linjc16/ctgov huggingface dataset:
Evaluating the Occurrence of Participation Trends Among Weight Loss Clinical Trials Patients

Study Overview
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Brief Summary
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Clinical studies, with a distinct focus on weight loss, play a crucial role in evaluating the safety and effectiveness of novel treatments. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.

Official Title
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Exploring Enrollment and Participation Patterns in Weight Loss Clinical Trials Patients: An Observational Clinical Trial Perspective

Conditions
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Weight Loss

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed Exclusion Criteria: Enrolled in another research study Inability to provide written informed consent Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who decide to enroll in a weight loss clinical study. |  | 3 months | 
| Number of weight loss study participants who remain in clinical study until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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weight loss
Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

Study Overview
=================
Brief Summary
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The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).

Detailed Description
-----------------
This is an observational prospective cohort study aimed at assessing the efficacy of different types of thromboprophylaxis in MM patients; the setting is the GIMEMA network of the Italian haematological Centers. The observation time for each patient will be of 3 years from the start of the active treatment for MM. Patients will remain in the study regardless of the stage of disease, type of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis, occurrence of thrombosis. Four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis, cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.

Official Title
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Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)

Conditions
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Multiple Myeloma, Diagnosis

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Age equal to or greater than 18 years of age. New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group First active treatment for MM started after recruitment in the study Signed informed consent Exclusion Criteria: Patients having had thrombosis within 6 months before diagnosis of MM Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs) Ongoing first active treatment for MM initiated before the starting of the study.

Ages Eligible for Study
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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 |
| --- | --- | --- |
| Rate of venous thromboembolism according to different thromboprophylaxis strategies | Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed: Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis. | 3 years |
Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation

Study Overview
=================
Brief Summary
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Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.

Official Title
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Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation

Conditions
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Cardiac Output, Low

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: patients with pulmonary artery catheter after cardiac surgery Exclusion Criteria: minimally invasive surgery unstable conditions bleeding unability to fit cuirass
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 |
| --- | --- | --- |
| Stroke Volume Index in ml/m2 |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate in beats/min |  | 1 hour | 
| blood pressure in mm/Hg |  | 1 hour | 
| arterial oxygen saturation in % |  | 1 hour | 
| mixed venous oxygen saturation in % | measured via pulmonary catheter | 1 hour | 
| right ventricular ejection fraction in % | measured via pulmonary catheter | 1 hour | 
| end diastolic volume index in ml/m2 | measured via pulmonary catheter | 1 hour | 
| Cardiac index in l/min/m2 | measured via pulmonary catheter | 1 hour | 
| tricuspid annular plane systolic excursion in mm | measured via transesophageal echocardiography | 1 hour | 
| right ventricular fractional area change in % | measured via transesophageal echocardiography | 1 hour | 
| Vena contract of tricuspid valve in mm | measured via transesophageal echocardiography | 1 hour |
TAD After Chemotherapy in Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).

Detailed Description
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The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.

Official Title
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Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Conditions
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Sentinel Lymph Node, Breast Cancer, Locally Advanced

Intervention / Treatment
-----------------
* Procedure: Target Axillary Dissection


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Axillary lymph node metastasis proven by cytology Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis) Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria Neoadjuvant chemotherapy Exclusion Criteria: cN3 verified by imaging tests N2 due to internal mammary involvement (N2b). Tumors whose surrogate molecular subtype is luminal A. Patients undergoing neoadjuvant endocrine therapy Patients with local recurrences and metastatic tumors.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Target Axillary Dissection|TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAD validation in locally advanced breast cancer | False negative rate when performing TAD after NAC | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound validity to evaluate axillary response after NAC | False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response | 3 years | 
| MRI validity to evaluate axillary response after NAC | False-negative and positive rates of axillary MRI after NAC to asses lymph node response | 3 years |
Factors That Affect Trust Between Physicians and Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate patient perception and preference in physician attire. Eligible subjects admitted to medical-surgical hospital unit will complete a survey expressing perceptions and preference regarding physician attire.

Detailed Description
-----------------
Hospitalists (internal medicine physicians) work in one week rotations. Each hospitalist will serve as a control. During one week rotation, the hospitalist will wear surgical scrubs throughout the rotation. At the end of the rotation (or prior to subject discharge, whichever occurs first), the hospitalist will ask subjects seen during that rotation to complete the survey regarding the hospitalist attire. During a second week of rotation, the hospitalist will wear professional attire with a white coat throughout that rotation. At the end of the rotation (or prior to subject discharge, whichever occurs first), the hospitalist will ask subjects seen during that rotation to complete the survey regarding the hospitalist attire.

Official Title
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Factors That Affect Trust Between Physicians and Patients

Conditions
-----------------
Trust

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 years of ages or older Admitted to LLUMC medical surgical unit, under care of internal medicine physician Primary language is English or Spanish Exclusion Criteria: Less than 18 years of age altered mental status or severe dementia Hearing or vision impairment that would preclude subject from completing survey

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 |
| --- | --- | --- |
| Patient Preference for Type of Physician Attire | Subjects will complete a one-time survey via paper or iPAD. The survey is based on the Modified Trust in Physician Scale: A Measure to Assess Interpersonal Trust in Patient Physician Relationships with answers provided on a 5 point Likert Scale where 1 means strongly disagree, 2 means disagree, 3 is neutral, 4 means agree and 5 means strongly agree. The total score will reflect patient preference for traditional physician attire (street clothes and white coat) or casual physician attire (surgical scrubs). A high score would reflect a favorable response for the physician wearing traditional attire. | At the end of hospitalist rotation or prior to subject discharge, whichever occurs first, not to exceed one week from study enrollment. |
Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective

Study Overview
=================
Brief Summary
-----------------
To learn about the communications that Supportive Care patients receive about sexual well-being from their healthcare provider. Researchers also want to learn about your attitudes, beliefs, and feelings about sexual well-being.

Detailed Description
-----------------
Primary Objectives: To determine the frequency of discussion about sexual dysfunction in palliative care patients. To evaluate the impact of cancer diagnosis and treatment on patient's sexual life. Secondary Objectives: To evaluate patient self-reported severity of sexual dysfunction To evaluate the proportion of patients suffering distress from body image concerns To identify patient self-reported barriers that prevent discussion about sexual dysfunction To evaluate patient self-reported impact of sexual dysfunction on their wellbeing

Official Title
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Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective

Conditions
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Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Patient's Perspective


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All patients who are evaluated as follow-ups in the Supportive Care clinic, and able to voluntarily consent to participate in the study Patients must be able to understand, read, write, and speak English Diagnosis of cancer Patients who are 18 years of age or older Exclusion criteria: New patients (consults) Patient who have declined to participate, or who are unable to 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient's Perspective<br>Participants will complete a questionnaire about sexual wellbeing, sexual dysfunction, and communication with your provider on this topic. Participants may choose to complete the questionnaire electronically (via email link), in-person, or over the phone, whichever you prefer. Your demographic information (such as age, gender, ethnicity, marital status, and cancer diagnosis) will be collected from your medical record. Some of this information may also be asked of you during the questionnaire. | Behavioral: Patient's Perspective<br>* Participants will complete a questionnaire about sexual wellbeing, sexual dysfunction, and communication with your provider on this topic. Participants/Researchers will learn about your attitudes, beliefs, and feelings about sexual well-being<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaires |  | through study completion an average of year |
A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with ASCVD and CKD. This study is a cross-sectional design conducted among cardiologists in United Kingdom, Italy, Germany, Brazil, Saudi Arabia, Japan, Australia, China, India and France, treating ASCVD and CKD patients. Study participants will be recruited to complete an approximately 20-minute self-administered online survey. Recruitment will be conducted through email and phone. Data is collected though online data collection using a programmed survey.

Official Title
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A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists

Conditions
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Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). Male or female, age above or equal to 18 years at the time of signing informed consent. Is a Cardiologist. Has been in practice greater than or equal to 3 years. Sees at least 15 ASCVD and CKD patients per month. Exclusion Criteria: Previous participation in this study. Participation is defined as having given informed consent in this study Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Does not meet inclusion criteria requirements

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 |
| --- | --- |
| Cardiologists<br>Cardiologists treating patients with ASCVD and CKD | Other: No treatment given<br>* No treatment given<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD. Multi-select from a defined list. | Numerical; A 7-point Likert scale for measurement of agreement from 1 strongly disagree to 7 strongly agree. | At the time of survey response (Day 1) |
Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.

Official Title
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Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

Conditions
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Infertility, Male

Intervention / Treatment
-----------------
* Other: Sperm DNA Fragmentation


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Unexplained infertile men who will undergo 1st or 2nd IVF treatment Age over 18 years Normal sperm parameters according to WHO criteria IVF treatment Exclusion Criteria: - ICSI

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertile male<br>Men with unexplained infertility | Other: Sperm DNA Fragmentation<br>* Sperm DNA Fragmentation analysis.<br>|
| Donors (control)<br>Fertile sperm donors | Other: Sperm DNA Fragmentation<br>* Sperm DNA Fragmentation analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of double-stranded DNA damage in sperm of men with unexplained infertility. | Sperm DNA Fragmentation done with a Comet Assay analysis | 30-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of single-stranded DNA damage in sperm of men with unexplained infertility | Sperm DNA Fragmentation done with a Comet Assay analysis | 30-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sperm DNA Fragmentation, Lifestyle, Doublestrand DNA Fragmentatio