linjc16/ctgov huggingface dataset:
Study of Screening Self-management Goals on Short Term Behavior Change

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether having patients identify a self-management goal (health goal), prior to a visit with their primary care provider, leads to health behavior improvement over six weeks.

Official Title
-----------------
Study of Screening for Patients Self-selected Health Goal and Treatment Modality Prior to Primary Care Visit and the Effect on Short-term Behavior Change

Conditions
-----------------
Patient Health Behaviors

Intervention / Treatment
-----------------
* Behavioral: Self-management goal elicitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years of age) Attending primary care visit at Lowry Family Health Center or Level One Physicians English- or Spanish-Speaking Exclusion Criteria: Exhibit signs of cognitive impairment or significant hearing impairment Provider recommendation against enrolling in study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>This group will receive usual care. | |
| Experimental: Self-Management Goal Elicitation<br>This group will receive usual care alongside a form that helps elicit self-management goals as well as preferred treatment modalities. | Behavioral: Self-management goal elicitation<br>* The intervention will be a form, given prior to a primary care visit, that allows patients to express a self-management goal (health goal) they would like to work on, and a preferred treatment modality.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-rated health | Single item measure of self rated health: How would you rate your overall health during the past week? (1=Very Poor, 7=Excellent)? We will compare scores between groups as well as change over 6-weeks between groups. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health behavior improvement | Our secondary outcome measure will include a measure of behavior specific improvements. We will evaluate both component improvements for their specified behavior, as well as the composite score of negative health behaviors assessed from a series of questions. | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Behavior, Behavior change, self-management goal, health goal
A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare a group psychotherapy intervention, the Integrative Outpatient Model, to a convenience control, in adults with bipolar disorder.

Detailed Description
-----------------
The psychotherapy literature suggests that psychological treatments can have a significant impact on the clinical course and outcome for bipolar disorder (Swartz & Frank, 2001). Very few outcome studies have been conducted in group psychotherapy for bipolar disorder, and there are no preliminary studies conducted using the Integrative Outpatient Model, developed specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a matched-control design is indicated to obtain preliminary data regarding this treatment modality and approach. The IOM is a weekly, long term psychotherapy. Comparison: Individuals who participate in group psychotherapy will be compared to a control group on mood and symptom ratings, up to 1 year post intervention.

Official Title
-----------------
A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: Group Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:bipolar disorder; functioning level appropriate for outpatient group psychotherapy; willingness to engage in a psychotherapeutic intervention - Exclusion Criteria: cognitive impairment; prominent psychosis; under 18 years old -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- |
|Behavioral: Group Psychotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression symptoms |  |  | 
| manic symptoms |  |  | 
| number of days without a bipolar mood episode |  |  | 
| global assessment of functioning |  |  | 
| clinical global impression for bipolar disorder |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychotherapy, bipolar disorder, psychodynamic, psychoeducation, illness management, controlled trial, pilot study
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating core autism symptoms, social and emotional problems, and adaptive behavior deficits in children with autism spectrum disorders.

Official Title
-----------------
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: cognitive behavioral therapy
* Behavioral: Usual community care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 7 - 11 years of age meet research criteria for a diagnosis of autism, Asperger Syndrome, or PDD-NOS meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder If taking medication, have maintained a stable dose for 1 month prior to baseline assessment Exclusion Criteria: child has an IQ of less than 80 begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period for any reason the child or parents appear unable to participate in the treatment program

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 11 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br> | Behavioral: cognitive behavioral therapy<br>* 32 weeks of CBT, 1.5 hours weekly.<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual community care<br>* 16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents) |  | 8 months (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral observations of social responsiveness |  | 8 months (post-treatment) |
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).

Detailed Description
-----------------
Asymptomatic bacteriuria (ASB) infection, a condition in which a large number of bacteria are present in the urine, often precedes the development of symptomatic UTIs. UTIs are common among women and may create complications during pregnancy. By incorporating cranberry juice into their diets, pregnant women may be able to lower their risk for UTIs caused by ASB, and cranberry juice may also prevent preterm labor and birth. This study will determine the cranberry juice-containing regimen that will work best for preventing ASB in pregnant women. For the duration of their pregnancy, participants in this study will be randomly assigned to one of three treatment arms: cranberry juice once a day, cranberry juice three times a day, or a placebo beverage three times a day. The level of bacteria in their urine will be measured at monthly study visits. Women who test positive for a UTI will receive oral antibiotic therapy. All women will be monitored throughout their pregnancies for UTIs and other related complications.

Official Title
-----------------
Cranberry for Prevention of Bacteriuria in Pregnancy

Conditions
-----------------
Urinary Tract Infection, Bacteriuria

Intervention / Treatment
-----------------
* Drug: Cranberry juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intrauterine pregnancy Mother and fetus in good health Mother pregnant for 16 weeks or less Exclusion Criteria: Suspected nonviable or ectopic pregnancy Mother plans to terminate pregnancy Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start Significant underlying medical complications that may interfere with the study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cranberry juice|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases of asymptomatic bacteriuria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases of symptomatic urinary tract infection |  |  | 
| Compliance with recommended therapy |  |  | 
| Number of preterm deliveries |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccinium macrocarpon, Asymptomatic Bacteriuria
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

Study Overview
=================
Brief Summary
-----------------
PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Detailed Description
-----------------
This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Official Title
-----------------
PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations

Conditions
-----------------
Breast Cancer, Hereditary Breast and Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria include: Triple Negative Breast Cancer ER/PR <10% and HER negative per current ASCO/CAP guidelines Stages I-IV Any age at diagnosis Patient must be within 5 years of diagnosis Eligible regardless of genetic testing status Genetic testing recommended for patients meeting NCCN and Medicare guidelines AND/OR Germline mutation Carriers Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer Healthy patients harboring mutations also eligible There is no time limit from the time of diagnosis of cancer and enrollment. Eligible regardless of personal history of cancer Exclusion Criteria include: Triple Negative Breast Cancer -Patient is not within five years of diagnosis Germline mutation Carriers: -Patient only carries a HBOC mutation that is classified as polymorphism of favor polymorphism
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 |
| --- | --- |
| Triple Negative Breast Cancer patients<br>No intervention | |
| Germline HBOC Mutation Carriers<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC |  | 5 years | 
| . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC |  | 5 years | 
| Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Triple Negative Breast Cancer, TNBC, Hereditary Breast and Ovarian Cancer, HBOC, Prospective Registry
Prehospital Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)

Study Overview
=================
Brief Summary
-----------------
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of NIRS as extra monitoring.

Official Title
-----------------
Cerebral Oxygenation During Resuscitation and Post-resuscitation Phase

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >16 year Exclusion Criteria: DNR code

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| prognostic value | Prognostic value of cerebral oxygenation during CPR | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac arrest, Cerebral oxygenation, Pre-hospital
Pharmacology of Aminophylline for Acute Kidney Injury in Neonates

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonate < 3 months post natal age Diagnosed with acute kidney injury (AKI) Receiving aminophylline for AKI treatment as per local standard of care. Exclusion Criteria: Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) Patient on renal replacement therapy Major genetic abnormalities (trisomy 13, 18 or 21).

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aminophylline per standard of care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug concentrations of theophylline |  | Day 1 or 2 and Day 3,4, or 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal Near-infrared spectroscopy (NIRS) |  | Day 1,2,3,4 | 
| Change in urine output |  | Day 1,2,3,4 | 
| Number of participants with adverse events |  | 5 days | 
| Change in urine biomarker levels |  | Day 1,2,3,4,5 | 
| Change in serum creatinine level |  | Day 1,2,3,4,5 |
The Effect of Central Sensitization and Neuropathic Pain After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
It has been well known that central sensitization (CS) is a risk factor for inferior outcomes following total knee arthroplasty (TKA). However, there are still insufficient studies on the relationship between CS and neuropathic pain (NP), and the effects of CS and NP on the patient-reported outcome measures (PROMs) of patients who underwent TKA. The purpose of this study was to investigate the relationship between CS and NP and whether CS and NP were associated with PROM in patients undergoing TKA.

Detailed Description
-----------------
A total of 312 patients who underwent primary TKA for end stage knee OA were enrolled. CS was defined as a patient with a score of 40 or higher using central sensitization inventory (CSI). NP was defined as a patient with a score of 12 or more using pain detect questionnaire (PDQ). PROMs were also evaluated based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score preoperatively and at postoperative 1 year. The patients were divided into 4 groups, group 1 with CS and NP positive, group 2 with only CS positive, group 3 with only NP positive, and group 4 with CS and NP negative, and PROM was compared between the groups.

Official Title
-----------------
The Effect of Central Sensitization and Neuropathic Pain on Patients Reported Outcomes Following Total Knee Arthroplasty

Conditions
-----------------
Neuropathic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary knee degenerative osteoarthritis Patients for total knee arthroplasty over the age of 60 Patients with 2 year postoperative medical records Exclusion Criteria: Rheumatoid arthritis Other inflammatory arthritis Neuropsychiatric patients Hepatic insufficiency Renal insufficiency Allergy or intolerance to study medications Patients with an acetylsalicylic acid of IV (angina, congestive heart failure, dementia, cerebrovascular accident) Chronic opioid use (taking opioids for longer than 3 months) Alcohol, drug abuser Narcotics addiction

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Western Ontario and McMaster University Arthritis Index (WOMAC) scale is a validated questionnarie for evaluation of patients who underwent knee operation. The questionnaire consists of 24 tiems, with five pain-related categories (score range 0-20), two stiffness categories (score range 0-8), and 17 physical functional categories (score range 0-68). All items were scored on a 5-point Likert scale (0 = none, 1 = slightly, 2 = moderate, 3 = serious, 4 = extreme). Total score range is 0-96. The lower the score, the better the result. | 2 years after TKA |