linjc16/ctgov huggingface dataset:
Learning From Our Patients, Learning From Our Practice: Implementing an Intervention to Support Patients on Dialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to gather preliminary estimates of the impact of using Capacity Coaching as an intervention for patients receiving dialysis.

Official Title
-----------------
Learning From Our Patients, Learning From Our Practice: Implementing an Intervention to Support Patients on Dialysis

Conditions
-----------------
Dialysis

Intervention / Treatment
-----------------
* Other: Capacity Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinician Participants: Clinicians employed at Mayo Clinic who provide care to patients visiting the Mayo Clinic - Department of Nephrology and Hypertension Dialysis Services. Patient Participants: Adult patients (18 years of age and older). Receive long-term dialysis treatment and services at Mayo Clinic. Exclusion Criteria: Minors (under the age of 18 years). Non-English speaking. Lack the ability to provide informed consent.

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: Capacity Coaching<br>Participants randomized to the Capacity Coaching arm will receive three months of coaching with a Health and Wellness coach. They will receive one one-hour session and five half-hour sessions approximately two weeks apart. | Other: Capacity Coaching<br>* Capacity Coaching focuses on developing the capacity within patients to adapt, endure, and function optimally in their lives along with illness and treatment.<br>|
| No Intervention: No Capacity Coaching<br>Participants randomized to the No Capacity Coaching arm will receive usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Illness Intrusiveness Score at Baseline, 3 Months, 6 Months | The extent to which a person's illness and treatment impact their life. The Illness Intrusiveness Score ranges from 13-91, with a higher score indicating worse outcome. | Baseline, 3 Months, 6 Months |
Value of Fecal Calprotectin

Study Overview
=================
Brief Summary
-----------------
For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin levels will be compared between patients with and without a diagnosis of IBD and the sensitivity, specificity and accuracy will be determined. For the secondary aim - the correlation between calprotectin levels and disease activity - in patients with IBD selected from this cohort, we will determine the association between calprotectin levels and clinical IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease score, pathological activity) and radiological features (bowel wall thickening, enhancement, edema, mesenteric inflammation).

Official Title
-----------------
Correlation of Fecal Calprotectin Level With the Clinical, Endoscopic, Histologic and Radiologic Activity in Inflammatory Bowel diseaseThe Value of Fecal Calprotectin for the Diagnosis and Assessment of Inflammatory Bowel Disease

Conditions
-----------------
Calprotectin, Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Calprotectin assay at IU in last 12 months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Electrocardiographic and Cardiac Magnetic Resonance Predictors of Ventricular Arrhythmias in Cardiomyopathic Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to assess ECG changes for predicting ventricular arrhythmia in cardiomyopathic patients

Detailed Description
-----------------
This study aims to assess ECG markers based on 24-hour Holter ECG recordings for predicting ventricular arrhythmia in patients with Structural Heart disease who have left ventricular dysfunction and Left Ventricular Ejection Fraction ≤40%. With special concerns to underlying structural abnormalities in cardiomyopathic patients using Cardiac Magnetic Resonance to determine ventricular function, scar distribution, and grey zone analysis

Official Title
-----------------
ECG and CMR for Predicting PVCs in Cardiomyopathic Patients

Conditions
-----------------
Premature Ventricular Complex

Intervention / Treatment
-----------------
* Device: Holter monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ischemic and non-ischemic cardiomyopathy, EF < 40 % Patient haemodynamically stable Patients accept to make test Exclusion Criteria: Patients with underlying arrhythmia ex heart block or atrial arrhythmia like PACs, AF. Patients on arrhythmogenic drugs ex digitalis, amiodarone. Patients on underlying Pacemaker device or CRT-D. Patients with MI in less than 40 days Patients refuse to make test .

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Holter monitoring|24 hours Holter monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Twenty-four hours Holter monitoring after Magnetic Resonance Imaging | 24 Holter monitoring to detect PVCs burden which is defined as ≥10% of total beats | One year |
Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.

Official Title
-----------------
Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Combination of Metformin + S. Baicalensis
* Drug: Combination of Metformin + Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as a diabetes mellitus patient at least 3 months ago on screening Treated with metformin of ≥ 500 mg/day over 3 months on screening Fasting glucose level of 110 180 mg/dl or HbA1c of 7.0 9.0% on screening Exclusion Criteria: With acute or chronic inflammation Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases With acute or chronic renal failure or nephrotic syndrome With impaired hepatic function. Drug or Alcoholic abuser Pregnant or nursing woman

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active drug-> Placebo<br>Metformin + S. Baicalensis --> Metformin + Placebo | Drug: Combination of Metformin + S. Baicalensis<br>* the combination therapy for 8 weeks<br>Drug: Combination of Metformin + Placebo<br>* the metformin single therapy for 8 weeks<br>|
| Other: Placebo -> Active drug<br>Metformin + Placebo --> Metformin + S. Baicalensis | Drug: Combination of Metformin + S. Baicalensis<br>* the combination therapy for 8 weeks<br>Drug: Combination of Metformin + Placebo<br>* the metformin single therapy for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum glucose level after 8 weeks from baseline |  | Day1 and Day 57 on the 1st and 2nd periods |
Inotuzumab Ozogamicin - PF-05208773

Study Overview
=================
Brief Summary
-----------------
Inotuzumab Ozogamicin Expanded Access Program

Intervention / Treatment
-----------------
* Drug: Inotuzumab Ozogamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inotuzumab Ozogamicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.

Official Title
-----------------
A Randomized, Double-Masked, Multi-Center Phase I Study of 6 Months Duration to Assess the Safety and Tolerability of Intravenous ACZ885 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Conditions
-----------------
Wet Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: ACZ885


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female ≥ 50 years old, with aged related macular degeneration Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration Exclusion criteria: Active intraocular inflammation or ocular infection in the study eye Eye disease that may result in visual loss during the study Chronic therapy with topical, local or systemic corticosteroids. Pregnant or nursing (lactating) women.

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

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

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: ACZ885|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wet age-related macular degeneration, ACZ885
Sensorial Block Assessment of Erector Spinae Block

Study Overview
=================
Brief Summary
-----------------
Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.

Official Title
-----------------
Assessment of Dermatomal Sensorial Block of Erector Spinae Plane Block: Randomized, Prospective, Study

Conditions
-----------------
Regional Anesthesia Morbidity

Intervention / Treatment
-----------------
* Procedure: Erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who received successful erector spinae plane block for postoperative analgesia Exclusion Criteria: Patients under 18 years old Patients who are not able to communicate with Patients who are on medication which may change the perception of pain.

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP block group<br>The patients who had paravertebral interfacial plane block for postoperative analgesia | Procedure: Erector spinae plane block<br>* Local anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spread of sensorial block | The sensorial block will be evaluated with dermatomal examination | in postoperative sixth hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regional anesthesia
Safety Study of AZD5672 in Renally Impaired Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers

Official Title
-----------------
An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: AZD5672


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed written informed consent. Females should not be of childbearing potential Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1. Exclusion Criteria: Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin >20mg once daily, medications that prolong QT/QTc interval Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only) Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with Moderate renal impairment and matched volunteers | Drug: AZD5672<br>* 100 mg oral single dose<br>|
| Experimental: 2<br>Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data | Drug: AZD5672<br>* 100 mg oral single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD5672
Digital Therapy in Shoulder Rehabilitation.

Study Overview
=================
Brief Summary
-----------------
Digital therapy may provides real time visual feedbacks. Instrumented devices objectively quantify the patient's performance during rehabilitation and thus could be helpful for the personalization of the exercises. The interactive ball of this trial allows measuring both movement and pressure applied on it. Therefore, the objectives of this study are: (i) to evaluate whether the use of a novel digital therapy gaming system was therapeutically relevant during shoulder rehabilitation; (ii) to understand whether the device was effective in improving patients' engagement in comparison to a control non-gaming rehabilitation program.

Official Title
-----------------
Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.

Conditions
-----------------
Shoulder Pain

Intervention / Treatment
-----------------
* Behavioral: PG
* Behavioral: CTRL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies pain between 2/10 and 8/10 on a visual analogue scale Exclusion Criteria: post-surgical patients inability to perform active exercises peripheral neurological deficits cervical-brachialgia algodystrophy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: PG<br> | Behavioral: PG<br>* Shoulder Digital therapy<br>|
| Active Comparator: CTRL<br> | Behavioral: CTRL<br>* Shoulder non-digital therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder pain | Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10) | From baseline up to two weeks | 
| shoulder strength | Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms | From baseline up to two weeks |
Endogenous Estrogen and Coronary Heart Disease in Women

Study Overview
=================
Brief Summary
-----------------
To investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease.

Detailed Description
-----------------
BACKGROUND: Studies suggest that estrogen replacement therapy (ERT) lowers the risk of coronary heart disease in postmenopausal women. However, it is not known whether higher endogenous levels of estrogens in the postmenopausal period likewise have a protective effect. DESIGN NARRATIVE: The study used an existing resource of frozen blood samples from a cohort of 7,058 postmenopausal women enrolled between 1985 and 1991 for a study of endogenous hormones and cancer. The cohort was followed up to identify incident cases of coronary heart disease. One hundred thirty cases of coronary heart disease (defined as nonfatal myocardial infarction or death from coronary heart disease) were expected to occur by the end of follow-up. A nested case-control study was conducted in which each case was matched to two women from the cohort who were the same age as the case, donated blood around the same time, and were alive and free of heart disease as of the date of diagnosis of the case. Frozen serum samples from cases and their matched controls were analyzed for total estradiol, bioavailable estradiol (the estradiol fraction not bound to sex hormone binding globulin) estrone, total cholesterol, and high- and low-density lipoprotein cholesterol. Conditional logistic regression for matched sets were employed to determine whether estrogen levels were lower in the cases than their matched controls. The association between estrogen levels and cholesterol fractions was also investigated.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Postmenopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| Postmenopausal women with coronary heart disease<br> | |
| Postmenopausal women without coronary heart disease<br>Matched in age to the women with heart disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |