louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06350708: Virtual Reality (VR) Paediatric Tracheostomy Training
Official title: Can Remote Training of Paediatric Emergency Tracheostomy Simulation be Performed Using VR Technology?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Educational Study
Keywords: virtual reality
tracheostomy
training
paediatric
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children.


Eligibility criteria: Inclusion Criteria:

* Healthcare student
* Clinical experience needed
* Healthcare staff
* Based at Manchester University Foundation Trust, or The University of Manchester

Exclusion Criteria:

* Not a healthcare student
* Not a healthcare student - have no clinical experience
* Not healthcare staff but working in the National Health Service
* Not based at Manchester University Foundation Trust, or The University of Manchester

Primary outcomes:
measure: Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed)
timeFrame: Measured at the beginning of study and 1 week.
Secondary outcomes:
measure: Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank.
timeFrame: Measured at the beginning of study,1 week and 4 weeks post intervention.
measure: Participant satisfaction measured using a bespoke data collection tool.
timeFrame: 1 week post initiation of intervention
measure: Virtual Reality Sickness
timeFrame: 1 week post initiation of intervention
measure: Usability using the validated system usability scale
timeFrame: 1 week post initiation of intervention
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
References:
Clinical trial NCT01870908: Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients
Official title: Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 664
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis who have been treated with biological agents

Brief summary: This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

Detailed description: The purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using SDAI, CDAI, DAS28-CRP, MMP-3, MHAQ in patients with rheumatoid arthritis who have not achieved SDAI remission despite of using biological agents for over 8 weeks.

Eligibility criteria: Inclusion Criteria:

* patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI \< 3.3)

Primary outcomes:
measure: Simplified disease activity index (SDAI)
timeFrame: Baseline and week-24
Secondary outcomes:
measure: Clinical disease activity index (CDAI)
timeFrame: Baseline, week-12 and week-24
measure: Disease Activity Score 28 (DAS28)
timeFrame: Baseline, week-12 and week-24
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT00167908: Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer
Official title: Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed squamous cell cancer of the head and neck
* Eligible sites: oral cavity, oropharynx, hypopharynx, larynx.
* Patients requiring postoperative IMRT.
* KPS \> 70%.
* Patient has signed specific protocol consent prior to registration.
* Calcium test within normal limits.
* No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years.
* Labs completed with 30 days of registration (CBC \& platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation.
* Liver CT if alk phos, SGOT, or bili elevated.
* Bone scan if elevated alk phos

Exclusion Criteria:

* Metastatic disease.
* Patient using Salagen or concurrent chemotherapy.
* Previous XRT for head and neck tumors.
* Active untreated infection.

Primary outcomes:
measure: Salivary function at 6 months and yearly compared to pre-treatment salivary function
Secondary outcomes:
measure: Local and regional tumor control
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Wade Thorstad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394108: Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions
Official title: Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CABG-Patients
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2006-10-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to evaluate neuropsychological disorders in CABG patients. Measurements are performed 1 day before, 6 days, 6 months and 3-5 years after the surgery. The relation with cerebrovascular reactivity and embolic load (measured by transcranial Doppler Ultrasonography) is evaluated. Two surgery techniques (on- and off-pump CABG) are compared.


Eligibility criteria: Inclusion Criteria:

* CABG-patients (not urgent)
* \< 70 years old
* Righthanded

Exclusion Criteria:

* Neurological or psychiatric disease
* Psychoactive medication
* Valve operation

Primary outcomes:
measure: Neuropsychological status
timeFrame: after 6 days, 6 months and 3-5 years
Secondary outcomes:
measure: Relation with intra-operative embolic load
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy Vingerhoets, Psychologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05777408: Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain
Official title: Additional Effect of Cranial Base Release on Cervical Range and Proprioception in Patients With Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Keywords: Range of Motion, Proprioception
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Natural apophyseal glides and the second will receive Natural Apophyseal Glides in addition to cranial base release with conventional physical therapy. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: Mechanical Neck pain is the second most commonly occurring musculoskeletal disorder worldwide, ranking 4th in overall disability. It is referred to as Nonspecific generalized neck pain with mechanical characteristics with a primary location between the supranuchal line and the first thoracic spinous process, includingpatients suffering from mechanical neck pain are reported to have several impairments, including pain, reduced cervical ROM, neck disability, and proprioceptive dysfunction. The treatment indicated involves the use of electrotherapy and thermal modalities. In addition, the use of different manual therapy techniques is advocated; however, the most effective management is still debatable. Evidence suggests that Natural Apophyseal glides have a significant positive effect on mechanical neck pain patients. So the study will identify the additional effect of cranial base release with natural apophyseal glides in alleviating pain and its effects on proprioception.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with mechanical neck pain having reproducible non-specific neck pain with a primary location between the supranuchal line and the first thoracic spinous process
* Male and Female
* Age 18-40 years
* Pain severity on NPRS \>3
* Neck Disability score of 20% or above
* Problem not older than 2 months

Exclusion Criteria:

* Patients with history of
* Recent significant trauma (including whiplash)
* Radiculopathy
* Cervical fracture
* Neck surgery
* Dizziness, vertigo
* Myelopathy, Malignancy
* Metabolic disease
* Diagnosed Osteoporosis, Rheumatoid arthritis
* Long-term corticosteroid and/or painkiller drug use

Primary outcomes:
measure: Change in Pain
timeFrame: 2 weeks
measure: Change in ROM
timeFrame: 2 weeks
measure: Change in Cervical Proprioception
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT04586608: Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.
Official title: Administration of an Intravenous Fat Emulsion Enriched With MCT/ω-3 Fatty Acids is Beneficial Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates: a Randomized, Double-blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: Iaso Maternity Hospital, Athens, Greece
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 92
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. The aim of the present study was to investigate the effects of a medium-chain triglyceride (MCT)/n-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile in preterm neonates. Methods: In this double-blind randomized study, 92 preterm neonates (gestational age \<32 weeks, birth weight \<1500g) were assigned to receive either MCT/n-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Neonates' parents gave their informed written consent for inclusion in the study. Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry.


Eligibility criteria: Inclusion Criteria:

Preterm neonates with gestational age \<32 weeks

* birth weight \<1500 g
* admitted to a tertiary neonatal intensive care unit within 12 hours after birth

Exclusion Criteria:

* anticipated needs for parenteral nutrition (PN) at ˃70% of total daily energy for \<10 days evidence of intrauterine infection,
* perinatal asphyxia
* major congenital anomalies
* refusal of parental consent

Primary outcomes:
measure: Alterations on Metabolic Fatty Acid Profile of the Premature Neonates
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Panos Papandreou
Study officials:
References:
Clinical trial NCT00693108: Androgens for Poor Responders in In Vitro Fertilization
Official title: Transdermal Testosterone to Improve Ovarian Response to Gonadotropins in Poor Responder IVF Patients With Normal Basal Concentrations of FSH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Response
Keywords: Poor
Response
Ovarian
Stimulation
IVF
Patients
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-06-06
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: it has been shown that androgens in non human primates may favour follicular growth in the ovaries when animals are treated with gonadotropins which are the hormones used in patients receiving treatment with in vitro fertilization. Therefore, this study investigates the potential usefulness of testosterone treatment preceding gonadotropin administration in in vitro fertilization patients having a previous poor response to gonadotropins alone.


Eligibility criteria: Inclusion Criteria:

* Patients receiving the second IVF treatment attempt having the first treatment cycle cancelled because of poor ovarian response to gonadotropins

Exclusion Criteria:

* Previous ovarian surgery
* Clinical or laboratory profile suggesting premature ovarian failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
citation: Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
Clinical trial NCT06558708: A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD
Official title: A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 60
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: This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.


Eligibility criteria: Inclusion Criteria:

* 1. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
* 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
* 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
* 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

Exclusion Criteria:

* 1.Presence or history of malignant neoplasm prior to screening.
* 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
* 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
* 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
* 5. Participated in another interventional clinical study within 4 weeks prior to randomization.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 0, week 16
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, Week 16
measure: Change in 7-point SMPG profile
timeFrame: Week 0, Week 16
measure: Incidence and Rate of Treatment-emergent AE/SAEs
timeFrame: Week 0, Week 19
measure: Incidence and Rate of hypoglycemia Events
timeFrame: Week 0, Week 19
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Study Site 01
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Clinical Transparency
role: STUDY_DIRECTOR
References:
Clinical trial NCT00778908: Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Locally advanced disease
Intensity-modulated radiation therapy
Accelerated hyperfractionation
Concomitant boost radiation therapy
Concurrent chemotherapy
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Guangxi Sci-Tech Office
First posted: 2008-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
* According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
* Age between 18-70
* Karnofsky performance status ≥70
* WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
* Without radiotherapy or chemotherapy
* Signed study-specific consent form prior to study entry

Exclusion Criteria:

* Patients with distant metastasis
* Pregnant or lactating women
* The presence of uncontrolled life-threatening illness
* Patients who received radiotherapy or chemotherapy previously

Primary outcomes:
measure: Local/regional control rate, Acute and late toxicities
timeFrame: 2-Yr
Secondary outcomes:
measure: Overall survival rate
timeFrame: 5-Yr
Other outcomes:
Locations:
city: Nanning
country: China
facility: People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
Study officials:
affiliation: Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region
name: Heming Lu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05540808: The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
Official title: Diagnostic Test of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis, Severe
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with sepsis

Brief summary: The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. However, the conventional pathogen mNGS has potential risks such as low detection rate, loss of intracellular bacteria and fungi. At present, the latest fully targeted pathogen capture mNGS technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. The aim of this study was to explore the value of fully targeted pathogen capture mNGS in improving etiological diagnosis in patients with sepsis compared with conventional methods.

Detailed description: This study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care Unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mNGS detection and follow-up etiological diagnosis based on blind method. The clinical diagnosis with clear etiology was taken as the gold standard.

Eligibility criteria: Inclusion Criteria:

* Critical care patients aged ≥ 18 years old
* Patients with sepsis

Exclusion Criteria:

* Lack of traditional pathogen detection results
* Discharge diagnosis without clear etiology

Primary outcomes:
measure: sensitivity
timeFrame: up to 3 year
measure: specificity
timeFrame: up to 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Ying Li
role: STUDY_CHAIR
References: