linjc16/ctgov huggingface dataset:
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

Detailed Description
-----------------
This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.

Official Title
-----------------
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

Conditions
-----------------
Arteriovenous Fistula, Arteriovenous Graft

Intervention / Treatment
-----------------
* Device: EchoMark/EchoSure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation Women of childbearing potential have a negative pregnancy test Exclusion Criteria: Age <18 years old Patient unable to sign informed consent Patient participating in another investigational device or pharmacological study Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

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

| Intervention/Treatment |
| --- |
|Device: EchoMark/EchoSure|Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance: Data Collection | Data collection to verify accuracy | 24 weeks | 
| Performance Endpoint | Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail. | 24 Weeks | 
| Safety Endpoint | Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period. | 24 Weeks |
The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.

Official Title
-----------------
The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Conditions
-----------------
Constipation Predominant, Irritable Bowel Syndrome (IBS-C)

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18 and older IBS-C patients diagnosed on the basis of Rome II criteria Ability to comply with the requirements of the entire study Exclusion Criteria: Evidence of structural abnormality of the gastrointestinal tract or disease/conditions. Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy. Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C |  |  | 
| by using Multiple Intraluminal Impedance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS-C, female
Becker Muscular Dystrophy - A Natural History Study to Predict Efficacy of Exon Skipping

Study Overview
=================
Brief Summary
-----------------
This is a multi-center natural history study that will be conducted at participating centers in the Cooperative International Neuromuscular Research Group (CINRG). Following a baseline evaluation, participants will have three follow-up visits over a three-year period. The investigators will characterize the Becker muscular dystrophy phenotype, and correlate specific abnormal dystrophin proteins with the range of clinical outcomes.

Detailed Description
-----------------
We will utilize the Cooperative International Neuromuscular Research group (CINRG) network to collect cohorts of Becker muscular dystrophy (BMD) patients with in-frame deletions in the dystrophin gene. We will collect clinical data across multiple body systems and correlate these findings to the high-resolution deletion break-point mapping performed from the tissue samples. We will investigate the observed variability to deepen our understanding of molecular mechanisms relevant to the optimization of exon skipping therapeutic approaches.

Official Title
-----------------
PITT0112: Becker Muscular Dystrophy - A Natural History Study to Predict Efficacy of Exon Skipping

Conditions
-----------------
Becker Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 4 or older Diagnosis of BMD with an in-frame deletion in the dystrophin gene, where the boundaries of the mutations are confirmed. Exclusion Criteria: • Investigator assessment of inability to comply with protocol

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Becker<br>BMD participants over 4 years of age with in-frame deletions in the dystrophin gene. . | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength and function |  | Annual | 
| Quality of life | These questionnaires include: Pediatric Quality of Life Inventory (PedsQL) Pediatrics and Adult Neuromuscular module Quality of Life (NeuroQOL) | Annual | 
| Medical history assessment - ambulation status, medication history, hospitalizations, surgeries, nutrition, fractures, and cardiac tests |  | Annual |
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS

Study Overview
=================
Brief Summary
-----------------
Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.

Detailed Description
-----------------
From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws

Official Title
-----------------
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infusing with Tysabri at a single site, Rocky Mountain MS Clinic Exclusion Criteria: If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.

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 |
| --- | --- |
| MS Tysabri<br>Patients with relapsing forms of multiple sclerosis and who are currently undergoing Tysabri® therapy at Rocky Mountain Multiple Sclerosis Research Group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natalizumab Concentrations in Serum | Validate a novel peptide-based laboratory test enabling the measurement of nadir natalizumab (Tysabri®) serum levels in multiple sclerosis patients undergoing therapy compared to the traditional ELISA assay | 12 Months |
Does Clomiphene Citrate Used for Induction of Ovulation Effect Levels of AMH and Inhibin B

Study Overview
=================
Brief Summary
-----------------
100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at 3 and 10 days of menstruation and count AMH and inhibin B.

Detailed Description
-----------------
100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at 3 and 10 days of menstruation. AMH and inhibit B level will be measured in serum. We want to search relation of AMH, inhibin b and ovulation induction.

Official Title
-----------------
Does Clomiphene Citrate Used for Induction of Ovulation Effect Levels of AMH and Inhibin B

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertility treatment Exclusion Criteria: Previous ovarian surgery Single functioning ovary

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 |
| --- | --- | --- |
| Does Clomiphene Citrate Used for Induction of Ovulation Effect Levels of AMH level |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clomiphene citrate, amh, inhibin b
Identification of Pathogens in the Neonatal Intensive Care Unit (NICU)

Study Overview
=================
Brief Summary
-----------------
To aim of this study is to identify the pathogens and their distribution in the NICU and to determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.

Official Title
-----------------
Identification of Pathogens and Their Antibiogram in the Neonatal Intensive Care Unit (NICU)

Conditions
-----------------
Pathogen Resistance

Intervention / Treatment
-----------------
* Other: Laboratory identification of positive cultures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns with positive cultures Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborns with positive cultures<br>Positive cultures of newborns hospitalized in the NICU in the past 5 years will undergo laboratory examination and identification | Other: Laboratory identification of positive cultures<br>* Laboratory identification of positive cultures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiogram | Positive cultures will be examined using an antibiogram and pathogens will be identified | One year |
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives

Official Title
-----------------
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Male or female age between 18-80 years of age, inclusive Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP >= 95 and =< 109 mmHg for non treated patients. Previously treated patients should have a MSDBP =< 109 mmHg at visit 1 and a MSDBP >= 95 and =< 109 mmHg at visit 2. Written informed consent to participate in the study prior to any study procedures Ability to communicate and comply with all study requirements Exclusion Criteria: Severe hypertension (grade 3 of WHO classification; >= 110 mmHg diastolic and/or >= 180 mmHg systolic). Malignant hypertension Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol. Known history of proteinuria (greater than 0.3 gram per day) Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed. Known Keith-Wagener grade III or IV hypertensive retinopathy. History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1. Transient ischemic cerebral attack during the last 12 months prior to Visit 1.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline diastolic blood pressure after 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure after 4 weeks |  |  | 
| Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks |  |  | 
| Adverse events and serious adverse events at each study visit for 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, valsartan
Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to determine whether a noninvasive hearing test may be used to predict blood glucose in people with diabetes.

Detailed Description
-----------------
Participation in the study will involve listening to sounds through earphones while blood glucose levels are measured by taking blood samples using a lancet. During the study, blood glucose levels will be increased by drinking a beverage containing sugar. Up to five visits to the NCRAR will be needed over a six-month period to complete the study. Each visit lasts either two or four hours, and will be scheduled at your convenience. You will be paid $20 for the first 2-hour screening visit and $50 for each 4-hour visit. You will be paid $30 if you are selected to participate in a 2-hour Attention Correlation Test that a sub-set of 10 participants will complete.

Official Title
-----------------
Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diabetes Normal hearing Hemoglobin A1C of 5.5-8% Exclusion Criteria: Volunteers may not participate if they have peripheral neuropathy visual impairment due to diabetic retinopathy organ failure (kidney, liver heart, or lungs) severe or unstable cardiovascular disease active alcohol or drug abuse schizophrenia bipolar disorder active major depressive disorder active foot ulcerations active viral or other infections such as HIV hepatitis, or pneumonia serious renal cardiac or cognitive dysfunction.

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 |
| --- | --- |
| Diabetic Subjects<br> | |
| Non diabetic subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoacoustic emissions change with blood sugar levels |  | One 2-hour screening visit, and on 4-hour visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes
Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare the time taken to obtain street fitness status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.

Official Title
-----------------
Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean

Conditions
-----------------
Cesarean Section; Dehiscence, Extra Peritoneal Caesarean Section

Intervention / Treatment
-----------------
* Procedure: Caesarean


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for a caesarean between 38 and 42 weeks pregnant Patient aged between 18 and 42 years old Singleton Caesarean section with a theoretical operating time < 1 hour (without major complications) Patient affiliated to a social security scheme Patient having signed the free and informed consent. Exclusion Criteria: BMI > 40 High blood pressure treated intravenously Pre-existing diabetes in pregnancy Allergy to analgesics Prenatal depression Pathological insertion of the placenta (placenta previa or accreta). History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery. Addiction (drugs) Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior. Patient participating in another clinical study with a drug or medical device Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Patient hospitalized without consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient with intraperitoneal caesarean section<br> | Procedure: Caesarean<br>* Two different caesarean section techniques : intra or extraperitoneal<br>|
| Experimental: patient with extraperitoneal caesarean section<br>Faucs technique | Procedure: Caesarean<br>* Two different caesarean section techniques : intra or extraperitoneal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative time in hours from which the patient stably fulfills the criteria for street fitness. | These criteria are defined in the Chung score. This score is between 0 and 10 and evaluate the vital signs, wandering, nausea or vomits, pain and surgical bleeding. | 1 month |