louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02837536: Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings
Official title: Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Robert Cizik Eye Clinic
First posted: 2016-07-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Must be able to understand and sign and informed consent form that has been approved by an Institutional Review Board/Ethics Committee

Exclusion Criteria:

* Evidence of corneal epithelial defects or pathology affecting corneal rigidity
* Use of topical ophthalmic medications (except for artificial tears)
* History or corneal surgeries
* Any condition that would prevent or inhibit intraocular pressure measurements using iCare or pneumotonometry
* Evidence of ocular infection 30 days prior to enrollment
* Allergy to proparacaine or latex

Primary outcomes:
measure: IOP taken by iCare - horizontal
timeFrame: 1 Day
measure: IOP taken by iCare - vertical
timeFrame: 1 Day
measure: IOP taken by pneumatonometer
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Robert Cizik Eye Clinic
state: Texas
Study officials:
affiliation: Robert Cizik Eye Clinic
name: Robert M. Feldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830036: RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation
Official title: RehaSleep Register - Prevalence of Sleep Apnea in Cardiac Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Keywords: cardiological treatment
sleep Apnea
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2013-04-11
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment as part of the routine diagnostics using 2-channel polygraphic

Brief summary: Prevalence of sleep-related breath disturbance in patients in cardiac rehabilitation.

The aim of the register is to enable a better diagnosis and early treatment initiation in the context of secondary prevention. In addition to the prevalence, the further course of the patients shall be documented after hospital discharge to verify any gaps (sleep laboratory, therapy introduction) and emphasize the importance of rehabilitation and to examine the possibility of initiating therapy in rehabilitation.


Eligibility criteria: Inclusion Criteria:

* terminal cardiac treatment in cardiac rehabilitation facility
* for example: Myocardial infarction, bypass surgery, stent implantation, valve replacement, ICD, CRT, pacemakers, heart failure

Exclusion Criteria:

* no informed consent form signed
* limited consent capacity (Dementia, addiction, psychosis)
* pregnancy

Primary outcomes:
measure: cardiological treatment
timeFrame: April 2013
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Aachen, Medical Clinic I
name: Stefan Krüger, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01986036: The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake
Official title: The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations.

This study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* BMI 18.5-29.9 kg/m2
* Age: 18-40 years

Exclusion Criteria:

* Smokers
* Food allergies
* Metabolic disorders (ie. type 2 diabetes)

Primary outcomes:
measure: Energy Intake
timeFrame: 60 min post test-meal
Secondary outcomes:
measure: Subjective appetite sensations
timeFrame: 1 hr
measure: Insulin concentrations
timeFrame: 1 hr
measure: GLP-1 (7-36) concentrations
timeFrame: 1 hr
measure: GIP concentration
timeFrame: 1 hr
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Javier T Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Astbury NM, Stevenson EJ, Morris P, Taylor MA, Macdonald IA. Dose-response effect of a whey protein preload on within-day energy intake in lean subjects. Br J Nutr. 2010 Dec;104(12):1858-67. doi: 10.1017/S000711451000293X. Epub 2010 Sep 28.
citation: Gonzalez JT, Rumbold PL, Stevenson EJ. Appetite sensations and substrate metabolism at rest, during exercise, and recovery: impact of a high-calcium meal. Appl Physiol Nutr Metab. 2013 Dec;38(12):1260-7. doi: 10.1139/apnm-2013-0056. Epub 2013 Jun 18.
citation: Gonzalez JT, Stevenson EJ. Calcium co-ingestion augments postprandial glucose-dependent insulinotropic peptide(1-42), glucagon-like peptide-1 and insulin concentrations in humans. Eur J Nutr. 2014;53(2):375-85. doi: 10.1007/s00394-013-0532-8. Epub 2013 May 21.
citation: Gonzalez JT, Green BP, Brown MA, Rumbold PL, Turner LA, Stevenson EJ. Calcium ingestion suppresses appetite and produces acute overcompensation of energy intake independent of protein in healthy adults. J Nutr. 2015 Mar;145(3):476-82. doi: 10.3945/jn.114.205708. Epub 2015 Jan 14.
Clinical trial NCT06300736: Design of a Predictive Score for Contamination of Pediatric Blood Cultures
Official title: HEPIC Study : Design of a Predictive Score for Contamination of Pediatric Blood Cultures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bacteremia
Keywords: Blood culture contamination
Predictive score
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immunocompetent children hospitalized in a tertiary children hospital with blood culture

Brief summary: The contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. It is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time.

On a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination.

Contamination has major consequences for patient management. Studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. In children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. It also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test.

The aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive".


Eligibility criteria: Inclusion Criteria:

* Having a blood culture in children's hospital in Nancy
* Under 18 years old
* in emergency department, medical department, intensive care unit or surgical department

Exclusion Criteria:

* immunodepression
* post mortem blood culture
* blood culture in onco-haematology department

Primary outcomes:
measure: Blood culture diagnosis
timeFrame: 2 years
Secondary outcomes:
measure: Score performance
timeFrame: 2 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Nathan GIROUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01252836: Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites
Official title: Randomized, Prospective, Pilot Study Evaluating a Temporary Skin Substitute (AWBAT-D) Versus the Standard of Care in the Postoperative Treatment of Split-thickness Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Healing of Donor Site
Pain Level
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.

Detailed description: The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years of age or older
2. Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
3. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Subjects \< 18 years of age
2. Subjects with an allergy to porcine products.
3. Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
4. Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
5. Subjects undergoing repeat skin graft harvesting at the same donor site.
6. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
7. Subjects participating in any other trials involving the split-thickness skin graft donor site.

Primary outcomes:
measure: Time for donor site to heal with AWBAT-D
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain at donor site
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital Center for Wound Healing
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Christopher A Attinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00900536: DNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE
Official title: TRANSORCE (A Sub-study of SORCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
papillary renal cell carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood and/or tissue in the laboratory from patients with kidney cancer receiving sorafenib may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to sorafenib.

PURPOSE: This research study is looking at the DNA in blood and/or tissue samples from patients with primary kidney cancer receiving sorafenib on clinical trial MRC-RE05-SORCE.

Detailed description: OBJECTIVES:

* Examine the relationship between tumor genotype, expression, and patient outcome.
* Examine the relationship between constitutional genotype and patient outcome.

OUTLINE: This is a multicenter study.

Patients undergo blood and/or tissue sample collection for laboratory studies. Laboratory studies include generation of tissue microarrays; analysis of protein expression by immunohistochemistry; tumor DNA extraction and whole genome amplification; detection of VHL or other relevant gene mutations by direct sequencing; and constitutional (lymphocyte DNA) genotyping by single nucleotide polymorphism analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed resected renal cell carcinoma

  * Clear cell or non-clear cell tumor
* Receiving sorafenib tosylate on clinical trial MRC-RE05-SORCE

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Relationship between tumor genotype, expression, and patient outcome
measure: Relationship between constitutional genotype and patient outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
Study officials:
affiliation: Cancer Research UK
name: Timothy Eisen
role: STUDY_CHAIR
References:
Clinical trial NCT03091036: Impact of a Health Intervention on Some Indicators in the Care of Chronic Complex Patient (CCP).
Official title: Impact of a Proactive and Integrated Health Intervention Between Different Assistance Levels Over Some Indicators in the Care of Chronic Complex Patient (CCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Care
Keywords: Chronic
Complex
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2017-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effectiveness of proactive and integrated healthcare program for chronic complex patients (CCP). This program are based in coordination the primary level of attention with and speciality level. The objective is reducing hospital readmissions and know the benefit in total cost of care in 4 month before and 4 after intervention.

Detailed description: Quasi-experimental study with single-arm (pre-post study design without control group). The investigators checking pre and post intervention the effectiveness of a healthcare program for CCP. The interventions consist:

1. - Help the nurse in the hospital to carry out the care plans and the continuity care report.
2. - Refer patients to the social workers.
3. - Collaborate with the social worker to refer to centers of media, long stay and reference hospital.
4. - Ensure the follow-up appointments for the CCP.
5. - Make proactive calls to the CCP and/or their caregiver after discharge
6. - Plan the hospital discharge 48 hours in advance, so that the family and the patient can be organized.

The investigator analysed if with this program, the CCP reducing hospital readmission and reducing the Hospital expenditure.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 75 years.
* Having attended 5 or more emergency visits or having had more than 3 hospital admissions in the last 12 months.
* Identified with social risk alert.

Exclusion Criteria:

* Participate in other health programs (AHT, diabetes mellitus,...).
* Terminal patient.

Primary outcomes:
measure: Pre-post change in days of Hospital stay from baseline to 16 weeks.
timeFrame: Baseline and 16 weeks.
Secondary outcomes:
measure: Number of hospital readmissions visits for CCP change from baseline to 16 weeks.
timeFrame: Baseline and 16 weeks.
measure: Number of urgency visits for CCP change from baseline to 16 weeks.
timeFrame: Baseline and 16 weeks.
measure: Number of primary care visits for CCP change from baseline to 16 weeks.
timeFrame: Baseline and 16 weeks.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre de Madrid
Study officials:
affiliation: Hospital 12 de Octubre de Madrid
name: María José del Olmo Rubio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349813: Perioperative Pediatric Blood Transfusion Therapy
Official title: Analysis of Perioperative Pediatric Blood Transfusion Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusion
Keywords: Transfusion, Pediatric, Patient Blood Management
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 14248
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children undergoing surgery

Brief summary: The present retrospective study analyses perioperative haemotherapy in children and adolescents at the University Hospital Frankfurt.

Detailed description: In the center of the analyses are the perioperative consumption of transfused red cell concentrates, platelet concentrates and frozen fresh plasma in children and adolescents. The distribution by subject area is also examined, demographic distribution and indicators on transfusion. With the introduction of the Patient Blood Management for adults at the University Hospital in 2013 have become potentially also result in changes in transfusion practice in children, which should also be investigated.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents \<18 years
* Hospital admission
* Operation

Exclusion Criteria:

- none

Primary outcomes:
measure: Transfused red cell concentrates
timeFrame: 01.01.2010 - 31.12.2019
measure: Platelet concentrates transfused
timeFrame: 01.01.2010 - 31.12.2019
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
state: NRW
Study officials:
References:
Clinical trial NCT01914913: Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa
Official title: An Open Labeled Clinical Study to Evaluate the Safety and Efficacy OF Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Retinitis Pigmentosa. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
Bone marrow
stem cell
BMMNC
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .

Detailed description: This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy .

Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Diagnosis of retinitis pigmentosa
* willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
* To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
* willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

* Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
* Women who are pregnant or lactating
* Complications of diabetic retinopathy.

Primary outcomes:
measure: visual acuity
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Pune,
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: Chaitanya Hospital
name: ANANT E BAGUL, MS ORTHO
role: PRINCIPAL_INVESTIGATOR
References: