louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01801592: Obstructive Sleep Apnoea in Patients With Intermittent Claudication
Official title: Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Keywords: OBSTRUCTIVE SLEEP APNOEA
INTERMITTENT CLAUDICATION
Respiratory disease
Peripheral artery disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-03-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: men or women over 18 years old with an Intermitent claudication.

Brief summary: The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

Detailed description: In patients with peripheral artery disease (PAD), exercise induced limb ischemia (claudication) which limits walking capacity. Symptoms are due to pain at hip and/or buttock. Couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. The rate of associated respiratory pathology to patients with lower extremity artery disease (LEAD) is around 15%. The intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. The exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. Tests which are performed to diagnose an intermittent claudication are the Ankle to Brachial Systolic pressure Index (ABI), the echo-Doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpO2).

Thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with PAD.

Eligibility criteria: Inclusion Criteria:

* Register to the social health insurance
* Referred for a walk test because of claudication
* Maximal walking ditance \< 750m
* Older than 18 years old
* Able to understand the protocol of the study

Exclusion Criteria:

* Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion
* Severe reparatory disease already known
* Parkinson disease, hémiplégia ou paraplégia
* Does not want to participate to the protocol
* Pregnant women
* Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
* Being in a period of exclusion from another biomedical study

Primary outcomes:
measure: Prevalence of an Apnea hyponea index > 15
timeFrame: up to 2 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital
Study officials:
affiliation: University Hospital in Angers
name: Guillaume Mahe, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044692: The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients
Official title: The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hunter Syndrome
Keywords: Hunter syndrome
Mucopolysaccharidosis II
Hunterase
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hunter Syndrome(Mucopolysaccharidosis II) Patients

Brief summary: The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients


Eligibility criteria: Inclusion Criteria:

* Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
* Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
* Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.

Exclusion Criteria:

* Patients who have participated in any other blind clinical trials.
* Patient who cannot be tracked about safety.
* Patients who are judged disqualified to participate clinical trials by investigator for other causes.

Primary outcomes:
measure: Incidence of adverse event and adverse drug reaction.
timeFrame: Once a week up to 5years
Secondary outcomes:
measure: Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status.
timeFrame: Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years)
Other outcomes:
measure: Percent change of urine GAG.
timeFrame: Baseline and every three months up to 5years.
measure: Percent change of 6 minute walking test.
timeFrame: Baseline and every 6 months up to 5years.
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung medical center, Seoul, Republic of Korea
name: Dong-Kyu Jin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218192: A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
Official title: A Trial to Reduce Hepatitis C Among Injection Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HCV Negative Status
HCV Risk Behavior
Keywords: hepatitis c
injection drug use
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 277
Sex: ALL
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: The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.

Detailed description: Injection drug users are at high risk for blood-borne viral infections during their first years of injecting when they are least likely to seek formal substance abuse treatment, and are likely to be practicing risky drug-use behaviors. Research has demonstrated that a brief motivational intervention that includes booster sessions and addresses drug and sex risks is effective in reducing HIV risk behaviors among injection drug users.

Because Hepatitis C Virus is a bloodborne pathogen like HIV, and transmission occurs via similar behaviors, successful HIV prevention strategies should be robust in preventing HCV but need to be tested. Motivational interventions, which aim to elicit a goal and plan from the patient to reduce injection and sexual risk taking, are particularly suited to address behaviorally-based changes. Motivational interventions are individualized and tailored to the risks and concerns of the participant, but can be standardized and evaluated to make this technique applicable in a variety of settings. The occurrence of injection drug use in a population with traditionally poor linkage to primary care, an enormous burden of illness, and high HCV and other blood-borne pathogen transmission risk, supports the use of motivational interventions in this group.

Comparison(s): Participants are assigned, in this 24 month longitudinal study, to an assessment-only condition or an assessment plus motivational intervention condition. Participants in the intervention condition receive up to 4 sessions of motivational interviewing during the first 6 months of the study.

Eligibility criteria: Inclusion Criteria:

* current opiate or cocaine use
* HCV seronegative
* able to complete the study procedures in English

Exclusion Criteria:

* current enrollment in a formal substance abuse treatment program

Primary outcomes:
measure: Hepatitis C seroconversion
Secondary outcomes:
measure: Substance use
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael Stein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein MD, Herman DS, Anderson BJ. A trial to reduce hepatitis C seroincidence in drug users. J Addict Dis. 2009 Oct;28(4):389-98. doi: 10.1080/10550880903183034.
Clinical trial NCT02577692: Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers
Official title: Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Sponsor class: OTHER
Collaborators: name: Airbus Defence and Space
name: DLR German Aerospace Center
First posted: 2015-10-16
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. However, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.

This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.


Eligibility criteria: Inclusion Criteria:

* healthy male volunteers who have given an oral and written informed consent

Exclusion Criteria:

* smoker or ex-smoker
* any pulmonary disease
* any heart disease
* any chemotherapy in the past
* any kind of daily medication

Primary outcomes:
measure: Change in exhaled breath oxidative stress biomarker
timeFrame: 1, 4, and 24 hour
Secondary outcomes:
measure: Change in blood oxidative stress biomarkers
timeFrame: 1, 4, and 24 hour
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Department of Aneshtesiology, University Hospital of Munich
Study officials:
affiliation: Klinikum der Universitaet Muenchen - Campus Grosshadern
name: Michael E Dolch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829892: Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
Official title: Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypathology and Autonomy Loss
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light nighttime sleep of residents.

Detailed description: Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment. In 2014, the Cochrane published a systematic review of the literature over the last 20 years concerning the use of light therapy in patients with a AD. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light therapy (from 5 a.m to 10 p.m) on nighttime sleep of residents. Secondary objectives were the study of sleep time on the day, anxiety by the COVI scale and behavioral disorders by the NPI scale.

Eligibility criteria: Inclusion Criteria:

* EHPAD residents at Les Pastoureaux Valenton having moderate to severe MASA
* More than 60 years
* Presenting motor behavioral disorders and / or anxiety and / or restlessness and / or insomnia .
* No underlying acute medical problems including no delirium

Exclusion Criteria:

* Residents refusing to lend to experimentation
* Resident who are not matching with the inclusion criteria
* total acquired or congenital blindness
* bedridden patient ( loss of physical autonomy)
* Entry to the residence less than 15 days before the start of the experiment.

Primary outcomes:
measure: Sleep duration between 10 p.m to 5 a.m
timeFrame: 14 days
Secondary outcomes:
measure: Sleep duration by day
timeFrame: 14 days
measure: Number of awake between 10 p.m to 5 a.m
timeFrame: 14 days
measure: Anxiety by the COVI scale
timeFrame: 14 days
measure: Behavioral disorders by the NPI scale
timeFrame: 14 days
Other outcomes:
Locations:
city: Valenton
country: France
facility: EHPAD ORPEA Valenton
Study officials:
References:
Clinical trial NCT01926392: Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
Official title: A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Burn
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Partial thickness burns are a common, painful injury requiring a great deal of resources in their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain control and resources required to deliver care.


Eligibility criteria: Inclusion Criteria:

* adult inpatients with partial thickness burns

Exclusion Criteria:

* superficial or full thickness burns, facial burns, intubated or sedated, pediatric

Primary outcomes:
measure: Pain level
timeFrame: 180 minutes
Secondary outcomes:
measure: time to perform dressing changes
timeFrame: up to 180 minutes
Other outcomes:
measure: narcotic medication administered
timeFrame: 180 minutes
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jonathan Black, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222192: Different Type Ultrasound Guided Epidural Block Methods
Official title: Evaluation of Different Type Ultrasound Guided Epidural Block Methods ; Paramedian Sagittal and Transverse Interlaminar View
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Anesthesia
Ultrasound
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The nerve blocks applied with ultrasonography are used for pain and operation after many operations today.

Applications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications.

However, the use of ultrasonography is not so common in neuraxial regional anesthesia applications. In the literature, epidural applications accompanied by ultrasonography were applied with different approaches.

Detailed description: In this study the investigators will used the two different ultrasound -guided epidural block approach .

Paramedian sagittal oblique and Transverse interlaminar. The investigators will used this two technique in epidural catheter placement using the real-time ultrasound.

Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Patients whom need medical epidural anesthesia
* Patients with consent to participate in the study

Exclusion Criteria:

* Patients with a known history of back surgery
* Bleeding diathesis disorder
* Allergy to local anesthetics
* Patient refusal

Primary outcomes:
measure: Number of needle routing
timeFrame: 20 minutes
measure: Epidural catheter placement time
timeFrame: 20 minutes
Secondary outcomes:
measure: Epidural igne visibility degree
timeFrame: 20 minutes
measure: Difficulty of catheter placement
timeFrame: 30 minutes
measure: distance measurement of neuraxial structures
timeFrame: 30 minutes
measure: Patient position
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Korgün Ökmen, Assoc. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016340: Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia (MCS_MOS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Male Oligoasthenospermia
Keywords: Male Oligoasthenospermia
MCS
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 3
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II randomized, double-blind, placebo-controlled study where eligible subfertile male subjects (age 20 years).


Eligibility criteria: Inclusion Criteria:

1. Male subjects who are 20 years old or older
2. Subjects who are diagnosed as idiopathic oligoasthenospermia
3. Subjects who have a normal baseline hormone profile
4. Subjects who were not able to impregnate female partners in the past 12 months under an active and unprotected sexual life
5. Subject's female partner has no endocrine or genital obstructive disorders and is capable of impregnation.
6. Subjects who have an acceptable baseline liver function
7. Subjects who have a normal baseline renal function.

Exclusion Criteria:

1. Subjects who have been diagnosed as male infertility for more than 5 years.
2. Subjects who have a baseline semen white blood cell count of 1\*106/mL.
3. Subjects who have genital/seminal tract obstruction, infection, inflammation or anatomic abnormalities.
4. Subjects whose female partner has been diagnosed as infertility of any kind.
5. Male infertility that is associated with hormonal deficiency/imbalance, poor nutrition, congenital/chromosomal disorders, erectile dysfunction, or psychological disorders.
6. Subjects who plan to undergo artificial insemination of any kind within the study period.
7. Subjects who have been treated with chemotherapy, pelvic irradiation or major pelvic surgery
8. Subjects who will undergo any invasive procedures within the study period
9. Subjects who will undergo any chemotherapy or radiotherapy of any kind during the study period.
10. Subjects who can not or are not willing to undergo the two-week wash-out period for any reasons.

Primary outcomes:
measure: To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT06593340: Evaluation of Report-Back Strategies for Long-term and Short-term Exposure Information in Rural Tribal Populations
Official title: Evaluation of Report-Back Strategies for Long-term and Short-term Exposure Information in Rural Tribal Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavior Change
Keywords: exposure
Native American
radon
particulate matter
PM2.5
report-back
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2024-09-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to evaluate different ways to provide feedback about environmental sampling results to participants. Specifically, we will look at exposures with long-term risk (radon) and short-term risk (indoor particulate matter, PM2.5). The hypothesis is that providing feedback in real-time will result in participants engaging in more activities to try to reduce their exposure. One of our main questions of interest is: How does the information messenger impact the effectiveness of report-back strategies in rural, tribal populations?

Participants will have radon and PM2.5 measurement equipment installed at their home and will answer questions about any actions they took to reduce exposure. Previously developed approaches to reporting back those exposures will be used to test which feedback method results in more actions to reduce exposure.


Eligibility criteria: Inclusion Criteria:

* Enrolled member of the participating tribe

Exclusion Criteria:

* Participant in one of our previous studies

Primary outcomes:
measure: Exposure Reduction Behaviors
timeFrame: 3 months after report-back
measure: Exposure Reduction Behaviors
timeFrame: 6 months after report-back
measure: Exposure Reduction Behaviors
timeFrame: 12 months after report-back
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: