linjc16/ctgov huggingface dataset:
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.

Official Title
-----------------
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

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

Intervention / Treatment
-----------------
* Drug: Nasal Beclomethasone Dipropionate
* Drug: CERCHIO 10 mg/ml OS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children 6-16 years of age with a history of AR in the previous year T5SS: ≥5 in the last week before enrollment Exclusion Criteria: asthma symptoms acute upper respiratory infections anatomic nasal defects (ie, septum deviation), or nasal polyps use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beclometasone Dipropionate (BDP)<br>Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days. | Drug: Nasal Beclomethasone Dipropionate<br>* Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.<br>* Other names: NBDP;|
| Active Comparator: CERCHIO 10 mg/ml OS<br>For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days. | Drug: CERCHIO 10 mg/ml OS<br>* For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal patency evaluated by acoustic rhinometry. | The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Beclometasone nasal spray on subjective nasal symptoms | The secondary objective is to measure the impact of Beclometasone nasal spray 100 µg on subjective nasal symptoms, in children aged 6-16 with perennial allergic rhinitis (PAR), assessed by T4SS Questionnaire(Total 4 Symptoms Score). | 21 days |
Influencing Factors on Training Efficacy in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of carbohydrate intake on training efficacy and health parameters of an endurance training program in healthy adults.

Detailed Description
-----------------
Carbohydrate availability in endurance exercise seems to attenuate exercise-induced perturbations of cellular homeostasis and consequently diminishes the stimulus for training adaptation. Therefore, a negative relationship with exercise efficacy seems plausible. However, experimental evidence is rare and far from conclusive. Therefore, the present study aims to test the influence of carbohydrate intake on the efficacy of a typical preventive training program.

Official Title
-----------------
The Influence of Carbohydrates on Training Efficacy and Health Status in Healthy Adults

Conditions
-----------------
Health Status, Maximal and Submaximal Parameters of Physical Performance

Intervention / Treatment
-----------------
* Behavioral: Endurance Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no diseases nonsmoker BMI 25-30 kg/m² blood pressure <160/100 mm/Hg unmedicated untrained status V̇O2max < 50 mL/kg/min

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrates<br>50 grams of carbohydrates 4 times a week for each training session | Behavioral: Endurance Training<br> <br> * Other names: 4 sessions a week at 70 percent heart rate reserve;|
| Placebo Comparator: Control<br>no carbohydrate intake | Behavioral: Endurance Training<br> <br> * Other names: 4 sessions a week at 70 percent heart rate reserve;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen consumption (VO2max) | VO2max | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerous serum parameters from venous blood (LDL, HDL, Cholesterol, Triglycerides) | cardiovascular parameters: LDL HDL Cholesterol Triglycerides | 24 weeks | 
| Resting heart rate |  | 24 weeks | 
| Resting blood pressure |  | 24 weeks | 
| Body fat (Skinfold thickness) | Skinfold thickness | 24 weeks | 
| Ventilatory anaerobic threshold (VT) | VT | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, Exercise, Health, Endurance
Parkinson's Disease Registry of the Muhammad Ali Parkinson Center

Study Overview
=================
Brief Summary
-----------------
The purpose of the Parkinson's disease Registry is to develop a national and international database of persons with Parkinson's disease (PD). The Registry will be used to facilitate the development of new therapies and healthcare services to improve the quality of life for people with PD. It will also be a means for investigators in the field of PD to quickly identify and notify subjects about other research studies for which they are eligible. Objectives include: Assess current treatment approaches and develop best-practice guidelines Track the functional abilities, access to healthcare and cost of illness of people with PD over time Drive the development of innovative research projects Accelerate the process of informing patients of research projects for which they may be eligible

Detailed Description
-----------------
What do you need to know? Any individual diagnosed with PD is eligible to enroll. Participation in the registry is voluntary, confidential and free of charge. Eligible participants will be notified about opportunities to participate in clinical trials, though they are under no obligation to enter. Participants will need to complete an updated questionnaire every six months. Participants may also be asked to complete additional surveys for PD research projects. Any data provided will be used in scientific publications in summary form only. Participant names will not be released to anyone outside the Parkinson's disease Registry management team without written authorization, nor will names be sold for advertising or fund-raising purposes.

Official Title
-----------------
Parkinson's Disease Registry

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's disease Exclusion Criteria: No clinical diagnosis of Parkinson's disease
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
-----------------
Parkinson's disease, Parkinson disease, Registry, quality of life, database
Gycabiane and Glycemic Control of Prediabetic Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

Detailed Description
-----------------
Cinnamon's effects on blood glucose have been the subject of many clinical and animal studies; however, the issue of cinnamon intake's effect on fasting blood glucose (FBG) in people with prediabetes still remains unclear. The main purpose of this study is to examine the effects of supplementation with Glycabiane, a dietary supplement rich in cinnamon extract, on fast blood glucose of overweight prediabetic subjects in a randomized, placebo-controlled, clinical trial.

Official Title
-----------------
Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Dietary Supplement: Glycabiane
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female from 25 to 65 years old 1.0g/L ≤ fast blood glucose < 1.26g/L overweight (IMC > 25) Exclusion Criteria: thyroid disease hypogonadism History of musculoskeletal, autoimmune or neurological disease Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycabiane, gelule<br> | Dietary Supplement: Glycabiane<br>* 2 gelule per day for 4 months<br>* Other names: Dietary supplement;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: placebo<br>* 2 gelules per day for 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fast Blood Glucose | Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cinnamon, chromium, prediabete, overweight
Bonefos and the Consumption of Analgesics

Study Overview
=================
Brief Summary
-----------------
The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.

Official Title
-----------------
Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis

Conditions
-----------------
Bone Neoplasms

Intervention / Treatment
-----------------
* Drug: Bonefos (Clodronate, BAY94-8393)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer or prostate cancer or multiple myeloma. Bone metastasis. Ability to use analgesics and clodronate 1600 mg/day. Exclusion Criteria: Hypersensitivity to bisphosphonates. Clodronate in previous therapy. Concomitant use of other bisphosphonates. Serious renal insufficiency.

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 |
| --- | --- |
| Group1<br> | Drug: Bonefos (Clodronate, BAY94-8393)<br>* Patients in regular clinical practice receiving Bonefos according to local drug information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in pain measured by VAS (Visual Analogue Scale) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Prostate cancer, Multiple myeloma
Postoperative Residual Curarization in 2018

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. Hypothesizing a change in our practice since 2006-2012 (Cammu G, Anesth Analg 2006; 102: 426-9 and Cammu G, Anaesth Intensive Care 2012; 40: 999-1006), residual neuromuscular block as well as the use of intraoperative neuromuscular transmission monitoring and reversal of neuromuscular blocking agents will again be prospectively evaluated in 2018. The present study aims to compare these three periods (2006-2012-2018) in terms of management of neuromuscular block in the operating room and to look for a relationship with the incidence of postoperative residual curarization.

Official Title
-----------------
Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018

Conditions
-----------------
Postoperative Residual Curarization

Intervention / Treatment
-----------------
* Other: neuromuscular transmission monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older; Informed consent signed; Admission for elective surgery; Administration of non-depolarizing neuromuscular blocking agents during surgery; Tracheal intubation Exclusion Criteria: Evidence of renal, hepatic, metabolic, and/or neuromuscular disorders Ejection fraction <20% Admission for emergency surgery; or cardiothoracic surgery Reoperation during the same hospital admission

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: neuromuscular transmission monitoring|The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of the TOFscan neuromuscular transmission monitor (iDMed, Marseille, France).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative residual curarisation | Incidence of postoperative residual curarisation defined by a train-of-four (TOF) ratio < 0,9 at post-anesthesia care unit arrival | Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle Relaxation
Japanese Pradaxa PMS, Long Term

Study Overview
=================
Brief Summary
-----------------
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab

Detailed Description
-----------------
The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice

Official Title
-----------------
Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Prazaxa® Capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 15 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 nonvalvular atrial fibrillation (NVAF)<br>Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. | Drug: Prazaxa® Capsules<br>* Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.<br>* Other names: Dabigatran etexilate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places. | From baseline till the last administration + 6 days. Up to 364 days. |
Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care plan in improving compliance among elderly polypharmacy users at community pharmacy settings. The specific objective of the project is to determine effects of pharmaceutical care program on medication adherence and persistence among elderly polypharmacy users.

Official Title
-----------------
Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program

Conditions
-----------------
Polypharmacy

Intervention / Treatment
-----------------
* Other: Pharmaceutical care program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both men and woman aged more than 65 years and taking more than 2 drugs Exclusion Criteria: Inhabitants of nursing homes People receiving unit dose dispensing of medicine

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Pharmaceutical care program<br>* The pharmaceutical care program consists of 2 elements, that includes individualized medication education and regular follow up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in medication adherence from run-in to the end of phase 1 |  | 6 months | 
| persistence of mean medication adherence |  | 12 months |