louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05609123: Endothelial Glycocalyx Damage in Brain Death Organ Donors
Official title: Endothelial Glycocalyx Status and Damage in Brain Death Organ Donors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Damage Due to Hypoxia
Organ Donors
Organ Transplant Failure or Rejection
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 100
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: Patients in the intensive care unit with intracranial pathology are predisposed to brain death. In a time of confirmed brain death by clinical examination, the patients will be enrolled. Confirmatory paraclinical study of brain death is not mandatory for enrollment.

Brief summary: The study aims the assessment of endothelial glycocalyx (EG) degradation in deceased organ donors. There is a lack of organs for the transplantation program. By the description of the EG status, we can open room for organ optimization before transplantation and improve the organ function after transplantation in marginal donors.


Eligibility criteria: Inclusion Criteria:

* patients in critical condition declared as brain dead by clinical examination

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Markers of endothelial glycocalyx damage
timeFrame: baseline at the time of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
References:
Clinical trial NCT06698523: To Assess Breathing Exercise as a Relaxation Method
Official title: Evaluation of Bubble-Blower Exercise and Pin-Wheel Exercise on Dental Anxiety in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: breathing exercise
play toys
heart rate
venham picture test
salivary alpha amylase
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety.

Detailed description: bubble blower and pin wheel are used to facilitate breathing exercise and to reduce dental anxiety hence more cooperation of participants during dental treatment

Eligibility criteria: Inclusion Criteria:

* children that had been introduced to dental setting without receiving any dental treatment
* According to Corah 's dental anxiety scale children classified with score 19 or more
* No learning disability or psychological disorder or parental anxiety

Exclusion Criteria:

* children in emergency visit
* Allergy to anesthetic drugs
* Use of analgesic before treatment
* Teeth with necrotic pulp
* children whose parents refused to sign informed consent

Primary outcomes:
measure: Heart rate to assess child's dental anxiety
timeFrame: during dental treatment after local anesthetic injection. Heart rate is measured in beats/min measured twice, first before any dental treatment and measured a second time after 7-10 minutes after injection of local anesthesia
measure: Venham picture test used to assess dental anxiety
timeFrame: during dental treatment recorded before any treatment is done and after five minutes of injection of local anesthesia
measure: Salivary Alpha amylase
timeFrame: before any dental treatment is done and 7-10 minutes after injection of local anesthesia
Secondary outcomes:
measure: Innovation of a new protocol in behavior management prior to painful dental procedure
timeFrame: during dental treatment that will take 15-30 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Faculty of Dentistry
Study officials:
affiliation: Ain Shams University Faculty of Dentistry
name: Passant Elbahy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180323: ACC - Atrial Contribution to CRT
Official title: ACC - Atrial Contribution to CRT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dilated Cardiomyopathy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in the event of right atrial pacing.

Detailed description: All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Eligibility criteria: Inclusion Criteria:

* Symptoms of heart failure
* Left ventricular dysfunction
* Ventricular dyssynchrony
* 18 years or of legal age in order to give informed consent according to national laws
* Able to understand the nature of the procedure
* Available for follow-up on a regular basis at an approved investigational center

Exclusion Criteria:

* Atrial Fibrillation
* Life expectancy of less than six months due to other medical conditions
* For women: pregnancy or absence of medically accepted birth control
* Inability or refusal to sign the Patient Informed Consent
* Inability or refusal to comply with the follow up schedule or protocol requirements
* Inability to undergo device implant, including general anaesthesia if required
* Mechanical tricuspid prosthesis
* Currently enrolled in another investigational study, including drug investigations
* Hypertrophic Obstructive Cardiomyopathy (HOCM)
* Not meeting the inclusion criteria

Primary outcomes:
measure: Aortic Velocity Time Integral (VTI)
timeFrame: At implant (baseline), 3 months and 6 months Follow-up
measure: Optimal AV-Delay (AVD)
timeFrame: Implant (baseline), 3 months and 6 months Follow-up
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: implant (baseline), 3 months and 6 months Follow-up
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: implant (baseline), 3 Months, 6 Months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jasper Hastrup Svendson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357923: Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age
Official title: Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance as Well as Variations and Allelic Mutations in the Main Genes Involved in the Occurrence of Age-related Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects \> 60 years of age respecting a male/female ratio = 1.

Detailed description: Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects \> 60 years of age respecting a male/female ratio = 1. After explanations and collection consent, collection of the patient's socio-demographic and medical characteristics and then carrying out a Peripheral venous blood sample (2 x 5ml tubes).

Eligibility criteria: Inclusion Criteria:

* Men and women over 60 years of age.

Exclusion Criteria:

* Inability to Understand Consent,
* Non-Security Beneficiaries
* social, subjects protected by law, subjects deprived of liberty,
* history of breast cancer,
* brain tumor,
* melanoma,
* colon cancer,
* lung cancer,
* prostate cancer,
* lymphoma,
* myeloma,
* syndrome myelodysplastic/myeloproliferative,
* leukemia,
* history of radiation therapy.

Primary outcomes:
measure: Expression level of LAMP2 (protein and isoform A and B mRNA)
timeFrame: day 0
Secondary outcomes:
measure: Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes
timeFrame: day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: Chu de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Andrea CICCONE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01926223: Massachusetts Healthy Families Evaluation-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Parenting
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2013-08-20
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT

Brief summary: Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child development; 3) educational achievement and economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged births.


Eligibility criteria: Inclusion Criteria:

* age between 16 and 21 years
* first-time parent

Exclusion Criteria:

* cognitive delay
* not fluent in either Spanish or English

Primary outcomes:
measure: Child abuse and neglect
timeFrame: 24 months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Medford
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
References:
citation: Easterbrooks MA, Bartlett JD, Raskin M, Goldberg J, Contreras MM, Kotake C, Chaudhuri JH, Jacobs FH. Limiting home visiting effects: maternal depression as a moderator of child maltreatment. Pediatrics. 2013 Nov;132 Suppl 2:S126-33. doi: 10.1542/peds.2013-1021K.
Clinical trial NCT00224523: Long Term Safety Of GW685698X Via Nasal Biopsy
Official title: A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects 18 Years of Age With Perennial Allergic Rhinitis (PAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: perennial allergic rhinitis
nasal biopsy
GW685698X
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

Detailed description: A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray \[Nasonex®\] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects \>18 Years of Age with Perennial Allergic Rhinitis (PAR)

Eligibility criteria: Inclusion criteria:

* History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
* Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria:

* Patients who require certain medications for their allergy.
* Patients with serious medical problems.

Primary outcomes:
measure: Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
Secondary outcomes:
measure: No Secondary Outcome Measures
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Fokkens W, Hellings P, Blom H, Jansen A, van Drunen K, Clements D, Wu W, Caldwell M, Philpot E. A comparison of the effects of fluticasone furoate and mometasone furoate nasal sprays on the nasal mucosa. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A12 (abstract)
Clinical trial NCT04934150: Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain
Official title: Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cor-tex for the Treatment of Chronic Pain: a Randomized Place-bo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted in a single-blinded, randomized, placebo-controlled design
Primary purpose: TREATMENT

Brief summary: This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation on nociception and quality of life in patients suffering from chronic pain conditions. Two cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and compared to Sham stimulation.

Detailed description: From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress Scale" (DASS) and quality of life (QoL) with the SF-12 questionnaire.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* clinical diagnosis of chronic LBP (low back pain) and or neck pain
* average resting pain-level \> than 3 in the Numeric Rating Scale (0-10)
* no changes in pain medication 4 weeks at baseline
* no surgical procedures in the last 2 years

Exclusion Criteria:

* metallic and electronic implants in the head, neck and chest
* medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses \> 100mg orally/d
* history of frequent headache or tinnitus
* alcohol or drug abuse
* pregnant patients
* breastfeeding patients

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: 36 weeks
Secondary outcomes:
measure: Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
References:
Clinical trial NCT02648750: Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service
Official title: A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: self-management
rehabilitation
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This feasibility study evaluates whether it is possible to run a larger scale study to investigate the use of a self-management programme with adults who have recently had a stroke. Half of the participants will receive support with self-management from stroke therapists, while the other half will receive it from rehabilitation assistants.

Detailed description: Supporting self-management post-stroke is a key priority in healthcare policy, but not yet embedded into the provision of stroke rehabilitation. Barriers to implementation include time and resource. The feasibility of using the Bridges Stroke Self-Management Programme within an Early Supported Discharge Service and delivery by Rehabilitation Assistants is unknown.

The aim of this study was to evaluate key trial parameters to inform the protocol of a future definitive trial into the effectiveness of Bridges delivered by rehabilitation assistants within an Early Supported Discharge Service.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of new stroke
* Being referred to the ESD service
* Medically stable
* Able to give informed consent
* Can follow a two-stage command

Exclusion Criteria:

* Being discharged to a care home

Primary outcomes:
measure: Change from baseline Stroke Self-Efficacy Scale at 6 weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change from baseline Modified Rivermead Mobility Index at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline SIPSO at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline EQ5D at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline PHQ-9 at 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Plymouth University
name: Jenny Freeman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04325750: Energy Transfer Therapy in Treatment of Medial Gastrocnemius
Official title: Effects of Capacitive and Resistive Energy Transfer Therapy in Pre and Post-treatment Medial Gastrocnemius in National Level Basketball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strain of Gastrocnemius Muscle (Diagnosis)
Diathermy Plate Burn
Thermography
Sports Physical Therapy
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 32
Sex: MALE
Minimum age (years): 16
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. The main objective of the study is to establish whether the TECAR produces physiological and mechanical changes in the subjects that improve muscle recovery.


Eligibility criteria: Inclusion Criteria:

* Male players
* Semi-professional players who are currently active
* Not have suffered a lower limb injury in the last 6 months before the study
* Not having suffered a rupture of the triceps surae
* Contain a latent trigger point in the medial gastrocnemius

Exclusion Criteria:

* Players suffering from any disease that could alter the study or be contradictory

Primary outcomes:
measure: Pain intensity
timeFrame: 30 minutes
Secondary outcomes:
measure: Back flexion
timeFrame: 30 minutes
measure: Thermographic evaluation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad Católica de Valencia San Vicente Mártir
Study officials:
affiliation: Universidad Católica de Valencia San Vicente Mártir
name: Carlos Barrios, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05694650: Perceptions of Hospital Care At Home for Patients with Cancer: a Qualitative Study of Cancer Providers, Patients and Caregivers.
Official title: Perceptions of Hospital Care At Home for Patients with Cancer: a Qualitative Study of Cancer Providers, Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 20
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: M D Anderson Cancer Center population

Brief summary: The objective of this qualitative research study is to assess the knowledge, attitudes and beliefs of cancer care providers, patients with cancer and caregivers regarding hospital care at home. We aim to conduct qualitative interviews to inform implementation of future on oncology hospital care at home programs

Detailed description: Interviews and focus groups will be conducted in English only using an interview guide (attached). The interview guide was based on the Consolidated Framework for Implementation Research (CFIR)8 to provide a broad understanding of the potential barriers and enablers of implementing a hospital care at home program. In summary, interviews will begin with an overview of the qualitative research study followed by verification of a completed demographic questionnaire

Eligibility criteria: Inclusion Criteria:

1. Cancer Care Providers

   * Cancer care providers of any specialty, including but not limited to oncologists, surgeons, hospitalists, emergency medicine physicians, nurses (including nurse practitioners), physician assistants, and any other member of the cancer care team (eg social workers or physical therapists)
   * Employed by the University of Texas MD Anderson Cancer Center
2. Patients

   * Adults ages 18 and over
   * Currently undergoing or completed cancer treatment within the last 5 years at MD Anderson
   * Able to speak and read in English
3. Caregivers

   * Adults ages 18 and over
   * Self-identifies as a caregiver of an individual over 18 who is currently undergoing cancer treatment or completed cancer treatment within the last 5 years at MD Anderson
   * Able to speak and read in English

Exclusion:

None

Primary outcomes:
measure: Quality of Life Questionnaires
timeFrame: through study completion an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Tacara Soones, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: