linjc16/ctgov huggingface dataset:
Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia

Study Overview
=================
Brief Summary
-----------------
This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.

Official Title
-----------------
Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Multi-level intervention to increase CRC screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 50-74 all races, sexes and genders resident of the study area Exclusion Criteria: .no exclusions based on gender, race or ethnicity

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Primary care clinics randomized to intervention or usual care
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-level Intervention<br>Receives the project intervention first | Behavioral: Multi-level intervention to increase CRC screening<br>* Intervention for the community, providers, patients, clinics and systems<br>|
| No Intervention: Delayed Multi-level Intervention<br>Offered the intervention later in the project | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC screening - clinic level | Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC screening - community level | Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys | 12 months |
Hair Up Prospective Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study

Official Title
-----------------
Hair Up Prospective Study

Conditions
-----------------
Hair Loss

Intervention / Treatment
-----------------
* Other: Hair Up
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who report hair loss during the past 3 months prior to the study Exclusion Criteria: Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hair Up<br> | Other: Hair Up<br>* Herbal topical<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of hair loss | Pull test | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of hair regrowth | Photographic evaluation of the change in hair density according to the Savin score (scale of 1-mild to 9-severe) | 3 months | 
| Quality of life questionnaire | Assessment of quality of life byThe Women's Androgenetic Alopecia Quality of Life Questionnaire (WAAQOL) | 3 months |
Diet/Growth Factor Mechanisms of Gut Adaptation

Study Overview
=================
Brief Summary
-----------------
This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Detailed Description
-----------------
This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Official Title
-----------------
Diet/Growth Factor Mechanisms of Gut Adaptation

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: recombinant human growth hormone
* Behavioral: diet modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Parenteral nutrition-dependent adults with short gut syndrome. Patients must not have diabetes mellitus or active malignancy within the past 5 years.

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: recombinant human growth hormone|nan|
|Behavioral: diet modification|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia

Study Overview
=================
Brief Summary
-----------------
The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions. It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion. Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments). The main criterion evaluation will be the surgical and endoscopic rates during the time. The treatments offered such as surgical, endoscopic ones or none of them will be followed. Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

Detailed Description
-----------------
A replay centralized pathological lesion slides corresponding to the different lesion will be done

Official Title
-----------------
A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases

Conditions
-----------------
Hyperplasia, Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia compliant patient endoscopic follow possible no settler cancer no serious pathology such as cancer Exclusion Criteria: settler cancer serious pathology such as cancer no compliant patient endoscopic follow not possible

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dysplasia or colorectal lesion<br>300 patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopies results | rates of surgery and endoscopic treatments frequency of development of a cancer or a high grade dysplasia according to a type of abnormal histological colorectal lesion | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abnormal histological colorectal lesions
PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting

Study Overview
=================
Brief Summary
-----------------
The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining. We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

Detailed Description
-----------------
Our first aim is to investigate the prevalence of altered vaginal microbiotas among women seeking fertility treatment in Denmark. Secondly we want to establish whether there are correlations between altered vaginal microbiotas and self-measurements of both the vaginal pH performed with the Saling pH glove™ and a self-collected swab with Copan Eswab™ because these would be useful for an easy-access longitudinal screening option. Finally, the third aim was to explore how the species composition of vaginal microbiotas measured by a multiplex qPCR assay was reflected in Nugent scores. A possible 4th aim is to identify patterns in the relative abundances of different species with 16sRNA primers among fertile women compared with infertile women because these differences could be indicative of a vaginal microbiota associated with bad fertility outcome.

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Other: pH glove


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seeking IVF treatment Exclusion Criteria: Bleeding and sexual intercourse within 24h

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pH test<br>VpH test gloves | Other: pH glove<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-benefit analysis of the molecular tests to conventional Gram staining |  | 1 year |
Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

Study Overview
=================
Brief Summary
-----------------
This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus

Official Title
-----------------
Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization

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

Intervention / Treatment
-----------------
* Other: additional blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients eligible for a treatment by everolimus in association with the exemestane Performance status of 0,1 or 2 according to the WHO Patients affected of a breast cancer advanced and\or metastatic HER2 negative expressing the hormonal receptor RH + menopausal Patients Exclusion Criteria: Psychiatric disease compromising the understanding of the information or the realization of the study Vulnerable people according to the law (minors, adults under protection, private persons of freedom) Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell) Not menopausal women Unaffiliated people to the Social Security People being for the period of exclusion from another study Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients. Symptomatic visceral achievement Legal incapacity or limited legal capacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus treatment<br> | Other: additional blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of the spontaneous anti-telomerase response | evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T lymphocytes level |  | 12 months | 
| everolimus level in serum patients |  | 12 months | 
| angiopoietin 2 level |  | 12 months | 
| CD138 level |  | 12 months | 
| ps6K expression |  | 12 months | 
| Merlin expression |  | 12 months | 
| neuropilin 2 expression |  | 12 months | 
| quality of life | EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23 | 12 months |
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.

Detailed Description
-----------------
RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus

Official Title
-----------------
Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: insulin resistant syndrome or Type 2 Diabetes. Exclusion criteria: Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start. Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start. Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months. Any history of surgical intervention in the right carotid artery. Clinically significant hepatic disease. Creatinine clearance <40ml/min.

Ages Eligible for Study
-----------------
Minimum Age: 35 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>study drug | Drug: Rosiglitazone<br>* study drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque occurrence & stenosis within the right carotid artery. |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosiglitazone, Type 2 diabetes, intima media thickness, Insulin resistance
Pilot Study of Remote Ischemic Preconditioning in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.

Official Title
-----------------
Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial

Conditions
-----------------
Heart Failure, Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Other: Remote ischemic preconditioning
* Other: Sham Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LV ejection fraction <40% NYHA functional class II-IV Non ischemic cardiomyopathy Stable Exclusion Criteria: recent cardiovascular hospitalization (within last 4 weeks) ischemic cardiomyopathy diabetes mellitus peripheral neuropathy ventricular assist device contraindications to exercise stress testing

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote ischemic preconditioning<br>4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure | Other: Remote ischemic preconditioning<br>* 4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure<br>|
| Sham Comparator: Sham control<br>4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive) | Other: Sham Control<br>* 4 cycles x 5mins blood pressure cuff inflation to 10mmHg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, remote ischemic preconditioning, heart failure, left ventricular dysfunction
All-Case Surveillance of Prizbind®

Study Overview
=================
Brief Summary
-----------------
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.

Official Title
-----------------
The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Drug: Prizbind®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prizbind® for Intravenous Solution<br>Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. | Drug: Prizbind®<br>* Prizbind®<br>* Other names: Idarucizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Drug Reactions (ADRs) | Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported. | From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is > 100, it was set to 100. | From the end of the first infusion up to 4 hours after the last infusion on Day 1. | 
| Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is > 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% <= and < 100% 50% <= and < 80% < 50% | From the end of the first infusion up to 4 hours after the last infusion on Day 1. |