cyrilzakka/clinical-trials huggingface dataset:
Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk

The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.

The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure is the gold standard treatment for OSAS. It consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment reduces cardiovascular morbi-mortality.

OSAS is associated with cardiovascular mortality. A dose response effect exists between severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces 24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a significant reduction in cardiovascular risk.

The aim of the present study is to include OSAS patients with a high cardiovascular risk and to measure the effect of CPAP on home measurements of arterial blood pressure. This controlled randomized trial will compare the effect CPAP on arterial blood pressure in a group with a telemedicine system versus a group with standard home care CPAP treatment.

An interim analysis will be carried out when 100 patients have been included in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years old men and women
* stable patient
* BMI\<40kg/m²
* OSA patients diagnosed with polysomnography or polygraphy
* SCORE\>5% and/or cardiovascular disease pas history :
* transient ischemic attack, stroke, cerebral haemorrhagy
* myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism

Exclusion Criteria:

* central sleep apnea syndrome
* SCORE\<5%
* cardiac failure
* past history of hypercapnic chronic respiratory failure
* past history of severe or intercurrent pathology which can not allow the patient follow-up
* Incapacitated patients in accordance with article L 1121-6 of the public health code
* patients taking part in another clinical trial
Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients

Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission

Determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. Central venous pressure (CVP) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. However, the conventional method used to measure CVP has notable limitations as it is an invasive procedure that requires placement of a central venous catheter.

Traditional, non-invasive methods of estimating CVP, such as physical examination and echocardiogram, are less accurate and more resource intensive. To overcome this challenge, new technology to assess CVP non-invasively using an oscillometric method has been developed. This new technology involves measurement of the enclosed zone central venous pressure (ezCVP), which, in a preclinical study, has been shown to correlate with invasive data.

Additionally, a previous correlation study demonstrated that the ezCVP value can be mathematically adjusted to estimate invasive CVP. The resulting value has been termed CVPNI (CVP Non-Invasive). Most recently, a limited pilot study of patients hospitalized with acute, decompensated heart failure demonstrated the feasibility of device use in this population and the expected and incremental fall in CVPNI with medical treatment over the course of hospitalization.

Moving forward, and in order to further improve the care of patients hospitalized with heart failure, an expanded pilot study of ezCVP technology is needed to prove that changes in CVPNI track with these patients' condition during admission and can be useful in their clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Arm circumference of 23 cm to 55 cm
* Subject admitted to the hospital with acute exacerbation of heart failure, with either reduced or preserved ejection fraction
* Subject is at risk for readmission (NYHA Functional Classification 2-3)
* Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent
* ezCVP indicator is high (CVPNI is over 9 mmHg) at admission
* Subject is willing and able to comply with protocol procedures
* Subject tested negative for COVID test after admission to the hospital

Exclusion Criteria:

* Finger and upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff
* Pregnant (self-reported)
* Upper extremity DVT (currently being treated)
* Severe skin disease involving the upper arm(s)
* Study investigator may exclude patients based on clinical judgement
Risk Factors for Endometrial Cancer in Black Women

RATIONALE: Learning about the risk factors for endometrial cancer in black women may help the study of endometrial cancer in the future.

PURPOSE: This clinical trial is studying risk factors for endometrial cancer in black women.

OBJECTIVES:

* Establish and evaluate procedures for conducting a hospital-based case-control study of risk factors for endometrial cancer in black women.

OUTLINE: This is a multicenter study.

Participants complete questionnaires about lifestyle factors and their usual diet and measure their waist and hips. Saliva or buccal specimens are collected for future research.

PROJECTED ACCRUAL:

* A total of 30 cases and 30 controls will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cases

  * Diagnosed with endometrial cancer within the past year
  * Self-identified as being black, African-American, black Hispanic, African, or Afro-Caribbean
* Healthy controls

  * Self-identified as being black, African-American, black Hispanic, African, or Afro-Caribbean
  * No history of endometrial or other cancer (except non-melanoma skin cancer)
  * No prior hysterectomy

PATIENT CHARACTERISTICS:

* Speak English
* No medical condition that would make it difficult to complete the interview

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Pediatric Myocardial Protection With Potassium Cardioplegia

The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of congenital heart disease encourage us to discuss problems that occur during this surgery especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI) as a result of cessation and re-initiation of coronary artery circulation

After approval of the local ethics committee of Assiut University and obtaining written informed consent from parents or guardians of all patients, 60 patients with congenital heart disease will be included. Patients will be randomly allocated into three groups

Eligibility Criteria:
Inclusion Criteria

* Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.
* Hemodynamic stability.

Exclusion Criteria:

* Previous cardiac surgery.
* Urgent or emergent cases.
* Any known allergies to components of either cardioplegia solutions.
The Effectiveness of Distance Yoga Learning in Improving Ma-ternal Pandemic-related Depression and Stress During Pregnancy

The goal of this quasi-experimental study design is to explore the effects of distance yoga learning in improving depression and pregnancy stress in pregnant women during the pandemic disease. The main questions which aim to answer are:

1. hypothesis1 - Distance yoga learning can decrease depression during pregnancy.
2. hypothesis2 -Distance yoga learning can decrease pregnancy stress. The experimental group received a 12-week pregnancy yoga program, including one weekly 60-minute distance yoga class and followed by 2 times of DVD yoga exercise at home while the control group received only routine nursing care.

This is a quasi-experimental study design for primiparous women in the obstetrics and gynecology department of a regional hospital as the research subjects. This study received ethical approval from the hospital and all participants provided written informed consent. After the researcher took convenience samples and explained the research purpose in the prenatal parent classroom, they were assigned to the experimental group and the control group according to the wishes of the cases. Pregnant women in the experimental group received routine prenatal care guidance and yoga exercises three times a week, while the control group only received routine pre-natal guidance and the differences between the two groups were compared.

The sample size was estimated using G-power 3.1.9.2 software. The sample size was estimated to be 52 participants. Assuming the attrition rate was 20%, there were 32 people in the experimental group and the control group making a total of 64 participants.

During the study, one participant in the experimental group had premature delivery due to early water rupture, and the other one was hospitalized for tocolysis due to frequent uterine contractions and therefore withdrew from the experiment, resulting in a loss of 2 samples. For control group, one participant was admitted to the hospital for tocolysis due to prepartum hemorrhage and was withdrew from the study. Therefore, a total of 61 participants completed the study .

Eligibility Criteria:
Inclusion Criteria:

* First-time mothers between 20 and 26 weeks of pregnancy.
* normal fetus with a singleton.
* no history of smoking, drinking, or drug abuse.
* no bleeding during pregnancy.
* no related high-risk complications during pregnancy (such as high blood pressure, preeclampsia, gestational diabetes, heart dis-ease, etc.).
* no early abortion symptoms.
* Able to move normally.
* Able to listen, speak, read and write Chinese.
* Able to participate in the research and cooperate in completing the questionnaire.

Exclusion Criteria:Exclusion conditions (any one)

* Multiparous women.
* First-time mothers with pregnancy \>26 weeks.
* Multiple births.
* Symptoms of bleeding or early miscarriage.
* Related high-risk pregnancy complications.
Dementia-friendly Community Training Using Virtual Reality Among College Nursing Students

This study aims to evaluate the effectiveness of a dementia course using virtual reality, world café teaching method and community practice on knowledge of dementia and dementia-friendly community, attitude toward dementia, and empathy toward people with dementia among nursing college students.

This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia course using virtual reality on knowledge of dementia and dementia-friendly community, attitude toward dementia, and empathy toward people with dementia among nursing college students.

The interventional group will receive the dementia course consists of dementia virtual reality activity, intergenerational learning, world café teaching method and community practice.

The control group will only receive the dementia course with intergenerational learning, world café teaching method and community practice but no dementia virtual reality activity.

Both groups will be assessed for their dementia knowledge, attitudes, empathy and knowledge of dementia-friendly community at baseline, week 8, and week 18.

Eligibility Criteria:
Inclusion Criteria:

* college nursing students with age ranged from 19 to 40 years,
* Taiwanese nationality,
* Sophomore and above
* provide informed consent to participate in the study.

Exclusion Criteria:

college nursing students who do not meet the inclusion criteria
IMPACT OF PAMPHLET ON THE KNOWLEDGE OF HEALTH EFFECT OF SMOKING

Tobacco smoke is one of the most preventable cause of mortality and morbidity worlwide, this study is conducted to compare the knowledge of the health effects of smoking among undergraduates exposed and those not exposed to educational pamphlet. This is designed as a randomized clinical trial among 390 undergraduate in University of Benin Edo State Nigeria. Data collection tool was an interviewer-administered questionnaire. Data obtained would be subjected to regression statistics using IBM SPSS version 21.0. The expected outcome will be a veritable tool in tobacco cessation model.


Eligibility Criteria:
Inclusion Criteria:

- HEALTHY

Exclusion Criteria:

* NOT CONSENTING
Determination of Fiberoptic Bronchoscopy Sedation Protocols in Turkey

Fiberoptic bronchoscopy (FOB), which is difficult to tolerate while awake, is recommended to be performed by the patient under sedation. The aim of this study is to determine the attitudes and behaviors of chest diseases specialists who do FOB in Turkey about sedation with a 30-question online questionnaire.

Fiberoptic bronchoscopy is the imaging of the tracheobronchial tree for diagnosis and treatment in lung diseases. The operation performed through the airway is difficult for the patient to tolerate. Therefore, it is recommended to perform the procedure under sedation. With this survey study, it was aimed to determine the sedation protocols preferred by pulmonologists who perform active fiberoptic bronchoscopy throughout Turkey during the procedure.

Thirty questions were determined for the questionnaire to be used as a data collection method by the researchers. The questions generally consist of three parts; In the first part, there are 8 questions containing the personal information of the doctors (age, gender, title, institution, etc.). In the second part, 13 questions were included in order to make a general assessment such as the sedative agents used by the doctors before and during the bronchoscopy procedure, and the satisfaction with the sedative method used. In the third part, 9 questions were given to determine the preferred follow-up methods during the procedure. The questions are designed to be presented to participants over the network using google forms.

Eligibility Criteria:
Inclusion Criteria:

* Currently working as a pulmonologist

Exclusion Criteria:

* Not actively performing fiberoptic bronchoscopy for the past five years
Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure

The purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure.

In every surgical procedure, there is a need to close the incision that was made. Current methods for incision closure include stitching, gluing and stapling. Some of these methods are time consuming, have potential for infection and may leave a significant scar. The bioWeld1 technology suggests a new approach for incision closure. It is a novel medical device that consists of a Chitosan film and the BioWeld1 plasma ejecting device. The Chitosan film is intended to be applied to the skin incision, while the BioWeld1device is used for welding the Chitosan to the skin by means of cold plasma technology.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 to 40 years old.
2. Women scheduled for child delivery using an elective C- section.
3. Women in their first or second pregnancy having a C-section for the first time
4. Healthy women with no systemic diseases such as diabetes, heart disease etc.
5. Women with average weight, BMI prior pregnancy of 18.5-25.
6. Women with no skin diseases
7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
8. The subject commits to return for the scheduled post-operative follow-up visits at the clinic

General Exclusion Criteria:

1. Women intended for any abdominal surgery other than C-section procedure
2. Women intended for C-section procedure for other purpose than child delivery
3. Any prior C-section procedure for any purpose
4. Women Received/Receiving radiotherapy or chemotherapy of any kind.
5. Women receiving steroids or any other medication that interferes with wound healing.
6. Women receiving Acutan in the last half year.
7. Women with bleeding diathesis or hypercoagulable state.
8. Women with prior cosmetic or medical treatment in the target area (e.g. phosphatydilcholine injections).
9. Women suffering from Thrombocytopenia (platelets count\<100,000/mm3) pre-procedure.
10. Women who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
11. Psychiatric background.

Intra operative exclusion criteria:

1. Severe excessive bleeding from the wound
2. Patient is not eligible for an experimental closure according to the physician discretion.
Feasibility of Health Coaching in Cancer Patients

This is a study to assess the feasibility of using health coaching sessions in cancer patients. The investigators are investigating whether health coaching sessions can be delivered to this group of participants in a semi structured way. The investigators hope that the study will allow us to see whether such sessions can be delivered in a timely manner that is acceptable to patients and staff. The longer term aim for this work, should it prove feasible, is to conduct a randomised controlled trial to assess health coaching.

The participants for the study will be selected using purposive sampling. The investigators will select a sample of 10 patients. The participants will be patients at the Oxford University Hospitals NHS Trust who are prescribed oral anticancer therapy. The sample will include male and female patients and try to cover a range of ages from 18 upwards. It will cover patients taking a range of oral anticancer agents, for a range of different cancer indications. The sample will look at patients who are newly prescribed oral anticancer therapy through to patients who have been taking therapy for years.

Participants will be identified for the study by multidisciplinary staff members who are running oral education sessions or by non-medical prescribers who are seeing patients in clinic. These members of the MDT will be given lists of the types of participants the investigators are looking for in the study and where appropriate offer patients the opportunity to take part. Patients will be contacted prior to the end of their subsequent cycle of treatment about whether they wish to participate. Patients wishing to take part will be consented at their next clinic visit.

All participants will attend for their usual clinic visits throughout the study. Participants will additionally be offered up to 3 health coaching sessions for a maximum of three cycles or until treatment with their oral anticancer agent ends, whichever comes first.

At the end of study visit participants will be asked to attend a qualitative based interview to discuss the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to comply with the protocol for the duration of the study.
* Patient is willing and able to give written (signed and dated) informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with cancer.
* Patient prescribed an oral anticancer agent.

Exclusion Criteria:

* Patients who are unable to complete 1 cycle of oral anticancer therapy from the time of being approached about the trial.
* Patients who would be unable to participate in a health coaching session with a health coach for any reasons, including, difficulty understanding or speaking English, other communication difficulties or hearing problems.
* Other psychological, social or medical condition, that the Investigator considers would make the patient a poor trial candidate, could interfere with protocol compliance, could affect the patient's ability to give informed consent or may affect the interpretation of trial results.
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
* Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study.

Exclusion Criteria:

* Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
* Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
* New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
* New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
* Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
* Interval organ transplantation.
* New active liver disease or hepatic dysfunction.
* Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
* Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study.
* Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days.
* Participants who currently inhale marijuana (recreational or medical).

Note: Other inclusion/exclusion criteria may apply.