changes in mitochondrial shape and mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.

Conditions
-----------------
Lung Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will collect paraffin blocked resected lung tissue samples from stage I IIIa non-small cell lung cancer patients (age, 40 80 years old) who received lobectomy of the affected lung. Exclusion Criteria: History of uremia, other malignant disease, and liver cirrhosis History of pneumonia and pulmonary tuberculosis History of long period of medications.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPA1, lung adenocarcinomas, Prognosis, Expression of optic atrophy type 1 (OPA1) protein in lung adenocarcinoma
Predicting COVID-19 Patients' Clinical Outcomes Using ICU Mobility Scale and MRC Sum Score

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for Coronavirus disease 2019(COVID-19) patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators proposed a retrospective cohort study to see if ICU mobility scale(ICUMS) and Medical Research Council Sum Score(MRCSS) can predicted the patients' Barthel index after discharge and hospitalization days.

Detailed Description
-----------------
The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for COVID-19 patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators checked the patient's baseline ICUMS and MRCSS upon admission. Also, blood test results were also obtained. Subsequently, the investigators measured their outcomes by Barthel index and hospitalization length, and divided them into two groups. The ICUMS, MRCSS and the blood test results differences between two groups were checked. For those factors that showed significant difference between two groups, the investigators recruited them into regression model. Last, receiver operating curve of those factors were plotted to find the appropriate cutoff points for identifying two groups of outcomes.

Official Title
-----------------
Predicting COVID-19 Patients' Barthel Index and Hospitalization Using ICU Mobility Scale and Medical Research Council Sum Score

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 patients diagnosed by positive polymerase chain reaction(PCR) Exclusion Criteria: Impaired baseline activities, such as stroke, fracture, neurodegenerative disease Baseline Barthel index score less than 100 Lost follow-up
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 |
| --- | --- | --- |
| Barthel index | Score from 0 to100. Higher score indicates better daily activities of living. | Barthel index score 3 months after discharge | 
| Hospitalization days | Hospitalization days | days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Activities of Daily Living, Muscle Strength
Infant Sleep Behaviour and Gut Microbacteria

Study Overview
=================
Brief Summary
-----------------
The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight into the functional coevolution of the GMB and host sleep behavior.

Official Title
-----------------
Sleep Behaviour and Gut Microbiota in Healthy Infants

Conditions
-----------------
Gut Microbiota and Sleep in Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health status exclusively breastfed (at baseline) vaginal birth delivery mode Exclusion Criteria: C-section delivery mode Formula fed (at baseline) Diseases or lesions of the central nervous system, acute pediatric disease, developmental/neurologic/metabolic disorders, chronic medical conditions, or head injury Family history of narcolepsy/psychosis/bipolar disorder Conceptual age of < 37 or > 42 weeks Low birth weight (< 2500g) Co-sleeping during > 50% of the time in the same bed Medication use affecting sleep/alertness Vaccination (2 weeks prior to study) Antibiotics (3 months prior to study) Travelling across a time zone (within 1 month prior to study) intrauterine drug exposure, intrauterine infection, known or suspected drug or alcohol abuse Insufficient knowledge of German (parents)

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 13 Months

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 |
| --- | --- | --- |
| Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers) |  | across the first twelve months of life | 
| Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes |  | across the first twelve months of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep) |  | across the first twelve months of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut Microbiota, Gut Microbiome, Sleep, Infancy, Development
Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the concurrent validity of a newly developed pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator in the stimulation of muscle proprioceptors.

Official Title
-----------------
Comparison of fMRI Compatible Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors

Conditions
-----------------
Proprioceptive Postural Control

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for healthy individuals: Age: 20-45 years old No history of low back pain A score of 0% on the Oswestry Disability Index Willingness to sign the informed consent Exclusion Criteria: History of major trauma and/or major orthopedic surgery of the spine, pelvis or lower quadrant One of the following conditions: Parkinson, MS, Stroke with sequels.... Radicular symptoms Not Dutch-speaking Strong opioids Neck pain Ankle problems Smoking

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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 |
| --- | --- |
| Healthy<br>Healthy persons, without non-specific low back pain | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprioceptive postural control | Center of pressure displacement on a force plate in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control. | 6 months |
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.

Official Title
-----------------
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

Conditions
-----------------
Meconium Aspiration Syndrome

Intervention / Treatment
-----------------
* Other: Heliox mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meconium aspiration syndrome diagnosed based on clinical and radiological findings, respiratory failure requiring mechanical ventilation Exclusion Criteria: congenital malformations or congenital genetic syndromes, persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Heliox<br> | Other: Heliox mechanical ventilation<br>* Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in acid-base balance and oxygenation | Acid-base balance and oxygenation assessed on arterial blood gas samples, saturation measured with a pulse oximeter and calculated values of oxygenation index and alveolar-arterial oxygen tension difference. | Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in respiratory parameters | Analyzed parameters: tidal volume (VT, [ml/kg]), minute ventilation (VE, [l]) and peak expiratory flow rate (PEFR, [l/min]). Recorded ventilator settings: respiratory rate (RR), mean airway pressure (MAP) and fraction of inspired oxygen (FiO2). | Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meconium aspiration syndrome, Heliox, Mechanical ventilation, Newborn