louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01663025: The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery
Official title: Evaluating The Effects Of Intra Operative Hand Reflexology on Pain and Anxiety During Out Patient Vein Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Randomised controlled trial
Pain
Anxiety
Ambulatory surgery
Hand massage
Local anaesthetic
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomised controlled trial aims to compare the effectiveness of hand reflexology received during office based vein surgery, under local anaesthetic on patient's reports of pain and anxiety, compared to usual standard care.

Detailed description: The negative effects of anxiety and pain on surgical recovery are well documented. It is also accepted that distraction can be effective in pain reduction. This randomised controlled trial will explore the effect of intra operative hand reflexology on pain perception and anxiety during office-based surgery under local anaesthetic. Participants will be randomly allocated to either the experimental condition, in which they will receive a hand reflexology during treatment, or control condition in which they will receive usual standard care. Immediate and longer term outcomes will be explored.

Eight weeks after surgery, participants will return to the clinic for a follow up appointment. While they are in the waiting area they will be asked to complete a short questionnaire to assess time taken to return to pre surgical levels of functioning, pain experienced in the first four weeks after surgery, severity of venous symptoms and satisfaction with treatment.

Eligibility criteria: Inclusion Criteria:

* To be aged between 18 and 80
* To be able to give informed consent
* To be receiving, endovenous laser ablation or phlebectomies for the treatment of varicose veins
* To have a good understanding of written and spoken English.
* To arrive at the clinic with sufficient time before their procedure to give consent and complete the questionnaire (\>20 mins)

Exclusion Criteria:

-To be aged under 18 or over 80

Primary outcomes:
measure: Pain
timeFrame: In the recovery area, immediately after surgery
Secondary outcomes:
measure: Anxiety
timeFrame: In the recovery area, immediately after surgery
measure: Satisfaction with treatment
timeFrame: in the recovery area, immediately after surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Whiteley Clinic at the Wimpole Clinic
Study officials:
affiliation: The Whiteley Clinic
name: Mark Whiteley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122225: Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
Official title: Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Failure
Keywords: septic shock
medical intensive care
Lead sponsor: Université Victor Segalen Bordeaux 2
Sponsor class: OTHER
Collaborators: name: Inverness Medical Innovations
First posted: 2010-05-13
Enrollment: 50
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 of a medical intensive care presenting with a septic shock

Brief summary: Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.

The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.

Detailed description: Primary Outcome Measures:

To correlate elevated serum NGAL with the diagnosis of intrinsic acute kidney injury in septic shock

Secondary Outcome Measures :

To compare serum NGAL with serum creatinine, serum urea and urine output in septic AKI Death within the intensive care unit Death from all causes at 28 days after inclusion

Eligibility criteria: Inclusion Criteria:

* Patients showing signs of infection and hypotension requiring the use of epinephrine despite of an appropriate fluid challenge.
* 18 years of age or older

Exclusion Criteria:

* Age under 18 years
* Prisoners or other institutionalized or vulnerable individuals
* Participation in an interventional clinical study within the previous 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital
state: Aquitaine
Study officials:
affiliation: University Hospital, Bordeaux
name: Fabrice Camou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02396225: Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Invasive Aspergillosis
Keywords: voriconazole
inhalation
aerosol
epithelial lining fluid
concentration
pharmacokinetic
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2015-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.


Eligibility criteria: Inclusion Criteria:

* Planned bronchoscopy in relation to work-up after hemoptysis or other symptom leading to bronchoscopy
* Informed written consent
* Performance status 0-1
* Ct scan of thorax without suspicion of malignancy
* Weight t ≥ 60 og ≤ 130 kg
* Male gender or female gender in postmenopausal state defined by amenorrhea in more than 12 months.

Exclusion Criteria:

* Voriconazole treatment up to one week before inclusion
* Se-creatinin≥ 100 uM
* ALAT ≥ 70 U/l
* QT-interval \> 480 ms
* Allergic reaction to voriconazole or constituents in Vfend
* Allergic reaction to other azoles
* Ischemic Heart disease, Heart failure or uncontrolled hypertension
* Treatment with statins or omeprazole, which cannot be paused for three days during voriconazole exposure
* Treatment with Efavirenz, rifabutin, ritonavir, everolimus, methadon, alfentanil, fentanyl, sufentanil, oxycodone, hydrocodone, fluconazole, aztemizol, cisaprid, pimozid, quinidine, terfenadine, carbamazepine, phenobarbital, mephobarbital, ergotamine, dihydroergotamine, rifampicine, st. johns worth, everolimus, phenytoin, warfarin, phenprocoumon, acenocoumarol, benzodiazepines as midazolam, triazolam, alprazolam, sirolimus, cyclosporine, tacrolimus, ibuprofen, diclofenac,tolbutamide, glipizide, vincristine, vinblastine or other vinca alkaloids, HIV-protease Inhibitors e.g. saquinavir, amprenavir and nelfinavir, delavirdine, nivrapine and other non-nocleaoside revers transcriptase inhibitors

Primary outcomes:
measure: Voriconazole concentration in serum
timeFrame: 2 years
Secondary outcomes:
measure: Voriconazole concentration in lunge epithelial lining fluid
timeFrame: 2 years
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT02112825: Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
Official title: Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus Chronic Kidney Disease With Hypertension
Keywords: Exercise
blood pressure
chronic kidney disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The general objective of the study is to investigate the effect of regular aerobic exercise on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and hypertension.


Eligibility criteria: Inclusion Criteria:

* • Non-diabetic and \>18 years of age

  * Diagnosed kidney disease with associated hypertension:
  * Non-nephrotic range proteinuria at diagnosis
  * No active glomerular disease or concomitant systemic inflammatory disease (e.g. lupus)
  * Systolic blood pressure \>130 and/or diastolic blood pressure \>80 mm Hg (on medication)
  * An estimated glomerular filtration rate of between 60 ml/min and 15 ml/min.
  * Individuals must be able to provide informed consent
  * Perform walking exercise training on a treadmill
  * Be able to participate in a 12-week supervised exercise program.

Exclusion Criteria:

* Currently participating in a formal exercise program
* Diabetes, active glomerular disease, or systemic inflammatory disease
* Requiring dialysis
* Have an Hematocrit \<27%
* Uncontrolled hypertension (\>200/110mmHg)
* Peripheral vascular disease.
* An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease, or having undergone a coronary revascularization within the past 6 months prior to enrollment.

Primary outcomes:
measure: blood pressure
timeFrame: at week 0 and at week 12
Secondary outcomes:
measure: effective vascular compliance
timeFrame: at week 0 and at week 12
measure: endothelial function
timeFrame: at week 0 and at week 12
measure: biomarkers associated with blood pressure
timeFrame: at week 0 and at week 12
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ulf G Bronas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06427525: The Effect of Mobile Application Supported Health Promotion Program on Obesity of Adolescents
Official title: The Effect of Mobile Application Supported Health Promotion Program on Obesity, Physical Activity and Stress Levels of Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescents
Mobile Application
School Health
Physical Activity
Nutrition Disorder, Child
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood.

Detailed description: The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood. The program aims to provide children with positive health behaviors, gain cognitive and behavioral skills that will enable them to increase their knowledge of physical activity, nutrition and stress management.

Eligibility criteria: Inclusion Criteria:

Obesity Adolescents, smartphone internet, 10-16 years old

Exclusion Criteria:

non-obese child, 17 years old

Primary outcomes:
measure: Healthy Lifestyle Behaviors Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Florance Nightingale Nursing Faculty
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Cumali Yıldızdal, phd student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128125: Study of Gesture and Executive Functions in Children With High Intellectual Potential
Official title: Study of Gesture and Executive Functions in Children With High Intellectual Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Intellectual Potential
Children
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control study, monocentric.
Primary purpose: OTHER

Brief summary: The main objective of this study is to determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children.


Eligibility criteria: Inclusion Criteria:

All participants :

* Informed consent of the child and both parents obtained
* Affiliated to Social Security
* Participants must be between 6 and 16 years of age.

Child with high intellectual potential :

* Score ≥ 130 on an intellectual efficiency scale administered by a psychologist

Control child :

* They will have to be intellectually efficient in the standard. To ensure this, the two sub-tests of the Intellectual Efficiency Scale (WISC-V) most closely correlated with intelligence (Vocabulary and Matrices) will be administered to them. Thus, the child must meet one of the following criteria in order to be included:
* Have two standard notes between -1 and +1 DS (between 7 and 13);
* Have one of its two notes between -1 and + 1DS (between 7 and 13) and the other between -2DS and \<+ 2DS (between 5 and 15).

Exclusion Criteria:

All participants :

* Neurological history (epilepsy, cranial trauma, prematurity ...)
* Psychiatric history (Autistic Spectrum Disorder ...),
* Known genetic disease,
* Motor deficiency (eg hemiplegia),
* Elementary sensory disorder (auditory and visual) or insufficient command of French, limiting the understanding and participation in the study likely to impact the results to the protocol.
* Gnosic visual or linguistic deficiency.
* Sensory disorder
* Psychotropic Intake

Control child :

* High intellectual potential
* Known or suspected learning disability (no dyslexia-dysorthography, dysphasia, dyspraxia, dyscalculia).

Primary outcomes:
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neurological assessments
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
measure: Neuropsychological assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital
Study officials:
affiliation: CHRU Brest
name: Sylviane PEUDENIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04027725: NEUROFEEDBACK TRAINING FOR OLDER ADULTS WITH MILD COGNITIVE IMPAIRMENT: A PILOT STUDY
Official title: Pilot Study Evaluating the Effectiveness of Neurofeedback Training in the Improvement of Cognitive Functions of the Elderly With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive Impairment
Neurofeedback
Electroencephalography
Memory
Attention
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of SMR neurofeedback training on cognitive performance and electrical brain activity in elderly with cognitive impairment.

Detailed description: Older adults with Mild Cognitive Impairment (MCI) are at high risk to progress to Alzheimer's disease (AD). Slowing down effect of dementia by enhancing brain plasticity represents on of the most prominent challenges. Neurofeedback is one of the promising techniques that showed therapeutic efficacy and cognitive improvement in attention-deficit hyperactivity disorder, epilepsy, stroke. The investigators aim to study the effects of a sensorimotor neurofeedback training protocol (SMR) on cognitive performances in elderly and to assess whether MCI patients change in brain electrical activity after training.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Mild Cognitive Impairment, educational level of 9 years of studies minimum, righthandedness, subjective memory complaint confirmed by an informant, a mini mental Status Examination score \> 20, preserve activity of daily living and absence of dementia.

Exclusion Criteria:

Elderly persons who were under guardianship, resident in nursing facilities, neurological disease, psychiatric disease and involved in another cognitive intervention.

Primary outcomes:
measure: Change on Rey Auditory Verbal Learning test
timeFrame: Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention , and after 1-month follow-up
Secondary outcomes:
measure: relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
timeFrame: assessment at baseline, change from baseline to immediately after the NF training and 1 month follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital BROCA
Study officials:
affiliation: APHP
name: Anne-Sophie RIGAUD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01312025: Conventional Versus Modified Laparoscopic Cholecystectomy
Official title: Randomized Controlled Trial Comparing Between The Conventional Technique of Laparoscopic Cholecystectomy and A Proposed Modified Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-03-10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: In conventional laparoscopic cholecystectomy, the cystic duct and artery are clipped by metal clips. we propose a new method in which the cystic duct is ligated and the cystic artery is cauterized. the investigators compare both methods.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy for symptomatic gallstones

Exclusion Criteria:

* Conversion to laparotomy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01906125: A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
Official title: A Phase 1, Open-Label 3 Sequence 3 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 1/2 And Phase 3 Formulation To Palbociclib ICH Formulation Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Cmax
AUC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 7 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 7 days
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 7 days
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 7 days
measure: Area Under the Curve From Time Zero to 72 hrs [AUC (0-72)]
timeFrame: 3 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 7 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 7 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 7 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: