louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06864923: The Effect of Hot Foot Bath on Sleep Quality and Fatigue
Official title: Investigation of the Effect of Hot Foot Bath on Sleep Quality and Fatigue
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatitis B
Keywords: fatigue
sleep quality
foot bath
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.


Eligibility criteria: Inclusion Criteria:

* being over the age of 18,
* having no disorder which could affect pain perception,
* having no communication problem, and voluntarily agreeing to participate in the research,
* Having been admitted to the clinic at least 24 hours ago,
* Not having a diagnosed sleep disorder,
* Not having a psychiatric disorder requiring treatment,
* Not having a problem with vital signs before the application,
* Not using narcotic drugs in the last 4 hours,
* Not eating two hours before going to bed at night

Exclusion Criteria:

* being under the age of 18
* not being conscious, refusing to participate in the research or opting to leave the study at any point,
* Having a problem with vital signs before the application,
* Having a diagnosed sleep disorder.

Primary outcomes:
measure: fatigue severity in score (0-10)
timeFrame: 4 months
measure: Sleep Quality in score
timeFrame: 4 months
Secondary outcomes:
measure: weight
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02340923: A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
Official title: A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Keywords: DMD
Duchenne Muscular Dystrophy
EIM
Lead sponsor: Skulpt, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2015-01-19
Enrollment: 327
Sex: MALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Duchenne Muscular Dystrophy Subjects

Brief summary: The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.


Eligibility criteria: Duchenne Muscular Dystrophy:

Inclusion Criteria:

* 1. Age 0-18
* 2. Male
* 3. Genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member.

Exclusion Criteria:

* 1. Age over 18
* 2. Female
* 3. Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.

Primary outcomes:
measure: Electrical Impedance Myography Measurements
timeFrame: Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Skulpt, Inc.
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
References:
citation: Leitner ML, Kapur K, Darras BT, Yang M, Wong B, Dalle Pazze L, Florence J, Buck M, Freedman L, Bohorquez J, Rutkove S, Zaidman C. Electrical impedance myography for reducing sample size in Duchenne muscular dystrophy trials. Ann Clin Transl Neurol. 2020 Jan;7(1):4-14. doi: 10.1002/acn3.50958. Epub 2019 Dec 25.
Clinical trial NCT04316923: Analysis of Cardiac Biomarkers, ECG and CPET Results in Children With Cardiomyopathies
Official title: Analysis of Cardiac Biomarkers, Electrocardiograms and Cardio-pulmonary Exercise Test (CPET) Results in Children With Dilated (DCM), Hypertrophic (HCM) and Left-ventricle Non-compaction (LVNC) Cardiomyopathies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathies
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will consist of children aged 0-18 years that have been diagnosed with DCM, HCM or LVNC who are under the care of our Deparment.

The control group will be composed of 30 healthy children, in whom heart disease will be excluded using echocardiography.

Brief summary: The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.

Detailed description: The study group will consist of children that have been diagnosed with DCM, HCM or LVNC. The control group will be composed of healthy children. Examination of cardiac biomarkers (in the study group), ECG, 24-hour- ECG monitoring, CPET will be performed.

Patients in the study group will be invited for 2 consecutive visits (in 6-10 months intervals). During the first and the last visit CPET will be performed. The control group will not be invited for consecutive visits.

Eligibility criteria: Inclusion Criteria:

* Children with HCM, DCM, LVNC diagnosed in 2D echo.
* Healthy children with no congenital heart disease (CHD) in 2D echo.
* Patients who signed consent form.

Exclusion Criteria:

* Patients with coexisting CHD, kidney and liver disfunction, taking anti-psychotic and anti-depressant medication, or patients with bundle bunch blocks in ECG.
* no consent form signed.

Primary outcomes:
measure: Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children.
timeFrame: 14 months
measure: Assessment of differences in CPET results in children with cardiomyopathies and healthy children.
timeFrame: 14 months
Secondary outcomes:
measure: Assessment of progression of heart failure in children with cardiomyopathies
timeFrame: 20 months
measure: Assessment of arrhythmia in time in children with cardiomyopathies
timeFrame: 20 months
measure: Assessment of changes in CPET results in children with cardiomyopathies
timeFrame: 20 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical Univeristy of Warsaw
Study officials:
affiliation: Medical Univeristy of Warsaw, Poland
name: Katarzyna M Luczak-Wozniak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00414323: Evaluation of the Effects of Duloxetine on Norepinephrine
Official title: Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.


Eligibility criteria: Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.

Primary outcomes:
measure: Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state).
Secondary outcomes:
measure: Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure.
measure: Effect of duloxetine versus escitalopram on heart rate variability.
measure: Ratio of duloxetine exposure in plasma to CSF at steady state.
measure: Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma.
Other outcomes:
Locations:
city: Glendale
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: San Antonio
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02308423: Clinical and Radiologic Follow up of Subchondral Fractures of the Glenoid
Official title: Clinical and Radiologic Follow up of Subchondral Fractures of the Glenoid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subchondral Fractures of the Glenoid
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients 18-80 yo who had subchondral fractures of the glenoid

Brief summary: in this study the investigators will call patients who had Subchondral fractures and treated in our department over the last 20 years.

The investigators will evaluate their shoulder function by a questionary, Constant score and radiologic evaluation.

Detailed description: Patient evaluation by:

- Physical examination, questionary Constant score: Pain (severe, moderate, mild, non), activity level (sleep affected/sport limitations/daily living limitations/arm positioning) and range of motion (forward flexion/lateral elevation, internal and external rotation).

- Radiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score.

Eligibility criteria: Inclusion Criteria:

* Any man or women who had subchondral fractures of the glenoid

Exclusion Criteria:

* Pregnant women
* Children

Primary outcomes:
measure: Function disability of the shoulder
timeFrame: 20 years
Secondary outcomes:
measure: Measurement of degenerative changes of the gleno-humeral joint.
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01022723: Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells
Official title: Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Circulating tumor cells
metastasis
cancer
cell isolation
mircofludics
cell detection
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: National University of Singapore
First posted: 2009-12-01
Enrollment: 817
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the following cancers:

Lung Cancer Nasopharyneal carcinoma Breast cancer Prostate cancer Colorectal cancer Gastric cancer

Brief summary: To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

Detailed description: * Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types
* Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method
* Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression
* Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
* Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
* Informed consent given for the purposes of blood sampling for this study
* Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types
timeFrame: 3 years
Secondary outcomes:
measure: Characteristics and viability of the CTC with this capture method
timeFrame: 3 years
measure: Clinical application of this capture method with the study of CTC titre correlation to treatment outcome
timeFrame: 6 years
measure: Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics
timeFrame: 6 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre
Study officials:
affiliation: National Cancer Centre, Singapore
name: Wan-Teck Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03243123: Upper Limb Robotic Rehabilitation After Stroke
Official title: Passive Mobilization With Robotic Assistance Improve Hemiparetic Upper Limb Circulation and Functional Status in Stroke Survivors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm study aimed at evaluating the acute effects induced by a single session of robot-assisted passive hand mobilization on local perfusion and upper limb function in post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke received 20 min passive mobilization of the paretic hand with robotic assistance. After the intervention, significant improvements were found in forearm perfusion, muscle tone significantly decreased and subjects reported decreased upper limb heaviness, stiffness and pain. This study supports novel evidence that hand robotic assistance promotes local forearm circulation, may help in the management of spasticity and acutely alleviates reported symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.


Eligibility criteria: Inclusion Criteria:

* first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position

Exclusion Criteria:

* bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.

Primary outcomes:
measure: Forearm perfusion
timeFrame: 30 minutes
measure: Muscle tone
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gobbo M, Gaffurini P, Vacchi L, Lazzarini S, Villafane J, Orizio C, Negrini S, Bissolotti L. Hand Passive Mobilization Performed with Robotic Assistance: Acute Effects on Upper Limb Perfusion and Spasticity in Stroke Survivors. Biomed Res Int. 2017;2017:2796815. doi: 10.1155/2017/2796815. Epub 2017 Sep 28.
Clinical trial NCT04001023: Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
Official title: Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Carcinoma
Hypoxia
Keywords: advanced ovarian cancer
EF5-PET/CT
hypoxia
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient.

A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.

Detailed description: MORE SPECIFIC AIMS

1. To validate the feasibility of PET-tracer EF5 in EOC imaging.

   * Quantify the amount and exact locations of hypoxic tumors in EOC patients using herein developed protocol and tracers (18F-EF5 and 18F-FDG) in diagnostic and neoadjuvant settings.
   * Measure the non-cancer related EF5 accumulation spots and establish the potential pitfalls in abdominal EF5 imaging
   * Establish a method to verify hypoxic locations with 18F-EF5-PET/CT information during the operation.
   * Develop and validate a model that predicts chemotherapy response based on functional imaging information.
2. To reveal hypoxia related alterations in collected tissue samples (i.e. altered DNA damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)

Eligibility criteria: Inclusion Criteria:

* newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
* age 18-79 years
* informed concent

Exclusion Criteria:

* previous cancer
* pregnancy or nursing

Primary outcomes:
measure: 18F-EF5 maximum standardized uptake values (SUVmax)
timeFrame: 2-3 years
Secondary outcomes:
measure: Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue
timeFrame: 2-3 years
measure: Disease-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University hospital
Study officials:
References:
Clinical trial NCT06919523: Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites
Official title: Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Refractory Ascites
Keywords: Refractory ascites
Dapagliflozin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 70
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 aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as:

Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
* Refractory ascites defined as one of the following:

  1. Ascites cannot be mobilized despite adherence to low sodium diet of ≤88 mmol/day for ≥1 week and maximum diuretic treatment dose (spironolactone 400 mg/day or furosemide (160 mg/day).
  2. Recurrence can't be prevented by medical therapy, Re-appearance of grade 2 or moderate ascites with moderate symmetrical abdominal distention, or grade 3 with massive ascites with marked abdominal distention within 4 weeks of initial mobilization.

Exclusion Criteria:

* Presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment.
* History of recurrent urinary tract infections, defined by the occurrence of 2 or more acute UTIs within months or 3 within a year.
* History of hypersensitivity to SGLT2 inhibitors.
* History of diabetic ketoacidosis or presence of risk factors for DKA (i.e alcohol consumption, type 1 diabetes).
* Pregnant or lactating women.
* History of recurrent episodes of hypoglycemia defined as plasma glucose concentration \<70mg/dL.
* Severe renal dysfunction defined as, eGFR \<20 ml/min/1.73m2.

Primary outcomes:
measure: Difference in ascites control between the two groups at the end of treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: