linjc16/ctgov huggingface dataset:
Motivational Interviewing in Orthodontic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.

Official Title
-----------------
Effectiveness of Motivational Interviewing in Improving Oral Hygiene in Orthodontic Patients

Conditions
-----------------
Oral Hygiene

Intervention / Treatment
-----------------
* Behavioral: Motivational interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthodontic patients wearing fixed appliances, within the first six months of treatment Eruption completed (except for the third molars) or late mixed dentition. Caucasian Exclusion Criteria: Pregnancy Periodontal disease Systemic illness Medical treatment

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral hygiene counseling and motivational interviewing<br>This group will receive a session of oral hygiene counseling and a single session of motivational interviewing to increase the readiness of change. | Behavioral: Motivational interviewing<br> <br> |
| No Intervention: Oral hygiene counseling<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in oral hygiene using plaque index Löe & Silness | Plaque index Löe & Silness (Time: baseline, 1 month and 6 months) | Baseline, 1 month and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in oral hygiene using gingival index Löe & Silness | Gingival index Löe & Silness ( Time: baseline, 1 month and 6 months) | Baseline, 1 month and 6 months |
the Effect of Spray on Propofol Injection Pain

Study Overview
=================
Brief Summary
-----------------
While propofol is widely used an anesthetic induction medication, it causes the mild to moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol injection pain.

Official Title
-----------------
the Effect of Ethyl Chloride Spray on Propofol Injection Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: ethyl chloride spray
* Drug: lidocaine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the female patients undergoing hysteroscopy Exclusion Criteria: the patients who are pregnant, have Raynaud's syndrome, or receive the pain killer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spray<br>apply the ethyl chloride spray before propofol injection | Drug: ethyl chloride spray<br>* apply the spray for 5 seconds on the dorsal hand before propofol iv injection<br>* Other names: spray;|
| Active Comparator: lidocaine<br>apply the lidocaine 0.5 mg/kg under the touniquette state before propofol injection | Drug: lidocaine<br>* apply lidocaine under the tourniquet state before propofol iv injection<br>|
| Placebo Comparator: placebo<br>apply the saline before propofol injection | Drug: placebo<br>* apply normal saline before propofol iv injection<br>* Other names: normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol injection pain | Propofol injection pain will be measured using the VAS (Visual analogue scale; 0cm=no pain, 10cm=the worst pain) | right after the propofol injection |
Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Official Title
-----------------
Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On a stable dose of metformin as defined by the protocol Blood glucose criteria must be met Body mass index (BMI) in the range 22-45 Exclusion Criteria: History of type 1 diabetes Pregnancy or lactation Evidence of significant diabetic complications Serious cardiovascular events within the past 6 months Laboratory value abnormalities as defined by the protocol Known sensitivity to pioglitazone Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 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: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 52 weeks of treatment |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change from baseline in body weight at 52 weeks |  |  | 
| Patients with endpoint HbA1c < 7% after 52 weeks |  |  | 
| Patients with reduction in HbA1c >/= to 7% after 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Predictive Factors of Inadequate Bowel Preparation in Inpatients

Study Overview
=================
Brief Summary
-----------------
About 50-70% only of inpatients who undergo colonoscopy have an adequate bowel cleansing, which is far below the recommended threshold of 90%. Variables associated to inadequate colon preparation have not been assessed yet. Identifying such variables would allow to augment the diagnostic yield of colonoscopy, and also to reduce costs related to the need to repeat colonoscopy. Aim of the present study is to find variables independently associated to an inadequate bowel cleansing and to subsequently build and validate a predictive model, which could prove useful in clinical practice to identify hard-to-prepare inpatients. Secondary endpoints are (i) to assess the proportion of patients with inadequate colon cleansing, (ii) to run a cost-effectiveness analysis between patients with adequate cleansing and patients who need to repeat colonoscopy. Patients undergoing urgent colonoscopy, and patients who take the preparation at home will be excluded.

Official Title
-----------------
Identification of Predictive Factors of Inadequate Bowel Preparation in Inpatients. The Quality-In-Patients Study (QIPS)

Conditions
-----------------
Bowel Preparation Solutions, Colonoscopy, Inpatient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient ≥18 y.o. who are scheduled elective colonoscopy during hospitalization irrespective of the indication. Exclusion Criteria: Urgent colonoscopy Patients who are not hospitalized when taking bowel preparation or when undergoing colonoscopy

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 |
| --- | --- | --- |
| Inadequate bowel cleansing rate | The number of inpatients with inadequate bowel preparation over the total number of patients enrolled. Bowel prep will be assessed according to the Boston Bowel Preparation Scale (BBPS). A score less than 2 at one segment of the colon will be considered as inadequate bowel preparation. | At the end of the study, 3 months after the beginning of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients scheduled for colonoscopy repetition due to inadequate bowel preparation | Total number of patients scheduled for repeating colonoscopy over the total number of patients enrolled scheduled for repeating colonoscopy due to poor bowel pre. | At the end of the study, 3 months after the beginning of the study. |
Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Negative pressure ventilation (NPV) is a non-invasive ventilation mode which provide better lung expansion. The major complication of NPV is decrease blood pressure and affects the hemodynamics. The effects of NPV on chronic obstructive pulmonary disease (COPD) patients with pulmonary rehabilitation program remains unknown.

Detailed Description
-----------------
Both of NPV or positive pressure ventilation (PPV) has impact of hemodynamics. NPV with cuirass ventilator increases venous return and leads to ventricular filling and increases cardiac output (CO); In contrast to NPV, the effect of PPV in most situations is a decreased venous return and leads to decreased CO. NPV improving ventilation and work of breathing in patients with chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease Assessed Using Non-Invasive Electrical Cardiometry

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: Received negative pressure ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD who received pulmonary rehabilitation program with NPV treatment Exclusion Criteria: Recent exacerbation within 3-months Existing of tracheostomy Absence of NPV used Required of oxygen supplement during NPV Diagnosed of neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| NPV group<br>Patients who had treated in pulmonary rehabilitation unit with NPV | Other: Received negative pressure ventilation<br>* Patients who received a negative pressure during inspiratory phase.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO (cardiac output) | Change of Cardiac output before and after NPV treatment | 20 minutes | 
| SV (stroke volume) | Change of stroke volume before and after NPV treatment | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 | Change of oxygen saturation before and after NPV treatment | 20 minutes | 
| RR (respiratory rate) | Change of respiratory rate before and after NPV treatment | 20 minutes |
GnRH Agonist and Antagonists in an Oocyte Donation Program

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.

Detailed Description
-----------------
The cycles with antagonists of the GnRHa present a series of advantages with respect the GnRHa in an oocyte donation program: treatment cycles are simpler and shorter, a lower amount of dose of gonadotrophins is needed for stimulation, and most important, a decreased rate of ovarian hyperstimulation syndrome is observed. Nevertheless, several clinical trials relate their use to a greater rate of abortion and worse oocyte/ embryo quality. In order to discriminate the endometrial factor from the quality of oocyte cohort, the best strategy is the oocyte donation model. In the present study, for the first time, the effect of different protocols (long versus antagonist protocol) will be studied in the same donor, acting as its own control, undergoing COH. We will compare the COH´s parameters and IVF outcome obtained in the same donor submitted to, firstly, GnRH antagonist protocol (Cetrorelix- n= 45) versus another consecutive cycle with long protocol (Ac. Leuprolide- n= 45).

Conditions
-----------------
Effect of Two Protocols of Ovarian Stimulation on Oocyte Quality

Intervention / Treatment
-----------------
* Drug: Cetrorelix and Leuprolide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2; Exclusion Criteria: PCO

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetrorelix and Leuprolide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

Detailed Description
-----------------
We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.

Official Title
-----------------
Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Telemonitoring of glucose values using GlucoNet device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus Age ≥ 18 HbA1c between 7.5 and 10% Treated with continuous subcutaneous insulin infusion for a minimum of 3 months Exclusion Criteria: Unstabilized diabetic microangiopathy Ongoing pregnancy or planned pregnancy Unwilling to perform a minimum of 4 capillary blood tests per day Unable to use the GlucoNet device

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- |
|Device: Telemonitoring of glucose values using GlucoNet device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin HbA1c |  |  | 
| monthly mean capillary blood glucose value |  |  | 
| blood glucose variability index (MAGE Index and LBGI index) |  |  | 
| quality of life score (DQOL score) |  |  | 
| frequency of hypoglycemic episodes (<70 mg/dl) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes mellitus, telecare, telemedicine, insulin pump therapy
Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia

Study Overview
=================
Brief Summary
-----------------
Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized prospective study.

Detailed Description
-----------------
We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular vision at baseline. The angle of strabismus was measured pre- and postoperatively in a standardized fashion. The primary parameter to assess difference between BR and RR was the variation of the latent angle of strabismus at distance at three months postoperatively, secondary outcomes were reduction of convergence excess and binocular vision.

Official Title
-----------------
A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia

Conditions
-----------------
Strabismus

Intervention / Treatment
-----------------
* Procedure: Bilateral recession
* Procedure: Unilateral recession and resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age one who visited one of the clinics during the study period. Exclusion Criteria: previous strabismus surgery, an angle of strabismus larger than 24° or smaller than 10°, any normal binocular vision, convergence excess with angle of strabismus at near fixation 1.5 times larger than the angle at distance, more than 1 line Logmar acuity difference between the two eyes, hypermetropia over 6 diopters or myopia over 3 diopters, up- or downshoot in (25°) adduction more than 8°, V-pattern (25° up and down gaze) over 8°, A-pattern (25° up and down gaze) over 5° and manifest vertical strabismus over 4°

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bilateral recession|nan|
|Procedure: Unilateral recession and resection|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
-----------------
Strabismus, Esotropia, Surgical techniques
Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions

Study Overview
=================
Brief Summary
-----------------
Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Detailed Description
-----------------
This is a multicenter, retrospective data collection to evaluate the in routine use performance and safety of platelet depletions performed via the Spectra Optia system. Data collection will include procedures in 2- 3 different centers in Europe done between November 2011 and April 2014.

Official Title
-----------------
Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Conditions
-----------------
Thrombocythemia, Myeloproliferative Disease, Thrombocytosis

Intervention / Treatment
-----------------
* Device: Spectra Optia Apheresis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having received a minimum of one platelet depletion procedure via the Spectra Optia system. Availability of complete blood count results prior to starting and after completing the platelet depletion procedure via the Spectra Optia system. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spectra Optia Apheresis System|Platelet Depletion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure | (PLTpre - PLTpost) / PLTpre x 100% | on average this will be within 15 minutes after the end of the procedure | 
| Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia. | (PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume) | on average this will be within 15 minutes after the end of the procedure | 
| Adverse Events |  | during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet depletion, apheresis