linjc16/ctgov huggingface dataset:
MEDEX Hidden Valley 2008

Study Overview
=================
Brief Summary
-----------------
During a multi-week expedition to the Himalaya, we aim to investigate i) whether dietary supplementation with carbohydrate drinks and gels can improve physical performance; and ii) the underlying mechanisms for any observed changes in performance. We hypothesise that i) carbohydrate supplementation will improve physical performance; and ii) the underlying mechanism of this improvement in performance will include maintenance of body glycogen (sugar) stores, prevention of dehydration and decrease in the incidence of acute mountain sickness.

Official Title
-----------------
MEDEX Hidden Valley 2008

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Dietary Supplement: Carbohydrate energy drink
* Dietary Supplement: Aspartame


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a healthy enthusiasm for the outdoors and/or a passion for research in remote and difficult circumstances Exclusion Criteria: Persons with Phenylketonuria

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: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Carbohydrate supplements (drinks and gels) | Dietary Supplement: Carbohydrate energy drink<br>* Complex carbohydrates including maltodextrin (97%) dissolved in water to make a a 10% solution, or dissolved in 25mL gels. Ad libitum. Twenty two days.<br>* Other names: PSP22 Energy, Science in Sport, Blackburn, UK;|
| Placebo Comparator: 2<br>Primarily Aspartame plus natural flavourings. Powder dissolved in water to provide non-distinguishable placebo drink. | Dietary Supplement: Aspartame<br>* Aspartame dissolved in water, ad libitum, 22 days.<br>* Other names: Science in Sport, Blackburn, UK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance (time to complete a physical performance task) |  | Mid study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | Pre, mid and post study | 
| Hydration status |  | Pre, mid and post study | 
| Body glucose stores |  | Pre, mid and post study | 
| Oxygen delivery |  | Pre, mid and post study | 
| Acute mountain sickness |  | Every day | 
| Spontaneous physical activity level |  | Pre, mid and post study | 
| Rating of perceived exertion during a stepping task |  | Pre, mid and post study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute mountain sickness, Body composition,Hypoxia, Carbohydrate supplementation, Expedition,, Hydration,, Hypoxia, Performance
Multicomponent Exercise on Executive Function and Balance

Study Overview
=================
Brief Summary
-----------------
The present study is to examine the effects of a multicomponent exercise on executive function and balance in pre-frail older adults.

Official Title
-----------------
Effects of A Multicomponent Exercise on Executive Function and Balance in Pre-frail Older Adults

Conditions
-----------------
Health Services for the Aged

Intervention / Treatment
-----------------
* Other: Multicomponent exercise
* Other: Home-program exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥ 65 Pre-frail according to the Fried Physical Frailty Phenotype Community-dwelling and able to walk independently>6m Exclusion Criteria: Unstable medical condition (ACSM Health Facility Pre-participation Screening Questionnaire) Neurological conditions(eg, Parkinson's disease, stroke, multiple sclerosis) MMSE<24 Visual or color discrimination impairment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent exercise group<br> | Other: Multicomponent exercise<br>* Aerobic exercise: 15 20 mins Resistance exercise: 15 mins Balance exercise: 15 20 mins Flexibility exercise: 10 mins<br>|
| Active Comparator: Home-program exercise group<br> | Other: Home-program exercise<br>* 60 mins exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail-Making test | Executive function | Change from baseline at 12 weeks | 
| Stroop test | Executive function | Change from baseline at 12 weeks | 
| Digit span test | Executive function | Change from baseline at 12 weeks | 
| Mini-Balance Evaluation Systems Test | Balance | Change from baseline at 12 weeks | 
| Time Up & Go test | Balance | Change from baseline at 12 weeks | 
| One leg standing test | Balance | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | Global cognition | Change from Baseline at 12 weeks | 
| Fried frailty criteria | Frailty reverse | Change from baseline at 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multicomponent Exercise, Executive Function, Balance, Pre-frail
A Comparison of FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.

Study Overview
=================
Brief Summary
-----------------
HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%, a sample size of 15 patients would be accrued in the study.

Official Title
-----------------
Phase II Study Comparing FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Procedure: FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post operative patients of documented high grade gliomas (grade III and IV) Patients who have not undergone any previous irradiation to brain. Performance Scale as defined by ECOG PS 0-3 Exclusion Criteria: Patients who are diabetic. Patients who are pregnant. Any documented contrast allergy to the agents used for imaging. Patients who are unable to comprehend or cooperate effectively for treatment planning.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDG-PET<br>A comparison of FDG-PET versus MRI based target volume delineation in glioblastoma and the role of FDG-PET/CT in the alteration of MRI based target volumes. | Procedure: FDG-PET<br>* Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor infiltration defined on FDG-PET not determined to MRI |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioblastoma, FDG-PET, MRI
Consequences From Use of Reminiscence: a Randomised Intervention Study in Ten Danish Nursing Homes

Study Overview
=================
Brief Summary
-----------------
Reminiscence is the systematic use of memories and recollections to strengthen self-identity and self-worth. The study aim was to investigate the consequences for nursing home residents and staff of integrating reminiscence into daily nursing care. Ten nursing homes were randomised into either an Intervention Group, who implemented reminiscence, or a Control Group, who continued with usual care. Data were collected at baseline and again 6 and 12 months after the intervention start. Results suggested that use of reminiscence can improve residents' quality of life and possibly delay progression in dementia symptoms. Nursing staff can experience greater satisfaction with personal and professional roles and develop a more positive view of the residents.

Conditions
-----------------
Consequences for Nursing Home Residents and Staff of Integrating Reminiscence Into Daily Nursing Care.

Intervention / Treatment
-----------------
* Behavioral: Implementation of reminiscence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nursing homes in the Mid-Jutland Region with at least one 35 residents who were willing to particpate in study signed informed consent from residents/relatives Exclusion Criteria: nursing homes that already used reminiscence on a systematic basis nursing homes with recent organisational changes/extensive staff training residents in protected-environment units, were bed-ridden/terminally ill or on short-term placement.
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation of reminiscence<br>Individual and group reminiscence sessions held with residents, supplemented by reminiscence boxes, posters and exhibitions. | Behavioral: Implementation of reminiscence<br> <br> |
| No Intervention: Usual nursing care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nurses' attitudes towards professional role and contact with residents |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residents' quality of life (proxy assessment) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Reminiscence, Nursing home staff, Nursing home residents
Family Based Interventions: Preschool Children and Parent

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of a 2-year family-based weight prevention program in a cohort of overweight preschool children and overweight parent pairs.

Detailed Description
-----------------
BACKGROUND: The proposal targets a population of individuals of great public health importance who are of high risk for weight gain: pre-school children of overweight parents. Family-based interventions are both theoretically and functionally reasonable approaches for use with these subjects, and the choice to focus on both increased physical activity and healthier food choices in the context of the family's environment is appropriate. The decision to include weight management outcomes on the parent as secondary endpoint is strategically wise and may provide important insights into the process of weight management. A broad array of data is to be collected and strong justification is provided for the inclusion of each. The study is in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled Innovative Approaches to the Prevention of Obesity. The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute. DESIGN NARRATIVE: Approximately fifty child/parent pairs were recruited and randomized evenly to one of two groups: usual care versus an intervention focused on diet and activity strategies that included weekly group visits (24 weeks), biweekly group visits for parents (12 weeks), monthly group visits for parents (6 months) and quarterly group visits (12 months). Cognitive-behavioral therapy was used to guide interventions, which focussed on empowering a parent as the primary medium by which lifestyle changes were made. Major data collection at baseline, twelve, and 24 months included measures of weight; food and activity records; activity monitor recordings; biopsychosocial profiles; blood lipids, glucose, and insulin; process measures; parenting behavior; and child behavior. The primary study outcome measure was age- and gender-appropriate changes in BMI (expressed as a binomial response). Additional outcomes of particular interest were weight changes in the parent, diet and physical activity levels, parenting skills, and biopsychosocial measures. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: M516102
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients (aged 18-65 years) with a diagnosis of AD. Female patients of child bearing potential must be using a medically acceptable form of contraception. Patients who are able and willing to give signed informed consent. Patients who have pruritus exceed the reference range. Exclusion Criteria: Patients who have a history of allergy to hydrocortisone. Patients who have a history of relevant drug hypersensitivity. Patients who have a history of contact dermatitis induced by a topical steroid. Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study. Patients who have a history or presence of any cancer. Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease. Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. Patients who have pruritus associated with conditions other than AD. Patients who have pruritus only on the face and head. Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study. Patients who have used M5161(active ingredient of M516102). Patients who cannot communicate reliably with the investigator. Patients who are pregnant or lactating. Patients who have used any IMP and/or participated in any clinical trial within 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: M516102|Twice a day|
|Drug: placebo|Twice a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus score |  |  |
Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk

Study Overview
=================
Brief Summary
-----------------
The management of type II odontoid fractures in geriatric trauma victims remains a source of substantial controversy. The purpose of this study was to compare anterior screw fixation with halo-vest-immobilization in patients with type II odontoid fractures.

Conditions
-----------------
Spinal Fractures

Intervention / Treatment
-----------------
* Other: ANTERIOR SCREW FIXATION
* Other: HALOV VEST IMMOBILIZATION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 65 years or older with an ASA (= American society of anesthesiologists) score of 2 or higher complete sets of collected data and a follow-up monitoring of at least five years Exclusion Criteria: type III odontoid fractures patients with incomplete data sets patients with penetrating mechanism of injury or congenital cervical spine anomalies

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Anterior screw fixation<br>Patients aged 65 years or older with an ASA score of 2 or higher who had undergone anterior screw fixation of type II odontoid fractures | Other: ANTERIOR SCREW FIXATION<br>* Patients aged 65 years or older with an ASA score of 2 or higher who had undergone anterior screw fixation of type II odontoid fractures<br>|
| Halo immobilization<br>Patients aged 65 years or older with an ASA score of 2 or higher who had undergone of halo immobilization of type II odontoid fractures | Other: HALOV VEST IMMOBILIZATION<br>* Patients aged 65 years or older with an ASA score of 2 or higher who had undergone halo immobilization of type II odontoid fractures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological deficits | Neurologic deficits measured including the CSOQ (Cervical Spine Outcome Questionnaire) before and after surgery as well as compared in both procedure groups | at least 60 months follow up | 
| radiographic outcome (documentation of boney union) | documentation of boney union compared in both procedure groups | at least 60 months follow up |
Spectacle Lens Visual Acuity Assessments Study

Study Overview
=================
Brief Summary
-----------------
This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.

Official Title
-----------------
Spectacle Lenses Visual Acuity Assessments Study

Conditions
-----------------
Myopia, Myopia Progression, Juvenile Myopia

Intervention / Treatment
-----------------
* Device: Novel spectacle lens design
* Device: Spectacle lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Existing subject from the CYPRESS Extension study (CPRO-1802-002) Ability to comply with study assessments The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form Exclusion Criteria: Any current ocular infection, inflammation or irritation likely to affect vision

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm<br>Single vision, impact resistant spectacle lenses; Test Arm | Device: Novel spectacle lens design<br>* Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia<br>|
| Placebo Comparator: Control Arm<br>Single vision, impact resistant spectacle lenses; Control Arm | Device: Spectacle lenses<br>* Single vision, impact resistant spectacle lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Reading Speed (maximum words per minute) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Visual Acuity with Glare | Mean and Standard Deviation at 15 minutes (short duration test) | 15 minutes |