louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02390557: Persons With Disabilities Generating Quality Metrics
Official title: Persons With Disabilities Generating Quality Metrics to Inform Integrated Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Chronic Mental Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-17
Enrollment: 451
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control v Survey v YESHealth
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: No standard way exists to measure the quality of medical care or independent living long-term services and supports provided to persons with disabilities. This project will: provide a broader picture of how consumers with disabilities define care and care quality; measure the value of using consumers' expertise in developing, collecting, and assessing quality measures; and use this information to assist One Care providers in improving care delivered to their enrollees

Detailed description: The aims of the project are as follows:

1. To work with persons with significant physical disabilities and serious and persistent mental illness to develop two new approaches to assess quality of care:

   Approach #1: We will survey enrollees about their experiences in One Care and their thoughts about the care they receive. This survey will also ask One Care enrollees about how they manage their care and what self-direction means to them. The survey will be called the Persons with Disabilities Quality Survey (PDQ-S), and it will be available in English and Spanish versions.

   Approach #2: Enrollees in One Care will provide information about their perceptions of care quality to a trained team of persons with disabilities who will report the information to One Care care teams. The goal of the activity is to support quality improvement in One Care through hearing the consumer's voice. This is called YES Health - Your Experience: Speak up for better health care.
2. We want to test how providing consumer informed and consumer directed quality information to One Care providers affects One Care quality.
3. We want to improve the ability of One Care enrollees to manage their own health care and to recognize and report quality problems

Eligibility criteria: Inclusion Criteria:

* One Care enrollee
* Permanent physical disability and/or serious mental illness
* Seen at designated practice site
* English or Spanish speaking

Exclusion Criteria:

* Persons with an intellectual or a developmental disability

Primary outcomes:
measure: Improved Quality of Care
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mongan Institute Health Policy Center, Massachusetts General Hospital
name: Lisa I Iezzoni, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05221957: Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
Official title: Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Anemia
Iron-deficiency
Keywords: Anemia
Iron-deficiency anemia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Propensity score matched cohort study
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery.

The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside.

The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included


Eligibility criteria: Inclusion Criteria:

* Undergoing curative intended surgery for colon or rectum cancer
* UICC stage I-III

Exclusion Criteria:

* Neoadjuvant oncological treatment
* Acute / subacute surgery
* Palliative surgery
* Other pathology than adenocarcinoma

Primary outcomes:
measure: Gene expression and lymphocyte infiltration of the tumor
timeFrame: 1 day after surgery
measure: Complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Length of stay
timeFrame: up to 100 days
measure: Readmission
timeFrame: Within 30 days after surgery
measure: Time to chemotherapy
timeFrame: up to 100 days
measure: Perioperative blood transfusions
timeFrame: from outpatient assesment to 30 days after surgery
measure: Mortality
timeFrame: 30 days, 90 days and one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03960957: Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 301
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: An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines


Eligibility criteria: Inclusion Criteria:

* Moderate to severe glabellar lines at maximum frown
* Understands the study requirements and signs an informed consent form

Exclusion Criteria:

* Botulinum toxin treatment in the face within 6 months prior to study treatment

Primary outcomes:
measure: Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo
timeFrame: Month 1 after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Redondo Beach
country: United States
facility: Galderma Study Site
state: California
city: San Diego
country: United States
facility: Galderma Study Site
state: California
city: Westport
country: United States
facility: Galderma Study Site
state: Connecticut
city: Washington
country: United States
facility: Galderma Study Site
state: District of Columbia
city: Coral Gables
country: United States
facility: Galderma Study Site
state: Florida
city: Atlanta
country: United States
facility: Galderma Study Site
state: Georgia
city: Saint Louis
country: United States
facility: Galderma Study Site
state: Missouri
city: Omaha
country: United States
facility: Galderma Study Site
state: Nebraska
city: Cincinnati
country: United States
facility: Galderma Study Site
state: Ohio
city: Austin
country: United States
facility: Galderma Study Site
state: Texas
city: Spring
country: United States
facility: Galderma Study Site
state: Texas
Study officials:
References:
Clinical trial NCT01857557: Evaluation of an Aerobic Exercise Program in Migraine Management
Official title: Evaluation of an Aerobic Exercise Program in Migraine Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine
Keywords: Exercise
Fitness program
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in patients with migraine. Patients can be assigned to one of two groups 1)The exercise group or 2)non-exercise group. This is a important area to study because there is currently limited information regarding exercise and its impact on migraine frequency and severity. In many cases, migraine patients are disabled by their headaches and sometimes will not have a significant response to medications. As a result, it is important to study other non-pharmacological interventions. In this study, the investigators hope to show the benefits of exercise by a reduction in number of headache days per month as well as by improvement in quality of life, disability,depression,anxiety,and aerobic fitness.This study will not interfere with the usual treatment patients receive at our headache clinic and patients can remain on medications deemed necessary.


Eligibility criteria: Inclusion Criteria:

1. Patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine.
2. Patients must be 18-50 years of age.
3. Individuals motivated to exercise and complete the study.

   -

Exclusion Criteria:

1. Patient has a headache on more than 25 days a month
2. Patient is a medication over-user by International Headache Society (IHS) criteria
3. Patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more.
4. Known cardiovascular disease which contraindicates the exercise program
5. Inability to complete the outcome measure questionnaires. -

Primary outcomes:
measure: Days with headache per month (based on headache diaries),comparing the change from baseline to month 3 and 6 post-randomization in the control versus the intervention group. Migraine Specific Quality of Life Questionnaire scores
timeFrame: At baseline,3, 6 months
Secondary outcomes:
measure: Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness
timeFrame: Baseline, 3 ,6 months post randomization
Other outcomes:
measure: Adherence to fitness program in the intervention group
timeFrame: At 6 months after randomization
Locations:
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: South Health Campus, Calgary, Alberta, Canada
name: Dr Farnaz Amoozegar, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02114957: Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)
Official title: Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: bio-availability
decursin
decursinol angelate
decursinol
subjects
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 20
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: BASIC_SCIENCE

Brief summary: This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.


Eligibility criteria: Inclusion Criteria:

* Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds)
* Subjects 18 to 65 years of age
* Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis

Exclusion Criteria:

* Subjects positive for HIV, HBV and HCV
* Subjects with diabetes-due to length of fasting
* Subjects regularly taking any kind of prescription medications
* Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections
* Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study.
* Female subjects that are pregnant, \<6 months postpartum, or breastfeeding women.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose
Secondary outcomes:
measure: vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb
timeFrame: 0 and 24 hours post-dose
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Jinhui Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Li L, Hale TW, Chee W, Xing C, Jiang C, Lu J. Single oral dose pharmacokinetics of decursin and decursinol angelate in healthy adult men and women. PLoS One. 2015 Feb 19;10(2):e0114992. doi: 10.1371/journal.pone.0114992. eCollection 2015.
Clinical trial NCT04613557: Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
Official title: Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapse/Refractory Multiple Myeloma
Lead sponsor: Celyad Oncology SA
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the IMMUNICY-1 study is to assess the safety, activity and cell kinetics of CYAD-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide

Detailed description: This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM) patients with relapsed or refractory disease.

Eligibility criteria: 1. Documented diagnosis of MM with relapsed or refractory disease to at least two prior MM treatment regimens which should include exposure to IMiD and PIs either alone or in combination.
2. Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
3. Eastern Cooperative Oncology Group (ECOG) below or equal 2
4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

1. History or presence of clinically relevant central nervous system (CNS) tumor involvement.
2. Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
3. Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
4. Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
5. Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.

Primary outcomes:
measure: Occurrence of Dose Limiting Toxicities
timeFrame: Up to 36 days post-infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: New York
country: United States
facility: Nyu Langone Hospitals
state: New York
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Roeselare
country: Belgium
facility: AZ DELTA
Study officials:
References:
Clinical trial NCT01262157: Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
Official title: A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
PDE5 Inhibitor
Low intensity shock wave therapy.
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Detailed description: In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Eligibility criteria: Inclusion Criteria:

* ED of more than 6 months
* Rigidity score \< 3 during PDE5i therapy
* SHIM \<21 during PDE5i therapy
* Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Prior prostatectomy surgery
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region

Primary outcomes:
measure: IIEF-ED Domain
timeFrame: 17 weeks
Secondary outcomes:
measure: rigidity score
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Yoram Vardi, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06364748: Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
Official title: Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: West Michigan Cancer Center
Sponsor class: OTHER
Collaborators: name: Veta Health
First posted: 2024-04-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction.

Detailed description: Remote patient monitoring (RPM) technology has the potential to improve the early detection and management of clinically significant hypertension in cancer patients undergoing therapy with bevacizumab, by allowing immediate communication of abnormal measurements to the clinical care team. Additionally, RPM may decrease patients' and caregivers' burdens of ongoing cancer care through an improved user experience compared to usual care.

Eligibility criteria: Inclusion Criteria:

1. Participant is a male or female 18 years of age or older.
2. Participant is a current patient at West Michigan Cancer Center/Bronson Cancer Center.
3. Participant is receiving bevacizumab as part of active treatment.
4. Participant is willing and able to provide written informed consent.

Exclusion Criteria:

1. Participant is unable to understand English.
2. Participant is hospitalized.
3. Participants are unable to obtain blood pressure readings at home.

Primary outcomes:
measure: To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring
timeFrame: Through study completion, an average of 18 months
measure: Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring
timeFrame: Through study completion, an average of 18 months
measure: Patient satisfaction with usual care blood pressure monitoring
timeFrame: 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment
measure: Patient satisfaction with remote blood pressure monitoring
timeFrame: 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
Study officials:
affiliation: West Michigan Cancer Center
name: David Shalowitz
role: PRINCIPAL_INVESTIGATOR
References: