louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02967055: The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Official title: The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2016-11-17
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG contraceptive implant for their primary mechanism of birth control, placed at least four weeks prior to study enrollment, but in place no longer than three years.

Brief summary: This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.

Detailed description: The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.

Eligibility criteria: Inclusion Criteria:

* Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
* Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
* Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
* Willing to abstain from taking any Vitamin A supplement during the study period
* Have a Body Mass Index (BMI) \>= 18.5

Exclusion Criteria:

* Currently breastfeeding
* Known contraindications to isotretinoin
* Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors

Primary outcomes:
measure: Serum Etonogestrel (ENG) Level
timeFrame: Baseline (enrollment)
measure: Serum Etonogestrel (ENG) Level
timeFrame: 4 weeks
measure: Serum Etonogestrel (ENG) Level
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Aaron Lazorwitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03485755: Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.
Official title: The Evolution of the Skin Microbiome of Children Approximately Ages 8-10 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: microflora
microbiome
bacteria taxa
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2018-04-02
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and their biological mothers

Brief summary: Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.


Eligibility criteria: Inclusion Criteria:

* Must be the biological mother of a child (approximately age 8-10 years) enrolled in the study
* All subjects are to have normal healthy skin and no presence of pre-existing or dormant dermatologic skin conditions;
* Willing to use only the provided cleansing product during the washout time period;
* Willing to refrain from topical product use on the skin for the duration of the study. Topical products that should not be used include moisturizers, lotions, sunscreens, oils, tanners;
* Willing to refrain from swimming, using hot tubs, excessive sun exposure or tanning beds during the course of this study;

Exclusion Criteria:

* Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer) a

Primary outcomes:
measure: Microbial Community Diversity for Children
timeFrame: Day 1
Secondary outcomes:
measure: Microbial Community Diversity for Adults
timeFrame: Day 1
measure: Microbial Community Richness for Children
timeFrame: Day 1
measure: Microbial Community Richness for Adults
timeFrame: Day 1
measure: Skin Barrier Function
timeFrame: Day 1
measure: Skin pH
timeFrame: Day 1
Other outcomes:
Locations:
city: Skillman
country: United States
facility: Consumer Experience Center
state: New Jersey
Study officials:
affiliation: Bruce L Moskovitz MD - private consultant
name: Bruce L Moskovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545555: Investigations on the Effect of Kale on the Lipid Status
Official title: Investigations on the Effect of Kale on the Lipid Status (Untersuchungen Zum Einfluss Von Grünkohl Auf Den Lipidstatus)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of Kale Ingredients on Lipid Status Parameter
Keywords: kale
antioxidant capacity
cholesterol
lipid status
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Lipid status parameters (total cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides) will be determined in blood. There is a correlation between contents of LDL cholesterol, total cholesterol and triacylglycerides and the risk for cardiovascular diseases (CVD). In contrast, a high content of HDL cholesterol is correlated with a lower risk for CVD. In addition, the contents of apolipoprotein A1 and apolipoprotein B will be analysed.


Eligibility criteria: Inclusion Criteria:

* total cholesterol \> 200 mg/dl

Exclusion Criteria:

* LDL cholesterol \< 130 mg/dl
* medication to lower blood lipids
* genetically based hypercholesterolemia

Primary outcomes:
measure: Change of lipid status parameters
timeFrame: weeks 0, 4 and 8
Secondary outcomes:
measure: Change of apolipoproteins
timeFrame: weeks 0, 4 and 8
measure: Change of antioxidant capacity
timeFrame: weeks 0, 4 and 8
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University, Institute iof Nutritional Science
state: Thuringia
Study officials:
References:
Clinical trial NCT00161655: Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis
Official title: A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Arthritis, Psoriatic
Keywords: Psoriasis
Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 60
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: The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.


Eligibility criteria: Inclusion Criteria:

* Active plaque psoriasis involving \>10% body surface area and/or minimal screening PASI score 8.
* Methotrexate \>7.5 mg/week for the last 3 months

Exclusion Criteria:

* Predominantly guttate, erythrodermic or pustular psoriasis
* Other skin conditions than psoriasis

Primary outcomes:
measure: Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
Secondary outcomes:
measure: Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
measure: and 90. Time to clear or almost clear on PGA.
Other outcomes:
Locations:
city: Fredriksberg Alle
country: Denmark
state: Copenhagen
city: Gentofte Amtsygehus
country: Denmark
state: Hellerup
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Rikshospitalet
country: Norway
state: Olso
city: Hudlegekontoret Akutten
country: Norway
state: Tromso
city: Lakarhuset Fasta Centrum
country: Sweden
state: Farsta
city: Lakarhuset
country: Sweden
state: Vallingby
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04612114: Pulse Oximeter for Sleep Evaluation
Official title: Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study (ROSA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
pulse oximeter
polysomnography
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Belun Technology Company Limited
First posted: 2020-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: i) 40 participants ii) All enrollment will be at Stanford iii) Patients with obstructive sleep apnea will be enrolled

Brief summary: The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms.

The investigators propose to recruit a total of 40 participants with symptoms of obstructive sleep apnea. The investigators will i) validate the overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture, using PSG analysis as a gold standard.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)

   * No more than 75% of subjects in one bin of: (male, female)
   * No more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
2. Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
3. Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
4. If taking any medication, must be on a stable dose of medication for a month
5. Able to read and understand English

Exclusion Criteria:

1. Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
2. If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
3. Under 18 or over 80 years of age

Primary outcomes:
measure: Validation with gold-standard polysomnography (PSG) recording
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Makoto Kawai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398214: A Sleep Hygiene-based Intervention Program for Infants and Toddlers
Official title: A Sleep Hygiene-based Intervention Program for Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Infants
Toddlers
Behavioral intervention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 247
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.

Detailed description: Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.

Eligibility criteria: Inclusion Criteria:

* Healthy singleton infant born at gestational age \>= 37 weeks

Exclusion Criteria:

* Infants born before 37 weeks gestation
* Infants born with a congenital abnormality or a genetic disorder
* Parents with insufficient Chinese

Primary outcomes:
measure: Actigraphic assessed sleep quantity variables
timeFrame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Secondary outcomes:
measure: Actigraphic assessed sleep quality variables
timeFrame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shao-Yu Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05776914: Fecal Microbiota Transplantation for IBS
Official title: Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Diarrhea
Keywords: Post-infection irritable bowel syndrome with diarrheal
Post-infection irritable bowel syndrome with mixed symptoms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
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 learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.


Eligibility criteria: Inclusion Criteria:

* IBS defined by Rome IV criteria
* Non IBS-C
* Moderate to severe symptoms defined by IBS-SSS≥175
* Able to safely undergo and consent to colonoscopy

Exclusion Criteria

* Immune deficiency or treatment with immunosuppressive medications
* Severe bowel or medical disease precluding administration of bowel prep
* Severe bowel or medical disease precluding colonoscopy with conscious sedation
* Active cancer
* Pregnant or lactating
* Abdominal surgery (exception of splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy)
* Severe psychiatric disorder (HADS-A or D\>16), or diagnosed alcohol or drug abuse disorder
* New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry)
* Use of treatments known to affect colonic motility (with exception of loperamide)
* Diagnosed h/o bleeding disorder
* Organic GI diseases (IBD, celiac disease, microscopic colitis)
* Chronic kidney or liver disease
* Absolute neutrophil count (ANC) \<500 IU/ml

Primary outcomes:
measure: Percentage of responders
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in level of fecal proteolytic activity
timeFrame: Baseline, 12 weeks
measure: Changes in in vivo excretion of 2-24 hr lactulose excretion
timeFrame: Baseline, 12 weeks
measure: Number of weekly responders
timeFrame: 12 weeks
measure: Global Adequate Relief Questionnaire
timeFrame: 12 weeks
measure: Alistipes putredinis proportion post-FMT
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Madhusudan Grover, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00142714: Effects of Spinal Cord Injury on Female Sexual Response
Official title: Effects of SCI on Female Sexual Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Sexual Dysfunction
Multiple Sclerosis
Spinal Cord Injury
Keywords: sexual response
sexual dysfunction in females
spinal cord injury
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2005-09-02
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The long term aims of this project are to 1) Understand the effect of varying degrees and levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new assessment and treatment methods for neurogenic sexual dysfunction in women.


Eligibility criteria: Inclusion Criteria:

* MS or SCI
* Normal menstrual periods
* Normal hand function
* Have ability to feel sensation from lower abdomen to upper thigh region.

Exclusion Criteria:

* Pregnant
* Menopausal

Primary outcomes:
measure: Our central hypothesis are:
measure: 1) In females the SNS regulates psychogenic genital vasocongestion 2) In females the orgasmic reflex requires the presence of an intact sacral spinal cord, 3) In females a pattern generator is responsible for the orgasmic reflex.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Marca Sipski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander M, Bashir K, Alexander C, Marson L, Rosen R. Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. Arch Phys Med Rehabil. 2018 Feb;99(2):299-305. doi: 10.1016/j.apmr.2017.09.001. Epub 2017 Sep 9.
Clinical trial NCT01336114: A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
Official title: A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2011-04-15
Enrollment: 11
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic scoliosis

Brief summary: Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 12 years
* Pre menarchial for the girls
* Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages.
* Cobb angle ≥25° and \< 40°
* Information to the parents and child, and signed approval

Exclusion Criteria:

* No idiopathic scoliosis
* Previous brace treatment
* Immediate indication for surgery
* Previous thoracic surgery

Primary outcomes:
measure: Photographs of the back and spine radiographs for making a corset
timeFrame: 3 years
Secondary outcomes:
measure: Recording of pressure from the brace
timeFrame: 3 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
Study officials:
affiliation: Rennes University Hospital
name: philippe violas
role: PRINCIPAL_INVESTIGATOR
References: