linjc16/ctgov huggingface dataset:
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML

Study Overview
=================
Brief Summary
-----------------
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia. Randomized,Open Label,Control

Official Title
-----------------
Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.

Conditions
-----------------
CML, CML-CP,MMR,TKI

Intervention / Treatment
-----------------
* Drug: Flumatinib 600mg qd
* Drug: Imatinib 400mg qd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18-75 year-old Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis Adequate organ function Exclusion Criteria: received TKIs drug treatment before enrollment Central nervous system leukemia Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation) Cardiac dysfunction Previous splenectomy History of congenital or acquired bleeding disorders unrelated to CML Previous malignancy except CML Acute or chronic liver or severe kidney disease unrelated to CML Pregnant, breastfeeding, child bearing potential but failed to take effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flumatinib mesylate tablets<br>Flumatinib mesylate tablets 600mg qd for 12 months | Drug: Flumatinib 600mg qd<br> <br> |
| Active Comparator: Imatinib mesylate tablets<br>Imatinib mesylate tablets 400mg qd for 12months | Drug: Imatinib 400mg qd<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIX-month major molecular response rate |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major molecular response rate |  | 3 months, 9 months and 12 months |
Evaluation of Correct PEP Use With the Time

Study Overview
=================
Brief Summary
-----------------
Healthy subjects will be trained to used correctly a positive expiratory pressure device. The aim of the study is to evaluate te reproductibility of the correct used of the device after training

Official Title
-----------------
Evaluation of the Reproductibility of the Pressure Generated by a Positive Expiratory Pressure Device

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

Intervention / Treatment
-----------------
* Device: Positive expiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No lung disease Older than 18 years Exclusion Criteria: Psychological disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive expiratory pressure<br> | Device: Positive expiratory pressure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expiratory pressure |  | within the 7 first days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Succes rate |  | Every day |
Frequent Ballgames Training for 9-11 Year Old Schoolchildren

Study Overview
=================
Brief Summary
-----------------
Inactivity among schoolchildren is a challenge to public health and for the municipality in particular. This study´s aim is to evaluate the cognitive and physical as well as social and fitness adaptations, and learning outcomes of short- and long term ball training for 9-11 years old girls and boys, and to determine to what extend the organisation (5x12 minutes og 3x40 minute a week) and type of training (ball games, circuit training or running) influence the magnitude of response.

Official Title
-----------------
Intense School Based Physical Activity - Physiological, Cognitive and Sociological Aspects

Conditions
-----------------
Body Composition, Echocardiography

Intervention / Treatment
-----------------
* Behavioral: Football
* Behavioral: Running
* Behavioral: Circuit training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 9-11 years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen Exclusion Criteria: Children with severe mental or physical disabilities

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>Football, circuit training or running 5x12 minutes or 3x 40 minutes | Behavioral: Football<br> <br> Behavioral: Running<br> <br> Behavioral: Circuit training<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function | echocardiography | 1 year | 
| Body composition | dual energy x-ray absorptiometry (DXA-scanning) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive effect | computer based tests for cognitive and learning effects | 1 year |
Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.

Study Overview
=================
Brief Summary
-----------------
The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.

Detailed Description
-----------------
Atraumatic extraction is done and the socket is either left for spontaneous healing or the ice cream cone technique using the collagen membrane and the socket is filled with xenograft.

Official Title
-----------------
Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.

Conditions
-----------------
Socket Preservation

Intervention / Treatment
-----------------
* Procedure: Ice Cream Cone Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single or double rooted teeth indicated for extraction Presence of a buccal defect. Maxillary and Mandibular Arches Exclusion Criteria: Systemic conditions/disease that contraindicated surgery. Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery. Patients who have any habits that might jeopardize the osseointegration process, such as current smokers. Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Ice Cream Cone Technique<br>Atraumatic extraction followed by addition of barrier membrane and xenograft in the socket. | Procedure: Ice Cream Cone Technique<br>* Guided bone regeneration<br>|
| No Intervention: Spontaneous Healing<br>Spontaneous Healing after Atraumatic Extraction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal Bone Dimension from the CBCT in mm. | from the CBCT in mm. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buccal Vertical Bone Dimension | from CBCT in mm. | 3 months | 
| Palatal Vertical Bone Dimension | from CBCT in mm. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Socket preservation, Alveolar Ridge Preservation, Ridge Preservation
Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Distraction osteogenesis, the gradual lengthening of bones, is performed in order to equalize leg length discrepancy and correct skeletal deformities or to achieve greater height in short stature people. The femur and tibia are the bones most frequently lengthened. The surgery is currently performed at Hadassah Medical Center routinely by the pediatric orthopedic team utilizing a variety of external fixation devices. The procedure involves application of an external fixation device to the bone, creation of an osteotomy and gradual, controlled distraction of the bone fragments On the last week of the distraction phase and every month thereafter, patients will be provided with a monthly supply of gastrolith calcium in a sealed container (65 capsules of 500 mg each, provided by Amorphical). Starting on the first day of the last week of the distraction phase, during the entire consolidation phase until the external fixator is removed; adults will orally consume two (2) 500 mg capsules a day (total of 1 gr of gastrolith calcium). Children will be given 25 mg calcium per kg body weight up to the daily adult dose of 1000mg .

Conditions
-----------------
Skeletal Deformities, Leg Length Discrepancy

Intervention / Treatment
-----------------
* Dietary Supplement: gastrolith calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Ages 4-30 years old. Exclusion Criteria: Product Allergy Refusal to participate the study. Metabolic Disorders

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 30 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gastrolith calcium treatment<br> | Dietary Supplement: gastrolith calcium<br> <br> |

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
-----------------
Distraction osteogenesis
Efficacy of Virtual Reality on Balance in Children With Ataxic Cerebral Palsy Randomized Controlled Trail

Study Overview
=================
Brief Summary
-----------------
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is

Official Title
-----------------
Efficacy of Virtual Reality on Balance in Children With Ataxic Cerebral Palsy Randomized Controlled Trail

Conditions
-----------------
Ataxic Cerebral Palsy

Intervention / Treatment
-----------------
* Device: virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ataxic cerebral palsy aged 7-13 years Exclusion Criteria: any musculoskeletal conditions that affect balance previous surgeries that affecting balance

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional physical therapy group<br>received traditional physical therapy protocol | Device: virtual reality<br>* All children in the two groups received physical therapy protocol for 30 minutes in addition to virtual reality game traditional physical therapy group traditional physical therapy group<br>|
| Experimental: virtual reality group<br>received the same traditional physical therapy in addition to virtual reality games | Device: virtual reality<br>* All children in the two groups received physical therapy protocol for 30 minutes in addition to virtual reality game traditional physical therapy group traditional physical therapy group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall stability index | change in overall stability index will measured by using biodex balance system | [Time Frame: baseline and after 3 months of intervention.] |
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation

Study Overview
=================
Brief Summary
-----------------
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4

Detailed Description
-----------------
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.

Official Title
-----------------
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: IMED-4 recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with an active implantable CRM device Subjects > 18 years of age Subjects who are ambulatory not requiring assistance for ambulation Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB Exclusion Criteria: Subjects who are pregnant or lactating or who have been pregnant within the past three months Subjects who have tattoos on the back in the electrode patch placement region Subjects who have had a past allergic reaction to adhesives Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

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 |
| --- |
|Device: IMED-4 recording|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMED-4 recordings | The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects. | 6 months |
Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

Official Title
-----------------
An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: VHX-896 and iloperidone
* Drug: Iloperidone and VHX-896


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female participants between 18 to 55 years (inclusive). Have a Body Mass Index (BMI) of > 18.0 and < 30.0 kg/m2; (BMI = weight (kg)/ [height (m)]2). Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit. Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI. Exclusion Criteria: Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded. Pregnant or nursing (lactating) women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A: VHX-896 then iloperidone<br> | Drug: VHX-896 and iloperidone<br>* oral tablet<br>|
| Experimental: Sequence B: Iloperidone then VHX-896<br> | Drug: Iloperidone and VHX-896<br>* oral tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence between VHX-896 tablets relative to iloperidone tablets | as measured by plasma concentrations | 96 hours | 
| Assessment of Safety and Tolerability of a single dose of VHX-896 | As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs | 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iloperidone, VHX-896, Bioequivalence
Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze both depressive symptomatology and psychological well-being fluctuation in a day-to-day basis in the general population, in order to identify contextual determinants of the mood and well-being changes

Detailed Description
-----------------
Introduction: The Experience Sampling Method is a research tool to study what people do and feel in their day to day. It allows to analyse temporal relationships between variables and has a high ecological validity. Aim: To evaluate fluctuations of depressive symptoms and subjective well-being and to analyse the factors related to these fluctuations. Methodology: Longitudinal study that will follow up for two weeks a representative sample of the population aged 18 to 65 years living in Madrid using the Experience Sampling Method. An interviewer will visit the participants at their home to carry out a structured interview on mental health and well-being and to install a mobile app on the smart phone of participants in order for them to fill out information about their emotional state during the following two weeks. Participants will use the smart phone screen to fill out a brief questionnaire about their feelings, the activities they are doing and the people with whom they are interacting. Multilevel analysis based on lineal hierarchical models will be employed for data analysis as well as methods based on machine learning.

Official Title
-----------------
Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population (FEDD).

Conditions
-----------------
Depression, Happiness, Personal Satisfaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Non-institutionalized resident in Madrid To own a smart phone Exclusion Criteria: To present noticeable cognitive or other limitations that impede following the interview

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Affect as measured by PANAS | Current experience of positive and negative emotions, along with the extent to which they are felt, by means of an adapted version of PANAS questionnaire. | 7 days |