louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04723381: The Effect of Web Based Genital Hygiene Education Provided to Orthopedically Disabled Women
Official title: A 15-Week Randomized Controlled Trial in Orthopedically Disabled Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Genital Infection
Keywords: web based education
disabled women
genital hygiene
self care agency
Lead sponsor: Siirt University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2021-01-25
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors.

Detailed description: It was a randomized controlled trial. The women in the experimental group were given web-based genital hygiene education that continued for seven weeks. No intervention was applied to the women in the control group.

Eligibility criteria: Inclusion Criteria:

* Being orthopedically handicapped
* Being literate, being over the age of 18
* Having access to the internet
* Being able to use the internet/computer
* Being able to maintain genital hygiene individually.

Exclusion Criteria:

* The inability to use the internet
* Not being a member of the website
* Having mental retardation
* Being dependent on someone else to maintain genital hygiene (bedridden, with spasticity)
* No willing to complete the study.

Primary outcomes:
measure: Introductory Questionnaire
timeFrame: Baseline
measure: Change from the Baseline Self-Care Agency Scale Points at 7th and 15th weeks
timeFrame: Baseline, at the end of the 7th week, at the end of the 15th week
measure: Change from the Genital Hygiene Behavior Scale Points at 7th and 15th weeks
timeFrame: Baseline, at the end of the 7th week, at the end of the 15th week
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Yurdagul Yagmur, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02979210: Infant Fecal Insult Study
Official title: Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects with Fitzpatrick Skin Types I, II or III

Exclusion Criteria:

* Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

Primary outcomes:
measure: Type of microbes present on skin after exposure to artificial fecal insult
timeFrame: up to 7 days
measure: Relative abundance of microbes present on skin measured in picograms of DNA
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irving
country: United States
facility: Reliance Clinical Testing Service
state: Texas
Study officials:
References:
citation: Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
citation: Ishikawa J, Shimotoyodome Y, Ito S, Miyauchi Y, Fujimura T, Kitahara T, Hase T. Variations in the ceramide profile in different seasons and regions of the body contribute to stratum corneum functions. Arch Dermatol Res. 2013 Mar;305(2):151-62. doi: 10.1007/s00403-012-1286-5. Epub 2012 Sep 18.
Clinical trial NCT04783610: Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.
Official title: Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome: Similarities in VHIT and VOG Data.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: vHIT- and VOG-model for Bilateral Vestibular Neuronitis
Keywords: vHIT
vestibular neuronitis
VOG
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, via ethanol administration in healthy human subjects.

Detailed description: Ethanol administration has an effect on vestibular function, measurable with video head impulse test (vHIT)- and vestibulo-oculography (VOG)-methods.

The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, a disease with difficult diagnostics, via ethanol administration in healthy human subjects.

As subjects are consuming ethanol via oral route, vHIT-measurements and VOG-measurements (slow and rapid eye movement recordings) are being recorded in order to measure the change in vestibular function.

During approx. 5 hours, 4 vHIT measurements will take place, while subjects ingest ethanol towards 1 per mille levels, measured via alcoholmeter.

Necessary precautions include strict exclusion criteria regarding health of the subjects and also comprehensive preparedness for management of allergic reactions and other unusual phenomena related to alcohol consumption.

Eligibility criteria: Inclusion Criteria:

* no previous ear diseases
* normal hearing
* no signs of alcohol dependence (6 points or less in AUDIT-questionnaire)

Exclusion Criteria:

* previous ear diseases
* abnormal hearing
* signs of alcohol dependence (7 points or more in AUDIT-questionnaire)

Primary outcomes:
measure: Ethanol-induced vestibular function decline as measured with vHIT-gain-value-measurements.
timeFrame: 5 hours or 1 work day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05948410: How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?
Official title: How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lower Urinary Tract Symptoms
Mood Change
Diagnosis
Keywords: invasive urodynamic study
mood
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication of invasive urodynamic study

Brief summary: The goal of this study is to learn about the patient's perspective regarding to psychological mood before and after an invasive urodynamic study.

Detailed description: The participants have already had an indication of an invasive urodynamic study. All patients will be given STAI, perceived stress scale and VAS forms just before, after and 1-week following an invasive urodynamic study. The scores will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients with an invasive urodynamic study indication

Exclusion Criteria:

* Non-Turkish speakers
* Poor conscious state

Primary outcomes:
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 1 week
measure: Visual Analogue Scale
timeFrame: 1 week
measure: Perceived Stress Scale
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04833010: Effects of Face Masks During Exercise
Official title: Effects of Face Coverings During Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary
Exercise
Cognitive Performance
Covid19
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To describe the primary and secondary outcomes of athletes during a Cardiopulmonary Exercise Test (CPET) on a cycle ergometer with and without a face mask.


Eligibility criteria: Inclusion Criteria:

* Be able to come to Baylor Scott \& White Sports Therapy and Research at The Star in Frisco, Texas twice in three weeks.
* Be willing to wear a face mask during exercise capacity testing on a stationary bicycle.

Exclusion Criteria:

-

Primary outcomes:
measure: VO2 max during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 1
measure: VO2 max during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 2
measure: Test duration (time) of cardiopulmonary exercise test on a cycle ergometer
timeFrame: Week 1
measure: Test duration (time) of cardiopulmonary exercise test on a cycle ergometer
timeFrame: Week 2
measure: Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer
timeFrame: Week 1
measure: Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer
timeFrame: Week 2
measure: Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer
timeFrame: Week 1
measure: Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer
timeFrame: Week 2
Secondary outcomes:
measure: Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 1
measure: Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 2
measure: Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 1
measure: Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 2
measure: Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 1
measure: Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 2
measure: Blood lactate during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 1
measure: Blood lactate during cardiopulmonary exercise testing on a cycle ergometer
timeFrame: Week 2
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Baylor Scott & White Sports Therapy & Research at The Star
state: Texas
Study officials:
References:
Clinical trial NCT00143910: Natural History Study of Azathioprine Adherence
Official title: Measurement of Compliance in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Keywords: Medication adherence
Patient compliance
Kidney transplant
Organ rejection
Allograft loss
Drug monitoring
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.

Brief summary: This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.

Detailed description: * The study is complete. Patient recruitment is closed and active patient involvement in the study has ended.
* Statistical analysis of monitor records and new patient outcome data continues

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipient
* Discharged from hospital with functioning graft,not on dialysis
* Prescribed azathioprine

Exclusion Criteria:

* Unable to give informed consent
* Non English speaking
* Previous or concurrent organ transplant other than kidney
* Taking liquid form of azathioprine
* Followed outside of the United states

Primary outcomes:
measure: acute transplant rejection
timeFrame: 10 years
Secondary outcomes:
measure: Allograft loss
timeFrame: 10 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Thomas E Nevins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nevins TE, Kruse L, Skeans MA, Thomas W. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001 Oct;60(4):1565-70. doi: 10.1046/j.1523-1755.2001.00961.x.
Clinical trial NCT03874910: Pathology Analysis of OPMD Patient Myotomies
Official title: Pathology Analysis of OPMD Patient Myotomies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oculopharyngeal Muscular Dystrophy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-03-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who suffer from oculopharyngeal muscular dystrophy (OPMD).

Brief summary: The study aims to characterize the effect of OPMD mutation on muscle function. Muscle samples will be received from oculopharyngeal muscular dystrophy (OPMD) patients who undergo cricopharyngeal muscle-cutting surgery, as part of their routine healthcare and treatment.


Eligibility criteria: Inclusion Criteria:

* OPMD patients both male and female.
* OPMD patients between the ages 18-70 years.
* OPMD patients who are referred to the cricopharyngeal muscle-cutting surgery as part of their usual treatment.

Exclusion Criteria:

• OPMD patients not referred to the cricopharyngeal muscle-cutting surgery as part of their usual treatment.

Primary outcomes:
measure: Number of genes that show changes in RNA profile, measured by sequencing.
timeFrame: Data will be collected within four years.
measure: Number of genes that show changes in protein profile, measured by SDS page.
timeFrame: Data will be collected within four years.
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center, Israel
name: Itzhak Braverman, Doctor (MD)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06129110: Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
Official title: Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Insulin Sensitivity
Muscle Weakness
Adiposity
Insulin Resistance
Keywords: IMAT
Intermuscular Adipose Tissue
Weight Loss
Diet
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this intervention study is to learn about how weight loss impacts molecular signaling of intermuscular adipose tissue (IMAT) in individuals with obesity. The main question it aims to answer is how inflammatory molecules secreted by IMAT promote muscle insulin resistance and inflammation, and how these same molecules are diminished after weight loss. Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were completed before the intervention. Researchers will then compare outcomes of individuals who lost weight to individuals who did not lose weight.


Eligibility criteria: Inclusion Criteria:

* Generally healthy men and women aged 18-70
* BMI between 30-40
* Less than 1 hour of exercise per week
* Women:

  1. may be pre or post menopausal

Exclusion Criteria:

* Type 1 or Type 2 diabetes
* Thyroid disease
* History of lung disease
* Active use of nicotine
* Severe plasma lipid disorders
* Taking hormone replacement drugs, blood thinners, or thiazoladinediones
* Women:

  1. Currently going through menopause or peri-menopause
  2. Pregnant or breastfeeding
  3. History of Polycystic Ovary Syndrome

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 12 weeks
measure: Body Weight
timeFrame: 12 weeks
measure: IMAT Content
timeFrame: 12 weeks
measure: Muscle Mass
timeFrame: 12 weeks
measure: Muscle Strength
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
References:
Clinical trial NCT01859910: Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery
Official title: Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Orbis
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2013-05-22
Enrollment: 306
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To investigate whether compression of the lid margin increase microbial contamination risk of patients undergoing cataract surgery


Eligibility criteria: Inclusion Criteria:

* (1) Age \> 60 years; (2) clinical diagnosis of age related cataract, without previous recent ocular surgery; (3) undergoing phacoemulsification with implantation of intraocular lens ; (4) able to give informed consent.

Exclusion Criteria:

* (1) any inflammation of the eye or other parts of the body within the previous 3 months; (2) chronic use of any types ophthalmic medication; (3) contact lens wear; (4) ocular surgery within the past 3 months; (5) use of systemic antibiotics within 30 days; (6) use of eyedrops in either eye within 3 days of enrollment; (7) need for concurrent glaucoma, cornea or other surgery.

Primary outcomes:
measure: positive rate of culture
timeFrame: 5months
Secondary outcomes:
measure: bacteria distribution of the culture
timeFrame: 5months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT03210610: Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients
Official title: Measurement of Colchicine Levels in the Serum of FMF Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: FMF
Colchicine Resistance
Colchicine Toxicity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FMF patients treated with a constant dose of colchicine

Brief summary: in this study the investigators will measure the colchicine trough levels in 80 FMF patients taking stable doses of colchicine

Detailed description: 80 FMF patients will enroll: 20 taking 1 mg colchicine a day 20 taking 1.5 mg colchicine a day 20 taking 2 mg colchicine a day 20 taking 2.5 mg colchicine a day one blood sample for trough colchicine levels will be taken. response to treatment, colchicine side effects and anthropometric data will be collected.

Eligibility criteria: Inclusion Criteria:

* constant colchicine levels

Primary outcomes:
measure: colchicine levels
timeFrame: a single measurement under a constant dosage at visit 1 (time=0, recruitment)
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: merav lidar, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00208910: Muscle Relaxation Therapy With Odorant Cue
Official title: A Study of Enhancement of Progressive Muscle Relaxation Therapy for Generalized Anxiety Disorder Through Use Of An Odorant Cue.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Anxiety
Keywords: Anxiety
Mental Health
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A novel procedure for generalized anxiety disorder where an odorant cue is paired with the state of deep relaxation during training. It is hypothesized that by smelling the odor in an anxiety-provoking situation, the patient will more easily invoke a state of relaxation, providing greater relief from the distressing tension and worry that characterize GAD.

Detailed description: We hypothesize that by presenting a novel odor to a patient in a state of deep relaxation, the odor will serve as a conditioned inhibitory stimulus, or safety signal, in anxiety-provoking situations. With the odor serving as a contextual cue for the state of relaxation.

Eligibility criteria: Inclusion Criteria:

* GAD without a comorbid active major psychiatric disorder.
* GAD must be the primary active psychiatric disorder.
* GAD determined via the Mini International Neuropsychiatric Interview (MINI).

Exclusion Criteria:

* Significant medical illness that might interfere with the relaxation therapy or with training using the odorant.
* Actively abusing alcohol.
* Illicit substances.
* Currently using rapid-acting anxiolytic agents (e.g. benzodiazepines, hydroxyzine).
* Started an antidepressant, antipsychotic or mood stabilizing agent within three months of screening visit.

Primary outcomes:
measure: PSWQ
Secondary outcomes:
measure: HAM-A
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Emory University
name: Philip T Ninan, MD
role: PRINCIPAL_INVESTIGATOR
References: