linjc16/ctgov huggingface dataset:
Digestive Events in Duchenne Muscular Dystrophy Patients

Study Overview
=================
Brief Summary
-----------------
Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

Detailed Description
-----------------
Clinical Data of the disease Digestive events (pseudo occlusion, gastrostomy, cholecystectomy) Nutritionnal parameters Genetic of dystrophin (approved genetic nationnal Data base, CHU Cochin, Paris France)

Official Title
-----------------
Digestive Events in Duchenne Muscular Dystrophy Patients

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all Duchenne muscular dystrophy patients in our center Exclusion Criteria: none

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of digestive events | Clinical parameters (yes or no): gastrostomy, bowel occlusion, acute gastric paresia, biliary complication | 11 years | 
| Prevalence of digestive events | Clinical parameters (yes or no) : gastrostomy, bowel occlusion, acute gastric paresia, biliary complication | 11 years | 
| Risk factors for digestive events (1) | age (years) | 11 years | 
| Risk factors for digestive events (2) | pulmonary functional tests (vital capacity in ml/kg) | 11 years | 
| Risk factors for digestive events (3) | echocardiography parameters (LVEF: left ventricular ejection fraction in %) | 11 years | 
| Risk factors for digestive events (4) | residual dystrophin level (Western blot and/or immunohistochemistry in muscle) | 11 years | 
| Risks factors for digestive events (5) | genetic parameters (type of mutation, functional domain of altered dystrophin) | 11 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status (1) | Weigh (kg) and height (in m) agregated in BMI (kg/m^2) | 11 years | 
| Nutritional status (2) | albuminemia in g/L | 11 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pseudo occlusion, gastrostomy
Erythrocyte Complement Receptor 1 and Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
Main objective: investigate whether a functional polymorphism of CR1 (length, number of binding sites in C4b C3b, erythrocyte density, rate of soluble CR1 ...) so determined genetic or acquired, is a susceptibility factor for the disease Alzheimer's.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Other: CR1 impact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caucasians people with a Alzheimer dementia defined on DSMIV criteria for patients and without Alzheimer disease for control subjects Exclusion Criteria: diseases modifying CR1 physiology

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: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: CR1 impact|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
HTEMS Treatment of Diabetic Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.

Detailed Description
-----------------
Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.

Official Title
-----------------
High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy

Conditions
-----------------
Diabetic Polyneuropathy

Intervention / Treatment
-----------------
* Device: HTEMS
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic diabetic neuropathy stable oral analgesic regimen Exclusion Criteria: history of drug or alcohol abuse cardiac pacemaker or defibrillator pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HTEMS<br>High-tone external muscle stimulation 5 times within a week for 12 weeks | Device: HTEMS<br>* high-tone external muscle stimulation<br>* Other names: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany);|
| Placebo Comparator: Placebo<br>Placebo stimulation 5 times within a week for 12 weeks | Device: Placebo<br>* Placebo stimulation<br>* Other names: Placebo treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathy symptom score | Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, neuropathy, pain, HTEMS
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

Study Overview
=================
Brief Summary
-----------------
SUMMARY INTRODUCTION: among various treatments for patients with primary snoring, upper airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS), the injection snoreplasty arose as a promising alternative in some selected cases. OBJECTIVE: to investigate the efficacy and tolerance of injection snoreplasty comparing Ethanol and Ethanolamine Oleate.

Official Title
-----------------
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients

Conditions
-----------------
Snoring, Apnea

Intervention / Treatment
-----------------
* Procedure: Injection Snoreplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Snoring RDI < 15 /h Exclusion Criteria: BMI > 35

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ethanol<br> | Procedure: Injection Snoreplasty<br>* Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)<br>|
| Active Comparator: Ethanolamine Oleate<br> | Procedure: Injection Snoreplasty<br>* Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snoring |  | 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Snoring and Mild Apnea
PEP-1324: Glycemic Response Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.

Conditions
-----------------
Glycemic Response

Intervention / Treatment
-----------------
* Other: Nutrient formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18-75 years of age Subject is male or non-pregnant females, 18-75 years of age, inclusive Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1). Subject has to be non-smoker. Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. Subject is willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit. Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L). Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits. Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A nutrient formulation without the active ingredient | Other: Nutrient formulation<br> <br> |
| Experimental: Nutrient formulation<br>Nutrient formulations with variable amounts of active ingredients. | Other: Nutrient formulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the blood glucose response cruve |  | 0-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak blood glucose |  | 0-2 hours | 
| peak insulin |  | 0-2 hours |
Open-Label Study of ARD-0403 in Testosterone Deficient Men

Study Overview
=================
Brief Summary
-----------------
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

Official Title
-----------------
A Phase III, Open-Label Follow-on Study for Long-Term Safety and Efficacy of Testosterone Cream, in Testosterone Deficinet Men Completing Study ARD-0403-004

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: ARD-0403


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Testosterone deficiency Completed study ARD-0403-004 Exclusion Criteria: Previous treatment with testosterone replacement therapy within 4 weeks Moderate-severe benign prostatic hypertrophy or prostatic cancer Haematocrit >50%

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

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

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: ARD-0403|Daily transdermal ARD-0403|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | Study Duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | Study Duration |
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.

Official Title
-----------------
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

Conditions
-----------------
Trauma-related Wound, Surgical Wound, Recent

Intervention / Treatment
-----------------
* Device: SNaP® Wound Care System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities Wound < 16 cm in greatest diameter Subject ≥ 18 years of age Exudate < 25 ml/ day (estimate) Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study Subject is willing and able to sign informed consent Exclusion Criteria: Wound > 45 days old Wound-related cellulitis Wound located in an area not amenable to forming an air-tight seal Subject has untreated osteomyelitis Subject is allergic to wound care products Wound has exposed blood vessels not suitable for negative pressure therapy Subject is pregnant Subject is actively participating in other clinical trials that conflict with current study Subject has fistulas

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 |
| --- | --- |
| SNaP® Wound Care System<br> | Device: SNaP® Wound Care System<br>* Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Wound Size Change | Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline) | Baseline and 4 weeks | 
| Percent Wound Size Change | Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4) | 4 weeks and 8 weeks | 
| Percent Wound Size Change | Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks) | 8 weeks and 12 weeks |
Breastfeeding Education and Support Trial for Obese Women (BESTOW)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of this study are: a) to characterize postpartum weight loss patterns and blood pressure values of obese women, by study group; and b) to evaluate potential differences in infant morbidity (diarrhea, otitis media and rehospitalization), by study group.

Official Title
-----------------
Breastfeeding Education and Support Trial for Obese Women (BESTOW)

Conditions
-----------------
Exclusive Breastfeeding, Breastfeeding Initiation

Intervention / Treatment
-----------------
* Behavioral: Breastfeeding Peer Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese (prepregnant BMI 27.0 or greater) pregnant women delivering at Hartford Hospital no more than 34 weeks gestation considering breastfeeding this child low income (<185% Federal poverty level) planning to remain in the greater Hartford area for 6 months postpartum must have access to a telephone for follow-up interviews delivery of a healthy, term, singleton Exclusion Criteria: HIV positive or having other conditions which interfere with exclusive breastfeeding Infant admitted to the Neonatal Intensive Care Unit

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding Peer Counseling<br> | Behavioral: Breastfeeding Peer Counseling<br>* 3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.<br>* Other names: BESTOW;|
| No Intervention: Standard Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive Breastfeeding Rate |  | 3 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Rate |  | 3 months postpartum | 
| Breastfeeding Initiation Rate |  | For the duration of the hospital stay, average equals 3 days |
Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus

Official Title
-----------------
Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

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

Intervention / Treatment
-----------------
* Drug: Micardis®
* Drug: MicardisPlus®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Hypertension Diabetes mellitus Exclusion Criteria: Age < 18 years

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 |
| --- | --- |
| Patients with hypertension and diabetes mellitus<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in systolic blood pressure (SBP) |  | Baseline, after 6 months | 
| Change from Baseline in diastolic blood pressure (DBP) |  | Baseline, afterr 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 6-point scale |  | after 6 months | 
| Assessment of metabolic effect on a 4-point scale |  | after 6 months | 
| Change from Baseline in laboratory parameters | Metabolic parameters - Triglyceride, total cholesterol, blood glucose and HbA1c | Baseline, after 6 months | 
| Assessment of tolerability by investigator on a 5-point scale |  | after 6 months | 
| Number of patients with adverse events |  | up to 6 months |
Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

Official Title
-----------------
Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On examination, have ocular findings considered to be normal, and which would not prevent a participant from safely wearing contact lenses. Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent. Be able to wear the study lenses in the available powers. Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. History of corneal refractive surgery. Other protocol-defined inclusion/exclusion criteria may apply.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lotrafilcon A<br>Investigational contact lens worn in both eyes for three months | Device: Lotrafilcon A contact lens<br>* Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort After Insertion | Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 3 months |