linjc16/ctgov huggingface dataset:
Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Detailed Description
-----------------
The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.

Official Title
-----------------
Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: sildenafil
* Drug: nitroprussiate iontophoresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 No significant medical history Exclusion Criteria: Age under 18 Period of exclusion for an other study Pregnancy Breast feeding Severe disease Cigarette smoking

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: sildenafil<br>* systemic absorption of sildenafil<br>|
| Active Comparator: 2<br>SNP iontophoresis | Drug: nitroprussiate iontophoresis<br>* nitroprussiate iontophoresis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil |  | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger |  | one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iontophoresis, cutaneous microcirculation, sildenafil, Healthy volunteers
Comparison of the Time to Recurrence Between Ranibizumab and Aflibercept

Study Overview
=================
Brief Summary
-----------------
The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.

Official Title
-----------------
Comparison of the Time to Recurrence After Ranibizumab or Aflibercept Loading for Age-related Macular Degeneration

Conditions
-----------------
The Injection Burden

Intervention / Treatment
-----------------
* Drug: IVA group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept. Exclusion Criteria: patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| IVR group<br> | Drug: IVA group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence after induction phase | Time frame depends on patients because recurrence time is different. | More than 3 months from baseline |
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049. The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Detailed Description
-----------------
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Official Title
-----------------
An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Combination Product: BCI-024 + BCI-049


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study. Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements. Exclusion Criteria: - Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BCI-024 and BCI-049 | Drug: Combination Product: BCI-024 + BCI-049<br>* BCI-024 and BCI-049 once a day at bedtime for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. |  | Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, combination
EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC

Study Overview
=================
Brief Summary
-----------------
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC

Detailed Description
-----------------
Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).

Official Title
-----------------
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC

Conditions
-----------------
Nonsmall Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Male or female patients aged 18 years and older. Histological confirmation of stage IIIB/IV NSCLC. Documented EGFR mutation positive . WHO Performance Status 0, 1 or 2 Exclusion Criteria: Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study. Previous (within 6 months) or current treatment with AZD9291.

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 |
| --- | --- | --- |
| The biomarker profile of EGFR-TKI resistance |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance, sensitivity and specificity in paired blood and tissue samples |  | Baseline |
Trial of New Dietary Treatment of Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes. Study terminated December 19, 2005 for administrative reasons.

Detailed Description
-----------------
Traditional dietary treatment of type 2 diabetes is complicated and often fails. This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals. A series of 10 overweight type 2 diabetic patients not well controlled, or needing medication for control, will be recruited to follow this plan; followup is to be until 6 months after the last patient is enrolled, or when all patients have normal A1Cs with no medication, whichever comes first. Primary endpoints to be measured are A1C, weight loss (in pounds and BMI reduction) and medication reduction. Secondary endpoints are occurrences of hypoglycemia, reduction of medications for hypertension and hyperlipidemia, and patient satisfaction. As this is a Phase 1 trial, the only control group is historical controls (the patients themselves and the medical literature).

Official Title
-----------------
Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Dietary treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus, type 2 Obesity Ability to attend office visits in Manassas, Virginia Exclusion Criteria: Dementia Institutionalized living Retinopathy, neuropathy Pregnancy Serious health problems such as heart disease or stroke

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Dietary treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (A1C) changes |  |  | 
| Weight (body mass index [BMI]) loss |  |  | 
| Diabetes medication reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia |  |  | 
| Other medication reduction |  |  | 
| Patient satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Dietary treatment, Fasting as medical therapy
The Impact of Educational Materials on Family Behavior

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.

Detailed Description
-----------------
Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet & Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.

Official Title
-----------------
The Impact of Educational Materials on Family Behavior

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Booklet on nutrition and physical activity.
* Behavioral: Safety Booklet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with a BMI greater than or equal to 85% along with a parent. All subjects must speak English. Exclusion Criteria: Genetic conditions associated with overweight. Endocrine conditions associated with overweight. Chronic steroid therapy. Current enrollment in a professional weight management program.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kid STRIDE Booklet<br> | Behavioral: Booklet on nutrition and physical activity.<br>* Parents will be asked to read the booklet and complete a pre- and post-questionnaire.<br>|
| Placebo Comparator: Safety Booklet<br> | Behavioral: Safety Booklet<br>* Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.

Official Title
-----------------
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Guardian RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of diabetes for more than 6 months Use of insulin pump for more than 3 months

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Guardian RT|The sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | Start of study, after 3 months, after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Before and after connecting to sensor | 
| Number of night hypoglycemias |  | During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting | 
| Mean glucose level |  | During the first week of connecting to sensor and during the last week of connecting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

Study Overview
=================
Brief Summary
-----------------
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.

Official Title
-----------------
A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics

Conditions
-----------------
Asthma, Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks
* Drug: Comparator: theophylline ER/Duration of Treatment: 16 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females between the ages of 18 and 60 with mild to moderate asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks|nan|
|Drug: Comparator: theophylline ER/Duration of Treatment: 16 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA |  |  |
Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women

Study Overview
=================
Brief Summary
-----------------
The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia.

Detailed Description
-----------------
Pregnancy induces physiological changes. Plasma volume, cardiac output, hepatic blood flow and protein binding are changed from the first trimester of pregnancy. These physiological changes give effect to the onset and duration of neuromuscular blocking drugs. Rocuronium is a commonly used neuromuscular blocking drug categorized as FDA category B. Rocuronium is widely used for pregnant women. Previous studies have evaluated the onset and duration of rocuronium in postpartum women. Lately, the investigators have evaluated the onset and duration of rocuronium in early second trimester pregnant women and the duration was significantly longer in early second trimester women compared to non-pregnant women. Since there is little research on the onset and duration of rocuronium in the late second trimester pregnant women, the investigators planned the present research.

Official Title
-----------------
Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women

Conditions
-----------------
Pregnancy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing general anesthesia Exclusion Criteria: liver disease renal disease diabetes mellitus asthma allergic to specific drugs BMI>30 or <18

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of rocuronium | time measured with TOFwatch-SX | time measured to 25% recovery with T1 using Train of Four watch, assessed upto 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of rocuronium | time measured with TOFwatch-SX | time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes |
Musculoskeletal Disorders and the Associated Factors of Healthcare Professionals

Study Overview
=================
Brief Summary
-----------------
The aim is to assess the prevalence of musculoskeletal disorders among Italian health professionals by analysing demographic and psychosocial factors. In addition, the impact of the symptoms detected on the quality of life and physical and mental health was analyzed. All health workers on duty in hospital wards for at least 12 months

Detailed Description
-----------------
The online questionnaire sent to the participants was divided into two sections. The first section concerned the collection of demographic data of the participants (eg age, gender, level of education, work experience, company to which they belong, department, profession, etc.). The second section concerned the assessment of the prevalence of musculoskeletal disorders, pain, quality of life and assessment of subjective perception of health and assessment of psychosocial factors in the workplace.

Official Title
-----------------
Correlation Between Musculoskeletal Disorders and the Associated Factors of Healthcare Professionals in the Hospital Setting

Conditions
-----------------
Musculoskeletal Disorders, Psychosocial Problem

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health personnel who were active in clinical practice during the study period from January to June 2022. All health professionals who signed the informed consent Health professionals in service in the wards for at least 12 months from the date of sending the questionnaire. Exclusion Criteria: Health workers with unsuitability for handling loads

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| musculoskeletal disorders | prevalence of musculoskeletal disorders | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographic and psychosocial factors | prevalence of factors and correlation with musculoskeletal disorders | 8 months |