louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05664997: Playing-Related Factors and Occupational Balance
Official title: Relationship Between Playing-Related Factors and Occupational Balance in Professional Violinists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Balance
Posture
Keywords: Functionality
Playing-related pain
Posture
Occupational balance
Violinists
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: violinists at Cemal Resit Rey Symphony Orchestra, Maltepe University Conservatory, Istanbul University State Conservatory, Okan University Conservatory, Cemal Resit Rey Jazz Orchestra and Cemal Resit Rey Youth Orchestra.

Brief summary: As the violin is the riskiest string instrument played by Turkish musicians, violinists were chosen for the sample in this study. The aim of this study was to investigate the relationship between posture, pain, functionality and occupational balance in violinists. The hypothesis was that good playing posture, lack of pain, and functionality affect occupational balance positively.

Detailed description: Occupational balance is the participation in and satisfaction derived from different elements of daily life, including work. Playing performance affects occupational balance of musicians so that complaints arising from the playing of their instruments may negatively affect occupational balance. Forty-five violinists at six different symphony orchestras and conservatories in Istanbul were included. The Personal Information Form, the Edinburgh Handedness Inventory, the Wong-Baker Faces Pain Rating Scale, the Disability of Arm, Shoulder and Hand - Sports/Musicians (DASH-SM), the Rapid Upper Limb Assessment, and the 11-item revised version of the Occupational Balance Questionnaire (OBQ11 - T) were used. Spearman correlation analysis was performed to examine the relationship between the variables.

Eligibility criteria: Inclusion Criteria:

* to play the violin in a conservatory or orchestra,
* to be at least 18 years old,
* to volunteer to participate in this study.

Exclusion Criteria:

* Those who played any other instrument professionally.

Primary outcomes:
measure: occupational balances of the violinists
timeFrame: 25 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Uskudar
country: Turkey
facility: Hulya Yucel
state: Istanbul
Study officials:
affiliation: Saglik Bilimleri University
name: Hulya Yucel, Assoc. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00234897: Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis
Official title: Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: adalimumab
rheumatoid arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 1938
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 purpose of the study is to assess the efficacy of adalimumab in subjects with rheumatoid arthritis focusing on subject-reported outcomes and early response to treatment


Eligibility criteria: Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject, based on assessment of investigator, meets the definition of active RA

Exclusion Criteria:

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Primary outcomes:
measure: Patient reported outcomes, clinical response indicators.
Secondary outcomes:
measure: Subject reported assessments of disease activity, physician reported assessments of disease activity, safety parameters, clinical response indicators.
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Global Medical Information - Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Beverly Paperiello
role: STUDY_DIRECTOR
References:
Clinical trial NCT04936997: Immune Response to the COVID-19 Vaccine
Official title: Immune Response to the COVID-19 Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Covid19
Cancer
Malignancy
Vaccine Response Impaired
Keywords: Covid-19 vaccine
Pfizer Covid-a9 vaccine
Covid vaccine study
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

Detailed description: In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.

Eligibility criteria: Inclusion Criteria:

1. Patients must have active solid tumor malignancy diagnosis
2. On active chemotherapy
3. Received two prior SARS-COV2 Pfizer vaccines
4. Age ≥ 18 years
5. Ability to understand and the willingness to sign a written informed consent
6. Agree to comply with study procedures
7. Subjects previously enrolled under the main study

Exclusion Criteria:

1. History of HIV or organ/bone marrow transplant
2. Actively receiving immunotherapy
3. On active, chronic immunosuppression (\>10 mg daily dose of prednisone equivalent)
4. Currently incarcerated or residence of another state
5. Speaks a language other than English.

