linjc16/ctgov huggingface dataset:
Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms

Study Overview
=================
Brief Summary
-----------------
The primary goal of this project is to determine if an innovative behavioral weight loss program that incorporates new developments from the field of behavior therapy produces superior weight control than standard behavioral treatment. A sample of 200 adults from the community are participating in this study.

Official Title
-----------------
Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms

Conditions
-----------------
Acceptance-based Treatment, Standard Behavioral Treatment

Intervention / Treatment
-----------------
* Behavioral: Acceptance-based treatment
* Behavioral: Standard behavioral treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 18 and 70 Have a BMI between 27-50 Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest). Agree to provide permission for the research team to regularly contact your physician throughout the study to share information on changes in your weight. Successfully complete all steps in the enrollment process Exclusion Criteria: You have a medical condition or psychiatric condition that may limit your ability to comply with the behavioral recommendations of the program or pose a risk to you during weight loss. You are pregnant or plan to become pregnant in the next three years. Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain. You are participating in or plan to participate in another weight loss program in the next three years. The research team identifies any factors that would render you potentially unable or unlikely to follow the protocol, or unable to benefit from it.

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: Acceptance-based treatment<br>Behavioral therapy for weight loss focusing on acceptance-based cognitive strategies and techniques. | Behavioral: Acceptance-based treatment<br> <br> |
| Active Comparator: Standard behavioral treatment<br>Standard behavioral therapy for weight loss, the gold standard treatment. | Behavioral: Standard behavioral treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Baseline - 2-year follow-up |
EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)

Study Overview
=================
Brief Summary
-----------------
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined. In Phase 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes. Minimum 2 - maximum 10 healthy volunteers will be included. There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional EEG-registration type 1<br>conventional EEG-registration with wet bridge electrodes and conductive gel | Device: EEG<br> <br> |
| Active Comparator: conventional EEG-registration type 2<br>conventional EEG-registration with wet cup electrodes and collodion | Device: EEG<br> <br> |
| Experimental: EEG-registration with dry electrodes<br>EEG-registration with dry electrodes | Device: EEG<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG signal quality (visual and clinical) (scale) |  | 10 minutes | 
| EEG signal quality (technical) (signal to noise ratio) |  | 10 minutes | 
| User experience (questionnaire) |  | 10 minutes |
MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)

Study Overview
=================
Brief Summary
-----------------
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.

Official Title
-----------------
MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: MLC901 or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 15 and 65 non-penetrating moderate (Glasgow Coma Scale score [GCS] 9-12) or severe (GCS 3-8) traumatic brain injury less than 24 hrs from traumatic injury anticipated intensive care unit length of stay at least 48 hrs Exclusion Criteria: GCS = 3 and fixed dilated pupils or penetrating injury coexisting injury or medical conditions which could adversely affect our study outcome measures dependence for everyday activities before the injury pregnancy or breastfeeding known allergy to any of MLC901 components

Ages Eligible for Study
-----------------
Minimum Age: 15 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>MLC901 capsules three times per day over 6 months | Drug: MLC901 or Placebo<br>* groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>Placebo capsules three times per day over 6 months | Drug: MLC901 or Placebo<br>* groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome 1 | functional outcome scales of GOS | at baseline | 
| functional outcome 2 | functional outcome scales of GOS | at 3rd month post-injury | 
| functional outcome 3 | functional outcome scales of GOS | at 6th month post-injury | 
| functional outcome 4 | functional outcome scales of MRS | at baseline | 
| functional outcome 5 | functional outcome scales of MRS | at 3rd month post-injury | 
| functional outcome 6 | functional outcome scales of MRS | at 6th month post-injury |
Acute Effect of Continuous Positive Airway Pressure in Heart Failure

Study Overview
=================
Brief Summary
-----------------
Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF) are unknown. The investigators hypothesized that acutely CPAP improves diastolic function, which is associated with increases exercise tolerance. Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices of patients with CHF. This is a randomized trial including 44 patients with compensated heart failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with 10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP. Wilcoxon or paired t tests were used to compare results, with significance level at p < 0.05.

Official Title
-----------------
Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure

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

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: functional class II or III (NYHA)heart failure agreement to participate in the study absence of acute exacerbation of dyspnea intact upper airway Exclusion Criteria: valvular heart disease chest pain or unstable angina acute myocardial infarction in the prior month uncontrolled hypertension atrial fibrillation or other arrhythmias acute infection orthopedic limitations intolerance to CPAP mask

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positive airway pressure<br> | Device: CPAP<br>* unique session of 30-minute of continuous airway positive pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of isovolumetric relaxation time | Doppler-derived isovolumetric time will be measured before and after intervention (CPAP). A decreasing in isovolumetric time after CPAP will be interpretated as an improvement in myocardial relaxation | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walk distance in the walk-test-six-minute (WT6M) | subjects will be tested before and after procedure (CPAP). An increasing distance after procedure will be interpretated as improved tolerance to exercise | 30 minutes |
Hybrid PET/CT in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of active malignancy in cancer patients with rising tumor markers after treatment and in the diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical impact of PET/CT in the management and treatment of these two groups of cancer patients will be evaluated

Official Title
-----------------
The Value of Novel Imaging Modality, Hybrid PET/CT, Using F18-Flurodeoxyglucose(FDG) in the Assessment of Cancer Patients. Impact of PET/CT on Clinical Management of Patients With Rising Tumor Markers and no Other Evidence of Disease and in Patients With Metastatic Cancer of Unknown Origin

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: PET/CT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients in complete remission after treatment, with serial elevation of serum tumor markers and negative CT or other conventional imaging test. Patients with newly diagnosed metastatic cancer with unknown primary tumor Glucose levels below 150-200 Patient signed informed consent Exclusion Criteria: Pregnant or lactating women Patient unable or not willing to tolerate the test until its completion One or more of the inclusion criteria is not fulfilled
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PET/CT imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the imaging modality on patient management |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the imaging modality on patient management |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer patients
Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry

Study Overview
=================
Brief Summary
-----------------
This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA).

Detailed Description
-----------------
One eye is randomly selected in 18 healthy subjects. OPA is assessed with Dynamic Contour Tonometry. Submacular choroidal blood flow is measured with Laser Doppler Flowmetry. During both examinations the systemic blood pressure is continuously recorded with Finometer. An average systolic and diastolic LDF parameter flow during 30 seconds are determined and the pulsatility index is calculated according to the formula (LDFsys-LDFdia)/LDFdia. An association of OPA with the LDF pulsatility index, systemic blood pressure values and mean intraocular pressure will be analysed.

Official Title
-----------------
Relationship Between Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry In Healthy Subjects

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects should present no history of ocular diseases, of current topical medication, or of drug or alcohol abuse. Furthermore, a best corrected visual acuity above 20/25 in both eyes, lack of pathological findings upon a slit-lamp examination and dilated direct fundoscopy, and an IOP < 21 mmHg in both eyes will be required. Exclusion Criteria: History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis. History of ocular trauma or intraocular surgery. History of infection or inflammation within the past 3 months. History and clinical evidence for other retinal disease such as age-related degeneration, or diabetic retinopathy.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An association of OPA with the LDF pulsatility index |  | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An association of OPA with the systemic blood pressure values |  | 30 seconds | 
| An association of OPA with mean intraocular pressure |  | 30 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Pulse Amplitude, Dynamic Contour Tonometry, Pulsatility Index, Choroidal Laser Doppler Flowmetry, Finometer
An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

Official Title
-----------------
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macedonian people with diabetes mellitus (Type 1 or Type 2)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* Prescribed at the discretion of the physician<br>|
| IDet users<br> | Drug: insulin detemir<br>* Prescribed at the discretion of the physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reaching HbA1c target of maximum 7.0% |  |  | 
| Postprandial plasma glucose (PPG) |  |  | 
| Fasting plasma glucose (FPG) |  |  | 
| Change in body weight |  |  | 
| Incidence of adverse events |  |  |
Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.

Official Title
-----------------
Ezetimibe Added to Statin Therapy

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe / Duration of Treatment: 6 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will remain on a stable statin dose of 40mg or more, for the duration of the study Patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin Exclusion Criteria: Illnesses such as congestive heart failure nyha class iii or iv Uncontrolled hypertension Myocardial infarction Coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit Unstable angina pectoris or unstable or severe peripheral vascular disease Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled Serum creatinine >0.18mmol/l at enrolment or active renal disease with significant proteinuria Disorders of the haematologic, digestive (including malabsorptive disorders) Central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation Active acute or chronic hepatobiliary disease Patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin Tg >4.0mmol/l while using a statin

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe / Duration of Treatment: 6 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment |  |  |