louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03410433: Suture Materials: an Evaluation
Official title: Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture Materials
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.

Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.

Material \& methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.


Eligibility criteria: Inclusion Criteria:

* 36 patients
* in need for periodontal surgery
* patients in good general health
* able to sign IC form

Exclusion Criteria:

* patients that were deemed unlikely to comply with the study protocol, as judged by the examiner
* patients who had a present alcohol and/or drug abuse

Primary outcomes:
measure: Accumulation of soft deposits
timeFrame: 7 to 14 days
Secondary outcomes:
measure: Area of inflammation
timeFrame: 7 to 14 days
measure: Microbial deposits on the sutures
timeFrame: 7 to 14 days
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Marc Quirynen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00098033: Investigation of Clofarabine in Acute Leukemias
Official title: Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Keywords: clinical
pharmacodynamics
investigational drug clofarabine
AML, ALL, CML-accelerated phase, CML-blastic phase
Chronic Myelogenous Leukemia - accelerated phase
Chronic Myelogenous Leukemia - blastic phase
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2004-12-03
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.

Detailed description: The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: * Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).
* No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.
* Adequate liver function (bilirubin \</= 2 mg%) and renal function (creatinine \</= 2 mg%).
* Pregnant and lactating females not eligible.
* Zubrod performance status 0-2
* Adequate cardiac status
* No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Hagop M Kantarjian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Jorge E Cortes, MD
role: STUDY_CHAIR
References:
citation: Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.
Clinical trial NCT02894333: Action-effect Anticipation in Patients With Parkinson's Disease : A Study of the Sensory Attenuation Marker.
Official title: The Process of Sensory Anticipation in Patients With PARKINSON's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Action-effect prediction
Sensory attenuation
Voluntary action
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Parkinson's disease

Brief summary: The ideomotor theory of action control is considered to be central to the understanding of human voluntary action. According to the ideomotor theory, an action is represented in terms of its desired sensory effects and actions are selected by internally activating these effect representations. Recent imagery and behavioral studies showed that this anticipated representation of action-effects triggered a "sensory attenuation", meaning a decrease of perceptive performances or a decrease of sensory event-related potentials (ERP) for an expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to investigate sensory anticipation impairment in patients with Parkinson's disease. In a behavioral paradigm, patients and matched control participants have to perform a perceptive task on predicted visual action-effects mixed with mispredicted visual action effects. Performances should be better in mispredicted visual action effects for control participants only.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Normal or corrected vision

Exclusion Criteria:

* Other pathology or neurological or psychiatric history
* Known pregnancy or breastfeeding
* Absence of affiliation to the French Social Security
* Person under legal protection
* Patient's opposition to participate

Primary outcomes:
measure: median score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT01737333: Multidetector Computed Tomography (MDCT) Tailored Protocol
Official title: A Multicenter, Multinational, Randomized Study of Standard vs. Patient-Adapted Protocols in Multidetector Computed Tomography (MDCT) of the Chest, Abdomen, Liver or Aorta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Contrast Enhanced Multidetector Computed Tomography of the Chest, Abdomen, Liver or Aorta for Any Diagnostic Cause
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 1493
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing MDCT of the abdomen, liver, chest or aorta and receiving high iodinated contrast agents

Brief summary: Collection of data from different sites regardless of whether they use standard or tailored protocols for the application of high concentration iodinated contrast agents to assess if the individually patient-adapted protocols result in a similar diagnostic image quality.

Detailed description: To record technical information and compare image quality regarding routine MDCT procedures with contrast administration using a tailored contrast injection and radiation dose protocol. The hypotheses are that the tailored protocols lead to a lower applied mean radiation dose compared to the use of standard protocols and will provide a more standardized contrast dose per patient size without impairing diagnostic quality.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Scheduled to undergo contrast enhanced MDCT of the abdomen, liver, aorta, or chest
* Provides written informed consent

Exclusion Criteria:

* Previously enrolled and completed the study
* Known allergy to iodinated contrast media
* Pregnancy or lactation
* Clinically unsuitable for the study

Primary outcomes:
measure: Diagnostic Quality
timeFrame: Immediately after the single injection of contrast agent
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Department of Radiology Carolinas Medical Center
state: North Carolina
city: Milan
country: Italy
facility: Oepedale Niguarda
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Martin Krix, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03215433: Study of Biomarkers of the Response to Biotine
Official title: Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Biotine
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 patients with progressive (primary or secondary) MS will be encountered over time during consultations at Dijon CHU. Treatment with biotine will be proposed to patients and a nominative TAU will be requested.

Brief summary: Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo.

The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.

The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* inactive progressive form of MS according to the Lublin classification and recorded in the Burgundy EDMUS database
* Patients with health insurance cover
* Patients who have provided written informed consent (OFSEP)

Exclusion Criteria:

* Patients unable to understand the information sheet
* Patients with remittent or active progressive MS
* Patients with a change in the disease-modifying treatment within the previous 3 months
* Patients treated with corticosteroids in the month before inclusion
* Impossibility to provide patients with the necessary information
* Patients in custody
* Patients under guardianship

Primary outcomes:
measure: validated disability scale (EDSS)
timeFrame: change from baseline validated disability scale at 3 and 12 months
measure: Walking test
timeFrame: change from baseline walking test at 3 and 12 months
measure: Evolution of blood lipid biomarkers
timeFrame: change from baseline evolution of biomarkers at 3 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03479333: Short vs Standard Implants in Maxilla
Official title: Short vs Standard Implants in Maxilla: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prosthetic treatment with dental implants is challenging in posterior maxilla, where there is a sinus pneumatization. For the rehabilitation of patients with intermediate bone level, short implants have been used as alternative. It is also needed to look for the prosthetic context of rehabilitation with implants, like the use of different materials as abutments. The aim of this study is to compare the survival of two sizes of implants (short vs standard) placed in upper premolars region with need of bone graft, with a minimum of three years of follow-up, and assess the behavior of different abutments (titanium vs zirconia) in prosthesis in this context. This will be a randomized clinical trial with two groups: 1) standard implants and sinus lift; and 2) short implants without sinus lift. The patients who fulfill the inclusion criteria and accept to participate of this study, will be included in the randomization process. At the implant installation, a brown envelope, with the word SHORT or STANDARD, will be open, in order to determine the group. Abutment type will be also randomized. Four months after the installation, torque will be confirmed and the abutment will be installed. Implant failure and prosthesis failure in function of the abutment will be the outcomes. Data analysis will be conducted following a previously established spreadsheet using the Kaplan-Meier method and log rank test for success and survival, followed by Cox regression, if possible and according to the number of failures.


Eligibility criteria: Inclusion Criteria:

* good general and dental health;
* minimum of 6 mm bone width (BP);
* bone height in sinus region between 5 and 9 mm;
* bilateral posterior occlusal contact.

Exclusion Criteria:

* removable or partial denture;
* patient with systemic disease treatment in course;
* pregnant women;
* recent extraction at the site to receive the implant.

Primary outcomes:
measure: implant survival
timeFrame: five months after the implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas - School of Dentistry
state: RS
Study officials:
References:
Clinical trial NCT02617433: Relationship Between Muscle Mass and Muscle Relaxation Time
Official title: Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and Muscle Relaxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find relationship between muscle mass and muscle relaxation time.

Detailed description: Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. Until now, dose of rocuronium has been judged by patient's weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find relationship between muscle mass and muscle relaxation time. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.

Eligibility criteria: Inclusion Criteria:

* All patient who undergo general anesthesia.
* Male; weight 70-75kg , height 170-175cm
* Female; weight 53-58kg , height 158-163cm

Exclusion Criteria:

* Liver and kidney disease
* Any types of muscle disorder.
* Metal materials or pacemaker in body

Primary outcomes:
measure: ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0)
timeFrame: two hours
Secondary outcomes:
measure: completely suppression time of result of first stimulus(T1).
timeFrame: ten minutes
Other outcomes:
measure: Time until reoccurrence of response of first stimulus(T1).
timeFrame: two hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university anam hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Seung Zhoo Yoon, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06126133: Evaluation of Lumbar Plexus Block Success With Near Infrared Spectroscopy (NIRS)
Official title: Near Infrared Spectroscopy (NIRS) Evaluation of Lumbar Plexus Block Success for Lower Extremity Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nerve Block
Lumbar Plexus
Near Infrared Spectroscopy
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Tests such as the pin-prick test, cold application or the Bromage scale are currently used to measure the success of nerve blocks and are considered subjective assessments as they require verbal consent from the patient.

Near Infrared Spectroscopy (NIRS) measures the differential absorption and reflection of near infrared light transmitted by human tissues, providing a tissue-oxygen saturation index. Modern NIRS-based instruments use multiple detectors to filter spectroscopy data from skin structures to detect subcutaneous tissue oxygenation.

Successful regional anesthesia results in decreased sympathetic activity within the distribution of blocked nerves. Regional oxygen saturation (rSO2) has been shown to increase in innervated areas after sympathetic block.

Detailed description: The aim of this study was to show whether the success of lumbar plexus block applied in lower extremity orthopedic surgeries can be evaluated by Near Infrared Spectroscopy (NIRS), which is used to measure tissue oxygenation.

Eligibility criteria: Inclusion Criteria:

* 18-90 years old
* femoral neck fracture,
* femoral shaft fracture,
* hip replacement surgery
* who will undergo velumbar plexus block will be included in the study.

Exclusion Criteria:

* BMI\>40 kg/m2
* infection in the block area
* peripheral neuropathy,
* hemoglobinopathy
* peripheral vascular disease
* allergy to local anesthetics
* patients with contraindications for lumbar plexus block

Primary outcomes:
measure: rso2
timeFrame: 40 minutes
Secondary outcomes:
measure: sensory block level
timeFrame: 40 minutes
measure: blood pressure values
timeFrame: 40 minutes
measure: so2
timeFrame: 40 minutes
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen, Assoc. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04887233: Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
Official title: Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection Viral
Keywords: Longan
nasal spray
COVID 19
efficacy
safety
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to evaluate efficacy and safety of longan extract spray (P80 spray) in volunteers with coronavirus disease 2019 (COVID19).Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) are enrolled in the study. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). After that, they will be nasal swabbed for detecting COVID 19 infection. Adverse event will also be evaluated by physician or nurse.

Detailed description: Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) and pass inclusion criteria are enrolled in the study. The patients will be checked the clinical symptoms and chest x-ray by physician. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). Physician or nurse will ask for adverse events every day. After 3 days, the patients will be nasal swabbed for detecting COVID 19 infection.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* Positive nasal swab test of coronavirus disease 2019 (COVID-19) (reverse transcriptase-polymerase chain reaction (RT-PCR) เป็นบวก (cycle threshold \<40))
* Mild symptom with normal chest radiograph
* No history of Chronic Obstructive Pulmonary Disease (COPD) and other chronic lung diseases, Chronic kidney disease (CKD), Cardiovascular diseases and congenital heart diseases, Cerebrovascular diseases, Poorly controlled diabetes,BMI \> 35 kg/m2, Cirrhosis, Immunocompromised condition
* Can read and write
* Vulnerable to participate

Exclusion Criteria:

* Allergic history to longan
* Uncontrollable disease status
* Pregnancy or lactation
* Participated in other studies

Primary outcomes:
measure: Nasal swab test negative
timeFrame: 3 days
Secondary outcomes:
measure: Absent of respiratory symptoms
timeFrame: 3 days
measure: No adverse event
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Ph.D
role: STUDY_DIRECTOR
References: