louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05158283: Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Official title: Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Ischemia
Keywords: Chocolate balloon
infrapopliteal artery
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 144
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: This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.

Detailed description: Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.

Eligibility criteria: Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.

Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.

Primary outcomes:
measure: 12-month Primary Patency Rate
timeFrame: 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 day
measure: freedom from clinically-driven TLR rate
timeFrame: 12 months
measure: Major Adverse Events at 12-month Post Procedure
timeFrame: 12 months
measure: 12-month Limb Salvage Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gu Yong Quan
state: Beijing
Study officials:
References:
Clinical trial NCT01344083: Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Conjunctivitis
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Conjunctivitis allergic conjunctivitis

Exclusion Criteria:

* Severe ocular allergy
* Vernal keratoconjunctivitis

Primary outcomes:
measure: Change from baseline of the score of tearing
timeFrame: Day 28
measure: Change from baseline of the score of itching
timeFrame: Day 28
measure: Change from baseline of the score of conjunctival hyperaemia
timeFrame: Day 28
Secondary outcomes:
measure: Global local tolerance assessment by the Investigator and the patient
timeFrame: Day 7
measure: Global local tolerance assessment by the Investigator and the patient
timeFrame: Day 28
Other outcomes:
Locations:
city: Clermont ferrand
country: France
facility: Pierre Huguet
Study officials:
References:
Clinical trial NCT01679483: Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
Official title: THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Fallopian Tubal Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2012-09-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
* FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
* Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
* Patients with adequate bone marrow, renal and hepatic function:

WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal

* American Society of Anesthesiology Physical Status 0-1
* Performance status of ECOG 0-2
* Patient must be suitable candidates for surgery
* Patients who have signed an approved Informed Consent

Exclusion Criteria:

* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant
* Patients with contraindications to surgery;
* Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patient's compliance and geographic proximity that do not allow adequate follow-up.
* Patients who undergo only lymph node sampling

Primary outcomes:
measure: Incidence of lymphocele an lymphatic ascites
timeFrame: within 1 year after surgery
Secondary outcomes:
measure: Time interval from surgery to removal of closed drain system
timeFrame: with 2 weeks after surgery
measure: Postoperative drain amount
timeFrame: with 2 weeks after surgery
measure: Postoperative hospital stay
timeFrame: within 2 weeks after surgery
measure: Postoperative bleeding incidence
timeFrame: within 2 weeks after surgery
measure: Postoperative complication incidence
timeFrame: within 1 month after surgery
measure: Quality of life
timeFrame: within 1 year after surgery
measure: 2-year disease free survival and overall survival
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01225783: The Validity and Reliability of Self Measurement of Upper Limb Volume
Official title: The Validity and Reliability of Self Measurement of Upper Limb Volume in Treating Lymphedema in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Limb Volume Measurement
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Lymphedema is a common, chronic, side effect resulting from the treatment of breast cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted conservative treatment is based on the anatomy and physiology of the lymphatic system. The aim of the treatment is to reduce the volume of the upper limb by, initial, intensive treatment and then to keep the arm volume at this reduced level.The measurement of limb volume involves measuring the circumference of the arm at defined points and then with the use of a formula the volume of the arm can be calculated. After intensive therapy is complete the responsibility for measuring limb volume moves to the patient. This study will examine the reliability and validity of self measurement of limb volume. The investigators will compare the results of self measurement using the accepted plastic tapemeasure against a paper tape measure adapted for self measurement.Both methods will be compared to the "gold standard volume displacement. In the study there will be two meetings with the subjects where the patient and physiotherapist will use the three methods.


Eligibility criteria: Inclusion Criteria:

* Women with arm edema after breast cancer who are being conservatively treated by a physiotherapist.

Exclusion Criteria:

* Active malignant disease

Primary outcomes:
measure: Comparison of self measurement of limb volume to water displacement
timeFrame: 2 years
measure: validity of self measurement
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rechovot
country: Israel
facility: Remez Health center
Study officials:
References:
Clinical trial NCT06570083: Mobile-Based Intervention to Promote Physical Activity Among the Elderly
Official title: Mobile-Based Intervention to Promote Physical Activity Among the Elderly With Chronic Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mobile Health
Physical Activity
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention among elderly individuals with chronic diseases.

Detailed description: Promoting physical activity among elderly individuals is an increasingly critical public health priority. Regular exercise is essential for maintaining mobility, enhancing mental well-being, and reducing the risk of exacerbating chronic conditions. However, many elderly individuals encounter significant barriers, including physical limitations, lack of motivation, and restricted access to safe environments.

This mobile phone-based intervention seeks to address these challenges by offering accessible support through age-appropriate exercise routines, motivational prompts, and educational content delivered directly to participants' mobile devices. The intervention's primary objective is to reduce sedentary behavior, increase physical activity levels, and ultimately enhance the overall health and well-being of elderly individuals with chronic diseases.

Eligibility criteria: Inclusion Criteria:

1. Age ≥60 years and diagnosed with at least one chronic disease
2. Owns a smartphone and is proficient in using WeChat
3. Daily sedentary time ≥6 hours

Exclusion Criteria:

1. recent surgeries, injuries, or other conditions that would prevent simple physical activity
2. hearing, vision, or physical disabilities

Primary outcomes:
measure: Time spent in sedentary behavior
timeFrame: 3 and 6 months follow-up
measure: Acceptability of the Mobile Phone-Based Intervention
timeFrame: 3 and 6 months follow-up
measure: Perceived Usefulness of the Mobile Phone-Based Intervention
timeFrame: 3 and 6 months follow-up
Secondary outcomes:
measure: Time spent in zero-time exercise
timeFrame: 3 and 6 months follow-up
measure: Exercise self-efficacy
timeFrame: 3 and 6 months follow-up
measure: Anxiety and depression
timeFrame: 3 and 6 months follow-up
measure: Perceived subjective happiness
timeFrame: 3 and 6 months follow-up
measure: Perceived life satisfaction
timeFrame: 3 and 6 months follow-up
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Beijing Normal University
state: Guangdong
Study officials:
References:
Clinical trial NCT02118883: Dehydration, Rehydration, and Blood Viscosity
Official title: Randomized, Double-blind, Parallel Arm Study of the Effect of Essentia Water, an Electrolyzed High-pH Bottled Water, on Serial Blood Viscosity and Other Hydration Biomarkers in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Keywords: exercise
hydration
dehydration
rehydration
alkaline water
blood viscosity
plasma osmolality
bioimpedance
Lead sponsor: Essentia Water, LLC
Sponsor class: INDUSTRY
Collaborators: name: Health Onvector Inc.
First posted: 2014-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine and compare the rehydration effect of Essentia Water, an electrolyzed high-pH bottled water, with industry-standard bottled water purified by reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3) bioelectrical impedance analysis, and (4) body mass change, using serial measurements in apparently healthy adults following exercise-induced dehydration in a controlled environment.


Eligibility criteria: Inclusion Criteria:

* Free from any medication for at least 1 week prior to the study

Exclusion Criteria:

* Any chronic condition requiring regular treatment or medical follow-up
* Bleeding disorder or susceptible to prolonged or uncontrolled bleeding
* Active infection
* Current smoker
* Subject has a BMI equal or greater than 30
* Use of oral contraceptives in the previous 3 months
* Subject is pregnant or breast-feeding
* Currently menstruating

Primary outcomes:
measure: Change in whole blood viscosity from dehydrated state
timeFrame: 120 min following rehydration
Secondary outcomes:
measure: Change in whole blood viscosity from dehydrated state
timeFrame: 15, 30, 60, and 90 min following rehydration
measure: Change in plasma osmolality from dehydrated state
timeFrame: 15, 30, 60, 90, and 120 min following rehydration
measure: Change in bioelectrical impedance
timeFrame: 45, 75, and 120 min following rehydration
measure: Body mass change
timeFrame: 45, 75, and 120 min following rehydration
Other outcomes:
Locations:
city: Camden
country: United States
facility: Health Onvector Inc
state: New Jersey
Study officials:
affiliation: A.J. Drexel Plasma Institute
name: Gregory Fridman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155428: Biomodel in Tetralogy of Fallot
Official title: Application of Biocardiac Model in Total Correction of Tetralogy of Fallot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tetralogy of Fallot
Keywords: biomodel
rapid prototyping
computed tomograpgy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Detailed description: Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Eligibility criteria: Inclusion Criteria:

Tetralogy of Fallot

Primary outcomes:
measure: diagnostic accuracy
Secondary outcomes:
measure: sensitivity
measure: specificity
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dept. Medical Imaging, NTUH
Study officials:
affiliation: Dept. Medical Imaging, NTUH
name: Shyh-Jye Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570828: Thermal Imaging in Neonates: A Feasibility Study in Healthy Babies and Babies With Suspected TTN
Official title: Thermal Imaging in Neonates: a Feasibility Study in Healthy Babies and Babies With Suspected Transient Tachypnea of the Newborn (TTN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thermal Imaging, Neonatal Pneumonia, Tachypnea
Keywords: healthy neonate, tachypnea, thermal imaging, pneumonia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 25
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a study to evaluate thermal imaging as a technology to monitor the normal clearing of amniotic fluid from healthy newborns and newborns suspected of having a condition called transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a non-identifiable image based on the heat pattern of an object. In this case, the object is a child's chest and back. It does not emit any radiation like an x-ray does.


Eligibility criteria: Inclusion Criteria (healthy and suspected TTN babies):

* Full term (greater than or equal to 37 weeks gestation)
* less than 3 days old
* born via normal vaginal delivery

Inclusion Criteria (only for suspected TTN babies):

* neonatologist assesses baby as possibly having TTN
* chest x-ray done as part of evaluation for TTN
* no other significant co-morbid conditions present

Exclusion Criteria:

* parents do not consent to have baby participate

Primary outcomes:
measure: asymmetric heat distribution
timeFrame: within the first 3 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Patricia L Hibberd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02855528: Tin Filter Calcium Scoring
Official title: Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dose Reduction
Keywords: Tin Filter
Coronary Artery Calcium Scoring
Radiation dose reduction
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.


Eligibility criteria: Inclusion Criteria:

* Subject must be between 19-90 years of age.
* Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
* Subject must provide written informed consent prior to any study-related procedures being performed.
* Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

* Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
* By testing (urine BHCG) within 24 hours before scan, or
* By surgical sterilization, or
* Post menopausal, with minimum one (1) year history without menses.
* Subject has an acute psychiatric disorder or is cognitively impaired.
* Subject is using or is dependent on substances of abuse.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject is in acute unstable condition.

Primary outcomes:
measure: Reduction in radiation dose using the new tin-filter system
timeFrame: 2 years
measure: Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Joseph U. Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311961: Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Exacerbations
Corticosteroids
Oral
Intravenous
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2006-04-07
Enrollment: 256
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.

The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.


Eligibility criteria: Inclusion Criteria:

* Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] severity stage II)
* Smoking history of \> 10 pack years

Exclusion Criteria:

* Signs of severe exacerbation (arterial pH \< 7.26 or pCO2 \> 9.3 kPa)
* History of asthma
* Significant or unstable co-morbidity
* Participated in another study 4 weeks before admission
* Previously randomized to this study
* Findings on chest radiography other than those fitting with signs of COPD
* Known hypersensitivity to prednisolone
* Non-compliant

Primary outcomes:
measure: Treatment failure defined as: death from any cause
measure: admission to the intensive care unit
measure: readmission to the hospital because of COPD
measure: and the necessity to intensify pharmacologic treatment
Secondary outcomes:
measure: Changes in forced expiratory volume in 1 second (FEV1)
measure: St. George's Respiratory Questionnaire (SGRQ) scores
measure: Clinical COPD Questionnaire (CCQ) scores
measure: and length of hospital stay
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
Study officials:
affiliation: Isala
name: Jan WK van den Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala
name: Ynze P de Jong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Jong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HA, van den Berg JW. Oral or IV prednisolone in the treatment of COPD exacerbations: a randomized, controlled, double-blind study. Chest. 2007 Dec;132(6):1741-7. doi: 10.1378/chest.07-0208. Epub 2007 Jul 23.