louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06599788: Work Design Interventions for Heat Resilience
Official title: Work Design Interventions for Heat Resilience
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperthermia
Fatigue; Heat
Work-Related Condition
Keywords: hyperthermia
worker
fatigue
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles.

Participants will come to the lab a total of six times. During four of the visits participants will complete a box lifting task, simulating loading and unloading a delivery truck. This will take place in a hot and humid room to simulate being outdoors during the summer.


Eligibility criteria: Inclusion Criteria:

* 40-65 years old

Exclusion Criteria:

* Musculoskeletal injury that would impact the ability to safely perform the trial
* Cardiovascular, metabolic, respiratory, renal, or neurologic conditions that would impact the ability to safely perform the trial

Primary outcomes:
measure: Cardiac Troponin
timeFrame: 2 hours following work protocol, approximately 6 hours into the trial
measure: Maximum Core Temperature
timeFrame: End of work protocol, approximately 4 hours into the trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04445688: Crossover Trial of AD036 in Obstructive Sleep Apnea
Official title: Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 62
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

Detailed description: The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.

Eligibility criteria: Inclusion Criteria:

* Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
* AHI 10 to \<20, or AHI ≥20 if meets PSG criteria

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: 1 day
Secondary outcomes:
measure: Hypoxic Burden
timeFrame: 1 day
measure: ODI
timeFrame: 1 day
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Santa Ana
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Chevy Chase
country: United States
facility: The Center for Sleep and Wake Disorders
state: Maryland
city: Chesterfield
country: United States
facility: Sleep Medicine & Research Center, St. Luke's Hospital
state: Missouri
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
Study officials:
References:
citation: Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13.
Clinical trial NCT02996188: Acute Hemodynamic Changes During Paracentesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tense Ascites
Liver Cirrhosis
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing routine therapeutic paracentesis due to refractory tense ascites at a university hospital.

Brief summary: The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.


Eligibility criteria: Inclusion Criteria:

* refractory tense ascites with indication for therapeutic paracentesis

Exclusion Criteria:

* pregnancy
* inability to give inform consent
* inability to perform rebreathing maneuver

Primary outcomes:
measure: change in cardiac output
timeFrame: 30 minutes
measure: change in systemic vascular resistance
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00961688: The Impact of Polycystic Ovary Syndrome (PCOS) on Quality of Life and Healthcare Beliefs
Official title: The Impact of PCOS on Quality of Life and Healthcare Beliefs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
polycystic ovary syndrome
Polycystic ovarian syndrome
infertility
ovulation
Lead sponsor: Georgia Reproductive Specialists
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55

Brief summary: Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55 are being recruited to participate in an online survey to determine the impact of PCOS on quality of life and interaction with the healthcare system. This online survey will take 15-20 minutes to complete. Participants will receive no direct benefit, but the information provided will contribute to the knowledge of this condition and the development of improved healthcare for women with PCOS. For more information or to participate in this study, please visit http://pcossurvey.vze.com


Eligibility criteria: Inclusion Criteria:

* Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Reproductive Specialists
state: Georgia
Study officials:
affiliation: Georgia Reproductive Specialists
name: Mark Perloe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328388: A Study to Evaluate the Effect of Lycomato on Skin Attributes in Healthy Participants.
Official title: A 12-week Clinical Study to Evaluate the Efficacy of Oral Lycomato Supplement on Skin Health and Appearance in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin
Lead sponsor: LycoRed Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will be performed with oral gels, with up to 55 study subjects who meet the inclusion and non-inclusion criteria required. Study subjects will be instructed to use the products during 12 weeks and they will be assessed and supervised throughout the study by clinic technicians, in order to check for possible adverse events. Efficacy documentation through digital photography, instrumental measurements with the devices Cutometer® MPA 580 and Tewameter®, image acquisition with Visia-CA® as well as self-assessment through questionnaires will be carried out.


Eligibility criteria: Inclusion Criteria:

1. Females in good general health, and between ages of 35 and 55 years old, inclusive at enrollment;
2. 50 subjects: 20 Caucasians + 10 Asians + 10 African Americans + 10 Latinos;
3. All Fitzpatrick skin types being II, III and IV for Caucasian/Asian;
4. Subjects to have Glogau skin classification of photoaging, Type 2;
5. Subjects with baseline signs of facial skin aging as conformed by visual expert grading of photographs

Exclusion Criteria:

1. Subjects participating in any other clinical studies;
2. Subjects that underwent beauty injections/ deep pealing/ cosmetic surgery/ tanning- for 3 months before study starts and for all the study duration.
3. Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes. Typical uncontrolled chronic or serious diseases and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes (insulin dependent), renal impairment, mental illness, drug/alcohol addiction;
4. Unreliable or unlikely to be available for the duration of the study;
5. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.;
6. Immunocompromised subjects

Primary outcomes:
measure: Expert clinical grading of efficacy attributes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Media Lab Science
state: California
Study officials:
References:
Clinical trial NCT03596788: Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running
Official title: Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anomalies Gastrointestinal
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Several previous studies have shown that repeatedly ingesting carbohydrate supplements during exercise training sessions, over a period of days and weeks, can gradually increase carbohydrate oxidation and reduce gut discomfort during exercise. However, repeatedly ingesting large amounts of carbohydrate during training sessions can be burdensome and can cause gut distress. Thus, it would be advantageous if the same long-term benefits could be realized from consuming these carbohydrate supplements at rest instead of specifically during training sessions. Therefore, the goal of this study is to examine whether repeatedly ingesting a carbohydrate-rich beverage at rest over a 5-day period alters metabolism and gut symptoms while ingesting carbohydrate during exercise.


Eligibility criteria: Inclusion Criteria:

* Be currently running ≥15 miles per week
* Have completed at least one run \>60 minutes over the past month
* Have completed one or more marathons within the past year

Exclusion Criteria:

* Overt cardiovascular disease or metabolic disorder
* Adverse symptoms (e.g., unusual shortness of breath, dizziness, chest pain) with exercise
* Allergies/intolerances to any of the ingredients in the beverages

Primary outcomes:
measure: Change in Gastrointestinal Symptom Ratings
timeFrame: Symptoms will be collected during a 60 minute run on a treadmill at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
measure: Change in Hydrogen Breath Production
timeFrame: Samples will be collected before after a 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Secondary outcomes:
measure: Change in Carbohydrate Oxidation
timeFrame: Respiratory gases will be collected during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
measure: Change in Feeling Scale
timeFrame: Ratings will be collected collected before and during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Human Performance Lab
state: Virginia
Study officials:
affiliation: Old Dominion University
name: Patrick Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02334488: Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function
Official title: Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 329
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: Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Patients receiving a first kidney transplant from a cadaveric or living donor

Exclusion Criteria:

* Double transplant
* Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus

Primary outcomes:
measure: Renal function as measured by estimated glomerular filtration rate GFR
timeFrame: One year after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Clermont Ferrand
country: France
facility: Clermont Ferrand University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Paris
country: France
facility: Necker Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Reims
country: France
facility: Reims University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Poitiers University Hospital
name: Antoine THIERRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05171088: Colorectal Resection in Emergency General Surgery
Official title: Colorectal Resection in Emergency General Surgery - To Anastomose, or Not to Anastomose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Resection
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing colon resection at Methodist Dallas Medical Center in the urgent/emergent setting meeting our inclusion/exclusion criteria will be enrolled in the study.

Brief summary: Primary anastomosis is associated with higher rates of perioperative morbidity/mortality and that fecal diversion improves overall mortality, decreases length of stay, and lowers rates of surgical complications requiring unplanned operative intervention.

Detailed description: This is a prospective observational study. All patients undergoing colon resection in the urgent/emergent setting meeting our inclusion/exclusion criteria will be enrolled in the study. Data will be collected prospectively and the decision to perform proximal diversion or anastomosis is solely the responsibility of the managing acute care surgeon. No guidelines or protocols will be suggested so as to avoid any influence on practitioner decision-making. The plan is to complete the data collection and analysis by 03/01/2020

Eligibility criteria: Inclusion Criteria:

* Patients undergoing urgent/emergent colon resection (less than 24 hours after decision to operate) by an acute care surgeon

Exclusion Criteria:

* Elective operations performed by acute care surgeons within 24-hours of the decision to operate (e.g., scheduled resection of non-obstructed, non-perforated malignancy)
* Prisoners
* Pregnancy
* Wards of the state
* Patients less than 18-years of age
* Traumatic mechanisms of injury
* Death within 24-hours of index operation

Primary outcomes:
measure: Perioperative mortality and need for unplanned procedural intervention
timeFrame: 1 days to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael Truitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01986088: Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
Official title: A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With or Without Aura
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.


Eligibility criteria: Inclusion Criteria:

* Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
* Patients had to be capable of taking study medication as outpatients and recording the effects.

Exclusion Criteria:

* Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
* Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.

Primary outcomes:
measure: Headache response at 1 hour after treatment of the first attack.
timeFrame: 1 hour
Secondary outcomes:
measure: Headache severity
timeFrame: .5, 1, 2, 4 and 24 hours
measure: Pain-free response
timeFrame: .5, 1, 2, 4 and 24 hours
measure: Functional response
timeFrame: .5, 1, 2, 4 and 24 hours
measure: Presence or absence of nausea, photophobia, and phonophobia
timeFrame: .5, 1, 2, 4 and 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: