louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03357523: Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography
Official title: Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Lead sponsor: Afeka, The Tel-Aviv Academic College of Engineering
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2017-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler

Detailed description: This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.

Eligibility criteria: Inclusion Criteria:

1. Healthy males and females, between 23 and 45 years of age.
2. Willing to sign informed consent

Exclusion Criteria:

1. Currently smoking
2. Any abnormal skin condition in the area of light irradiation.
3. Pregnant having given birth less than 3 months ago, and/or breastfeeding.
4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
5. Having any illness that might affect the vasculature, such as diabetes (type I or II)
6. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
7. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Primary outcomes:
measure: Capillary blood flow
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Temperature distribution over hands measured by thermography
timeFrame: Up to 1 hour
measure: Tissue oxygenation (tcPO2)
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Afeka, Tel-Aviv Academic College of Engineering
Study officials:
affiliation: Afeka Tel Aviv Academic College of Engineering
name: Zehava Blechman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gavish L, Hoffer O, Rabin N, Halak M, Shkilevich S, Shayovitz Y, Weizman G, Haim O, Gavish B, Gertz SD, Ovadia-Blechman Z. Microcirculatory Response to Photobiomodulation-Why Some Respond and Others Do Not: A Randomized Controlled Study. Lasers Surg Med. 2020 Nov;52(9):863-872. doi: 10.1002/lsm.23225. Epub 2020 Feb 17.
Clinical trial NCT05238623: Imbalances of Regional Pulmonary Ventilation in Patients With Post-acute-COVID-19
Official title: Imbalances of Regional Pulmonary Ventilation in Patients With Post-acute-COVID-19 Symptoms
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Pneumonia
Post-acute COVID-19 Syndrome
Electric Impedance
Keywords: Electric Impedance
CT
Tomography
regional ventilation
post-acute-COVID-19 syndrome
post-COVID-19
EIT
electroimpedance tomography
long-COVID
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the post-COVID-19 outpatient clinic are screened.

Brief summary: Investigation of the correlation of CT-morphological changes of the lung compared to regional ventilation distribution on electrical impedance tomography in patients with post-acute-Covid-19 symptoms.

Detailed description: Prospective non-interventional, monocentric observational study on imbalances in regional lung ventilation compared to chest CT in post-acute-Covid-19. The aim is to verify the agreement between computerized tomography derived imaging variables and electrical impedance tomography in detecting lung ventilation imbalances. The primary study objective is to match CT morphological changes in regional ventilation in post-acute-COVID-19 patients and/or changes in lung function examination, with changes that can be visualized by electroimpedance tomography.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing a Chest CT due to suspected post-acute-Covid-19-syndrome
* \>18 years
* informed consent.

Exclusion Criteria:

* trauma patients and patients with unstable spinal injuries or fractures
* patients with an BMI over 50
* patients with uncontrolled body movements
* Patients with a pacemaker

Primary outcomes:
measure: Correlation between tomography and electroimpedance tomography
timeFrame: until May 2022
Secondary outcomes:
measure: Correlation between lung function testing and electroimpedance tomography
timeFrame: until May 2022
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Klinik für Notfallmedizin
state: Thuringia
Study officials:
affiliation: Jena University Hospital, Klinik für Innere Medizin IV
name: Phillip A Reuken, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00315523: Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
Official title: Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Levocetirizine
Xyzal
Rhinitis
Allergic
Seasonal
Ragweed
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-04-18
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.


Eligibility criteria: Inclusion Criteria:

* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
* Have used forbidden concomitant medications as defined by the protocol

Primary outcomes:
measure: Compare efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.
Secondary outcomes:
measure: Reduction in other SAR symptoms at different time points; Safety .
Other outcomes:
Locations:
city: Mississauga
country: Canada
state: Ontario
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Patel P, Patel D. Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. Ann Allergy Asthma Immunol. 2008 Sep;101(3):287-94. doi: 10.1016/S1081-1206(10)60494-2.
Clinical trial NCT03542123: Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
Official title: Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure Acute
Heart Failure
Keywords: Electrical Stimulation Therapy; Electrodes; Parasympathetic Nervous System; Sympathetic Fibers, Post Ganglionic; Congestive Heart Failure; Heart Failure
Lead sponsor: NeuroTronik Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.


Eligibility criteria: Inclusion Criteria:

* Normal sinus rhythm by ECG
* Men and women 21-75 years old
* Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV.

Exclusion Criteria:

* Systolic Blood Pressure \< 90 mmHg or \> 160 mmHg
* Current amiodarone therapy or any other antiarrhythmic therapy
* Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month
* Enzyme-positive MI within prior 1 month
* Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release)
* History of recent severe ventricular arrhythmias
* Pre-existing carotid artery or cerebral disease
* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
* Patients with prior vagalotomy
* Patients with current or prior vagal nerve stimulators
* Subjects with narrow angle glaucoma
* Renal failure - on dialysis or serum creatinine \> 2.0 mg/dl
* Hepatic failure - bilirubin, SGOT, or SGPT \> 4X upper limit of normal
* Patients with a life expectance \< 12 months per physician judgment
* Women who are pregnant
* Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
* Subjects unwilling or unable to provide consent for the protocol

Primary outcomes:
measure: Left ventricular pressure and volume
timeFrame: One hour
Secondary outcomes:
measure: Heart rate
timeFrame: One hour
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
References:
Clinical trial NCT06766123: Outcomes of Coronary Artery Bypass Grafting in Israeli Jews and Arabs
Official title: Outcomes of Coronary Artery Bypass Grafting in Israeli Jews and Arabs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CABG
Ethnic Group
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 7067
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing isolated CABG at Carmel medical center, Beilinson medical center and Soroka medical center at Israel

Brief summary: Retrospective study of adult patients with multivessel disease undergoing isolated CABG in three centers between January 1st, 2009, and December 31st, 2023. The primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE). Patients were grouped according to their ethnic origin, Arabs and Jews.


Eligibility criteria: Inclusion Criteria:

* isolated CABG

Exclusion Criteria:

* members of different HMO

Primary outcomes:
measure: MACCE
timeFrame: through study completion, a median of 78 months
Secondary outcomes:
measure: Mortality
timeFrame: through study completion, a median of 78 months
measure: MI
timeFrame: through study completion, a median of 78 months
measure: CVA
timeFrame: through study completion, a median of 78 months
measure: repeat revascularization
timeFrame: through study completion, a median of 78 months
measure: utilization of multi-arterial grafting
timeFrame: through study completion, a median of 78 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02434523: Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Official title: Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Laryngeal Diseases
Chronic Laryngeal Neuropathy
Keywords: laryngeal sensory neuropathy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: American Laryngological Association
First posted: 2015-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Detailed description: The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older and able to consent for themselves.
* Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
* Able to speak and read the English language.
* Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal reflux.
* Women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study.

Exclusion Criteria:

* Environmental allergies.
* Smoking within past 5 years.
* Using ginko bilboa (or unwilling to cease using it).
* Current upper respiratory infections.
* Use of narcotics (e.g. oxycodone, methadone).
* Any prior history of amitryptiline use.
* Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
* History of urinary retention.
* Any history of major depressive disorder.
* Any prior history of allergy to a tricyclic antidepressant.
* Current diagnosis of gastroesophageal reflux (GERD).
* For women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods).

Primary outcomes:
measure: Reflux Symptom Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Voice Handicap Index
timeFrame: 8 weeks
measure: Side Effects
timeFrame: 8 weeks
measure: Lost to Follow up
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: J. Pieter Noordzij, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01412723: Ferrous Sulfate Versus Iron Amino Acid Chelate
Official title: EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency
Keywords: Iron Deficiency
Child, Preschool
Dietary Iron
Ferrous sulfate
Bis-glycino iron II
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: Nutreva S.A.S.
name: Foundation Child Care - FAN
First posted: 2011-08-09
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide.

Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate.

It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.


Eligibility criteria: Inclusion Criteria:

Children who

* Belong to institute FAN in Medellín
* Attend full time to institute FAN (eight hours)
* Have 2 to 5 years inclusive
* Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)

Exclusion Criteria:

Children who

* Submit anemia (hemoglobin level equal to or less than 11 g/dL)
* Have not stool analysis before intervention

Primary outcomes:
measure: Ferritin
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Hemoglobin
timeFrame: Up to 8 weeks
measure: Infection
timeFrame: Daily. During 2 months of intervention
measure: Adverse reaction
timeFrame: Daily. During 2 months of intervention
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Universidad CES
state: Antioquia
Study officials:
affiliation: CES University
name: Ana M Herrera, PhD en Patología
role: STUDY_DIRECTOR
References:
Clinical trial NCT01274923: Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders
Official title: The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Low Intensity Shock Wave
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Medispec
First posted: 2011-01-12
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Detailed description: This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

Eligibility criteria: Inclusion Criteria:

* ED of more than 6 months
* Rigidity score ≥ 3 under PDE5i therapy
* SHIM ≤21 under PDE5i therapy
* Non- hormonal, neurological or psychological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Prior prostatectomy surgery
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region

Primary outcomes:
measure: International Index of Erectile function- Erectile Function Domain
timeFrame: At screening and 17 weeks later at last visit
Secondary outcomes:
measure: Rigidity scale
timeFrame: At screening and 17 weeks later at last visit
measure: Flow Mediated Dilatation Technique
timeFrame: At screening and 17 weeks later at last visit
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT03635723: Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)
Official title: Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Mobility Limitation
Keywords: Technology
Rehabilitation
Wearables
Breast surgery
Physical activity
Enhanced recovery after surgery
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 75
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 undergoing breast surgery.

Brief summary: This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.


Eligibility criteria: Inclusion Criteria:

* Breast or axillary surgery

Exclusion Criteria:

* Other diagnosed movement disorder
* Cannot consent due to language or capacity

Primary outcomes:
measure: Arm movements
timeFrame: Post-operative for 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Richard Kwasnicki
role: PRINCIPAL_INVESTIGATOR
References: