louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06068751: Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment
Official title: The Effectiveness of Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment: A Randomized Controlled Single-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine in Children
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled single-blind trial will include 60 pediatric migraine patients. Participants will be divided into two groups: one performing aerobic exercise, and the other conducting neck exercises. Assessments include attack frequency, severity, duration, and neck pain over three months.


Eligibility criteria: Inclusion Criteria:

- Pediatric Migraneurs, as per International Classification of Headache Disorders-3 guidelines

Exclusion Criteria:

* individuals with any other concomitant headaches
* those showing findings beyond nonspecific hyperintense areas on cranial Magnetic Resonance Imaging
* patients with systemic diseases other than migraine, such as fibromyalgia
* individuals who had experienced treatment changes or required treatment changes within the last month
* limited mental capacity or psychological illnesses that could hinder their participation in surveys and exercises
* a history of increased attack frequency or severity with previous physical activity program involvement, or a history of trauma to the neck or face
* individuals with a history of a herniated disc in the cervical region or symptoms of cervical radiculopathy

Primary outcomes:
measure: Migraine Attack Frequency
timeFrame: Baseline, first and third month follow-ups
measure: Migraine Attack Duration
timeFrame: Baseline, first and third month follow-ups
measure: Migraine Attack Severity
timeFrame: Baseline, first and third month follow-ups
measure: Neck Pain Severity
timeFrame: Baseline, first and third month follow-ups
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Research and Training Hospital
Study officials:
affiliation: Gaziosmanpaşa Research and Training Hospital
name: Orhan Coskun, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03476551: Bariatric Surgery and Pharmacokinetics of Hydrochlorothiazide
Official title: Bariatric Surgery and Pharmacokinetics Hydrochlorothiazide: BAR-MEDS Hydrochlorothiazide
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Hydrochlorothiazide
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on hydrochlorothiazide are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Hydrochlorothiazide concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05577351: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke
Official title: PULSE-F: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Large Vessel Occlusion
Mechanical Thrombectomy
Neurovascular Intervention
Lead sponsor: RapidPulse, Inc
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

Detailed description: The purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
* Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
* Target occlusion can be accessed by the Medtronic React 71 aspiration catheter

Exclusion Criteria:

* Known or suspected intracranial atherosclerotic disease (ICAD)
* Tandem occlusions

Primary outcomes:
measure: First Pass Reperfusion Effect (FPE)
timeFrame: Intra-procedural
Secondary outcomes:
Other outcomes:
measure: Frontline Technical Success
timeFrame: Intra-procedural
measure: Final mTICI
timeFrame: Intra-procedural
measure: Modified First Pass Reperfusion Effect (mFPE)
timeFrame: Intra-procedural
measure: Device-related and procedure-related adverse events
timeFrame: Intra and post-procedural (up to 24 hours)
Locations:
city: Tbilisi
country: Georgia
facility: National Institute of Surgery
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystems
Study officials:
affiliation: University of Pittsburgh Medical Center Stroke Institute
name: Raul G Nogueira, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01617551: Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones
Official title: Effect of Renal Denervation on NO-mediated Regulation of Salt- and Water Excretion, Vasoactive Hormones and Tubular Transport Proteins in Patients With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Hypertension
Keywords: Essential hypertension
Nitric oxide
Renal denervation
Sodium
GFR
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.

To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.


Eligibility criteria: Inclusion Criteria:

* Age 30-70 years
* Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
* Day-time ambulatory blood pressure \> 145/75 mmHg

Exclusion Criteria:

* Non compliance
* Pregnancy/no-anticonception in fertile women
* Radiocontrast allergy
* Malignancy
* Congestive heart failure (EF \< 50)
* eGFR \< 45
* Unstable angina pectoris
* Recent myocardial infarction or PCI (\< 6 mdr)
* Secondary hypertension
* Renal artery stenosis or multiple renal arteries on CT
* Claudication

Primary outcomes:
measure: Fractional excretion of sodium after acute L-NMMA treatment
timeFrame: 1 month before and after CRD
Secondary outcomes:
measure: Glomerular filtration rate (GFR) before and after L-NMMA treatment
timeFrame: 1 month before and after CRD
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Dept. of medical research
Study officials:
affiliation: Dept. of medical research
name: Jesper N Bech, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01973751: Asthma Biomarkers for Predicting Response to Therapy
Official title: Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description: This will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay of asthma therapy. Only about half of the asthmatic patients have improved lung function after treatment of inhaled corticosteroid. The investigators hypothesize that there are biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of asthmatic patients which could predict the response of asthmatic patients to inhaled corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the optimal treatment for individual asthmatic patient.


Eligibility criteria: Group A:

Inclusion Criteria:

* Male and female subjects between the ages of 18 and 70 years
* No respiratory symptoms
* Normal spirometric value and methacholine PD20 \>2.5mg

Group B:

Inclusion Criteria:

* Male and female subjects between the ages of 18 and 70 years
* History of asthma
* No use of oral or inhaled corticosteroids for the treatment of asthma
* No use of leukotriene antagonist for the treatment of asthma
* Hyperreactivity to methacholine (PD20 FEV1 Methacholine \< 2.5 mg) and/or ≥12% increase in FEV1 following inhalation of 200μg salbutamol
* Asthma symptoms of episodic cough, wheeze and/or breathlessness

Exclusion Criteria:

* Current or former smokers
* Pregnant women
* Subjects with a history of lung disease other than asthma
* Subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study

Primary outcomes:
measure: Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Respiratory and Critical Care Medicine, Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT02541851: Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study
Official title: Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain, Chronic
Intensive Care, Surgical
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 100
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: Patients admitted in the surgical critical care unit of the Centre Hospitalier Universitaire de Besançon, France.

Brief summary: The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care.

Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU).

If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care.

The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.


Eligibility criteria: Inclusion Criteria:

* Admission in the surgical critical care unit of the University Hospital of Besançon from February 2015
* Age over 18 yr old
* Informed consent

Exclusion Criteria:

* Age under 18 yr old
* Death within the first 6 months after the end of the stay in the surgical intensive unit of the University Hospital of Besançon
* Glasgow Coma Score under 8 at admission and/or at discharge
* Planned admission after elective surgery
* Medical history of cognitive disorder
* Refuse to participate

Primary outcomes:
measure: Incidence of chronic pain
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of anxiety and depression
timeFrame: 6 months
measure: Incidence of neuropathic pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Guillaume Besch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.
Clinical trial NCT01071551: The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality, Physical Activity and Dental Health Among Children From Socioeconomically Disadvantaged Families in Beer Sheva
Official title: The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Keywords: Children
Obesity
Lifestyle
LSES
Caries
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 258
Sex: ALL
Minimum age (years): 48
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Childhood socioeconomic status (SES) is related to poor physical health, obesity, elevated cardiovascular risk factors and iron deficiency anemia. We plan to offer a comprehensive framework allowing the "Nutrition Enrichment and Healthy Living Model" (NEHLM) among a low SES Kindergarten children. The model offered is designed to take into account the current economic status of the child's family. We shall conduct a randomized controlled trial to assess the efficacy of the intervention.

Our main objective:

To compare the influence of the intervention on changes in food consumption, physical activity and ,and caries rates in the children in kindergartens where it is applied versus the control kindergartens.

The research hypothesis:

Integrative Nutrition Enrichment and Healthy Living Model (NEHLM) will improve health behaviors among children and parents in comparison to control intervention (physical activity only).


Eligibility criteria: Inclusion Criteria:

* Kindergarten children aged 4-7 Children from kindergartens defined as Low- SES population (by local municipality)
* Children whose parents agree to participate in the research

Exclusion Criteria:

* Children who suffer from any chronic disease
* Children who suffer from developmental problems
* Children who participate in a weight reduction treatment or program
* Children or parents who have any psychiatric problem or diagnosis

Primary outcomes:
measure: Children's weight and Height
timeFrame: Baseline, post intervention and at 4 months post intervention termination
Secondary outcomes:
measure: Caries rate (DMFT score)
timeFrame: Baseline, post intervention
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Kindergardens
Study officials:
affiliation: Ben Gurion Universty of the Negev Israel
name: Natalya Bilenko, MD, M.PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufman-Shriqui V, Werbeloff N, Faroy M, Meiri G, Shahar DR, Fraser D, Novack Y, Bilenko N, Vardi H, Elhadad N, Pietrzak RH, Harpaz-Rotem I. Posttraumatic stress disorder among preschoolers exposed to ongoing missile attacks in the Gaza war. Depress Anxiety. 2013 May;30(5):425-31. doi: 10.1002/da.22121.
Clinical trial NCT06427551: Volume Effect in Peng Block for Total Hip Replacement
Official title: Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Post Operative Pain
Keywords: postoperative
orthopedic surgery
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent total hip replacement in elective surgery

Brief summary: This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.

Detailed description: patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery

Eligibility criteria: Inclusion Criteria:

* ASA I, ASA II, ASA III
* Age≥18
* Total hip replacement surgery in spinal anesthesia
* Informed consent

Exclusion Criteria:

* ASA IV
* INR\>1.3
* platelet values\<100\*10\^3/ml a
* patients on anticoagulant or antiplatelet therapy
* general anesthesia for total hip replacement surgery
* patients on chronic opioid therapy
* altered sensitivity or motility
* Patients in chronic opioid therapy
* Refuse to sign informed consent form
* Unable to sign informed consent form
* Know allergies to medication used for analgesia

Primary outcomes:
measure: NRS evaluation
timeFrame: 24h post-op
Secondary outcomes:
measure: NRS variation in time
timeFrame: 24 h
Other outcomes:
measure: presence of side effects
timeFrame: 24 hours
measure: analgesic requirements
timeFrame: 24 hours
Locations:
city: Pisa
country: Italy
facility: Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello
state: Toscana
Study officials:
affiliation: aoupisa
name: manuela nicastro, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04967651: Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications
Official title: Analysis of Risk Factors and Establishment and Application of a Clinical Early Warning Model for Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pulmonary Complications
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Wuhan Central Hospital
name: Shanxi Cardiovascular Hospital
name: Qinghai People's Hospital
First posted: 2021-07-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who planned elective cardiac surgery under general anesthesia

Brief summary: The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years or older;
* Elective cardiac surgery under general anesthesia

Exclusion Criteria:

* Patients and their family members refused to be enrolled;
* Patients unable to communicate due to language barriers such as dementia;
* Patients admitted to ICU 24h before surgery;
* Estimated duration of surgery less than 2 hours;
* Patients died or discharged within 24 hours after surgery

Primary outcomes:
measure: The occurrence of postoperative pulmonary complications
timeFrame: 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
Study officials:
References: