louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03637218: Acute Exposure of High Altitude on Cardiac Output
Official title: Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: High Altitude
non-invasive cardiac output
Finapres
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments at Low altitude and High altitude
Primary purpose: PREVENTION

Brief summary: Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response High Altitude (Säntis; 2500m above sea level) on non-invasive cardiac output assessments by Finapres® NOVA Technology at rest and under exercise

Detailed description: Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure High Altitude (2500m) and Low Altitude (Zurich; 470m) up to 5 hours, the participants cardiac output non-invasively assessed will be measured repetitive during the whole intervention.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Cardiac Output measured non-invasively
timeFrame: Averaged over two minutes rest and 30 seconds end of exercise (exhaustion)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807118: Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 3-Way Crossover Study To Determine Bioequivalence Of 4 Mg And 8 Mg Fesoterodine SR Tablet Of Commercial Formulation And 8 Mg Fesoterodine SR Tablet Between Formulation E(1) And Formulation F And Investigate Food Effect On Commercial Formulation In Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Food
Keywords: bioequivalence, food effect
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 108
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy male subject

Exclusion Criteria:

* Evidence or history of clinically significant findings at screening

Primary outcomes:
measure: AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition
timeFrame: Day 1 and 2
measure: AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition
timeFrame: Day 1 and 2
measure: AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1)
timeFrame: Day 1 and 2
Secondary outcomes:
measure: Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment
timeFrame: Day 1 and 2
measure: AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II
timeFrame: Day 1 and 2
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03546218: Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position
Official title: Immediate Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position: A Randomized Controlled Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kibi International University
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 24 years of age
* Males and Females

Exclusion Criteria:

* Person with physical disability that is enough to interfere with daily life

Primary outcomes:
measure: Multi-Directional Reach Test
timeFrame: Baseline and immediately after the intervention protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Takahashi
country: Japan
facility: Kibi International University
state: Okayama
Study officials:
References:
citation: Azukizawa K, Hirose K, Morigami Y, Higashi N, Uchida H, Hirao K. Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial. Ann Med. 2021 Dec;53(1):1402-1409. doi: 10.1080/07853890.2021.1968483.
Clinical trial NCT03578718: Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations
Official title: Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatologic Disease
Pediatric ALL
Collaboration
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients Under 18 years old consulting for a dermatological problem in emergency department or in a private pediatric consultation

Brief summary: Dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice.

The principal aim is to estimate the degree of concordance of the main diagnosis between a pediatrician and a pediatric dermatologist.

The secondary aims is to estimate the degree of concordance of the treatment, advices and follow-up.


Eligibility criteria: Inclusion Criteria:

* Under 18 years old
* consultating for dermatologic problem in emergency department (1 department) or private pediatric center (1 center)
* signed consent
* consécutives consultations

Exclusion Criteria:

* no consent

Primary outcomes:
measure: principal diagnosis
timeFrame: baseline
Secondary outcomes:
measure: treament
timeFrame: baseline
measure: advices
timeFrame: baseline
measure: follow-up
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00687518: Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
Official title: Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron Metabolism Disorders
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2008-05-30
Enrollment: 14
Sex: MALE
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: The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* male aged 18 - 30
* normal routine laboratory values
* normal ECG
* normal iron status

Exclusion Criteria:

* C282Y mutation of the HFE gene
* alcohol or tobacco consumption

Primary outcomes:
measure: serum hepcidin levels
timeFrame: over 24 hours
Secondary outcomes:
measure: urinary hepcidin levels
timeFrame: over 24 hours
measure: serum iron and ferritin levels
timeFrame: over 24 hours
Other outcomes:
Locations:
city: Rennes
country: France
facility: Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Fabrice LAINE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RennesUniversity Hospital
name: Bruno LAVIOLLE, MD
role: STUDY_CHAIR
References:
citation: Laine F, Laviolle B, Ropert M, Bouguen G, Morcet J, Hamon C, Massart C, Westermann M, Deugnier Y, Loreal O. Early effects of erythropoietin on serum hepcidin and serum iron bioavailability in healthy volunteers. Eur J Appl Physiol. 2012 Apr;112(4):1391-7. doi: 10.1007/s00421-011-2097-7. Epub 2011 Aug 5.
Clinical trial NCT03522818: Enuresis Alarm - Is a Manual Trigger System Beneficial?
Official title: Enuresis Alarm - Is a Manual Trigger System Beneficial?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enuresis, Nocturnal
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: PottyMD
First posted: 2018-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.

Detailed description: Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.

Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.

Participants must first be evaluated by a pediatric urology specialist.

Eligibility criteria: Inclusion Criteria:

* children ages 5-15 years
* Diagnosis of Primary Monosymptomatic Nocturnal Enuresis
* \>2 wet nights per week
* Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire
* Patients/parents compliance in recording data \> 50% of nights

Exclusion Criteria:

* Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery
* Concomitant DDAVP use, anticholinergic use, B3 agonist use

Primary outcomes:
measure: Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Gina M Lockwood, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01887418: Pharmacokinetic Study of Testosterone Enanthate
Official title: 3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone enanthate
Lead sponsor: Antares Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Detailed description: Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Eligibility criteria: Inclusion Criteria:

* Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Exclusion Criteria:

* Normal testosterone levels
* Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study

Primary outcomes:
measure: The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
measure: The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
measure: The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
Secondary outcomes:
measure: Number of Patients in the PK Parameter Category
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Mens Health Boston
state: Massachusetts
Study officials:
affiliation: Prestige Clinical Research
name: Gary Bedel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193518: Arsenic Trioxide in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title: A Phase II Trial Of Arsenic Trioxide (TRISENOX) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: CTI BioPharma
First posted: 2005-09-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Additional active agents are needed to further improve the treatment of patients with CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other hematologic malignancies. Since arsenic trioxide produces mild to moderate myelosuppression and is not as immunosuppressive as other available agents, it may be an additional treatment option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide in patients with relapsed or refractory CLL/SLL

Detailed description: Upon determination of eligibility, patients will receive:

* Arsenic Trioxide

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically proven B-cell CLL/SLL.
* Must have had a minimum of 1 and a maximum of 3 previous systemic regimens
* Must have progressive CLL/SLL
* Measurable or evaluable disease
* ECOG performance status 0, 1, or 2
* Age \> 18 years.
* Patients with cytopenias caused by bone marrow involvement are eligible
* All patients must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Unstable active infection on the basis of neutropenia
* Previous severe opportunistic infections
* Severe immune mediated anemia or thrombocytopenia
* Serious underlying medical conditions
* Brain metastases or meningeal involvement
* History of other neoplasms
* Significant underlying heart dysfunction
* Women who are pregnant or

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Progression-free survival
measure: Toxicity
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906918: Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries
Official title: Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Keywords: ischemia
reperfusion
myocardial ischemia
myocardial reperfusion
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Scheduled for coronary artery bypass grafting with or without valve replacement associated
* Use of blood cardioplegia
* EuroSCORE II greater than or equal to 1.0%

Exclusion Criteria:

* History of cardiogenic shock
* Complications in the admission
* Pregnant patients
* Severe peripheral arterial disease affecting the upper limbs
* Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)
* Significant pulmonary disease (˂ FEV1 40%)
* Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²
* Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)

Primary outcomes:
measure: Molecular pathway activation
timeFrame: 2 days
measure: Inflammatory response
timeFrame: 10 days
Secondary outcomes:
measure: All cause of mortality
timeFrame: 30 days
measure: All cause of mortality
timeFrame: 180 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital das Clínicas da Unicamp
state: Sao Paulo
Study officials:
affiliation: University of Campinas
name: Orlando Petrucci, MD, PhD
role: STUDY_CHAIR
affiliation: University of Campinas
name: Fany Lima, RN
role: PRINCIPAL_INVESTIGATOR
References: