louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02983929: Short-Term Follow-up Indicator for Total Knee Arthroplasty and Body Mass Index
Official title: Impact of Elevated Body Mass Index on Short-term Follow-up Indicators for Total Knee Arthroplasty : a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Body Mass Index
Rehabilitation
Lead sponsor: Centre Hospitalier Durécu Lavoisier
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 244
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic.

Brief summary: The main purpose of this study is to determine the influence of obesity on the short term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty. It is a retrospective, comparative study

The secondary purposes are to explore the links between length of stay and short-term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patient admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic during the january 2007/October 2016 period

Exclusion Criteria:

* Uncompleted case file or case file anterior to 2007 ;
* Inter-current orthopedic complication ;
* Evolutive or inter-current pathology written in the case-file (neurologic affection, etc...).

Primary outcomes:
measure: Body Mass Index
timeFrame: 2 Month
measure: Range Of Motion of the Knee
timeFrame: 2 Month
measure: Age
timeFrame: 2 Month
measure: Mansat Score
timeFrame: 2 Month
Secondary outcomes:
measure: Length of stay
timeFrame: 2 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04685629: Covid-19 Long-term Revalidation Follow-up
Official title: Long-term Follow-up of Covid-19 Patients in Their Home Environment After Hospitalization in a Covid Department or Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid19
Keywords: COLONEL
Tele-monitoring
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We want to follow up 50 patients from hospital discharge, where we want to distinguish 2 groups:

* patients after admission to the intensive care unit (25)
* patients without admission to the intensive care unit (25)

Brief summary: In this monocentric, prospective and descriptive trial we want to evaluate the long-term consequences for patients treated for Covid-19. Covid patients who were hospitalized for min. 5 days either in a Covid-19 department or in intensive care unit will be followed-up for 8 weeks after hospital discharge. This is done via an innovative electronic platform in the home environment (UZA@home). On the one hand the quality of life, rehabilitation and reintegration of the patient will be evaluated and on the other hand the patient will be screened for various psychosocial aspects such as anxiety, depression and post-traumatic stress syndrome.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Adult age
* Hospitalization with proven Covid-19 infection with a minimum stay of 5 days
* Signed Informed Consent

Exclusion Criteria:

* The patient does not have a smartphone or computer with internet connection.The patient is not sufficiently skilled in entering data via a digital interface. This degree of skill is estimated by the research doctor or nurse.
* Patient in a palliative setting (DNR 2 or higher outside of COVID condition
* The patient does not speak the Dutch language

Primary outcomes:
measure: Health related Quality of life (general well-being) questionnaire
timeFrame: in the first 7 days after hospital discharge
measure: Health related Quality of life (general well-being) questionnaire
timeFrame: 4 weeks after hospital discharge
measure: Health related Quality of life (general well-being) questionnaire
timeFrame: 8 weeks after hospital discharge
Secondary outcomes:
measure: Revalidation & Reintegration
timeFrame: daily, up to 8 weeks after hospital discharge
measure: Depression and/or anxiety
timeFrame: 3 times after hospital discharge: first at week 0, second time at week 4, third time 8 weeks after discharge
measure: Post traumatic stress syndrome
timeFrame: 8 weeks after hospital discharge
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
Study officials:
References:
Clinical trial NCT04480229: Telenursing and Breast Cancer: The Turkish Case
Official title: A Randomized Controlled Study on the Influence of Telenursing Services to the Chemotherapy Treatment of Breast Cancer Patients: The Turkish Case
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: telenursing
breast cancer
chemotherapy
symptom management
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey.

Detailed description: This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey. The study employs an experimental research methodology with a sample of 96 ambulatory patients (48 experimental, 48 control) who were receiving chemotherapy for breast cancer for the first time in a state hospital. Research data were collected by using "Patient Information Form", "Edmonton Symptom Assessment Scale", "General Comfort Questionnaire, "Symptoms Follow-up Form", and "Telephone Call Form". The experimental group received telenursing service every week until the end of the four-cycle chemotherapy treatment, which started one week after the first treatment. The control group did not receive any intervention. Investigators analyzed data with SPSS 15.0 (Statistical Package for the Social Sciences) with comparative statistical methods of MannWhitney U Test, Chi-Square Test, One Way Analysis of Variance in Repeated Measurements, and Pearson Correlation.

Eligibility criteria: Inclusion Criteria:

* is volunteering to participate in the research,
* is 18 years of age or over,
* can communicate in Turkish,
* has Turkish literacy skills,
* has no hearing, vision problems, and mental disability that may hinder communication,
* is female,
* has a diagnosis of breast cancer for the first time in her life and consequently receiving chemotherapy treatment in the same protocols for the first time,
* did not have a different diagnosis of cancer and related chemotherapy treatment.

Exclusion Criteria:

* Having been diagnosed with breast cancer before and received chemotherapy treatment accordingly,
* Having been diagnosed with different cancers before and had chemotherapy treatment related to it,
* Cancer treatment with oral medications,
* Refuse to participate in the study
* Refuse education/counseling
* Not knowing Turkish

Primary outcomes:
measure: Edmonton Symptom Assessment System
timeFrame: 10 minutes
Secondary outcomes:
measure: General Comfort Questionnaire
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Istinye University
name: Cicek Yagci, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06061029: Brief Yoga and Mindfulness for Women Who Have Experienced Domestic Violence
Official title: A Brief Yoga- and Mindfulness-Based Psychoeducation Program for Women Who Have Experienced Domestic Violence: A Randomized Control Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Keywords: Brief yoga and mindfulness
online psychoeducation
self-compassion
rumination
domestic violence
psychological health
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to examine the effectiveness of a brief yoga- and mindfulness-based psychoeducation program and its working mechanisms in improving psychological health parameters (depression, anxiety, and stress) among women who have experienced domestic violence (DV).

In a randomized controlled trial, 51 DV-victimized women were assigned to an intervention group (n = 27) or a waitlist control group (n = 24). The intervention was a five-week yoga- and mindfulness-based psychoeducation program.

The researchers planned to provide support for the effectiveness of a brief yoga- and mindfulness-based psychoeducation program for improving the psychological health of DV-victimized women. Self-compassion and rumination were hypothesized as working mechanisms underlying the intervention's success.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for this study required participants to be women aged 18 years or older who had experienced domestic violence in the previous 12 months but were no longer in an ongoing domestic violence situation. Additionally, participants needed to have secure access to a smartphone or a laptop / Personal Computer.

Exclusion Criteria:

* Refusal to give consent or missing more than one session of the psychoeducation program were the exclusion criteria. The individuals who met the absence criterion were still able to continue the rest of the sessions; however, their questionnaires were not included.

Primary outcomes:
measure: Depression Anxiety Stress Scales-21
timeFrame: 6 weeks
measure: The Self-Compassion Scale-Short Form
timeFrame: 6 weeks
measure: The Brief State Rumination Inventory
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Navidreza Hosseinzadeh Asl
Study officials:
References:
Clinical trial NCT05554029: Coronaphobia in Rheumatic Diseases
Official title: Coronaphobia in Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatic Diseases
Keywords: coronaphobia
Rheumatic diseases
COVID-19
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Firat University
First posted: 2022-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). The most common symptoms are fever, cough and dyspnoea. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine.

Detailed description: COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Therefore, pandemic caused changes in routine life for millions of people. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. The aim of this study is to investigate coronaphobia in rheumatic diseases and compare with healthy people.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 to 65
* Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia

Exclusion Criteria:

* Being pregnant
* Diagnosed with malignancy
* Had changes of medical treatment in the last 3 months
* Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits

Primary outcomes:
measure: Covid-19 Phobia Scale
timeFrame: 2 minutes
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Songul Baglan Yentur
Study officials:
affiliation: Gazi University
name: Songul B Yentur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841529: Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Official title: Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Left Atrial Appendage Occlusion
Keywords: left atrial appendage
LAA
atrial fibrillation
AF
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA


Eligibility criteria: Inclusion Criteria:

* Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
* Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (\>=60 years of age), CABG (\< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
* The subject is willing and able to provide written informed consent and comply with study requirements
* The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)

Exclusion Criteria:

* Thrombus in the LAA and/or left atrium
* Prior LAA isolation attempts
* Subject is unable to take an anticoagulant during the study follow-up period
* Subject is undergoing an emergency cardiac procedure
* Life expectancy of less than 12 months
* Pregnancy or desire to be pregnant within the 12 months of the study procedure

Primary outcomes:
measure: Complete occlusion of the left atrial appendage
timeFrame: 3 Months
Secondary outcomes:
measure: To evaluate the composite incidence rate of device-related adverse events
timeFrame: Discharge/30 days
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Patrick McCarthy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01394029: Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox
Official title: International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusional Hemosiderosis
Keywords: iron overload
iron chelation
deferasirox
observational
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

Brief summary: This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.


Eligibility criteria: Inclusion Criteria:

-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

(the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

Exclusion Criteria:

* Patients with non-transfusional hemosiderosis
* Patients treated with deferasirox in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Serum Creatinine and liver enzyme levels
timeFrame: 3 years
measure: Adverse Drug Reactions
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: West Midlands
country: United Kingdom
facility: Novartis Investigative Site
state: Birmingham
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04750629: Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
Official title: Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 CoviDx™ Rapid Antigen Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Covid19
Keywords: Antigen
Rapid
Point of care testing
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Rapid Pathogen Screening
First posted: 2021-02-11
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic patients who are suspected of having SARS-CoV-2

Brief summary: Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.

Detailed description: All patients who present with Covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (NP) collected for SARS-CoV-2 RT-PCR with EUA as per standard of care and nasal swab collection for CoviDx Rapid Antigen testing.

Eligibility criteria: Inclusion Criteria:

* Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection
* First onset of COVID-19-like symptoms within the last 5 days
* ≥ 1 year of age
* Signed Informed Consent

Exclusion Criteria:

* Unable or unwilling to provide signed, Informed Consent
* Less than 1 year of age
* SARS-Cov-2 RT-PCR collection that occurred \> 3 hours from CoviDx Rapid Antigen Swab collection
* First onset of COVID-19-like symptoms occurring more than 5 days from study visit
* Invalid or missing PCR test results
* Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
* Enrollment in another study involving the collection of a nasopharyngeal or nasal swab
* Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study

Primary outcomes:
measure: Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Doral Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Research
state: Florida
Study officials:
References: