linjc16/ctgov huggingface dataset:
Predictors for Successful Neurofeedback Training

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to identify predictors of neurofeedback training success.

Detailed Description
-----------------
In the last decades, neurofeedback has been established as a promising scientific tool. Learning voluntary control over their own brain activity allows for establishing causal links between brain activity and mental functions. However, patients participants differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand why some participants are more successful in regulating their own brain activity than others. The objective of the present study is thus to identify predictors for successful learning self-regulation with real-time fMRI neurofeedback. To achieve this goal, we will evaluate the introspection ability of healthy participants using standardized psychological questionnaires and tasks. These scores will then be correlated with how well they learned self-regulation skills using established real-time fMRI neurofeedback protocols.

Official Title
-----------------
Predictors for Successful Neurofeedback Training

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

Intervention / Treatment
-----------------
* Other: Neurofeedback training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 65 years. Magnetic resonance imaging compatibility. Exclusion Criteria: Physical or psychiatric disorders (DSM-V diagnosis). Current substance abuse. Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Neurofeedback training|In a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between introspection scores and learning success | The primary outcome measure is a correlation between introspection scores and neurofeedback learning success across all subjects. | 48 months |
Virtual Observed Therapy for Patients With Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Using modern technology, investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Detailed Description
-----------------
Using modern technology, the investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment. Investigators will connect to the participants mobile phone, iPod or computer at a mutually convenient time three times per week who will observe participants taking their TB medication. The Virtual Observed Therapy will be carried out using NHS Lothian approved software (mobile app called POLYCOM) three times per week. This is software similar to Skype but POLYCOM is the approved software we use in NHS Lothian.

Official Title
-----------------
Virtual Observed Therapy for Patients With Tuberculosis

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Device: Virtual observed therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient requiring Tuberculosis treatment Exclusion Criteria: Those refusing consent; the healthcare professional deems the patient that will not be able to comply with VOT

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Observed Therapy<br>Intervention = Virtual observed therapy of participants taking TB therapy | Device: Virtual observed therapy<br>* Virtual Observation of participants taking their medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment completion rates using VOT compared with historical completion rates. |  | length of TB treatment (usually 6-12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Cure from TB treatment |  | length of TB treatment (usually 6-12 months) | 
| number of VOT actually observed divided by the expected VOT observed |  | length of TB treatment (usually 6-12 months) | 
| patient satisfaction questionnaire at end of treatment |  | length of TB treatment (usually 6-12 months) | 
| Mortality |  | length of TB treatment (usually 6-12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Management, Observed therapy
Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Study Overview
=================
Brief Summary
-----------------
Multi-centre, international, non-interventional, prospective survey

Detailed Description
-----------------
To assess after 84 days, on a large scale patient population, the evaluation of ocular surface diseases and the satisfaction of dry eye disease (DED) treatment naïve patients or those who had to switch for tolerance, dissatisfaction or efficacy reasons to Thealoz® Duo.

Official Title
-----------------
Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: Thealoz Duo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc…) Outpatients of either sex, aged at least 18 years Patients informed of the objectives of the survey and agreeing to participate. Exclusion Criteria: Use of cyclosporine, lifitegrast, tacrolimus, sirolimus within last 3 months and during the survey Use of topical ophthalmological treatments (glaucoma, etc…) Use of lacrimal plugs Ocular surgery in the last 12 months Concomitant use of corticosteroids Concomitant use of autologous serum or any blood derivatives Severe blepharitis Severe dry eye associated to Eyelid malposition Corneal dystrophy Ocular neoplasia Sjogren syndrome Any systemic pathologies Pregnancy/lactation

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thealoz Duo|Non applicable|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSDI | Change from baseline for patient symptoms using the ocular surface disease index (OSDI©) questionnaire at Day 84. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. | 84 days |
Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML

Study Overview
=================
Brief Summary
-----------------
The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.

Conditions
-----------------
Leukaemia, Myelocytic, Acute

Intervention / Treatment
-----------------
* Drug: AZD2171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Male/female, 18 yrs or over WHO performance status 0-2 Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy Exclusion Criteria: Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3 Previous treatment against new blood vessel formation (anti-angiogenic) Chest X-ray showing leukaemia in the lungs

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, PK |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, AML, de novo or secondary AML, AZD2171
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss

Study Overview
=================
Brief Summary
-----------------
Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size.

Official Title
-----------------
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients

Conditions
-----------------
Muscle Disuse, Neuromuscular Electrical Stimulation (NMES), Critical Illness

Intervention / Treatment
-----------------
* Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris
* Procedure: Sham-treatment: no NMES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age between 18 and 80 years Expected sedated time of >24h Exclusion Criteria: Spinal Cord Injury Arterial operaties on the legs Local wounds that prohibit NMES Chronic use of corticosteroids Intake of certain antithrombotic drugs Presence of implantable cardioverter defibrillator and/or pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMES<br>The 'NMES' arm will be treated with NMES. | Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris<br>* Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator<br>* Other names: Electrical stimulation;|
| Sham Comparator: No NMES<br>The 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used. | Procedure: Sham-treatment: no NMES<br>* Sham comparator<br>* Other names: No electrical stimulation; the leg will be sham-treated;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle fiber cross sectional area (CSA) | Muscle fiber cross sectional area (in um2) for type I and II fibers will be analyzed by using immunohistochemistry; the change of muscle fiber CSA over time will be measured | 3 hours before and 12 hours after 10 days of twice-daily NMES | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in upper leg circumference | Upper leg circumgerence will be measured; the change of upper leg circumference over time will be measured | 3 hours before and 12 hours after 10 days of twice-daily NMES |
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure

Study Overview
=================
Brief Summary
-----------------
A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.

Official Title
-----------------
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure - a Randomized Clinical Trial

Conditions
-----------------
Abortion, Missed

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol. Age equal or greater than 18 years Gestational age less than 12 complete weeks. Exclusion Criteria: Complete, incomplete, inevitable, or septic abortion. Hemodynamically unstable patients. Misoprostol sensitivity or contraindication. Multifetal pregnancies.

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: Single dose group<br> | Drug: Misoprostol<br> <br> * Other names: Cytotec;|
| Active Comparator: Repeated dose group<br> | Drug: Misoprostol<br> <br> * Other names: Cytotec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) | Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound. | Day 8 from first misoprostol dose |
Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Detailed Description
-----------------
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy. Study is performed during 24 hours after surgery.

Official Title
-----------------
Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: palonosetron
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non smoking, female patients, scheduled for laparoscopic cholecystectomy Exclusion Criteria: Patients with gastrointestinal disorder, Patients with allergies to any study medication, Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aprepitant plus palonosetron<br>aprepitant 80 mg palonosetron 0.075 mg | Drug: aprepitant<br>* aprepitant 80 mg is given to all patients before surgery<br>Drug: palonosetron<br>* palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia<br>|
| Active Comparator: aprepitant plus ramosetron<br>aprepitant 80 mg ramosetron 0.3 mg | Drug: aprepitant<br>* aprepitant 80 mg is given to all patients before surgery<br>Drug: Ramosetron<br>* ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Postoperative Nausea and Vomiting | The incidence of postoperative nausea and vomiting during 24 hours postoperatively | 24 hours |
Ear Acupuncture Effectiveness In Reducing The Signs And Symptoms Of Stress And Anxiety

Study Overview
=================
Brief Summary
-----------------
Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and effective in reducing these levels. The LSS questionnaire and IDATE state were applied before, two months and two and a half months after the start of the applications, the STAI trait was applied once prior to the sessions. The sample comprised 56 individuals who had higher levels of stress above the average LSS 100 students who answered the questionnaires. Participants were divided randomly into three groups: control group with 15 patients without care, intervention group with 20 individuals using specific points for treatment and Group Sham at 21 points using individuals without indication for treatment of anxiety and stress. The results showed that the sham points decreased anxiety levels of participants.

Detailed Description
-----------------
After checking the levels of stress and anxiety of students and workers from a school of massage and acupuncture concluded that auricular acupuncture in this study had significant results in reducing anxiety levels with the use of points and Ear Handle, but more studies are necessary so that it can be said that these points have sedating and calming effects for anxiety.

Official Title
-----------------
EAR ACUPUNCTURE EFFECTIVENESS IN REDUCING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY

Conditions
-----------------
Inclusion Criteria:, Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months., Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form., Exclusion Criteria:, Pregnant Students.

Intervention / Treatment
-----------------
* Other: Ear acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary participation in the study with available time for submission to the sessions, which occur over two months. Have a score of stress medium, high or very high in the LSS questionnaire, completion of the STAI and general form. Exclusion Criteria: Pregnant students. The only contraindication to this treatment is for pregnant women until the 3rd month of pregnancy
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 |
| --- | --- |
| Sham Comparator: 21<br>sham acupuncture | Other: Ear acupuncture<br> <br> |
| No Intervention: 15<br>Control | Other: Ear acupuncture<br> <br> |
| Active Comparator: 20<br>intervention | Other: Ear acupuncture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of the Regimen of Antiretroviral Therapy in HIV Patients

Study Overview
=================
Brief Summary
-----------------
The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.

Official Title
-----------------
Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of Antiretroviral Treatment Regimen in HIV-positive Patients Between January 2011 and July 2012 in Spanish Hospitals

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Patients with HIV Patients in antiretroviral regimen, that have changed the antirretroviral treatment. Exclusion Criteria: Patients unable to sign the consent form patients that changing their treatment are going to take the same components in co-formulated patients that changing their treatment are going to take the same components separately Total or selective interrupts not indicated by the specialist Patients that after changing antiretroviral therapy between January 2011 and July 2012, and during the next year, again suffered another change of treatment

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 |
| --- | --- | --- |
| Number of patients that change the treatment and the reason for it | Describe the changes in combination antiretroviral therapy and the causes that led, in patients with HIV infection, between January 2011 and July 2012 in routine clinical practice | 18 months |