louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04115891: Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children
Official title: Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Anxiety Disorder
Aromatherapy
Keywords: lavandula
phytotherapy
aromatherapy
dental anxiety
anaesthesia
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 126
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.

Detailed description: Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.

Eligibility criteria: Inclusion Criteria:

* being between 6 and 12 years of age
* children who are determined as Frankl 2, 3 or 4
* intellectually sufficient to complete the anxiety scale
* volunteer to take part in the study
* whose parents were willing to participate into the study

Exclusion Criteria:

* aged under 6
* has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
* common allergies or dental pain

Primary outcomes:
measure: Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
timeFrame: through study completion an average of 9 months
measure: Vital Sign Measurements - 2 (heart rate)
timeFrame: through study completion an average of 9 months
measure: Vital Sign Measurements - 3 (saturation)
timeFrame: through study completion an average of 9 months
Secondary outcomes:
measure: Anxiety Scale - Face Image Scale (FIS)
timeFrame: through study completion an average of 9 months
measure: Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)
timeFrame: through study completion an average of 9 months
measure: Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)
timeFrame: through study completion an average of 9 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nazife Begüm KARAN
state: Merkez
city: Ri̇ze
country: Turkey
facility: Nazife Begüm KARAN
state: Merkez
Study officials:
References:
Clinical trial NCT03211091: Cerebrovascular Registry
Official title: Prove/Cerebrovascular Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Disorders
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
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 stroke or stroke history

Brief summary: Patients with stroke were registered based on the WHO/ MONICA protocol and were followed-up for 28 days, starting in 2015 in PROVE Registry

Detailed description: PROVE program started in 2015, the registration of stroke continued but followed the WHO Stepwise method instead of WHO/MONICA .Patients are followed up for two years. The corresponding questionnaire covered the patients' demographic data, medical history upon hospital admission, history of comorbidities, medications used prior to the treatment, history of drug abuse, heart and brain imaging, history of blood tests and blood diseases, hospital treatments received, hospitalization complications, medications prescribed at the time of discharge, discharge status and the definite diagnosis of type of stroke according to CT or MRI.

The patients were followed-up over the phone or in person from the 1st, 3rd and 12th months to two years. The patients' disabilities were measured using the Barthel Index and the Modified Rankin Scale (MRS). The reliability and validity of these two questionnaires have already been investigated in Persian. In addition, secondary prevention measures, rehabilitation status and the incidence of new cardiovascular events were also examined in the follow-up. The stroke registration personnel received an initial training of three two-hour sessions and monthly one-hour retraining sessions. They visited the archives of various hospitals on a daily basis and registered the data contained in the records

Eligibility criteria: Inclusion Criteria:

\* patients with acute Stroke (Hemorrhagic and Non Hemorrhagic)

Exclusion Criteria:

* patients who do not agree to continue cooperation
* patients with incomplete documents

Primary outcomes:
measure: disability
timeFrame: 3 months
Secondary outcomes:
measure: rehabilitation
timeFrame: 3 months
measure: rehabilitation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01765491: Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients
Official title: Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Keywords: colonoscopy
bowel preparation
polyethylene glycol
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2013-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.

Detailed description: This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance. N: 120 hospitalized patients scheduled for diagnostic colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization

Exclusion Criteria:

* Critically ill/Intensive Care Unit patients
* Suspected bowel obstruction/perforation
* History of colon resection
* Patients with altered mental status/inability to provide informed consent
* Incarcerated patients
* Pregnant females

Primary outcomes:
measure: To compare the efficacy of colonoscopy preparation measured by the Ottawa scale
timeFrame: Day of procedure
Secondary outcomes:
measure: Patient compliance
timeFrame: Day of procedure
measure: Patient tolerance
timeFrame: Same day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Jr Hospital of Cook County
state: Illinois
Study officials:
affiliation: Cook County Health & Hospitals System
name: Bashar Attar, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02947191: Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation
Official title: The Safety and Efficacy Assessment of Collagen Membrane Combined With Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Nasal Septum Perforation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Nasal Septum Perforation
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2016-10-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation.


Eligibility criteria: Inclusion Criteria:

1. Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
2. Male or female, 18-45 years old.
3. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

1. Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
2. Syphilis, leprosy, tuberculosis and other specific infections.
3. Severe Sinusitis.
4. Autoimmune diseases or long term treatment with corticosteroids.
5. Alzheimer's disease.
6. Systemic diseases (e.g.,hypertension, diabetes and so on).
7. Previous history of nasal cancer or after receiving radiotherapy.
8. Drug abuse.
9. History of mental illness.

Primary outcomes:
measure: The change of integrity of nasal septum assessed by endoscopic examination
timeFrame: baseline, 1,2,3,4,8,12 weeks after surgery
Secondary outcomes:
measure: The change of nasal mucosal physiology assessed by olfactory test
timeFrame: baseline, 12 weeks after surgery
measure: The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT)
timeFrame: baseline, 12 weeks after surgery
measure: The change of nasal airway resistance assessed by rhinomanometry
timeFrame: baseline, 12 weeks after surgery
measure: The change of nasal obstruction assessed by acoustic rhinometry
timeFrame: baseline, 12 weeks after surgery
measure: The change of nasal obstructive symptom assessed by visual analogue scale (VAS)
timeFrame: baseline, 12 weeks after surgery
measure: The change of nasal symptom severity assessed by total nasal symptom score (TNSS)
timeFrame: baseline, 12 weeks after surgery
measure: Change from baseline in computed tomography (CT)
timeFrame: baseline, 12 weeks after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00067691: Acupuncture for Shortness of Breath in Cancer Patients
Official title: Acupuncture for Shortness of Breath in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Breast Neoplasms
Keywords: Lung cancer
Breast cancer
Shortness of breath
Dyspnea
Metastasis
Breathlessness
Acupuncture
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of local or metastatic breast or lung cancer
* Shortness of breath with onset after cancer diagnosis
* Life expectancy of at least 4 weeks

Exclusion Criteria:

* Prior acupuncture
* Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity
* No chest wall deformity
* Neuromuscular disorders
* Pulmonary vascular disease
* Anemia
* Uncontrolled pain or infection
* Heart valve dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Institute for Cancer Research
state: New York
Study officials:
References:
Clinical trial NCT06676891: Expanded Access Program for GBM Subjects
Official title: Expanded Access to RZ-001 in Combination with Valganciclovir in the Treatment of Subjects with Glioblastoma
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Glioblastoma
Lead sponsor: Rznomics, Inc.
Sponsor class: OTHER
First posted: 2024-11-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This small-size patient population expanded access program is to provide access to investigational product RZ-001 for up to around 4 patients with human telomerase reverse transcriptase(hTERT)-positive Glioblastoma (GBM) who are not eligible to participate in the RZ-001-201 clinical study or in any other study involving the use of RZ-001

Detailed description: This expanded access protocol provides expanded access to RZ-001 to patients with glioblastoma. After provision of written informed consent, subjects will be evaluated for eligibility during the Screening period, a period of 28 days prior to the RZ-001 administration on Day 1. Subjects will then undergo treatment, 8 weeks of follow-up, and bimonthly or quarterly (after 6 months from RZ-001 administration) survival follow-up.

Eligibility criteria: Inclusion Criteria:

1. Males and females legally considered to be adults in the country in which they are participating in the study.
2. Histologically-confirmed Grade 4 astrocytoma, GBM, per The 2021 WHO Classification of central nervous system (CNS) Tumors.
3. Recurrent GBM with radiographic evidence of the PD (progressive disease) which contains measurable disease (≥ 1 cm bidirectional diameters) by contrast-enhancement on MRI, as defined by the mRANO (modified Response Assessment in Neuro-Oncology) criteria. Only localized unifocal or multifocal recurrence is allowed, while other type of recurrences such as intraventricular, diffuse recurrence are not allowed.

Exclusion Criteria:

1. Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
2. Have received chemotherapy within 4 weeks, and/or immunomodulatory therapy, immunotherapy, antibody therapy, gene vector therapy, vaccine therapy, and/or matrix metalloprotease inhibitor(s) within 3 months from Screening.
3. Have received radiotherapy within 12 weeks from Screening.
4. Have extracranial metastases of the tumor cells.
5. The subject is eligible for participation in any ongoing clinical study with RZ-001, or has already received RZ-001 in the past.
6. The subject is being transferred from an ongoing clinical study for which they are still eligible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03006991: Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics and Pharmacometrics
Official title: Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Idiopathic Arthritis
Keywords: methotrexate, Juvenile Idiopathic Arthritis
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with Juvenile Idiopathic Arthritis

Brief summary: This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

Detailed description: In order to find out "The critical reasons for individual variances in MTX of JIA pediatric patients and quantize the influence of these factors", based on early research, this study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with Juvenile Idiopathic Arthritis
* 7.5-10mg/m2 per week per dose of methotrexate
* all patients have been treated with methotrexate at least for 3 months

Exclusion Criteria:

* co-treated other drugs which can interact with methotrexate

Primary outcomes:
measure: Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism
timeFrame: 3 months
Secondary outcomes:
measure: Concentration as measured by liquid chromatography mass spectrometry
timeFrame: 3 months
Other outcomes:
Locations:
city: Guandong
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Xiaolan Mo, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yanagimachi M, Naruto T, Hara T, Kikuchi M, Hara R, Miyamae T, Imagawa T, Mori M, Kaneko T, Morita S, Goto H, Yokota S. Influence of polymorphisms within the methotrexate pathway genes on the toxicity and efficacy of methotrexate in patients with juvenile idiopathic arthritis. Br J Clin Pharmacol. 2011 Feb;71(2):237-43. doi: 10.1111/j.1365-2125.2010.03814.x.
Clinical trial NCT04799691: Comparison of 2 Ventilatory Support Strategies During Coronavirus Disease 2019 (Covid-19) Pneumonia
Official title: Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Invasive strategy
Non-invasive strategy
Continuous Positive Airway Pressure
High Flow Nasal Canula
Prone position
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID 19 acute hypoxemic respiratory failure admitted in Hospital Sainte Musse ICU in 2020

Brief summary: This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.


Eligibility criteria: Inclusion Criteria:

* Patient with confirmed SARS COV2 infection
* Acute Respiratory Distress Syndrome
* Patient more than 18 year old

Exclusion Criteria:

* Intensive Care Unit admission for extra pulmonary failure
* "Do Not Reanimated" order
* Patient from another Intensive Care Unit
* Patient objection
* Judicial protection

Primary outcomes:
measure: Length of stay in ICU
timeFrame: At the moment of ICU discharge or death, up to 3 month
Secondary outcomes:
measure: Mortality
timeFrame: At the moment of ICU discharge or death, up to 3 month
measure: Complications
timeFrame: At the moment of ICU discharge or death, up to 3 month
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital Sainte Musse
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Aude Garnero, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01532180: Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Signs and Symptoms, Respiratory
Syndrome, Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea, neurostimulation, hypoglossal nerve
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).


Eligibility criteria: Inclusion Criteria:

* Moderate to severe obstructive sleep apnea (AHI 15 to 60).
* Cannot or will not tolerate CPAP treatment.
* Body mass index (BMI) between 25 and 40
* Able to read, understand, sign and date the written informed consent form

Primary outcomes:
measure: Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
timeFrame: 3 and 12 months post-implant
measure: Adverse events and Serious Adverse events peri and post-operatively
timeFrame: 3 and 12 months post-operative
Secondary outcomes:
measure: Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
timeFrame: 3 and 12 months post-operative
measure: Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
timeFrame: 3 and 12 months post-implantation
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Univ. Saint-Luc
Study officials:
affiliation: Clinique Univ. Saint-Luc
name: Daniel Rodenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.