linjc16/ctgov huggingface dataset:
Mohs Surgery: Patient Satisfaction & Quality of Life (QOL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether there is significant difference between two groups: extra care (EC) and usual care (UC) in improvement of patients' quality-of-life (QoL) scores between the baseline and 90-day post-surgery in patients undergoing Mohs micrographic surgery (MMS).

Official Title
-----------------
Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Extra Care (EC) Intervention
* Other: Usual Care (UC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and/or male subjects undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) and/or Squamous Cell Carcinoma (SCC). Subjects must be at least 18 years of age. Exclusion Criteria: Subjects who are not able to complete the surveys (pre-surgery, 1 week post-surgery, and 3 months post- surgery) Subjects under the age 18 Subjects unable to consent Subjects who are not undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC).

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extra Care (EC) Treatment Group<br>Participants in this group will receive the EC intervention pre and post standard of care (SoC) scheduled Mohs Surgery. | Behavioral: Extra Care (EC) Intervention<br>* The EC intervention includes pre- and post- procedure calls from the surgeon, written educational material, personalized music during the operation, post-procedure skin cancer protection education, and are allowed to bring a guest into the procedure room.<br>|
| Active Comparator: Usual Care (UC) Group<br>Participants in this group will receive the usual care provided to patients undergoing standard of care (SoC) scheduled Mohs Surgery. | Other: Usual Care (UC)<br>* Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PSQ Scores | Patient Satisfaction Questionnaire (PSQ) is a 7 item questionnaire with a total score ranging from 7 to 35 with the higher score indicating greater satisfaction | Baseline, 3 months |
Enhanced External Counterpulsation

Study Overview
=================
Brief Summary
-----------------
Enhanced external counterpulsation (EECP) is a noninvasive circulatory assist device that has been as a treatment option for refractory angina in left ventricular (LV) dysfunction. Recently, its potential role in heart failure management has been shown. However, although the concept of EECP was introduced almost four decades ago, and despite growing evidence supporting the clinical benefit and safety of this therapeutic modality, little is firmly established regarding the mechanisms responsible for the benefit of EECP include improvement in endothelial function, promotion of coronary collateralization, enhancement of ventricular function, and peripheral effects. Therefore, the major aim of this study is to provide an alternative treatment, EECP, for those unsuitable for standard procedures, especially for patients whose heart failure was caused by repeated myocardial infarction, called ischemic cardiomyopathy (ICMP), and to evaluate the clinical outcome and the endothelial function before and after 35 hours of EECP treatment.

Official Title
-----------------
Enhanced External Counterpulsation for Ischemic Cardiomyopathy

Conditions
-----------------
Congestive Heart Failure, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria is left ventricular ejection fraction (LVEF) less than 40% by means of left ventricular angiography and symptomatic mild-to-moderate heart failure (New York Heart Association [NYHA] functional class II-III). The patient was included if there is no suitable target for either percutaneous coronary intervention or surgical bypass grafting. Exclusion Criteria: IF he/she has moderate or severe aortic regurgitation (AR), history of deep vein thrombosis, or significant arrhythmia.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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EECP, ischemic cardiomyopathy, endothelin-1, ischemia coronary artery diseases, congestive heart failure not amenable to standard procedures
Magnesium Nutrition and Sleep Behavior in Older Adults

Study Overview
=================
Brief Summary
-----------------
Insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. One of these factors may be a deficient magnesium status. This study will look at whether or not magnesium supplementation will improve sleep.

Detailed Description
-----------------
Insomnia affects approximately one-third of older Americans. More than half of all people aged 65 and older experience sleep problems. The prevalence of insomnia and other sleep disorders is not a natural part of aging but is high in older adults because of a variety of factors common in late life. One of those factors may be a deficient magnesium status. There is a close association between sleep architecture, especially slow wave sleep, and activity in the glutamatergic and gamma-aminobutyric acid (GABA) system. Because magnesium is a natural N-methyl-D-aspartate (NMDA)antagonist and GABA agonist, magnesium apparently plays a key role in the regulation of sleep. Such a role is supported by supplementation, correlation, and animal studies showing that magnesium intake or status affects sleep organization.

Official Title
-----------------
Magnesium Nutrition and Sleep Behavior in Older Adults

Conditions
-----------------
Nutritional Deficiency, Insomnia

Intervention / Treatment
-----------------
* Dietary Supplement: Sugar Pill
* Dietary Supplement: magnesium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have sleep complaints Score greater than 5 on Pittsburgh Global Sleep Quality Index Exclusion Criteria: taking medications that affect sleep taking 100 milligrams or more of magnesium body mass index of 40 or higher abnormal breathing conditions

Ages Eligible for Study
-----------------
Minimum Age: 51 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill<br>Sugar Pill | Dietary Supplement: Sugar Pill<br>* Sugar pill supplementation for 9 weeks<br>|
| Active Comparator: magnesium<br>300 milligrams of magnesium daily | Dietary Supplement: magnesium<br>* 300 milligrams daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Pittsburgh Sleep Quality Index | Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep. | 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnesium, Nutritional Requirements, Sleep
Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty acids on executive functions. The investigators hypothesize that participants ages 7-9 years with a ratio closer to 4:1 will do better on tests of executive function than participants with a ratio closer to the purported Western diet norm of 15:1.

Official Title
-----------------
Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds

Conditions
-----------------
Typical Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: typically-developing Exclusion Criteria: not fluent in English

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 9 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 |
| --- | --- |
| 7-9 year olds<br>Typically developing 7- to 9-year-olds will be enrolled and tested. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between executive function and n-6/n-3 fatty acid intake | Executive function will be measured using a validated and standardized system known as CANTAB (Cambridge Neuropsychological Test Automated Battery) and correlated with the ratio of fatty acid intake. 24-hour diet recalls will be completed using the NDSR (Nutrient Data System for Research) software. Across one week, the children will be interviewed 3 times (two weekdays, one weekend day) about what they ate in the previous 24 hours. The dietary data will be averaged to arrive at the n-6/n-3 intake. The children will then come to lab for one visit where they will be assessed using the CANTAB. | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperament | Temperament will be measured using a Rothbart written assessment completed by the caregiver. | Baseline | 
| Socioeconomic status | Demographic information will be collected from caregiver using a lab-typical questionnaire. | Baseline |
Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.

Official Title
-----------------
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 250 mg Clarithromycin Tablets Under Fasting Conditions

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Cardiac Toxicity in Medical Treatment of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer. In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.

Official Title
-----------------
Cardiac Toxicity in Medical Treatment of Breast Cancer

Conditions
-----------------
Heart Failure, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HER2 positive breast cancer Adjuvant treatment with trastuzumab Exclusion Criteria: Left ventricle ejection fraction (LVEF) <50% Chronic or persistent atrial fibrillation History of moderate or severe valvular heart disease.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global longitudinal strain by two dimentional speckle tracking. |  | Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month. | 
| Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE). |  | Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure related to medical treatment of breast cancer
NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to: Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema. Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin. Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.

Detailed Description
-----------------
Primary endpoint: Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin. Secondary endpoints: Determination of Cut-off(s) Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema Determination of treatment costs of the initial hospital stay Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis. Time to diagnosis. Hospitalization rate /Intensive care treatment rate between day 1 and 28 Duration of initial hospital stay 30-day re-hospitalization rate 30 day mortality rate and adverse event rate 1 and 5 year mortality rates 1 and 5 year rehospitalization rates

Official Title
-----------------
Mannheim NT-proBNP Study (MANPRO) Evaluating NT-proBNP and New Biomarkers in Patients Suffering From Dyspnea and/or Peripheral Edema for the Differential Diagnosis of Congestive Heart Failure

Conditions
-----------------
Dyspnea, Peripheral Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-90 years Dyspnea or/and peripheral edema Informed consent Exclusion Criteria: Renal insufficiency with creatinine > 2.8mg/dl Anemia (hemoglobin < 8.0mg/dl) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natruretic peptides, NT-proBNP, new biomarkers, congestive heart failure, atrial fibrillation, acute myocardial infarction, lung embolism
Central Sensitization and Outcome of Endometriosis Surgery

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether the degree of central sensitization as measured by the questionnaire central sensitization inventory CSI is related to the outcome of surgical endometriosis treatment

Official Title
-----------------
Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Diagnostic Test: central sensitization inventory (questionnaire)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary surgery because of pelvic/abdominal pain under suspected diagnosis of and with the aim to confirm endometriosis Elective abdominal surgery in women with pelvic/abdominal pain and confirmed endometriosis Exclusion Criteria: Patient is unable to give consent Cognitive impairment Patient outcomes questionnaire is not available in a language that the patient knows. Secondary surgery due to complications Endometriosis Surgery due to infertility

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: central sensitization inventory (questionnaire)|T.G. Mayer, R. Neblett, H. Cohen, et al. The development and psychometric validation of the central sensitization inventory Pain Pract, 12 (2012), pp. 276-285|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometriosis health profile EHP-30 pain subscale | Pain subscale of the questionnaire endometriosis health profile EHP-30, scale from 0-100, higher values indicate worse health status | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other subscales of the endometriosis health profile EHP-30 | control and powerlessness scale, emotional well-being scale, social support scale, self-image scale, all scales from 0-100, higher values indicate worse health status | 6 months |
Spiking-and-Recovery Experiment DOREMI Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the validity of our in-house chemiluminescence assay for measurement of folliclestimulating hormone (FSH) serum levels before and during exogenous recombinant FSH (rFSH) administration.

Detailed Description
-----------------
Study question Does our in-house Beckman-Coulter Unicel DXi800 (Woerden, the Netherlands) chemiluminescence assay completely and consistently recover added known quantities of FSH on top of a known basal serum FSH concentration? Spiking-recovery experiment The investigators propose a spiking-recovery experiment in which 30 serum samples of different women with basal FSH concentration varying between 0-14 IU/L will be divided into two equal volume parts and spiked with a specific concentration of rFSH (Gonal-F, follitropin alpha; Merck Serono) which will provide a calculated rise in FSH concentration similar to in vivo serum levels. To perform more reliable testing, the samples will be tested over multiple days. Basal FSH spiking experiment In the table below an example is given of different basal FSH levels spiked with rFSH diluted 2000 times and the theoretical rise in serum that should be established. Gonal F concentration is 600 U/L but this concentration unit cannot directly be compared to the units used for the for the routine serum FSH measurement (IU/L). From a pilot experiment the investigators know that on average 60% of rFSH is picked up by the Beckman-Coulter assay. Buffer spiking In order to determine whether recovery is also influenced by properties of blood serum, the investigators will conduct another spiking experiment in which different concentrations of rFSH will be added to an amount of buffer, with no basal [FSH]; 0,1 M phosphate buffer, pH 7.4 with 1-2% of bovine serum albumin (BSA). A calibration line will be constructed with 6 concentrations of recF: range 0-40 U/L.

Official Title
-----------------
Spiking-and-Recovery Experiment DOREMI Study

Conditions
-----------------
FSH Assay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Basal FSH concentration varying between 0-14 IU/L Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Recovery rate | Recovery rate of recombinant FSH in blood serum as measured by our in-house assay | 1 day |