louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01041729: Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease
Official title: Phase IV Study of Statins for Assess the Long-term Pleiotropic Effect Upon Nitric Oxide and C-Reactive Protein Levels in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2010-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the long-term effects of statins, atorvastatin, upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of PAD.


Eligibility criteria: Inclusion Criteria:

* patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound)
* over 18 years old

Exclusion Criteria:

* patients had previously undergone revascularization
* patients were receiving treatment with statins
* patients with contraindications to statin use.
* patients with coexistence of chronic inflammatory diseases or steroidal medication

Primary outcomes:
measure: High-sensitivity C-Reactive Protein (hsCRP) and nitrites plasma levels at baseline and after one month and one year of inclusion.
timeFrame: Baseline and after one month and one year of inclusion.
Secondary outcomes:
measure: Lipid profile
timeFrame: baseline and after one month and one year of inclusion.
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario Getafe
name: Joaquin De Haro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205229: Compounded Pain Preparation Absorption Study
Official title: Compounded Pain Preparation Absorption Study (ComPPAS)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Pain
Lead sponsor: Medimix Specialty Pharmacy, LLC
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient between the ages of 30 and \<65 years old not taking concomitant medications that may interact with study ingredients.

Brief summary: Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.

Detailed description: Single center, prospective, observational, open-label, cohort study of participants that receive a combination topical pain medication from Medimix Specialty Pharmacy with no comparator group designed to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications.

Eligibility criteria: Inclusion Criteria:

* Participants must apply and consistently use the supplied cream for 1 month at a prescribed
* Participants must be ≥ 30 and \<65 years of age
* Participants must be able to provide sound written and verbal informed consent
* Participants must be diagnosed with an ICD9 code indicative of chronic pain

Exclusion Criteria:

* Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription
* Participants must not be pregnant or breastfeeding
* Participants must not have used any study drug greater than 180 days from the day of Screening
* Participants must not be utilizing medications that may interact with those being used in the topical formulation as determined by the PI
* Participants must not be using any systemic medications that may influence drug serum concentrations of ingredients being used in the topical compound. These include medications from the same class of studied drugs or drugs that may falsely increase or decrease serum levels of the study drugs

Primary outcomes:
measure: Serum concentration of ingredients used in multi-ingredient, topical compounded medications
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Medimix Specialty Pharmacy
state: Florida
Study officials:
References:
Clinical trial NCT02517229: The Effect of Altered Gravity Condition on Postural Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The scientific goal of this experiment is to evaluate changes in balance control in response to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions. To induce postural responses among the test subjects, an electromagnetic maneuverable postural platform will be used in order to randomly elicit perturbations. Postural reactions will be quantified by means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex measurements were chosen as they allow reliable information about inhibitory and facilitatory mechanisms taking place at the spinal level.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 21 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Person with medical history of neurological disorders
* Person with medical history of musculoskeletal disorders of the lower limbs, especially of the ankle and knee joint.
* Pregnant women

Primary outcomes:
measure: balance skill, expressed by the postural sway in mm
timeFrame: baseline
measure: neuromuscular activity, expressed by the Electromyograpy (EMG)-amplitudes
timeFrame: baseline
measure: spinal excitability, expressed by H-Reflexes
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT05148429: Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.
Official title: Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postnatal Complication
Mesenteric Pregnancy
Keywords: Pregnant women
2nd trimester ultrasound examination
Mesenteric vessels positionning
Pediatric follow up +/- treatment
Postnatal confirmation
Evolution and complication
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending for 2nd trimester scan

Brief summary: Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels


Eligibility criteria: Inclusion criteria:

* Pregnant women attending for 2nd trimester ultrasound
* Abnormal positionning of mesenteric vessels
* No other foetal malformation
* Singleton pregnancy
* Age \>18 years

Exclusion criteria:

* Chromosomal abnormality
* polymalformative syndrom
* Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis...)

Primary outcomes:
measure: Percentage of intestinal malrotation among foetuses
timeFrame: day 1
Secondary outcomes:
measure: Rate of correlation between prenatal
timeFrame: day 1
measure: Rate of postnatal ultrasound
timeFrame: day 1
measure: type of intestinal malrotation
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03170089: Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus
Official title: Effect of Oral Health Educational Program on Awareness and Oral Health Status of Children With Insulin Dependent Diabetes Mellitus: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Attitude
Diabetes type1
Keywords: oral-health-awareness, Diabetes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.

Detailed description: First visit: (baseline)

1. Awareness questionnaire is given to parent or caregiver to fill.
2. Child information will be recorded in the diagnosis chart of Pediatric Dentistry and Public Health Department
3. Intra-oral and extra-oral examination to all children included and recording Oral Hygiene Index simplified.
4. Intervention group will receive:

   * Supra-gingival scaling
   * Oral Health Educational Program through life demonstration of tooth brushing on a model, power point presentation and a poster.
   * Package containing tooth brush, tooth paste, poster and follow-up chart.

Second and third visits: (every month)

1. Oral hygiene index simplified will be recorded for both groups.
2. Follow-up chart is collected from intervention group.

Forth visit: (final visit)

1. Awareness questionnaire is given for parents of both groups.
2. Oral Hygiene Index simplified is recorded for both groups.
3. Follow up charts is collected from intervention
4. Control group will receive the same program after collection all data.

Number of visits \& follow up period:

* Four visits, time interval between each visit is one month and the follow up period is three months

Eligibility criteria: Inclusion Criteria:

1. Children aged 6-8 years old.
2. Cooperative children.
3. Both genders.
4. Insulin Dependent Diabetes Mellitus children

Exclusion Criteria:

1. Children with any other medical condition.
2. Children undergoing orthodontic treatment.
3. Parents unable to give informed consent

Primary outcomes:
measure: Patient awareness
timeFrame: Baseline
Secondary outcomes:
measure: Oral hygiene
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Fatma El-Shehaby, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00693589: Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease
Official title: Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Endothelial Dysfunction
Keywords: endothelial function
flow mediated dilatation
rosuvastatin
folic acid
B vitamins
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-06-09
Enrollment: 36
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: Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Detailed description: Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Eligibility criteria: Inclusion Criteria:

* CAD or PAD (\>50% luminal stenosis), previous myocardial infarction or bypass surgery \>3 month ago
* history of percutaneous coronary intervention (PTCA or stenting)
* confirmed consent

Exclusion Criteria:

* myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago
* ongoing treatment with statins
* ongoing vitamin supplementation with folic acid and B vitamins
* \<18 years
* active smokers
* uncontrolled arterial hypertension
* renal insufficiency
* atrial fibrillation
* liver disease
* NYHA class \>2
* familial hypercholesterolemia

Primary outcomes:
measure: Flow mediated dilatation (FMD)
timeFrame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
Secondary outcomes:
measure: changes in biochemistry parameters
timeFrame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
Other outcomes:
Locations:
Study officials:
affiliation: Cardiology, Inselspital, University hospital Bern
name: Kerstin Wustmann, MD
role: STUDY_DIRECTOR
affiliation: Cardiology, Inselspital, University hospital Bern
name: Yves Allemann, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05485129: Use of HRV Measuring Hearing-aid Device to Detect Acute Stress
Official title: Use of HRV Measuring Hearing-aid Device to Detect Acute Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Validation of in-ear device to measure acute mental stress in comparison with a Polar H10 chest band. Stress is measured on the basis of heart rate variability.


Eligibility criteria: Inclusion Criteria:

* Dutch speaking and understanding
* Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally recognized representative) has been informed of all pertinent aspects of the study
* Age ≥ 50 years
* No contra-indications for the use of the receiver in-the-ear device (BiometRIC SR 26UAA01GF), and smartwatch and chest strap heartrate monitor

Exclusion Criteria:

* • Smokers

  * Obese patients (BMI \>30 kg/m2)
  * Presence of a pacemaker
  * Supraventricular tachycardias: atrial fibrillation, atrial flutter, frequent supraventricular extrasystole or frequent ventricular extrasystole
  * Otologic contraindications determined by licensed otolaryngologist

Primary outcomes:
measure: Heart rate variability measured BIOMETRIC in-ear device
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References:
Clinical trial NCT02197429: Acupuncture for the Treatment of Vulvodynia
Official title: Acupuncture for the Treatment of Vulvodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Vulvar Vestibulitis
Pain
Dyspareunia
Female Sexual Dysfunction Due to Physical Condition
Keywords: Vulvodynia
Acupuncture
Provoked Vestibulodynia
Vulvar Vestibulitis
Vulvar Pain
Dyspareunia
Female Sexual Function
Lead sponsor: Schlaeger, Judith M., CNM, LAc, PhD
Sponsor class: INDIV
First posted: 2014-07-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia.

Hypotheses:

1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.
2. Acupuncture increases sexual function in women with vulvodynia.


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
* Provoked vulvodynia
* Unprovoked vulvodynia
* Women between 18 years of age and menopause

Exclusion Criteria:

* Pregnancy
* Menopause
* Interstitial cystitis
* Irritable bowel syndrome
* Untreated vaginitis
* Cervicitis
* Pelvic inflammatory disease
* Diagnosed with other pelvic pathology causing pain
* Concomitantly receiving physical therapy
* Concomitantly receiving biofeedback,
* Concomitantly receiving massage
* Concomitantly receiving additional acupuncture.

Primary outcomes:
measure: vulvar pain
timeFrame: Baseline and 5 weeks
Secondary outcomes:
measure: Dyspareunia
timeFrame: Baseline and 5 weeks
Other outcomes:
measure: Female sexual function
timeFrame: Baseline and 5 weeks
Locations:
city: Glenview
country: United States
facility: Glenview Healing Arts
state: Illinois
Study officials:
name: Judith M. Schlaeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.
citation: Curran S, Brotto LA, Fisher H, Knudson G, Cohen T. The ACTIV study: acupuncture treatment in provoked vestibulodynia. J Sex Med. 2010 Feb;7(2 Pt 2):981-95. doi: 10.1111/j.1743-6109.2009.01582.x. Epub 2009 Nov 12.
citation: Danielsson I, Sjoberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41.
citation: Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
Clinical trial NCT02510729: SPG Neurostimulation in Cluster Patients
Official title: Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cluster Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.

Detailed description: We conducted a double-blind, randomized, sham-controlled, crossover study to investigate cluster attack induction following LF (20 Hz and 0.2-2.1 amplitude) and sham (amplitude = 0) stimulation in 20 CH patients with implanted SPG neurostimulator. In addition, we measured plasma concentrations of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal peptide (VIP), as markers for parasympathetic activation before, during and after SPG stimulation. We also investigated if LF SPG stimulation induces changes in cardiac autonomic regulation and whether any attacks induced by SPG stimulation are associated with such changes.

Eligibility criteria: Inclusion Criteria:

* Chronic cluster patients

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of cluster-like attacks and cephalic autonomic symptoms
timeFrame: 0-60 min
Secondary outcomes:
measure: Mechanical detection and pain thresholds
timeFrame: 0-60 min
measure: Plasma concentrations of PACAP38 and VIP
timeFrame: 0-60 min
measure: Cardiac autonomic regulation (HRV)
timeFrame: 0-60 min
measure: Mean arterial blood pressure and heart rate
timeFrame: 0-60 min
measure: Headache intensity
timeFrame: 0-60 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo S, Petersen AS, Schytz HW, Barlose M, Caparso A, Fahrenkrug J, Jensen RH, Ashina M. Cranial parasympathetic activation induces autonomic symptoms but no cluster headache attacks. Cephalalgia. 2018 Jul;38(8):1418-1428. doi: 10.1177/0333102417738250. Epub 2017 Oct 30.