Clinical trials: Patient Reported Outcome (PRO)
Glioma, Patient Reported Outcome Measures
Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population
Given the increasing importance of patient's perspective in adverse events reporting, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) has been proposed as new PRO measures in…
- Conditions
- Glioma, Patient Reported Outcome Measures, Self Report, Adverse Effects
- Trial name
- VERONICA (NCT05486923)
- Where
- 14 sites in China
- Volunteers
- 450 people
- Sponsor
- Huashan Hospital
Necrotizing Soft Tissue Infection, Necrotizing Fasciitis
Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial
The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in…
- Conditions
- Necrotizing Soft Tissue Infection, Necrotizing Fasciitis, Gas Gangrene, Fournier Gangrene
- Trial name
- INSTINCT (NCT02111161)
- Testing
- IVIG (Privigen), Saline 0.9%
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Anders Perner
Proximal Humerus Fracture
Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy
Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM).
- Trial name
- NCT05952622
- Testing
- Continuous passive motion therapy
- Where
- Germany
- Volunteers
- 103 people
- Sponsor
- Technische Universität Dresden
Patient Reported Outcome Measures, CAR T-Cell Therapy
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy
This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting.
- Trial name
- CARTePRO (NCT05354973)
- Testing
- Consilium CareTM
- Where
- Switzerland
- Volunteers
- 11 people
- Sponsor
- Stiftung Swiss Tumor Institute
Smoking, Smoking Cessation
Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness
This is a pilot trial to examine the feasibility and preliminary effect of a multilevel intervention 'Nudges to Quit' on smoking cessation in patients with serious mental illness who smoke in a community mental health center…
- Conditions
- Smoking, Smoking Cessation, Tobacco Use Cessation
- Trial name
- ISRAISE (NCT05952401)
- Testing
- Usual Care, "Nudges"
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Washington University School of Medicine
Achilles Tendon Rupture
PATH-2: Platelet Rich Plasma in Achilles Tendon Healing
Platelet Rich Plasma in Achilles Tendon Healing Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles…
- Trial name
- PATH-2 (NCT02302664)
- Testing
- PRP Injection into Achilles tendon rupture gap, Imitation Injection into Achilles tendon rupture gap
- Where
- 18 sites in United Kingdom
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- University of Oxford
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
Primary Brain Tumour, Radiation Toxicity
Cognitive Function After Radiation Therapy for Primary Brain Tumours
This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction.
- Conditions
- Primary Brain Tumour, Radiation Toxicity, Cognitive Impairment
- Trial name
- NCT04306432
- Testing
- Cognitive tests and Patient Reported Outcomes
- Where
- 5 sites in Denmark
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Glottis Tumor, Larynx Cancer
VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
Laser surgery and radiotherapy are well-established standards of care for unilateral stage 0 \& I carcinoma in situ (Cais) and squamous cell carcinoma of glottic larynx (SCCGL).
- Trial name
- VoiceS (NCT04057209)
- Testing
- Single Vocal Cord Irradiation (SVCI), Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)
- Where
- 4 sites in France, India and 1 more
- Volunteers
- 34 people
- Sponsor
- Olgun Elicin
Chronic Disease, Quality of Life
Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic Trial
Canadian and international health care systems require solutions on how to address the needs of a relatively small population that take up a large portion of health care resources.
- Trial name
- NCT02917954
- Testing
- ePRO Tool Intervention
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Mount Sinai Hospital, Canada
Recurrent Acute Pancreatitis, Chronic Pancreatitis
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).
- Trial name
- SMV in CP (NCT05771675)
- Testing
- Simvastatin
- Where
- 5 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cedars-Sinai Medical Center
Chronic Anal Fissure
AI-Assisted Written Information in Chronic Anal Fissure
This single-center, prospective, 1:1 randomized, parallel-group controlled superiority trial compares standard verbal counseling with AI-assisted written patient information in adults with primary chronic anal fissure receiving…
- Trial name
- AF-AI (NCT07701811)
- Testing
- AI-assisted written patient information, Standardized verbal counseling
- Where
- Turkey (Türkiye)
- Volunteers
- 220 people
- Sponsor
- Sanliurfa Education and Research Hospital
Hallux Valgus
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Trial name
- NCT03846687
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Ipsen
Breast Neoplasm Malignant Female, Exercise
Step Count and Treatment Response in Neoadjuvant Breast Cancer
This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth…
- Conditions
- Breast Neoplasm Malignant Female, Exercise, Breast Cancer Females, Wearable Technology
- Trial name
- NEOBRE-STEP (NCT07162675)
- Testing
- Huawei Fit 2 Smartwatch
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 82 people
- Sponsor
- Ankara Etlik City Hospital
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
The Functional Arm Scale for Throwers (FAST) is a patient-reported outcome measure that assesses upper extremity function in overhead throwing athletes.
- Conditions
- Shoulder Injuries and Disorders, Elbow Injuries and Disorders, Athletic Injuries
- Trial name
- NCT07893899
- Where
- Turkey (Türkiye)
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Elif Turgut
Osteo Arthritis Knee and Hip, Osteo Arthritis
General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis.
- Conditions
- Osteo Arthritis Knee and Hip, Osteo Arthritis, Inflammatory Joint Disease (IJD)
- Trial name
- GASPS (NCT07334132)
- Testing
- General Anaesthesia, Spinal Anesthesia (bupivacaine)
- Volunteers
- 600 people
- Sponsor
- Region Örebro County
Chemotherapy-induced Peripheral Neuropathy
A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to discontinuation or omission of antineoplastic drugs, possibly affecting efficacy of…
- Trial name
- CINCAN-1 (NCT04167319)
- Testing
- QST and PRO measurements during treatment
- Where
- Denmark
- Volunteers
- 32 people
- Sponsor
- Zealand University Hospital
Ulcerative Colitis
Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Ulcerative colitis (UC) is one of the two primary forms of inflammatory bowel disease. This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon.
- Trial name
- NCT06615765
- Testing
- Acupuncture
- Volunteers
- 64 people
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Soft Tissue Sarcoma
Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
The primary objective of the study is to compare quality of life (QoL) between patients suffering from soft tissue sarcoma, receiving a multidimensional intervention with those receiving standard treatment.
- Trial name
- YonLife (NCT02204111)
- Testing
- Intervention
- Where
- 7 sites in Germany
- Volunteers
- 77 people
- Sponsor
- GWT-TUD GmbH
Obesity
Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology
This study will assess the feasibility of using patient-centered, commercial off-the-shelf (COTS) health information technology (IT) solutions to collect patient generated health data (PGHD) and patient-reported outcomes (PROs)…
- Trial name
- NCT03386773
- Testing
- 16-week program, Patient generated health data
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Denver Health and Hospital Authority