louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05745675: Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO16)
Official title: Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2023-02-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.

Brief summary: The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Detailed description: This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study

Primary outcomes:
measure: Accuracy of Sensor Oxygen Saturation by Arms Calculation
timeFrame: 30 seconds
Secondary outcomes:
measure: Accuracy of Sensor Pulse Rate by Arms Calculation
timeFrame: 30 seconds
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: UCSF Hypoxia Research Laboratory
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02010775: Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Official title: BOTOX® Treatment of Masseter Muscle Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Masseter Muscle Hypertrophy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).


Eligibility criteria: Inclusion Criteria:

-Participants with Masseter Muscle Hypertrophy

Exclusion Criteria:

* Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
* History of or current temporomandibular joint disorder (TMJD)

Primary outcomes:
measure: Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
timeFrame: Baseline (Day 1) to Day 90 of Treatment Cycle 1
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
timeFrame: Day 90 of Treatment Cycle 1
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Shape Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Central Sydney Dermatology
state: New South Wales
city: Main Beach
country: Australia
facility: Esteem Beauty & Day Spa
state: Queensland
city: North Fremantle
country: Australia
facility: The Rose Medical & Aesthetic Centre
state: Western Australia
city: Vancouver
country: Canada
facility: Dr. Jean Carruthers Cosmetic Surgery, Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Shannon Humphrey Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Project Skin MD
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics
state: British Columbia
city: Woodbridge
country: Canada
facility: Bertucci MedSpa
state: Ontario
city: Montreal
country: Canada
facility: Arthur Swift Research Inc.
state: Quebec
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital of CGMF
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Allergan
name: Beta Bowen
role: STUDY_DIRECTOR
References:
Clinical trial NCT06471075: Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure
Official title: Brief (i.e., <10 Minute) Behavioral Intervention for Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Chronic Pain
Acute Pain
Keywords: mindfulness
kyphoplasty
radiofrequency ablation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 80
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: This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.


Eligibility criteria: Inclusion Criteria:

* Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
* Fluency with English
* Being 18 and above

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 7-minute audio recording
Secondary outcomes:
measure: Acute Pain
timeFrame: Immediately before to after 7-minute audio recording
measure: Anxiety
timeFrame: Immediately before to after 7-minute audio recording
measure: Treatment Satisfaction
timeFrame: At the end of the medical provider visit - approximately 1 hour.
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT05301075: Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery
Official title: Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Rhomboid Intercostal Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes


Eligibility criteria: * Inclusion criteria Adult patients between 18-60 years. Genders eligible for study: both sexes ASA physical status I and II Undergoing open nephrectomy surgery
* Exclusion criteria Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV

Primary outcomes:
measure: nalbuphine consumption i
timeFrame: 24 hours
Secondary outcomes:
measure: nalbuphine consumption.
timeFrame: 2 hours
measure: Patient's satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT00184275: Characterization of Brain Metastases
Official title: Brain Metastases Tissue Characterized by High-resolution Magic Angle Spinning MR and Micro Array
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Metastasis
Lung Neoplasms
Breast Neoplasms
Melanoma
Keywords: Brain metastasis
HR MAS spectroscopy
Tissue micro array
DNA micro array
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2005-09-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with brain metastases

Brief summary: The purpose is to characterize tumour biological markers in brain metastases tissue from patients with different primary tumour by using ex vivo techniques as high-resolution magic angle spinning MR spectroscopy and micro array.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of brain metastases

Exclusion Criteria:

* children
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Faculty of Medicine
Study officials:
affiliation: Cancer Clinic, St.Olavs Hospital Trondheim University Hospital
name: Steinar Lundgren, MD PhD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Faculty of Medicine
name: Ingrid S Gribbestad, PhD
role: STUDY_CHAIR
References:
citation: Sjobakk TE, Johansen R, Bathen TF, Sonnewald U, Kvistad KA, Lundgren S, Gribbestad IS. Metabolic profiling of human brain metastases using in vivo proton MR spectroscopy at 3T. BMC Cancer. 2007 Jul 27;7:141. doi: 10.1186/1471-2407-7-141.
citation: Sjobakk TE, Vettukattil R, Gulati M, Gulati S, Lundgren S, Gribbestad IS, Torp SH, Bathen TF. Metabolic profiles of brain metastases. Int J Mol Sci. 2013 Jan 22;14(1):2104-18. doi: 10.3390/ijms14012104.
Clinical trial NCT05320575: Zanubrutinib for HLH
Official title: Zanubrutinib Monotherapy in Patients With Hemophagocytic Lymphohistiocytosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HLH
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective single-arm clinical study, focusing on Hemophagocytic lymphohistocytosis，to evaluate the clinical efficacy and safety of zanubrutinib.


Eligibility criteria: Inclusion Criteria:

1. Unlimited gender, age ≥ 14 years old;
2. HLH was diagnosed according to HLH-04 diagnostic criteria;
3. Before the study, there was no severe liver function injury; Serum creatinine ≤ 1.5 times the upper limit of normal value;
4. Sign informed consent

Exclusion Criteria:

1. Allergic to zebutinib;
2. Currently active important cardiovascular diseases with clinical significance; The functions of important organs such as heart and lung unrelated to HLH were seriously abnormal;
3. Known human immunodeficiency virus (HIV) or active hepatitis B (HBV) or hepatitis C (HCV) infection;
4. Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial;
5. Serious mental illness;
6. Active massive hemorrhage of internal organs;
7. Uncontrollable infection;
8. At the same time, participate in other clinical researchers

Primary outcomes:
measure: evaluation of treatment response
timeFrame: Change from before and 2,4,6 and 8 weeks after initiating therapy
measure: Progression Free Survival
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT06298175: Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions
Official title: Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions: Effects on Self-Management, Emotion Regulation, and Occupational Balance: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Self-Management
Chronic Conditions
Young Adults
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-post test, randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks.

Detailed description: Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks.

Eligibility criteria: Inclusion Criteria:

* having no communication barriers
* having a chronic disease such as asthma, diabetes, heart disease, or hypertension

Exclusion Criteria:

* being under 35 years old
* undergoing concurrent psychological treatment/therapy
* having Covid-19
* requiring treatment for other diseases during the training process

Primary outcomes:
measure: Self-Control Self-Management Scale (SCMS)
timeFrame: pre-treatment and post-treatment up to 8-weeks
Secondary outcomes:
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: pre-treatment and post-treatment up to 8-weeks
measure: The Occupational Balance Questionnaire (OBQ)
timeFrame: pre-treatment and post-treatment up to 8-weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Esma Ozkan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06279975: Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study
Official title: Investigative Neurological Study With Pupillometric Evaluation os a Clinical Tool in Patients Declared Brain Dead (INSPECT) - a Prospective Quality Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Death
Adults
Keywords: Pupillometry
Brain Death
Diagnosis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population is defined as all adult patients (i.e. ≥18 years of age) treated on the intensive care unit at the University Hospital Basel (USB) in whom the treating physicians suspect brain death and plan to perform brain death diagnostic procedures.

Brief summary: The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

Detailed description: This prospective quality control study will evaluate the reliability of the clinical exam regarding pupils' reaction to light (as performed by two board certified physicians in Neurology and/or Intensive Care Medicine) as recommended by the SAMW guidelines for brain death diagnosis (SAMW-guidelines) when compared to the results of a noninvasive automated and highly-precise pupillometry in adult patients with clinically suspected brain death. Automated pupillometric measurements will be performed by the PI (RS), or the co-investigator (Dr. Pascale Grzonka) using the NeurOptics® NPi®-200 pupillometer system immediately before and after the standardized diagnostic workup for suspected brain death. In addition, demographics, clinical characteristics , treatment and laboratory data from the patients examined will be anonymously collected.

Eligibility criteria: Inclusion Criteria:

* Suspected diagnosis of brain death
* Brain death diagnostic procedures planned
* Treated at the intensive care unit at the University Hospital Basel (USB)

Primary outcomes:
measure: Reliability of clinical examination of pupils in patients with suspected brain death
timeFrame: baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Intensive care unit at the University Hospital Basel
state: Basel-Stadt
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Raoul Sutter, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554475: Use of Alternative Medicine in Patients With Dementia and Mild Cognitive Dysfunction
Official title: Use of Alternative Medicine Among Patients With Dementia and Mild Cognitive Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Cognitive Impairment
Keywords: herbal drugs
dietary supplements
drug interactions
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Kløveråsen Center for dementia, Bodø
First posted: 2012-03-15
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with dementia, under follow-up at Kløveråsen out-patient clinic

Brief summary: So far, no drugs have shown to stop or delay the pathological processes of dementia. Available pharmacological treatment includes a small number of drugs; cholinesterase inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist memantine, all of which only affect the symptoms of the disease. At the same time, alternative medicines like herbal products and dietary supplements are often intensively marketed with the assertion of curative or alleviating effects on dementia. The documentation of clinical effects, side effects and the potential for interaction with prescribed drugs are, however, generally scarce. The aims of this study are to make a survey of the use of alternative medicine in patients with dementia and mild cognitive dysfunction attending the investigators out-patient dementia clinic, and to assess the interaction potential with the patient's other medications.

Detailed description: Patients: All patients with a diagnosis of dementia under follow-up at the out-patient clinic are invited to participate, if giving a written consent.

Method: a semi-structured interview is undertaken by the doctor at the end of the consultation. Patients and their company are asked to name their alternative medicines (if any), for how long the products have been used, where and how they learned about the products, ant to tell about their experiences with the products (i.e if they have noticed effects or side-effects). After the consultation information of the the actual product's contents and properties are obtained and an assessment of possible interactions with the patient's other drugs (prescriptions and self-reported use of over-the-counter drugs) is made. Reported effects or side-effects are registered.

Eligibility criteria: Inclusion Criteria:

* diagnosed with dementia

Primary outcomes:
measure: Number of patients taking alternative medicines
timeFrame: Up to 2 years
Secondary outcomes:
measure: Numbers of potential and clinical relevant interactions
timeFrame: Up to 2 years
measure: The patient's subjective experiences with alternative medicines
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Kløveråsen
Study officials:
affiliation: University Hospital North-Norway
name: Trude Giverhaug, PhD
role: STUDY_CHAIR
References: