louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05813782: The Effect of Baby Massage on Postpartum Depression and Maternal Attachment
Official title: The Effect of Baby Massage on Postpartum Depression and Maternal Attachment in the Postpartum Period: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression, Postpartum
Maternal Behavior
Attachment
Keywords: Primiparous mother
Baby massage
Postpartum depression
Maternal attachment
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2023-04-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.

Detailed description: The transition to motherhood is one of the life stages that brings about stress and change. Primiparous mothers, who will experience motherhood for the first time due to anxiety about the unknown, may experience more stress and their communication with their babies may deteriorate. In this process, the mother's seeing, touching and interacting with her baby positively affects her perception of her baby. The easiest and most natural way to do this is baby massage. Touching and massaging the baby maintains the baby's body contact, which strengthens the baby's sense of trust and supports the mother's development of attachment behavior. It also reduces mothers' levels of stress hormones such as cortisol and relieves depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* Primiparous,
* Cesarean section,
* Having a single baby,
* Between the ages of 19-35,
* Literate
* Effective communication.

Exclusion Criteria:

* Having a premature baby,
* Mother and baby have a disease that prevents massage,
* Loss of vision and hearing.

Primary outcomes:
measure: Postpartum depression
timeFrame: Postpartum 42nd day
measure: Maternal attachment
timeFrame: Postpartum 42nd day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University
Study officials:
affiliation: Tokat Gaziosmanpaşa University
name: Ayla KORKMAZ, asst. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03632382: Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome
Official title: Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnea diagnosis
3D acquisition
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: SATT Linksium GRENOBLE
name: ARTEHIS
name: ARCTIC
First posted: 2018-08-15
Enrollment: 280
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective
Primary purpose: DIAGNOSTIC

Brief summary: This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

Detailed description: Polysomnography is the gold-standard for obstructive sleep apnea (OSA) diagnosis. However, OSA is still undiagnosed. Maxillofacial profile can influence OSA severity. Morphological characteristics can be identified but are not enough measurable and analysable by physicians. 3D acquisition of maxillofacial characteristics with a user-friendly tool, quick and low-priced could be used to obtain a predictive model as an OSA risk indicator. Thus, the aim of this study is to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

Eligibility criteria: Inclusion Criteria:

* BMI \< 35 kg/m²
* caucasian men
* patients from the sleep laboratory (CHU Grenoble Alpes) admitted for a polysomnography
* Patient who has given free and informed consent in writing

Exclusion Criteria:

* history of maxillofacial surgery
* dental malocclusion
* patient involved in another clinical research study
* patient not affiliated with social security
* patient deprived of liberty or hospitalized without consent

Primary outcomes:
measure: Establish and evaluate a predictive model for OSA diagnosis by 3D acquisition of characteristics maxillofacial
timeFrame: 1 measure at inclusion
Secondary outcomes:
measure: Sensitivity study from different stages of OSA severity
timeFrame: 1 measure at inclusion
measure: Compare diagnosis performances of predictive model and Berlin or NoSAS questionnaires
timeFrame: 1 measure at inclusion
measure: Evaluate performances of the combination (Berlin questionnaire + predictive model) to estimate the OSA risk
timeFrame: 1 measure at inclusion
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
Study officials:
affiliation: CHU Grenoble Alpes
name: Jean-Louis PEPIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monna F, Ben Messaoud R, Navarro N, Baillieul S, Sanchez L, Loiodice C, Tamisier R, Joyeux-Faure M, Pepin JL. Machine learning and geometric morphometrics to predict obstructive sleep apnea from 3D craniofacial scans. Sleep Med. 2022 Jul;95:76-83. doi: 10.1016/j.sleep.2022.04.019. Epub 2022 Apr 29.
Clinical trial NCT05270382: Effect of Mouthwashes on Oral Wound Healing and Microbiome
Official title: Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Oral Microbiome
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.


Eligibility criteria: Inclusion Criteria:

1. Male or female volunteers 18-45 years of age.
2. Good general health.
3. Must sign informed consent form.
4. Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.

Exclusion Criteria

1. Oral pathology, chronic disease, or history of allergy to testing product.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.
4. Five (5) or more decayed untreated dental sites at screening (cavities).
5. Impaired salivary function.
6. Use of medications that can currently affect salivary flow.
7. Use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, antibiotics, antimicrobial, anti-inflammatory medication or daily analgesics within 30 days prior to the start of the study or scheduled to start such intake during the course of the study.
8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
9. Pregnant or nursing women.
10. Participation in any other clinical study within 1 week prior to enrollment into this study.
11. Use of any tobacco products.
12. Subjects who must receive dental treatment during the study dates.
13. Presence of an orthodontic appliance that interferes with required clinical assessments.
14. History of allergy to common dentifrice ingredients.
15. Subjects who wear night guard, denture retainers
16. Not willing to abstain from eating crunchy (eg. Granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period;
17. Not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period
18. Non English-speaking subjects

Primary outcomes:
measure: Wound healing
timeFrame: 7 Days
measure: Microbiome
timeFrame: 5 Days
Secondary outcomes:
measure: Biomarker expression
timeFrame: 3 Days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Research Center, College of Dentistry, University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Praveen Gajendrareddy, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06292182: Red Light Ptosis Proof-of-Concept
Official title: Can Red Light Lift Droopy Eyelids? An Open-label Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitochondrial Diseases
Blepharoptosis
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Moorfields Eye Hospital NHS Foundation Trust
First posted: 2024-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light.

We use a torch to shine a red light through the closed eyelid for 3 minutes a day. The study will run for 18 months.

We believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint.


Eligibility criteria: Inclusion: Age 3 to less than 18 years Genetically confirmed diagnosis of primary mitochondrial disease (known pathogenic mutation(s) in mitochondrial or nuclear DNA known to cause primary mitochondrial disease) Ptosis

Exclusion: Genetic diagnosis not consistent with primary mitochondrial disease. No genetic diagnosis Unable to cooperate with light treatment or ophthalmological assessments.

Primary outcomes:
measure: Palpebral fissure width
timeFrame: 3 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05817682: Interprofessional Education of Medical Students Using Medical Simulation
Official title: Interprofessional Education of Medical Students Using Medical Simulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medical Students
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Due to the growing role of medical simulation in the education of medical students and the development of cooperation in interdisciplinary teams in the health care sector, a study was designed to examine the relationship between the competences and resources of students and the role of education through simulation classes based on the development of technical and in cooperation with specialists in these fields. Researchers want to focus on students' levels of stress and anxiety, coping strategies, and self-efficacy. An important element will be the self-assessment of students on the level of their non-technical competences.


Eligibility criteria: Inclusion Criteria:

* Voluntary consent to participate in the study
* Declaration of participation in the Interdisciplinary Simulation Circle
* Student status in the field of medicine (6th year) or nursing (3rd year of first-cycle studies) or medical rescue (3rd year)

Exclusion Criteria:

* Completed another course of medical studies

Primary outcomes:
measure: Evaluation of the ongoing interprofessional education
timeFrame: 10 months
measure: Evaluation of the impact of interprofessional education on soft-skill development
timeFrame: 10 months
measure: Evaluation of the impact of interprofessional education using the simulation method on self-efficacy.
timeFrame: 10 months
measure: Evaluation of the impact of interprofessional education using the simulation method on student stress level.
timeFrame: 10 month
measure: Evaluation of the impact of interprofessional education using the simulation method on stress coping.
timeFrame: 10 month
measure: Evaluation of the impact of interprofessional education using the simulation method on perception of medical professions.
timeFrame: 10 month
measure: Evaluation of the impact of interprofessional education using the simulation method on students anxiety.
timeFrame: 10 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Andrzej Frycz Modrzewski Krakow University
Study officials:
References:
Clinical trial NCT05376982: Comparison of NT Vs Body Weight Supported TT Along With CT on Lower Extremity in Chronic Stroke Patients
Official title: Comparison of Neurodevelopmental Treatment Vs Body Weight Supported Treadmill Training Along With Conventional Therapy on Lower Extremity Among Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effect of Neurodevelopment Treatment vs Body Weight Supported Treadmill Training along with conventional therapy on lower extremity among chronic stroke patients.


Eligibility criteria: Inclusion Criteria:

* Application of M-Cog test for checking patients cognition.
* Chronic ischemic stroke patients.
* Both Male and Female Patients.
* Patients of 35 or above years of age.

Exclusion Criteria:

* Patients with history of recurrent stroke.
* Patients with lower limb fractures or dislocations.
* Patients with Peripheral vascular disease
* Patients with skin discoloration or skin ulcers.

Primary outcomes:
measure: For lower extremity among chronic stroke patients
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: • General Hospital. • Chaudhary Muhammad Akram Teaching and Research Hospital, University of Lahore Teaching Hospital, Shadman Medical Center, Services Hospital, Bahria International Hospital
Study officials:
References:
Clinical trial NCT01894282: Mind Body Intervention for Chronic Lower Back Pain
Official title: Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lower Back Pain
Keywords: Chronic Lower Back Pain
Manual Therapy
Cognitive Behavioral Therapy
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2013-07-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of CBT-p and MT and those undergoing MT alone.

Detailed description: Given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the two trained practitioners utilizing kappa statistics. We will perform data analyses using SPSS.

Eligibility criteria: Inclusion Criteria:

* 18 to 69 years of age with CLBP who are
* "high risk" for poor prognosis based on SBST
* currently undergoing chiropractic care.

Exclusion Criteria:

* Contraindications to either MT or CBT-p.
* Patients who are currently undergoing CBT-p
* who have been treated for substance abuse in the past year.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline and 6 weeks post baseline (immediately post intervention)
Secondary outcomes:
measure: PROMIS Global Health Scale (GHS)
timeFrame: Baseline and 6 weeks post baseline (immediately post intervention)
Other outcomes:
measure: Patient Satisfaction Questionnaire
timeFrame: Baseline and post intervention
Locations:
city: Rochester
country: United States
facility: Rochester Outpatient Clinic
state: New York
Study officials:
affiliation: Canandaigua VA Medical Center
name: Paul Dougherty, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619382: An Evaluation Of Healthy Ankle Motion And Morphology
Official title: An Evaluation Of Healthy Ankle Motion And Morphology In Different Phases Of Simulated Gait Using A Weight-bearing CBCT Scan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Ankle
Keywords: ankle
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
Collaborators: name: Focus Medical Design and Development
First posted: 2018-08-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers who have a healthy ankle

Brief summary: Determine motion and morphology of the healthy ankle during simulated gait.

Detailed description: Healthy volunteers will undergo weight-bearing, cone beam CT scans of their foot/ankle during 3 phases of simulated gait. Motion and morphology of the foot and ankle will be quantified and analyzed.

Eligibility criteria: Inclusion Criteria:

1. The subject self-reports having a right healthy ankle.
2. The subject agrees to comply with the requirements of the study and complete the study measures.
3. The subject is between the ages of 18 and 65.
4. The subject is willing to provided written informed consent.

Exclusion Criteria:

1. The subject is pregnant.
2. The subject reports having been diagnosed with any form of diabetes.
3. The subject reports having surgery on the right foot, right ankle and/or right knee.
4. The subject reports a history of repeated ankle sprains or injuries to the right ankle.
5. The subject reports a history of instability of the right ankle.
6. The subject reports chronic or recurring pain of the right ankle.
7. The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, and/or known abuser of alcohol and/or drugs.

Primary outcomes:
measure: Relative rotations of bones
timeFrame: 1 day
Secondary outcomes:
measure: Relative translations of bones
timeFrame: 1 day
measure: Morphology - size and shape of the bones of the foot and ankle
timeFrame: 1 day
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: Orthopedic Center of Palm Beach County
state: Florida
Study officials:
affiliation: Orthopedic Center of Palm Beach County
name: James Clancy, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04966182: Application CT and MRI in Cerebral Venous Sinus Thrombosis
Official title: the Application CT and MRI in the Diagnosis of Cerebral Venous Sinus Thrombosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Magnetic Resonance Imaging
Cerebral Venous Sinus Thrombosis
Computer Tomographgy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients with the diagnosis of cerebral venous thrombosis or cerebral venous sinus thrombosis at admission were included.

Brief summary: Cerebral venous thrombosis (CVT) is a rare disease, and with poor prognosis. Computed tomography (CT) andmagnetic resonance imaging (MRI) are the most commonly used image modalities for patients with non-specific neurologic symptoms. We are going to assess the accuracy of CT and MRI in the differential diagnosis of CVT and cerebral venous sinus thrombosis (CVST).


Eligibility criteria: Inclusion Criteria:

A. The patients were diagnosed with cerebral venous thrombosis or cerebral venous sinus thrombosis; B. The patients completed at least cranial CT or MRI examination upon admission;C. The patients complete at least one of the CTV, MRV or DSA examination.

Exclusion Criteria:

A. Patients with severe cardiopulmonary insufficiency;B. Patients lost to follow-up;C. Patients with incomplete access to imaging data;D. Patients with cerebral venous sinus thrombosis that was not diagnosed at discharge.

Primary outcomes:
measure: specificity and sensitivity of CT
timeFrame: 2022.01
measure: specificity and sensitivity of MRI
timeFrame: 2022.01
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00071682: Evaulation of Interaction Between Herbal Products and Anticoagulants
Official title: Early Identification of Adverse Reactions to Herbs
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coagulation Disorders
Keywords: herbal medicine
alternative medicines
anticoagulation
side effects
bleeding
clotting
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine if the use of herbal products interferes with normal anticoagulation, leading to either excessive thinning of the blood and bleeding problems or inadequate thinning of the blood and clotting problems. Many patients who are on long term anticoagulation, or blood thinning, for a variety of medical problems, also take herbal products. It is not yet known whether use of herbal products interferes with this anticoagulation, and puts patients at risk for bleeding or clotting. This study will carefully monitor patients who are taking herbs and anticoagulants to determine if their laboratory tests show signs of being affected by the herbs. The study will ask all patients about their herbal product use, so all reported herbs will be included and monitored.


Eligibility criteria: Inclusion criteria:

* Taking longer-term (\>6 months) anticoagulation
* Enrolled in one of Kaiser Permanente Northern California anticoagulation clinics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephen Bent, MD
role: PRINCIPAL_INVESTIGATOR
References: