linjc16/ctgov huggingface dataset:
Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.

Official Title
-----------------
A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Amlodipine/benazepril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African-American males and females current diagnosis of type 2 diabetes documented by medical history; mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg; HbA1C ≤ 9.5% Exclusion Criteria: having unilateral or bilateral renal artery stenosis; having clinically significant cardiac dysrhythmias; having a significant history of coronary artery disease within the past 6 months; having a history or diagnosis of congestive heart failure (CHF); having any clinically relevant cardiac valvular disease

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

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

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: Amlodipine/benazepril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in sitting diastolic BP at Week 24 |  |  | 
| change from baseline in sitting systolic BP at Week 24 |  |  | 
| change from baseline in urinary protein excretion at Week 24 |  |  | 
| change from baseline in HbA1c at Week 24 |  |  | 
| change from baseline in estimated glomerular filtration rate (EGFR) at Week 24 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, diabetes, African-American, amlodipine/benazepril
Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis

Study Overview
=================
Brief Summary
-----------------
Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.

Detailed Description
-----------------
The aim of this study is therefore to measure antro-pyloro-duodenal motor activity in patients with idiopathic gastroparesis.

Official Title
-----------------
Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic gastroparesis or healthy volunteers Idiopathic gastroparesis must have delayed gastric emptying shown using C13 breath test Exclusion Criteria: Diabetic or post-surgical gastroparesis Treatment modifying GI motility (prokinetics, opioids...) Parkinson or neurologic disease Evoluting inflammatory process or neoplasia Treatment modifying coagulation Patients not affiliated to the French healthcare insurance

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Healthy volunteers | |
| Idiopathic gastroparesis<br>Idiopathic gastroparesis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antro-pyloro-duodenal pressure | the main outcome is the pressure measured using pressure sensors within the antrum, the pylorus, and the first part of the duodenum. This will be measured during 3h fast. Pressures measured in the antrum, the pylorus, and the duodenum wiil be compared between healthy volunteers and gastroparetic patients | 3h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastroparesis, gastric emptying, antro-duodenal manometry
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Study Overview
=================
Brief Summary
-----------------
This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: YM060


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS Exclusion Criteria: Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YM060|nan|

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
-----------------
Nasea®, Irritable Bowel Syndrome, Diarrhea, Irribow®, ramosetron
Influence of Latent Miofascial Trigger Points in the Vertical Jump in Female Voleyball Players

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of dry needling of latent myofascial trigger points on vertical jump height in female volleyball players

Detailed Description
-----------------
Evaluate a sample of female volleyball players after using dry needling on latent myofascial trigger points and verify if it would have an improvement of the vertical jump

Official Title
-----------------
Influence of Latent Miofascial Trigger Points in the Vertical Jump in Female Voleyball Players

Conditions
-----------------
Sports Physical Therapy

Intervention / Treatment
-----------------
* Device: Dry Needling plus normal volleyball training
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volleyball players No Lower limbs injuries in the last 6 months Presence of latent trigger points in gastrocnemius Familiar with performing CMJ test Exclusion Criteria: Active trigger points in the lower limbs Any contraindication of usind dry needling Any pathology that prevented the performance of CMJ test

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needly Group<br>Once the trigger point has been identified, we will use the Hong tecnique looking for a local spasm response | Device: Dry Needling plus normal volleyball training<br>* Once the trigger point has been identified, we will use the Hong tecnique looking for a local spasm response<br>|
| Active Comparator: Control Group<br>Normal volleyball training | Other: Control Group<br>* Normal volleyball training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical Jump | Vertical jump will be measured CMJ test using the app My Jump 2 | pre-intervention | 
| Vertical Jump | Vertical jump will be measured CMJ test using the app My Jump 2 | Immediately post-intervention | 
| Vertical Jump | Vertical jump will be measured CMJ test using the app My Jump 2 | 72 hours post-intervention | 
| Vertical Jump | Vertical jump will be measured CMJ test using the app My Jump 2 | one week post-intervention |
MRI Screening for Auditory Pathway Malformations in Visually Impaired Children

Study Overview
=================
Brief Summary
-----------------
This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children.

Official Title
-----------------
MRI Screening for Auditory Pathway Malformations in Visually Impaired Children

Conditions
-----------------
Visual Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 18 years old visual impairment MRI scheduled to explore their visual impairment parents' informed consent for participation in the study Exclusion Criteria: tumoral origin for the visual impairment no health insurance coverage

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| number of patients with Auditory Pathway Malformation |  | baseline |
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Detailed Description
-----------------
This is a cross-sectional, population-based study. No randomization procedure will be executed in this study. Approximately 1000 subjects over a 36-month period. The aim of this screening study is to identify the Fabry disease as the cause in patients with young stroke. To measure the level of α-Gal A activity, male subjects will initially provide a DBS sample and female subjects will start with a test by whole blood sample. The prevalence of Fabry disease among patients with young stroke will be estimated by a confirmative diagnosis in gene testing.

Official Title
-----------------
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Conditions
-----------------
Fabry Disease

Intervention / Treatment
-----------------
* Genetic: GLA gene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 20 or over Patients aged under 56 years old, not included 56 Patients with acute stroke Patients and/or their legal representatives are willing to provide written informed consent Exclusion Criteria: Patients with a confirmed diagnosis of Fabry disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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 |
| --- | --- |
| Young stroke<br>Patients with acute stroke aged 20 or over, and under 56 years old (Not included 56) . | Genetic: GLA gene<br>* Genetic test will be performed when enzyme activity is found abnormal in the whole blood test or confirmation is required. 5 ml of blood sample will be obtained and polymerase chain reaction (PCR) sequencing will be executed to determine mutations in the GLA gene.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fabry disease | The prevalence of Fabry disease in patients with young stroke | 3 years later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry disease, Young stroke
A Study of Vitamin D in Subjects With Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might contribute to the pathogenesis of alopecia areata.

Detailed Description
-----------------
Alopecia Areata (AA) is a T-Cell mediated, non-scarring, polygenic, autoimmune disease of the hair follicle. It has been reported to be associated with other autoimmune diseases, especially autoimmune thyroid disease and vitiligo. It is more common in females. Recently, vitamin D deficiency has been claimed to contribute to the pathogenesis of multiple autoimmune disease. There is a strong inverse correlation between the level of 25-hydroxyvitamin D levels and the autoimmune disease in adolescents.

Official Title
-----------------
A Pilot Study of Vitamin D in Subjects With Alopecia Areata

Conditions
-----------------
Alopecia Areata

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women who are at least 18 years old Subjects with newly diagnosed with alopecia areata Exclusion Criteria: Subjects who take supplemental Vitamin D, by itself or as a part of a multivitamin

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alopecia Areata<br>Individuals with Alopecia Areata (AA) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels will be reported in subjects and correlated with the calcium and parathyroid levels. | This study consists of a single clinic visit. After subject has completed the informed consent process and meets eligibility criteria, a blood sample will be collected. Lab results from this one-time lab draw will be evaluated. | Initial clinic visit (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alopecia Areata, Vitamin D, Parathyroid, Calcium
Cardiac Surgery and Diaphragm Function

Study Overview
=================
Brief Summary
-----------------
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress. The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation. The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.

Official Title
-----------------
Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and older planned surgery ready for weaning from mechanical ventilation Exclusion Criteria: protected patient patient refusal

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 |
| --- | --- |
| cardiac surgery<br> | Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm inspiratory thickening fraction |  | At the begining of the spontaneous breathing trial (around 4hours after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm dysfunction before surgery |  | the day before surgery | 
| Severity score (Euroscore) |  | the day before surgery | 
| extracorporeal circulation duration |  | peroperative | 
| left ventricular ejection fraction |  | the day before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, diaphragm dysfunction, mechanical ventilation weaning, respiratory paralysis, muscle weakness, cardiac bypass, valvular surgery, respiratory insufficiency
911 Nurse Triage Line

Study Overview
=================
Brief Summary
-----------------
Each year, millions of Americans call 911 for time-sensitive issues that don't require Emergency Medical Services (EMS). In need of medical help, these callers may treat 911 as an entry point into the healthcare system, yet an ambulance to the emergency department can harm both their own long-term health and the health of others. In a field experiment in Washington, DC, the investigators randomly assign nurses directly into 911 calls in order to triage low-acuity calls. While other 911 reforms have denied callers access to alternative resources, this effort reforms 911 by offering appropriate care.

Official Title
-----------------
911 Nurse Triage Line Randomized Controlled Trial

Conditions
-----------------
Emergencies

Intervention / Treatment
-----------------
* Behavioral: Triage nurse
* Behavioral: No triage nurse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-acuity call Exclusion Criteria: Incarcerated

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triage Nurse<br>Triage nurse | Behavioral: Triage nurse<br>* Triage nurse joins 911 call<br>|
| Active Comparator: No Triage Nurse<br>No triage nurse | Behavioral: No triage nurse<br>* Triage nurse does not join 911 call (business as usual)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulance dispatch | Ambulance is dispatched in response to the 911 call | During or immediately subsequent to call | 
| Ambulance transport | Caller is transported in dispatched ambulance | During or immediately subsequent to call | 
| ED visit, 24 hours | Emergency department visit within 24 hours | 24 hours | 
| ED visit, 6 months | Emergency department visit with 6 months | 6 months | 
| Primary care visit, 24 hours | Primary care visit within 24 hours | 24 hours | 
| Primary care visit, 6 months | Primary care visit within 6 months | 6 months | 
| 911 use, 24 hours | Whether caller made subsequent calls to 911 within 24 hours | 24 hours | 
| 911 use, 6 months | Whether caller made subsequent calls to 911 within 6 months | 6 months | 
| Health expenditures | Total dollars and log-transformed dollars of Medicaid health expenditures | 6 months |
Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.

Detailed Description
-----------------
independent variable: continuous Nutri -jelly intake dependent variable (outcome): changes in health-related quality of life score

Official Title
-----------------
Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy

Conditions
-----------------
Head and Neck Cancer, Dysphagia

Intervention / Treatment
-----------------
* Dietary Supplement: Nutri-jelly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as head and neck cancer definitive or palliative radiotherapy treatment plan can communicate well Exclusion Criteria: bleeding in the mouth respiratory distress psychiatric disorders radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutri-jelly along with radiotherapy<br>Continuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy | Dietary Supplement: Nutri-jelly<br>* an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement<br>|
| No Intervention: Radiotherapy only<br>Receive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Health-related quality of life score | Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks | 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy |