linjc16/ctgov huggingface dataset:
Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

Study Overview
=================
Brief Summary
-----------------
This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

Official Title
-----------------
A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release

Conditions
-----------------
Hypercholesterolemia, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: niacin (+) laropiprant
* Drug: niacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL Exclusion Criteria: Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL. Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: niacin (+) laropiprant|Duration of Treatment: 18 Weeks|
|Drug: niacin|Duration of Treatment: 18 Weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Flushing Severity Score (GFSS) over 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Study Overview
=================
Brief Summary
-----------------
This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.

Conditions
-----------------
Excisional Hemorrhoidectomy

Intervention / Treatment
-----------------
* Device: Slotted Anoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are at least 18 years of age Are willing to give consent and comply with evaluation and treatment schedule Meet institutional criteria for excisional hemorrhoidectomy Are able to understand and complete study questionnaires. Exclusion Criteria: Previous Hemorrhoid surgery Chronic daily narcotic use Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure Internal hemorrhoids that may be suitable for office management (surgeon discretion) Fecal or urinary incontinence Inflammatory Bowel Disease (Crohns, ulcerative colitis) Acutely thrombosed hemorrhoids (surgeon discretion) Evidence of acute sepsis or the presence of a fistula Anal stricture.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Slotted Anoscope|SA411|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Duration (Surgery Time) | Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope. | Time of surgery |
Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: nisoldipine
* Drug: lisinopril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic nephropathy, type 1 diabetes, hypertension Exclusion Criteria: child bearing potential, non-diabetic kidney disease, malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nisoldipine|nan|
|Drug: lisinopril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glomerular filtration rate from study start to study end |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure response |  |  | 
| change in urinary albumin excretion rate |  |  |
Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy

Study Overview
=================
Brief Summary
-----------------
The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies: to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy. fetal chromosomal abnormalities

Official Title
-----------------
Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy

Conditions
-----------------
Chromosome Abnormality, Twin Pregnancy With Antenatal Problem

Intervention / Treatment
-----------------
* Procedure: Fetal Selective Reduction Technology
* Drug: Potassium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ultrasound diagnosis as twin pregnancy at 11-14 gestational weeks Exclusion Criteria: Multiple pregnancies (three or more) Maternal history of chromosome aneuploidy abnormality or tumor

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fetal Selective Reduction Technology<br>Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure | Procedure: Fetal Selective Reduction Technology<br>* Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16 24 weeks, 24 27+6 weeks,>28weeks<br>Drug: Potassium Chloride<br> <br> |
| No Intervention: control group<br>normal dichorial twins without any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate for the operation |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term complications after surgery |  | 1 year |
Quality of Life in Pediatric Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Measurement of the quality of life (QoL) of children and adolescents with inflammatory bowel diseases (IBD) has had little attention, despite the importance of understanding key factors affecting QoL, especially for measuring the effects of clinical trials to improve IBD outcomes. The main purpose of this pilot study is to examine the impact of clinical severity and treatment social factors on the quality of life (QoL) of a diverse population of children and adolescents with inflammatory bowel disease (IBD). Secondary purposes include determining the effects of sociodemographic factors on QoL and exploring the concordance of views of parents and children of QoL. The study aims are to 1) determine the associations of of clinical characteristics (condition type, activity/severity, and treatment) with specific components of general health-related quality of life and IBD-specific QoL; 2) describe the effects of sociodemographic characteristics (SES, age, and gender) on these measures; and 3) compare the views of different observers (parent and child with IBD) of the child's QoL. The study will apply both general and condition-specific QoL measures among a random sample of 250 children and adolescents with IBD, ages 5-18 years, in six clinical sites. We will obtain measures of QoL from both the child and a parent in each case. The study will obtain additional data regarding the subjects' clinical condition (condition type, severity/activity, treatment [including surgery], age of onset) and socioeconomic status (household structure and income). Main analyses will compare general and specific measures of QoL and examine the influence of clinical and sociodemographic variables on QoL, through multivariate regression techniques. We will also examine the differences in child and parent assessments of QoL. The information from this study will provide a stronger base for future studies of treatment and natural history of IBD. It will help to clarify the life domains that are affected by IBD and will inform interventions to improve QoL for children with IBD.

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
All children ages 8-17 years in any of six centers for inflammatory bowel disease in children who have already enrolled in the IBD consortium database.

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric IBD, Inflammatory, Bowel
Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.

Detailed Description
-----------------
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.

Official Title
-----------------
A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Desvenlafaxine Sustained Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study. Women of childbearing potential must have a negative serum pregnancy test result at study start. Exclusion criteria: Presence of any new/and or clinically important medical condition that might compromise patient's safety. Use of prohibited treatment. Meets any of the exclusion criteria listed for study 3151A4-327.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desvenlafaxine Sustained Release|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure. |  |  |
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography

Study Overview
=================
Brief Summary
-----------------
This is a clinical study of gadoteric acid in non-coronary MR angiography.

Official Title
-----------------
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)

Conditions
-----------------
Arterial Occlusive Disease

Intervention / Treatment
-----------------
* Drug: gadoteric acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least the age of legal maturity Strongly suspected of having non-coronary arterial disease, detected clinically Scheduled to undergo x-ray angiography examination Female patients must be using effective contraception or be surgically sterilized or post-menopausal. Females of childbearing potential must have a documented negative urine pregnancy test. Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI) Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations Congenital morphologic vascular abnormalities Known allergy to gadolinium chelates Pregnant, breast feeding, or planning to become pregnant during the trial Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gadoteric acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution

Study Overview
=================
Brief Summary
-----------------
Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

Detailed Description
-----------------
Since 2014, Edwards society has developed a completely non-invasive monitoring device for measurement of blood pressure and continuous cardiac output without inserting foreign intravascular bodies in the patient. Initially tested on healthy volunteers cardiac disease -free, the correlation with the other devices seems to be good. If this ClearSight © system show a relevant accuracy in measuring blood pressure and cardiac output with a specific ICU hospitalized population, it could justify its place in the therapeutic arsenal of monitoring in intensive care. This is a common care ,prospective observational single center study , concerning the results of blood pressure , cardiac output values and their variations.

Official Title
-----------------
Comparaison de Mesure de débit Cardiaque Entre système Clearsight® et Thermodilution Transpulmonaire.

Conditions
-----------------
Shock, Cardiac Output, Low

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 hospitalized in surgical ICU, with hemodynamic instability or vaso-active drugs No opposition formulated Exclusion Criteria: Impossibility of establishment of one of the cardiac output measurement devices Pregnant woman Refuse to participate

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of values and changes in cardiac index between the two devices |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of values and variations in mean arterial pressure between the two devices |  | 2 days | 
| Comparison of values and variations in mean cardiac output between the two devices |  | 2 days | 
| Comparison of values and variations in mean stroke volume variation between the two devices |  | 2 days |
Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study

Study Overview
=================
Brief Summary
-----------------
This observational study looks at Carotid Stenosis in two groups of subjects using a non-invasive procedure, B-mode ultrasound. One group of subjects has had long-term intensive lipid altering therapy (lowering LDL-C plus raising HDL-C). The second group of patients has been on conventional standard of care treatment for carotid stenosis. The study will look at the Carotid Intima-media Thickness (CMIT) in both groups. Hypothesis: CIMT will differ between the two groups, such that the CIMT will be less in the subjects on intensive lipid altering therapy.

Official Title
-----------------
Effects of Long-term Therapy With LDL-lowering Plus HDL Raising on Carotid Intima-media Thickness (CIMT) - Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study

Conditions
-----------------
Carotid Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive Lipid-lowering Therapy Group: Subjects currently enrolled in the Familial Atherosclerosis Treatment Observational Study. Usual Care Group: Subjects who were in the FATS OS Study in the past, but have since quit the study and opted for conventional standard of treatment. Exclusion Criteria: No past or present participation in the FATS OS Study.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive Lipid-lowering therapy<br>Subjects on intensive long-term lipid lowering therapy (lowering LDL-C plus raising of HDL-C). | |
| Usual Care<br>Subjects with Atherosclerosis who have been on conventional standard of care treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Intima-media Thickness |  | Up to 3 years |
Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

Study Overview
=================
Brief Summary
-----------------
In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other molecules such as proteins and nucleic acids. In patients with central nervous system (CNS) and other conditions, the levels of these molecules may be altered. In several other studies at our institution, the investigators are investigating such molecules in tumor specimens as well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However, these levels are difficult to interpret without comparing them to levels in patients without CNS tumors. The investigators propose a study to collect small amounts of blood and cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.

Official Title
-----------------
Collection of Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

Conditions
-----------------
Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children without central nervous system tumors who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will be obtained Between the ages of 1 year and 21 years Patients must be having blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs or VPS as part of routine clinical care. Exclusion Criteria: Patients who do not require routine blood draws and/or CSF collection as part of their routine clinical care Patients who are considered too ill to participate as determined by their treating physician Patients with documented bacterial of viral infections of the CSF, brain parenchyma and/or neurosurgical devices and/or Patients with suspected de-myelinating conditions Patients who are pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 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 |
| --- | --- |
| Children without central nervous system tumors<br>Children without central nervous system tumors between the ages of 1 year and 21 years who are undergoing a neurosurgical procedure to address hydrocephalus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of miRNAs in the blood and CSF |  | 2 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivin and biologic markers levels in the CSF and blood |  | 2 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus, Survivin, miRNA