louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04557605: Effects of a Face Mask on Oxygenation During Exercise
Official title: The Effects of Wearing a Face Mask During COVID-19 on Blood and Muscle Oxygenation While Performing Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.

Detailed description: There is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. The purpose of the study is to determine the effect of wearing two different types of commonly-worn face masks (diposable and cloth) during exercise on blood and muscle oxygenation. Twelve participants who are experienced with cycling will take part in this randomized cross-over study that will assess blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during a progressive step exercise test to exhaustion. The conditions include no mask, a disposable mask, and a cloth mask. Outcome variables include exercise duration, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.

Eligibility criteria: Inclusion Criteria:

* Experienced with cycling

Exclusion Criteria:

* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")

Primary outcomes:
measure: Time to exhaustion during exercise
timeFrame: Up to 20 minutes
measure: Change from baseline in peak power output
timeFrame: Up to 20 minutes
Secondary outcomes:
measure: Change from baseline in blood oxygen saturation
timeFrame: Up to 20 minutes
measure: Change from baseline in quadriceps tissue oxygenation index
timeFrame: Up to 20 minutes
measure: Change from baseline in rating of perceived exertion
timeFrame: Up to 20 minutes
measure: Change from baseline in heart rate
timeFrame: Up to 20 minutes
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip Chilibeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaw K, Butcher S, Ko J, Zello GA, Chilibeck PD. Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals. Int J Environ Res Public Health. 2020 Nov 3;17(21):8110. doi: 10.3390/ijerph17218110.
Clinical trial NCT00032305: Research Study in Patients With Severe Ulcerative Colitis
Official title: A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Keywords: Colitis
Gastrointestinal Disease
Digestive System Disease
Intestinal Disease
Colonic Disease
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2002-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Detailed description: A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Eligibility criteria: 1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.
2. Active disease despite ongoing treatment with steroids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
References:
citation: Plevy S, Salzberg B, Van Assche G, Regueiro M, Hommes D, Sandborn W, Hanauer S, Targan S, Mayer L, Mahadevan U, Frankel M, Lowder J. A phase I study of visilizumab, a humanized anti-CD3 monoclonal antibody, in severe steroid-refractory ulcerative colitis. Gastroenterology. 2007 Nov;133(5):1414-22. doi: 10.1053/j.gastro.2007.08.035. Epub 2007 Aug 21.
Clinical trial NCT02897505: Music Workshops in the EMPOWER Clinic
Official title: Evaluating the Effect of Music on Emotional Regulation Among Survivors of Sexual Violence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sex Trafficking
Sexual Violence
Trauma
Keywords: post traumatic stress disorder (PTSD)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women will be recruited from the EMPOWER clinic when they present for care; they may be given a flyer as part of their clinic entry paperwork, or approached by a study staff member in the waiting area of the clinic. Women who are clients of Sanctuary for Families may find out about the music workshops and the study through Sanctuary for Families staff, who will post flyers in their noticeboards or offices.

This study will use a repeated measures survey design to evaluate the effect of a musical workshop intervention to aid in the management of mood, anxiety, and stress among women enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence. Assessment of the feasibility and acceptability of this music intervention will be carried out on participants as they are taught to manage stress and emotions.


Eligibility criteria: Inclusion Criteria:

* Women enrolled in the EMPOWER clinic and/or Sanctuary for Families

Exclusion Criteria:

* Unwilling or unable to participate or provide informed consent.

Primary outcomes:
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Baseline to Three (3) Months
Secondary outcomes:
measure: Life Events Checklist (LEC-5):
timeFrame: Baseline to Three (3) Months
measure: Physiological and Emotion Thermometers Survey
timeFrame: Baseline to Three (3) Months
Other outcomes:
Locations:
Study officials:
affiliation: New York University Medical School
name: Veronica Ades, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02330705: Timing of HCG Administration in IUI Cycles
Official title: Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Intrauterine insemination
IUI
HCG
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 225
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Detailed description: Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.

Eligibility criteria: Inclusion Criteria:

* Mild male factor infertility or unexplained infertility.

Exclusion Criteria:

* Advanced male factor infertility.
* Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
* Endometriosis.
* Tubal disease.
* Uterine abnormalities or myoma.
* Previous uterine surgery.
* Metabolic or hormonal abnormalities.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4-6 weeks after IUI
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Fertility care unit (FCU) in Mansoura University Hospitals
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private fertility care centers
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed I Eid, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06822205: Identification and Treatment of Renal Stenosis in Transplanted Kidneys
Official title: Identification and Treatment of Renal Stenosis in Transplanted Kidneys
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Artery Stenosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endovascular treatment of renal stenosis following kidney transplantation at the Vascular Surgery Unit from January 2020 to April 2023 (retrospective phase) and from May 2023 up to 2 years from the start of the study.

Brief summary: Renal artery stenosis is a complication that may follow kidney transplantation1-5. Renal artery stenosis greater than 50% of the lumen of the artery, associated with clinical symptoms or laboratory worsening of renal function, may lead to transplant failure, however, the indications for treatment and the modalities of treatment remain, to date, a debated topic in the literature. The guidelines of the European Society of Urology recommend endovascular treatment as the first-line treatment by means of angioplasty and/or stent placement6. A recent review of the literature7 examined the results of 56 studies: the results fully support endovascular treatment of the disease which appears to be effective and with a low rate of complications.

Detailed description: The primary objectives of the study are to evaluate the efficacy (in terms of technical success and graft salvage) and safety (in terms of complications) of endovascular treatment using stenting in patients with renal artery stenosis following kidney transplantation.

Patients undergoing endovascular treatment of renal stenosis following kidney transplantation at the Vascular Surgery Unit from January 2020 to April 2023 (retrospective phase) and from May 2023 up to 2 years from the start of the study.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Indication of renal transplant and diagnosis of renal artery stenosis of the transplant
* Obtaining informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Reduction of stenosis
timeFrame: From the first patient enrolled up to the 30th patient, an average of 3 years
measure: Renal function improvement
timeFrame: From the first patient enrolled, up to the 30th patient. An average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna Policlinico di Sant'Orsola
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Mauro Gargiulo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00422305: Assessment of Lung Structure and Function of Infants Born Prematurely
Official title: Assessment of Lung Structure and Function of Infants Born Prematurely
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Bronchopulmonary Dysplasia
Asthma
Keywords: Infant, Premature
Bronchopulmonary dysplasia
asthma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-01-15
Enrollment: 104
Sex: ALL
Minimum age (years): 2
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from Infant Lung Disease Clinics at Riley Hospital, flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for Children, Indiana University and Methodist Hospital.

Brief summary: The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.

Detailed description: SPECIFIC AIM #1:

Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.

We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.

SPECIFIC AIM #2:

Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.

We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.

Eligibility criteria: Inclusion Criteria:

Group 1:

* 37 weeks or greater gestational age
* Age 2 to 36 months

Group 2:

* 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
* Age 2-36 months

Group 3:

* 23-35 weeks gestational age

Exclusion Criteria:

Group 1 and Group 2:

* Congenital cardio-respiratory disease
* Hospitalization for respiratory illness
* Treatment with asthma medications
* Small for gestational age at birth

Group 3:

* Congenital cardio-respiratory disease
* Severe developmental delay

Primary outcomes:
measure: Pulmonary Function Testing
timeFrame: day of testing
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Robert S. Tepper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02835105: A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clostridium Difficile Associated Diarrhea (CDAD)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2016-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.


Eligibility criteria: Inclusion Criteria:

* Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease or gastroesophageal reflux disease documented on endoscopy
* Electrocardiogram (ECG) shows no clinically significant abnormalities
* Is able to swallow capsules
* is in good health

Exclusion Criteria:

* Pregnant or lactating females
* Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
* Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
* Participants 18 to 49 years of age had taken any regular, prescribed, or over-the-counter medication
* Has any significant concurrent therapies
* Has a positive drug screen
* Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
* Has given more than 450 mL of blood (one unit) in the 60 days preceding screening
* Is an active intravenous drug user or abuses alcohol
* Has had a malignancy within the last 5 years
* Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
* Has received any antibiotics within 30 days prior to first dose of study drug
* Has been hospitalized within the past 30 days prior to Study Day 1
* Has known hypersensitivity to daptomycin

Primary outcomes:
measure: Number of participants with an Adverse Event (AE)
timeFrame: Up to Day 9
measure: Number of participants who discontinued study due to an AE
timeFrame: Up to Day 9
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chandorkar G, Zhan Q, Donovan J, Rege S, Patino H. Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers. BMC Pharmacol Toxicol. 2017 Mar 28;18(1):24. doi: 10.1186/s40360-017-0123-z.
Clinical trial NCT02540005: Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
Official title: Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysmatic Subarachnoid Haemorrhage
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2015-09-03
Enrollment: 32
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: Acute aneurysmal subarachnoid haemorrhage patients

Brief summary: The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)
* Onset of symptoms ≤ 12 hours
* Expected to stay 72 hours in the ICU

Exclusion Criteria:

* Pregnancy
* Any long-term anticoagulant medication, except for low-dose aspirin (\<150 mg/day)
* Known active cancer

Primary outcomes:
measure: ROTEM analysis: MCF (mm) by EXTEM activators
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
References:
Clinical trial NCT01744405: Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
Official title: Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Lactation
Keywords: Chagas disease
lactation
breastmilk
postpartum period
infants
pediatric clinical pharmacology
developmental clinical pharmacology
parasitology
trypanosoma cruzi
nifurtimox
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of young women with Chagas disease referred to our center for evaluation and treatment

Brief summary: The investigators propose to study the transfer of nifurtimox into breastmilk of lactating women who receive the drug for the treatment of Chagas disease.

Breastmilk and blood samples will be obtained from these patients at pre-specified times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by these women to nifurtimox. This study will help clarify safety of continuing breastfeeding while receiving treatment with nifurtimox for Chagas disease.


Eligibility criteria: Inclusion Criteria:

* Lactating women with Chagas disease, not treated before
* Use of contraception

Exclusion Criteria:

* History of allergy to nifurtimox or its excipients
* Pregnancy
* Significant heart involvement (due to Chagas disease)
* Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator

Primary outcomes:
measure: Nifurtimox concentration in breastmilk and in plasma
timeFrame: at randomly selected, pre-specified, time points during the 30 days of treatment
Secondary outcomes:
measure: Incidence of adverse drug reactions in women treated with nifurtimox during lactation
timeFrame: throughout the 30 days of treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Study officials:
affiliation: Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
name: Facundo Garcia Bournissen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Gonzalez N, Ballering G, Altcheh J, Garcia-Bournissen F. Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease. PLoS Negl Trop Dis. 2019 Aug 15;13(8):e0007647. doi: 10.1371/journal.pntd.0007647. eCollection 2019 Aug.