linjc16/ctgov huggingface dataset:
DBT in Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
Subjects will receive a 6-month course of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist.

Official Title
-----------------
Dialectical Behavioral Therapy for Patients With Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Dialectical Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has had at least 2 prior instances of suicidal or parasuicidal behavior. Either is off psychotropic drugs or is on a stable medication regimen. (During the study, psychotropic medications will be prescribed by a psychiatrist in the Mood and Personality Disorders Group.) Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation or current or recent Substance Dependence. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.)

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 |
| --- |
|Behavioral: Dialectical Behavioral Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of parasuicidal behavior, suicidal ideation, mood and emotion, dissociation and health care utilization at baseline, 3 months, 6 months and 9 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of cognitive processing at baseline and 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Borderline Personality Disorder, BPD, Dialectical Behavior Therapy, DBT
Work and Health Disparities Among Rural Women

Study Overview
=================
Brief Summary
-----------------
This is a study of the effects of fast paced assembly line work on women. We are studying problems women in poultry processing have with their muscles, tendons, and nerves as well as acute injuries they have in the workplace. We are also studying how their work affects the quality of their lives.

Conditions
-----------------
Tendonitis, Carpal Tunnel Syndrome, Cumulative Trauma Disorders, Overuse Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Women employed in poultry processing less than 9 months

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?
-----------------
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
-----------------
Industrial Injuries, Tendonitis, Assembly Line
Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer is a common and lethal disease. It still remains the third most common cause of cancer death in women and the second leading cause of death in men. Pain control is an important direction of postoperative management in malignancy surgery. Inadequate pain control increases cardiac and respiratory complications in these critical patients. Erector spinae plane (ESP) block is a recently described regional anesthesia technique that blocks the dorsal and ventral rami of the spinal nerves and the sympathetic nerve fibers. While the ESP block has been shown to provide effective postoperative analgesia after thoracic, and abdominal surgeries. Our aim in this study was to investigate bilateral thoracic ESP block for providing successful postoperative pain management following colorectal surgery.

Official Title
-----------------
The Comparison of the Erector Spinae Plane Block and Wound Infiltration on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Colorectal Surgery

Conditions
-----------------
Colorectal Cancer, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine Hcl 0.25% ESP block
* Drug: Bupivacaine Hcl 0.25% infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II-III patients undergoing Colorectal surgery Exclusion Criteria: renal or hepatic insufficiency, chronic pain, patients with an allergic reaction to anesthesia and analgesia drugs to be used

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group ESPB<br>Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side | Drug: Bupivacaine Hcl 0.25% ESP block<br>* Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side<br>|
| Active Comparator: Group Infiltration<br>Wound infiltration with 20 ml %0.25 bupivacaine | Drug: Bupivacaine Hcl 0.25% infiltration<br>* Wound infiltration with 20 ml %0.25 bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Opioid consumption postroperative period | Postoperative first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score | Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) | Postoperative first 24 hours |
Growth Hormone in Obese Cases With Covid-19

Study Overview
=================
Brief Summary
-----------------
The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

Detailed Description
-----------------
It is well known that lymphoid organs such the thymus, the spleen and peripheral blood produce growth hormone (GH) and GH receptor is expressed on different subpopulations of lymphocytes. Many in vitro and in animal studies demonstrate an important role of GH in immunoregulation. GH stimulates T and B cells proliferation and immunoglobulin synthesis, enhances the maturation of myeloid progenitor cells and is also able to modulate cytokine response. The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

Official Title
-----------------
The Impact of Growth Hormone in Obese Cases With Covid-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Growth Hormone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese with BMI > 30 Exclusion Criteria: History of hypersensitivity to GH

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth hormone<br>Recombinant GH will be used for those patients | Drug: Growth Hormone<br>* Recombinant growth hormone will be used<br>* Other names: Recombinant growth hormone;|
| Placebo Comparator: Placebo<br>Saline will be used | Drug: Placebo<br>* Saline injection with the same amount<br>* Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hospitalization | need to be hospitalized due to deterioration | one to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Time to recovery from symptoms and signs | one to four weeks | 
| Percentage of reduction in CRP | Percentage of reduction in CRP | one to two weeks | 
| Percentage of reduction in LDH | Percentage of reduction in LDH | one to two weeks | 
| Percentage of reduction in Ferritin | Percentage of reduction in Ferritin | one to two weeks | 
| Time to recovery from leucopenia | Time to recovery from leucopenia | one to two weeks |
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.

Detailed Description
-----------------
56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain. A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.

Official Title
-----------------
A Standardized Integral Nutritional Intervention 1 and Physical Activity Program

Conditions
-----------------
Breast Cancer, Body Weight Changes, Weight Loss, Nutrition Related Cancer

Intervention / Treatment
-----------------
* Behavioral: Control group
* Behavioral: Nutrition and physical activity group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Years: ≥18 Sex: Female Newly diagnosed breast cáncer Exclusion Criteria: Patients who have disseminated disease. Associated eating behavior disorders. Patients with dementia, mental illness or decreased cognitive function. Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study). Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism. Pregnant or breastfeeding women.

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

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

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: Control group<br>Individual nutritional intervention. | Behavioral: Control group<br>* A nutritional intervention program that consisted of two individual nutritional consults.<br>|
| Experimental: Experimental group<br>Individual nutritional intervention with two groupal sessions and physical activity. | Behavioral: Nutrition and physical activity group<br>* A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program. | To examine the frequency of food consumption | Six months |
Hysteroscopy for Pregnancy of Unknown Location

Study Overview
=================
Brief Summary
-----------------
About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on first visit and are classified as pregnancy of unknown location (PUL). The etiology includes ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D&C, and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.

Detailed Description
-----------------
If TVU showed no evidence of intra-uterine and extra-uterine pregnancy, a blood test for β-hCG was done. If β-hCG was < 1000 IU/L, the woman was followed with β-hCG 2 days later. Women with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC. If gestational tissues were visualized, ectopic pregnancy was ruled out. Otherwise, the tentative diagnosis was ectopic pregnancy.

Official Title
-----------------
Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Device: hysteroscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PUL Exclusion Criteria:
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnancy of unknown location<br>pregnant women of at least 5 weeks by last menstrual period and transvaginal ultrasound did not revealed intra-uterine pregnancy or ectopic pregnancy Intervention: hysteroscope | Device: hysteroscope<br>* Women of PUL with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of women with PUL waived from laparoscopic examination |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysteroscope
ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)

Study Overview
=================
Brief Summary
-----------------
This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants.

Official Title
-----------------
Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™

Conditions
-----------------
Herpes Zoster, Shingles

Intervention / Treatment
-----------------
* Biological: ZOSTAVAX™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with continuous Kaiser Permanente Northern California (KPNC) membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date Exclusion Criteria:

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

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 |
| --- | --- |
| Vaccinated Cohort<br>Participants vaccinated with at least one dose of ZOSTAVAX™ | Biological: ZOSTAVAX™<br>* ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use<br>* Other names: Zoster Vaccine Live;|
| Unvaccinated Comparison Cohort<br>Participants who are not yet vaccinated with any zoster vaccine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination |  | 10 years | 
| Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination |  | 10 years | 
| Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Varicella-zoster vaccine, herpes zoster, shingles, Varicella-zoster virus, postherpetic neuralgia, Herpesviridae Infections, DNA Virus Infections, Virus Diseases
Extended Follow up of the TARGIT-A Trial

Study Overview
=================
Brief Summary
-----------------
All UK patients who participated in the TARGIT-A Trial were initially treated for early breast cancer between 2000-2012. A total of 3451 patients from 33 hospitals in 11 countries participated in the trial and a comparison was made between traditional radiotherapy given over several weeks (external beam radiotherapy, EBRT) with TARGeted Intraoperative radioTherapy (TARGIT-IORT) as a single dose given during the operation to remove the breast cancer. The trial was funded by the Health Technology Assessment (HTA) programme of the Department of Health, UK and sponsored by University College London. The results from this trial have been published in major medical journals and have already started changing the way breast cancer in treated around the world; please see www.targit.org.uk for more details. We would like to continue to collect data about the health status of all patients to enable us to learn about longer term differences in the effects of these treatments on health. An analysis of this information could improve treatment for patients with breast cancer. For this, HTA have granted us further funding.

Official Title
-----------------
Extended Follow up of the TARGIT-A Trial

Conditions
-----------------
Breast Neoplasm Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who participated in the TARGIT-A trial (NCT00983684). Exclusion Criteria: Any patient who has withdrawn consent for further follow-up, or died.

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Long-term follow-up through direct patient contact | Maintaining regular contact with subjects to obtain self-reported health status in order to collect long-term follow-up of patients participating in the TARGIT A Trial. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term follow-up through national registries | Collect death & new primary cancer data from UK patients through the Office for National Statistics. | Up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-operative radiation therapy
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)

Study Overview
=================
Brief Summary
-----------------
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial

Conditions
-----------------
Vitrectomy

Intervention / Treatment
-----------------
* Drug: Ocriplasmin 25µg
* Drug: Ocriplasmin 75µg
* Drug: Ocriplasmin 125µg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in whom vitrectomy is indicated Exclusion Criteria: Posterior Vitreous Detachment (PVD) present at baseline Vitreous hemorrhage Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) Have had a vitrectomy in the study eye at any time

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocriplasmin 25µg<br>25µg of ocriplasmin intravitreal injection | Drug: Ocriplasmin 25µg<br>* Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.<br>* Other names: Microplasmin;|
| Experimental: Ocriplasmin 75µg<br>75µg of ocriplasmin intravitreal injection | Drug: Ocriplasmin 75µg<br>* Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.<br>* Other names: Microplasmin;|
| Experimental: Ocriplasmin 125µg<br>125µg of ocriplasmin intravitreal injection | Drug: Ocriplasmin 125µg<br>* Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.<br>* Other names: Microplasmin;|
| Placebo Comparator: Placebo<br>Intravitreal injection of placebo | Drug: Placebo<br>* Intravitreal injection of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention. | Day 7 |