louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03730818: Water-based Versus Land-based Exercise for Breast Cancer Survivors
Official title: Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Exercise Therapy
Aquatic Therapy
Health-Related Quality of Life
Cancer-related Fatigue
Exercise Tolerance
Physical Activity
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital del Mar
name: Centre Esportiu Claror Marítim
First posted: 2018-11-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical activity and exercise have demonstrated to be an integral part of the cancer-continuum care. Despite strong evidence suggesting that both endurance and strength training should be encourage in cancer patients, there is still controversy regarding exercise dosage, frequency, volume and optimal environment of delivery. In this randomised controlled trial we aim to compare water-based versus land-based exercise in breast cancer survivors to decrease cancer-related fatigue (CRF), improve Health-Related Quality of Life (HRQoL), exercise tolerance, muscle strength and physical activity levels.


Eligibility criteria: Inclusion Criteria:

* Breast Cancer patients post cancer treatment (at least for 6 months)
* Cancer-free at the time of recruitment
* Signed informed consent
* Living in the metropolitan area of Barcelona

Exclusion Criteria:

* Fear of water
* Receiving cancer therapy at the time of recruitment
* Not willing to participate/Refuse to sign informed consent
* Physical of cognitive impairments precluding the patient to perform the exercises

Primary outcomes:
measure: Changes in Cancer-related Fatigue
timeFrame: Cancer-related fatigue from baseline throughout the study period (24 weeks)
Secondary outcomes:
measure: Change in Exercise Functional Capacity
timeFrame: Exercise functional capacity from baseline throughout the study period (24 weeks)
measure: Change in Physical Activity levels
timeFrame: Physical activity levels from baseline throughout the study period (24 weeks)
measure: Change in Upper Body Strength
timeFrame: Upper body strength from baseline throughout the study period (24 weeks)
measure: Change in Lower Body Strength
timeFrame: Lower body strength from baseline throughout the study period (24 weeks)
measure: Change in Health-Related Quality of Life
timeFrame: Health-related quality of life from baseline throughout the study period (24 weeks)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centre Claror - Fundació Marítim
Study officials:
References:
Clinical trial NCT06386718: Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients
Official title: Comparison of Ultrasonographic Measurements of Radial and Ulnar Arteries in Pediatric Patients Undergoing Elective Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulnar and Radial Artery
Keywords: ultrasonography for cannulation
pediatrics
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 184
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Between 0 and 10 years of ages pediatric patients scheduled for elective surgery under general anesthesia

Brief summary: Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients.

Detailed description: Radial artery cannulation is the most commonly used technique for invasive arterial catheterization in pediatric patients. Ultrasound guidance has significantly reduced cannulation success rates and complication risks. The ulnar artery presents an anatomical alternative to the radial artery and has emerged as a potential cannulation site. This study aims to comprehensively evaluate the suitability of the radial or ulnar artery for cannulation in pediatric patients.

Finding of this study objectives are

To obtain a large sample of pediatric patients from different age groups To measure arterial diameters using ultrasound at different angles and with ultrasound and to assess the optimal artery and the angle.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 or 2
* Patients scheduled for elective surgical procedures
* Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.

Exclusion Criteria:

* Patients over 10 years of age
* Patients with congenital anomalies or syndromic conditions
* Abnormal Allen Test
* Skin Erosion or infection at the cannulation site
* Hematoma at the cannulation site

Primary outcomes:
measure: Determining the Diameter and Depth at different angles
timeFrame: only once
measure: Comparing Ulnar and Radial Artery Diameters Across Age Groups
timeFrame: only once
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine
Study officials:
References:
Clinical trial NCT01328119: Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration
Official title: Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration; a Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uremic Toxins
Haemodynamic Stability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high. This may at least be partly due to the insufficient removal of (especially protein-bound) uremic toxins which have been associated with cardiovascular morbidity and mortality. It is unknown whether the combination of long-hour haemodialysis (HD) with convection increases the removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve haemodynamic stability which is an important factor in treatment quality. The investigators aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the haemodynamics between 4-hour and 8-hour HD and HDF.

Objectives: The primary aim is to study the removal of (especially protein-bound) uremic toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic response between 4-hour and 8-hour HD and HDF.


Eligibility criteria: Inclusion Criteria:

* prevalent conventional HD patients
* AV-fistula enabling double-needle vascular access with blood flow rate of at least 350 ml/min
* informed consent
* age more than 18 years

Exclusion Criteria:

* withdrawal of consent
* acute intercurrent illness (infection, malignancy, cardiovascular event, uncontrolled diabetes)

Primary outcomes:
measure: removal of uremic toxins
timeFrame: before dialysis and at 15,30,60,120,240 minutes (4-hour and 8-hour sessions) and at 360 and 480 minutes (8-hour sessions)
Secondary outcomes:
measure: haemodynamic response
timeFrame: every 30 minutes until end of dialysis
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
citation: Perl J, Chan CT. Home hemodialysis, daily hemodialysis, and nocturnal hemodialysis: Core Curriculum 2009. Am J Kidney Dis. 2009 Dec;54(6):1171-84. doi: 10.1053/j.ajkd.2009.06.038. Epub 2009 Sep 12. No abstract available.
Clinical trial NCT00189319: To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Official title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Tambocor
Paroxysmal Atrial Fibrillation
Quality of Life
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 200
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.


Eligibility criteria: Inclusion Criteria:

* In sinus rhythm at treatment initiation
* Experienced symptomatic AF episodes
* Left ventricular ejection fraction of at least 40%
* Females of child bearing potential must be using reliable method of contraception

Exclusion Criteria:

* Intolerance and/or failure of previous therapy with flecainide immediate release
* Currently receiving \>200mg/day flecainide immediate release
* Severe symptoms during episodes of arrhythmia
* History of other cardiac conditions/abnormalities
* Heart surgery within the last 2 months
* Renal failure
* Pregnant or lactating females
* Significant extra cardiac or systemic disease
* Abnormal electrolyte levels
* Receiving defined cardiac and/or other treatments

Primary outcomes:
measure: To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
Secondary outcomes:
measure: assessment of treatment success based on an efficacy/safety composite criterion;
measure: assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
measure: assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
measure: assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
measure: evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes).
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Cardiologique, Service de Cardiologique CHR de Lille
Study officials:
affiliation: Hopital Cardiologique, CHR de Lille, France
name: Salem Kacet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05170919: Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
Official title: An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Anorexia Nervosa with Significantly Low Body Weight
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 170
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: To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

Detailed description: Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

Eligibility criteria: Inclusion Criteria:

* • 18 years of age or older

  * Able to provide informed consent
  * Pathologically and/or clinically confirmed diagnosis of advanced cancer
  * At any point of treatment with standard chemotherapy\*

    o Scheduled to start, have discontinued or completed, or currently receiving
  * Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation

    o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).
  * Life expectancy of at least 4 months
  * Able to communicate well and comply with study requirements, including by phone and written logs

    * Patients on Dexamethasone will be allowed

Exclusion Criteria:

* • Abnormal liver function defined as \> twice upper limit of normal

  * Elevated QTc

    o EKG performed within 1 year of enrollment will be accepted
  * Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for \>70% of their primary source of daily calorie intake
  * Taking Marinol within 2 week of enrollment onto study

Primary outcomes:
measure: Weight
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life of patient
timeFrame: 6 months
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
Study officials:
References:
Clinical trial NCT04725019: Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
Official title: Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).


Eligibility criteria: Inclusion Criteria:

Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.

Exclusion Criteria:

* Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
* Current use of medications known to lower the seizure threshold
* Previous episode of unprovoked neurocardiogenic syncope
* Indwelling metal or incompatible medical devices
* Centrally-acting medications including anti-seizure medications
* Evidence of scalp disease or skin abnormalities
* Current medical illness unrelated to CP
* High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
* Severe spasticity
* Lack of asymmetry in hand function
* Orthopedic surgery in affected arm
* Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
* Currently receiving intrathecal baclofen
* History of broken arm (either arm) 1 year prior to study enrollment

Primary outcomes:
measure: Changes in the Assisting Hand Assessment
timeFrame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
measure: Changes in the Box and Blocks test
timeFrame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Secondary outcomes:
measure: Changes in Motor-evoked Potential assessment
timeFrame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06151119: 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
Official title: A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Myelofibrosis
Keywords: Myelofibrosis
positron emission tomography / computed tomography
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese people

Brief summary: To evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.

To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT.

Detailed description: This study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (Sensitivity, Specificity, Positive prediction rate, Negative prediction rate) of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
3. The expected survival time is over 3 months
4. Voluntarily sign informed consent.
5. Willing and able to follow the research protocol;
6. The subject must be able to lie on the scanning bed for 20 minutes;

Exclusion Criteria:

1. Known allergic history to 68Ga FAPI or its excipients;
2. Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
3. Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
4. pregnant and lactating women;
5. Workers who are exposed to radiation for a long period of time;
6. Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis;
7. Participating in other interventional clinical trials within 1 month before screening;
8. Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;
9. There are other circumstances that the researcher thinks are not suitable for participating in this study;

Primary outcomes:
measure: Sensitivity
timeFrame: Up to 24 months
measure: Specificity
timeFrame: Up to 24 months
measure: Positive prediction rate
timeFrame: Up to 24 months
measure: Negative prediction rate
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Bing Xu
state: Fujian
Study officials:
affiliation: The First Aiffiliated hosptical of xiamen University
name: Bing Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04151719: An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
Official title: An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 0
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: This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).


Eligibility criteria: Inclusion Criteria:

* Adult participants greater than or equal to (≥)18 years of age on the date the Informed Consent Form (ICF) is signed, with the capacity to provide voluntary informed consent.
* Enrolled in double-blind Study SAL-REL-2042 (NCT04083651) and completed an end of study (EOS) visit (Day 168) or completed Day 56 of the Study SAL-REL-2042 (NCT04083651).
* Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved ICF and provide authorization, as appropriate, for local privacy regulations.
* Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
* Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.

Exclusion Criteria:

* Concurrent therapy with any other investigational agent during the study.
* Current use of a peripherally acting mu-opioid-receptor antagonist.
* Current evidence of untreated brain metastasis(es).
* Diarrhea greater than Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
* Bowel obstruction.
* Advanced liver disease.
* Renal disease.
* Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Principal Investigator, would make the participant inappropriate for the study.

Primary outcomes:
measure: Overall Survival
timeFrame: From first MNTX dose administration until death from any cause (up to 4 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bausch Health Americas, Inc.
name: John Lahey
role: STUDY_DIRECTOR
References: