louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00034671: PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)
Official title: Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycoses
Keywords: Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis
Invasive Fungal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-02
Enrollment: 98
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II study will be conducted to:

1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and
2. identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.

Detailed description: This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.

The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.

Eligibility criteria: Inclusion Criteria:

* A proven, either probable or possible invasive fungal infection which is refractory to standard antifungal therapies.
* Subjects who received \>72 hours of systemic empiric antibacterial therapy and are neutropenic (\<500 neutrophils per mm3 and, have had fever that has reached an oral temperature \>38c (or \>100.4f)twice in the last 48 hours, or

have a recurrence of fever (oral temperature, \>38c or \>100.4F) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy.

* Able to take oral medication or take medication via enteral feeding tube.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ullmann AJ, Cornely OA, Burchardt A, Hachem R, Kontoyiannis DP, Topelt K, Courtney R, Wexler D, Krishna G, Martinho M, Corcoran G, Raad I. Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection. Antimicrob Agents Chemother. 2006 Feb;50(2):658-66. doi: 10.1128/AAC.50.2.658-666.2006.
Clinical trial NCT03124771: Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-40 years of age
* Weight of at least 110 lbs and less than 250 lbs or a BMI under 36 for subjects taller than 6 feet.
* Physical status of ASA I of II
* Able to read and communicate in English
* Has signed written informed consent
* Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion Criteria:

* Age less than 18 yrs and greater than 40 years
* Weight of less than 110 lbs or more than 250 lbs. or a BMI of 36 or greater for people over 6 feet tall.
* Hemoglobin less than 11 g/dL
* ASA physical status of III. IV, V.
* Pregnant
* Subject has known drug or alcohol abuse
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
* Subject has experienced a head injury with loss of consciousness within the last year.
* Subject has known neurological and psychiatric disorder that interferes with the subjects' level of consciousness.
* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
* Systolic BP \>140 mmHg or Diastolic BP \> 100 mmHg.
* Baseline heart rate \< 50 bpm.
* Inability to tolerate sitting still or minimal movement for up to 90 minutes
* Discretion of investigator

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo
state: California
Study officials:
References:
Clinical trial NCT00867971: Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Growth Hormone Treatment
Glaucoma
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children age 6-18 treated with growth hormone

Brief summary: Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.


Eligibility criteria: Inclusion Criteria:

* Age 6-18 years
* treatment with recombinant growth hormone

Exclusion Criteria:

* Underlying Chronic diseases
* Family history of eye diseases
* elevated occular pressure prior to starting treatment

Primary outcomes:
measure: Intraoccular pressure in children treated with RGH
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf harofeh medical center
Study officials:
References:
citation: Youngster I, Rachmiel R, Pinhas-Hamiel O, Bistritzer T, Zuckerman-Levin N, de Vries L, Naugolny L, Eyal O, Braunstein R, Rachmiel M. Treatment with recombinant human growth hormone during childhood is associated with increased intraocular pressure. J Pediatr. 2012 Dec;161(6):1116-9. doi: 10.1016/j.jpeds.2012.05.024. Epub 2012 Jun 23.
Clinical trial NCT04782271: Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops
Official title: Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers
Choroidal Neovascularization
Keywords: Oligonucleotide
siRNA (Small Interfering Ribonucleic Acid)
Eye Drops
wet AMD (Age-related Macular Degeneration)
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
Primary purpose: TREATMENT

Brief summary: Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) between 19.5 and 29.0 kg/m2
* Intraocular pressure (IOP) \<=21 mmHg
* Best Corrected Visual Acuity (BCVA) \>= 70 ETDRS
* Normal corneal and conjunctival assessment
* Normal funduscopy

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method
* Current relevant diseases according to the investigator's judgement.
* Previous relevant chronic processes according to the investigator's judgement
* Relevant visual alterations according to the investigator's judgement
* Administration of systemic medications
* Case history of hypersensitivity to medicinal products or any other allergic process
* Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.

Primary outcomes:
measure: Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment).
timeFrame: 72 hours after last instillation
measure: Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (7 days of treatment).
timeFrame: 72 hours after last instillation
measure: Determination of the maximum Plasma Concentration [Cmax]
timeFrame: - 15 - 30 minutes, 1- 4 and 24 hours after last administration
measure: Determination of the Area Under the Curve of plasma concentrations until the last extraction time [AUT 0-t]
timeFrame: - 15 - 30 minutes, 1- 4 and 24 hours after last administration
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Sylentis Clinical Trial Site
Study officials:
References:
Clinical trial NCT00606671: Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)
Official title: Insulin Resistance in Polycystic Ovary Syndrome (PCOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome (PCOS)
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Diabetesforeningen
name: Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland.
name: Aage Bangs Fond
First posted: 2008-02-04
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lean and obese women with and without PCOS

Brief summary: The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women that meet the Rotterdam criteria for PCOS (BMI \< 40)
* Age and BMI matched control women that do not have any signs or symptoms of PCOS

Exclusion Criteria:

* BMI \> 40. mani fest diabetes or other known diseases

Primary outcomes:
measure: insulin resistance
timeFrame: 2004-2006
Secondary outcomes:
measure: gene expression of cytokines in fatty tissue
timeFrame: 2004-2006
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
Study officials:
affiliation: Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
name: Pernille Fog Svendsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02312271: Enteral Formula Tolerance of Standard Tube Feedings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteral Feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 102
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: Adults with established enteral access receiving standard tube feeding formula

Brief summary: This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Currently tolerating enteral feeding
* Has enteral access
* Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days
* Having obtained his/her and/or his/her legal representative's informed consent.

Exclusion Criteria:

* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
* Currently participating in another conflicting clinical study that would interfere with anticipated endpoints
* Judged to be at risk for poor compliance to the study protocol.
* Lack of informed consent.

Primary outcomes:
measure: Daily percentage of caloric nutritional goal met
timeFrame: 21 days
Secondary outcomes:
measure: Daily percentage of protein goal met
timeFrame: 21 days
measure: GI tolerance
timeFrame: 21 days
measure: Adverse events and serious adverse events
timeFrame: 21 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Ottawa
country: Canada
facility: Bruyere Research Institute
state: Ontario
Study officials:
References:
Clinical trial NCT00656071: Retrospective Postoperative ARDS Study at Vanderbilt University
Official title: Intraoperative Anesthetic Characteristics and the Development of ARDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Keywords: ARDS
Acute respiratory distress syndrome
Adult respiratory distress syndrome
respiratory distress
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 89
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The surgical and post-op patients at VUMC. The collection dates will be from October 1, 2001 until August 31, 2007.

Brief summary: By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS.

Detailed description: Acute respiratory distress syndrome (ARDS) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. Extensive research has been conducted in the diagnosis and treatment of ARDS. To date, however, very little research examining the effect of the operative course on the development of ARDS has been reported. By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ARDS in surgical patients.

Eligibility criteria: Inclusion Criteria:

* ARDS
* post-surgical
* ventilator

Exclusion Criteria:

* rib fracture
* pneumonia
* sepsis

Primary outcomes:
measure: ARDS
timeFrame: data pulled from 10/2000 - 08/2007
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Christopher G Hughes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01983371: Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer
Official title: Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer.

Detailed description: This study will investigate the accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer. This study will be performed in addition to any ongoing routine care and will not serve as a substitute for any imaging tests that would be routinely performed prior to surgery.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older with histologically confirmed colorectal cancer
* Planned for surgical resection of tumor

Exclusion Criteria:

* Contraindications for MRI
* Contraindication or known allergy to ferumoxytol or parental iron products (e.g. iron sucrose, iron dextran, etc.)
* Planned chemotherapy or radiation treatment prior to surgical resection of primary tumor
* Uncontrolled serious medical illness
* Unable or unwilling to give informed consent
* Pregnancy
* Breastfeeding women
* Clinically documented or known risk of primary or secondary iron overloading including history of thalassemia, sickle cell anemia, hereditary hemochromatosis or first-degree relative with known hemochromatosis, multiple transfusions for any reason within the past 5 years, or use of over-the-counter ferrous sulfate without the supervision of his/her doctor

Primary outcomes:
measure: Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Vermont Medical Center
name: Scott E Potenta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329771: Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.
Official title: Brush Allodynia in Patients With Episodic Migraine During an Acute Attack.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-05-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy

Brief summary: Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18-65, inclusive
* Diagnosis of episodic migraine with or without aura.
* Ability to read and understand an informed consent form and study procedures

Exclusion Criteria:

* Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
* Patients who suffer from headache (of any type) 15 or more days per month
* Patients who are cognitively impaired, as determined by investigator
* Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
* Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
* Patients with skin diseases that may cause abnormal skin sensation.
* Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing

Primary outcomes:
measure: Proportion of Subjects With Allodynia During a Migraine Attack
timeFrame: allodynia assessed within 4 hours from onset of migraine head pain
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Jefferson Headache Center
name: Abraham A Ashkenazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: