louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06909396: Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy
Official title: Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy: Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Response
Hemodynamic Changes
Intrathecal Anesthesia
Caudal Epidural Anesthesia
Infants
Laparoscopic Inguinal Herniorrhaphy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy.

Detailed description: Inguinal hernia repair is the most frequent surgical procedure in early childhood. Various regional anesthetic techniques have been employed to provide optimum intraoperative and postoperative pain control after this procedure.

Introduced decades ago, the use of intrathecal (spinal) anesthesia and caudal block in procedures for different types of laparoscopic abdominal surgery is safe and efficient.

Caudal block is now frequently used in intraoperative and postoperative analgesia for pediatric surgery. In infants and children, central neuraxial block is an important modality for acute postoperative analgesia in addition to combined anesthesia, the goals of postoperative analgesia in children are pain eradication, expedient recovery to daily activities, and prevention of progression of acute postsurgical pain to chronic pain or hyperalgesia

Eligibility criteria: Inclusion Criteria:

* Age from full term one month to one year.
* Both sexes.
* Patients with clinical criteria of laparoscopic inguinal herniorrhaphy.

Exclusion Criteria:

* Refusal of patients' parents.
* Diseases of the central nervous system.
* Patients with metabolic and coagulation defects.
* Pre-term infant.
* Infection at the site of injection.
* Congenital anomaly in vertebral column.
* Patient treated with corticosteroids.
* Patients with respiratory dysfunction.

Primary outcomes:
measure: Serum glucose level
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Serum cortisol level
timeFrame: 24 hours postoperatively
measure: Heart rate
timeFrame: Till the end of surgery (Up to 1 hour)
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 1 hour)
measure: Intraoperative anesthetic consumption
timeFrame: Intraoperatively
measure: Total analgesics consumption
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00335296: PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
Official title: The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Patent Foramen Ovale
Keywords: PFO
Migraine
Stroke
TIA (transient ischemic attack)
Decompression Illness
Lead sponsor: Cierra
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Detailed description: Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years old
* Documented PFO
* Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness

Exclusion Criteria:

• Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Primary outcomes:
measure: PFO closure 6 months post procedure
timeFrame: 6 months
Secondary outcomes:
measure: PFO closure at 30 days and 12 months post procedure
timeFrame: 30 days, 12 months
measure: AE event rates for all subjects
timeFrame: 30 days, 6 and 12 months
measure: Migraine severity
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Middleheim Hospital
city: Massy
country: France
facility: Institut Hospitalier Jacques Carter
city: Paris
country: France
facility: Bichat Hospital
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt Sankt katharinen
Study officials:
affiliation: Bichat Hospital
name: Alec Vahanian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266496: Discovering the Effect of Venous Insufficiency on Nocturia
Official title: Discovering the Effect of Venous Insufficiency on Nocturia: a Prospective, Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturia
Venous Insufficiency of Leg
Fluid Overload
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 84
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: With this prospective controlled trial, we hope to obtain more information about the coexistence between venous insufficiency and nocturia.

In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation in the lower limbs due to moving around all day. When laying down during nighttime, this fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal frequency and urine production before and after surgical treatment of venous insufficiency.


Eligibility criteria: Inclusion Criteria:

* CEAP 2 till 4A

Exclusion Criteria:

* BMI higher than 30
* Previous surgery due to venous insufficiency at the lower limbs
* Cronic edema (Cronic heart failure, liver cirrosis, nefrotic syndrome)
* Pregnant patient
* Patients on the following medication: Calcium-antagonists, lithium, NSAID's or corticosteroids, glitazones, insuline, diuretics, sartans, ACE-inhibitors, desmopressine,

Primary outcomes:
measure: Change of micturition frequency
timeFrame: 2 months after surgery
Secondary outcomes:
measure: Change in nocturnal diuresis
timeFrame: 2 months after surgery
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of urology
Study officials:
affiliation: UZ Ghent
name: Karel Everaert, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03899896: Voice Feminisation in Transgender Women
Official title: Voice Feminisation in Transgender Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Speech Therapy
Transgender Women
Gender Dysphoria
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participation to the study will be proposed consecutively to all subjects, fulfilling inclusion criteria, attending in-office follow-up visit for gender dysphoria in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy

Brief summary: The voice is a reflection of our identity. In the case of transgender women, there may be a gap between perceived male voice and female appearance. Indeed, hormonal treatment in transgender women has no effect on the voice quality. This gap can have negative consequences on everyday life in banal situations such as telephonic contact leading to limited use of phone calls and social isolation.

Differences between female and male voices seem to be socially determined and do not depend directly on sexual dimorphism of the phonatory organs.

Speech therapy might thus be indicated as a vocal support for transgender women.

Only few studies have examined the impact of perceived voice on the quality of life of transgender women.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Follow-up in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
* Gender dysphoria according to the ICD 11
* Voluntary, informed consent to participate in research
* Compulsory affiliation to the social security system

Exclusion Criteria:

-Refusal or incapacity to be involved in the study

Primary outcomes:
measure: To measure the perceptions of transgender women regarding their voice
timeFrame: 1 year
Secondary outcomes:
measure: generic quality of life: physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health
timeFrame: 1 year
measure: Anxiety: State-Trait Anxiety Inventory, STAI-Y
timeFrame: 1 year
measure: Self-esteem : Physical self inventory, 25 items (PSI-25)
timeFrame: 1 year
measure: Depression: Center for Epidemiologic Studies Depression Scale, CES-D
timeFrame: 1 year
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: University Hospital Nancy
Study officials:
References:
Clinical trial NCT05413096: Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Official title: Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oral Mucositis
ORAS
Oral Infection
Oral Ulcer
Keywords: diclofenac
oral disease
oral Aphthosis
propolis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical, double-blind, placebo-controlled study
Primary purpose: TREATMENT

Brief summary: The combination of diclofenac and propolis could enhance the healing of recurrent aphthous ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral ulceration


Eligibility criteria: Inclusion Criteria:

* patients have an oral mucosal ulcer

Exclusion Criteria:

* patients allergic to any component of the diclofenac formulation and other NSAIDs

Primary outcomes:
measure: chronic oral mucosal disease questionnaire
timeFrame: 10 days
Secondary outcomes:
measure: ulcer characters
timeFrame: 10 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar university
Study officials:
References:
Clinical trial NCT06098196: Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness
Official title: Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness and on BIS (Bispectral Index) After Total Intravenous Anaesthesia With TCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Propofol
Anesthesia Brain Monitoring
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, with or without aminophylline bolus at the end of surgery will be recruited

Brief summary: Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

We aimed to compare its effect during a total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.

Detailed description: Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

We aimed to compare its effect during a total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital (with Eleveld or Schnider Pharmacokinetic/Pharmacodynamic-PK/PD model).

The timing from stop of propofol infusion to eye opening and return of responsiveness, the relative Concentration of Propofol (CeP) and the power spectrum of the Bispectral Index (BIS) with or without aminophylline bolus were taken into account.

Eligibility criteria: Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity

Primary outcomes:
measure: Correlation between Concentration at the effector site of Propofol after Aminophylline
timeFrame: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of anaesthesia until the emergence from anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: ULSS 2 Marca Trevigiana
state: Tv
city: Treviso
country: Italy
facility: ULSS2 Marca Trevigiana
Study officials:
References:
Clinical trial NCT01999296: Prospective Evaluation of the Use of Thunderbeat Vessel Sealing Device in Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Indication for Laparoscopic Surgery (Any)
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 250
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: Patients with an indication for laparoscopic visceral or gynecologic surgery.

Brief summary: All patients undergoing laparoscopic visceral and gynecologic procedures using the combined bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a prospective registry. Data will be analysed concerning the safe use of the instrument and perioperative blood loss.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing laparoscopic visceral or gynecologic surgery
* need for a vessel sealing device during surgery

Exclusion Criteria:

* non able to understand informed consent or missing consent
* age \<18

Primary outcomes:
measure: Intra- and postoperative device-related complications
timeFrame: 30 days
measure: Use of additional vessel sealing devices
timeFrame: one day
Secondary outcomes:
measure: Perioperative Blood Loss
timeFrame: 30 days
measure: Duration of Surgery
timeFrame: one day
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland Bruderholz
Study officials:
References:
Clinical trial NCT06711796: Measurement of Muscle Relaxation of the Hand in From Two Muscles and Two Hand Positions
Official title: Measurement of Muscle Relaxation of the Hand in From Two Muscles and Two Hand Positions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relaxation
Keywords: Train of four
EMG
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery with estimated time over 45 minutes and no need for muscle relaxation

Brief summary: Does movement of hand from supination to pronation affect the cut threshold for electomyography (EMG) relaxation measurement Does the threshold level differ between adductor pollucis and dorsal interosseus muscle


Eligibility criteria: Inclusion Criteria:

* age 18-65 years
* American society of anesthesiology (ASA) classification 1-2
* Elective surgery under general anesteshia with no planned need for muscle relaxation
* Body mass index \<35 kg/m3

Exclusion Criteria:

* Know central nervous system disease
* Know central nervous system impairment
* known medication affection peripheral nervous system

Primary outcomes:
measure: To differ the difference in the stimulation current between adductor pollucis and dorsal interosseus muscles
timeFrame: 30 minutes
measure: To differ the stimulation threshold in hand supination and pronation postures
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
Clinical trial NCT03522896: Effect of Orange Juice on Glycemic Response
Official title: Effect of Hesperidin in Orange Juice on Glycemic Response in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Food on Postprandial Hyperglycemia
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Orange juice naturally contains high concentrations of hesperidin, which affects glucose absorption in in vitro experiments. This study is to test if hesperidin and other components of orange juice (not other sugars or organic acids) affect the post-prandial blood glucose concentration derived from sugars already present in the orange juice.

Detailed description: Healthy volunteers will consume orange juice with added water or food-grade hesperidin.

Eligibility criteria: Inclusion Criteria:

* fasting blood glucose below 5.9 mM

Exclusion Criteria:

* fasting glucose above 6 mM pregnant

Primary outcomes:
measure: Blood glucose concentration
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
References:
Clinical trial NCT03005496: The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
Official title: The Effect of Zinc, Beta-carotene, and Vitamin D3 Supplementation as Pro-inflammation Mediated Regulator in Preterm Delivery Through Placental Protein Adaptor MyD88 and TRIF, Transcription Factor NFkB, and Pro-inflammatory Cytokine IL-1β
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PreTerm Birth
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a controlled trial which compares the effect of zinc, beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels in placenta.

Detailed description: The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital.

Each participant of each group will be given the medication of preterm birth hospital protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene 25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the intervention. Each participant will be observed until delivery. After delivery, level of zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of MyD88, TRIF, NFκB, and IL-1β in placenta.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who has preterm birth in 26-36 weeks gestational age

Exclusion Criteria:

* Multiple pregnancy
* Drug allergy
* Intra Uterine Growth Retardation (IUGR) is detected
* Congenital malformation in fetus was found
* Preterm Premature Rupture of Membrane (PPROM)
* Maternal complication such as gestational hypertension, preeclampsia, gestational diabetes mellitus, heart disease, infection, and autoimmune disease

Primary outcomes:
measure: placenta MyD88
timeFrame: 1 year
measure: placenta TRIF
timeFrame: 1 year
measure: Placenta NFkB
timeFrame: 1 year
measure: Placenta 25(OH)D
timeFrame: 1 year
measure: Placenta vitamin A
timeFrame: 1 year
measure: Placenta zinc
timeFrame: 1 year
measure: Placenta IL-1B
timeFrame: 1 year
measure: Serum zinc
timeFrame: 1 year
measure: Serum 25(OH)D
timeFrame: 1 year
measure: Serum vitamin A
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: