louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03621527: Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty
Official title: Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vertebral Compression Fractures in Osteoporotic Patients
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vertebral compression fractures in osteoporotic patients is a major healthcare problem. Percutaneous vertebroplasty is commonly used to restore stability of the vertebra and to alleviate pain. However, the anesthetic techniques commonly used during these procedures such general anesthesia or a combination of local anesthesia and sedation are not satisfying as they are associated either with side effects or insufficient pain reduction.

This study compares the standard procedure of local anesthesia to a new technique of fluoroscopy-guided epidural anesthesia carried out by the radiologist.

The investigator's hypothesis is that fluoroscopy-guided epidural anesthesia

* provides better pain relief during the injection of high viscosity cement
* and thus, reduces the need of additional intravenous analgesia by remifentanil (morphine analogue)
* minimizes remifentanil potential adverse effects such as respiratory depression, hypoxemia, pruritus and nausea
* improves working conditions and satisfaction of the radiologist
* improves the global satisfaction of the patient

It is a monocentric, prospective, comparative and randomized study.


Eligibility criteria: Inclusion Criteria:

* - Two osteoporotic vertebra compression fractures in the low thoracic or lumbar spine
* men and women \> 18 years old
* patients with healthcare insurance
* signed and dated informed consent

Exclusion Criteria:

* men and women \< 18 years
* pregnant or breastfeeding women
* patients under trusteeship or guardianship or patients under the protection of court
* bad comprehension or cooperation
* bleeding disorders
* local or general infection
* intracerebral or severe cardiac affections

Primary outcomes:
measure: Morphine used in the procedure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Thi Mai BERNEMANN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373527: Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study
Official title: Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.

Detailed description: For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.

Eligibility criteria: Inclusion Criteria:

* Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients

Exclusion Criteria:

* Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
* Pregnant Women
* Prisoners

Primary outcomes:
measure: Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia
timeFrame: 72 hours
Secondary outcomes:
measure: Patient Satisfaction score
timeFrame: 72 hours
measure: Total cost of hospitalization
timeFrame: 72 hours
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Daniel Sporn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Guthrie Clinic
name: Abhishek Mishra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183427: Corpus Callosum Size in Patients With Pineal Cyst
Official title: Corpus Callosum Size in Patients With Pineal Cyst
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pineal Gland Disorder
Corpus Callosum Atrophy
Cerebral Palsy
Lead sponsor: Military University Hospital, Prague
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * study group: consecutive patients with pineal cyst that were examined in our institution between 2000-2017
* control group: matched healthy subjects without pineal cyst

Brief summary: This study aims to determine size of corpus callosum on midsagittal MR scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst.

Detailed description: A pineal cyst (PC) is a benign affection of the pineal gland, its prevalence in population reaches 1-2 %. Etiopathogenesis of PC is unknown, several hypotheses have been proposed. One of the hypothesis consider perinatal hypoxia as a causative factor for a development of PC in later life. Ozmen et al. showed significantly higher prevalence of PC in patients with cerebral palsy (p\<0.001). Bregant et al. studied presence of PC in patients that suffered from a mild to moderate perinatal hypoxia. Prevalence of PC reached 36 % in these patients and presence of PC was associated with a atrophy of the corpus callosum (p\<0.005). The atrophy of the corpus callosum is considered to be a sign of a periventricular leukomalacia, i.e. an ischemic insult in a perinatal period.

In the present study, we are going to compare an area of corpus callosum on a midsagittal magnetic resonance T2-weighted scan in the group of patients with PC and in the control group without PC. The goal of the study is to determine if there is a relationship between atrophy of the corpus callosum and PC. Such finding would support abovementioned theory of etiopathogenesis of PC.

Eligibility criteria: Inclusion Criteria:

* 3T MR examination of the brain including T2 sagittal scans

Exclusion Criteria:

* other intracranial pathology discovered on the MR
* other known neurological disease (e.g. multiple sclerosis, stroke, tumor, etc.)

Primary outcomes:
measure: size of corpus callosum
timeFrame: time of the MR examination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02338427: Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis
Official title: Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloidosis
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 140
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: Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.

The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).

In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.

The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.


Eligibility criteria: Inclusion Criteria:

* Upper age to 18 years
* Amylose diagnosis establish by tissue sample, after "Rouge Congo" coloration
* All patient with amylose identified by the two laboratory of anatomopathology
* Sample necessary for realized proteomic analysis
* No opposition at the participation of the study
* Patient sign an informed consent for biology collection

Exclusion Criteria:

* Tissue sample inadequate for apply immunohistochemistry or proteomic identification
* Patient trust, guardianship, under legal protection measure, deprived of freedom

Primary outcomes:
measure: Identification success of amylose by immunohistochemistry and proteomic analysis
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendee
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Centre Hospitalier Départementel Vendée
name: Hervé MAISONNEUVE, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04891627: Gingival Crevicular IL-34 and CSF-1 Levels in Patients With Periodontitis and Uncontrolled Type 2 Diabetes
Official title: Usak University Faculty of Dentistry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Diabetes
Keywords: Diabetes,
periodontitis
cytokines
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals have diabetes and periodontitis

Brief summary: Type 2 diabetes mellitus is a metabolic disorder. There is a bidirectional association between periodontal disease and DM. Currently there is no data relationship between CSF-1 and IL-34, periodontal disease and diabetes.The aim of this study to investigate GCF levels of IL-34 and CSF-1 in periodontitis subjects with diabetes.

Detailed description: Periodontally healthy (H), periodontitis, and periodontitis with diabetes patients, were recruited for this study.

1. Inclusion criteria for H groups: Individuals with clinically healthy gingiva, no attachment and bone loss, and less than 10% bleeding on probing were included.
2. Inclusion criteria for periodontitis groups: Systemically healthy individuals with interdental CAL ≥ 5 mm and PPD ≥ 6 mm were included.
3. Inclusion criteria for periodontitis with diabetes groups: Type 2 diabetes patients with interdental CAL ≥ 5 mm, PPD ≥ 6 mm, and HbA1c ≥ 6.5% were included.

The plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), PD, and clinical AL were used for clinical periodontal assessments. All assessments were done with a manual probe. GCF samples were obtained and analyzed using an enzyme-linked immunosorbent assay.

Eligibility criteria: Inclusion Criteria:

* have 20 teeth
* have diabetes .

Exclusion Criteria:

* Individuals have systemic disease
* smokers;
* pregnant
* those using drugs;

Primary outcomes:
measure: It was aimed to compare IL-34 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.
timeFrame: GCF samples taken within the 1. week after the clinical examination of the patient
Secondary outcomes:
measure: It was aimed to compare CSF-1 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.
timeFrame: GCF samples taken within the 1. week after the clinical examination of the patient
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: University of Usak
Study officials:
affiliation: University of Usak
name: ahu dikilitas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05528627: PECs for Implantable Cardiac Electronic Device Insertion
Official title: Evaluation of the Efficacy of Pectoral Nerve (PECs) Blocks in Patients Undergoing Cardiac Implantable Electronic Device Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Implantable Electronic Device
Nerve Block
Anesthesia
Analgesia
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion.

Detailed description: Implantable Cardiac Electronic Device (CIED) insertion can be performed under local anesthesia, regional anesthesia, or general anesthesia. Novel regional blocks may improve pain management for such patients and can shorten their length of stay in the hospital. At the study, the investigators aimd to evaluate the efficacy and feasibility of the PECS block for CIED insertion procedure.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists grade II-IV patients
* in the age group of 18-80 years,
* Patients undergoing CIED insertion

Exclusion Criteria:

* pre-existing infection at the block site,
* coagulopathy,
* morbid obesity (Body mass index \>35 kg m-2 ),
* allergy to local anaesthetics,
* decreased pulmonary reserve,
* psychiatric illness

Primary outcomes:
measure: amount of intraoperative additional local anesthetic
timeFrame: 1 hour
measure: number of patients who requiring intraoperative additional local anesthetic
timeFrame: 1 hour
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: 24 hours
measure: time to first postoperative analgesic requirement
timeFrame: 24 hours
measure: patient satisfaction
timeFrame: 24 hours
measure: cardiologist satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Mustafa Kilin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836727: Use of Laparoscopy in the Treatment of Pelvic Ring Ruptures
Official title: Use of Laparoscopy in the Treatment of Pelvic Ring Ruptures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Fracture
Keywords: Pelvic ring surgery
Trauma Surgery
Plate Fixation
Laparoscopy
Case series
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent laparoscopy for the treatment of pelvic ring disruption

Brief summary: Case series to describe the use of laparoscopy for the treatment of pelvic ring disruption.


Eligibility criteria: Inclusion Criteria:

* patients who underwent laparoscopy for the treatment of pelvic ring disruption

Exclusion Criteria:

* patient \< 18 years old

Primary outcomes:
measure: conversion rate to open surgery
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT00981227: Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
Official title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2093) as Therapy for Patients With Post-herpetic Neuralgia: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: pain herpetic neuralgia
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent to participate in the study
* Men and women aged 18 years or older
* Previous diagnosis of herpes zoster
* Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
* Cooperation and willingness to complete all aspects of the study
* Completion of at least 4 daily diaries during the week preceding randomisation
* A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

* Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
* Active herpes zoster lesion or dermatitis of any origin at the affected site
* Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
* Significant or unstable medical or psychiatric disorders
* Drug or alcohol abuse in the preceding 2 years
* Severe renal function impairment, as shown by calculated creatinine clearance values \< 30 mL/min at screening
* Relevant clinical laboratory abnormalities (e.g., Na+ \<130 mmol/L, alanine (ALT) or aspartate (AST) transaminases \>2.0 times the upper limit of the normal, white blood cell count (WBC) \<2,500 cells/mm3)
* Previous participation in any study with eslicarbazepine acetate
* Pregnancy or breast feeding
* History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
* History of non-compliance
* Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
* Participation in a clinical study within 3 months prior to screening
* Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.

Primary outcomes:
measure: Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
timeFrame: baseline and 13 weeks
Secondary outcomes:
Other outcomes:
measure: Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose
timeFrame: baseline and 13 weeks
Locations:
Study officials:
References:
Clinical trial NCT00765427: Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers
Official title: A Phase 1a, Repeat-Dose Escalation Study to Investigate the Safety and Tolerability of a 7-Day Repeated Dose of Retinoid QLT091001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Human Volunteers
Lead sponsor: QLT Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate

Exclusion Criteria:

* Subjects with any clinically important abnormal physical finding at screening.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline.
* Female subjects who are either pregnant or lactating.

Primary outcomes:
measure: Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
timeFrame: 30 days
Secondary outcomes:
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
name: Victor Lao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: QLT Inc.
name: Andrew Strong, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024127: Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia
Official title: Genetic Predictors of AML Treatment Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Acute Myeloid Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-12-02
Enrollment: 2500
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosis of AML in remission

Brief summary: This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.

II. Validate positive associations seen in the genome-wide scan with a fine mapping approach.

III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.

OUTLINE:

Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AML

  * In remission
* Adequate DNA from peripheral blood or bone marrow samples
* Concurrent enrollment on CCG-2961, COG-AAML03P1, COG-AAML0531, AML-93, AML-97, AML-04,AML-09, or Canada AML Infection clinical trial required

Primary outcomes:
measure: Incidence of first acute myeloid leukemia relapse
timeFrame: Up to 2 years
measure: Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at risk
timeFrame: From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Richard Aplenc, MD
role: PRINCIPAL_INVESTIGATOR
References: