louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06824740: Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia (PAICAN)
Official title: Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Analgesia
Keywords: cesarean section
neuraxial anesthesia
pain
analgesia
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 318
Sex: FEMALE
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: Pregnant women undergoing a caesarean section under neuraxial anesthesia in a tertiary hospital in Barcelona (Spain).

Brief summary: Pain during caesarean section under neuraxial anesthesia is often underestimated and could be related to perinatal psycholocal disorders.

The implementation of an evidence-based anesthestic management protocol for caesarean sections aims at reducing intraoperative and postoperative pain.

This prospective observational single-center study aims at determining whether this protocol helped to reduce the prevalence of insufficient analgesia in during caesarean sections.

Detailed description: Caesarean surgery is one of the most frequent surgeries around the world and neuroaxial anesthesia is the preferred anesthesia technique in most settings. Still, many women experience pain during caesarean section, and it has implications in their birth experience. The PAICAN study (Prevalence of Insufficient Analgesia in Caesarean Section under Neuroaxial Anesthesia) aims to study how the implementation of a specific protocol of anesthetic management during caesarean section reduces the intraoperative pain and the need of postoperative painkillers.

Other objectives are:

* To study the adherence to the new protocol in our centre
* To understand the mechanisms of the failure of neuraxial anesthesia
* To study the related factors to insufficient analgesia during surgery (demographic, obstetric, anesthetic, etc.).

Hypothesis: the implementation of an anesthestic management protocol for caesarean sections under neuroaxial anesthesia decreases the prevalence of insufficient analgesia during surgery and in the recovery room.

Design: Prospective observational single-center study.

Eligibility criteria: Inclusion Criteria:

- Pregnant women aged 18 or more undergoing a caesarean section under neuraxial anesthesia

Exclusion Criteria:

* Non pregnant women
* Women under 18 years old
* General anesthesia as first option for anesthesia
* Refusal to participate in the study
* Women with cognitive impairment or held in an institution by legal or official order

Primary outcomes:
measure: Prevalence of Insufficient Analgesia during cesarean section
timeFrame: During the cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalunya
Study officials:
affiliation: Hospital del Mar
name: Adriana Vilches, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06820840: Hybrid Resin Composite Vs. Hybrid Ceramic Onlays for Restoring Carious Molars
Official title: Comparative Clinical Performance of Hybrid Resin Composite Vs. Hybrid Ceramic Onlays in the Restoration of Carious Molars: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carious Molars
Keywords: Onlay
Onlays
Hybrid resin composite
Hybrid ceramic
SHOFU
Ceramage
S-PRG
SPRG
Vital molars
Block HC
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the clinical performance of hybrid resin composite and hybrid ceramic onlays in restoring carious molars. It will also evaluate the wear resistance of both materials. The main questions it aims to answer are:

* Does the hybrid resin composite or hybrid ceramic onlay perform better in clinical settings over time?
* How much wear occurs in each type of onlay over 18 months?

Researchers will compare SHOFU Ceramage (hybrid resin composite) to SHOFU HC (hybrid ceramic) to see which material performs better in restoring molars with extensive caries.

Participants will:

* Receive either a hybrid resin composite or hybrid ceramic onlay for their molar cavities.
* Visit the clinic for checkups at baseline, 6 months, 12 months, and 18 months.
* Undergo visual assessments of their restorations and quantitative wear analysis during follow-ups.


Eligibility criteria: Inclusion Criteria:

* Able to tolerate necessary restorative procedures
* Willing to sign the informed consent
* Accepts the follow-up period

Exclusion Criteria:

* ICDAS 4/5 cavities in first and second permanent molars
* Onlay cavities with at least one cusp coverage
* Patients with acceptable oral hygiene

Primary outcomes:
measure: Clinical Performance
timeFrame: From baseline to 18 months
Secondary outcomes:
measure: Quantitative Wear Analysis
timeFrame: From baseline to 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01216540: Vancomycin-Associated Nephrotoxicity
Official title: Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotoxicity
Keywords: vancomycin
nephrotoxicity
length of stay
costs
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2010-10-07
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A simple random sample of 400 patients treated with greater than 48 hours of intravenous vancomycin exposure during hospitalization during the time period from July 1, 2009 through June 30, 2010

Brief summary: The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events.


