louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04067648: Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
Official title: Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sufentanil
Keywords: Sufentanil
perfusion index
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. The vital signs during anesthesia, the recovery period of anesthesia and the complications after anesthesia were compared among the groups. The anesthetic effects and safety of sufentanil at different doses were discussed, which provided theoretical basis for clinical selection of the best drug dosage.

Detailed description: Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG, SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage of remifentanil during operation.

The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation were observed before anesthesia induction, immediately after tracheal intubation, during tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room. Then record the recovery time, restlessness and pain score during recovery period, postoperative pain, nausea and vomiting and other complications.

Eligibility criteria: Inclusion Criteria:

* Age 1-12 years,
* ASA I-II grade;
* selective adenotonsillectomy
* BMI 18.5～23.9,
* Sign informed consent

Exclusion Criteria:

* Emergency surgery;
* Abnormal liver and kidney function
* severe dehydration and malnutrition or Hb \< 10g/dl;
* BMI \<18.5 or \<23.9;
* Children with neurological disorders

Primary outcomes:
measure: adequate sufentanil dose
timeFrame: 24 hours
Secondary outcomes:
measure: cut off value of Pi for valid stress assessment
timeFrame: 24 hours
measure: Narcotrend index
timeFrame: 24 hours
measure: postoperative complications with different doses of sufentanil
timeFrame: 7days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Aijun XU, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04325048: Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients
Official title: Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Keywords: COVID-19 positive
Lead sponsor: Cordio Medical
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 positive patients, from medical center departments, ER, home/hotels hospitalization

Brief summary: Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet.

The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.


Eligibility criteria: Inclusion Criteria:

1. 18+ years old
2. Diagnosed with COVID-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. Patients that diagnosed with pneumonia, should be confirmed by X-ray and/or CT.
3. Able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients).

Exclusion Criteria:

1. Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
2. Patients with severe alcohol or drug use.
3. Women who are pregnant or lactating.
4. Participating in another investigation therapy that may interfere with study results (according to investigator discretion)

Primary outcomes:
measure: Voice anaysis
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Zaher Azzam, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825148: GLP-1 Receptor Targeting in Diabetic and Healthy Individuals
Official title: Clinical Proof-of-principle of the Determination of the Beta Cell Mass in Vivo by SPECT Imaging With the 111-In-labeled GLP-1 Analogue DTPA(Diethylenetriamine Pentaacetic Acid)-[K40]-Exendin 4
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Diabetes
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 Diabetes patients and healthy volunteers responding to advertisment

Brief summary: The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.


Eligibility criteria: Inclusion Criteria:

* type 1 Diabetes

Exclusion Criteria:

* breast feeding
* pregnant

Primary outcomes:
measure: pancreatic uptake of radiolabeled Exendin
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
References:
citation: Brom M, Woliner-van der Weg W, Joosten L, Frielink C, Bouckenooghe T, Rijken P, Andralojc K, Goke BJ, de Jong M, Eizirik DL, Behe M, Lahoutte T, Oyen WJ, Tack CJ, Janssen M, Boerman OC, Gotthardt M. Non-invasive quantification of the beta cell mass by SPECT with (1)(1)(1)In-labelled exendin. Diabetologia. 2014 May;57(5):950-9. doi: 10.1007/s00125-014-3166-3. Epub 2014 Feb 1.
Clinical trial NCT05392348: Human Gut Microbiota and microRNA Expression
Official title: Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gut Microbiota
microRNA
Keywords: stachyose
gut microbiota
microRNA
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention

Detailed description: In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.

Eligibility criteria: Inclusion Criteria:

* healthy human

Exclusion Criteria:

* people who need intake antibiotics，probiotics or its product

Primary outcomes:
measure: expression of microRNA
timeFrame: up to 4 weeks
measure: structure of gut microbiota
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliate Hospital of the Air Force Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Chao Guo
role: STUDY_CHAIR
References:
Clinical trial NCT00196248: Out-of Hospital Resuscitation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Fibrillation
Asystoly
Resuscitation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Sudden cardiac arrest is one of the most common causes of death in industrial countries. The main objective of this study is to built up a register of all out-of hospital resuscitation in a defined area. According to this register, it is possible to evaluate for example predictors of survival to improve training and organisation of prehospital resuscitations.


Eligibility criteria: Inclusion Criteria:

* out of hospital cardiac arrest

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Heidi Estner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06585748: Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization
Official title: The Effect of Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization: a Prospective,observational ,controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure
Keywords: Bladder catheterization
Pain control
Lidocaine spray
Patient comfort
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients who required bladder catheterization during the follow-up and treatment process and came to the emergency departments of two major city hospitals in Ankara.

Brief summary: Bladder catheterization is a procedure frequently performed in emergency departments and may cause symptoms such as pain and discomfort in patients. This study hypothesizes that lidocaine spray application will improve patient compliance and comfort from the outset and facilitate smoother medical procedures. In our prospective, case-controlled study, the patients were divided into two groups: Group L (lidocaine) and Group P (placebo). Pain conditions after bladder catheterization were evaluated at 0 minutes (during the procedure) and 15, 30 and 60 minutes after the procedure. Face Legs Arm Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used. All time periods in Group L, FLACC score and Wang Baker scores were found to be statistically significantly lower.The differences between the first measurement and the measurements at 15-30-60 minutes of the FLACC score were found to be significantly higher in group P than in group L. As a result, we recommend that lidocaine spray be applied before urinary catheter insertion. This study showed that lidocaine spray increased patients\&#39; sleep at the end and reduced the feeling of restlessness by reducing pain.


Eligibility criteria: Inclusion Criteria: The study included male patients over 18 years old, without trauma, with spontaneous urine output, and who were oriented and cooperative. -

Exclusion Criteria: Exclusion criteria were patients under 18 years old, female patients, patients with trauma, patients with globe vesicale (due to the need for rapid bladder catheterization), patients with anatomical variations, patients with urethral-bladder outlet problems preventing catheterization, and patients who refused to participate in the study.

-

Primary outcomes:
measure: Lidocaine and Pain
timeFrame: 0., 15., 30., and 60. minutes
Secondary outcomes:
measure: Lidocaine and comfort
timeFrame: 0., 15., 30., and 60. minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
References:
Clinical trial NCT05697848: Pain Education in Chronic Low Back Pain
Official title: Pain Education: Treatment of Patients Affected by Chronic Low Back Pain, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Rehabilitation
Pain
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 40
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: The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue.

The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a conventional treatment.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Patients with low back pain of musculoskeletal origin for at least 3 months
* Patients free from NSAID and/or opioid analgesic therapy for at least 1 month
* Years of education: over 13
* Italian mother-tongue

Exclusion Criteria:

* Presence of neurological symptoms on provocative tests
* Recent surgical procedure
* Patients suffering from fibromyalgia or other rheumatological pathology
* Psychiatric pathologies

Primary outcomes:
measure: NRS
timeFrame: Baseline
measure: NRS
timeFrame: 4 weeks
measure: NRS
timeFrame: 6 months
measure: PCS
timeFrame: Baseline
measure: PCS
timeFrame: 4 weeks
measure: PCS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
References:
Clinical trial NCT02001948: Intrathecal Morphine for Inguinal Hernia Repair.
Official title: The Comparison of Two Different Doses of Morphine Added to Spinal Bupivacaine for Inguinal Hernia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Nausea
Vomiting
Pruritus
Postoperative Pain
Keywords: Spinal anaesthesia
morphine
postoperative analgesia
vomiting
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 46
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: The aim of this study was to compare the effects of two different doses of intrathecal morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block regression times, postoperative analgesia and the severity of side effects, for inguinal hernia repairs.

Detailed description: The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation, first voiding) time were compared. Also the postoperative pain management and side effects (nausea, vomiting and pruritus) were assessed.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiology physical status I-II patients
* aged 18-65 years
* undergoing elective unilateral open inguinal hernia repair surgery

Exclusion Criteria:

* contraindications to spinal anesthesia
* central or peripheral neuropathies
* severe respiratory or cardiac diseases
* chronic analgesic use
* history of substance abuse
* allergy to local anesthetics

Primary outcomes:
measure: Sensory and motor block
timeFrame: The change in motor block and sensory block levels will be assessed after performing spinal block, every 5 minutes for 30 minutes and then at the end of the procedure.
Secondary outcomes:
measure: first mobilisation, first urination and first analgesic times
timeFrame: after the procedure, during the first 24 hours
Other outcomes:
measure: postoperative nausea, vomiting and pruritus
timeFrame: after the procedure, during the first 24 hours
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Basak Ceyda Meco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05454748: Simultaneous Recording of Cognitive and Motor Functions After Stroke
Official title: Simultaneous Recording of Cognitive and Motor Functions After Stroke : Dissociation of Motor and Cognitive Deficits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients group and Age comparable healthy controls group

Brief summary: Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects.

Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* First symptomatic stroke more than 3 months ago
* Box and blocks test score \< 52
* Mini Mental State Examination Test \> 25

Exclusion Criteria:

* Psychiatric disease
* Risk of Pregnancy
* History of previous stroke
* Disability that may interfere with the performance of tasks

Primary outcomes:
measure: Saccade inhibition rate
timeFrame: Baseline measurement (one occasion)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Sainte Anne
Study officials:
References:
Clinical trial NCT04358848: Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator
Official title: Follow-Up to Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supplemental Oxygen
Lead sponsor: Belluscura LLC
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population It is patients requiring supplemental oxygen, as prescribed by a physician.

Brief summary: This study was a follow-up evaluation of modifications made to the instructions in the User Manual following the initial study evaluating how well an individual can put together and use a Portable Oxygen Concentrator (POC).

Detailed description: The Belluscura X-PLO2R Portable Oxygen Concentrator (POC) is intended for the provision of supplemental oxygen to patients with chronic pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD), and for a patient requiring supplemental oxygen, as prescribed by a physician. The purpose of this study is to evaluate if the X-PLO2R POC can be used by the intended users without serious errors or problems for the intended use and under the expected use conditions. Specifically, the study is to evaluate if potential users of the device can correctly, safely and effectively set-up, activate and operate the X-PLO2R POC to receive the required supplemental oxygen; if the intended user can understand and apply the information contained in the Belluscura X-PLO2R Quick Start Guide and User Manual; and to identify any and all use difficulties, problems and errors made during device assembly and operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Male or female.
* Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional.
* Voluntarily signed subject consent form.

Exclusion Criteria:

* Company employee.
* Former human factors study participants.

Primary outcomes:
measure: Ability to correctly assemble and use the X-PLO2R POC
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Plano
country: United States
facility: Belluscura LLC
state: Texas
Study officials:
References: