linjc16/ctgov huggingface dataset:
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy of the text messaging (SMS-based) disease management intervention to improve adherence to stimulants in adults with Attention Deficit/Hyperactivity Disorder (ADHD) within the Partners primary and psychiatry care settings. Participants in the study will receive customized text messages twice a day, every day, for a duration of 9 months. The text messages will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment

Official Title
-----------------
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting

Conditions
-----------------
Attention Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Other: SMS Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults ages 18-55 years Receipt of a prescription for stimulant medication by their primary care physician or psychiatrist Proficient in English Has a cellular phone with text messaging capabilities and is interested in and willing to receive free of charge planned text messages Exclusion Criteria: Investigator and his/her immediate family Unwilling/unable to comply with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS Intervention<br>All subjects will receive customized text messages twice a day, every day for 9 months that will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment. | Other: SMS Intervention<br>* Delivery of text messages will use the Rip Road Mobile platform.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Stimulants | Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SMS Intervention, Attention Deficit/Hyperactivity Disorder, ADHD
WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.

Detailed Description
-----------------
In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.

Official Title
-----------------
Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML

Conditions
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Biological: WT1 126-134 peptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AML or myelodysplastic syndromes (MDS) Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation HLA-A2+ WT1-expression in bone marrow

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 |
| --- |
|Biological: WT1 126-134 peptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation of T cell response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome |  |  | 
| Safety |  |  |
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings

Study Overview
=================
Brief Summary
-----------------
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.

Detailed Description
-----------------
A single type of femoral component with 3 different HA coatings will be evaluated in this study. Patients with fractured neck of femur requiring hemi-arthroplasty will be recruited. Safety and performance of the device will be determined by adverse events (device related or non-related), survival and histological exam.

Official Title
-----------------
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings

Conditions
-----------------
Femoral Neck Fractures

Intervention / Treatment
-----------------
* Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA
* Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
* Device: Hip stem with Interloc Titanium surface + Bonemaster H.A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fractured neck of femur requiring hemi-arthroplasty. Selection of subjects for this evaluation should include the following considerations:-. A likelihood of obtaining relief of pain and improved function. Full skeletal maturity. Ability to follow instructions. Good general health for age. Willing to return for follow-up evaluations . No bias to sex. Exclusion criteria: • None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA | Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA<br>* Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA<br>|
| Experimental: 2<br> | Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA<br>* Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA<br>|
| Active Comparator: 3<br> | Device: Hip stem with Interloc Titanium surface + Bonemaster H.A<br>* Hip stem with Interloc Titanium surface + Bonemaster H.A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event |  | Anytime | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Exam |  | Anytime |
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.

Official Title
-----------------
A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: rasagiline mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol. Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0. Patients must be willing and able to give informed consent. Exclusion Criteria: Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133. Premature discontinuation from study TVP 1012/133 for any reason. A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rasagiline mesylate<br>rasagiline mesylate 1 mg oral once daily | Drug: rasagiline mesylate<br>* rasagiline mesylate 1 mg oral once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy | To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy | until commericially available |
Feasibility Trial of the Early Psychological Support for the Critically Ill

Study Overview
=================
Brief Summary
-----------------
This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI)

Official Title
-----------------
Feasibility Trial of the Early Psychological Support for the Critically Ill

Conditions
-----------------
PICS

Intervention / Treatment
-----------------
* Behavioral: Early Psychological Support for the Critically Ill (EPSCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
critically ill adults admitted to the medical intensive care unit (ICU) and expected to stay >48 hours Inclusion criteria: -mechanically ventilated patients receiving vasopressors Exclusion criteria: history of dementia mental retardation suicide attempt psychotic disorders such as schizophrenia patients on comfort care non-English speaking.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Psychological Support for the Critically Ill (EPSCI)<br>patients will receive EPSCI in parallel with medical treatment | Behavioral: Early Psychological Support for the Critically Ill (EPSCI)<br>* early psychological support based on positive therapeutic suggestion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Events Scale-Revised (IES-R) score | rate of PTSD following ICU stay | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of administering Early Psychological Support for the Critically Ill (EPSCI) | how much time therapy takes, how many interruptions, feedback from staff/family/patient | 1 year | 
| Hospital Anxiety and Depression Scale (HADS) score | rate of anxiety and depression following intensive care unit (ICU) stay | 1 year | 
| Montreal Cognitive Assessment-Blind (MoCA-blind) score | rate of cognitive dysfunction following ICU stay | 1 year |
Impact of an Oral Health Intervention

Study Overview
=================
Brief Summary
-----------------
This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.

Official Title
-----------------
Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)

Conditions
-----------------
Eating Disorder

Intervention / Treatment
-----------------
* Behavioral: Smiles Matter Oral Health Education Series


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of the UNC Center for Excellence for Eating Disorders inpatient unit or outpatient clinic. Diagnosis of anorexia nervosa or bulimia nervosa Aged 13-50 years English-speaking Exclusion Criteria: Decisionally impaired (i.e., Incapable of providing informed consent in the opinion of the primary care provider in UNC Center for Excellence for Eating Disorders) Involuntarily committed to the inpatient service of the UNC Department of Psychiatry

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education Program Effectiveness<br>Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic | Behavioral: Smiles Matter Oral Health Education Series<br>* Three sessions scheduled 2 weeks apart consisting of 15-20 minutes of didactic learning, 10 minutes of a group/personal exercise, and 10 minutes of questions that the patients have on the topic discussed that day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders | A multiple choice survey inquiring about potential effects of eating disorders (e.g., Tooth erosion, Probable erosion sites, Tooth sensitivity, Dry mouth, Enlarged saliva glands, Oral cancer, or No pain) and Positive Self-Perception (e.g., Confidence, Appearance, Kissing, General Health Attendance) posed as Yes/No response. | Baseline, Week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia nervosa, Bulimia
Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A

Study Overview
=================
Brief Summary
-----------------
To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.

Detailed Description
-----------------
This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.

Official Title
-----------------
An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.

Conditions
-----------------
Human Immunodeficiency Virus (HIV)-1 Infection

Intervention / Treatment
-----------------
* Drug: Elvucitabine
* Drug: Lamivudine
* Drug: Emtricitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART. Exclusion Criteria: Failure to meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Elvucitabine|Elvucitabine 10 mg in combination with background ART|
|Drug: Lamivudine|nan|
|Drug: Emtricitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART |  | September 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks |  | September 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extension study to Study ACH443-014A
Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

Study Overview
=================
Brief Summary
-----------------
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin. In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.

Official Title
-----------------
Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Drug: Colistin
* Drug: Colistin plus Rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Hospitalized to Siriraj Hospital Infection with MDR A.baumanii or P.aeruginosa Nescessary for treatment with Colistin Patient agrees to participate by giving written informed consent. Exclusion Criteria: pregnancy or lactating mother Colistin or Rifampicin allergy Active hepatic disease or abnormal liver function test patient who suspected infection with mycobacterium tuberculosis patient who can not drug by enteral feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colistin<br>Colistate | Drug: Colistin<br>* Colistimethate Sodium dose 2.5-5mg/kg/day<br>* Other names: Colistate;|
| Experimental: Colistin plus Rifampicin<br>Colistate Rifampin | Drug: Colistin plus Rifampicin<br>* Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day<br>* Other names: Rifampin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with cure or improvement | Cure Improvement Worse Death | up to day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with eradication of causative bacteria | Eradication Persistence Superinfection | up to day 28 |