Eligibility criteria: Inclusion Criteria:

* 18 years or older at time of hospital admission
* Had an absolute neutrophil count of ≥ 1000 cells/mm\^3
* Received \> 48 hours of intravenous vancomycin therapy
* Had one or more vancomycin trough levels reported within the 96 hours after therapy initiation
* Had a baseline serum creatinine level of \< 2.0 mg/dL and baseline creatinine clearance level of ≥ 30 mL/min

Exclusion Criteria:

* Previous diagnosis of cystic fibrosis

Primary outcomes:
measure: Time to nephrotoxicity
timeFrame: within 72 hours post completion of vancomycin therapy
Secondary outcomes:
measure: Hospital costs
timeFrame: until discharge
measure: Length of stay
timeFrame: until discharge
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Jack Brown, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Internal Medicine, Division of Epidemiology, University of Utah School of Medicine
name: Vanessa Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05013840: Opinions of Healthcare Providers About Neuromodulation
Official title: Opinions of Healthcare Providers About Neuromodulation for Pain: an Online Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromodulation
Pain
Survey
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses).The survey will be spread at the 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris from 2/9/2021 to 4/9/2021.

Brief summary: The goal of this online survey is to gain further insight in the goals, expectations and definition of success for neuromodulation for pain, according to healthcare providers.


Eligibility criteria: Inclusion Criteria:

- Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses).

Exclusion Criteria:

- Not involved in management of chronic pain through neuromodulation.

Primary outcomes:
measure: Physician goals, evaluated with a self-constructed question.
timeFrame: Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September.
measure: Physician expectations, evaluated with a self-constructed question.
timeFrame: Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September.
measure: Physician definition of success, evaluated with a self-constructed question.
timeFrame: Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
References:
citation: Goudman L, De Smedt A, Billot M, Roulaud M, Rigoard P, Moens M. Opinions of Health Care Providers About Neuromodulation for Pain: Results of an Online Survey at the 2nd Joint Congress of the International Neuromodulation Society European Chapters. Neuromodulation. 2023 Dec;26(8):1887-1892. doi: 10.1016/j.neurom.2022.04.038. Epub 2022 May 10.
Clinical trial NCT03364140: A Registry of Peripartum Cardiomyopathy in Turkey
Official title: Clinical A Nation-wide Registry of Peripartum Cardiomyopathy: Clinical Status in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripartum Cardiomyopathy
Keywords: Peripartum Cardiomyopathy
Heart Failure
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Turkish Society of Cardiology
First posted: 2017-12-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with unexplained Heart Failure symptoms developed towards the end of pregnancy or in the first 6 months of postpartum period

Brief summary: Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality of young women. Its' etiology, epidemiology and treatment is not yet well described. This will be a retrospective, national, multicenter observational study, conducted in Turkey. It is expected that approximately 50 women with PPCM will be recorded.

Detailed description: Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality of young women. Its' etiology, epidemiology and treatment is not yet well described. This will be a retrospective, national, multicenter observational study, conducted in centres in Turkey. It is expected that approximately 50 women with PPCM will be recorded.

The objectives of the study are:

To define the clinical status and clinical characteristics of PPCM in Turkey

To define the outcome of PPCM (short and long term)

To define the demographical and possible etiological factors

To define prognostic factors

Eligibility criteria: Inclusion Criteria:

* Patient above 18 years of age
* Unexplained Heart Failure symptoms developed towards the end of pregnancy or in the first 6 months of postpartum period
* Ejection fraction less than 45% documented with echocardiography

Exclusion Criteria:

* Patients with any other known cardiac pathology

Primary outcomes:
measure: Pregnancy outcome
timeFrame: 5 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University Medical School Cardiology Department
Study officials:
affiliation: Koc University Medical school
name: Dilek Ural, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00337740: Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Official title: Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Liver Cirrhosis
Esophageal Varices
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2006-06-16
Enrollment: 120
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: Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal bleeding is subject to debate. A randomized comparison between the two treatments was performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with high risk varices and no previous variceal bleeding are randomized to propranolol or variceal bleeding. Primary end point is variceal bleeding


Eligibility criteria: Inclusion Criteria:

* liver cirrhosis
* child pugh\>=B7
* studied for transplantation
* age between 18 an 65 ys
* no previous bleeding from varices
* signed informed consent

Exclusion Criteria:

* esophageal varices less than F2 blue
* gastric varices
* previous variceal surgical or radiological or endoscopical treatment
* hepatocarcinoma
* portal vein thrombosis
* severe heart, respiratory or renal failure
* contraindications to betablockers
* treatment with nitrates, calcium antagonist or anti-arhythmic drugs that can not be suspended
* Pregnancy
* neoplasias
* non cooperation

Primary outcomes:
measure: variceal bleeding
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2
Study officials:
affiliation: University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
name: Lorenzo Norberto, prof, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
name: Umberto Cillo, prof. M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy
name: Francesco Grigoletto, prof, M.D.
role: STUDY_DIRECTOR
affiliation: Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
name: Davide D'Amico, prof, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01467440: Efficacy of Selective Laser Trabeculoplasty in Patients Under Treatment With Topical Prostaglandines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma and Ocular Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: glaucoma patients

Brief summary: Retrospective analysis of efficacy of selective laser trabeculoplasty in patients under treatment with topical prostaglandins compared to patients without topical prostaglandins is performed.

Inclusion criterion are patients with glaucoma or ocular hypertension, who underwent treatment with selective laser trabeculoplasty due to insufficient control of intraocular pressure during their routine treatment at the University Hospital Zurich / Division of Ophthalmology.


Eligibility criteria: Inclusion criteria:

* Patients with ocular hypertension or glaucoma who underwent selective laser trabeculoplasty due to insufficient control of intraocular pressure despite maximum tolerated topical treatment.

Exclusion criteria:

* Optic neuropathy other than glaucoma

Primary outcomes:
measure: IOP
timeFrame: t0
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmic Clinic
state: ZH
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Ophtalmic Clinic
name: Jens Funk, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04384640: The Effect of Patient's Position After Intra-tympanic Injection
Official title: The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Hearing Loss
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-05-12
Enrollment: 20
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 diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids

Brief summary: The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
* Patients who signed an informed consent form

Exclusion Criteria:

* Dysgeusia
* Inner or middle ear malfomation
* Eustachian tube dysfunction

Primary outcomes:
measure: Degree of taste
timeFrame: 0 Minutes, and then 10, 20, 30 minutes after the injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01797640: Intramedullary Nailing of Tibia Fractures
Official title: Intramedullary Nailing of Tibia Fractures in the Presence of Medial or Posterior Malleolar Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibial Fractures
Malleolar Fractures
Keywords: Tibia Fractures
Medial Fractures
Posterior Malleolar Fractures
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospectively evaluating all patients that have been treated at the University of Utah over the past five years for Tibial Fracture combined with medial or posterior malleloar fracture.

Brief summary: Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.


Eligibility criteria: Inclusion Criteria:

* All patients, 18+ years of age, that have been treated at the University of Utah over the past five years for tibial fracture combined with medial or posterior malleolar fracture.

Exclusion Criteria:

* None

Primary outcomes:
measure: Malleolar involvement in tibial fracture
timeFrame: 6 Week Post-Op
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopedics Center
state: Utah
Study officials:
affiliation: Orthopedic Surgery Operations
name: Erik Kubiak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03733340: Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT
Official title: Antibacterial Prophylaxis With Imipenem vs no Prophylaxis for Hematological Malignancies Patients Before Allogenetic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Antibacterial Prophylaxis
Hematological Malignancies
Allogenetic Hematopoietic Stem Cell Transplantation
Imipenem
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematologic malignancies. Bacterial infections remain a common complication of allo-HSCT, especially in the pre-engraftment phase. Pre-engraftment neutropenia typically lasts for up to 2 weeks in autologous HSCT but is considerably longer in allogeneic HSCT recipients who receive myeloablative conditioning regimens. This is a prospective, randomized, controlled, phase II/III clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with hematological malignancies before allo-HSCT. All patients aged above 14 years, diagnosed with hematological malignancies and ready to undergo allo-HSCT, no active infection within 3 weeks before allo-HSCT, with a normal CT scan-chest before entering the transplantation cabin and willing to participate in the trial will be enrolled.


Eligibility criteria: Inclusion Criteria:

* aged above 14 years;
* diagnosis with hematological malignancies and be ready to undergo allo-HSCT;
* no active infection within 3 weeks before allo-HSCT;
* with a normal CT scan-chest before entering the transplantation cabin.

Exclusion Criteria:

* age \< 14 years;
* active and documented infection at admission;
* with a abnormal CT scan-chest before entering the transplantation cabin;
* with any conditions not suitable for the trial;
* unwilling to participate in the trial.

Primary outcomes:
measure: Infectious incidence
timeFrame: pre-engraftment in allo-HSCT
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
measure: Incidence of acute GVHD
timeFrame: 100 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Liu Qifa
role: PRINCIPAL_INVESTIGATOR
References: