linjc16/ctgov huggingface dataset:
Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.

Official Title
-----------------
Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial

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

Intervention / Treatment
-----------------
* Device: Koning Breast CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female gender Age 18 years or older Any ethnicity Are undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy Is able to provide informed consent. Exclusion Criteria: Pregnancy Lactation Women who are unable or unwilling to understand or to provide informed consent Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. Women who are unable to tolerate study constraints. Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to): Treatment for enlarged thymus gland as an infant Irradiation for benign breast conditions, including breast inflammation after giving birth Treatment for Hodgkin's disease Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to): Tuberculosis Severe scoliosis

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing neoadjuvant therapy<br> | Device: Koning Breast CT<br>* Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.<br>* Other names: Dedicated breast CT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor volume change from baseline during neoadjuvant treatment | Tumor volume will be measured with KBCT imaging at the beginning of the therapy (baseline), mid-point of the therapy (about 3 months after the treatment starts) and end of therapy (about 4-6 months after the treatment starts). The volume change from the baseline during the treatment will be recorded. Adverse Events will be recorded as a measure of safety. | Baseline, mid-point ( 3 months), and end of therapy (4-6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast CT
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

Study Overview
=================
Brief Summary
-----------------
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Detailed Description
-----------------
The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.

Official Title
-----------------
A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: Synthetic Conjugated estrogens, B
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Naturally or surgically postmenopausal Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse) Exclusion Criteria: Known sensitivity or contraindication to estrogens or progestins History or current diagnosis of endometrial hyperplasia Recent history of vaginal bleeding of unknown cause Recent history or diagnosis of endometriosis Any contraindication to estrogen therapy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Synthetic Conjugated estrogens, B<br>* 1 (0.3mg) tablet daily<br>* Other names: Enjuvia;|
| Placebo Comparator: 2<br> | Other: Placebo<br>* 1 tablet daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the symptom identified by the patient to be most bothersome |  | Randomization to Week 12 | 
| Mean change in vaginal pH |  | Randomization to Week 12 | 
| Mean change in maturation index |  | Randomization to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of Enjuvia |  | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain, dyspareunia
Impact of the Be Well Care Well Program on Early Care Education Teachers

Study Overview
=================
Brief Summary
-----------------
The study will address the following specific aims: (1) assess the impact of the BWCW program on teacher stress and physical activity, (2) Examine feasibility of collecting cortisol.

Official Title
-----------------
Targeting Teacher Stress and Well-being to Improve Child Outcomes: Impact of the Be Well Care Well Program

Conditions
-----------------
Burnout, Caregiver

Intervention / Treatment
-----------------
* Behavioral: Be Well Care Well


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Teachers that meet the following criteria will be included: currently employed as a teacher or assistant teacher at a participating ECE center; ages 18 or older; men or women; able to speak, read, and write English. 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Be Well Care Well<br> | Behavioral: Be Well Care Well<br>* Be Well Care Well addresses teacher well-being through activities implemented in the classroom aimed at reducing teacher stress and improving physical activity. A subset of teachers involved in the program will complete classroom observations and cortisol testing to examine additional measures of stress.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score of Devereux Adult Resilience Survey | The DARS assesses social networks, internalized beliefs, and professional skills and knowledge. A high score represents high levels of adult resilience. | Baseline and 1 year follow-up | 
| Change in score of Child Worker Job Stress Inventory | The Child Worker Job Stress Inventory measures provider stress. A high score represents high job stress. | Baseline and 1 year follow-up | 
| Change in score on the Lifestyle Questionnaire | The Lifestyle Questionnaire measures physical activity and health. A high score represents high levels of physical activity. | Baseline and 1 year follow-up | 
| Change in score on the Early Childhood Job Satisfaction Survey | The ECJSS examines job satisfaction among young providers. A high score represents high job satisfaction. | Baseline and 1 year follow-up |
Hyoscine ButylBromide for Intrapartum Analgesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine for analgesia during the first stage of labor.

Official Title
-----------------
Efficacy of Intravenous Hyoscine ButylBromide as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial

Conditions
-----------------
Analgesia, Obstetrical

Intervention / Treatment
-----------------
* Drug: Hyoscine
* Drug: Pethidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparity Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes) Maternal age between 20-30 years Singleton term pregnancy (37-42 weeks of gestation) Vertex-presenting fetus Exclusion Criteria: Clinical evidence of cephalopelvic disproportion. Scarred uterus; previous cesarean section, hysterotomy or myomectomy. Any medical disorders associated with pregnancy. Fetal distress Receiving any regional or parenteral analgesia before recruitment in the study Known hypersensitivity to the drug family

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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 |
| --- | --- |
| Experimental: Hyoscine<br>Intravenous administration of Hyoscine N-butylbromide diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team. | Drug: Hyoscine<br> <br> |
| Active Comparator: Pethidine<br>Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team. | Drug: Pethidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale. | Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain]. | 4 hours |
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain

Study Overview
=================
Brief Summary
-----------------
Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects. Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain extent. In practice, there are different treatment modalities for injuries, uses of drugs & dietetics as well as practices of rehabilitation. Although, previous evidences support the efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint swelling, mobility restriction and early morning joint stiffness. But there is no treatment studies have been performed to evaluate the clinical outcome for specific sports injuries. This study assessed the efficacy and safety of ayurveda gel and patches applied to the painful injury site for the treatment of acute minor sports injury pain.

Official Title
-----------------
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain:Results of a Multicenter Controlled Clinical Trial

Conditions
-----------------
Acute Pain, Sports Injury

Intervention / Treatment
-----------------
* Device: Ayurveda
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inversion ankle injury; injury sustained during sporting activity Exclusion Criteria: other lower limb injury; concurrent fracture with or without dislocation or with or without complete rupture; surgery for ankle injury.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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 |
| --- | --- |
| Experimental: Ayurveda<br> | Device: Ayurveda<br>* Ayurveda combinations in the form of gel and patches were applied on acute pain site.<br>|
| Placebo Comparator: Placebo<br> | Device: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain intensity (VAS) |  | baseline to 3, 7 and 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ayurveda, Acute pain, Sports Injury
Prostate Biopsies With Target Lesion on MRI

Study Overview
=================
Brief Summary
-----------------
Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).

Official Title
-----------------
Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > or = at 18 years old Prostatic MRI performed at the Montpellier University Hospital Realization of targeted prostate biopsies (by fusion of MRI - ultrasound images) and non-targeted biopsies Exclusion criteria: Pre-biopsy MRI performed outside of the Montpellier University Hospital MRI with artefacts Not performing 12 non-targeted prostate biopsies

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

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

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 |
| --- | --- | --- |
| Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies | Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Targeted prostate biopsy, Non-targeted prostate biopsy, MRI, prostate, biopsy
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).

Study Overview
=================
Brief Summary
-----------------
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Model SN60WF
* Device: Model MA60AC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 50 years Clear cornea Pupil mydriasis ≥ 7mm In the bag Intraocular Lens (IOL) Exclusion Criteria: Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia Previously operated eye Proliferative diabetic retinopathy Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Active Comparator: Model SN60WF<br>Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | Device: Model SN60WF<br>* Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.<br>|
| Active Comparator: Model MA60AC<br>Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) | Device: Model MA60AC<br>* Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior Capsule Opacification (PCO) | Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective. | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Patients, bilateral, age related, undergoing, phacoemulsification
Glider PTCA Balloon Catheter Registry

Study Overview
=================
Brief Summary
-----------------
The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease.

Official Title
-----------------
Registry for PCI With the TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing PCI who are at least 18 years old PCI procedure included the use of at least one Glider PTCA Balloon Catheter Patient has been informed, in accordance with local requirements, that their data will be used in the Glider Registry Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| PCI patients treated with Glider Device<br> | Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter<br>* Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure. | average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Percentage of patients treated with at least one Glider PTCA Balloon Catheter having <50% residual diameter stenosis, or TIMI 3 flow if at a bifurcation side branch, without the development of in-hospital MACE (Major Adverse Cardiac Event). | average of 2 days |
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of chronic elevated levels of Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia before and after treatment.

Official Title
-----------------
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment

Conditions
-----------------
Hyperprolactinemia, Insulin Resistance

Intervention / Treatment
-----------------
* Other: Cabergoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent Age between 18 and 70 At diagnose a serum prolactin > 200 microgram/l (10 U/l) Exclusion Criteria: Hypothyroidism Use of any medication Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Hyperprolactinemia<br>Patients recently diagnosed with hyperprolactinemia | Other: Cabergoline<br>* Cabergoline 0,25 - 1,0 mg once a week, controlled by our outpatient clinic. The drug regimen is not influenced by participating in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | Before and after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance |  | Before and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prolactin, Insulin resistance, Glucose tolerance, Body Composition, Substrate metabolism