louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06102512: A Study of [14C]-LOXO-783 in Healthy Adult Participants
Official title: A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-10-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 (\[¹⁴C\]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and \[¹⁴C\]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.


Eligibility criteria: Inclusion Criteria:

* Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator
* Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator

Primary outcomes:
measure: Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)
timeFrame: Predose on day 1 up to postdose on day 21 (Part 1)
measure: PK: Cumulative Feur
timeFrame: Predose on day 1 up to postdose on day 21 (Part 1)
measure: PK: Fraction of Dose Excreted in Feces (Fefeces)
timeFrame: Predose on day 1 up to postdose on day 21 (Part 1)
measure: PK: Cumulative Fefeces
timeFrame: Predose on day 1 up to postdose on day 21 (Part 1)
measure: PK: Fraction of Dose Excreted in Expired Air (Feair)
timeFrame: Predose on day 1 up to postdose on day 21 (Part 1)
measure: PK: Absolute Bioavailability (F) of LOXO-783
timeFrame: Predose on day 1 up to postdose on day 9 (Part 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research
state: Wisconsin
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin
role: STUDY_DIRECTOR
References:
Clinical trial NCT02530112: Functional Outcome Measures for Head and Neck Patients
Official title: Functional Outcome Measures for Head and Neck Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Otorhinolaryngology Subjects Undergoing Free Flap Surgery
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 1000
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: Subjects who have consented to Otorhinolaryngology Research Registry and are undergoing free flap surgery.

Brief summary: The objective of this study is to identify outcome measures for cancer control in Head and Neck cancer patient populations at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's quality of life, and help with therapeutic interventions and explanation of expectations prior to surgery.

Detailed description: Few studies examine quality of life outcome measures with initial diagnosis, surgical procedures,perioperative measures (such as use of perioperative blood transfusion or pressors), and outcomes for cancer control and free flap survival. This sub-protocol, in conjunction with protocol #816676 (Otorhinolaryngology Research Registry) will serve as a hypothesis generating study for future research on reconstructive free flap surgery outcomes by narrowing down existing questionnaires to tailor it specifically for these patients.

Eligibility criteria: Inclusion Criteria:

* Subjects who have consented to Otorhinolaryngology Research Registry and are undergoing free flap surgery.

Exclusion Criteria:

* No children, pregnant women, or prisoners will be consented.

Primary outcomes:
measure: Completion of Survey
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Steven Cannady, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02043912: Drug Interactions With Risk of QT-prolongation in a General Hospital
Official title: Drug Interactions With Risk of QT-prolongation in a General Hospital: an Epidemiological Point Prevalence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: QT-prolongation
Keywords: QT-prolongation
Torsade de Pointes
Haloperidol
Drug interactions
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2014-01-23
Enrollment: 222
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: patients who are treated with haloperidol (every tuesday we will make a selection of the patients who received haloperidol on monday)

Brief summary: In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.

Detailed description: Study design: epidemiological point prevalence study

Target population: Patients with haloperidol treatment

The following aspects will be investigated:

* The medication profiles will be checked for drug interactions with risk of QT-prolongation.
* Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
* Safety measurements (e.g. ECG) will be documented.

Eligibility criteria: Inclusion Criteria:

* treatment with haloperidol (started in the hospital)

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
measure: QTc-interval (corrected for heart rate)
timeFrame: maximum one year before inclusion / one week after inclusion
Secondary outcomes:
measure: number of drug interactions (with risk of QT-prolongation)
timeFrame: one week before/after inclusion
Other outcomes:
measure: number of patients with an ECG before or after the start of haloperidol
timeFrame: maximum one year before inclusion / one week after inclusion
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
Study officials:
affiliation: KU Leuven
name: Eline Vandael, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05483712: Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy
Official title: A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Radiation Therapy
Brass Mesh
Bolus
Skin Dose
Lead sponsor: Nova Scotia Cancer Centre
Sponsor class: OTHER
Collaborators: name: Hannah Dahn
First posted: 2022-08-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.
Primary purpose: TREATMENT

Brief summary: The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.

Detailed description: Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.

Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.

Primary outcome

1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.

Eligibility criteria: Inclusion Criteria:

Women undergoing rotational chest wall radiotherapy following mastectomy for breast cancer treatment who would utilize Superflab bolus on some, but not all, days of radiotherapy treatment.

Exclusion Criteria:

Patients who require daily bolus due to skin involvement or other high-risk features requiring a high skin dose will not be included.

Primary outcomes:
measure: Skin Dose Enhancement Under Brass Mesh Bolus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
References:
Clinical trial NCT01475812: Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dynamic Lung Hyperinflation
COPD Patients
Activities of Daily Livin.
Keywords: COPD
activities of daily living
pulmonary hyperinflation
exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators included 19 COPD patients (13 male) with moderate to very severe degree of airway obstruction, with a mean post bronchodilator forced expiratory volume in the first second (FEV1) of 48.7 ± 7.1% predicted and mean age of 64.1 ± 5.3.

Brief summary: Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow limitation usually progressive and associated with inflammatory response of lung noxious particles. During a physical activity chronic obstructive pulmonary disease patients may develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity performance. The investigators hypothesize that some specific activities of daily living induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung hyperinflation and its influence in dyspnea perception in moderate and severe chronic obstructive pulmonary disease patients after activities of daily living. Methods: The investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation, heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients. These measurements were taken at rest and after daily living activities (such as going up and down a set of stairs, going up and down a ramp and sweeping and mopping a room).


Eligibility criteria: Inclusion Criteria:

* COPD patients diagnosed with moderate to very severe airway obstruction according to GOLD classification (9)
* clinical stability with no clinical exacerbation during the previous 30 days prior to the beginning of the study and to sign an informed consent form

Exclusion Criteria:

* Inability to perform the slow vital capacity maneuver
* excessive perceived dyspnea during the test
* arterial oxyhemoglobin saturation (SpO2) lower than 80% during activities and/or need of oxygen supplementation

Primary outcomes:
measure: Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
state: São Paulo/SP
Study officials:
References:
Clinical trial NCT06998212: The Effect of Smartphone-Based Recording Offer on Patient Satisfaction in Orthopedic Care
Official title: The Effect of Smartphone-Based Recording Offer on Patient Satisfaction in Orthopedic Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Keywords: Satisfaction
Smartphone
Recording
Record
Preop
Preoperative
Orthopedic
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
Collaborators: name: Riverside University Health System Medical Center
First posted: 2025-05-31
Enrollment: 972
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine patient satisfaction with orthopedic preoperative encounter based on offer to record the encounter on patient personal smartphone.


Eligibility criteria: Inclusion Criteria:

* All patients presenting to RUHS for preoperative orthopedic evaluation

Exclusion Criteria:

* Patients without smartphones

Primary outcomes:
measure: Patient satisfaction with preoperative orthopedic encounter
timeFrame: From enrollment to survey completion
Secondary outcomes:
measure: Patient survey responses including if patient recorded visit, reason for recording visit, preference for recording visit
timeFrame: From enrollment to survey completion
measure: If satisfaction varies by demographic factors (age, race, ethnicity, sex) or by type of procedure that the preop is for
timeFrame: Through study completion, average 1 year
Other outcomes:
Locations:
city: Moreno Valley
country: United States
facility: Riverside University Health System
state: California
Study officials:
References:
citation: Norgaard B, Kofoed PE, Ohm Kyvik K, Ammentorp J. Communication skills training for health care professionals improves the adult orthopaedic patient's experience of quality of care. Scand J Caring Sci. 2012 Dec;26(4):698-704. doi: 10.1111/j.1471-6712.2012.00982.x. Epub 2012 Mar 16.
citation: Meakin R, Weinman J. The 'Medical Interview Satisfaction Scale' (MISS-21) adapted for British general practice. Fam Pract. 2002 Jun;19(3):257-63. doi: 10.1093/fampra/19.3.257.
citation: Koh TH, Butow PN, Coory M, Budge D, Collie LA, Whitehall J, Tattersall MH. Provision of taped conversations with neonatologists to mothers of babies in intensive care: randomised controlled trial. BMJ. 2007 Jan 6;334(7583):28. doi: 10.1136/bmj.39017.675648.BE. Epub 2006 Dec 1.
citation: Wolderslund M, Kofoed PE, Holst R, Axboe M, Ammentorp J. Digital audio recordings improve the outcomes of patient consultations: A randomised cluster trial. Patient Educ Couns. 2017 Feb;100(2):242-249. doi: 10.1016/j.pec.2016.08.029. Epub 2016 Aug 29.
citation: Elwyn G, Barr PJ, Grande SW. Patients recording clinical encounters: a path to empowerment? Assessment by mixed methods. BMJ Open. 2015 Aug 11;5(8):e008566. doi: 10.1136/bmjopen-2015-008566.
Clinical trial NCT04312412: Outcome of the Treatment of Flexor Tendon Injuries
Official title: Outcomes of Flexor Tendons Repair in Zones I-III From 2014-2025: a Swiss Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Finger Injuries
Tendon Injury - Hand
Keywords: tendon injuries
flexor tendons
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: University of Bern
First posted: 2020-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: In order to gather enough data for meaningful statistics, a multicenter register of all flexor tendon repairs was established with surgical, clinical and rehabilitation patient data. The controlled active motion (CAM) protocol was administered in all patients after surgery. The purpose was to (i) measure surgery and therapy outcomes in the three centers and (ii) evaluate potential influencing factors on outcomes.


Eligibility criteria: Inclusion Criteria:

* Injury between 2014 and 2025
* Flexor tendon injury of the fingers or thumb in zones 1-3

Exclusion Criteria:

* No given consent
* Concomitant injuries as fractures, large soft tissue injuries, replantation
* Bony avulsion fracture of flexor tendon (Jersey finger)
* Basic disease as rheumatoid diseases
* Primary and secondary tendon reconstruction and tendon transfer

Primary outcomes:
measure: Range of motion
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 13 weeks
measure: Range of motion
timeFrame: 26 weeks
measure: Range of motion
timeFrame: 52 weeks
measure: Grip or pinch strength
timeFrame: 13 weeks
measure: Grip or pinch strength
timeFrame: 26 weeks
measure: Grip or pinch strength
timeFrame: 52 weeks
measure: Time return to work
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Clinic of Reconstructive Surgery
state: ZH
Study officials:
affiliation: University of Zurich
name: Maurizio Calcagni, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270112: Enhanced Diagnostics for Early Detection of Atrial Fibrillation
Official title: Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
atrial electrophysiology
stroke
vascular stiffness
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All inhospital and outpatient patients of our Institution with known paroxysmal AF are screened for eligebility. Control Group is equally recruted from patients of our intitution matching the studygroup.

Brief summary: Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is present.

The investigators hypothesize that the activation of the atrial myocardium resulting in the p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.

Detailed description: In the first part of this trial different diagnostic techniques to detect arrythmogenic substrates of atrial fibrillation will be tested. If suitable parameters can be identified, a follow up trial to identify patients at risk for AF will be conducted before a stroke happens.

Parameters tested are

1. Electrophysiological differences between patients with paroxysmal AF and no history of AF
2. "Vascular Stiffness" detected by an iPhone app

All patients will undergo a cardiogoniometrie and a pulse wave analysis with an iPhone. Each exam takes 5 minutes.

Eligibility criteria: Inclusion Criteria:

* paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion Criteria:

* acute cerebral trauma
* antiarrhythmic medication

Primary outcomes:
measure: Beat to beat variation of the electrical activation vector of the atrium
timeFrame: Once during the exam (baseline) - No further follow up planned
Secondary outcomes:
measure: Averaged slope of pressure-curve
timeFrame: Once during exam (5min, baseline) - No further follow up planned
measure: Averaged slope of pressure-curve
timeFrame: Once during exam (5min, baseline) - No further follow up planned
measure: Heart rate variability
timeFrame: Once during exam (5min, baseline) - No further follow up planned
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
affiliation: Universityhospital Basel
name: Jens Eckstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brasier N, Engelter S, Kolbitsch T, Tabord A, Knobeloch J, Kuhne M, Conen D, Traenka C, Kreutzberger T, Vollmin G, Eckstein J. The quest for indicators of paroxysmal atrial fibrillation in sinus rhythm - the DETECT AF trial. Acta Cardiol. 2019 Aug;74(4):301-307. doi: 10.1080/00015385.2018.1493248. Epub 2018 Aug 19.