louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05608512: Emotional Labor, Physical Labor and Mental Labor of Hospice Care Nurses: A Mixed-method Study
Official title: Emotional Labour, Mental Labour, Self-efficacy and Potential Influencing Factors of Hospice Care Nurses During COVID-19: A Mixed-method Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospitalism
Keywords: hospice
advanced cancer
palliative care
nurse
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses working as registered nurses for 6 months or more.

Brief summary: Hospice care is a nurse-led multidisciplinary team care that provides physical, mental, and social care to end-of-life patients. According to the WHO, the role of hospice nurses is addressing suffering involves taking care of issues beyond physical symptoms, to support patients and their caregivers. Different from other disease care, hospice nurses face end-of-life patients and their families. As the primary nursing contact of a dying family, hospice nurses have a more intense and complex emotional experience. In China, with the improvement of human rights protection awareness, the nurse-patient relationship is particularly important, and the social requirements for nursing workers are also getting higher and higher. In addition, hospice nurses not only provide physical and psychological care to patients, but also provide comprehensive care to families of end-of-life patients. It is not just the mental work of learning expertise and dealing with emergency situations, and the physical labor of caring for large numbers of patients; but also requires emotional labor that has rarely been recognized before. When facing end-of-life patients and their families, it is particularly important to express appropriate emotions and pay emotional labor.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were nurses working as registered nurses for 6 months or more.

Exclusion Criteria:

* Nurses who were not directly involved in patient care (e.g., central sterile supply department nurses), and intern nurses were excluded.

Primary outcomes:
measure: Chinese version scale of emotional labor
timeFrame: 1 day
measure: Depression, Anxiety, and Stress Scale -21 (DASS-21)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Wu Ye
state: Jiangsu
Study officials:
References:
Clinical trial NCT04789512: Respiratory Muscle Strength in Volleyball Players Suffered From COVID-19
Official title: Evaluation of Respiratory Muscle Strength and Pulmonary Functions in Volleyball Players Suffering From Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: respiratory muscles
pulmonary functions
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 42
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female volleyball players

Brief summary: In literature, there is no data evaluating respiratory functions in volleyball players during Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions, respiratory muscle strength, body compositions and performance situations perceptions in female volleyball players with Covid-19 and non-Covid-19.


Eligibility criteria: Inclusion Criteria:

* having passed at least 30 days after the Polymerase Chain Reaction (PCR) test turned negative
* willing to participate in the study

Exclusion Criteria:

* having a history of chronic lung disease
* unwilling to participate in the study

Primary outcomes:
measure: Respiratory muscle strength
timeFrame: 10 minute
Secondary outcomes:
measure: FEV1
timeFrame: 5 minute
measure: FVC
timeFrame: 5 minute
measure: FEV1/FVC
timeFrame: 5 minute
measure: PEF
timeFrame: 5 minute
measure: FEF2575
timeFrame: 5 minute
measure: Fat mass
timeFrame: 2 minute
measure: Fat mass percent
timeFrame: 2 minute
measure: Fat-free mass
timeFrame: 2 minute
measure: Body mass index
timeFrame: 2 minute
measure: Predicted muscle mass
timeFrame: 2 minute
measure: Symptom severity perceptions
timeFrame: 1 minute
measure: Performance situations perceptions
timeFrame: 1 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Çankaya
Study officials:
References:
citation: Celik Z, Guzel NA, Kafa N, Kokturk N. Respiratory muscle strength in volleyball players suffered from COVID-19. Ir J Med Sci. 2022 Oct;191(5):1959-1965. doi: 10.1007/s11845-021-02849-z. Epub 2021 Nov 8.
Clinical trial NCT00503412: Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
Official title: A Phase 1, Open Label, Non-Randomised, Single Centre Pharmacokinetic and Mass Balance Study of Orally Administered 14-C-AZD2171 in Patients With Solid Metastatic Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Metastatic Tumor
Keywords: phase I
AZD2171
solid tumor
metastatic tumor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 6
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: Open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and its metabolites.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed metastatic tumor which is refractory to standard therapies
* life expectancy is 12 weeks or longer
* WHO performance status is 0-12

Exclusion Criteria:

* radiotherapy and chemotherapy within 4 weeks before the start of the study treatment
* patients with a history of poorly controlled hypertension
* history or evidence of any medical condition that might affect gastrointestinal function
* patients that have participated in a radiolabelled study in the last 5 years

Primary outcomes:
measure: The primary objective is to determine the rates & routes of excretion of 14C radiolabelled AZD2171 in patients by assessment of concentrations of total 14C radioactivity and AZD2171 in plasma & concentrations of total radioactivity in urine&faeces
timeFrame: assessed at time intervals post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Nick Botwood, BSc, MBBS, MRCP, MFPM
role: STUDY_DIRECTOR
affiliation: Royal Marsden NHS Foundation Trust
name: Stan Kaye, Prod
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639012: Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
Official title: Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Postoperative Nausea
Satisfaction
Sleep
Postoperative Complications
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial into 1 of 2 groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy.

Outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) PONV rates in recovery, prior to discharge home and again on Day 1 postoperatively; 4) sleep quality night after surgery.

Detailed description: Children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. Patients will be recruited from the ENT outpatient clinics in conjunction with the ENT surgeons.

Data collection will be undertaken with the aid of experience research assistants.

Eligibility criteria: Inclusion Criteria:

* Undergoing Tonsillectomy and/or adenoidectomy
* consented to undertake preop carbohydrate drink and follow up procedures

Exclusion Criteria:

* Increased risk of aspiration or unable to swallow liquids
* outside age range
* non-consent to undertake treatment or follow up

Primary outcomes:
measure: Postoperative Pain Score
timeFrame: day 1 postoperatively
Secondary outcomes:
measure: Patient and parent satisfaction
timeFrame: Day 1 postoperatively
measure: Quality of sleep
timeFrame: Day 1 post operative
measure: Postoperative Nausea and Vomiting
timeFrame: 4 hours postoperatively
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT04493112: SeQuent Please Neo Multicenter Registry
Official title: SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Coating Balloon (DCB), Sequent Please
Keywords: Drug coating Balloon (DCB), Sequent Please
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 patients approx per site who fulfill inclusion/exclusion criteria.

Brief summary: The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success of the procedure and the preservation of vascular permeability.

Detailed description: The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal objective is to determine the success of the procedure and the preservation of vascular permeability.

Eligibility criteria: Inclusion Criteria:

* ISR in a coronary artery with a diameter stenosis of at least 70%, a length of the stented segment of \<25 mm, and a vascular diameter of at least 2.5 and up to 3.5 mm

Exclusion Criteria:

* There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.

Primary outcomes:
measure: Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Success of balloon dilation.
timeFrame: Baseline
measure: Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.
timeFrame: From baseline to 12 months
measure: Premature follow-up indication
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Oriol Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886312: Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Delivery
Patient Monitoring
Patient Comfort
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.

Brief summary: This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery system. The goals of the study are to evaluate different oxygen flow rates and oxygen delivery modes. In addition, the investigators will investigate if the system can detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators will also investigate how well high flow oxygen delivered only during inspiration is tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow delivered only during the inhalation phase of the breath.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.

Exclusion Criteria:

* Volunteers who self report respiratory diseases such as acute respiratory distress syndrome, pneumonia and lung cancer will be excluded. In addition, volunteers who self report respiratory conditions such as nasal or bronchial congestion due to a cold or allergies will be excluded.

Primary outcomes:
measure: End-tidal Oxygen
timeFrame: Continuously throughout 30 minute volunteer study
measure: Patient Comfort
timeFrame: Every 2 minutes up to 30 minutes
measure: End-tidal Carbon Dioxide
timeFrame: Continuously throughout 30 minute volunteer study
measure: Respiratory Rate
timeFrame: Continuously throughout 30 minute volunteer study
measure: Oxygen Saturation
timeFrame: Continuously throughout 30 minute volunteer study
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.
citation: Sasaki H, Yamakage M, Iwasaki S, Mizuuchi M, Namiki A. Design of oxygen delivery systems influences both effectiveness and comfort in adult volunteers. Can J Anaesth. 2003 Dec;50(10):1052-5. doi: 10.1007/BF03018373.
citation: Burk KM, Sakata DJ, Kuck K, Orr JA. Comparing Nasal End-Tidal Carbon Dioxide Measurement Variation and Agreement While Delivering Pulsed and Continuous Flow Oxygen in Volunteers and Patients. Anesth Analg. 2020 Mar;130(3):715-724. doi: 10.1213/ANE.0000000000004004.
Clinical trial NCT05091112: Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch
Official title: Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Facet Arthrosis
Nerve Degeneration
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be the cohort of patients who are scheduled to undergo lumbar spinal surgery. The potential population will be identified from the patients who are being invited for the surgery. All prospective participants will be sent an invitation letter and Participant Information Sheet along with their the clinical appointment letters.

Brief summary: The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.

Detailed description: After written informed consent, the nerves supplying the facet joints - lumbar dorsal rami and its medial branches, will be harvested when they are exposed during spinal surgery. These nerves will be fixed, washed and further dissected to enable smaller sections. The cut section will be stained and subjected to analysis of overall cross-sectional area and presence of connective tissue sheaths under light microscope.

Eligibility criteria: Inclusion Criteria:

* Be aged 18 or over
* be able to give informed consent
* scheduled to undergo lumbar spinal surgery

Exclusion Criteria:

* Children under 18 years old
* Vulnerable adults
* Adults with incapacity
* Inability to provide informed consent
* History of previous spinal surgery
* history of previous RF ablation for low back pain
* has COVID-19 or displaying symptoms of COVID-19

Primary outcomes:
measure: Nerve Histology
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Woodend Hospital
state: Scotland
Study officials:
affiliation: NHS Grampian
name: Saravanakumar Kanakarajan, MD FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04248712: Antihistamines in Eosinophilic Esophagitis
Official title: A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

Detailed description: The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18, male and female.
* Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (\>15 eosinophils per hpf on at least 2 esophageal levels)
* Subjects must be able to give appropriate informed consent

Exclusion Criteria:

* Not willing or able to sign consent.
* Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
* Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
* Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
* Patients with known allergies or hypersensitivity to anti-histamines.
* Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
* Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
* Patients who are pregnant.

Primary outcomes:
measure: Adverse Events
timeFrame: 12 weeks
measure: Change in Maximum Eosinophil Count
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire
timeFrame: 12 weeks
measure: Change in Endoscopic Response, as Measured by the Endoscopic Reference Score
timeFrame: 12 weeks
measure: Change in Histologic Response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Dawn Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464212: Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients
Official title: Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients: A Randomized Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine, Headache
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic migraine (CM) is related to headache-related disability and reduced quality of life. Therefore, patients with CM require preventive treatment. The aim of this double-blind, comparative-effectiveness study was to compare ultrasound-guided great occipital nerve (GON) block and pulsed radiofrequency (PRF) application in CM patients.

The study consisted of 2 groups: GON block (group GONB) and GON block + pulsed RF (group GONB+PRF). Each group had 16 patients. Ultrasound-guided GONB was performed to locate the nerve more accurately. With 0.5 Hz sensorial stimulation, a 5-cm-long radiofrequency needle was advanced under ultrasound guidance in both groups. GON block was performed in all patients by administering 5mg bupivacaine through a PRF needle. After the GON block, the PRF neuromodulation was applied at 42 degrees for 4 minutes in the GONB-PRF group. In the GONB group, no pulse was given. The patients were examined for follow-ups at the 1st, 2nd, 3rd, and 6th months after the procedure. The severity and the number of migraine attacks, and the number of analgesic drugs were noted.


Eligibility criteria: Inclusion Criteria:

* Age 18-65;
* ICHD-3 defined chronic migraine

Exclusion Criteria:

* Patients who had been started on an effective preventive medication within the past three months;
* Medication-overuse headache;
* Treatment with peripheral nerve blocks, trigger point injections or botulinum toxin injections within the past three months;
* Known allergic reaction to local anaesthetics;
* Pregnancy or nursing;
* History of another headaches;
* History of chronic medical conditions (e.g. cardiovascular, hepatic, renal, endocrine);
* History of other chronic pain syndromes (e.g. low back pain and fibromyalgia).

Primary outcomes:
measure: Visuel Analog Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Odunpazari
Study officials:
References: