linjc16/ctgov huggingface dataset:
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H&N35 questionnaire. Weight loss, duration of tube feeding.

Official Title
-----------------
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Behavioral: Swallowing Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck cancer Planned curative radiotherapy Planned irradiation of level II+III lymph nodes >46 Gy >=18 y Speaks and reads Danish No previous Surgery to the head and neck area except biopsies Exclusion Criteria: -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Swallowing Exercises|Daily exercises|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing |  | 2 mths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 2 mths | 
| Duration of tube feeding |  | 2 mths | 
| Swallowing scale of EORTC HN 35 |  | 2 mths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and neck cancer, Radiotherapy, Dysphagia, Exercise, Deglutition, Randomized controlled trial, Quality of life, Tube feeding
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Study Overview
=================
Brief Summary
-----------------
The major objective of this study is to conduct a double-blind, placebo-controlled, randomized clinical trial to assess whether oral alpha lipoic acid supplementation will decrease cardiovascular disease and type 2 diabetes risk in obese subjects.

Official Title
-----------------
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Conditions
-----------------
Obesity, Cardiovascular Disease, Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Alpha Lipoic Acid
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Han ethnicity BMI≥25kg/m2 Having at least one of the following risk factors: borderline hypertension (130mmHg≤SBP<140mmHg or 85mmHg≤DBP<90mmHg), dyslipidemia (fasting total cholesterol ≥240mg/dl or HDL-C<40mg/dl), or impaired fasting glucose (fasting glucose levels between 6.1 and 7.0mmol/L) 18-60 years old Not on any antioxidant vitamin supplement Exclusion Criteria: Pregnancy, lactation or child-bearing age without birth control device History of hypertension, diabetes, coronary heart disease(CHD), cancer or liver disease Anything that would impede the subject from complying with the ALA treatment History of psychiatric problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALA<br>alpha lipoic acid 1200 mg/day | Dietary Supplement: Alpha Lipoic Acid<br>* 1200 mg/day<br>* Other names: Lipoic acid;|
| Placebo Comparator: Placebo<br>placebo 1200 mg/day | Dietary Supplement: Placebo<br>* 1200 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of oxidative stress |  | 2 months | 
| Insulin sensitivity |  | 2 months | 
| Endothelial function |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers |  | 2 months | 
| Blood pressure |  | 2 months | 
| Fasting lipid profile |  | 2 months | 
| Pulse wave velocity |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antioxidant, Obesity
Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
Purpose: A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB. Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.

Detailed Description
-----------------
A prospective randomized study is a study based on basic urological data. This study aims to evaluate the effect of NE in patients diagnosed with OAB.

Official Title
-----------------
The Role of Primary Nocturnal Enuresis in the Etiology of Overactive Bladder Syndrome

Conditions
-----------------
Overactive Bladder Syndrome, Enuresis, Nocturnal

Intervention / Treatment
-----------------
* Other: basicly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overactive bladder syndrome enuresis nocturna Exclusion Criteria: diabetes mellitus, neurological diseases bladder outlet obstruction, active urinary system infection

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 |
| --- | --- |
| Enuresis, Non-Enuresis<br>Patients were divided into two gruops according to whether having NE or not during childhood | Other: basicly<br>* Do not repeat information already included in arm/group descriptions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A diagnose of childhood NE in OAB patients can cause more severe semptomatologic progression | This study aims to evaluate the effect of NE in patients diagnosed with OAB.Definition of NE is urinary incontinence in children over the age of 5 during sleep ,as defined by International Children's Continence Society. Overactive Bladder Symptom Score (OABSS) questionnaire were used for the assessment of OAB. OABSS is an questionnaire ,consisting of 4 questions, was prepared by Homma et al. in 2006 | 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enuresis nocturna, treatment, etiology, Overactive bladder
To Study Different Levels of MK0493 for Safety, Efficacy, and Tolerability in Obese Patients (0493-017)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: MK0493


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is between 21 and 65 years of age Exclusion Criteria: HIV positive as determined by medical history Patient is pregnant, lactating or plans to become pregnant Patient has undergone surgical treatment for obesity Patient has undergone a surgical procedure within 4 weeks prior to Visit 1 or plans to undergo a surgical procedure during the study Patient plans to consume more than 2 glasses of grapefruit juice per day during the study Patient has participated in another clinical study (involving an investigational drug) within 3 months prior to restudy screening

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0493|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Perception of Smell and Taste During Antibiotic Treatment

Study Overview
=================
Brief Summary
-----------------
Antibiotic use may be associated with effects on the perception of smell and taste. These effects are poorly known. The mechanisms can be very diverse, and the effect can be very variable depending on the type of antibiotic used, the dose, and the duration. The aim of this study is to analyze the perception of the taste and olfactory capacities of patients, during an antibiotic treatment.

Official Title
-----------------
Perception of Smell and Taste During Antibiotic Treatment

Conditions
-----------------
Infectious Disease

Intervention / Treatment
-----------------
* Behavioral: Smell and Taste and questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Patient with bacterial infectious disease requiring antibiotic treatment. Having been informed about the study and not having opposed to participate Exclusion Criteria: Patient under legal protection Patient refusing to participate

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 |
| --- |
|Behavioral: Smell and Taste and questionnaire|The questionnaire must be completed before the antibiotic is taken, if a change of antibiotic is planned (stop of a treatment or addition of another treatment) and at the end of the antibiotic treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on Perception of taste | Collection of scores on perception of taste, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis. | Time of antibiotic treatment (maximum 6 months) | 
| Questionnaire on Perception of smell | Collection of scores on perception of smell, during questionnaires to be completed before, during, and after taking antibiotics. Qualitative analysis. | Time of antibiotic treatment (maximum 6 months) |
ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial

Study Overview
=================
Brief Summary
-----------------
This project has been completed and consisted of a randomised trial of six tailored decision aids giving patients evidence-based information about faecal occult blood test screening for bowel cancer. 314 Australians aged between 50-74 years were recruited from five general practices and randomised to received either the tailored decision aid with age-gender and family history specific information and values clarification exercise or a standard government information sheet. The decision aid significantly increased the proportion of people who were informed participants in the screening program.

Official Title
-----------------
Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening

Conditions
-----------------
Colorectal Cancer Screening

Intervention / Treatment
-----------------
* Behavioral: Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People aged 50-74 years who were eligible for FOBT screening under current Australian guidelines and had not had screening for colorectal cancer in the preceding two years Exclusion Criteria: Poor English, impaired cognition, significant comorbidity

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Decision Aid|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
-----------------
Decision Aid, Faecal Occult Blood Test, Colorectal Cancer Screening, Informed Decision-making
Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

Study Overview
=================
Brief Summary
-----------------
Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.

Official Title
-----------------
Awake Prone Position in Critical and Severe COVID-19 Patients Undergoing Noninvasive Respiratory Support: a Retrospective Multicenter Cohort Study

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Behavioral: Prone position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria patients aged ≥18 and < 80 years old acute respiratory failure Exclusion Criteria: endotracheal intubation performed within the first 24 hours from admission, ceiling of escalation of intensive care do not intubate order as expressed by patient willing or upon clinical judgement missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).

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 |
| --- | --- |
| Prone position<br>Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position | Behavioral: Prone position<br>* Prone position maintained at least 3 hours/day<br>|
| Standard care<br>Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal intubation |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28 days | 
| Tracheostomy |  | 28 days | 
| Length of Respiratory Intensive Care Unit stay |  | 60 days | 
| Length of Hospital stay |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spontaneous breathing, Awake pronation, COVID-19, Respiratory failure
Systemic Erythropoietin Injection in Patients Having Optic Atrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy.

Detailed Description
-----------------
The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy. The intervention is systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.

Official Title
-----------------
Systemic Erythropoietin Injection in Patients Having Optic Atrophy

Conditions
-----------------
Optic Atrophy

Intervention / Treatment
-----------------
* Drug: Systemic erythropoietin injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post papilledemic optic atrophy patients Exclusion Criteria: Refuse to give an informed consent

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?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study included 10 patients diagnosed as post papilledemic optic atrophy that were attending Alexandria main university hospital. All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systemic erythropoietin injections<br>The study included 10 patients diagnosed as post papilledemic optic atrophy | Drug: Systemic erythropoietin injection<br>* Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).<br>* Other names: Eprax 10000;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | VIsual acuity assessed at the follow up | 3 months | 
| Pattern visual evoked Potential . | Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control | 3 months | 
| Pattern electroretinogram | Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control | 3 months |
Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is asymptomatic. it is characterized by discomfort LV filling may worsen and lead typically to a pressure increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction. Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. The onset of symptoms sign an intolerance to the increase in LV filling pressures and LA , causing pulmonary hypertension . Therefore, the study of the level of LV and LA filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced. Pressures filling pressures can be explored by two methods: cardiac catheterization, which is a direct and invasive measurement method echocardiography, which is an indirect measurement method which has the advantage of being non-invasive The goal of this research is to compare the two methods.

Official Title
-----------------
Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation

Conditions
-----------------
Valvular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years; Patients hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization Exclusion Criteria: Pregnant women Patients with a history of valve replacement surgery, Patients with other valvular> grade 2 associated with the coarctation Patients known to have ischemic heart disease or in whom angiography showed significant coronary artery disease; Patients with chronic or paroxysmal atrial fibrillation Patients with a permanently pacemaker

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 |
| --- | --- | --- |
| quality of echocardiography | Evaluate the diagnostic quality of echocardiography to measure the volume of the LA indexed to body surface area compared to cardiac catheterization |  |