louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06979141: Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia
Official title: Comparative Study Between Efficacy of Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression During General Anesthetic Emergence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cough
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective randomized controlled double-blinded study is to compare the efficacy of dexmedetomidine, MgSO4 and lidocaine for cough suppression during general anesthetic emergence as regard number and severity.


Eligibility criteria: Inclusion Criteria:

* Aged 21-60 years.
* Both genders.
* Body mass index \< 30 kg/ m2
* American Society of Anesthesiology (ASA) physical status I-II.
* Mallampati score class I or II.
* Patients undergoing surgery under general anesthesia.

Exclusion Criteria:

* Known allergy to study drugs.
* History of psychiatric illness.
* Patients with major organ diseases.
* Pre-existing neurological deficits.
* Body mass index \>30 kg/m2.
* Active airway infection or history of tracheal and laryngeal surgery.
* Lower esophageal sphincter incompetence (and reflux).
* Increased intracranial and intraocular pressure.
* Use of cough-inducing medications
* Pregnant, and lactating women.

Primary outcomes:
measure: Cough suppression as regard number and severity.
timeFrame: at 0 and 10,20,30,40 minutes after endotracheal extubation.
Secondary outcomes:
measure: Intraoperative heart rate (HR).
timeFrame: at 15-minutes interval.
measure: Intraoperative mean arterial blood pressure (MAP).
timeFrame: at 15-minutes interval.
measure: Intraoperative arterial oxygen saturation (Spo2).
timeFrame: at 15-minutes interval.
measure: Sedation score.
timeFrame: at 0,10,20,30, and 40 minutes after tracheal extubation.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Al-Azhar university Assiut, Egypt.
Study officials:
affiliation: mahmoud.talaat750@gmail.com
name: Mahmoud T Abd Elhafeez, Specialist.Mcs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04930341: The Effect of Self-Acupressure Application on Pain, Fatigue and Sleep Quality in Cancer Patients Receiving Chemotherapy
Official title: The Effect of Self-Acupressure Application on Pain, Fatigue and Sleep Quality in Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Self-Acupressur
Cancer patients
Pain
Fatigue
Sleep quality
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of Self-Acupressure application on pain, fatigue and sleep quality in cancer patients receiving chemotherapy.

Detailed description: Self-Acupressur application will improve pain, fatigue and sleep quality in cancer patients receiving chemotherapy.

Eligibility criteria: Inclusion Criteria:

* To have received at least one course of adjuvant chemotherapy before,
* Not having a psychiatric diagnosis,
* Being an early stage cancer patient
* To be able to communicate adequately
* Not having psychiatric problems
* Volunteering to participate in research

Exclusion Criteria:

* None

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1. week
measure: Visual Analog Scale
timeFrame: 4. week
measure: The Piper Fatigue Scale
timeFrame: 1. week
measure: The Piper Fatigue Scale
timeFrame: 4. week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1. week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4. week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
state: Küçükçekmece
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz ÖZER, PhD
role: STUDY_CHAIR
References:
citation: He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.
citation: Dogan N, Tasci S. The Effects of Acupressure on Quality of Life and Dyspnea in Lung Cancer: A Randomized, Controlled Trial. Altern Ther Health Med. 2020 Jan;26(1):49-56.
Clinical trial NCT00796341: Endometrial Injury and IVF-ET Outcome
Official title: Does Endometrial Injury in the Non-Transfer Cycle Improve the IVF-ET Outcome in the Subsequent Cycle in Patients With Previous Failed IVF Cycles: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: invitro-fertilization ,embryo transfer,endometrial injury
Lead sponsor: Bangalore Assisted Conception Centre
Sponsor class: OTHER
First posted: 2008-11-24
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created causes release of substances which help in implantation.

Detailed description: Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF.

Patients will be randomly allotted to control and intervention group The patients in the intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior to IVF transfer cycle.

Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.

SAMPLE SIZE: 100 PATIENTS (50 in each group).

Eligibility criteria: Inclusion Criteria:

* Previous failed In-vitro fertilization embryo transfer cycle
* Patients who are good responders and have good quality embryos in the previous attempts
* Age of patients upto 37yrs

Exclusion Criteria:

* Those detected to have endometrial tuberculosis in the past, including those treated with Antituberculosis treatment
* Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma
* Those with sonographically detected hydrosalpinx

Primary outcomes:
measure: PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;
timeFrame: 9 MONTHS
Secondary outcomes:
measure: CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE
timeFrame: 9 MONTHS
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Bangalore Assisted Conception Centre
state: Karnataka
Study officials:
affiliation: Bangalore Assisted Conception Centre
name: SACHIN A NARVEKAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
citation: Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
Clinical trial NCT02989441: Perfusion Index in Anesthesia
Official title: Peripheral Perfusion Index as Marker for Systemic Hemodynamics During Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monitoring, Physiological
Keywords: Perfusion Index
Hemodynamics
Anesthesia
Stroke Volume
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 20
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 for elective and sub-acute surgical repair of para-oesophagal hernia.

Brief summary: In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)


Eligibility criteria: Inclusion Criteria:

* Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
* Willingness to participate

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)
timeFrame: Intra-operative
Secondary outcomes:
measure: Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Capital Region
Study officials:
affiliation: Hvidovre University Hospital, University of Copenhagen
name: Nicolai B Foss, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02187341: Effects of Exercise and 5-HTP on Cortisol Levels
Official title: Effects of Exercise and 5-HTP on Cortisol Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plasma Cortisol
Lead sponsor: Benedictine University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it has been shown that intense exercise stimulates an increase in plasma and salivary cortisol levels. The purpose of this study is to examine the combined effects of 5-HTP + intense exercise on plasma and salivary cortisol levels.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women, not taking medication known to alter glucocorticoid metabolism

Exclusion Criteria:

* Diabetes
* Obesity
* Hypertension
* Coronary artery disease
* Psychiatric disorders
* Any disease preventing them from participating in intense exercise
* Subjects taking medication known to interfere with glucocorticoid metabolism will be excluded

Primary outcomes:
measure: Change in plasma cortisol from baseline to 20 minutes post
timeFrame: baseline, 20 min
Secondary outcomes:
measure: Change in plasma cortisol from baseline to 5 minutes post
timeFrame: baseline, 5 minutes
Other outcomes:
Locations:
city: Lisle
country: United States
facility: Benedictine University
state: Illinois
Study officials:
affiliation: Benedictine University
name: Pedro Del Corral, PhD-MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03076541: Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
Official title: Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Keywords: Restless legs syndrome
Periodic leg movements
Heart rate
Heart rate variability
Microarousals
Autonomic nervous system activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with restless legs syndrome with a diagnosis from January 1rst 2012 to september 1rst 2016.

Brief summary: Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.


Eligibility criteria: Inclusion Criteria:

* Restless legs syndrome patients
* Hospital routine for periodic leg movements diagnosis
* PLMS index \> 0

Exclusion Criteria:

* Narcolepsy-cataplexy
* Sleep irregularities and sleep deprivation symptoms
* Lack of neurological or psychiatric diseases
* Upper airway resistance syndrome
* Obstructive sleep apnea
* Treatment, cerebral lesion, medical illness
* Medication or drinks affecting sleep and wake state

Primary outcomes:
measure: Amplitude of heart rate response associated with periodic leg movements.
timeFrame: At diagnosis
Secondary outcomes:
measure: Other Heart rate variability indices: Ptot, very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu), LF/HF.
timeFrame: At diagnosis
measure: electromyography (EMG) power
timeFrame: At diagnosis
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Vincent PICHOT, PhD
role: STUDY_CHAIR
affiliation: CHU SAINT-ETIENNE
name: Emilia SFORZA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556941: Metacognitive Intervention for Individuals With Severe Mental Disorders
Official title: Development and Efficacy of Metacognitive Intervention for Individuals With Severe Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Executive function
Meta-cognition
Schizophrenia
Meta-cognitive intervention
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 84
Sex: ALL
Minimum age (years): 23
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Before and after intervention
Primary purpose: TREATMENT

Brief summary: The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia

Detailed description: The overall aim of this study was to develop a Meta cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia. The specific objectives were to:

1. Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness.
2. Compare the use of cognitive strategies between participants with schizophrenia and their matched controls following the Meta cognitive group intervention and to correlate the cognitive strategies use and participation following the Meta cognitive group.
3. Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of schizophrenia by a licensed psychiatrist
* Fluency in Hebrew
* t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version

Exclusion Criteria:

* Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
* Used drugs or alcohol

Primary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Haifa
name: Naomi Josman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaizerman-Dinerman A, Roe D, Josman N. An efficacy study of a metacognitive group intervention for people with schizophrenia. Psychiatry Res. 2018 Dec;270:1150-1156. doi: 10.1016/j.psychres.2018.10.037. Epub 2018 Oct 13.
citation: Kaizerman-Dinerman A, Josman, Roe D. The use of cognitive strategies among people with schizophrenia: a randomized comparative study. The Open Journal of Occupational Therapy. 2019; 7(3): 1-12.
Clinical trial NCT04971941: Evaluation of the Dental Vibe Injection Comfort System
Official title: Evaluation of the Dental Vibe Injection Comfort System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Pain
Keywords: Anesthesia, local
Pain
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 60
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: This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. The study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block.

Detailed description: Objective: Pain from local anesthesia injections can be reduced by distraction and counter-stimulation techniques. This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation.

Design: Our study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block.

Methods: The sixty subjects, equally split by sex, ages 21-32, rated injection pain on a visual analog scale and discomfort, unpleasantness, and difficulty in enduring the injection on a modified symptom severity index. Each subject received bilateral LB injections and an IAN block. Using block design, DV Generation 3 (DV3) was randomly assigned to either the first or second LB injection and to thirty subjects on their third injection, the IAN block. No topical anesthesia was applied.

Eligibility criteria: Inclusion Criteria: Able to volunteer for dental anesthesia -

Exclusion Criteria: Non volunteer

-

Primary outcomes:
measure: VAS
timeFrame: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute
Secondary outcomes:
measure: SSI
timeFrame: measured by subject during procedure but recorded directly after each procedure
measure: Time in Minutes
timeFrame: After procedure until lip numbness, an average of four minutes
Other outcomes:
Locations:
Study officials:
affiliation: Harvard School of Dental Medicine
name: Jeffry R Shaefer, DDS MS MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259841: Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
Official title: Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for cholecystectomy are included.

Brief summary: Investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy.

Detailed description: Investigators evaluate the gastric volume through cross sectional area and amount of clear fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for cholecystectomy

Exclusion Criteria:

* Presence of gastric anatomic abnormality or pathology
* A previous surgery of esophagus or stomach
* Current pregnancy
* Who could not lie in the right lateral decubitus (RLD) position

Primary outcomes:
measure: Incidence of full stomach
timeFrame: Before the induction of anesthesia
Secondary outcomes:
measure: Cross sectional area of the stomach
timeFrame: Before the induction of anesthesia
measure: Volume of stomach
timeFrame: Before the induction of anesthesia
measure: Type of gastric contents
timeFrame: Before the induction of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jin-Young Hwang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang JE, Kim H, Won D, Lee JM, Jung JY, Min SW, Hwang JY. Ultrasound assessment of gastric content in fasted patients before elective laparoscopic cholecystectomy: a prospective observational single-cohort study. Can J Anaesth. 2020 Jul;67(7):810-816. doi: 10.1007/s12630-020-01668-7. Epub 2020 Apr 20.