linjc16/ctgov huggingface dataset:
Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

Study Overview
=================
Brief Summary
-----------------
Traumatic injury is a major public health problem with an immense societal cost. Despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. Evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. Determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. The goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.

Official Title
-----------------
Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Injury, ICU admission Exclusion Criteria: Isolated TBI, Admission beyond 6 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Multiple Organ Failure |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sex hormones, Testosterone, Estradiol
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma

Study Overview
=================
Brief Summary
-----------------
This is an extension of a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.

Official Title
-----------------
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma

Conditions
-----------------
Trauma, Psychological, Motor Vehicle Accident

Intervention / Treatment
-----------------
* Behavioral: EMDR-based Flash technique
* Behavioral: PC-based Flash technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult reporting distress related to motor vehicle accident-related trauma English-speaking Exclusion Criteria: already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview) any indication of instability during interactions prior to the therapy session an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye movement desensitization and reprocessing (EMDR) arm<br> | Behavioral: EMDR-based Flash technique<br>* Initial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour<br>|
| Experimental: Progressive counting (PC) arm<br> | Behavioral: PC-based Flash technique<br>* Initial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SUDS following treatment | Subjective Units of Distress Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment | 
| Change in PRS following treatment | Problem Rating Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment | 
| Change in PDS following treatment | PTSD Diagnostic Scale | Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment |
Women At Risk: The High Risk Breast Cancer Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.

Detailed Description
-----------------
This is a longitudinal cohort study that collects data of eligible women at risk for developing breast cancer. Patient information will be entered into a secured computerized database that is used for research on the prevention, early detection and treatment of breast cancer.

Official Title
-----------------
Women At Risk: The High Risk Breast Cancer Program

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or more first-degree relatives (mother, daughter, or sister) with pre-menopausal breast cancer two or more first-degree relatives with post-menopausal breast cancer tested positive for a BRCA1 or BRCA2 mutation a history of biopsy-proven atypical ductal hyperplasia or atypical lobular hyperplasia a history of biopsy-proven lobular neoplasia (lobular carcinoma in situ) Exclusion Criteria: DCIS (ductal carcinoma in situ) previous diagnosis of breast cancer

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BRCA mutation, benign breast disease, family history of breast cancer, strong family history of breast cancer, atypical ductal hyperplasia, atypical lobular hyperplasia, high risk for breast cancer
Prospective Comparison Between SADI-S and Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a variable limb length between 250 cm and 300 cm or gastric bypass. Results on weight loss, comorbidities resolution, complications, re-operations, need of supplements are registered.

Detailed Description
-----------------
Morbid obese patients and patients with an initial BMI over 35 with associated comorbidities - as diabetes mellitus - are evaluated for bariatric surgery. Candidates are offered a standard gastric bypass or a single anastomosis duodeno-ileal bypass with sleeve gastrectomy. Patients with higher BMI and those with worse metabolic condition are encouraged to accept the malabsorptive option. Gastric bypass is performed with a 150 cm alimentary limb and a calibrated pouch and anastomosis over a 14 mm bougie. SADI-S is performed with a sleeve gastrectomy over a 54 French (18 mm) gastric bougie and a 250 cm common limb. Patients are managed equally during admission: 6 hours to initiate oral intake, 2 days to remove abdominal drain and 3 days to discharge unless contraindicated. Follow up is performed through visits every 3 months the first 2 postoperative years and every 6 months from the 3rd to the 5th year.

Official Title
-----------------
Non-randomized Prospective Comparison Between SADI-S and Gastric Bypass for the Treatment of Morbid Obesity and Its Associated Co-morbidities

Conditions
-----------------
Diabetes, Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obesity Exclusion Criteria: Drug addiction Alcoholic Neoplasms Immunosuppression Mental diseases

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric bypass<br>Subjects submitted to gastric bypass | |
| SADI-S<br>Subjects submitted to SADI-S | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Excess weight loss percentage and total weight loss percentage in the first 5 years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes remission | Normalization of glycemia and HbA1c with no anti-diabetic medications | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, malabsorption, gastric bypass, SADI-S
Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.

Official Title
-----------------
Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain

Conditions
-----------------
Chronic Phantom Limb Pain

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic PLP > 6 months Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16 Age ≥ 18 years old Inpatient or Outpatient Able to come to all appointments, in the opinion of the investigator Able to give informed consent, in opinion of investigator Exclusion Criteria: Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI) Substance abuse or dependence within the last six months, as assessed by the MINI Known Diabetes Mellitus to exclude diabetic peripheral neuropathy History of coronary artery disease, hepatic disease, renal disease Other pain syndromes Any unstable medical conditions in the opinion of the investigator Other psychotropic medications excluding hypnotics

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

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Short Form Pain Questionairre |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fiser Side effect scale |  |  | 
| visual analog pain scale |  |  | 
| Present Pain intensity |  |  | 
| Tylenol # 3 consumption |  |  |
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

Study Overview
=================
Brief Summary
-----------------
The investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.

Official Title
-----------------
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

Conditions
-----------------
Anxiety Disorders, Depression

Intervention / Treatment
-----------------
* Behavioral: MBSR
* Behavioral: control (health education)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 65+ current depressive and/or anxiety symptoms current depressive and/or anxiety disorder able to participate in behavioral study Exclusion Criteria: unable to participate in study

Ages Eligible for Study
-----------------
Minimum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Stress Reduction<br>All participants in this arm receive Mindfulness Based Stress Reduction (MBSR). | Behavioral: MBSR<br>* Mindfulness-Based Stress Reduction<br>|
| Active Comparator: control<br>All participants in this arm receive an attention control | Behavioral: control (health education)<br>* health education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive functioning | neuropsychological battery examining memory, executive functioning, and attention | approximately 2 months of study intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mind-wandering | computerized task(s) of mind-wandering | 2 months of intervention | 
| mindfulness | self-report plus ecological momentary assessment measurements of mindfulness (process variable). | 2 months of intervention | 
| anxiety and depressive symptoms | scales of self-report anxiety and depressive symptoms from NIH PROMIS, and worry severity (Penn State Worry Questionnaire Abbreviated). also we will examine ecological momentary assessment measurements of anxiety and depressive symptoms. | 2 months of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, depression, cognition, MBSR, mindfulness, stress, elderly
FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

Study Overview
=================
Brief Summary
-----------------
This randomized trial evaluates an intervention to minimize use of opioids following total hip and total knee replacement. Half the participants will receive an intervention (mailed educational materials, followed by a pharmacist call), and half will receive usual care.

Detailed Description
-----------------
Surgeons and anesthesiologists prescribe opioids and other analgesic medications for acute, post-surgical pain. Recent studies have reported that some patients persist in taking opioids for months beyond the surgery. While opioids are commonly used for pain management following surgery, patients and their providers often don't have a planned method to optimize opioid exposure. This can lead to patients entering a cycle of opioid use that is difficult to manage, because, as opioid exposure is continued, pain relief is reduced and side effects increase. The investigators' study is aimed at reducing opioid exposure following total hip and total knee replacement.

Official Title
-----------------
Reducing the Use of Opioid Therapy Following Orthopedic Surgery: A Randomized Controlled Trial

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Behavioral: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total hip replacement or total knee replacement 1 year membership with KPNW prior to enrollment Exclusion Criteria: managed by pain clinic, in other pain management trial patients at low risk of persistent opioid use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Informational letter mailed approximately 2 weeks prior to surgery, informational letter mailed approximately 2 weeks post surgery, pharmacist call if refill opioid medicine more than 28 days after surgery | Behavioral: Intervention<br>* Intervention consisted of a mailing 2 weeks prior to surgery, another 2 weeks post surgery, and a pharmacist intervention if a refill of opioid medication was requested within 90 days of surgery.<br>|
| No Intervention: Control<br>Usual Care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average morphine equivalents | post surgery use of opioids | 90 days |
Conventional SILS vs Harmonic Scalpel SILS

Study Overview
=================
Brief Summary
-----------------
Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.

Conditions
-----------------
Gallbladde Stones

Intervention / Treatment
-----------------
* Procedure: converntional SILC
* Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with symptomatic gallbladder stones Exclusion Criteria: acute cholecystitis cbd stones contraindications for laparoscopy

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conventional SILC<br>Conventional method of single incision laparoscopic cholecystectomy | Procedure: converntional SILC<br> <br> Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy<br> <br> |
| Active Comparator: HS-SILC<br> | Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  |  |
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.

Official Title
-----------------
Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy

Conditions
-----------------
Prostatic Cancer

Intervention / Treatment
-----------------
* Device: Hyaluronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified prostatic cancer Low or intermediate risk prostatic cancer Lymph node negative Suitable for radiotherapy Exclusion Criteria: Earlier treatment for prostatic cancer Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Hyaluronic acid<br>Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum. | Device: Hyaluronic acid<br>* Injection in connection with ultrasound<br>* Other names: NASHA Spacer Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remaining volume of HA | Measurement on the remaining volume of HA by MRI | 24 month after end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy | 24 month after end of radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatic cancer, Radiotherapy, Hyaluronic acid