linjc16/ctgov huggingface dataset:
Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

Study Overview
=================
Brief Summary
-----------------
The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway. The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.

Official Title
-----------------
Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors. 18 years or older Exclusion Criteria: BMI >30 or <18 Osteoporosis as defined by protocol. Subjects currently on bisphosphonate therapy. History of primary or secondary hyperparathyroidism History of Hypo-or Hyperthyroidism History of Vitamin D levels below LLN History of creatinine clearance below the EGFR History ofLiver function tests above 1.5 times ULN including LDH, SGOT, SGPT, Alkaline phosphatase, and Bilirubin History of documented cirrhosis of the liver History of chronic heparin use History of chronic glucocorticoid therapy

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 |
| --- | --- |
| Post menopausal breast cancer patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estrogen level suppresses DKK1 | With the start of AI treatment, estrogen levels will decline to almost undetectable levels. We believe this decrease in estrogen will lift suppression of DKK1 and allow its expression to peak during the 1st month of treatment, and decline more slowly thereafter. During the first 26 weeks of treatment, we expect levels of CTx to rise, PTH to fall, and P1NP to show no change, findings that would be consistent with Heshmati's study. | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aromatase Inhibitors
Digital Voice Analysis in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
There is a differences in voice frequency of schizophrenic patients compared to patients with other mental diseases and compared to mentally healthy people.

Official Title
-----------------
Digital Voice Analysis in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenic patients Other mental disease patients Healthy people People above age 18 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Schizophrenia<br>People who are diagnosed as schizophrenic by DSM-IV | |
| Mental diseases<br>Patients who are deagnosed as having mental disease other then schizophrenia | |
| Mentally healthy<br>People who have no mental disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Relation Between Body Mass Index and Endometrial Thickness

Study Overview
=================
Brief Summary
-----------------
Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles [

Detailed Description
-----------------
Premalignant lesions and malignant lesions most commonly complex hyperplasia with atypia and carcinoma of the endometrium are present in 1/3 of patients evaluated for postmenopausal bleed-ing, and so investigations for cases of postmeno-pausal bleeding are mandatory

Official Title
-----------------
The Relationship Between Transvaginal Ultrasound Endometrial Thickness and Body Mass Index and Pathology in Postmenopausal Bleeding

Conditions
-----------------
Postmenopausal Bleeding

Intervention / Treatment
-----------------
* Diagnostic Test: transvaginal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopausal women (defined as minimum of 1 year of amenorrhea after the age of 45 years if only the amenorrhea is not related to pregnancy, medication or disease), Exclusion Criteria: Women with chronic diseases as diabetes mellitus, hypertension or hematological disorders, those received hormone replacement therapy, Tamoxifen or anticoagulant therapy and women with adnexal massed detected by TVUS or apparent causes of bleeding from cervix or vagina e.g. ulcer were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transvaginal ultrasound|transvaginal ultrasound to measure endometrial thickness|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will have a relation between endometrial thickness and BMI | if there is a relation between increased BMI and endometrial thickness | within 2 weeks |
Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis

Study Overview
=================
Brief Summary
-----------------
When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. However, these recommendations are rarely followed in France. These recommendations were not applied in the Children's Emergency Department of BREST University Hospital. The investigators changed the protocol and shared it with the caregivers of the emergency unit. The investigators studied the impact of this change of protocol

Detailed Description
-----------------
The main purpose was to assess the proportion of children rehydrated by nasogastric tube(NG) after protocol change. Secondary outcomes were to assess hospital length of stay and sides effects. It is a retro and prospective study. The first phase took place from June to September 2018 and the second from June to September 2019. Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included.

Official Title
-----------------
Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis: Evaluation of Professional Practices Before and After Protocol Change

Conditions
-----------------
Acute Gastroenteritis, Dehydration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included Exclusion Criteria: acute gastroenteritis on return from tropical countries child with endocrine system diseases requiring parenteral rehydration history of chronic pathology requiring enteral feeding

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 15 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 |
| --- | --- | --- |
| Number of nasogastric tube after changing gastroenteritis rehydration protocol | assessed by the number of NG tube and IV in each group | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital lenght of stay between each group | evaluate by administrative data of each case (arrival time and departure time) | 4 months | 
| Number of Participants With Treatment-Related Adverse Events for each method | Serious sides effect were death and epilptic seizure. Mild sides effects were multiple (IV or NG ripped out, vomiting, failure...). | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasogastric tube, Emergency medicine, Pediatric medicine
Efficacy of Cervical Epidural Injection and Selective Nerve Root Block

Study Overview
=================
Brief Summary
-----------------
Cervical epidural steroid injections are an accepted treatment modality for radicular pain secondary to disc pathology. With the developing ultrasound technology, ultrasound guided cervical selective nerve root block has been successfully used in the treatment of cervical radiculopathy. We aimed to compare the efficacy of cervical interlaminar epidural injections and cervical selective nerve root block.

Official Title
-----------------
Comparison of the Efficacy of Cervical Epidural Steroid Injection and Selective Nerve Root Block in Patients With Cervical Radicular Pain

Conditions
-----------------
Cervical Radiculopathy

Intervention / Treatment
-----------------
* Procedure: Interlaminar cervical epidural injection
* Procedure: Cervical selective nerve root block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cervical radicular pain based on history and physical exam NRS pain score > 3 Exclusion Criteria: Previous spine surgery Allergic reactions to drugs used in procedure Epidural steroid injection within past 2 years Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor) Untreated coagulopathy

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interlaminar cervical epidural steroid injection<br> | Procedure: Interlaminar cervical epidural injection<br>* Fluoroscopy-guided interlaminar cervical epidural injection<br>|
| Experimental: Cervical selective nerve root block<br> | Procedure: Cervical selective nerve root block<br>* Ultrasound-guided cervical selective nerve root block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain | Pain assessment will be performed using the Numerical Rating Scale (NRS) score (0 = no pain, 10 = the most severe pain felt). | Change from baseline pain score to 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index |  | baseline to 6 months post-procedure |
Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications

Study Overview
=================
Brief Summary
-----------------
This is a randomized study to compare asthma patients using Foster or Relvar.

Detailed Description
-----------------
The Global Asthma Association (GAA) and the World Allergy Organization (WAO) recently issued statements stating that the small airway is caused by asthma and chronic obstructive pulmonary disease (COPD). Both pathogenesis and treatment play an important role. The small airway is an airway with diameter less than 2 mm and is one of the main sites where airflow obstruction occurs. Small particles (<2 μm) and large particles are more likely to deposit in the distal airways, and have shown to have better effects on asthma and pulmonary obstruction. At the same time, real-life research has also shown that extra-fine particles provide better asthma control than large particles, and can better improve quality of life.The aim of the study is to compare the efficacy of asthma inhalers between extra-fine particles and non-extra-fine particles.

Official Title
-----------------
Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Foster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosis with asthma with treatment naive asthma patients with poor controlled status Exclusion Criteria: COPD smoking history pregnancy cardiaovascular disease patients with acute respiratory infection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foster<br>uncontrolled asthma patients were randomized into Foster treatment group | Drug: Foster<br>* a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation<br>* Other names: Relvar;|
| Active Comparator: Relvar<br>uncontrolled asthma patients were randomized into Relvar treatment group | Drug: Foster<br>* a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation<br>* Other names: Relvar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function improvement | FEV1 | one year |
REM Sleep and Dreaming- a Case Study

Study Overview
=================
Brief Summary
-----------------
a case study of a man with a unique condition that negatively affects his sleep architecture. we want to study this man's sleep and see (through interviews) how his condition affects his ability to dream

Official Title
-----------------
REM Sleep and Dreaming- a Case Study

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - one patient- not relevant Exclusion Criteria: - one patient- not relevant
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|not relevant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dream reports | dream free-recall upon awakenings | 5 nights |
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

Study Overview
=================
Brief Summary
-----------------
EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries > 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.

Official Title
-----------------
A U.S. Post-Approval Study of the SYNERGY 4.50/5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (Evolve 4.5/5.0)

Conditions
-----------------
Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: SYNERGY 4.50 mm and 5.0 mm Coronary Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm SYNERGY stent for the treatment of their disease in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki. Exclusion Criteria: Planned treatment with a non-SYNERGY stent.

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

| Intervention/Treatment |
| --- |
|Device: SYNERGY 4.50 mm and 5.0 mm Coronary Stent System|The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) rate | 12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-Eluting Stents
Electronic Cigarette Use in Young Adult Men and Women

Study Overview
=================
Brief Summary
-----------------
This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible tobacco product dual users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors (location, activity, social cues) associated with each episode of use. Participants will also complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction with the e-cigarette experience during the study.

Official Title
-----------------
Electronic Cigarette Use in Young Adult Men and Women

Conditions
-----------------
Cigarette Smoking, Tobacco Use

Intervention / Treatment
-----------------
* Behavioral: Survey Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be 18 through 29 years of age; Smoke cigarettes; have experience with e-cigarette use; fluent in English; have a functioning cell phone for personal use ; have access to wireless networks at least once daily; have self-reported good health. Exclusion Criteria. report serious medical illness; are women who are currently/planning to be pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 30 non-treatment seeking young adult e-cigarette/cigarette dual users (15 males/15 females) will participate in a contingency-management reinforced 1 week observation period
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Survey Arm<br>Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week | Behavioral: Survey Arm<br>* Contingency Management for completion of surveys and evidence of tobacco use status<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contextual Factors Associated With Tobacco Use Episode Reported Via Ecological Momentary Assessment | Participant responses to prompt during ecological momentary assessment about their activity, location, and companionship during a tobacco use episode that occurred within the past 15 minutes. | week 1 |
Budesonide Treatment for Lymphocytic Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Detailed Description
-----------------
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Official Title
-----------------
Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis

Conditions
-----------------
Microscopic Colitis

Intervention / Treatment
-----------------
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lymphocytic colitis diarrhea effective contraception written informed consent Exclusion Criteria: other forms if IBD celiac disease infectious colitis history of colonic surgery use of budesonide, 5-ASA, steroids within th previous 4 weeks pregnancy, lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in clinical remission after 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 
| quality of life |  |  | 
| histological improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lymphocytic colitis, microscopic colitis, budesonide