louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05707741: Dexmetomedine for Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia
Official title: Feasibility of Different Doses of Dexmetomedine to Prevent Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Keywords: Delirium , Dexmetomedine
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized trial
Primary purpose: PREVENTION

Brief summary: Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries

Detailed description: On the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 L min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. The midline or Para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (Marcaine® Spinal Heavy 0.5%, AstraZeneca) will be injected using a 25 G spinal needle . After establishment of spinal anesthesia , A loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then Three types of syringes will be prepared on 50 ml syringes Group A: saline 50 ml, Group B: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and Group C: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups

Eligibility criteria: Inclusion Criteria:

* ASA physical status I- II
* Age from 65to 75 years old,
* Elective total knee arthroplasty under spinal anaesthesia.

Exclusion Criteria:

* Bleeding disorders
* Allergy to any of the drugs used in the study
* Renal insufficiency
* Liver failure-Neurological abnormalities -patients with hearing and visual impairment

Primary outcomes:
measure: cognitive functions
timeFrame: 3 days
Secondary outcomes:
measure: Post operative pain
timeFrame: 3days
measure: Sedation
timeFrame: 3days
Other outcomes:
Locations:
city: Menoufia
country: Egypt
facility: Menoufia University
Study officials:
affiliation: Menoufia University
name: rabab M habeeb, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00687141: Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects
Official title: A Phase I, Randomized, Double-blind (with-in Panel), Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Healthy Elderly Volunteers After Oral Multiple Ascending Doses of AZD0328
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Safety
tolerability
AZD0328
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to investigate the safety and tolerability of AZD0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity
* Intake of any prescribed medicine or St John's Wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug

Primary outcomes:
measure: Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG
timeFrame: Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.
measure: Safety and tolerability of AZD0328 by assessment of adverse events
timeFrame: Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study.
Secondary outcomes:
measure: Determine the single and multiple dose pharmacokinetics (PK) of AZD0328
timeFrame: PK sampling taken at defined timepoints during residential period.
measure: Evaluate the cognitive dose response relationship for AZD0328
timeFrame: Psychometric test battery performed at defined timepoints during residential period.
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Quintiles ABStrandbodgatan 1S-753 23 Uppsala
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D SödertäljeMedical Science S-151 85 Södertälje Sweden
name: Erik Eliasson, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00653341: Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
Official title: Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: insulin naive
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 764
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.


Eligibility criteria: Inclusion Criteria:

* Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
* Body mass index between 26 and 40 kg/m2
* HbA1c between 7.5% and 10.0%
* Fasting plasma glucose \>7.8 mmol/L and fasting C-peptide \> or =0.25 nmol/L

Primary outcomes:
measure: Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
Secondary outcomes:
measure: Safety data (Adverse events, vital signs, laboratory values, etc.)
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-aventis administrative office
state: New Jersey
city: Laval
country: Canada
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi
name: Public Registry ICD
role: STUDY_DIRECTOR
References:
citation: Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.
citation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Clinical trial NCT04260841: Passive Leg Raising and Fluid Responsiveness
Official title: Passive Leg Raising 3.0 and Fluid Responsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Passive Leg Raising
Keywords: fluid responsiveness
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU with clinical signs of fluid need

Brief summary: In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.

Detailed description: PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.

Eligibility criteria: Inclusion Criteria:

* admission on Intensive Care
* clinical signs as; mean arterial pressure \< 60, lactate \> 2.0 mmol/L

Exclusion Criteria:

* age \< 18

Primary outcomes:
measure: fluid responsiveness expressed in volume
timeFrame: from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
measure: blood pressure expressed in mmHg
timeFrame: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
measure: cardiac output
timeFrame: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
affiliation: MCL
name: Matty Koopmans, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822041: 14C-ARN-509 Microtracer Label AME and Absolute BA Study
Official title: 14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
mass balance study
Pharmacokinetics
Lead sponsor: Aragon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-02
Enrollment: 12
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).

Detailed description: Two cohorts of 6 healthy volunteers will be enrolled for the AME and absolute BA parts, respectively. The dose for both cohorts is 240 mg. The expected exposure of the dose is 7-fold lower than the steady state reached in patients with castration-resistant prostate cancer.

Eligibility criteria: Key Inclusion Criteria:

1. Gender : male
2. Age : 50 - 80 years, inclusive
3. Body Mass Index (BMI) : 18.5-30.0 kg/m2
4. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research center until discharge
5. Medical history without major pathology

Key Exclusion Criteria:

1. Evidence of clinically relevant pathology.
2. Mental handicap.
3. History of relevant drug and/or food allergies.
4. Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center.
5. Smoking.
6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
7. Use of concomitant medication, except for acetaminophen (paracetamol) and topical medications
8. Irregular defecation pattern (less than once per 2 days).
9. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, and alcohol).
10. Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
11. Positive screen on HBsAg, anti-HCV or anti-HIV 1/2.
12. Illness within five days prior to drug administration.

Primary outcomes:
measure: Mass Balance
timeFrame: 2 months 10 days
measure: Absolute Oral Bioavailability
timeFrame: 2 months 10 days
Secondary outcomes:
measure: Metabolite Profile
timeFrame: 2 months 10 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA - Clinical Research Unit, University Medical Centre Groningen
Study officials:
affiliation: PRA International Group BV
name: Nada al Kotbi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PRA International Group BV
name: Helen Pruim-Tait, MA, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05508841: Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation
Official title: Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: BrightFocus Foundation
First posted: 2022-08-19
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.


Eligibility criteria: Inclusion Criteria:

* Mild to Moderate AD
* Score between 18 and 25 on the MoCA
* Able to do the N-Back task during the initial screening

Exclusion Criteria:

* No history of stroke or TBI
* No shunts or metal in the body
* No history of significant heart disease, alcoholism and drug use

Primary outcomes:
measure: N-Back
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT03582241: NGS in AML Relapse
Official title: Retrospective Study of AML Relapses Using Targeted NGS Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
Relapse
Mutations
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with AML that relapsed studied in the clinical laboratory of hematology of the Hopitaux Universitaires de Strasbourg, France

Brief summary: Acute myeloid leukemia (AML) relapse is often associated with a clonal evolution at the cytogenetic and molecular level and therefore represents a challenge in the treatment of AML. Targeted sequencing is now usually done at diagnosis in AML, as only a small core group of genes is frequently mutated in AML and myelodysplastic syndromes. This approach, contrary to WGS is cheaper, together with a rapid turnaround and high sequencing coverage depths allowing the detection of variant allele fractions as low as 2%.

In the investigator's center, targeted analysis of AML patients is routinely realized at diagnosis and at relapse. In thses patients, five different clonal evolution patterns including cytogenetic and molecular analysis at relapse will be evaluated: (1) Stability, defined by no clonal change, (2) Gain, strictly defined by acquisition of additional variations (mutations or cytogenetic alterations), (3) Loss, strictly defined by loss of variants or regression, (4) Gain and Loss, indicating the combination of both Gain and Loss patterns, (5) Emergence, defined by the emergence of alterations that were unrelated to those found at diagnosis.

Karyotype and the mutations of up to 40 AML patients benefited from targeted NGS in the clinical hematology laboratory of the Hopitaux Universitaires de Strasbourg both at the time of the diagnosis of and the relapse will be studied, together with clinical and other biological characteristics.


Eligibility criteria: * Inclusion criteria:

  * patients with AML that relapsed studied in the clinical laboratory of hematology of the Hopitaux Universitaires de Strasbourg, France
  * given consentment or non-opposition for retrospective anonymous analysis of clinical and data
* Exclusion criteria:

  * person under tutorship-
  * persons who asked to withdraw from the study

Primary outcomes:
measure: overall survival of the different clonal evolution patterns
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire d'Hématologie
Study officials:
References:
Clinical trial NCT04221841: Executive Functions and Reinforcement Sensitivity in Women With Obsessive Compulsive Symptoms
Official title: University of Bojnord
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Symptom
Executive Dysfunction
Lead sponsor: University of Bojnord
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 365
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The statistical population consisted of all adult women living in Sabzevar city in 2019. The sampling was conducted using cluster sampling method. In randomly selected areas, participants were selected from among local women

Brief summary: Methods: The study population consisted of all adult women living in Sabzevar city (Iran). Using cluster sampling, 365 women were selected as the study sample. Participants completed Obsessive-Compulsive Inventory, Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Revised and Clarified (SPSRQ-RC) as well as Behavior Rating Inventory of Executive Function (BRIEF). Data analysis was conducted using correlation and regression tests.


Eligibility criteria: Inclusion Criteria:

having age between 18 to 54, be female, be literacy,

Exclusion Criteria:

be male, be illiteracy, having psychotic disorders

Primary outcomes:
measure: executive functions
timeFrame: 1 month
measure: obsessive-compulsive symptom
timeFrame: 1 month
measure: reinforcement sensitivity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bojnourd
country: Iran, Islamic Republic of
facility: Malahat Amani
state: North Khorasan
Study officials:
References:
Clinical trial NCT06434441: Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks.
Official title: Radiographic Assessment of Horizontal Bone Augmentation of Full Atrophic Maxillary Alveolar Ridges Using Calvarial Versus Iliac Crest Bone Blocks:
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Atrophy
Keywords: Bone graft
Iliac crest blocks
Calverial bone blocks
Horizontal bone gain
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A) The Study group:

The patients within the study group will receive mono-cortical bone block calvarial grafts

B) The Control group:

The patients within the control group will receive mono-cortical bone block iliac crest grafts,
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones

Detailed description: Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft.

The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation.

This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.

Eligibility criteria: Inclusion Criteria:

* Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm

Exclusion Criteria:

* Any previous maxillary reconstructive or dental implant treatment.
* Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.

Primary outcomes:
measure: Horizontal bone gain
timeFrame: 6 months consolidation period
Secondary outcomes:
measure: Immunohistochemical bone formation
timeFrame: 6 months consolidation period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amr Gibaly
Study officials:
References: