louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05766332: Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant
Official title: Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing evaluation for autologous or allogeneic bone marrow transplant.

Brief summary: This study evaluates whether clinical evaluation tools such as the six-minute walk test, hand grip strength test, and gait speed test, are useful in predicting risk of complications in patients undergoing hematopoietic stem cell transplants (HCT). Being able to predict who is at increased risk of post-HCT complications can help better inform patients and providers on the risks and benefits of undergoing HCT and determine whether certain patients should have closer post-HCT monitoring due to an increased risk of complications.

Detailed description: PRIMARY OBJECTIVE:

I. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications.

OUTLINE: This is an observational study.

Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age \>= 18 years old)
* Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester
* Scheduled for pre-HCT pulmonary function test by the primary team

Exclusion Criteria:

* Limited mobility requiring use of gait aid or wheelchair
* Fall risk

Primary outcomes:
measure: Pulmonary complication following hematopoietic stem cell transplant (HCT)
timeFrame: Up to 1 year after transplant
Secondary outcomes:
measure: 100-day mortality
timeFrame: At 100 days after transplant
measure: 1 year mortality
timeFrame: At 1 year after transplant
measure: Relapse-free survival
timeFrame: At 1 year after transplant
measure: Hospital or intensive care unit admission post-HCT
timeFrame: Up to 1 year after transplant
measure: Need for noninvasive or invasive mechanical ventilation
timeFrame: Up to 1 year after transplant
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hemang Yadav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01716832: Walking for Stress Reduction
Official title: Effectiveness of Mindfulness Walking on Stress Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women between 18 and 65 years
* Increased level of stress (visual analog scale \>40 mm (0-100))

Exclusion Criteria:

* Regular walking training in the last 6 weeks
* Medical therapy with psychopharmacological drugs
* Regular mindfulness based meditations/exercises in the last 6 weeks
* CAM therapies against stress in the last 6 weeks
* medium or severe chronic diseases
* Stress due to chronic diseases
* Acute disease at inclusion
* Not being able to walk

Primary outcomes:
measure: Cohens Perceived Stress Scale 14 Items
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality of Life (SF 36)
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Subjective Stress Level (Visual Analogue Scale)
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Assessment of effect on a Likert - Scale
timeFrame: 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Berlin
Study officials:
References:
Clinical trial NCT04701632: Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool
Official title: Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019.

Brief summary: The objective of the study is to complete a retrospective chart review of subjects who were treated at the Wound Care Clinic at Methodist Dallas Medical Center, presented for treatment between June 2018 and February 2019, and were administered the PHQ-9. The study aims to measure the prevalence of depression in this sample, feasibility of using PHQ-9 in this patient population, and identifying variables and functional impairment associated with clinically significant depression.

Detailed description: The study will review medical records of new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019. These patients were all administered PHQ-9 as part of a quality improvement project. The medical records included for analysis will be from male and female patients aged 18 years or older. The medical records will be reviewed for the following information: general demographics, information including age, sex, ethnicity, race, PHQ-9 score (total and individual items), medical conditions, wound history, past medical history, general symptoms, abuse and suicide risk, activities of daily living, motivation assessment, mental status, and pain ratings. This information will be used to measure the prevalence of clinically significant depression in the sample, which is the primary aim. We will also use the data to establish factors and variables correlated with the presence and severity of clinically significant depression.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Received care at the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019
3. Completed a PHQ-9 form at the time of initial evaluation/examination

Exclusion Criteria:

1. Patients less than 18 years of age will be excluded from the study

Primary outcomes:
measure: PHQ-9 score
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Wound care & Hyperbaric Clinic
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Asma Khatoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00276432: Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.
Official title: Diagnosis and Treatment of Acute Coronary Syndrome in the Emergency Department- The Impact of Rapid Bedside cTnl on Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unstable Angina
Non-ST-Elevation Myocardial Infarction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Abbott
name: University of Cincinnati
name: William Beaumont Hospitals
First posted: 2006-01-13
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary outcome in this study will be time to discharge for low-risk patients and therapeutic turnaround time for patients with NSTEMI or unstable angina.

Detailed description: Phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. Assess the reduction in time taken to dispostion or discharge patients. Assess the ability of POC testing to satisfy guidelines for a 30 minute turn around time of results. Assess and differences in clinical decision-making for other diagnostic procedures including nuclear imaging, echo, and stress treadmill, disposition from the ED, time to catherterization lab, PCI, and CafBG based on the cardiac troponinn results from the bedside analyzer and the central lab instrument.Assess the difference for in-hospital and 30 day post hospital discharge cardiac events including all-cause and cardiac-specific deaths, CHF, cardiomyopathy, and atrial and ventricular arrhythmia, beween the bedside analyzer and the central lab instrument. Assess the differences in hospital care costs for the hospitalization period, and assess direct medical and indirect productivity costs in the 30 day post hospital discharge period to patients who are diagnosed, using the bedside cTnl test and the central lab cTn tests, and subsequently treated as per the guidelines.

Eligibility criteria: Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.

Primary outcomes:
measure: Time to discharge for low-risk patients
measure: Therapeutic turnaround time for patients with NSTEMI or unstable angina
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Wyatt W. Decker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00436137: Improving Followup of Abnormal Colon Cancer Screening Tests
Official title: Improving Followup of Positive Fecal Occult Blood Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Fecal occult blood test
Abnormal test result
Missed diagnosis
Delayed diagnosis
Lead sponsor: Harvard Vanguard Medical Associates
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2007-02-16
Enrollment: 70
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.

Detailed description: Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.

Eligibility criteria: Inclusion Criteria:

* Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result

Exclusion Criteria:

* Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
* Colonoscopy within 5 years prior to positive fecal occult blood test
* Age \> 80 years

Primary outcomes:
measure: Performance of colonoscopy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
Study officials:
affiliation: Harvard Vanguard Medical Associates
name: Thomas D Sequist, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04739137: Smart-TV Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients
Official title: Development and Validation of a Smart-tv Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Vision
Macular Edema
Refractive Errors
Keywords: smart features
Smart-tv App
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal- and low-sighted participants aged 40 to 85 years

Brief summary: Primary objective of our study is the development and validation of an application for smart-TVs for the self-examination of the distant visual acuity of patients diagnosed with macular edema.

Detailed description: Present study aims to develop and validate an application installed in Smart-TVs. This application will be referred to patients suffering from macular edema, allowing the self-examination of the patient in terms of distant visual acuity. The development of a simple but reliable way of self-examination of distant visual acuity would bring beneficial results in the overall management of these patients as significantly would reduce the flows to the outpatient ophthalmology clinics of the NSS Hospitals, would serve the purposes of the social distancing imposed by the current state of the pandemic but also any analogous situation and would help the patient to be vigilant and actively involved in the management of his disease.

Eligibility criteria: Inclusion Criteria:

* age-dependent macular degeneration
* diabetic macular edema

Exclusion Criteria:

* corneal diseases
* glaucoma
* psychiatric disorders
* inability to cooperate

Primary outcomes:
measure: Distance visual acuity test via ETDRS chart
timeFrame: 1 week
measure: Distance visual acuity self assessment via DDiVAT
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris
role: STUDY_CHAIR
References:
Clinical trial NCT04069637: Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
Official title: Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early-Onset Scoliosis Deformity of Spine
Keywords: Titanium Levels
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Scoliosis Research Society
First posted: 2019-08-28
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients treated by the Pediatric Orthopaedic Surgery department at Michigan Medicine.

Brief summary: The investigators are conducting research to compare serum and urine titanium levels in children with early onset scoliosis who are being treated with certain types of metal spinal rods. These rods include traditional growing rods (TGR), magnetically-controlled growing rods (MCGR), and Vertical Expandable Prosthetic Titanium Rib (VEPTR). Children with metal rods may have elevated serum and urine titanium levels. These levels may remain elevated over time. The investigators will collect serum titanium levels from children with metal rods and children without metal rods to see if there are differences in their titanium levels. The investigators will then collect a second serum titanium level from children with metal rods at least 6 months later to see if the participants titanium levels remain elevated over time. The investigators will also collect urine titanium levels from children with metal rods to see if titanium is excreted in the urine.


Eligibility criteria: Inclusion Criteria:

Cases: Patients with early onset scoliosis treated with traditional growing rods (TGR), magnetically controlled growing rods (MCGR), and the Vertical Expandable Prosthetic Titanium Rib (VEPTR).

Controls: Patients with operative fractures.

Exclusion Criteria:

Cases: Patients who had a previous limited spinal fusion, conversion from one type of GSI to another, TGR with stainless steel or cobalt chromium instrumentation, and indwelling implants for 6 months or less.

Controls: Patients with indwelling implants or prior implant insertion and removal.

Primary outcomes:
measure: Serum titanium levels between groups
timeFrame: At enrollment
measure: Serial serum titanium levels in scoliosis patients
timeFrame: Roughly 6 months apart
measure: Urine titanium levels in scoliosis patients
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
References:
Clinical trial NCT05207137: Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake
Official title: [In Norwegian]: Samtale Med Fastlegen Som Tiltak for å øke Covid-19-vaksinedekningen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Health services research
Quality improvement
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2022-01-26
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will randomise individuals from family doctors' lists of patients that are at risk of severe Coronavirus Disease 2019 (COVID-19), and that are not registered as having taken the vaccine against the disease. The patients will be randomised to receiving a phone call from their family physician where the participants are given the opportunity to raise questions they might have around vaccination. The investigators will assess whether this has an impact on vaccine uptake.


Eligibility criteria: Inclusion Criteria:

* Belonging to group at risk of severe COVID-19

Exclusion Criteria:

-

Primary outcomes:
measure: Vaccination status (COVID-19)
timeFrame: 3-6 weeks after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Bolteløkka legesenter
Study officials:
affiliation: Norwegian Institute of Public Health
name: Atle Fretheim, PhD
role: STUDY_DIRECTOR
References:
citation: Tuv M, Elgersma IH, Furuseth E, Holst C, Helleve A, Fretheim A. GP phone calls to improve COVID-19 vaccine uptake among patients at increased risk of severe COVID-19: a randomised trial. BJGP Open. 2023 Jun 27;7(2):BJGPO.2022.0175. doi: 10.3399/BJGPO.2022.0175. Print 2023 Jun.
Clinical trial NCT00703937: Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
Official title: A Multi-center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL
* Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

Exclusion Criteria:

* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery
* AST or ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually-active females who are not willing to use an effective form of birth control

Primary outcomes:
measure: Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC
timeFrame: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References: