louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06495034: Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema
Official title: A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer-related lymphedema
airwave compression therapy
quality of life
Lead sponsor: Shantou Central Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).

Detailed description: This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;
* Female, ≥18 years old and ≤70 years old at the time of signing the ICF;
* Patients with unilateral breast cancer diagnosed by histopathology or cytology;
* No distant metastasis;
* To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;
* Have not received any treatment for arm lymphedema;
* No lymphangitis and other infections.

Exclusion Criteria:

* Breast malignancy derived from other tumors rather than the primary breast cancer;
* Patients with second primary tumor;
* Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;
* Have a history of mental illness or other reasons can not cooperate with treatment;
* Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;
* Patients using any medication that affects fluid or electrolyte balance.

Primary outcomes:
measure: Incidence of lymphedema
timeFrame: 18 months
Secondary outcomes:
measure: Symptoms
timeFrame: 18 months
measure: Quality of life assessment
timeFrame: 18 months
Other outcomes:
Locations:
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00577434: Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery
Official title: The Pharmacokinetics and Pharmacodynamics of a Single Dose of Pentobarbital for Clinically Indicated Sedation for Neonates, Infants, and Children Recovering From Open Heart Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Surgical Procedures
Keywords: Procedural sedation
Sedation for diagnostic imaging
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 37
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients enrolled in this study will be postoperative from cardiac surgery adn have require sedation for a procedure or diagnostic imaging.

Brief summary: This medication is used for procedural sedation and sedation for diagnostic imaging. The purpose of this study is to find out what happens to pentobarbital in the body after it is given to children who have had heart surgery.

Detailed description: This clinical trial of pentobarbital admistered as a bolus dose for procedural or imaging seddation will determine the PK of the drug in neonates, infants,, and children who are postoperative from cardiac surgery. Pediatric patients hsopitalized in the CICU who would receive IV bolus doses of pentobarbital as standard of care are eligible.

Eligibility criteria: Inclusion Criteria:

* Will receive intravenous pentobarbital for procedural/imaging sedation as standard of care
* Age(Neonates, Young Infants, Older Infants, and Children Up to 6 years old)
* Diagnosis either postop from cardiac surgery or requrie sedation with IV pentobarbital as standard of care
* Adequate liver function tests
* Informed consent

Exclusion Criteria:

* Pregnant or lactating females
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Athena Zuppa, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02350634: 18F-AV-1451 High Resolution Autopsy Study
Official title: A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 3
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.


Eligibility criteria: Inclusion Criteria:

* Projected life expectancy ≤ 6 months

Exclusion Criteria:

* Primary brain tumor, known metastases to the brain, central nervous system lymphoma
* Major, focal structural brain lesion
* Aggressively being treated with life sustaining measures
* Clinically significant infectious disease
* History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
* Have received or participated in a trial with investigational medications in the past 30 days
* Females of childbearing potential who are pregnant or not using adequate contraception

Primary outcomes:
measure: Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region
timeFrame: autopsy within 6 months of scan
measure: Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region
timeFrame: autopsy within 6 months of scan
measure: Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region
timeFrame: autopsy within 6 months of scan
measure: Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region
timeFrame: autopsy within 6 months of scan
measure: Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region
timeFrame: autopsy within 6 months of scan
measure: Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region
timeFrame: autopsy within 6 months of scan
measure: Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region
timeFrame: autopsy within 6 months of scan
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ushizima D, Chen Y, Alegro M, Ovando D, Eser R, Lee W, Poon K, Shankar A, Kantamneni N, Satrawada S, Junior EA, Heinsen H, Tosun D, Grinberg LT. Deep learning for Alzheimer's disease: Mapping large-scale histological tau protein for neuroimaging biomarker validation. Neuroimage. 2022 Mar;248:118790. doi: 10.1016/j.neuroimage.2021.118790. Epub 2021 Dec 20.
Clinical trial NCT05462834: Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
Official title: Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep-Disordered Breathing
Glucose Intolerance
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: PRISMA A.B.
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-07-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 intervention periods lasting 14 days, separated by a 7-day washout
Primary purpose: TREATMENT

Brief summary: Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations.

The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.


Eligibility criteria: Inclusion Criteria:

* Permanent residents of Puno, Peru

Exclusion Criteria:

* Recent travel to low altitude (\<3000 m)
* Oxygen use
* Pregnancy
* Morbid obesity (BMI \> 40 kg/m2)
* Current smoking
* Diabetes
* Other sleep disorders (e.g. circadian rhythm disorder or insomnia)
* Use of open fires in the home (i.e. for cooking or heat)
* Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation \< 85%, Qinghai CMS \>10 or excessive erythrocytosis as defined by hemoglobin \>19 g/dL in women or \>21 g/dL in men.

Primary outcomes:
measure: Mean glucose level
timeFrame: 14 days after start of intervention
Secondary outcomes:
measure: Mean fasting glucose level
timeFrame: 14 days after start of intervention
measure: Mean fasting insulin
timeFrame: 14 days after start of intervention
measure: Morning blood pressure
timeFrame: 14 days after start of intervention
measure: Inflammatory marker interleukin-6 (IL-6)
timeFrame: 14 days after start of intervention
measure: Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)
timeFrame: 14 days after start of intervention
measure: C-Reactive Protein (CRP) level in blood (mg/L)
timeFrame: 14 days after start of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Luu Pham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02705534: Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
Official title: Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Cirrhosis
Keywords: Hepatitis C
Cirrhosis
Sofosbuvir
Ledipasvir
Ribavirin
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Bakhtar Bioshimi Co
First posted: 2016-03-10
Enrollment: 50
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: TREATMENT

Brief summary: The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Detailed description: Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Eligibility criteria: Inclusion Criteria:

* Positive qualitative hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart

Exclusion Criteria:

* Renal failure \[estimated glomerular filtration rate (eGFR) \< 30 cc/min\],
* Model or End stage Liver Disease (MELD) score \> 20,
* Child's class C (score \> 12),
* Heart rate \< 50/min,
* Taking amiodarone

Primary outcomes:
measure: The sustained viral response rate
timeFrame: week 24 (12 weeks after end of treatment)
Secondary outcomes:
measure: Adverse drug events
timeFrame: week 2, 4, 8, 12, 24
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Reza Malekzadeh, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01436734: Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglucagonemia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.


Eligibility criteria: Inclusion Criteria:

* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria:

* HbA1c \>9 %
* Liver disease (ALAT/ASAT \>2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \>130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III og IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* pregnancy or lactation
* Fasting plasma glucose \>15 mM on screening day.

Primary outcomes:
measure: Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).
timeFrame: 120 min
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Mikkel Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02221817: Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis
Official title: Prospective, Randomized Trial of Ultrasound Guided and Blind Corticosteroid Injection for Trochanteric Bursitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bursitis
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trochanteric bursitis is a common condition, effecting 20% of the population. \\Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter.

The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. Accordingly, the use of corticosteroid injections has been shown to provide considerable relief. However, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. Fortunately, blind injections have yielded positive results in majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections.

Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. Fluoroscopy allows for bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of trochanteric bursitis
2. 18 years of age or older when written informed consent is obtained
3. Signed Institutional Review Board (IRB) approved informed consent form

Exclusion Criteria:

1. Allergy to triamcinolone or bupivicaine
2. Coagulopathy
3. Active Infection
4. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments

Primary outcomes:
measure: Pain Intensity Measured on Visual Analog Scale (VAS)
timeFrame: 3 month
Secondary outcomes:
measure: Disability Measured on Becks Disability Scale
timeFrame: Baseline, 2 weeks, 3 month
measure: Adverse Effects
timeFrame: 2 weeks, 3 month
measure: Pain Improvement
timeFrame: 2 weeks, 3 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
References:
Clinical trial NCT04121117: Usefulness of the Chronic Obstructive Pulmonary Disease-population (COPD-PS) Questionnaire and the COPD-6 Device in the Chronic Obstructive Pulmonary Disease Detection in a Tobacco Detoxication Consultation
Official title: Usefulness of the Chronic Obstructive Pulmonary Disease-population (COPD-PS) Questionnaire and the COPD-6 Device in the Chronic Obstructive Pulmonary Disease Detection in a Tobacco Detoxication Consultation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
COPD
Chronic obstructive pulmonary disease population questionnaire
COPD-PS
COPD-6
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 245
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smoker patients that are treated in the tobacco detoxication consultation

Brief summary: The aim of this study is to evaluate the usefulness of the chronic obstructive pulmonary disease-population questionnaire (COPD-PS) and the COPD-6 device in the early detection of chronic obstructive pulmonary disease in smoker patients .


Eligibility criteria: Inclusion Criteria:

* \> 35 years old
* Accumulative tobacco rate \> 10 paq-year that go to the tobacco detoxication consultation

Exclusion Criteria:

* Unable to fulfill the questionnarie
* Unable to adequately perform the COPD-6 or forced spirometry maneuvers included in the study.
* Reject to participate and sign the informed consent.

Primary outcomes:
measure: Evaluate the usefulness in the COPD early detection of the combination of the COPD-PS questionnaire and the COPD-6 device.
timeFrame: Up to 12 months after the first consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Agustín Valido Morales
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05020717: Retrospective Survey of Hyperkalemia in Hemodialysis
Official title: A Multicenter Retrospective Survey of Hyperkalemia Clinical Burden on Hemodialysis Facility-level in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis Complication
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-08-25
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HD centers in China

Brief summary: This study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level.

Detailed description: This study is an observational survey study. We estimate 300 hemodialysis (HD) centres will be enrolled in the study. Summarized data on serum potassium (sK) after long interdialytic interval (LIDI), facility practice pattern and patient characteristics which may be related with sK management, and death records information including number of deaths for each centre will be collected. All the data collected and analysed are on HD facility level, not on patient-level. We are aiming to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level. Association between sK management and long-term outcome will also be explored.

Eligibility criteria: Inclusion Criteria:

-

For HD centers:

* ≥ 100 patients under MHD within 3 years prior the study initiation
* Willing to participate in the study
* Have routine blood collection after LIDI
* Have death records

For HD patients:

• On chronic HD for ≥ 3 months

Exclusion Criteria:

* Blood test on other days than those after LIDI
* Unable to provide detailed data required by study protocol
* Being unable to comply with study-specified procedure

Primary outcomes:
measure: To investigate the risk factors associated with hyperkalemia clinical burden on HD facility level
timeFrame: 3 years
Secondary outcomes:
measure: To describe hyperkalemia clinical burden on HD facility level
timeFrame: 3 years
measure: To describe sK management pattern on HD facility level
timeFrame: 3 years
measure: To investigate the risk factors associated with crude mortality on HD facility level
timeFrame: 3 years
Other outcomes:
measure: To investigate the risk factors associated with sK > 6.0 mmol/L and sK > 6.5 mmol/L on HD facility level
timeFrame: 3 years
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Li Zuo
role: PRINCIPAL_INVESTIGATOR
References: