louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03612947: TAP Block in Laparoscopic Cholecystectomy.
Official title: Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-02
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: PREVENTION

Brief summary: Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.

Detailed description: A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.

Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.

Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.

Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.

Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient refusal
* Patients with a history of cardiac, or respiratory diseases ( \>ASA III).
* Patients with allergy to amide local anesthetics or medication included in the study.
* Infection at the needle insertion site.
* Pregnancy
* BMI \>35
* Drug abusers

Primary outcomes:
measure: The postoperative pain
timeFrame: The first 24 hours after surgery
Secondary outcomes:
measure: Time to first dose of post-operative analgesia
timeFrame: First occurrence during hospitalization (up to 24 hours postoperatively)
measure: Postoperative nausea and vomiting
timeFrame: The first 24 hours after surgery
measure: postoperative sedation
timeFrame: The first 24 hours after surgery
measure: Patient satisfaction
timeFrame: At 24 hours after surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assuit University
state: Asyut
Study officials:
References:
Clinical trial NCT06446947: Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
Official title: Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis Syndrome
Septic Shock
Sepsis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 25
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients admitted to critical care for sepsis after thoracic or chest surgery.

Brief summary: Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.

The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.


Eligibility criteria: Inclusion Criteria:

* Male patients,
* Patients between 45 and 75 years of age,
* Patients undergoing major esophageal or digestive carcinological surgery,
* Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).

Exclusion Criteria:

* patients under 45 and aged 76 and over,
* female patients,
* non-carcinological or minor surgery,
* non-esophageal or non-digestive surgery,
* Gram-positive bacterial or fungal infections in the absence of associated BGN,
* patients with hematological cancer,
* immunocompromised patients,
* septic surgery (surgical site infection),
* patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study,
* patients under guardianship or curatorship,
* patients not affiliated to a social security system or equivalent in France,
* patients deprived of their liberty.

Primary outcomes:
measure: Identify prognostic markers for the progression of sepsis to septic shock
timeFrame: 18 months
Secondary outcomes:
measure: Epigenetic markers comparaison
timeFrame: 18 months
measure: Differentials in epigenetic marks and associated candidate genes
timeFrame: 18 months
measure: Epigenetic marks and associated candidate genes identified in PBMC
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille
state: Bouches du Rhône
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: François CREMIEUX
role: STUDY_DIRECTOR
References:
Clinical trial NCT03238547: Screening of Microalbuminuria Using a Semi-quantitative UACR Test
Official title: Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Microalbuminuria
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: diabetic patients following Seoul National University Hospital

Brief summary: Microalbuminuria is an important biomarker for the development of diabetic nephropathy and cardiovascular complications. Since microalbuminuria is not easily detected on routine urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio (uACR) annually in a patient with diabetes mellitus. While the standard method is quantitative measurement using turbidimetric immunoassay, it requires high cost and special laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and inexpensive, could be used as a substitute to the current standard quantitative measurement. The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* diabetes

Exclusion Criteria:

* microscopic hematuria
* pyuria
* urinary cast

Primary outcomes:
measure: Diagnostic Sensitivity and Specificity
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04914247: Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease
Official title: Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non-healing Wound
Thromboangiitis Obliterans
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2021-06-04
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program (EAP) is to provide Selexipag (Uptravi) for the treatment of participant with non-healing wound, buerger's disease.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Actelion
name: Actelion Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01419847: Topical Penlac Nail Lacquer for Onychomycosis in Children
Official title: A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Onychomycosis
Lead sponsor: Rady Children's Hospital, San Diego
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.

Detailed description: Therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of two and sixteen years
* Clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate
* Positive DTM reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold
* Consent to participate in the study
* Women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

* Children with allergy to Penlac or one of its ingredients
* Structural deformity of target nail plate
* Presence of active psoriasis or severe foot eczema
* Presence of immunodeficiency disorder
* Concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months
* Previous systemic antifungal therapy within the last 6 months
* Previous topical antifungal therapy within the last 14 days
* Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant

Primary outcomes:
measure: Mycological cure or global evaluation of 2 or less Mycological Cure
timeFrame: Week 20
Secondary outcomes:
measure: Estimated cost of therapy
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Children's Hospital-San Diego
state: California
Study officials:
affiliation: Rady Children's Hospital, San Diego
name: Sheila F Friedlander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedlander SF, Chan YC, Chan YH, Eichenfield LF. Onychomycosis does not always require systemic treatment for cure: a trial using topical therapy. Pediatr Dermatol. 2013 May-Jun;30(3):316-22. doi: 10.1111/pde.12064. Epub 2012 Dec 28.
Clinical trial NCT03966547: Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714
Official title: Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postdural Puncture Headache
Sphenopalatine Ganglion Block
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.


Eligibility criteria: Study Population:

Subjects who have consented to participate in GSPB-2018 will be approached for participation in this sub-study. Subjects who have consented to participate in GSPB-2018 are not required to participate in this sub-study.

Inclusion Criteria:

* Age \> 18 years
* Patients with postdural puncture headache defined as moderate to severe postural headache (VAS \>= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
* Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
* Patients who have given their written informed consent for participation in the study and substudy after fully understanding the protocol content and limitations.

Exclusion Criteria:

* Patients who cannot cooperate to the study
* Patients who does not understand or speak Danish
* Allergy to the drugs used in the study
* Has taken opioids within 12 hours prior to intervention
* No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.

Primary outcomes:
measure: Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.
timeFrame: <1h before and 1 hour after each intervention
measure: Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.
timeFrame: <1h before and 1 hour after each intervention
Secondary outcomes:
measure: Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.
timeFrame: <1h before and 1 hour after each intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital, University of Copenhagen
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University of Copenhagen
Study officials:
References:
Clinical trial NCT01651247: Assessment of the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants and Toddlers, Following Administration of IPV (Inactivated Poliovirus Vaccine)-Containing Vaccines
Official title: Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants Aged 2 and 6 Months and Toddlers Aged 4-6 Years Following Administration of GlaxoSmithKline (GSK) Biologicals' IPV-containing Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presence of Materials From PCV-1
Keywords: Toddlers
Retrospective
Porcine circovirus type 1 (PCV-1)
Infants
Laboratory evaluations
IPV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged 2 and 6 months who were previously given a primary vaccination series consisting of a single dose of combination DTaP-HepB-IPV (PEDIARIX®) vaccine at 2, 4, and 6 months of age or separately administered DTaP (INFANRIX®), HepB (ENGERIX-B®), and IPV (Sanofi-Pasteur's IPOL) vaccines in the study 217744/085 and toddlers aged 4-6 years who were previously vaccinated with a single dose of either the combination DTaP-IPV (KINRIX®) vaccine or separately administered DTaP and IPV vaccines in the study 213503/048.

Brief summary: This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® \[GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine\] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies \[217744/085 and 213503/048\] conducted in the United States.

Detailed description: Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are used in this study.

Eligibility criteria: Inclusion Criteria:

* Subjects enrolled previously in randomized, open and multicentre studies \[217744/085; 213503/048\].
* Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
* Subjects for whom sufficient residual volume of the pre and post vaccination blood samples is available.

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Presence of serum anti-PCV-1 antibody.
timeFrame: At Day 0 and post vaccination time points (up to 1 month after vaccination).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02822547: Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults
Official title: Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2016-07-04
Enrollment: 253
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks


Eligibility criteria: Inclusion Criteria:

* History of HBsAg positive for more than 6 months
* HBeAg-positive or HBeAg-negative within 8 weeks
* Serum AST or ALT ≥ 80 IU/L
* HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10\^5 copies/mL (or 20,000 IU/mL)
* HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10\^4 copies/mL(or 2,000 IU/mL)

Exclusion Criteria:

* History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
* Prior treatment of interferon
* Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
* Other chronic liver disease or decompensated liver disease
* platelet\<90,000/mm3 or absolute neutrophil count \< 1,500 mm3
* Pregnant or lactating woman
* History of Organ transplantation
* Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry

Primary outcomes:
measure: The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B
timeFrame: 12 week from baseline
measure: The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB
timeFrame: 12 week from baseline
Secondary outcomes:
measure: The change of HBV DNA at Week 12 from baseline
timeFrame: 12 week from baseline
measure: The change of HBsAg at Week 4, 8, 12 from baseline
timeFrame: 4, 8, 12 week from baseline
measure: The change of ALT at week 4, 8, 12 from baseline
timeFrame: 4, 8, 12 week from baseline
measure: The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12
timeFrame: 12 week from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Sang Hoon Ahn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01148147: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty
Official title: Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Angioplasty
Keywords: Adenosine
randomized trial
periprocedural myocardial necrosis
elective coronary angioplasty
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.

Detailed description: This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo.

This is a double-blind randomized trial single-center study. The enrollment will last 10 months.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective coronary angioplasty

Exclusion Criteria:

Marked Bradycardia (\< 40 bpm)

* Previous allergy to adenosine
* Inability to sign the informed consent
* Asthma
* Elevated cardiac enzymes (troponin I o CK-MB)

Primary outcomes:
measure: Increase in troponin I (> 3 times the upper normal limit)
timeFrame: At 12 hours after the procedure
Secondary outcomes:
measure: MACE(death, MI, urgent target-vessel revascularization)
timeFrame: 72 hours
measure: Angiographic Coronary flow, as evaluated by corrected TIMI frame count.
timeFrame: 1 minute after the final stent implantation
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Giuseppe De Luca
Study officials:
affiliation: AOU Maggiore della Carità
name: Giuseppe De Luca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Luca G, Iorio S, Venegoni L, Marino P. Evaluation of intracoronary adenosine to prevent periprocedural myonecrosis in elective percutaneous coronary intervention (from the PREVENT-ICARUS Trial). Am J Cardiol. 2012 Jan 15;109(2):202-7. doi: 10.1016/j.amjcard.2011.08.027. Epub 2011 Oct 14.