louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03778190: Magnet for Corneal Foreign Bodies
Official title: The Use of a Magnet to Remove Corneal Foreign Bodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Foreign Body
Lead sponsor: Kendall Healthcare Group, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nova Southeastern University
First posted: 2018-12-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, interventional study to assess the effectiveness and safety of a commercially available "eye magnet" to remove corneal foreign bodies.

Detailed description: The vast majority of corneal foreign bodies are metallic and thus are frequently ferromagnetic. Consequently, it may be possible to use a magnet to remove most corneal foreign bodies. There are commercially available products for removing corneal foreign bodies, but there are no published studies assessing these devices.

This will be a prospective interventional study to assess the use of an eye magnet for the removal of metallic corneal foreign bodies in the emergency department.

After the patient signs written, informed consent, the physician will attempt to remove the corneal foreign body with the North by Honeywell 326734G Eye Magnet with Loop. If the physician is unable to remove the corneal foreign body with the magnet, he or she may proceed with standard care.

The treating physician will fill out a brief data collection form for each patient to track various outcomes as discussed below.

Eligibility criteria: Inclusion Criteria:

* present to the emergency department with a metallic corneal foreign body

Exclusion Criteria:

* prisoners
* pregnant women
* have pacemakers or metallic facial implants
* possible globe rupture

Primary outcomes:
measure: Success Rate
timeFrame: 5 minutes.
Secondary outcomes:
measure: Epithelial Damage
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
Study officials:
affiliation: Kendall Healthcare Group, Ltd.
name: Tony Zitek, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06331390: Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis
Official title: Randomized Controlled Trial of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contact Dermatitis
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days

Detailed description: The efficacy of niacinamide cosmetic product on contact dermatitis will be evaluated using Courage Khazaka device and probes for hydration, redness and transepidermal water loss

Eligibility criteria: Inclusion Criteria:

* young, healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation

Primary outcomes:
measure: tewameter
timeFrame: day 1- day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: USSM
name: JOSIPA BUKIĆ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01241890: Prevention of CF Exacerbation in Childhood: PREVEC Study
Official title: Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Children
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds
Home Monitoring
Quality of Life
Keywords: Cystic Fibrosis
Children
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds
Home monitoring
Quality of life
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: NCFS
name: Chiesie Pharmaceuticals B.V.
First posted: 2010-11-16
Enrollment: 49
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with Cystic Fibrosis

Brief summary: Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.


Eligibility criteria: Inclusion Criteria:

* CF disease is defined as the combination of:

  1. characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea);
  2. and/or abnormal sweat test (Chloride \> 60mM);
  3. and/or two CF mutations.

Exclusion Criteria:

1. cardiac abnormalities;
2. mental retardation;
3. no technical satisfactory performance of measurements;
4. on the waiting list for lung transplantation;
5. non-compliance with the home-assessments;
6. patients with Burkholderia Cepacia;
7. participation in another intervention trial.

Primary outcomes:
measure: Number of exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Utrecht
country: Netherlands
facility: University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: E Dompeling, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00125190: Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Official title: Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With Primary IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Insulin-Like Growth Factor-1 Deficiency
Growth Disorders
Keywords: Primary IGF-1 Deficiency
IGF-1
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-07-29
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

Detailed description: Growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (\<-2 standard deviations \[SDs\] below the mean for age and gender), and abnormal serum IGF-1 (\<-2 SDs below the mean for age and gender).

The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.

Eligibility criteria: Inclusion Criteria:

* Chronological age ≥ 3
* Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls
* Prepubertal at Visit 1
* Height SD score of \< -2
* IGF-1 SD score of \< -2

Exclusion Criteria:

* Prior treatment with GH, IGF-1, or other growth-influencing medications
* Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
* Chronic illness such as diabetes, cystic fibrosis, etc.

Primary outcomes:
measure: Height Velocity From Pretreatment (Week 0) to Week 34
timeFrame: Pretreatment to Week 34
measure: Height Velocity From Week 34 to 86
timeFrame: Week 34 to 86
Secondary outcomes:
measure: Change in Height SD Score From Pretreatment to Week 34
timeFrame: Pretreatment and Week 34
measure: Change in Height SD Score From Pretreatment to Week 86
timeFrame: Pretreatment and Week 86
measure: Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age
timeFrame: Pretreatment to Week 86
measure: Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86
timeFrame: Pretreatment and Week 86
measure: Percent Change in Serum Concentration of ALS From Pretreatment to Week 86
timeFrame: Pretreatment and Week 86
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Ipsen
state: California
Study officials:
affiliation: Ipsen
name: Ipsen Study Director, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00572390: Oestrogen Withdrawal in Hypopituitary Women
Official title: Oestrogen Withdrawal in Hypopituitary Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypopituitarism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: By exploring hormonal status in hypopituitary women during oestrogen treatment and without estrogen substitution the influence on sexhormones and organ function is estimated.

Detailed description: 38 hypopituitary women were examinined twice. During oestrogen treatment and after 1 month estrogen withdrawal. A control group of healthy women were examined once.Antropometric data and hormonal parameters were collected.

Eligibility criteria: Inclusion Criteria:

* Hypopituitarism

Primary outcomes:
measure: androgens, IGF-I, body composition, liver enzymes,
timeFrame: 1 month
Secondary outcomes:
measure: Grehlin, adiponection, leptin
timeFrame: 1 month
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Århus Universityhospital
Study officials:
affiliation: Århus Universityhospital
name: Jens J Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Host C, Christiansen JJ, Christiansen JS, Jorgensen JO, Gravholt CH. Discontinuation of hormone replacement therapy in young GH-treated hypopituitary women increases liver enzymes. Growth Horm IGF Res. 2010 Feb;20(1):26-30. doi: 10.1016/j.ghir.2009.07.001. Epub 2009 Aug 5.
Clinical trial NCT03152890: Insulin Therapy for Postreperfusion Hyperglycemia
Official title: Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hyperglycaemia (Diabetic)
Liver Transplantation
Keywords: Insulin
Liver transplantation
Hyperglycemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
Primary purpose: TREATMENT

Brief summary: Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.

Detailed description: Hyperglycemia is common during liver transplantation ,especially after graft reperfusion. Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. The primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation.

In the retrospective study, adult liver recipients (\>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. The relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia.

In the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. The frequency and magnitude of glucose reduction is the primary outcome. The secondary outcome is the incidence and degree of hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* Liver recipients who showed hyperglycemia (blood glucose \>180mg/dL) after reperfusion of liver graft.

Exclusion Criteria:

* pediatric patients

Primary outcomes:
measure: Change of blood glucose level 20 minutes after insulin administration
timeFrame: 20 minutes after insulin administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532090: A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
Official title: Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic solid tumor malignancy;
* measurable or evaluable disease;
* ECOG performance status 0 or 1.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
* major surgery within 28 days of first receipt of study drug.

Primary outcomes:
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Secondary outcomes:
measure: Tumor assessments
timeFrame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
measure: Pharmacokinetic profile
timeFrame: After first dose and last dose (or day 15) of cycles 1 and 2
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: New Brunswick
country: United States
state: New Jersey
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00828490: Electronic Pharmacotherapy Risk Management
Official title: Developing a Utah Pharmacotherapy Risk Management System With an Electronic Surveillance Tool (Utah ePRM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Mental Health
Pain
Keywords: Fraud and Abuse
opioids
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Utah Department of Health
First posted: 2009-01-26
Enrollment: 174000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all medicaid recipients in the salt lake area

Brief summary: The purpose of the Utah ePRM (electronic Pharmacotherapy Risk Management) project is to improve quality and safety of medication use while simultaneously controlling costs and detecting fraud and abuse.

Detailed description: The ePRM project has two objectives:

1. Refine and implement a computerized surveillance and trigger tool to support medication therapy and risk management services. The ePRM tool will be used to (1) identify potential drug-therapy problems, which include quality, safety and cost-related problems; (2) select patients and providers for in-depth clinical reviews and possibly direct intervention (i.e., letter, phone call, Medication Therapy Management Services (MTMS), or Academic Detailing); (3) identify potential fraud and diversion of controlled substances; and (4) track patterns of medication use and evaluate ePRM performance, identify improvements, and direct policy change.
2. Conduct innovative multi-pronged interventions that are guided by the ePRM trigger tool. Clinical areas chosen for review include diabetes therapy, hypertension, asthma, antipsychotic therapy, pain management (opioid narcotics and anticonvulsants) and anticoagulation/antiplatelet drugs. Interventions in these areas will address potential under and overuse, or patient safety concerns. Clinical pharmacists and physicians will implement five types of inter-related interventions: a) provider level reviews, which includes prescribers' profiling and feedback for outlier prescribers; b) patient level reviews and letters to prescribers for high-risk patients; c) phone consultation and Academic Detailing with outlier prescribers; d) MTMS; and e) detecting and pursuing suspected fraud and abuse cases.

Eligibility criteria: Inclusion Criteria:

* All medicaid recipients and providers with in the salt lake area

Exclusion Criteria:

* each participant much be a Medicaid recipient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Multi-clinic site
state: Utah
Study officials:
affiliation: VASLCHCS
name: Jonathan R Nebeker, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Gary Oderda, PharmD, M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00798590: The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
Official title: The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Critically Ill
Hypoglycemia
Keywords: Intensive insulin therapy (IIT)
Insulin infusion
Tight glycemic control
Intensive Care Units
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Society of Critical Care Medicine
First posted: 2008-11-26
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.

Detailed description: All patients whom on admission to the ICU (surgical, burn, \& cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.

Eligibility criteria: Inclusion Criteria:

* Men and women age \> 21 to 75 years of age.
* All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
* Able to obtain patient or proxy consent.

Exclusion Criteria:

* Current diagnosis of malignancy.
* Type 1 diabetes.
* Inability to obtain informed consent.
* On any Phase 1 trial.

Primary outcomes:
measure: To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
timeFrame: 2 years
Secondary outcomes:
measure: Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dariush Elahi, PhD
role: PRINCIPAL_INVESTIGATOR
References: