louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04253431: The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
Official title: A Single-blind, Randomized, Single-centre Study to Investigate the Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: lancing device
lancet
fingerprick
capillary blood
self-monitoring of blood glucose
Lead sponsor: HTL-Strefa S.A.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized single-blind study with the use of different lancing devices equipped with personal lancets to determine and to compare the amount of capillary blood volume and perceived pain after a single lancing of the fingertip.


Eligibility criteria: Inclusion Criteria:

* Willing to sign the informed consent.
* Must currently be diagnosed with either Type I or Type II diabetes mellitus.
* Otherwise in good physical and mental health.
* Must currently be performing self-monitoring of blood glucose (self reported).
* Must be between 18-75 years of age (inclusive).
* Ability to read and follow study instructions.

Exclusion Criteria:

* Pregnancy (self reported).
* Severe poor blood circulation in the fingers.
* Any skin condition on his or her fingers that prevents blood sampling.
* History of a bleeding disorder.
* Neuropathy or other condition affecting sensation in the hands.
* Self-reported blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
* Currently participating in another study.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
* Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
* Any prescription or OTC medication within two days of starting the study which might affect pain perception (for example, ibuprofen or paracetamol).
* Alcohol 48 hours before study start.

Primary outcomes:
measure: Volume (uL) of blood in the capillary tube
timeFrame: The blood from the puncture site was collected to the capillaries for 30 seconds, and afterwards amount of the blood was measured using a calibrated ruler
Secondary outcomes:
measure: The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).
timeFrame: 3 minutes (+/- 1 minute) after lancing
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00517231: Cytokines and Acute Phase Reactants as Markers of Pulmonary Tuberculosis Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Tuberculosis
Keywords: Pulmonary tuberculosis
Mycobacterium tuberculosis
Cytokines
Acute Phase Response
Treatment
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2007-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium tuberculosis. Cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. Besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy.

Detailed description: Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium tuberculosis. Cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. Besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy. The propose of this work was to evaluate the production of IFN- γ in cell supernatants of peripheral blood mononuclear cells (PBMC) culture, TNF-α, IL-10 and TGF-b in cell supernatants of monocytes (MO) culture and biochemical (total proteins, albumin, globulin, α-1-acid glycoprotein and C-reactive protein) and hematological (VHS) serum parameters before and after 3 and 6 months of therapy

Eligibility criteria: Inclusion Criteria:

* diagnosis of Mycobacterium tuberculosis infection

Exclusion Criteria:

* all other granulomatous or neoplastic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Botucatu School of Medicine - Unesp
name: Jussara Marcondes-Machado, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01168531: The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
Official title: The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: patients undergoing lumbar spinal surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. This study investigated the analgesic effect of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for lumbar spinal surgery, aged 20 to 70 years, with a body mass index (BMI) from 18 to 32 and an American Society of Anesthesiologists (ASA)physical status classification of I-II were eligible for the study.

Exclusion Criteria:

* allergy to any drugs in the study
* alcohol and/or drug abuse
* treatment with antacids or antidepressants
* a history of diabetes or epilepsy
* a daily intake of analgesics or an intake of any analgesic within 24 h before surgery
* treatment with systemic glucocorticoids within 4 weeks before surgery
* known impaired hepatic and renal function.

Primary outcomes:
measure: the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone
timeFrame: Assessment was performed during the first 72 hour following emergence from general anesthesia, subdivided into 5 time periods; on arrival of patient to the PACU, 1-6 hour, 6-24 hour, 24-48 hour and 48-72 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02521831: Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants
Official title: Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants: A Randomized, Controlled, Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Inguinal Hernia
Keywords: Circumcision
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 0
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Significant concern regarding the safety of general anesthesia in children has arisen due to myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents. Inflammation of the central nervous system after anesthesia may have a significant role in the pathogenesis of anesthetic-induced neural injury. To evaluate this hypothesis, the investigators propose to randomize healthy infants undergoing elective surgery to one of two anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with isoflurane, laryngeal mask airway (LMA) or endotracheal tube (ETT), and single-shot caudal block. Primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and secondary endpoint will be neurocognitive outcome at 6 months and 1 year.


Eligibility criteria: Inclusion Criteria:

1. Otherwise healthy child aged 0-less than 13 months undergoing elective (non-emergent) general, urologic, orthopedic, and plastic surgery
2. Parent/guardian must provide written informed consent in accordance with human investigation committee guidelines
3. Participants must be American Society of Anesthesiologist (ASA) physical status ≤ 2

Exclusion Criteria:

1. Any active bacterial or viral infection within the last 14 days
2. Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or corticosteroid medications, or any other drug known to suppress or induce inflammation
3. Anticoagulant administration in the last 48 hours
4. Patients that have an American Society of Anesthesiologists physical status \>2
5. Infants born more than 4 weeks premature

Primary outcomes:
measure: Change in proinflammatory miRNAs
timeFrame: Blood will be drawn before surgical incision, at the conclusion of the surgery (typically ~1 hour after incision), and at arrival to the PACU (typically 10-30 minutes after end of surgery)
Secondary outcomes:
measure: Change in systemic inflammation
timeFrame: Blood will be drawn before surgical incision, at the conclusion of the surgery (typically ~1 hour after incision), and at arrival to the PACU (typically 10-30 minutes after end of surgery)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00298831: Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
Official title: A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of a Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-03-03
Enrollment: 224
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: The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.


Eligibility criteria: Inclusion criteria:

* American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Exclusion criteria:

* Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
* Participants taking medications known to interfere with neuromuscular blocking agents.
* Participants who are of child-bearing potential, pregnant, and breast feeding

Primary outcomes:
measure: Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9
timeFrame: Up to approximately 30 minutes following administration of study treatment
Secondary outcomes:
measure: Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7
timeFrame: Up to approximately 10 minutes following administration of study treatment
measure: Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8
timeFrame: Up to approximately 15 minutes following administration of study treatment
measure: Clinical Assessment of Recovery - Participant's Level of Consciousness
timeFrame: Up to 24 hours
measure: Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL)
timeFrame: Up to 24 hours
measure: Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW)
timeFrame: Up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hudson ME, Rietbergen H, Chelly JE. Sugammadex is effective in reversing rocuronium in the presence of antibiotics. BMC Anesthesiol. 2014 Aug 15;14:69. doi: 10.1186/1471-2253-14-69. eCollection 2014.
Clinical trial NCT06038331: Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Official title: Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis Hand
Keywords: ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of STT osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Male or female; age between 18 and 75 years.
* Patient with symptomatic STT OA.
* Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
* Patient with a QuickDash score \> 33 points (converted to 50%).
* Patient with wrist pain in front of the STT joint at rest = or \> 4/10 on VAS.
* Patient who received the study information and provided consent.
* Member or beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman; woman without effective contraception.
* Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
* Patient with signs of neuropathy with functional disorders such as hyperesthesia.
* Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
* Person confined by a judicial or administrative decision.
* Adult subjected to legal protection measures or unable to provide his/her consent.

Primary outcomes:
measure: Decrease of the symptomatology related to the STT OA
timeFrame: 12 months
Secondary outcomes:
measure: Absence of inflammatory reactions and good local tolerance of the implant
timeFrame: Through study completion (12 months)
measure: Decrease of pain related to STT OA
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Improvement of functional activities involving the thumb
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Increase of thumb strength
timeFrame: 3 months, 6 months, 12 months
measure: Increase of grip strength
timeFrame: 3 months, 6 months, 12 months
measure: No apparent joint space anomaly
timeFrame: 12 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Lyon
country: France
facility: Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)
city: Nantes
country: France
facility: Centre de la Main - Clinique Jules Verne
Study officials:
References:
Clinical trial NCT02027831: NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG
Official title: Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: lymph nodes
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if NIR fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour

Detailed description: Primary objective:

definition of the distribution of intravenously injected ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients or in nodes recurrences in head and neck cancer

Secondary objectives:

* Evaluation of the ability of NIR fluorescence imaging to determine the tumoral volume, specifically the margins of the tumoral tissues (in the operating room and in the pathology department)
* Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes

Eligibility criteria: Inclusion Criteria:

* All patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
* Informed consent form signed.

Exclusion Criteria:

* Age less than18 years old.
* Inability to give informed consent.
* History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
* Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
* Documented coronary disease.
* Advanced renal impairment (creatinine \> 1,5mg/dl).
* During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
* Pregnancy, breastfeeding

Primary outcomes:
measure: Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Institute
Study officials:
affiliation: Jules Bordet Institute
name: Antoine Digonnet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01305031: Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
Official title: Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asphyxia
Keywords: Asphyxia
Resuscitation
Room Air
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.

Detailed description: The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.

Eligibility criteria: Inclusion Criteria:

* inborn infant
* gestation 34 weeks to 36 weeks 6 days

Exclusion Criteria:

• known chromosomal or congenital anomalies

Primary outcomes:
measure: oxidative stress status
timeFrame: 7 days
measure: oxygen saturations
timeFrame: 10 min
Secondary outcomes:
measure: Days on oxygen
timeFrame: 28 days
measure: Days on conventional ventilation
timeFrame: 28 days
measure: Days on high frequency ventilation
timeFrame: 28 days
measure: Days on nasal canula
timeFrame: 28 days
measure: Pneumothorax
timeFrame: 28 days
measure: Oxygen requirement
timeFrame: At 36 weeks adjusted age
measure: Patent ductus arteriosus
timeFrame: 28 days
measure: Necrotizing Enterocolitis
timeFrame: 28 days
measure: Intracranial hemorrhage
timeFrame: 28 days
measure: Hypoxic ischemic encephalopathy
timeFrame: 28 days
measure: Retinopathy of prematurity
timeFrame: 28 days
measure: Death
timeFrame: 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Shuping Han, PhD
role: STUDY_DIRECTOR
References: