linjc16/ctgov huggingface dataset:
Genetics of Cardiovascular and Neuromuscular Disease

Study Overview
=================
Brief Summary
-----------------
We are studying the genetics of human cardiovascular and neuromuscular disease. There are many different genetic regions that have been associated with the development of cardiomyopathy. An equal number of genetic regions have been associated with muscular dystrophy and there is overlap because some of the identical genes, when mutated, produce both cardiomyopathy and muscular dystrophy. We are working to identify genes and gene mutations associated with cardiomyopathy, arrhythmias and muscular dystrophy. We propose to screen these samples for mutations in genes known to be involved in these disorders.

Official Title
-----------------
Genetic Studies of Patients and Their Families With Inherited Cardiovascular and Neuromuscular Diseases.

Conditions
-----------------
Cardiomyopathy, Arrhythmia, Muscular Dystrophy

Intervention / Treatment
-----------------
* Procedure: Blood draw (genetic testing)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of all ages will be considered for the study. In particular, families with more than one affected relative will be sought. Exclusion Criteria: Subjects without a suspected inherited cardiovascular or neuromuscular disorder will be excluded from this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood draw (genetic testing)|Blood draw (genetic testing)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic causes of cardiomyopathy |  | unlimited | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiomyopathy, Arrhythmia, Muscular Dystrophy
P Gingivalis Oral Infection, Intimamedia Thickening in Infants, Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
To determine if there is an association between Porphyromonas gingivalis infection of dental gingiva during primary tooth eruption and thickening of the radial artery intimamedial layers. Thickening of these layers in infants could be a promoting factor for later development of atherosclerosis.

Detailed Description
-----------------
Specific Aim 1. To determine the presence of Pg in the mouth of edentulous pre-eruption and then teething infants. Over a 9-month period 15 normal babies will be recruited for a prospective pilot study from Creighton University students. Cotton swabs of the tongue mucosa and dental plaque will be made to detect the presence of Pg by DNA analysis. Specific Aim 2. To determine the daily temperature of infants. Daily child temperatures will be recorded by the parent. Specific Aim 3. To measure the thickness of the radial artery using a 50 MHz ultrasound probe. A 50 MHz ultrasound scan will be made by a trained dental hygienist of the left radial artery at an initial visit and at 3-monthly intervals to measure IMT.

Official Title
-----------------
Early P Gingivalis Oral Infection and Ultrasound Detection of Intimamedia Thickening in Radial Arteries of Young Children

Conditions
-----------------
Tooth Eruption, Atherosclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-primary tooth eruption infants in the range of 4-8 months - Exclusion Criteria: No erupted teeth. No diabetes, obesity, chronic inflammatory disorders, hyperlipidemia, -

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasound|Measurement of thickness of radial artery wall thickness by ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial wall thickness | Increase in thickness of intimamedia layers | 9 months |
Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

Study Overview
=================
Brief Summary
-----------------
If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and more important. Treatment of patients presenting TMD is based on conservative and reversible therapeutics. The behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.

Official Title
-----------------
Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

Conditions
-----------------
Temporomandibular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female over 18, Patient who was informed about the protocol and who did not refuse to take part in the programme, Patient who suffers of dysfunctions of masticatory apparatus: myofascial pain, joint clicking or crepitations, disc deplacement with reduction, mandibular limitation and/or deviation, Patient who presents more or less obvious parafunctions, which are associated or not to other etiologies Patient consulting for the 1st time for TMD Exclusion Criteria: Persons over 18 who are under legal protection (guardianship), persons who are deprived of their freedom, Patient who is already followed in the consultation of dysfunctions of masticatory apparatus and who is under treatment, Patient who is under treatment of occlusal splint (not in the framework of the consultation of TMD Patient with pains other than orofacial pains (cephalalgia, neuralgia, vascular algia of the face, migraine), Patient who needs a treatment other than a behavioural reeducation (pharmacological treatment, occlusal splint , addressed to another therapist, prosthetic treatment)

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 |
| --- | --- | --- |
| Assessment of pain based on the analogical visual scale | To know the incidence of a treatment which is unique, reversible and performed in first intention: behavioural reeducation in the evolution of clinical signs of TMD : pain; disc deplacement with reduction, limitation or mandibular deviation during mouth opening. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction | Evaluation of parafunctions as an etiological factor of dysfunctions of masticatory apparatus. | 1 year | 
| Assessment of behavioural reeducation | Interest of diagnosis criteria of investigation on temporomandibular disorders. | 1 year |
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).

Detailed Description
-----------------
In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.

Official Title
-----------------
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical neoplasia HPV infection patient Exclusion Criteria: no HPV infection no intra-epithelial neoplasia lesion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 2<br>Group 1: normal pap smear Group 2: cervical neoplasia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of mRNA expression |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The integrated HPV DNA |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mRNA,, DNA,, integrated HPV DNA, human papillomavirus,, cervical neoplasia
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Actos
* Drug: aleglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes for >=1 month; drug naive, or receiving stable oral antihyperglycemic medication; HbA1c 6.5-10.0% at screening. Exclusion Criteria: type 1 diabetes; current or previous treatment with insulin; history of renal disease other than diabetic nephropathy; uncontrolled hypertension; clinically significant cardiovascular disease; Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Aleglitazar<br> | Drug: aleglitazar<br>* 0.6mg po daily<br>|
| Active Comparator: Actos<br> | Drug: Actos<br>* 45mg po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline in glomerular filtration rate |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR) |  | 26 weeks | 
| Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI). |  | End of treatment | 
| Adverse events (AEs), laboratory parameters. |  | Throughout study |
Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.

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

Intervention / Treatment
-----------------
* Other: Use of impedance threshold device during spontaneous ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18-65 years of age Exclusion Criteria: Dilated cardiomyopathy Congestive heart failure Pulmonary hypertension Severe aortic stenosis Flail chest Chest pain Shortness of breath

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: All<br>All subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after | Other: Use of impedance threshold device during spontaneous ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated venous oxygen saturation | Oxygen saturation will be calculated from the five minute period of time prior to use of the impedance threshold device (0-4 mins), and then again in the 2 minute period after the impedance threshold device is applied (5-6 mins) | From 5 to 6:59 minutes after applying the impedance threshold device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD).

Study Overview
=================
Brief Summary
-----------------
For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on refining the target for DBS in OCD will be included in this follow-up study as well. They will be psychiatrically evaluated on regular bases: at least twice yearly in the years two to five after surgery, at least once a year for the years thereafter. The duration of this protocol is indefinite, but spans at least 10 years. The main aim of this study is to investigate the long-term effect of DBS in OCD patients.

Official Title
-----------------
Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Severe Treatment Refractory Obsessive Compulsive Disorder (OCD).

Conditions
-----------------
Obsessive Compulsive Disorder (OCD)

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have received DBS implantation for the treatment of OCD Exclusion Criteria: -

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DBS for OCD<br> | Device: Deep Brain Stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obsessive compulsive disorder (OCD), deep brain stimulation (DBS), psychosurgery, long-term follow-up
Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion

Study Overview
=================
Brief Summary
-----------------
The are 2 principal goals in this study: To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states. To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.

Official Title
-----------------
Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion

Conditions
-----------------
Hypoosmolality, Hyperosmolality, Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic renal failure grade I through IV healthy age-matched controls Exclusion Criteria: chronic renal failure grade V heart failure liver disease nephrotic syndrome anemia (hemoglobin level < 100 g/L) uncontrolled hypertension (systolic BP > 160 mmHg; diastolic BP > 95 mm Hg) coexisting severe disease known thyroid disease known hypocortisolism known hypercortisolism known diabetes insipidus pregnancy lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoosmolality, Hyperosmolality, Copeptin, Vasopressin
Cheese and Human Health

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter. The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.

Official Title
-----------------
Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: cheese


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign written consent Age: 20-70 BMI: 20-32 Refrain from dietary supplements and blood donations prior to, and during the study Exclusion Criteria: Known or suspected abuse of alcohol, drugs or medication Poor compliance Current or previously cardiovascular disease Diabetes Mellitus or other severe chronic disease, including severe allergies

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: butter<br>Danish butter | Other: cheese<br>* the effect of cheese intake versus butter intake on blood lipids (primarily)<br>* Other names: cheese, butter, dairy;|
| Experimental: cheese<br> | Other: cheese<br>* the effect of cheese intake versus butter intake on blood lipids (primarily)<br>* Other names: cheese, butter, dairy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  | 6 weeks | 
| LDL cholesterol |  | 6 weeks | 
| HDL cholesterol |  | 6 weeks | 
| Triglyceride |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin |  | 6 weeks | 
| Glucose |  | 6 weeks | 
| fasting hsCRP |  | 6 weeks | 
| Blood pressure |  | 6 weeks |
Growth Hormone Treatment in Short Children Born Small for Gestational Age

Study Overview
=================
Brief Summary
-----------------
Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

Official Title
-----------------
Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial

Conditions
-----------------
Infant, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born small for gestational age actual body height less than or equal -3 SDS chronological age greater than 3 years Exclusion Criteria: Growth hormone deficiency any defined syndromal disease Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- |
|Drug: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 2 different doses used are non-inferior to each other |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profiles |  |  | 
| Compare absolute height velocity |  |  |