louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05298228: Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion
Official title: Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Laryngeal mask airways (LMA) are widely used in patients receiving general anesthesia and are known to have the following advantages over the endotracheal tube: lower incidence of postoperative sore throat, lower incidence of cough during emergence, and lower incidence of postoperative vomiting. Although LMAs can be inserted without the use of muscle relaxants, a sufficient depth of anesthesia is necessary for placement. Remimazolam is a newer anesthetic that is ultra-short acting with a rapid onset and short context-sensitive half-life allowing for fast recovery. However, the dose of remimazolam needed for LMA insertion without muscle relaxants is not well known. This dose-finding study aims to find the ED50 and ED95 of a single bolus dose of remimazolam for LMA insertion without muscle relaxants in adult patients.

This is an interventional study done in a single group using the Dixon's up-and-down method which requires at least six success/failure pairs in the same direction. The primary endpoint of this study is to investigate the dose of remimazolam associated with 50% (ED50) and 95% (ED95) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 19\~65 year
* ASA class I\~III
* Patients scheduled for orthopedic surgery under general anesthesia and eligible for LMA use.

Exclusion Criteria:

* Patient refusal
* Patients unable to read consent form
* Anticipated difficult mask ventilation
* Active URI or uncontrolled asthma
* Pneumonia
* Risk of aspiration such as GERD
* History of allergies to benzodiazepines
* Decreased liver or kidney function
* Pregnant or breastfeeding patients
* BMI \> 30kg/m2
* History of substance abuse/addiction

Primary outcomes:
measure: Dose of remimazolam associated with 50% (ED50) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants.
timeFrame: During procedure (Immediately after LMA insertion attempt)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT02087228: Evaluation of the Endometrial Cavity After Endometrial Ablation
Official title: Evaluation of the Endometrial Cavity After Endometrial Ablation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menorrhagia
Keywords: Endometrial ablation, menorrhagia
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.

Detailed description: The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy. Participants are randomly assigned to one or the other device.

A vaginal ultrasound will be performed before the procedure and again at six months post-procedure.

The inside of the uterus will be visualized via hysteroscopy before the procedure and again at six months post-procedure. Measurements will be taken and the investigator will compare photos taken pre-procedure and six months post-procedure.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation

Exclusion Criteria:

* Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure

Primary outcomes:
measure: Visualization of the inside of the uterus
timeFrame: 6 months post-ablation
Secondary outcomes:
measure: Measurments of endometrial thickness
timeFrame: 6 months post-ablation
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Health Care
state: Texas
Study officials:
affiliation: Texas Health Care, Baylor Research Institute
name: Delbert A Johns, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05423028: Vitamin B12 and Dextrose for Median Nerve Hydrodissection
Official title: The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. Oral administration of vitamin B 12 had been reported to reduce the discomfort from peripheral neuropathy although the level of evidence is not strong. This prospective, double-blind randomized control trial aims to compare the effects of different kinds of the injection agents on carpal tunnel syndrome.


Eligibility criteria: Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study.

Exclusion Criteria:

* Previously undergone wrist surgery or steroid injection for CTS
* Thrombocytopenia
* Coagulopathy
* Inflammation status
* Polyneuropathy
* Brachial plexopathy
* Cervical radiculopathy
* Autoimmune disease
* Malignancy
* Pregnancy

Thoracic outlet syndrome

Primary outcomes:
measure: Change of Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: Pre-treatment, 1st, 3rd, 6th month after injection
Secondary outcomes:
measure: Visual analog scale of pain and tingling
timeFrame: Pre-treatment, 1st, 3rd, 6th month after injection
measure: Cross-sectional area of the median nerve
timeFrame: Pre-treatment, 1st, 3rd, 6th month after injection
measure: Median nerve elastography
timeFrame: Pre-treatment, 1st, 3rd, 6th month after injection
measure: Median nerve conduction velocity and amplitude
timeFrame: Pre-treatment, 1st, 6th month after injection
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Study officials:
References:
Clinical trial NCT06234228: Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
Official title: Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Keywords: Vascular access
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.


Eligibility criteria: Inclusion Criteria:

* Between age 4-99
* Will undergo a vascular access procedure
* English speaking participant and parent or LAR

Exclusion Criteria:

* Legal guardian not present to obtain consent
* Child is unable to self-report pain or anxiety
* Child with a significant neurological condition, or major developmental disability
* Child with active infection of the hand or arm
* Major surgery within the last 48 hours

Primary outcomes:
measure: Faces Pain Scale-Revised (FPS-R) for patients aged 4-11
timeFrame: during vascular access procedure
measure: Numerical Rating Pain Scale (NRPS) for patients aged 12-17
timeFrame: during vascular access procedure
Secondary outcomes:
measure: External observation for pain and anxiety using HRAD scale
timeFrame: during vascular access procedure
measure: External observation for pain and anxiety using OBSD-r scale
timeFrame: during vascular access procedure
measure: modified induction compliance checklist (mICC)
timeFrame: during vascular access procedure
measure: Self formulated procedural satisfaction survey
timeFrame: after vascular access procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Childrens Hospital Stanford
state: California
Study officials:
affiliation: Stanford University
name: Thomas Caruso, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06464328: The Impact of Tai Chi Combined With Music Therapy Intervention on Depression and Anxiety Among College Students
Official title: The Impact of Tai Chi Combined With Music Therapy Intervention on Depression and Anxiety Among College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unrecognized Condition
Keywords: Tai Chi combined with music therapy
depression
anxiety
college students
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate the effects of Tai Chi combined with music therapy on alleviating depression and anxiety among college students. Depression and anxiety are prevalent among college students and have a significant impact on their lives and academic performance. Therefore, exploring effective interventions is crucial for promoting the mental health of college students.


Eligibility criteria: Inclusion Criteria:

* This study were being enrolled as a student at Tianjin University of Sport
* aged between 18 and 25 years
* proficient in reading and communicating in Chinese.

Exclusion Criteria:

* Students with visual impairments
* Students with auditory
* Students with other impairments

Primary outcomes:
measure: Change from the Self-Rating Depression Scale (SDS) at week 12
timeFrame: 12 weeks
measure: Change from the Self-Rating Anxiety Scale (SAS) at week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
Clinical trial NCT01731028: Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®
Official title: Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Growth Hormone Deficiency
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with inadequate secretion of growth-hormone; growth retardation due to Turner's syndrome

Brief summary: The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.


Eligibility criteria: Inclusion Criteria:

* therapeutic need according to the approved specific products characteristics (SPC)

Exclusion Criteria:

* contraindication according to the SPC

Primary outcomes:
measure: Efficacy of Zomacton® treatment measured by the increase in body height per annuum
timeFrame: 5 years
Secondary outcomes:
measure: Efficacy of Zomacton® treatment measured by the increase in body weight per annuum
timeFrame: 5 years
measure: Safety of Zomacton® and the application device measured by local adverse reactions to the application device
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT06715228: Efficacy of Shitali Respiratory Rehabilitation Program in Obstructive Sleep Apnea
Official title: Efficacy of Shitali Respiratory Rehabilitation Program in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration

Detailed description: in this study, patients (n=40) with obstructive sleep apnea will participate in this study to be divided in to group I and group II with an equal number of patients (n = 20 for the group). Group I will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, the other group, Group II, will act as control group.

Eligibility criteria: Inclusion Criteria:

* non-obese patients
* obstructive sleep apnea (mild and moderate form)

Exclusion Criteria:

* cardiac patients metabolic diseases kidney diseases

Primary outcomes:
measure: apnea hypopnea index
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: systolic blood pressure
timeFrame: it will be assessed after 12 weeks
measure: diastolic blood pressure
timeFrame: it will be assessed after 12 weeks
measure: Pittsburg sleep quality index
timeFrame: it will be assessed after 12 weeks
measure: respiratory rate
timeFrame: it will be assessed after 12 weeks
measure: Epworth sleepiness scale
timeFrame: it will be assessed after 12 weeks
measure: visual analogue scale of by-partner reported sleep difficulty
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02449928: Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients
Official title: Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Sepsis With Septic Shock
Lactate
Keywords: Severe Sepsis with Septic Shock, Lactate
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-05-20
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: Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, in order to make clear whether can improve the prognosis.

Detailed description: Experimental evidence repeatedly demonstrated that the shock patients can use substrates other than glucose to sustain increased activity, including lactate.Increased lactate can be the consequence of anaerobic metabolism, i.e., the formation of lactate in the presence of low oxygen. However, emerging evidence demonstrated that in patients with sepsis increased lactate seems predominantly non-hypoxic/ischemic and rather the consequence of increased glycolysis. Utilization of lactate as an alternative fuel may be an adaptive response to maximize energy function and limit substrate reduction.Uptake of exogenous lactate has indeed been demonstrated after traumatic brain injury and acute heart failure in humans.

The investigators assume that administration of supplemental lactate significantly contributes to energy metabolism in septic shock, which can have beneficial help for septic shock resuscitation.

Inclusion criteria:diagnosis in patients with septic shock and age 18 years old or more. Exclusion criteria: pregnant women and nursing mothers, severe liver failure with child class C , use linezolid anti-infection treatment, pheochromocytoma patients, CVVH therapy patients, malignant tumor patients, using epinephrine.

The investigators will use sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, the organ function monitoring include heart, kidney,and brain. Others study endpoints include 28-day mortality,hospitalized mortality.

Eligibility criteria: Inclusion Criteria:

* diagnosis in patients with septic shock

Exclusion Criteria:

* pregnant women and nursing mothers
* severe liver failure with child class C
* using Linezolid
* pheochromocytoma
* hematologic malignancy
* using epinephrine
* during CVVH treatment

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days after the diagnosis of septic shock
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Critical Care Medicine, Peking Union Medical College Hospital
name: Da-Wei Liu, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00596128: Standard Operating Procedures in Daily Clinical Routine
Official title: Does Implementation of a Standard Operating Procedure for Blood Sugar Control Into Daily Clinical Routine Improve Care of Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Keywords: Blood glucose
Clinical pathways
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary study endpoint: blood sugar values

Patients: Patients admitted to an ICU

5 steps:

1. Routine treatment,
2. Implementation of SOP for blood sugar monitoring and intervention,
3. Education of intensive care nurses,
4. 6 months free interval without further education or check-up of SOP implementation,
5. Check of SOP implementation and clinical outcome concerning range of blood sugar

Detailed description: SOP for blood glucose monitoring and treatment was implemented on an intensive care unit. Staff was trained. After a free interval patient's outcome was monitored in terms of daily blood sugar profile prior implementation of SOP and after implementation+free interval of SOP.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to an ICU

Exclusion Criteria:

* Patient's or close relative's refusal

Primary outcomes:
measure: blood sugar range
timeFrame: 4 times a day for total ICU stay
Secondary outcomes:
measure: ICU length of stay
timeFrame: After discharge from ICU
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel, kiel, Germany
name: jens Scholz, MD, Chair
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05852028: A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma
Official title: A Real-world Study: Efficacy and Safety of Selinexor-based Regimens for Non-Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
DLBCL
T Cell Lymphoma
Keywords: SELINEXOR
LYMPHOMA
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 250
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: DLBCL, T or NK cell lymphoma

Brief summary: This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma

Detailed description: this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility criteria: Inclusion Criteria:

* Know and voluntarily sign the Informed Consent Form (ICF)
* Clinically confirmed DLBCL, T or NK cell lymphoma
* Patients with DLBCL or T or NK cell lymphoma who have used selinexor-based therapy in the past 3 months are included
* Cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials

Exclusion Criteria:

* Previously received selinexor
* Poor patient compliance
* physicians evaluate that patients are not suitable for enrollment

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: throughout the study, an average of 1 year
measure: incidence of adverse events/ serious adverse events
timeFrame: throughout the study, an average of 2 year
Secondary outcomes:
measure: incidence of dose delays or interruptions
timeFrame: throughout the study, an average of 2 year
Other outcomes:
measure: duration of response (DOR)
timeFrame: throughout the study, an average of 2 year
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Wuhan
country: China
facility: Union Hospital Affiliated to Huazhong University of Science and Technology
Study officials:
References: