linjc16/ctgov huggingface dataset:
Questionnaire and Laboratory Data on Vitiligo Vulgaris

Study Overview
=================
Brief Summary
-----------------
Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. The triggers for disease onset have not yet been identified. The intent of this study is to research trends in laboratory data, social and medical history that may be contributory to vitiligo onset, location of disease, course of illness and response to therapy.

Detailed Description
-----------------
Patients who participate in this study will be asked to complete a survey and have blood/ laboratory testing performed that relates or may relate to the diagnosis of vitiligo.

Official Title
-----------------
Demographic and Laboratory Data Collection for Patients With Vitiligo Vulgaris

Conditions
-----------------
Vitiligo Vulgaris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Vitiligo Vulgaris Ability to sign consent Exclusion Criteria: Pregnant Inability to sign consent Inability to complete questionnaire
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 |
| --- | --- | --- |
| Quality of life disturbances in people with vitiligo | dermatology life quality indices were you used and correlated with location of disease | point prevalence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reporting of vitiligo disease symptoms and history | Correlation of the patient survey response with chart documentation was performed. | single survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitiligo Vulgaris
Inflammatory Bowel Disease and Thromboembolic Events

Study Overview
=================
Brief Summary
-----------------
The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.

Official Title
-----------------
Inflammatory Bowel Disease and Thromboembolic Events

Conditions
-----------------
Inflammatory Bowel Diseases, Thromboembolism, Coagulation Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 18 years of age or older, diagnosed with IBD, followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu, between November 2016 and April 2017. Exclusion Criteria: Individuals with other risk factors for TE (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).

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 |
| --- | --- |
| IBD patients<br> | Other: No intervention was made<br>* No intervention was made<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of thromboembolic events in IBD | To evaluate the coagulation parameters and the prevalence of thromboembolic events in IBD patients | 36 months | 
| Coagulation parameters variations in IBD | To investigate the correlation between coagulation parameters and disease phenotype and activity. | 36 months |
Body Weight Gain, Parkinson, Subthalamic Stimulation

Study Overview
=================
Brief Summary
-----------------
Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

Detailed Description
-----------------
Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be : Clinical examination Autoevaluation dietary questionnaire Biological tests Study in calorimetry chamber (only in Clermont-Ferrand centre) Heart rate recorded during 7 days in usual conditions of life Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D) Acute Ldopa challenge (in both conditions of dopa and stim) Apathy evaluation Body weight, and body compositions measurements

Official Title
-----------------
Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: Energy metabolism by chronic bilateral subthalamic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 70 years old Diagnosis of Parkinson' disease established for 5 years at least Ldopa effect > 50 % Hoehn and Yarh score > 2.5 in On phase Exclusion Criteria: Metabolism disorder Biological analysis abnormal

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Energy metabolism by chronic bilateral subthalamic stimulation|Patients will be studied before and after STN-DBS surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate recorded during 7 days in usual conditions of life |  | 7 days in usual conditions of life | 
| energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D) |  | 14 days in usual conditions of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease, Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.
The Role of ITGAM in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.

Official Title
-----------------
TAP0307.6: Sub-study of TAP 0307- Enrollment of Normal Controls to Study the Role of ITGAM in Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females, age 18 or older, enrolled in Genotype and Phenotype Registry, in general good health Participants who carry the genotype of interest, based on a buccal or blood derived DNA sample Exclusion Criteria: History of Systemic Lupus Erythematosus, rheumatoid arthritis, or other autoimmune disease History of cancer or lymphoma Current use of aspirin, prednisone, or NSAID or any immunosuppressant Self reported HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
At present, there are few studies on the clinical remission rate of diabetes after one year discontinuation of oral hypoglycemic drugs after intensive treatment. HMS5552 is a kind of GKA hypoglycemic drug. This study intends to observe the clinical remission rate of diabetes mellitus, beta cell function and blood sugar fluctuation of patients with type 2 diabetes mellitus who have been treated with HMS5552 for 52W or 28W and whose glucose control is up to the standard.

Official Title
-----------------
A Study to Observe the Progress of Diabetes Mellitus After 52 or 28 Weeks of HMS5552 Treatment for Type 2 Diabetes Mellitus

Conditions
-----------------
Type2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: HMS5552


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete HMS5552 treatment and safety visit; HbA1c < 8.0% was detected in our laboratory; Researchers judged the stability of glucose control based on the data of subjects'visits during HMS5552 treatment and the indicators of our hospital; Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise; Willing to sign written informed consent and abide by the research program. Exclusion Criteria: There was a state of illness in the subjects who could not complete the follow-up during the observation period. The researchers judged that subjects'compliance with HMS5552 was affected during treatment.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HMS5552 treatment<br> | Drug: HMS5552<br>* To observe the progress of diabetes mellitus after 52 or 28 weeks of HMS5552 treatment for type 2 diabetes mellitus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Changes of HbA1c | 4 weeks | 
| Fasting glucose | Changes of fasting glucose | 4 weeks | 
| Postprandial glucose | Changes of postprandial glucose | 4 weeks | 
| C peptide | Changes of C peptide | 4-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-α | Changes of TNF-α | 52 weeks | 
| IL-6 | Changes of IL-6 | 52 weeks | 
| 8-iso PGF2α | Changes of 8-iso PGF2α | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucokinase Activator, Glucose control
Arterial Blood Pressure-complexity in Septic Patients

Study Overview
=================
Brief Summary
-----------------
Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops resulting in a variable and complex time course. According to the decomplexification theory of illness, disease is characterised by a loss or impaired function of feedback loops resulting in a decreased complexity of the ABP-time course and an impaired adaptability of the cardiovascular system. Decomplexification of physiologic parameters has been shown to occur in coronary heart disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been evaluated in sepsis. This study is intended to test the hypothesis that complexity of ABP is lower in cardiac surgery versus non-cardiac surgery septic patients, decreases as severity of sepsis increases to severe sepsis and septic shock, is associated with outcome three month after sepsis.

Official Title
-----------------
Investigation of Arterial Blood Pressure-complexity and Its Relation to Outcome in Comparison Between Cardiac Surgery Versus Non-cardiac Surgery Septic Patients

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from sepsis, severe sepsis or septic shock Exclusion Criteria: pregnancy

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 |
| --- | --- | --- |
| short form-36 |  | 3 month after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, arterial blood pressure, complexity, variability
Neonates With Neurological Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study is to identify all neonates (newborns < 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution

Detailed Description
-----------------
Studies have shown that between one-quarter and one-half of infants undergoing cardiac surgery will suffer brain injury during surgery (the perioperative period). Some infants with congenital heart disease have neurological injury prior to cardiac surgery as a result of cyanosis, acidosis and abnormal circulation. The spectrum of neurological injury ranges from agitation and subtle disturbances in learning and new memory acquisition to visual and motor development abnormalities, seizures, stroke and encephalopathy. The patient will be identified from the cardiothoracic surgery database. Their hospital medical records and the neurological database will be reviewed for type of neurological complication (i.e. seizure, stroke), neuro-imaging and any mortality for these patients. We will review the patient outcome data that is available, after the initial surgery, through June 20, 2006. No patients will be contacted.

Official Title
-----------------
Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children's Healthcare of Atlanta patients January 1, 2002 through June 20, 2006 < 30 days of age neurological complications following cardiac surgery Exclusion Criteria: Those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

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 |
| --- | --- | --- |
| The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates. | In congenital cardiac defects where there was a choice of palliation vs complete anatomic repair, premature neonates underwent palliative procedures more frequently than term neonates. Premature neonates spent more days of mechanical ventilation compared to their term counterparts. Importantly, there was no difference in mortality between the two groups. | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonates, neurological complications, surgery
Digital Breast Tomosynthesis in Younger Symptomatic Women

Study Overview
=================
Brief Summary
-----------------
This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.

Official Title
-----------------
Digital Breast Tomosynthesis (DBT): Sensitivity for Cancer and Accuracy in Assessing Extent of Malignant Disease in Symptomatic Women Below 60 With Clinical or Ultrasound Signs Compatible With Malignancy

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Under 60 years old Clinical or ultrasound suspicion of breast cancer Exclusion Criteria: Unable to give informed consent Male Obvious advanced breast cancer Obvious medical problems meaning surgery would not be an option

Ages Eligible for Study
-----------------
Maximum Age: 59 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 |
| --- | --- |
| Digital Breast Tomosynthesis<br>Digital Breast Tomosynthesis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of DBT for breast cancer, compared with FFDM |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of DBT compared with FFDM in assessment of tumour extent |  | Two years | 
| Relative accuracy of DBT and FFDM by breast density |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast, Cancer, Digital, Mammography, Tomosynthesis
A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.

Official Title
-----------------
A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.

Conditions
-----------------
Healthy Condition

Intervention / Treatment
-----------------
* Diagnostic Test: Medical examination or treatment.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned for YVOIRE Y-Solution 360 or 540 or 720 filler injection in facial area (except middle of the forehead, lips) for the volume enhancement or anti-wrinkle treatment. Male and female of 19 years or above age. Informed consent to participate in the study. Able to participate throughout the study period. Exclusion Criteria: Prohibited in the Product Label. Have active or infectious skin disease in injection area. Autoimmune disease or HIV infected patient. Received immunosuppressive therapy within 2 weeks. Previously experienced Delayed-onset nodule after filler injection in facial area. Previously experienced Hypertrophic scar or Keloid. Have participated in an interventional clinical investigation within 30 days or plan to participate one during the study period. Ineligible for this clinical investigation as per Investigator's discretion.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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: Medical examination or treatment.|Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed-onset nodule. | Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected. | 1 year. | 
| Other adverse events. | Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected. | 1 year. |
Studies on Aldosterone and Vascular Function

Study Overview
=================
Brief Summary
-----------------
A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.

Official Title
-----------------
Studies on Aldosterone and Vascular Function

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: aldosterone
* Dietary Supplement: low or high sodium diet
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects age >18 years Exclusion Criteria: Any chronic medical disease or chronic use of medications

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Aldosterone plus low salt diet | Drug: aldosterone<br>* 4 hour infusion<br>Dietary Supplement: low or high sodium diet<br> <br> |
| Experimental: B<br>Aldosterone plus high sodium diet | Drug: aldosterone<br>* 4 hour infusion<br>Dietary Supplement: low or high sodium diet<br> <br> |
| Placebo Comparator: C<br>Placebo plus low sodium diet | Dietary Supplement: low or high sodium diet<br> <br> Drug: placebo<br>* placebo<br>|
| Placebo Comparator: D<br>placebo plus high sodium diet | Dietary Supplement: low or high sodium diet<br> <br> Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilation brachial artery |  | 0 and 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular endothelium, nitric oxide, aldosterone, vascular biology