louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05474547: Meditation and Youth Mental Health
Official title: Effect of Meditation on the Young Mental Health - A Feasibility Pilot Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Habib University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Youth is a crucial time of life when physical and mental well-being is critical. Students are vulnerable due to academic and pandemic stresses. Meditation research has been showing effects on improved parameters of mental health (sleep quality, attention, memory, and concentration), emotional wellbeing (reduced stress and anxiety), and physiological parameters (better metabolism, circulation, immunity, etc.), which influence the life and academic performance of students. This study is designed to examine the feasibility of conducting a meditation intervention among students of a small liberal arts university in Pakistan. Future larger and longer randomized controlled clinical trials on high-risk youth may be planned at a later stage to see the impact on academic performance and career progression.


Eligibility criteria: Inclusion Criteria:

* Healthy students

Exclusion Criteria:

* Students suffering from a serious illness
* Students already meditating regularly

Primary outcomes:
measure: Meditation Practice
timeFrame: 10 days
measure: Sleep quality (sleep duration, deep sleep, light sleep, REM)
timeFrame: 10 days
Secondary outcomes:
measure: Physical activity and Heart Rate
timeFrame: 10 days
measure: Stress and Breathing Score
timeFrame: 10 days
measure: Food intake and nutrient profile
timeFrame: 10 days
Other outcomes:
measure: Emotional wellbeing
timeFrame: 10 days
measure: Depression Anxiety and Stress
timeFrame: 10 days
measure: Resilience and Resilience Coping
timeFrame: 10 days
measure: Grit
timeFrame: 10 days
measure: Loneliness
timeFrame: 10 days
measure: Gratitude, Resentment and Appreciation
timeFrame: 10 days
measure: Happiness
timeFrame: 10 days
measure: Empathy
timeFrame: 10 days
measure: Internet Use
timeFrame: 10 days
measure: Nomophobia Questionnaire
timeFrame: 10 days
measure: Social Networking Addiction
timeFrame: 10 days
Locations:
Study officials:
affiliation: Integrated Sciences and Mathematics, Dhanani School of Science and Engineering, Habib University
name: Humaira Jamshed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122147: Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
Official title: Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Aphthous Stomatitis
Keywords: Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis .


Eligibility criteria: Inclusion Criteria:• Confirmation of clinical diagnosis of aphthae

* Having the experience of oral aphthae at least once in a month
* Two weeks wash out periods after the last treatment

Exclusion Criteria:

* History of any systemic disease
* Using drugs which affect immune system
* Pregnancy and breast feeding
* Aphthous related syndromes

Primary outcomes:
measure: protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
timeFrame: 3 months
Secondary outcomes:
measure: This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer
timeFrame: 3 months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Madical Science,Research Center of Mashhad Dental School
state: Khorasan Razavi
Study officials:
affiliation: mashhad UMS
name: seyyed amir seyyedi, DDS-MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00473447: A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy
Official title: Phase1 Effectiveness of a Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy: a Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemiparesis
Cerebral Palsy
Keywords: Rehabilitation
Children
Cerebral Palsy
Arm
Paresis
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy. In these children one main problem the non-use of the affected arm. Many studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6 hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is effective in improving use and function of children paretic arm


Eligibility criteria: Inclusion Criteria:

* presence of mild-moderate arm paresis (after cerebral palsy) enabling to
* reach and grasp a pellet
* age between 1-10 years
* active participation during proposed activities
* parents consent for participation -

Exclusion Criteria:

* presence of severe behaviour disturbances
* presence of severe mental retardation (QI\<60)

Primary outcomes:
measure: Arm Use Test
timeFrame: Four months for each patient
Secondary outcomes:
measure: Arm Function Test
timeFrame: Four months for each patient
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurological and Vision Sciences, University of Verona
name: Antonio Fiaschi, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02380547: Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
Official title: Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Invasive Mechanical Ventilation
Keywords: Sonography
Diaphragmatic function
Non invasive ventilation
Critical care patients
Extubation after 24 hours of invasive ventilation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical care patients (surgical or medical)

Brief summary: Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).

Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.

The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function


Eligibility criteria: Inclusion Criteria:

* Patient extubated after at least 48 hours of invasive ventilation
* Requiring non invasive ventilation
* Consent of patient

Exclusion Criteria:

* Diaphragmatic paralysis
* Neuromuscular disease
* significant pleural effusion
* atelectasis requiring bronchoscopy
* abdominal hypertension

Primary outcomes:
measure: Diaphragmatic excursion
timeFrame: Before the first NIV session
measure: Diaphragmatic thickening
timeFrame: Before the first NIV session
measure: Diaphragmatic excursion
timeFrame: After the first NIV session
measure: Diaphragmatic thickening
timeFrame: After the first NIV session
measure: Diaphragmatic excursion
timeFrame: After 24 h of NIV use
measure: Diaphragmatic thickening
timeFrame: After 24 h of NIV use
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Gharib AJOB, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748147: Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol
Official title: Cervical Ripening in Obese Women: a Prospective, Randomized Trial Comparing Efficacy of 25 mcg Versus 50 mcg of Misoprostol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
Primary purpose: TREATMENT

Brief summary: This is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.

Detailed description: We will perform a prospective, randomized, double-blind clinical trial with parallel assignment.

Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.

Eligibility criteria: Inclusion Criteria:

* Labor induction, BMI of 30 or greater, English speaking

Exclusion Criteria:

* Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction

Primary outcomes:
measure: Vaginal delivery
timeFrame: Variable, but within 4 days
Secondary outcomes:
measure: Completed cervical ripening
timeFrame: 2 days
measure: Specific time interval from start of induction to active labor
timeFrame: 2 days
measure: Rate of tachysystole, fetal nonreassuring status, uterine rupture
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01557647: Safety and Efficacy of Inhaled Treprostinil in Patients With PAH
Official title: Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.


Eligibility criteria: Eligible subjects must:

* Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed),
* Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use.
* Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening.
* Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.

Primary outcomes:
measure: Six-minute walk test
timeFrame: 6 months
Secondary outcomes:
measure: Time to clinical worsening
timeFrame: 1 day to 2.5 years.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03320447: Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease
Official title: Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bowen's Disease
Keywords: ablative fractional laser
photodynamic therapy
protoporphyrin IX
methy-aminolevulinate
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.

Detailed description: To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.

Eligibility criteria: Inclusion Criteria:

* •Patients aged 18 years or more who diagnosed as bowen's disease

Exclusion Criteria:

* pregnancy or lactation
* active systemic infectious disease
* other inflammatory, infectious, or neoplastic skin diseases in the treated area
* allergy to MAL,other topical photosensitizers, or excipients of the cream
* history of photosensitivity
* use of immunosuppressive or photosensitizing drugs
* participation in any other investigational study in the preceding 30 days
* history or indicators of poor compliance
* Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria

Primary outcomes:
measure: Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
timeFrame: Short-term CR rate was evaluated at 3 months
measure: Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
timeFrame: Long-term CR rate was evaluated at 60 months
measure: Difference of long-term recurrence rate between AFL-PDT and MAL-PDT at 60 months
timeFrame: Recurrent rate was evaluated at 60 months
Secondary outcomes:
measure: Difference of the cosmetic outcome between AFL-PDT and MAL-PDT
timeFrame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months
Other outcomes:
measure: Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT
timeFrame: Within 60 months after each treatment
Locations:
Study officials:
References:
Clinical trial NCT02900547: Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure
Official title: Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearth Failure, Systolic
Keywords: Systolic Heart Failure
medical algorithm decision support system
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for acutely decompensated systolic heart failure

Brief summary: The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart Failure will be enrolled and health data will be collected at hospital admission and during hospital stay. No data will be collected before detailed information is given to the patient and a non-opposition is obtained.

The aim of this observational and prospective study is to evaluate the concordance actual patient management during the in hospital treatment of heart failure and the therapeutic proposals from a medical algorithmic decision support software.

Detailed description: Main Objective:

The aim of this observational and prospective study is to evaluate retrospectively the concordance between the actual systolic heart failure patient management during the inhospital treatment of heart failure (as recorded from the usual healthcare data collected) and the therapeutic proposals from a medical algorithmic decision support software.

Secondary Objectives:

To study the evolution of biological, hepatic and cardiopulmonary ultrasound usual markers in hospitalization, in connection with the duration of hospitalization and drug administered.

Eligibility criteria: Inclusion Criteria:

* 18 years old or over
* Patients hospitalized for decompensated systolic heart failure
* Patients informed

Exclusion Criteria:

* Patients unwillingness to participate

Primary outcomes:
measure: Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals
timeFrame: an average of 7 days
Secondary outcomes:
measure: Duration of hospitalization (number of days)
timeFrame: an average of 7 days
measure: Weight evolution (Kilograms)
timeFrame: an average of 7 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT06743347: Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study
Official title: Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebrospinal Fluid
Healthy Subjects or Volunteers
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research will enhance our knowledge and understanding of Cerebrospinal Fluid (CSF) circulation around the Central Nervous System (CNS) (brain and spinal cord).

The main objective is to obtain flow velocities using Phase Contrast (PC) MRI over the entire subarachnoid space (SAS). This will enable us to develop and validate a numerical model of the SAS.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at the time of agreement
* Free subject, without guardianship or curatorship or subordination
* Patients benefiting from a Social Security scheme or benefiting from it through a third party
* Informed consent signed by the patient after clear and complete information about the study

Exclusion Criteria:

* 3T MRI contraindications (pacemaker, cochlear implant, metallic splinter, etc)
* History of neurological pathology
* Previous operations involving the central nervous system (spinal surgery, neurological surgery, etc.)
* Current pathology or treatment that may interfere with the CSF or subarachnoid spaces (CSF dysregulation, disc herniation, hydrocephalus, Chiari malformation, etc.)
* Concurrent participation in another clinical research study
* Persons not covered by Social Security or not covered by Social Security through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)

Exclusion criteria during the study:

- Discovery of a contraindication to 3T MRI (pacemaker, cochlear implant, metallic splinter, etc)

Primary outcomes:
measure: To evaluate the velocity displacement of CSF about 7 planes (intracranial plane, C2-C3, C5-C6, T4-T5, T10-T11, L3-L4, L5-S1)
timeFrame: Time PC-MRI will be around 60min
Secondary outcomes:
measure: Using morphological MRI to model a digital twin
timeFrame: Time PC-MRI will be around 60min
measure: To evaluate the velocity displacement of blood about 2 planes (intracranial plane, C2-C3)
timeFrame: Time PC-MRI will be around 60min
Other outcomes:
Locations:
Study officials:
References: