louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03075787: Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea
Official title: Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive sleep apnea
Heart rate
Heart rate variability
Microarousals
Autonomic nervous system activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 60
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 with obstructive sleep apneas with a diagnosis from January 1st 2012 to September 1st 2016.

Brief summary: Obstructive sleep apnea is often associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between obstructive sleep apnea severity, age, gender and heart rate response associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.


Eligibility criteria: Inclusion Criteria:

* Restless legs syndrome patients
* Hospital routine for sleep disorders breathing diagnosis
* Apnea index \> 0

Exclusion Criteria:

* Narcolepsy-cataplexy
* Sleep irregularities and sleep deprivation symptoms
* Lack of neurological or psychiatric diseases
* Periodic leg movements
* Central sleep apnea, treatment
* Cerebral lesion
* Medical illness
* Medication or drinks affecting sleep and wake state.

Primary outcomes:
measure: Amplitude of heart rate response associated with obstructive sleep apneas
timeFrame: At diagnosis
Secondary outcomes:
measure: Other Heart rate variability indices: Ptot
timeFrame: At diagnosis
measure: Other Heart rate variability indices: very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu)
timeFrame: At diagnosis
measure: Other Heart rate variability indices: LF/HF
timeFrame: At diagnosis
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Vincent PICHOT, PhD
role: STUDY_CHAIR
affiliation: CHU SAINT-ETIENNE
name: Emilia SFORZA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295787: Intranasal Ketamine for Late-Life Depression and Suicidal Ideation
Official title: Intranasal Ketamine for Late-Life Depression and Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Depression
Suicide
Suicidal Ideation
Keywords: Depression
Suicide
Suicidal Ideation
Ketamine
Late-Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators of this study plan to investigate the feasibility and efficacy of repeated doses of intranasal ketamine in severely depressed patients who are at least 65 years of age and experiencing suicidal ideation. The results of the study could lead to development of new strategies for treating depression.


Eligibility criteria: Inclusion Criteria:

1) be ≥65 years old, 2) provide written informed consent, 3) meet criteria for a primary psychiatric diagnosis of major depressive disorder according to the Structured Clinical Interview for DSM-IV (SCID) and have a HDRS28 total score ≥20; depression may have started at any time point in their life, and certain co-morbid diagnoses (e.g., anxiety disorders) will be allowed insofar as they are not the primary psychiatric diagnosis, 4) have a history of ≥2 failed medication trials during the current episode (per the Massachusetts General Hospital Antidepressant Treatment History Questionnaire; MGH ATRQ), 5) endorse suicidal ideation for more than 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS) and have a HDRS28 suicide item score ≥1 (thoughts that life isn't worth living), 6) be on a stable antidepressant regimen for ≥14 days prior to Study Phase II, 7) maintain a treating psychiatrist who is in agreement with study participation, and 8) have a reliable chaperone accompany them home following the completion of the intranasal administration.

Exclusion Criteria:

* Patients will be excluded if any of the following criteria are met: 1) Delirium or dementia diagnosis, 2) unstable medical illness, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects, 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders or homicidality, 6) active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine abuse, 7) requirement of excluded medications (narcotics, barbiturates, theophylline, or St. John's Wort), or 8) concurrent or recent participation in other research studies.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Dawn F Ionescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03799887: Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease
Official title: Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease: A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
gait
balance
treadmill training
fatigue
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD.

Detailed description: Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT. All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP), Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the beginning and end of the rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria.
* Subjects had clinically moderate to advanced severity of disease (Hoehn and Yahr stage 2 - 4).
* Subjects whose medical treatment had been on stable dosage of dopaminomimetics for at least 4 weeks before the study.
* Subjects ability to walk with or without assistive device.

Exclusion Criteria:

* Subjects had cardiovascular, inflammatory or musculoskeletal problems that could prevent them to participate in an exercise program.
* Subjects whose mini mental status examination score was less than 26.

Primary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: 6 weeks
measure: Berg Balance Scale (BBS):
timeFrame: 6 weeks
measure: Unified Parkinson's Disease Rating Scale (UPDRS):
timeFrame: 6 weeks
Secondary outcomes:
measure: Nottingham Health Profile (NHP):
timeFrame: 6 weeks
measure: Fatigue Impact Scale (FIS):
timeFrame: 6 weeks
measure: Fatigue Severity Scale (FSS):
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Tuğba Atan
Study officials:
References:
Clinical trial NCT01093287: Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome
Official title: Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients meeting the American European Consensus definition of acute respiratory distress syndrome will be included, regardless of etiology of respiratory failure.

Brief summary: In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and intensive care unit stay. However, glucocorticoids may induce serious adverse events and these adverse events might compensate the positive effect of prolonged methylprednisolone infusion and discourage physicians from treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to continue or not prolonged methylprednisolone infusion and this could reduce the drug related adverse events. We project to evaluate the predictors of responsiveness to prolonged methylprednisolone infusion in early acute respiratory distress syndrome .


Eligibility criteria: Inclusion Criteria:

* AECC definition of acute respiratory distress syndrome
* Early acute respiratory distress syndrome (within 72 h of diagnosis)
* PF ratio \< 200 at PEEP ≥ 8 cmH2O

Exclusion Criteria:

* Imminent death
* Contraindication to corticosteroid treatment
* Already on more than 0.5 mg/kg of methylprednisolone or its equivalent
* Evidence of uncontrolled infection
* Refusal of managing physician to participate in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Jeon K, Chung CR, Yang JH, Park CM, Suh GY. Predictors of response to corticosteroid treatment in patients with early acute respiratory distress syndrome: results of a pilot study. Yonsei Med J. 2015 Jan;56(1):287-91. doi: 10.3349/ymj.2015.56.1.287.
Clinical trial NCT06848387: Unbound Cloxacillin Concentrations During Continuous Infusion
Official title: Concentration of Unbound Cloxacillin in Adults Treated With Continuous Infusion Via Elastomeric Pump
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Staphylococcal Infections
Keywords: cloxacillin
Lead sponsor: Region Västmanland
Sponsor class: OTHER
Collaborators: name: Region Västmanland
First posted: 2025-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Low intervention trial according to Regulation (EU) No 536/2014. The investigational medical product - cloxacillin - is authorized and according to the protocol of the clinical trial

1. Cloxacillin is used in accordance with the terms of the marketing authorization
2. The use of cloxacillin is evidence-based
3. The additional monitoring procedures - four blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin - do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.
Primary purpose: OTHER

Brief summary: Cloxacillin is the first-line choice for the treatment of severe infections caused by the bacterium Staphylococcus aureus in Sweden. Over the past year, cloxacillin is increasingly administred through continuous infusion. In this study, the free (unbound) concentration of cloxacillin when administered as a continuous infusion will be measured to ensure that the free concentration is neither too high nor too low. A PK/PD model will be developed to predict which dosage of cloxacillin is appropriate for an individual based on age, gender, kidney function, and serum-protein level.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Treating physician has decided to start continuous infusion of cloxacillin

Exclusion Criteria:

* Unwilling or unable to provide written informed consent

Primary outcomes:
measure: Free (unbound) cloxacillin concentration
timeFrame: From enrollment to end of follow up at 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01641887: Decision Aid for Gastroesophageal Reflux Disease Management
Official title: Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux Disease
Esophageal Cancer
Barrett's Esophagus
Keywords: GERD
Heartburn
Decision Aid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-17
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: NON_PROBABILITY_SAMPLE
Study population: Patients who have GERD who have not yet had endoscopy.

Brief summary: The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on \~100 patients who have GERD to assess effectiveness.


Eligibility criteria: Inclusion Criteria:

* Patients with GERD,
* Age at least 18,
* Able to give consent

Exclusion Criteria:

* Unable to perform decision aid on a computer

Primary outcomes:
measure: Participant acceptability
timeFrame: Patients will be surveyed on the day of the decision aid (1 day).
measure: Participant Satisfaction
timeFrame: Patients will be surveyed on the day of the decision aid (1 day).
Secondary outcomes:
measure: Patient decisions
timeFrame: Patients will be surveyed on the day of the decision aid (1 day).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00192387: Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate Viral Shedding in Healthy Children (6 Mos and Less Than or Equal to 18 Months of Age) Vaccinated With Two Doses of Liquid Formulation of Influenza Virus Vaccine, Live Cold Adapted (CAIV-T)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of \<1:10, who shed each vaccine virus strain following a single dose of CAIV-T.


Eligibility criteria: Inclusion Criteria:

* children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
* whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
* who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion).

Exclusion Criteria:

* whose parents or legal guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; intranasal steroids or cytotoxic agents;
* have an immunosuppressed or an immunocompromised individual living in the same household;
* with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
* who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

Note: A pregnant household member is not considered a contraindication to enrollment.

Primary outcomes:
measure: Measurement of influenza-specific immune response following receipt of CAIV-T.
Secondary outcomes:
Other outcomes:
Locations:
city: Monroe
country: United States
facility: Monroe Clinic
state: Wisconsin
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00427687: Study Evaluating AGG-523 in Subjects With Osteoarthritis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel-Group Study of the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Subjects With Mild to Moderate Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of AGG-523 administration on biomarkers related to osteoarthritis. Safety and tolerability of AGG-523 will also be assessed.


Eligibility criteria: Inclusion:

* Mild to moderate Osteoarthritis of the target knee.
* Subjects must be generally healthy but enrolled with stable chronic illness if well controlled.

Primary outcomes:
measure: The effect of AGG-523 on biomarkers related to osteoarthritis.
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Altoona
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05296187: Efficacy of TEAS On Prevention of Propofol Injection Pain in Children
Official title: Efficacy of Transcutaneous Electrical Acupuncture Point Stimulation (TEAS) for the Prevention of Propofol Injection Pain in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Injection Site
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.

Detailed description: Pain from the injection of propofol is a common side effect during anesthetic practice. Various methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing propofol injection pain in children.

Eligibility criteria: Inclusion Criteria:

* ASA I-II and aged 6-13 years patents who will undergo elective surgery under general anesthesia

Exclusion Criteria:

* patients with propofol allergy
* patients who have renal, hepatic, cardiac, neurological, psychiatric disease
* Cardiac and cranial surgery
* Pacemaker,
* Emergency surgery and patients requiring rapid serial induction

Primary outcomes:
measure: Pain with propofol injection
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References: