linjc16/ctgov huggingface dataset:
Development of T-sec Questionnaire

Study Overview
=================
Brief Summary
-----------------
To design and validate a questionnaire that allows objective assessment of the level of bronchial mucus hypersecretion.

Detailed Description
-----------------
Asthma is a chronic inflammatory disease associated with bronchial mucus hypersecretion (MBH) due to various mechanisms, such as increased mucin secretion, plasma exudation and cytokines. It is currently known that MBH in asthmatic patients is associated with increased mortality and reduced pulmonary function, but there is no tool for its objective assessment. The aim of the study is to design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion in patients with asthma.

Official Title
-----------------
Validation of a Questionnaire to Assess Bronchial Mucus Hypersecretion in Asthmatic Patients. Questionnaire T-sec (Secretion Test).

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 30 and 99 years Clinical diagnosis of asthma Exclusion Criteria: Non-Spanish-speaking patients Inability to complete the questionnaires Failure to sign the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Hypersecretion questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A questionnaire for bronchial mucus hypersecretion | To design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the results of the questionnaire with exacerbations | Perform a statistical analysis to determine the correlation of the results of the questionnaire with exacerbations | 1 year | 
| Correlation of the results of the questionnaire with FEV1 | Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1 | 1 year | 
| Correlation of the results of the questionnaire with ACT | Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Hypersecretion, Sputum
QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is show that intensity-modulated radiotherapy (IMRT), as compared with conventional radiotherapy, improves the precision of tumor targeting and reduces the acute and late effects of radiation toxicity when used to treat anal cancer. Results from this work will provide a basis for incorporating the use of IMRT to treat anal cancer in future treatment protocols.

Detailed Description
-----------------
The objectives of this study are three-fold. First, we would like to learn and compare the doses of radiation received by the tumor and the normal tissues in anal cancer patients treated with IMRT, and in those treated with conventional radiotherapy. Second, we wish to compare the acute effects of radiation treatment in both groups of patients. Our third objective is to evaluate the late effects of radiation treatment in both groups of patients. The first two objectives will be studied using a retrospective analysis of patients with anal cancer treated at Stanford University Medical Center. The third objective will require these patients to complete and return three quality of life questionnaires.

Official Title
-----------------
Quality of Life and Functional Outcomes After Combined Modality Therapy for Anal Cancer: A Comparison of Conventional Versus Intensity-Modulated Radiation Therapy (ANAL0002)

Conditions
-----------------
Anal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Histologically confirmed diagnosis of squamous cell carcinoma of the anus. Must be able to provide informed consent. Exclusion Criteria:History of new malignancy since the time of treatment for anal cancer. Non-English speaking.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Evaluate the late effects of radiation treatment | Quality of life questionnaires | one day |
Children's Familiarity With Snack Foods Changes Expectations About Fullness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to measure and quantify children's beliefs about the satiating properties (i.e. expected satiation)of snack foods. The investigators predicted that children who were especially familiar with snack foods would expect them to deliver greater satiation.

Detailed Description
-----------------
Palatability is regarded as a major determinant of children's energy intake. However, few studies have considered other non-hedonic beliefs about foods. In adults there is emerging evidence that expectations about the satiating properties of foods are an important determinant of meal size, and that these beliefs are learned over time. In the current study, we measured and quantified children's 'expected satiation' across energy-dense snack foods using a psychophysical technique known as method of adjustment. Participants changed a comparison-food portion (pasta and tomato sauce) to match the satiation that they expected from a snack food. We predicted that children who were especially familiar with snack foods would expect them to generate greater satiation, and that children who were unfamiliar would match expected satiation based on the physical characteristics (perceived volume) of the foods. In our study, seventy 11- to 12-year-old children completed computerised measures of expected satiation, perceived volume, familiarity, and liking across six snack foods. Our analyses focused on the associations between these measures. This approach enabled us to establish differences in healthy behaviours that are evident across individuals.

Official Title
-----------------
Children's Familiarity With Snack Foods Changes Expectations About Fullness

Conditions
-----------------
Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 11 to 12 years English speaking normal or corrected-to-normal vision Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-clinical sample of children<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
-----------------
Obesity, Child, Dietary Habits
Fiberoptic Evaluation of the LMA(Laryngel Mask Airway) Position During Anesthesia With Spontaneous Respiration or Controlled Ventilation in Children

Study Overview
=================
Brief Summary
-----------------
LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of LMA insertion. When the investigators evaluate the LMA position, the investigators can use fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will bring high risk of aspiration. Recent studies reported the LMA position after general anesthesia induction not after operation. Therefore, the investigators will observe the LMA position three times; after general anesthesia induction, after caudal block, and after operation as well as the difference regarding to spontaneous and controlled ventilation.

Conditions
-----------------
Pediatric Urologic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status 1 or 2, pediatric patients from 1month to 7 years old under general anesthesia using LMA getting informed consent from the guardian Exclusion Criteria: difficult airway airway diseases ; URI, asthma, pneumonia not getting informed consent from the guardian

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 7 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 |
| --- | --- |
| spontaneous group<br>maintain spontaneous breathing during the operation, and recording tidal volume, ET CO2, respiratory rate, peak airway pressure, SpO2 | |
| controlled group<br>controlled ventilation(tidal volume 8ml/kg, ET CO2 35 40mmHg) during the operation, recording peak airway pressure, SpO2 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sucess rate of LMA insertion |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FOB(fiberoptic bronchoscope) grading of LMA position | Grade 1: only the larynx visible, Grade 2: larynz and epiglottis visible, Grade 3: epiglottis was impinging on the LMA grille, Grade 4: epiglottis was downfolded and the larynx could not be seen) | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fiberoptic, LMA, caudal block
Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure in Chronic Obstructive Pulmonary Disease Exacerbation

Study Overview
=================
Brief Summary
-----------------
Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis . The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.

Official Title
-----------------
Study of the Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Acute Heart Failure, COPD Exacerbation

Intervention / Treatment
-----------------
* Other: Valsalva maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria We included in this group, patients with a history (previous history) of COPD who consulted the emergency room for an exacerbation of COPD defined by a respiratory rate> 25c/min and a pH <7.35 and a PaCO2 >6 KPa. This group is also divided into two groups according to clinical expert assessment and the BNP value: Group1 : BNP> 400pg/ml, Group2 : BNP <400PG / ml Exclusion Criteria: We excluded from this study patients with Prominent cardiac arrest Rhythm disorders including severe tachycardia arrhythmia Auricular fibrillation Hemodynamic instability requiring the use of vasoactive drugs and a contre indications of non invasive ventilation such us consciousness disorders with a Glasgow score <12/15,a swallowing disorder A significant bronchial obstruction ,the upper airway obstruction , in upper gastrointestinal bleeding in progress, an extreme obesity and Cirrhosis or cancer. We are also excluded patients who did not cooperate and those who refused the study.

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: acute heart failure<br>control arm | Other: Valsalva maneuver<br> <br> |
| Experimental: COPD exacerbation<br>COPD exacerbation | Other: Valsalva maneuver<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular dysfunction |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Left Ventricular Failure, Valsalva Manoeuver
Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find an alternative to the six minute walk test by validating six minute step test and four metre gait speed in healthy children. Both tests were previously validated in adults and are easier to achieve in non-hospital settings.

Conditions
-----------------
Children, Healthy

Intervention / Treatment
-----------------
* Other: 6 minutes walking test
* Other: 6 minutes step test
* Other: 4 meters gait speed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: a lung disease an overweight an orthopedic disability which can slow down the subject during tests execution

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 minute walking test<br>walking during 6 minutes | Other: 6 minutes walking test<br> <br> * Other names: walk during 6 minutes as fast as possible;|
| Experimental: 6 minute step test<br>stepping during 6 minutes | Other: 6 minutes step test<br> <br> * Other names: up and down a step during 6 minutes as fast as possible;|
| Experimental: 4 meter gait speed<br>walking as fast as possible on 4 meters | Other: 4 meters gait speed<br> <br> * Other names: walk a four metre distance;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walked distance | The distance walked by subjects during a 6 minute walk test | At 6 minutes | 
| Steps count | Steps number raised and lowered by subject during a 6 minute step test | At 6 minutes | 
| Time | Time to walk four metres | at 1 minute | 
| 6MWT speed | Subjects speed (number of metres/minute) during the 6 minute walk test | at 6 minutes | 
| 6MST speed | Number of steps/minute during the 6 minute step test | at 6 minutes | 
| 4MGS speed | Number of metres/second during the four metre gait speed | at 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Dyspnea is measured by a visual analogue scale | at 6 minutes | 
| Perceived exertion | Percieve exertion is measured by a perceive exertion scale | at 6 minutes | 
| Heart rate | Heart rate was measured after each test | at 6 minutes | 
| Oxygen saturation | Oxygen saturation was measured after each test | at 6 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
evaluation, exercise tolerance, healthy children, 6MWT
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions. Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients. The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.

Conditions
-----------------
Knee Arthritis

Intervention / Treatment
-----------------
* Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients candidate for unilateral primary total knee arthroplasty Exclusion Criteria: Existing orthopaedic metal implants A history of hypersensitivity to metals Preoperative patch-test positivity to Co, Cr, Ni and Ti Malignancies Renal insufficiency Severe illnesses that would impair participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 undergoing unilateral TKA<br> | Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months |  | Preoperative and at 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with metal sensitivity at 1 year tested by patch-testing |  | 1 year follow-up |
Photoscreening for Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Retinoblastoma is the most common pediatric eye malignancy and manifests between 1 and 5 years of age. The tumor is most often diagnosed by leukocoria ( white reflex in the pupil). There is often a significant delay in diagnosis and early diagnosis enables good life prognosis and better vision outcome.There is currently not a standardized screening protocol for detection of retinoblastoma. Vision screening methods are recommended for children 3-5 years of age. The investigators are attempting to use instrument based screening started from birth to detect leukocoria.

Official Title
-----------------
Prospective Evaluation of a Smartphone Application, GoCheckKids TM, as a Screening Tool for Leukocoria in the Infant and Pediatric Population

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Device: Photoscreening -


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age birth to 10 years Informed consent given by parent or legal guardian Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single visit cross sectional prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photoscreening<br>Photoscreening of patients 0 to 10 years of age | Device: Photoscreening -<br>* external picture taken with a an phone based app<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability to detect leukocoria | Testing the reliability of the app to detect leukocoria with good sensitivity and specificity | 1 year |
Plating of Humeral Shaft Fractures in Multiple Trauma Patients.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.

Official Title
-----------------
Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.

Conditions
-----------------
Multiple Trauma, Humeral Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF) patients for whom the above fracture has healed patients willing and able to provide informed consent and able to participate in study procedures Exclusion Criteria: patients with known pathological fractures patients with metabolic bone disease patients with humeral head or inter-articular surface fractures, or other upper extremity fractures patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.) patients with neurologic injury to upper extremities

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 |
| --- | --- | --- |
| DASH (Disabilities of the Arm, Shoulder and Hand) Score |  | At Enrollment | 
| Strength of injured arm compared to uninjured arm |  | At enrollment | 
| Range of motion in injured arm compared to uninjured arm |  | At enrollment |