Primary outcomes:
measure: Immune response
timeFrame: 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Rachna Shroff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shroff RT, Chalasani P, Wei R, Pennington D, Quirk G, Schoenle MV, Peyton KL, Uhrlaub JL, Ripperger TJ, Jergovic M, Dalgai S, Wolf A, Whitmer R, Hammad H, Carrier A, Scott AJ, Nikolich-Zugich J, Worobey M, Sprissler R, Dake M, LaFleur BJ, Bhattacharya D. Immune responses to two and three doses of the BNT162b2 mRNA vaccine in adults with solid tumors. Nat Med. 2021 Nov;27(11):2002-2011. doi: 10.1038/s41591-021-01542-z. Epub 2021 Sep 30.
Clinical trial NCT00628797: Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis
Official title: Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Systemic Scleroderma
Systemic Sclerosis
Keywords: systemic sclerosis
skin fibrosis
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2008-03-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue involving the skin and internal organs. To date there is no proven therapy for the skin fibrosis available. A number of case reports and small uncontrolled cohort studies suggest that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc using a randomized, intraindividual half body irradiation protocol.


Eligibility criteria: Inclusion Criteria:

* systemic sclerosis ACR criteria
* skin fibrosis at least involving the distal third of the lower arm

Exclusion Criteria:

* photosensitizing drugs
* recent UV therapy

Primary outcomes:
measure: modified skin score
timeFrame: 3 months
Secondary outcomes:
measure: modified skin score
timeFrame: 6 months
measure: histologic examination
timeFrame: 3 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen, Dept. of Dermatology
state: BW
city: Cologne
country: Germany
facility: University of Cologne, Dept. of Dermatology
state: NRW
Study officials:
affiliation: University of Cologne, Dept. of Dermatology
name: Nicolas Hunzelmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04678297: Physical Activity Interventions to Heal Chronic Low Back Pain
Official title: Role of Emotion Regulation on Low Back Pain Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain, physical activity, emotion regulation
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institutes of Health (NIH)
First posted: 2020-12-21
Enrollment: 204
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: This study will advance understanding on the mechanisms that mediate improved outcomes for chronic low back pain and provide specific directions for optimizing physical activity interventions for this population.

Detailed description: In this study, participants with chronic low back pain will be randomized to receive a 12-week physical activity intervention (2 times per week with encouragement for home practice). The experimental condition will entail physical activity with components for strengthening emotion regulation skills, behaviors, and attitudes while the control condition will entail physical activity alone.

Eligibility criteria: Inclusion Criteria:

- Age \> 18;

Report of low back pain \>3 of last 6 months;

Willing to attend 12-weeks of yoga or stretching (twice per week);

Willing to complete 4 assessments;

English Literacy;

No changes in pain treatments in the past month;

Willing to not change pain treatments during study unless medically necessary;

Have not practiced yoga \> 2x in the last 12 months;

Exclusion Criteria:

- back surgery within the last 1 year;

back pain due to specific systemic problem (e.g., lupus);

lower extremity weakness (motor strength 4/5 of the quads, gluts, hamstrings, EHL);

sciatica or (+) straight leg raise (SLR);

coexisting chronic pain problem (migraine headaches, fibromyalgia);

Serious or unstable psychiatric illness (e.g. psychosis, mania, history of suicide attempt);

major coexisting medical illness (e.g., cancer, COPD, morbid obesity);

Positive Romberg test (with or without sensory neuropathy).

Primary outcomes:
measure: Emotion regulation abilities
timeFrame: Baseline and 6 weeks and 3 months and 6 months
Secondary outcomes:
measure: Pain severity/interference
timeFrame: Baseline and 6 weeks and 3 months and 6 months
measure: Pain sensitization
timeFrame: Baseline and 6 weeks and 3 months and 6 months
Other outcomes:
Locations:
city: Storrs Mansfield
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Crystal Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184897: Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
Official title: Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.


Eligibility criteria: Inclusion Criteria:

* age: above 17 years, below 65 years old
* informed consent
* ECOG 0-1
* autologous stem cell transplant candidate among patients with multiple myeloma

Exclusion Criteria:

* prior history of hematopoetic stem cell transplantation
* history of failure to mobilize hematopoietic stem cells
* history of G-CSF administration within 2 weeks before enrollment to this study

Primary outcomes:
measure: pharmacokinetic data of lenograstim
timeFrame: on day 1 of apheresis
Secondary outcomes:
measure: pharmacodynamic data: CD34+ cell count by flow cytometry
timeFrame: on day 1 of apheresis
measure: pharmacodynamic data: absolute neutrophil count
timeFrame: on day 1 of apheresis
measure: pharmacodynamic data: hematopoietic progenitor cells (HPC)
timeFrame: on day 1 of apheresis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03684005: MyPatientPal: An App to Help Patients Manage Their Cancer Care
Official title: MyPatientPal: An App to Help Patients Manage Their Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: MyPatientPal was developed in collaboration with both patient and oncologist stakeholders, is designed to facilitate such patient self-management through the daily reporting of side effects and medications.

Detailed description: MyPatientPal is a patient app that is designed to help patients track and manage treatment side effects and medication adherence on a daily basis. Side effects (e.g., pain, fatigue, diarrhea, nausea) can be physically and emotionally debilitating, and when uncontrolled, can cause treatment complications, resulting in unscheduled care costs, patient out-of-pocket costs, and delays or discontinuation of treatment. The app allows personalization of daily entries such that patients can select the specific medications and dosage and side effects (using items from the NCI Common Terminology Criteria for Adverse Events) that they and/or their providers want to track. A charting feature provides an easy-to-read display of patients' daily reports, summarizing the intensity and frequency of side effects and medication use either by week or by month. These reports can also be printed out and shared with providers.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of any solid tumor cancer
* Be starting treatment using an oral cancer therapeutic agent
* Be able to speak, read, and write English
* Willing and able to use their smartphone to use MyPatientPal

Exclusion Criteria:

* Patients with cognitive or perceptual disturbances

Primary outcomes:
measure: Treatment-related symptoms
timeFrame: Symptoms will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Secondary outcomes:
measure: Adherence to medications
timeFrame: Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
measure: Patient self-efficacy
timeFrame: Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Associate Professor/PI
name: Felicity Harper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05909605: Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor
Official title: Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feasibility Study
Medical Device
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants without any severe cardiac anomalies

Brief summary: Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor oﬀers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.


Eligibility criteria: Inclusion Criteria:

* Are able to provide informed consent
* Have at least one arm

Exclusion Criteria:

* Active cardiac arrhythmias
* Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)
* Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)
* Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff
* Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure
* Diagnosis of dementia

Primary outcomes:
measure: Device comparison to standard monitoring (Sphygmomanometer)
timeFrame: 2 years
measure: Device comparison to standard monitoring (A-line)
timeFrame: 2 years
measure: Device comparison to standard monitoring (A-line)
timeFrame: 3 years
measure: Device comparison to standard monitoring (Sphygmomanometer)
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References:
Clinical trial NCT00994305: Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
Official title: Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Transplantation
Keywords: kidney transplantation
oxidative stress
acetylcysteine
graft rejection
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-10-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.

Detailed description: Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.

Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.

Eligibility criteria: Inclusion Criteria:

* primary deceased renal transplant recipients
* adult (\>18 yo)

Exclusion Criteria:

* unable to drink N-acetylcysteine during the first 7 PO
* participation in other study

Primary outcomes:
measure: Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.
timeFrame: 7 days
Secondary outcomes:
measure: Graft function: measure of serum creatinine
timeFrame: 3 months
measure: Graft function:estimated creatinine clearance by Cokcroft-Gault formula
timeFrame: 3 months
measure: Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital Kidney Transplant Unit
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Alexandre Danilovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danilovic A, Lucon AM, Seguro AC, Shimizu MHM, Ianhez LE, Nahas WC, Srougi M. N-acetylcysteine attenuates oxidative stress in deceased renal transplantation. The Journal of Urology 181 (4): 740; 2009.