linjc16/ctgov huggingface dataset:
Functional and Structural Characterization of Arteriopathy in Pseudoxanthoma Elasticum (PXE)

Study Overview
=================
Brief Summary
-----------------
To determine the specific structural and functional features of the peripheral arteriopathy in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.

Detailed Description
-----------------
The primary objective of this study is to characterize the structural and functional characteristics of the peripheral arteries (lower and upper limbs) . a secondary objective will be to determine the arterial calcification using CT-scan as a useful tools for the diagnosis and the follow-up of this disease. Data will be collected from a cohort of patients PXE monitored in our Health and Research PXE center at the University Hospital of Angers. The structural and functional variables of the distal arteries (radial and tibialis arteries) will be studied using high-resolution echography. Scoring of the arterial calcium load will be determined by helicoidal CT-scan in the lower limb arteries. These variables will be compared to matched (gender and age) controls without PXE.

Official Title
-----------------
Functional and Structural Characterization of the Peripheral Arteriopathy in Pseudoxanthoma Elasticum (PXE)

Conditions
-----------------
Pseudoxanthoma Elasticum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with phenotypically and genetically (ABCC6) proved PXE or control patients paired for age and gender Written formed consent obtained Patient affiliated to a Health care system Exclusion Criteria: Patient with unproved PXE Pregnant woman Patient unwilling to participate to the study Not affiliated to a Health care System

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 |
| --- | --- | --- |
Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate whether chronic hypercortisolemia is specifically toxic to hippocampal cells and causes structural reduction of hippocampal volume in patients with Cushing's syndrome. II. Determine whether reduced hippocampal volume is associated with specific memory dysfunction. III. Examine the relationships of adrenal androgen to hippocampal volume and memory dysfunction. IV. Examine the reversibility of hippocampal structural changes and cognitive dysfunction after cortisol levels are normalized.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo a psychiatric evaluation for mood and cognition during confirmation of diagnosis. Neuropsychologic exams include pencil and paper test and a cognitive assessment. Endocrine studies include dexamethasone and corticotropin-releasing hormone stimulation tests. The hippocampal complex volume is assessed with coronal magnetic resonance imaging. There is a follow-up 1 year after the initiation of treatment.

Conditions
-----------------
Cushing's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Adults and teenagers with untreated, spontaneous active Cushing's syndrome Diagnosis verified at the University of Michigan Medical Center, including the following: Excessive cortisol secretion measured by urinary-free cortisol, cortisol secretion rate, and plasma cortisol level Lack of normal circadian cortisol secretion and failure to suppress following 2 mg of dexamethasone

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rare disease, Cushing's syndrome, endocrine disorders
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.

Official Title
-----------------
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis

Conditions
-----------------
Perennial Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: levocetirizine (Xyzal)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICF signed Diagnosis of PAR for 6-12 months greater 12 years and older Decreased nasal NO values at baseline Compliance and ability to perform maneuvers and responsibilities Exclusion Criteria: Oral or systemic steroids for 60 days prior Inhaled, nasal, nebulized steroids w/i 4 weeks Hospitalization or life threatening asthma Use of nasal or oral antihistamines w/i 4 weeks Upper or lower airways infection Direct cigarette smoke exposure

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Sugar tablet | Drug: placebo<br>* sugar tablet<br>|
| Active Comparator: Xyzal<br> | Drug: levocetirizine (Xyzal)<br>* 5mg po QD<br>* Other names: Xyzal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in objective measure of inflammation nasal NO after LC treatment. |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in nasal eosinophils, QOL and diary scores after LC treatment. |  | two weeks |
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Safety.

Study Overview
=================
Brief Summary
-----------------
To prove the safety in normal conditions of use.

Official Title
-----------------
Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral skin test in the region; Use of cosmetic product of the same category; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time; Exclusion criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs; Atopic antecedent or allergic to cosmetic product; Active cutaneous disease in the evaluation area; Diseases which cause immunology decrease, such as diabetes and HIV; Endocrinal pathologies; Intense solar exposure 15 days before the evaluation; Treatment until four months before the selection The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower | Drug: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study |
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children

Conditions
-----------------
Environmental Enteric Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Lactoferrin
* Dietary Supplement: Lysozyme
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 12-35 months youngest eligible child in each household Exclusion Criteria: severe or moderate acute malnutrition severe chronic illness children unable to drink 20 mL of dual sugar solution children in need of acute medical treatment for illness or injury at time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 35 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin+Lysozyme<br>lactoferrin and lysozyme in rice flour | Dietary Supplement: Lactoferrin<br> <br> Dietary Supplement: Lysozyme<br> <br> |
| Placebo Comparator: Placebo<br>rice flour | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 8 weeks | 
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 8 weeks | 
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 16 weeks | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 8 weeks | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 16 weeks |
Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
The pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms by which goiter leads to swallowing difficulties are unknown. By investigating esophageal motility using high resolution esophageal manometry before and after thyroidectomy we seek to examine the impact of the goiter mass on the esophagus and swallowing with six months follow-up.

Official Title
-----------------
Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery - a Prospective Cohort Study

Conditions
-----------------
Esophageal Motility Disorders

Intervention / Treatment
-----------------
* Other: Thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic benign nodular goiter referred for thyroidectomy Exclusion Criteria: Previous surgery to the neck; Suspicion of thyroid cancer Age below 20 years or above 80 years Neuromuscular disease.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Thyroidectomy|Thyroid surgery for benign nodular goiter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motility disturbances | Change in number of failed swallowings from baseline | Before and six months following thyroidectomy |
Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

Study Overview
=================
Brief Summary
-----------------
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).

Official Title
-----------------
Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies - PROCEED Study

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Other: Data Management and Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Participants with chronic pancreatitis. Exclusion Criteria: N/A

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 |
| --- | --- |
| Chronic Pancreatitis<br> | Other: Data Management and Monitoring<br>* The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center responsible for monitoring protocol and regulatory compliance for consortium. CDMC responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance Monitoring of Regulatory Documents by the Statistician for Consortium Study of Chronic Pancreatitis by CDMC by Implementing Quality Assurance and Quality Control Systems to Ensure Quality Data and Protocol Compliance |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pancreatitis, Data management, Regulatory compliance, Protocol monitoring
The Seatbelt Intervention Study

Study Overview
=================
Brief Summary
-----------------
The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.

Official Title
-----------------
A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma

Conditions
-----------------
High Risk Population of Part-time Seatbelt Users

Intervention / Treatment
-----------------
* Other: Interactive interview and tailored family centered seatbelt safety intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 7-14 and their parent or guardian, at a pediatric trauma center Child admitted to hospital with diagnosis of injury other than sexual assault and suicide Identify as part time seat belt users Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervener Brief Intervention (IBI)<br>Subjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals. | Other: Interactive interview and tailored family centered seatbelt safety intervention<br> <br> |
| No Intervention: Enhanced Usual Care<br>Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seat belt use | Follow up telephone assessment on full time seat belt use by parent and child | 1 month | 
| Seat belt knowledge | Follow up telephone assessment on level of knowledge of seat belt use and risk factors | 1 month | 
| Attitudes | Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use. | 1 month |
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases

Study Overview
=================
Brief Summary
-----------------
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support national efforts to reduce serious adverse outcomes resulting from opioid abuse. This study will evaluate trends before and after the ER/LA REMS implementation for changes in mortality rates associated with prescription opioids utilizing state medical examiner databases from multiple states. Databases from 2005 through the most recent year available will be obtained.

Official Title
-----------------
Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol

Conditions
-----------------
Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse

Intervention / Treatment
-----------------
* Other: Surveillance of state medical examiner databases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fatalities associated with prescription opioids in several states during 2005-2015 (or later). Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall group of all ER/LA opioid excluding hydrocodone<br> | Other: Surveillance of state medical examiner databases<br> <br> |
| Each type of opioid that has an ER/LA opioid formulation<br> | Other: Surveillance of state medical examiner databases<br> <br> |
| Overall group that includes all prescription opioids except<br> | Other: Surveillance of state medical examiner databases<br> <br> |
| Comparator Group taking benzodiazepines<br> | Other: Surveillance of state medical examiner databases<br> <br> |
| Comparator Group taking IR hydrocodone<br> | Other: Surveillance of state medical examiner databases<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems |  | Review over period from January 2005 to 2016 | 
| Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states |  | Review over period from January 2005 to 2016 |
Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel .

Study Overview
=================
Brief Summary
-----------------
Insulin as an adjuvant to local anesthetic and cortisone to decrease pain recurrence

Official Title
-----------------
Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel .

Conditions
-----------------
Pain Relief

Intervention / Treatment
-----------------
* Drug: insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diabetic patients with mild to moderate carpal tunnel syndrome Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Dexmehtasone and local anesthetics in carpal tunnel syndrome | |
| Active Comparator: Insulin group<br>insulin added to dexamehtasone and local anesthetics | Drug: insulin<br>* sonar guided insulin combined with dexamethasone and local anesthetics<br>* Other names: Sonar guided median nerve hydrodissection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain neuropathy | relief chronic pain from caroal tunnel | 12 weeks |