louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03703713: Colloid Osmotic Pressure and Osmolality in Hyponatremia
Official title: Colloid Osmotic Pressure and Osmolality in Hyponatremia. Additional Diagnostic Aspects and Guide to Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyponatremia
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 1
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: All patients treated for severe hyponatremia, at the intensive care unit.

Brief summary: Hyponatremia (serum sodium of less than 135 mmol/L)is a very common electrolyte disorder. The reasons for the disorder varies as well as if it is acute or chronic.

In this study we wish to follow changes in colloid osmotic pressure and osmolality during the initial treatment hours. We also wish to use mass balance for the calculation of body compartments and to detect fluid translocation between these.

Detailed description: Patients with hyponatremia arriving att the intensive care unit are asked to participate in the study. The first blood samples are collected before initializing the treatment as well as measurements of body compartments with a bioimpedance analyzer. Collected blood samples are electrolytes (Sodium, Potassium and Chloride), colloid osmotic pressure, osmolality and hemoglobin. These samples are repeated at 4 and 8 hours after start of the study. Amount of infused fluid as well as electrolytes are recorded. Urine volume is measured and urine samples are analyzed for the loss of electrolytes.

Additional samples for guidance of treatment are collected every hour.

Hopefully the addition of colloid osmotic pressure, osmolality and mass balance can be beneficial in the diagnosis of the reason for the disorder as well as for the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients treated for Hyponatremia at the intensive care unit.

Exclusion Criteria:

* Circulatory instable patients in need of treatment for more than the hyponatremia.

Primary outcomes:
measure: Colloid osmotic pressure
timeFrame: 8 hours
Secondary outcomes:
measure: Body compartments
timeFrame: 8 hours.
measure: Body compartments
timeFrame: 8 hours
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Intensive Care Unit, Vrinnevi Hospital
Study officials:
References:
Clinical trial NCT02030613: Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Official title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: juvenile idiopathic arthritis
etanercept
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 126
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis

Detailed description: Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability

Eligibility criteria: Inclusion Criteria:

* Patient with Juvenile Idiopathic Arthritis
* Age \<18 years and\> 4 years (which corresponds to the pediatric AMM)
* Patient on Etanercept treatment in the context of his usual care, whatever the dose (but the dose should remain stable in the weight during the study period). The patient must have received at least one injection of etanercept before participating in the study.
* Signature of consent by the guardians of the child
* Patient affiliate or entitled to a social security scheme

Exclusion Criteria:

* Infection progressive
* Pregnancy and lactation. For adolescents of reproductive age and sexually active, contraception should be used during the duration of treatment with etanercept
* Contraindication to treatment with Etanercept
* Refusal of the study

Primary outcomes:
measure: Etanercept concentration-time courses
timeFrame: one year
Secondary outcomes:
measure: Wallace criteria
timeFrame: one year
measure: anti-etanercept antibodies levels
timeFrame: one year
measure: analogical visual scale
timeFrame: one year
measure: arthritis number
timeFrame: one year
measure: number of limited joints
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Necker
Study officials:
affiliation: Necker Hospital
name: Brigitte Bader-Meunier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586713: Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries
Official title: Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries In Adult Patients With Non Cavitated Pits And Fissure Discoloration: Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' teeth will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made
Primary purpose: DIAGNOSTIC

Brief summary: This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to modified ICDAS-II criteria in clinical

Detailed description: volunteers patients will be assigned in this study. Each patient should have at least one posterior tooth with pits and fissure discoloration and maximum 4 teeth. The teeth will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (ICDAS-II) and D2 represents light induced fluorescence intraoral camera.Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera.

Eligibility criteria: Inclusion Criteria:

* Patients aged from 15 to 50 years.
* No gender restriction.
* Patients should have an acceptable oral hygiene level.
* Patients must have at least one posterior with fissure discoloration

Exclusion Criteria:

* • Patients with a compromised medical history.

  * Severe or active periodontal disease.
  * Heavy bruxism or a traumatic occlusion.
  * Acute or chronic dental infection.
  * Pregnant or breastfeeding women.
  * Patients with posterior restorations on molars or premolars.

Primary outcomes:
measure: reliability and reproducibility of intra oral light fluorescence camera using kappa strength
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dentistry Cairo University
Study officials:
References:
Clinical trial NCT02073513: Kinesiotaping the Hand in Cerebral Palsy
Official title: Effects of Kinesiotaping the Hand of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity
Keywords: Spasticity, Hand Function, Cerebral Palsy, Kinesiotape
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.

OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure hand function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.

Detailed description: BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.

OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on upper extremity function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure upper extremity function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Cerebral Palsy
* Stable clinical status
* Hand and/ or wrist spasticity
* No passive movement limitation
* Receiving regular neurodevelopmental rehabilitation
* Sufficient cognitive level

Exclusion criteria:

* Surgery of the upper extremity
* Orthotic treatment
* Sensory deficit

Primary outcomes:
measure: Nine hole peg test
timeFrame: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed
Secondary outcomes:
measure: nine parts puzzle test
timeFrame: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Hacettepe University Ethical Committee
name: Fatma UYGUR, Prof. PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02388113: Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes
Official title: The Effect of Accumulated Versus Traditional Exercise Training on Metabolic Control and Heart Function in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise therapy
Time factors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 40
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: TREATMENT

Brief summary: This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* insulin treatment
* severe chronic diabetic complications
* liver dysfunction
* kidney dysfunction
* inflammatory diseases
* heart failure
* myocardial ischemia
* major cardiovascular event history
* physical exercise more than current guidelines for type 2 diabetes
* inability to exercise

Primary outcomes:
measure: glycosylated hemoglobin (HbA1c)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Diagnostic Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Charlotte Ingul, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00376636: Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension
Official title: A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Speedel Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2006-09-15
Enrollment: 35
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: TREATMENT

Brief summary: This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Detailed description: Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.

Eligibility criteria: Inclusion Criteria:

* male or female patients with mild to moderate hypertension

Exclusion Criteria:

* female patients of child-bearing potential or breast-feeding

Primary outcomes:
measure: Lowering of systolic office blood pressure
timeFrame: four weeks
measure: Lowering of diastolic office blood pressure
timeFrame: four weeks
Secondary outcomes:
measure: Lowering of systolic and diastolic blood pressure (ABPM)
timeFrame: four weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: IKP Bobenheim GmbH
Study officials:
affiliation: IKP Bobenheim GmbH
name: Sybille Baumann-Noss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590836: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
* Body mass index (BMI) 18.0-28.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin (HbA1c) maximum 9.5 %
* Fasting C-peptide maximum 0.3 nmol/L

Exclusion Criteria:

* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

Primary outcomes:
measure: Area under the glucose infusion rate curve during one dosing interval
timeFrame: At steady state (0-24 hours)
Secondary outcomes:
measure: Maximum glucose infusion rate (GIRmax)
timeFrame: At steady state (within 0-24 hours after last dosing)
measure: Area under the serum insulin degludec concentration-time curve during one dosing interval
timeFrame: At steady state (within 0-24 hours after last dosing)
measure: Maximum observed serum insulin degludec concentration
timeFrame: At steady state (within 0-24 hours after last dosing)
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours
measure: Maximum observed serum insulin aspart concentration
timeFrame: Within 0-12 hours after dosing of IDegAsp
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Nosek L, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):255-65. doi: 10.1007/s13300-014-0070-2. Epub 2014 Jun 3.
Clinical trial NCT05011136: Physician Reimbursement Home Patients
Official title: Physician Reimbursement for Home Dialysis: Assessment of Validity of CMS Compensation for Nephrologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ESRD
Keywords: ESRD
Home Dialysis
Compensation
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 68
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: All US nephrologists who care for dialysis patients.

Brief summary: This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients.

Detailed description: Physician reimbursement today for care of a home dialysis patient is a capitated reimbursement, defined by the age of the patient and their days on home dialysis. Due to the multiple advantages of home therapy, CMS is working on increasing home dialysis uptake; however, there is little to no data on the time and effort involved in providing care to home dialysis patients.

In this study, we will develop and distribute a survey to capture the components of home dialysis patient care and the perceived time and effort of nephrologists across the US to do so. This will provide data for CMS as they consider the adjustment of their policy values in physician reimbursement for home dialysis patient care, which is currently labeled as misvalued (Centers for Medicare and Medicaid Services, 2021).

Eligibility criteria: Inclusion Criteria:

* All nephrologists in the US who care for dialysis patients.

Exclusion Criteria:

* Nephrologists who have not cared for dialysis patients in the last year.

Primary outcomes:
measure: To provide data to facilitate a data-driven adjustment of the capitated physician payment for caring for home dialysis patients.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Satellite Health Care
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Wael F Hussein, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05980013: Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500
Official title: Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Loss
Blood Loss
Lead sponsor: Zynex Monitoring Solutions
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Ability and willingness to comply with the study procedures and duration requirements
* 18 years of age or older
* Consented and eligible to undergo a single unit whole blood donation

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Undergone an amputation of any upper extremity
* Diagnosed with dextrocardia
* Subjects who have a pacemaker
* Subjects with body hair density which prevents adequate application of device electrodes

Primary outcomes:
measure: Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)
timeFrame: Recovery period following donation (10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Vitalant Research Institute
state: Colorado
city: Bradenton
country: United States
facility: SunCoast Blood Centers
state: Florida
Study officials:
affiliation: SunCoast Blood Centers
name: Debra Smith, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: