louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02401425: Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
Official title: Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Complete Miscarriage
Keywords: Letrozole
Misoprostol
First-Trimester
Pretreatment
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 423
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed description: Primary outcome:

Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)

Secondary outcome:

Need for surgical evacuation of the products of conception

* Incomplete expulsion of the products of conception (incomplete miscarriage).
* Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
* Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
* Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit

Eligibility criteria: Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age less than 13 weeks.
* Hemoglobin \>10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Missed abortion.
* Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age more than 12 weeks.
* Hemoglobin \<10 g/dL.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25kg/m2 and more than 35kg/m2.
* Coagulopathy.
* History or evidence of adrenal pathology.
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Primary outcomes:
measure: Incidence of complete abortion
timeFrame: 1 week
Secondary outcomes:
measure: Need for surgical evacuation of the products of conception
timeFrame: 1 week
measure: Maternal morbidity
timeFrame: 1 week
measure: Hemoglobin and hematocrit deficit
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT01019525: Posture and Pulmonary Function of Mouth-breathing Children
Official title: Posture and Pulmonary Function of Mouth-breathing Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mouth Breathing
Keywords: respiration
respiratory disorders
Otolaryngology
Otorhinolaryngology
Posture
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mouth-breathing children were referred by Pediatrics Service (Federal University of Rio de Janeiro) and by School of Dentistry (Federal University of Rio de Janeiro), after the diagnosis of mouth breathing was confirmed.

Nasal breathing children were recruited from Tia Ciata Municipal School (Praça Onze-Rio de Janeiro, Brazil).

Brief summary: The purpose of this study is to characterize the posture and respiratory function of mouth-breathing children.

Detailed description: Mouth-breathing children presents changes in stomatognathic system, which results in head projection, tension augment in scapular belt muscles and postural adaptations. Although thoracic shape and posture can influence ventilatory dynamics, we didn't find studies addressing pulmonary function of mouth-breathing children. This was a transversal study, designed to analyze the posture of mouth-breathing children, and verify the existence of correlation between posture and pulmonary volumes.

Eligibility criteria: Inclusion Criteria:

* Nasal breathing (normal subjects group) or mouth breathing (mouth-breathing group), and the age between eight (08) and twelve (12) for both groups.

Exclusion Criteria:

* Prior physiotherapeutic treatment or in process, presence of diagnostic or report on acute or chronic pulmonary disease, neurofunctional or cognitive impairment and alteration of the osteomuscular system.

Primary outcomes:
measure: Pulmonary function, by means of forced spirometry.
timeFrame: Within the first 30 days after recruitment.
Secondary outcomes:
measure: Posture, by means of photogrammetry.
timeFrame: Within the first 30 days after recruitment.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Sara LS Menezes, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02202525: Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy in Patients With Essential Arterial Hypertension
Official title: Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 2148
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: Patients with essential hypertenstion treated by private or hospital cardiologists

Brief summary: The main purpose of this prospective, multicentre, french observational study is to analyse the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive patients three months after initiation of a new hypertensive therapy. The PP is defined as the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).


Eligibility criteria: Inclusion Criteria:

* Patients with essential arterial hypertension needing a new antihypertensive therapy
* A patient was included by the physician only if he/she had agreed after being informed about the study

Exclusion Criteria:

Primary outcomes:
measure: Changes from baseline in pulse pressure
timeFrame: Up to 3 months after start of treatment
measure: Number of patients with adverse drug reactions
timeFrame: Up to 3 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06241625: Virtual Reality Based Vision Test in Patients With AMD
Official title: Virtual Reality (VR) Based Vision Test in Subjects With Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
Lead sponsor: Augenklinik Zurich West
Sponsor class: OTHER
Collaborators: name: Apellis Pharmaceuticals, Inc.
First posted: 2024-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

Detailed description: In order to bridge the gap between the existing functional measures and AMD lesions, researchers are considering the use of VR tools.

This study is designed to assess the contrast sensitivity function mapping test (CSF radial sweep) in an elderly population with AMD.

The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

The secondary objective of this study is to assess the relationship between the metrics generated by VR-based functional tasks and the metrics derived from conventional clinical measurements of retinal anatomy and visual function.

The primary efficacy endpoint is the Contrast sensitivity function (CSF) area under curve (AUC) correlation to Snellen BCVA.

Eligibility criteria: Inclusion Criteria:

1. Subjects ≥18 years of age diagnosed with AMD
2. Subject Snellen BCVA score is 20/100 or better
3. Ability to undergo quality optical coherence tomography (OCT) imaging
4. Willing and able to give written informed consent

Exclusion Criteria:

1. Unwilling to use headset
2. Previous negative experience with a VR headset (eg, motion sickness, discomfort)
3. Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
4. Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
5. Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)

Primary outcomes:
measure: Usability, tolerability and repeatability
timeFrame: 20 minutes
Secondary outcomes:
measure: Contrast sensitivity function (CSF)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Augenklinik Zurich West
state: Zurich
Study officials:
affiliation: Augenklinik Zurich West
name: Stephan Michels, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05829525: Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number
Official title: Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young Adult
Keywords: Step count
Physical activity
Heart rate
Sleep quality
Sleep duration
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to evaluate the relationship among sleep duration, heart rate, number of steps, and sleep quality.

Detailed description: There are studies examining the relationship between sleep quality and physical activity in young adults. In these studies, weakly significant relationships were recorded between sleep quality and physical activity level. However, in these studies, the level of physical activity was evaluated with the International Physical Activity Questionnaire and the questionnaire was filled in within the framework of certain activities. In this study, physical activity will be evaluated with the number of steps taken per day. In addition, there is no study examining the relationship between sleep quality, sleep duration, and heart rate in young adults. With the current study, parameters that will affect physical activity such as sleep duration, heart rate, and the number of steps will be evaluated and their relationship with sleep quality will be determined. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, sleep duration, heart rate, and step count will be assessed by the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA), and quality of life will be assessed by the Nottingham Health Profile. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-30,
* Without any chronic disease,
* No past or present mental illness,
* Can speak, read, and write Turkish and
* Who volunteered to participate in the study

Exclusion Criteria:

* With any neurological, psychiatric or cognitive impairment,
* Who cannot speak, read or write Turkish

Primary outcomes:
measure: Sleep quality
timeFrame: 1 day
measure: Sleep duration
timeFrame: Single assessment for 1 day
measure: Nottingham Health Profile
timeFrame: 1 day
measure: Heart rate
timeFrame: 1 day
measure: Step count
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Merkez
Study officials:
References:
Clinical trial NCT00946725: To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg
Official title: A Comparative Bioavailability Study of Atenolol Tablets, 100 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Angina
Hypertension
Keywords: Angina (Chest Pain)
Hypertension
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of atenolol tablets, 100 mg.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Ronald Goldwater, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05326048: Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis
Official title: Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CIS patients

Brief summary: The objective of APOLLO is therefore to identify biomarkers associated with the CNS involvement phenotype in early MS patients.

Detailed description: This is a multicenter, non-interventional, retrospective cohort study. In MS patients, a recent study suggests that the location of lesions in the brain relative to the ME is associated with different effector T cell responses (Th17 vs. Th1) to myelin proteins. Thus, lesion localization may be associated with different immune profiles.

Recently, high-resolution techniques such as mass cytometry (CyTOF) have allowed to better decipher immune diversity and thus to identify new potential therapeutic targets. The combination of CyTOF and high dimensional analysis techniques (viSNE, SPADE, MEM) offers robust and reliable methods to identify new subgroups within heterogeneous cell populations. Several studies have explored immune subpopulations by these methods, including B, T, NK or myeloid populations, from peripheral blood or tissues in other pathologies.

Genetic analysis of regions of interest in MS patients could thus allow the establishment of stratification elements potentiating the contribution of immunological markers.

The main objective is to evaluate the relevance of an immunological stratification by CyTOF, allowing the identification of new immune subpopulations associated with the lesion phenotype (brain or brain + ME), in a cohort of MS patients at the beginning of the disease (CIS+) The second objective will focus on genomic profiling of our two groups of MS patients (brain/brain + ME) for different genetic burdens of MS

Eligibility criteria: Inclusion Criteria:

* Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
* At least 18 years old
* Diagnosed with MS according to the 2017 criteria at the time of their last visit
* Not opposed to participating in the study
* Had at least one visit in the year following sampling
* Followed up for at least 1 year after collection.
* Signed OFSEP consent form

Exclusion Criteria:

* CIS patients with progressive MS

Primary outcomes:
measure: Differences in Immune profile
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: University hospital of Rennes
Study officials:
References:
Clinical trial NCT05233748: Neuromotor Control During Walking in Children With Cerebral Palsy
Official title: Neuromotor Control During Walking in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: locomotor control
balance
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross sectional study of responses to visual perturbations in two groups, children with CP and age-and sex- matched TD (typical development). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a control / no stochastic resonance (noSR) condition while walking with and without visual perturbations.
Primary purpose: BASIC_SCIENCE

Brief summary: One out of every three children with cerebral palsy (CP) falls daily, with more than half of the falls occurring while walking. To avoid falling, the nervous system must continuously monitor how the body moves and, when an imbalance is detected, activate muscles for an appropriate correction. In this project, we will use small electrical stimulation of muscles and tendons that enhances the sense of body positioning, to allow children with CP to generate more accurate balance corrections.


Eligibility criteria: Inclusion Criteria:

* Age 8 - 24 years
* Diagnosis of spastic diplegic or hemiplegic CP (for participants with CP group only)
* GMFCS classification level I or II (ability to walk independently with using any assistive device)
* Visual, perceptual, and cognitive/ communication skills to follow multiple step commands
* Seizure-free or well controlled seizures
* Ability to communicate pain or discomfort during testing procedures
* Parental/guardian consent and child assent/consent

Exclusion Criteria:

* Diagnosis of athetoid, ataxic or quadriplegic CP
* Significant scoliosis (scoliometer angle \> 9°)
* History of selective dorsal root rhizotomy
* Botox injections in the lower limb within the past 6 months
* Severe spasticity of the lower extremity muscles (e.g. a score of 4 on the Modified Ashworth Scale)
* Severely limited range of motion/ irreversible muscle contractures
* Lower extremity surgery or fractures in the year prior testing
* Joint instability or dislocation in the lower extremities
* Marked visual or hearing deficits

Primary outcomes:
measure: Change in Margin of Stability(MOS)
timeFrame: At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation MOS.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: John Jeka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03062748: Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index
Official title: Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obstructive Sleep Apnea
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected OS who are being seen at the Sleep Research and Treatment Center.

Brief summary: The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate OSA (5≤ AHI \<30)
* BMI ≤ 45
* Age ≥ 18
* Men \& Women

Exclusion Criteria:

* AHI ≥ 30
* BMI \>45
* Current use of steroids or anti-inflammatory medication
* Diagnosis of insulin dependent diabetes
* Diagnosis of autoimmune disorder
* Shiftwork
* Current use of CPAP

Primary outcomes:
measure: Presence of the metabolic syndrome
timeFrame: baseline
measure: Obstructive Sleep Apnea
timeFrame: baseline
measure: Markers of systemic inflammation
timeFrame: baseline
Secondary outcomes:
measure: Heart rate variability
timeFrame: baseline
measure: Subjective measure of sleepiness
timeFrame: baseline
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01596348: Exercise Perceptions and Preferences Among Rheumatoid Arthritis Patients
Official title: Perceived Exercise Benefits, Barriers and Preferences Among Swiss Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Exercise
Barriers
Benefits
Preferences
Stages of change
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2012-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected in the Rheumatology Department of the Centre Hospitalier universitaire Vaudois in Lausanne.

Brief summary: The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis
* Age 30 to 80 years

Exclusion Criteria:

* Language difficulties and no help from family members or friends

Primary outcomes:
measure: Exercise status
measure: Exercise stages of change
measure: Perceived exercise benefits
measure: Perceived exercise barriers
measure: Exercise preferences
Secondary outcomes:
measure: Functional status
measure: Pain
measure: Fatigue
measure: Disease activity
measure: Quality of life
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois, Département de l'Appareil Locomoteur
Study officials:
affiliation: Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
name: Alexander KL So, PhD, FRCP
role: STUDY_DIRECTOR
References: