linjc16/ctgov huggingface dataset:
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Official Title
-----------------
A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow

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

Intervention / Treatment
-----------------
* Drug: Fulvestrant
* Drug: Anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation Exclusion Criteria: Inflammatory and/or metastatic breast cancer. Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer). History of bleeding diathesis.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anastrozole monotherapy | Drug: Anastrozole<br>* 1 mg oral tablet<br>* Other names: ZD1033;|
| Experimental: 2<br>Anastrozole + Fulvestrant | Drug: Fulvestrant<br>* intramuscular injection<br>* Other names: ZD9238;Drug: Anastrozole<br>* 1 mg oral tablet<br>* Other names: ZD1033;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) | Number of patients event-free | 12 month period following randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasms, breast cancer, early breast cancer, oncology, cancer, breast cancer micrometastasis, fulvestrant
Hybrid Mathieu Urethroplasty

Study Overview
=================
Brief Summary
-----------------
the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.

Detailed Description
-----------------
background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty. Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.

Conditions
-----------------
Distal Penile Hypospadias (Disorder)

Intervention / Treatment
-----------------
* Procedure: hyebrid Mathieu Urethroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: distal penile hypospadias Exclusion Criteria: sever hypospadias cases need redo

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hyebrid Mathieu Urethroplasty|incision of the urethral plate during the procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful treatment of distal penile hypospadias | use of HOSE as a measure o success o repair | 6 moths post operative | 
| increase the scope of classic Mathieu urethroplasty | cases with glanular width from 10 mm to 15 mm were included | 6 months post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal hypospadias, Mathieu urethroplasty, modified, urethral plate
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.

Detailed Description
-----------------
Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.

Official Title
-----------------
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3 2000 international units daily
* Dietary Supplement: Vitamin C 500mg daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Hemoglobin A1c >7% measured in the 3 months prior to randomization Age 21 to 75 years Exclusion Criteria: Renal insufficiency (defined as CrCl <30mL/min) Gestational diabetes Malabsorption syndrome Patients taking vitamin D supplements at doses >400 international units daily

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D 2000 international units daily<br> | Dietary Supplement: Vitamin D3 2000 international units daily<br>* Vitamin D3 2000 international unit tablets once daily for 3 months<br>|
| Active Comparator: Vitamin C 500mg daily<br> | Dietary Supplement: Vitamin C 500mg daily<br>* Vitamin C 500mg tablets once daily for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 3 months |
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.

Official Title
-----------------
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

Conditions
-----------------
Osteoarthritis, Hip, Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Teleconsulting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post hip or knee surgery Fulfilment of criteria for home rehabilitation (no need for hospital treatment post surgery) Exclusion Criteria: Social isolation Life threatening condition No GSM network No DSL network

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teleconsulting<br>Teleconsulting | Device: Teleconsulting<br> <br> * Other names: Telemedicine;|
| No Intervention: No Teleconsulting<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional subscore of simplified WOMAC Scale |  | up to 30 days after start of rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Paint measured with visual analogue scale |  | up to 30 days after start of rehabilitation | 
| Patient satisfaction questionnaire |  | The last 1 day of the rehabilitation | 
| Medical and paramedical staff satisfaction questionnaire |  | 6 months after enrollment of the first patient | 
| Overall costs of treatment |  | 6 months after enrollment of the first patient | 
| Number of hospitalizations and use of emergency units |  | Within 30 days after start of rehabilitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Procedures, Operative
Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.

Study Overview
=================
Brief Summary
-----------------
The investigators are planning to investigate the effect of each 5% slope time change on mechanical power and SPO2 of the patients with Covid 19 ARDS diagnosis which are on mechanical ventilation PCV mode support.

Detailed Description
-----------------
In this study, with inspiration/expiration 1:2 and 1:1 time ratios in pressure controlled ventilation mode with different slope times mechanical power will be calculated in covid ARDS patients. In this way, the effect of every 5% slope time change in PCV on mechanical power and SPO2 will be investigated.

Official Title
-----------------
Retrospective Evaluation of the Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.

Conditions
-----------------
COVID-19 Pneumonia, COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis intubated Covid-19 ARDS patients Covid-19 ARDS patients on mechanical ventilator support Exclusion Criteria: heart failure disease Chronic Obstructive Pulmonary Disease (COPD) hemodynamically unstable patients pregnancy

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 |
| --- | --- |
| Covid-19 ARDS patients on PCV mode<br>No Intervention | Other: mechanical ventilation<br>* Pressure controlled ventilation mode on mechanical ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical power | Mechanical power calculated by Becher et al. comprehensive formula (MPpcv(slope)) and Trinkle, Christine A et al lineer model mechanical power formula (MPLM). | 100 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tslope, Pressure controlled ventilation, mechanical ventilation
Age-related Cognitive Change of Femur

Study Overview
=================
Brief Summary
-----------------
Age-related change of femur is not well-known. The investigators investigated the longitudinal changes of femur.

Detailed Description
-----------------
Recently, bisphosphonate-related atypical fracture of femur (AFF) is paid attention in clinicians. Almost all AFFs were occurred in thicker cortical thickness. But age-related change of femur is not well-known. The main objective of this study is to reveal the age-related change of femur.

Official Title
-----------------
Age-related Cognitive Change of Femur

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporosis or osteopenia patients who presented to our hospital Exclusion Criteria: Patients without osteoporosis or osteopenia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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 |
| --- | --- | --- |
| Age-related change of femur | We investigate radiographic features in patients with osteopenia/opsteoporosis. We investigate bilateral femur radiographs concerning to cortical thickening. We analyze age-related change of femur. To determine the age-related change of femur , statistical analyses are performed using Spearman correlation, paired t-test, chi-square test, Fisher's exact test and Mann-Whitney U test. Finally, we conclude the effects of age on femur. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cortical thickness, age
Medication Therapy Management (MTM) for a Medicaid Managed Care Population Within Patient-Centered Medical Homes

Study Overview
=================
Brief Summary
-----------------
The primary objective of this project is to determine the estimated cost avoidance (ECA) resulting from medication therapy management (MTM) interventions in a patient-centered medical home (PCMH). The secondary objective of this study is to quantify the number and types of MTM interventions recommended by pharmacists and accepted by physicians within a PCMH.

Detailed Description
-----------------
CareSource™, the largest Medicaid managed care provider in Ohio, pays for pharmacist-provided MTM using the OutcomesMTM™ platform for claims submissions. In May of 2013, pharmacists at three PCMHs affiliated with a large academic medical center began providing MTM to patients with CareSourceTM through the OutcomesMTMTM platform. A retrospective chart review of the OutcomesMTM™ platform was performed for all patients who received MTM services between May 2013 and October 2014. The number and type of MTM interventions was tracked. For each intervention, the ECA level submitted to and accepted by the third party reviewer was collected. The ECA will be calculated using the cost associated to the CareSource™ managed care provider for each ECA level.

Official Title
-----------------
Medication Therapy Management (MTM) for a Medicaid Managed Care Population Within Patient-Centered Medical Homes

Conditions
-----------------
MTM, Medication Therapy Management, Estimated Cost Avoidance, Medication Management

Intervention / Treatment
-----------------
* Behavioral: medication therapy management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of a primary care doctor within The Ohio State University Division of General Internal Medicine CareSource™ Medicaid managed care as the insurance provider Exclusion Criteria: n/a

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: medication therapy management|Patients receive medication therapy management within the primary care office|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated cost avoidance |  | 1.5 years of data collected retrospectively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of medication therapy management claims made |  | 1.5 years of data collected retrospectively | 
| Types of medication therapy management claims made |  | 1.5 years of data collected retrospectively |
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Official Title
-----------------
Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: Premarin/MPA
* Drug: Premarin/MPA
* Drug: Provera 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea BMI in the range of 18 to 35 kg/m2 History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic) History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs) Use of any prescription or investigational drug within 30 days before test article administration

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Premarin/MPA<br>* 0.625 mg/2.5 mg X4<br>Drug: Premarin/MPA<br>* 0.625 mg/5 mg X 2<br>|
| Active Comparator: 2<br> | Drug: Provera 10 mg<br>* 2.5 mg of MPA, 4 tablets dissoved in water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). |  | 4 days |
Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users

Study Overview
=================
Brief Summary
-----------------
Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time. Aim: To study ECAP in children during the first year of CI use. Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY. Descriptors: Cochlear Implantation,cochlear nerve,child.

Official Title
-----------------
Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users

Conditions
-----------------
Cochlear Nerve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
This study selected only children implanted younger than three years old and followed them during their first year of CI use.

Ages Eligible for Study
-----------------
Maximum Age: 3 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 |
| --- | --- |
| 1<br>The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. Series Study Results: During the first year of CI use there was a significant statistical growth for the amplitude of N1 peak, in basal electrodes, between the second and third returns. There were not any significant differences obtained for N1 peak, latency, slope, neither for p-NRT nor recovery time, among the returns. | |

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
-----------------
Cochlear Implantation., Cochlear nerve., Child., study, ECAP, During, First year
Media Background and Test Performance

Study Overview
=================
Brief Summary
-----------------
This study aims to test whether middle school students test performance is affected by background TV. Students will complete a high school entrance exam either with or without a TV on in the test room. Scores will be compared.

Conditions
-----------------
Test Performance When Distracted or Not

Intervention / Treatment
-----------------
* Other: TV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grades 6-8 Exclusion Criteria: non english speaking

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TV<br>Test taken with TV on | Other: TV<br>* test taken with TV on<br>|
| No Intervention: Control<br>test taken in quiet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ISEE test prep evaluation |  | immediate (day 1) |