louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00571467: Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
Official title: An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Idiopathic Thrombocytopenic Purpura (ITP)
Keywords: Autoimmune Diseases
Bleeding Disorders
Blood and Blood Disorders
Lead sponsor: Protalex, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-12
Enrollment: 9
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: The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied.

Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic ITP \> 4 months
* Mean platelet count \<50 x 10\^9/L for patients not receiving corticosteroids; or mean platelet count \>=50 x 10\^9/L for patients receiving stable dose of corticosteroids

Exclusion Criteria:

* Splenectomy within 45 days of screening
* Rituximab within 6 months prior to screening
* Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening
* IVIG, WinRho or other anti-RhD within 30 days prior to screening

Primary outcomes:
measure: Evaluate the overall safety of PRTX-100 during the 3 month study duration
timeFrame: 3 months
Secondary outcomes:
measure: Characterize the pharmacokinetics of multiple doses of PRTX-100
timeFrame: over the first 35 days
measure: Explore immunogenicity of multiple doses of PRTX-10
timeFrame: 3 months
measure: Evaluate treatment effect on platelet count
timeFrame: 3 months
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Sydney
country: Australia
facility: St. George Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane
state: Queensland
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fremantle
country: Australia
facility: Freemantle Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
state: Auckland
Study officials:
affiliation: Protalex, Inc.
name: Edward Bernton, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01883167: RDEA3170 and Febuxostat Drug Interaction Study
Official title: A Phase 1 Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Febuxostat in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.


Eligibility criteria: Inclusion Criteria:

* body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values, per the Investigator's judgment.
* a screening serum urate level ≥ 4.5 mg/dL.

Exclusion Criteria:

* history or suspicion of kidney stones.
* history of cardiac abnormalities as assessed during screening, including abnormal and clinically relevant electrocardiogram changes and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years.
* undergone major surgery within 3 months prior to Day 1.
* donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening Period.
* inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: PK profile of RDEA3170 from plasma and urine and febuxostat from plasma
timeFrame: Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only)
Secondary outcomes:
measure: PD profile of RDEA3170 and febuxostat alone and in combination
timeFrame: Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only)
measure: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kalamazoo
country: United States
state: Michigan
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S. Baumgartner
role: STUDY_DIRECTOR
References:
citation: Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19.
Clinical trial NCT06529367: Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children
Official title: Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Home Vision
Office-Based Snellen Visual Acuity
Myopic Children
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional study will be carried out on 80 myopic children aged ≤ 18 years, who completed the home visual acuity test and have a subsequent office-based VA test at South Valley University for a period from July 2024 to January 2025 after approval from the institutional ethical committee.

Brief summary: This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.

Detailed description: Visual impairment is an important public health issue worldwide, with a heavy socioeconomic burden. More than 400 million people globally have mild to severe visual impairment.

Visual acuity (VA) screening is the most basic part of ophthalmic examination. Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Knowing a patient's VA can help ophthalmologists remotely triage acute calls, monitor visual recovery after medical or surgical interventions, and ensure visual stability in follow-up telemedicine visits.

Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Numerous electronic home vision assessment tools exist, but many of these are used through applications on mobile or tablet devices.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 18 years.
* Both sexes.
* Patients who completed the home visual acuity test and have a subsequent office-based visual acuity test.

Exclusion Criteria:

* Last in-office visual acuity of 20/125 or worse in both eyes (to allow for a buffer of at least 2 lines of vision from the upper limit of 20/200 on the home vision assessment).
* Lack of access to MyChart.
* History of keratopathy, cataract, glaucoma, retinal detachment, neuro-ophthalmic disease, or other eye diseases.
* History of ophthalmic surgery or trauma.
* History of systemic diseases.
* Severe psychological or psychiatric diseases.

Primary outcomes:
measure: Agreement of visual acuity between office and home
timeFrame: immediately after test performing
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
References:
Clinical trial NCT01438567: A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
Official title: A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Constipation
Keywords: oxycodone naloxone combination
severe chronic and non-malignant pain
Malignant and non-malignant pain that requires around-the clock opioid therapy
Opioid related constipation
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

Detailed description: The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.

Eligibility criteria: Inclusion Criteria

* Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
* Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

Exclusion Criteria

* Females who are pregnant or lactating.
* Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study.

Primary outcomes:
measure: Bowel function Index (BFI)
timeFrame: 5 weeks and a 6 month extension
Secondary outcomes:
measure: Pain Intensity Scale (PIS)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Ballygomartin Group Practice
Study officials:
References:
Clinical trial NCT04979767: Function of Circulating Exosomes in Sepsis-induced Immunosuppression
Official title: Function of Circulating Exosomes in Sepsis-induced Immunosuppression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Sepsis Syndrome
Sepsis Bacterial
Sepsis, Severe
Sepsis Bacteremia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2021-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized adult patients admitted to the intensive care unit with sepsis

Brief summary: This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.


Eligibility criteria: Inclusion Criteria:

* ≥ 50 years with ≥ 2 chronic comorbidities
* Highly suspected bacterial infection based on clinical or radiologic evidence
* ≥ 2 systemic inflammatory response syndrome (SIRS) criteria
* Actual/anticipated admission to intensive care unit (ICU)
* Anticipated length of hospital stay ≥ 5 days

Exclusion Criteria:

* Pregnancy
* Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
* Current immunotherapy use
* Confirmed COVID-19 infection

Primary outcomes:
measure: 28-day mortality
timeFrame: From enrollment to 28 days
Secondary outcomes:
measure: Hospital mortality
timeFrame: From enrollment until hospital discharge, up to 90 days
measure: 90-day mortality
timeFrame: From enrollment to 90 days
measure: Length of stay
timeFrame: From enrollment until hospital discharge, up to 90 days
measure: Duration of infection
timeFrame: From enrollment until resolution of SIRS, up to 90 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Nicholas S Britt, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670967: Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials
Official title: Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, hypertensive, hypercholesterolaemic, diabetic

Brief summary: The present study conducted a meta-analysis of 22 randomly controlled trials to assess the effects of soluble fiber intake on blood pressure in human subjects.

Using the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and meta-analysis was conducted. Information regarding study methods, characteristics, mean BP and standard deviations were extracted The data from each study were pooled using a random effects model to estimate the effects of soluble fiber consumption on blood pressure.


Eligibility criteria: Inclusion Criteria:

* Randomized Controlled Trials
* Parallel or Crossover Design
* Duration: \>3 weeks
* Human trials
* Viscous (soluble) fiber
* Viable endpoint data
* Articles published in English

Exclusion Criteria:

* Non-human
* Non-randomized
* Lack of control
* Less than 4 weeks in duration
* No viable endpoint data

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 4 weeks
measure: Diastolic Blood Pressure
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Kashif Khan, BSc
role: STUDY_DIRECTOR
References:
citation: Khan K, Jovanovski E, Ho HVT, Marques ACR, Zurbau A, Mejia SB, Sievenpiper JL, Vuksan V. The effect of viscous soluble fiber on blood pressure: A systematic review and meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2018 Jan;28(1):3-13. doi: 10.1016/j.numecd.2017.09.007. Epub 2017 Oct 7.
Clinical trial NCT04158167: Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study
Official title: Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After completion of clinical and cognitive assessments, all subjects will undergo a baseline fMRI scan. Later subjects will receive24IU oxytocin and saline placebo in counterbalanced order on two separate days and undergo repeat fMRI scans.
Primary purpose: OTHER

Brief summary: To investigate whether 24IU oxytocin can result in changes in functional brain connectivity in patients with schizophrenia and healthy individuals using functional magnetic resonance imaging (fMRI). The study will also examine the effect of oxytocin receptor gene polymorphism on the functional connectivity


Eligibility criteria: Inclusion and Exclusion Criteria:

Schizophrenia subjects:

Inclusion criteria 1) Males between 18 and 50 years 2) Diagnosis of DSM-IV schizophrenia, schizoaffective or schizophreniform disorder 3) capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research Exclusion criteria

1. General impairment in intellectual functioning
2. History of alcohol or substance dependence in the last 12 months (with the exception of nicotine)
3. Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
4. Past history of head injury resulting in loss of consciousness or neurosurgery
5. Concomitant severe medical conditions
6. Metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.

Healthy volunteers:

Inclusion criteria

1. Males between 18 and 50 years
2. Capacity to provide informed consent Exclusion criteria

1) Life-time diagnosis of psychiatric illnesses including substance abuse 2) General impairment in intellectual functioning 3) Past history of head injury resulting in loss of consciousness or neurosurgery 4) Concomitant severe medical or neurological conditions 5) Metal implants or paramagnetic objects or claustrophobia 6) Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member (sibling, parent or offspring) 7) Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma.

Primary outcomes:
measure: fMRI changes with oxytocin
timeFrame: Upto 90 minutes after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: National Institute of Mental Health and Neurosciences
state: Karnataka
Study officials:
References:
Clinical trial NCT03675867: Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers
Official title: Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Childhood
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 59
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese teenagers with previous PFT available in the medical record

Brief summary: In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer.

We wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.


Eligibility criteria: Inclusion Criteria:

* Children aged \>12 y.o and \<18 y.o
* BMI \> 30
* with a previous pulmonary function test (PFT) available in the medical record

Primary outcomes:
measure: Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Bruno Degano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426867: A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Official title: A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
Brinzolamide
Brimonidine
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent document.
* Diagnosis of open-angle glaucoma or ocular hypertension
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
* Severe central vision loss in either eye.
* Any chronic or recurrent inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or ocular inflammation within the preceding 3 months.
* Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
* Any intraocular surgery within the preceding 6 months.
* Any ocular laser surgery within the preceding 3 months.
* History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Ocular Discomfort Score
timeFrame: Week 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Ravaughn Williams, OD, MS
role: STUDY_DIRECTOR
References: