louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03997461: Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device
Official title: Comparison of Arterial Tonometry Sensor (BPro) With Standard Oscillometric Blood Pressure Monitoring Device (Oscar 2) for Ambulatory Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood Pressure
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2019-06-25
Enrollment: 33
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions

Detailed description: The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions. Measurements will be taken at 15 minutes intervals during the day and 30 minutes intervals during the night.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent

Exclusion Criteria:

* Difference in blood pressure between the arms higher than 10 mmHg

Primary outcomes:
measure: Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices
timeFrame: 24 hours
measure: Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Institute for Biological and Medical Engineering
state: Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Maria Rodriguez Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652661: Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics
Official title: Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dexmedetomidine
Midazolam
MRI
Pediatrics
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes:

Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
Primary purpose: OTHER

Brief summary: An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.

Detailed description: This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.

Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:

Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Eligibility criteria: Inclusion Criteria:

Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.

Exclusion Criteria:

1. Patient's guardian refusal.
2. Body mass index \>30 kg/m2
3. Known allergy to dexmedetomidine or midazolam.
4. Suspected difficult airway.
5. Upper respiratory tract infection
6. Anatomical structural deformity of the nasal cavity.
7. Severe liver or renal impairment.
8. Severe bradycardia or atrioventricular block above II degree type 2.
9. Administration of digoxin or beta blockers

Primary outcomes:
measure: The incidence of successful sedation
timeFrame: One hour
Secondary outcomes:
measure: The onset time of sedation
timeFrame: One hour
measure: The occurrence of Adverse effects
timeFrame: One hour
measure: The degree of operator satisfaction
timeFrame: One hour
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT06815861: Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B)
Official title: Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adult Scoliosis
Spine Deformity
Neurosurgery
Keywords: adult scoliosis
spine deformity
neurosurgery
spine surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital

Brief summary: Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. This retrospective study, conducted at Brest University Hospital since 2017, aims to analyze these complications to provide a detailed assessment, particularly since the introduction of the OARM (intraoperative CT navigation), with the goal of optimizing the safety and effectiveness of surgical interventions. The complications studied include neurological, infectious, mechanical, and cardiopulmonary complications, along with an additional "other" category for rare complications. The period analyzed extends from the immediate postoperative phase to the most recent follow-up consultation with the referring surgeon, which varies depending on the duration of follow-up for each patient.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient affiliated with a social security system
* Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital

Exclusion Criteria:

Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of scoliosis surgery performed by another surgeon, regardless of the center or year

Primary outcomes:
measure: Number of postoperative complications
timeFrame: at the time of inclusion
Secondary outcomes:
measure: ODI SORE
timeFrame: at the time of inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT05436561: Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies
Official title: A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Disease-free Survival
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 61
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \>=55 years.

Detailed description: Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \>=55 years.

Eligibility criteria: Inclusion Criteria:

* Age 55-65
* patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors.
* patients with AML in remission, or MDS in any stage, or CMML in any stage
* inform consent provided

Exclusion Criteria:

* patients with abnormal liver (\>3N), renal (1.5N) or cardiac function
* patients with active infection

Primary outcomes:
measure: disease-free survival
timeFrame: 2 year
Secondary outcomes:
measure: overall survival
timeFrame: 2 year
measure: GVHD and relapse free survival
timeFrame: 2 year
measure: Non-relapse mortality
timeFrame: 2 year
measure: Relapse
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai No 6 Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jiong Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03192683: Modified "Providence" Pedi Cast-Sling vs.Cast and Sling
Official title: Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Pediatric ALL
Lead sponsor: Lifespan
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 71
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.


Eligibility criteria: Inclusion Criteria:

* patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call
* patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast.

Exclusion Criteria:

* open fractures
* fractures at multiple levels (e.g. wrist AND elbow fracture)
* fractures requiring immediate/urgent surgery
* patients requiring admission for any reason
* bivalved LAC's for any reason

Primary outcomes:
measure: Patient satisfaction scores
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02826083: Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia
Official title: Randomized, Double-blind Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia and on Lipoprotein Kinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with XXS in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.


Eligibility criteria: Inclusion Criteria:

* Persons who have provided written consent
* Persons aged over 18 years
* Presenting LDL levels between 1.30 and 1.90 g/l and/or triglyceride levels between 1.5 and 3 g/l

Exclusion Criteria:

* Persons without national health insurance cover
* Pregnant or breastfeeding women
* Adults under guardianship
* Patients with diabetes (Insulin-Dependent Diabetes (IDD) or Non-Insulin-Dependent Diabetes NIDD)
* Patients with coronary artery disease
* Patients with atherosclerosis
* HDL\>0.80 g/l
* receiving treatment with lipid-lowering agents (statins, fibrates, ezetimibe or Ω3)
* Consuming vitamin supplements (A, C, E...)
* Consuming oligoelements or minerals (Se, Zn, Ca...)
* Renal insufficiency (creatinine clearance \< 30 ml/min calculated according to the Modification of the Diet in Renal Disease (MDRD))

Primary outcomes:
measure: Quantification of Malondialdehyde (MDA)
timeFrame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
measure: Quantification of oxidized Low Density Lipoprotein (LDL)
timeFrame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Secondary outcomes:
measure: Measure of overall free-radical defences in the blood by KRL Kyrial Internationaltest
timeFrame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Other outcomes:
measure: Quantification of LDL
timeFrame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
measure: Quantification of High Density Lipoprotein (HDL)
timeFrame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT01106183: Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults
Official title: A Double Blind Study on the Efficacy of a Colostrum and Egg Yolk Supplement vs. Placebo to Reduce Frequency and Duration of Upper Respiratory Tract Infections in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections Due to Influenza or Rhinovirus
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of our study are to critically evaluate if a healthy population supplemented with Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. In this study we will give either Transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. The frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. Saliva samples will be collected weekly and assessed for salivary IgA secretion rate. Data from this study will establish the efficacy of Transfer Factor to support a healthy immune system.


Eligibility criteria: Inclusion Criteria:

* Males and females (18 - 40) who are in good health

Exclusion Criteria:

* Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of \>12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT05705583: A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
Official title: A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cell Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with renal cell carcinoma

Brief summary: Immune checkpoint inhibitors targeting PD-1 or PD-L1 have been developed and clinical trials showning better response in unselected patients with metastatic renal cell carcinoma (RCC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 RCC responsiveness. The objective of this study is to develop and evaluate the utility of circulating exosomes as companion diagnostic biomarker for predicting response to immunotherapy in patients with RCC.


Eligibility criteria: Inclusion Criteria:

* Advanced Metastatic RCC
* Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
* Age \>= 18 years
* Able to provide informed consent

Exclusion Criteria:

* Other, unrelated, concomitant active, invasive malignancy

Primary outcomes:
measure: The correlation between the circulating exosomes levels and the tumor responsiveness
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: An Zhao
Study officials:
References:
citation: Wang H, Zhu Z, Zhang Y, Jiang T, Zhang M, Wang Z, Zhang Y, Zhao A, Su B. New insight into immune checkpoint inhibitors in the treatment of advanced renal cell carcinoma. Sci China Life Sci. 2023 Apr;66(4):875-878. doi: 10.1007/s11427-022-2197-7. Epub 2022 Dec 1. No abstract available.
citation: Yu M, Liu X, Xu H, Shen S, Wang F, Chen D, Li G, Wang Z, Zuo Z, Zhao A. Comprehensive Evaluation of the m6A Regulator Prognostic Risk Score in the Prediction of Immunotherapy Response in Clear Cell Renal Cell Carcinoma. Front Immunol. 2022 Jun 17;13:818120. doi: 10.3389/fimmu.2022.818120. eCollection 2022.
citation: Zhang W, Ni M, Su Y, Wang H, Zhu S, Zhao A, Li G. MicroRNAs in Serum Exosomes as Potential Biomarkers in Clear-cell Renal Cell Carcinoma. Eur Urol Focus. 2018 Apr;4(3):412-419. doi: 10.1016/j.euf.2016.09.007. Epub 2016 Oct 14.
Clinical trial NCT03560583: Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients
Official title: Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients: a Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Poor Responders in IVF
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Poor ovarian response population of ART are considered the biggest challenge for providers. Hitherto, no one protocol has been proven to be effect in this subgroup of IVF patients.

Metoclopramide belongs to the antiemetic group, used for motion sickness and during early gestation for hyperemesis gravidarum.

The mechanism of action is antagonisim to dopamine receptors. We hypothesize than by blocking dopamine receptors and decreasing the dopaminergic tone there is a possibility to increase the sensitivity of ovarian response to gonadotropins during controlled ovarian stimulation and result in increased oocyte retrival.


Eligibility criteria: Inclusion Criteria:

* Poor response according to "Bologna criteria"

Exclusion Criteria:

* Allergy to metoclopramide
* Prolactinemia
* Women treated with dopamine agonists

Primary outcomes:
measure: Number of oocytes
timeFrame: Approximately 5 weeks from first dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai University Medical Center
state: Ashkelon District
Study officials:
affiliation: Barzilai Medical Center
name: Leon Grin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boelig RC, Barton SJ, Saccone G, Kelly AJ, Edwards SJ, Berghella V. Interventions for treating hyperemesis gravidarum: a Cochrane systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2018 Sep;31(18):2492-2505. doi: 10.1080/14767058.2017.1342805. Epub 2017 Jul 11.
citation: Hernandez I, Parra A, Mendez I, Cabrera V, Cravioto MC, Mercado M, Diaz-Sanchez V, Larrea F. Hypothalamic dopaminergic tone and prolactin bioactivity in women with polycystic ovary syndrome. Arch Med Res. 2000 Mar-Apr;31(2):216-22. doi: 10.1016/s0188-4409(00)00059-x.
citation: Prelevic GM, Wurzburger MI, Peric LA. Metoclopramide effect on serum prolactin LH and FSH in patients with polycystic ovary syndrome. J Endocrinol Invest. 1988 Apr;11(4):255-9. doi: 10.1007/BF03350148.
citation: Mendes MC, Ferriani RA, Sala MM, Moura MD, Carrara HH, de Sa MF. Effect of transitory hyperprolactinemia on in vitro fertilization of human oocytes. J Reprod Med. 2001 May;46(5):444-50.
Clinical trial NCT00001883: Quality Control of Cardiopulmonary Exercise Equipment
Official title: Quality Control of P-CCMB Cardiopulmonary Exercise Equipment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Treadmill
Bicycle
Lung Function
Physiology
Quality Control
Normal Volunteers
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study is designed to make sure exercise equipment used by the National Heart, Lung, and Blood Institute is working properly. Healthy volunteers will be requested to use P-CCMB cardiopulmonary exercise equipment (treadmills and exercise bicycles) two times a month to ensure the machines are functioning properly.

Detailed description: Proper functioning of recently acquired P-CCMB cardiopulmonary exercise equipment will be verified by testing healthy volunteers. In addition, quality control will be verified by performing monthly testing of healthy volunteers as biologic standards.

Eligibility criteria: INCLUSION:

Healthy research volunteers who are between 21 and 65 years.

EXCLUSION:

Patients with a history of ischemic or valvular heart disease.

Patients with history of chronic pulmonary disease.

Pregnant women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Sue DY, Wasserman K. Impact of integrative cardiopulmonary exercise testing on clinical decision making. Chest. 1991 Apr;99(4):981-92. doi: 10.1378/chest.99.4.981. No abstract available.
citation: Whipp BJ. The bioenergetic and gas exchange basis of exercise testing. Clin Chest Med. 1994 Jun;15(2):173-92.
citation: Wagner PD. Central and peripheral aspects of oxygen transport and adaptations with exercise. Sports Med. 1991 Mar;11(3):133-42. doi: 10.2165/00007256-199111030-00001. No abstract available.