cyrilzakka/clinical-trials huggingface dataset:
Mobile Phone Detection of Atrial Fibrillation

The aim of this study is to evaluate the reliability of smartphone seismocardiographic detection of AF in comparison to the gold standard of continuous telemetry ECG recording.

In the this case-control study, 300 patients being treated in the wards of Heart Center and Department of Acute Internal Medicine of Turku University Hospital in Turku, Finland between April and September 2017 were included in the study. Patients were assigned to two groups according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation). A smartphone equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to obtain a seismocardiographic recording. Simultaneous telemetry electrocardiography was obtained to assess the reliability of seismographic rhythm recordings. Results will be analyzed to describe the specificity and sensitivity of the method.

Eligibility Criteria:
Inclusion Criteria for patients with FA:

* ≥18 years of age
* telemetry ECG available
* being treated in Turku University Hospital Heart Center / Acute internal medicine ward
* atrial fibrillation

Inclusion Criteria for patients with sinus rhythm:

* ≥18 years of age
* telemetry ECG available
* being treated in Turku University Hospital Heart Center / Acute internal medicine ward
* sinus rhythm
* gender and age matching pair in FA group

Exclusion Criteria:

* ≤18 years of age
* paced rhythm
* cardioversion during preceding 7 days
* informed consent not signed
Component and Couple Analysis of Cancer Communications

Component and Couple Analysis of Cancer Communication

CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that provides information, social support and skills training to women with breast cancer. Previous CHESS clinical trials found improved patient outcomes but little is known about what services in CHESS produce those results. This study will examine whether breast cancer patient outcomes change when conceptually distinct CHESS services (information, social support, and skills training) are systematically added to a patients treatment resources.

Primary Aims:

* Determine the relative efficacies of different types of cancer communication treatments when they are presented alone or in combination
* Determine routes or processes via which these elements work
* Determine for whom the different treatment types work best.


Eligibility Criteria:
Inclusion Criteria:

Eligibility for this protocol is as follows:

* All subjects must be within 2 months of their primary breast cancer diagnosis,
* All subjects must be at least 18 years of age,
* All subjects must be able to read and write English at the 6th-grade level
* Not homeless
Patient Care Outreach, Navigation, Technology and Support 2.0

This is a feasibility study employing virtual patient navigation for underserved individuals who speak English, Chinese or Spanish and were diagnosed with breast cancer or cardiovascular disease to determine the extent of usability for a virtual patient navigation portal serving people in underserved communities. While not able to entirely replace in-person interactions, virtual patient navigation may be used to expand reach and availability of navigation services to a much greater segment of the population.

Patient COUNTS 2.0 aims to improve and scale up the current Patient COUNTS program.

PRIMARY OBJECTIVES:

I. Identify underserved individuals who speak English, Chinese or Spanish and were diagnosed with breast cancer or cardiovascular disease through collaboration with Zuckerberg San Francisco General Hospital (ZSFG), University of California, San Francisco clinics (Athena), University of California, San Francisco registries (via medical chart review), San Francisco State University, and other community organization collaborators.

II. Conduct outreach to potential participants to let them know about the availability of virtual patient navigation via the Patient Care Outreach, Navigation, Technology and Support (COUNTS) web portal, and the Patient COUNTS patient navigation program (NCT03867916).

III. Provide patient navigation virtually.

OUTLINE:

The patient COUNTS portal will be available in English and expanded to include content in Chinese and Spanish. An initial cohort of focus group of 15 breast cancer patients, 5 navigators, social workers, caregivers or other person involved in breast cancer care will help develop the culturally and language specific components of the COUNTS program. Following implementation, breast cancer participants and cardiovascular participants will participate in an online navigation program along with family members of the patient community will be enrolled. Participants will use the online COUNTS portal to access navigation program and may choose to have online/virtual navigation support or in-person navigation support. Participants also complete data collection and surveys over 15 minutes via web portal at baseline and 6 months and user experience survey at end of program participation.

Eligibility Criteria:
Inclusion Criteria:

For Focus groups:

* Breast cancer patients: Diagnosed with breast cancer, ages 18 or older, speaks English, Mandarin/Cantonese, or Spanish
* Navigators: any patient navigator who has provided care to underserved populations diagnosed with cancer

For Portal Implementation phase:

* Ages 18 or older
* Speaks English, Mandarin/Cantonese, Spanish,
* Has any stage breast cancer
* Has access to a phone that is able to receive text messages, is willing to stay in the study for six-seven months.

Family User experience survey:

* Family member or friend who may have assisted breast cancer participant with registration, accessing or otherwise assisting breast cancer family member or friend participant with the online portal.

Exclusion Criteria:

* Any medical or psychological conditions precluding informed consent
Rheumatoid Arthritis-associated Interstitial Lung Disease Definition

This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA).

This is a prospective multi-centric longitudinal study of the prevalence and incidence of pulmonary diseases in patients with RA.

During one year, patients with a RA diagnosis (according to the criteria of the American Society of Rheumatology) in the south of Belgium will be enrolled on a voluntary basis. If available, data including quality of life and symptoms questionnaires, medical examinations, 6-minute walk-tests, pulmonary function tests and chest CT will be collected during two years.

Furthermore, patients could be included (if available data) in two additional sub-cohorts:

* "RAIDbio" sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers;
* "RAIDomix" sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest).

Due to a non-specific and poor clinical expression at beginning, there is currently an under-diagnosis of rheumatoid arthritis associated-interstitial lung disease (RA-ILD) at an early stage and we assume that an annual pneumological follow-up, search of early biomarkers and a radiomic approach of RA patients will overcome this issue. This should lead to a better follow-up and management (including the use of anti-fibrotic therapies in the future) of these patients and ultimately to a decrease in morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis according to the criteria of the American Society of Rheumatology
* Age \> 18 years
* Willing to participate in the study and sign the informed consent form (ICF) of participants or their legal authorized representative
* RAIDbio subcohort : available data for one of the following analysis of biomarkers: volatile organic compounds, induced sputum or blood markers
* RAIDomix : available data for high resolution computed tomography of the chest

Exclusion Criteria: none
Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya

This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.


Eligibility Criteria:
Inclusion Criteria:

Women between 18 and 40 years old are eligible for inclusion if they have had a safe normal delivery of a live infant delivery at a Jacaranda Health facility. Eligible women must reside in a 20 km radius from the Jacaranda Health's hospital facility in peri-urban Nairobi. Women must provide a phone number to where they expect that can be reached 2 weeks postpartum.

Exclusion Criteria:

Women who elect to leave the Jacaranda Health facility before the recommended 24 hours, against medical advice, postpartum are not eligible to participate in the postpartum care study. Women and their newborns who are referred to another hospital for higher level emergency obstetric or neonatal care will not be eligible to participate. Women who relocate outside the defined geographic area surrounding the hospital after their delivery are also not eligible.
The First 1,000 Days Program: Maternal-Child Obesity Prevention in Early Life

The First 1000 Days (conception to age 2) is a crucial period for the development and prevention of obesity and its adverse consequences in mother-child pairs and their families. The overall aim of the First 1000 Days program is to work across early-life systems to prevent obesity, promote healthy routines and behaviors, address social determinants of health, and reduce health disparities among vulnerable children and families at community health centers in the Boston, MA area.

The study aims to simultaneously implement and evaluate an obesity prevention program across early life systems to reduce the prevalence of obesity risk factors within racial/ethnic minority families, close the gap in maternal-child health disparities, and assess and address social determinants of health.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women receiving prenatal care at select community health centers in the Boston, MA area
* All families of children aged 0-2 years receiving pediatric care at select community health centers in the Boston, MA area
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects

This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects.

It is planned to enroll 14 subjects who will receive single oral doses of active IMP in a sequential manner over 5 periods, with a minimum of 7days between dosing in each period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females
* Body mass index (BMI) of 18.0 to 32.0kg/m² and a body weight\>50kg as measured at screening
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to adhere to the contraception requirements

Exclusion Criteria:

* Subjects who have received any IMP formulation in a clinical research study within the 90 days prior to Period 1, Day 1
* History of any drug or alcohol abuse in the past 2 years
* Subjects with pregnant or lactating partners
* Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed.
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4g of paracetamol per day or HRT/hormonal contraception) in the 14 days before first IMP administration.
Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects older than the minimum legal adult age (country specific);
* Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
* Able to provide written informed consent

Exclusion Criteria:

* thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
* More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
* Calculated Creatinine clearance (CrCL) \< 30 mL/min;
* significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
* patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
* active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
* chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
* treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
* concurrent treatment with potent P-gp inhibitors;
* subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery

Recent studies have shown an increased incidence of renal replacement therapy after the use of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However, studies showing detrimental effects of HES have been conducted in mostly non-surgical subjects. There are very few studies analyzing the effects of HES on renal function after cardiac surgery, a population already at risk of renal dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing cardiac surgery

Exclusion Criteria:

* Heart transplantation
* Ventricular assist devices
* Patients requiring extracorporeal life support before or after cardiac surgery
* Patients revised for bleeding and/or tamponnade presenting with hemodynamic instability
* Patients in whom the administered volume therapy was not completely available
* Subjects who required renal replacement therapy before surgery
* Trauma patients who were put on cardiopulmonary bypass
* Patients who died intra-operatively or soon after arrival in the intensive care unit in whom no postoperative creatinine measurements were available
ACOMPANYEM: A COMmunity Program Accessing Lonely, Disabled Neighbors (Young, Elder, and Midlife)

Social prescription prioritizes interventions for people at risk of social isolation or unwanted loneliness based on community assets and offers them a series of activities that can contribute to their emotional well-being as a healthy alternative to medicalized healthcare. Disabled homebound people deal with more difficulty accessing the social health assets available in the community. Volunteers from the same neighborhood may accomplish the social function of accompaniment and listening accessing them at home or walking them out to attain social prescription goals. The Community Emotional Well-Being Referent (REBEC) may enhance all of this by conducting emotional counseling and management groups for volunteers.

OBJECTIVE: To evaluate the effectiveness of a community intervention of accompaniment and emotional management with volunteers on the unwanted loneliness of people with social isolation, their emotional well-being, and their quality of life.

METHODOLOGY: a community-based quasi-experimental non-randomized pre-post intervention study with control group, and a qualitative study. Candidate detection by the Driving Group, composed of neighborhood organizations and the community health team, was conducted opportunistically. Recruitment of isolated individuals and volunteers was carried out, with registration based on inclusion criteria. Implementation of the multi-level intervention for volunteers and isolated individuals took place at home or by participating in community resources on the street, with parallel support groups for volunteers using REBEC. Each round of participants was followed for three months, continuing until the sample was complete. Qualitative analysis was conducted upon reaching information saturation. In cases where architectural barriers were detected, technical aids (such as portable stairlifts) were proposed, and their impact was studied.


Eligibility Criteria:
Inclusion Criteria:

Previously detected by community and professional assets among people over 16 years of age with the following criteria:

* Disabled physical or mental homebound persons.
* Unwanted loneliness, with difficulty in accessing other assets of the social prescription program.
* less than 8 on the Oslo Social Support Scale or less than 20 on the LSNS-R scale or less than 2 on the LSNR-6 scale in people over 65 years of age.

Exclusion Criteria:

* Impossibility of communication
* End-of-life situations.
A Dietary Supplement for Early Cigarette Withdrawal

The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal.

100 subjects who smoke at least 20 cigarettes per day will come in on two different days, at least one week apart, in a randomized, double blind, within subject, placebo controlled design. On each day subjects will refrain from smoking cigarettes for 8 hours. On one day subjects will take the active DS (taken in two doses, the evening dose is taken at 22:00 of the night before the test day and the morning dose is taken at 8:00 of the test day) and on the other day subjects will take placebo (also taken in two doses at the same time points of the active DS). Mood symptoms and symptoms of cigarette withdrawal will be compared across the two different days. Measures of mood symptom monitoring will include self report on a scale of 1 to 10, standardized rater questions about mood, and 6 hours into withdrawal, a standardized mood induction will be done with mood assessment. Symptoms of cigarette withdrawal will be assessed over the duration of withdrawal with applied standardized rating scales by trained raters. For the first 15 - 30 subjects, on each day, a health assessment of a physical exam and blood work will be completed at the end of the withdrawal period on both test days as well as for the initial assessment appointment.

Eligibility Criteria:
Inclusion Criteria:

* males and females
* age 18-65
* generally good physical health
* not using any illicit substances
* smoke on average at least 20 cigarettes/day.

Exclusion Criteria:

* Recent history of myocardial infarction and / or stroke
* active substance abuse except for nicotine and active fluctuant medical conditions. (present and ongoing within 3 months)
* Score of higher than 7 on the 17- item Hamilton Depression Rating Scale
* Positive results for the pregnancy testing done on the first assessment visit.
* A specific allergy to fruit-based ingredient.
Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing

Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain

Objectives: This study was directed to compare the outcomes of internal sinus lifting between osseodensification approach and piezoelectric surgery approach on the primary stability and osseointegration of dental implant.

Background data: Successful osseointegration considered the cornerstone in implant sta-bility which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone surrounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain.

Materials and Methods: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to determine implant stability by recording the values of implant stability quotient (ISQ) immediately after implant placement and after 3 months. CBCT was performed before, after 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 , 12 months via CBCT.

Eligibility Criteria:
Inclusion Criteria:

free of systemic disease bone height at the site of the implant is ≤ 6 mm. have good oral hygiene.

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Exclusion Criteria:

systemic diseases active periodontal disease , limited mouth-opening ability maxillary sinus disease or previous sinus surgery were also excluded smokers pregnant