louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00703430: Memantine on Aggression and Agitation of Alzheimer's Disease (AD)
Official title: The Effect of Memantine on Aggression and Agitation and Its Impact on Caregiver Burden of Patients With Alzheimer's Disease: A 12-week Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease, agitation, aggression, dementia
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2008-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of AD patients in Beijing. Agitation, and aggression specifically, is considered the most serious noncognitive symptom experienced in patients with dementia. Memantine is a recognized treatment for Alzheimer's disease either alone or in combination with cholinesterase inhibitors. Its efficacy in vascular dementia is also established. Family members continue to play a central role in home care for the demented elderly in China. This proposal is to conduct a study in Beijing, China to investigate the efficacy and safety of Memantine in the treatment of agitation and aggression in AD patients. In addition, this proposal aims to explore the impact of memantine on caregiver burden of AD patients in Chinese culture.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Clinical diagnosis of Alzheimer's disease.
3. Having at least a minimum aggression score on the Cohen-Mansfield Agitation Inventory (CMAI): a score of ≥ 4 on at least 1 aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occurring at a frequency of 2 and 1 at a frequency of 3.
4. Availability of a responsible family member or carer to ensure treatment compliance and provide information for informant assessments.

Exclusion Criteria:

1. Unavailability of a responsible family member or carer
2. Severe renal impairment.
3. History of seizures
4. Diagnosis of any concomitant life threatening illness.

Primary outcomes:
measure: CMAI score
timeFrame: 12 weeks
Secondary outcomes:
measure: CBI score
timeFrame: 12 weeks
measure: RUD
timeFrame: 12 weeks
measure: NPI score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Mental Health
Study officials:
affiliation: Peking University Institute of Mental Health
name: Xin Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00356330: Safety of Cardiac Pacemakers in 3 Tesla MRI
Official title: Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Diseases
Keywords: pacemaker
magnetic resonance imaging
safety
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2006-07-26
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Detailed description: Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.

Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.

In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.

Eligibility criteria: Inclusion Criteria:

* Urgent need for an MRI examination
* Stable pacemaker physical parameters

  * Battery voltage \> 2.7 V
  * Battery impedance \< 2000 Ohm
  * Battery estimated remaining lifetime \> 6 months
  * Lead impedances 200-2000 Ohm
* Stable pacing parameters

  * Pacing capture threshold \<2.5V at a pulse duration of 0.4ms
  * Sensing \> 5mV
* Minimum 3 months since pacemaker and lead implantation

Exclusion Criteria:

* History of ventricular tachycardia (VT) or ventricular fibrillation
* Unstable angina
* Myocardial infarction within the previous 3 months
* Cardiothoracic surgery within the previous 3 months
* Presence of an abdominal pacemaker with lead length \> 70 cm
* Presence of MRI incompatible bioimplants or other MRI incompatible materials

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Department of Radiology
state: NRW
Study officials:
affiliation: University of Bonn, Department of Radiology
name: Torsten Sommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02055430: Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage
Official title: Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage in Children With Obstructive Anuria and Acute Renal Failure Due to Ureteral Calculi: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Obstructive Uropathy
Acute Renal Failure
Ureteric Stones
Keywords: anuria
children
nephrostomy
stents
urinary calculi
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 90
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children

Detailed description: To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children with obstructive calcular anuria and acute renal failure due to ureteric calculi to identify selection criteria for initial urinary drainage method to improve drainage, to decrease complications and to facilitate subsequent definitive clearance of stones as this comparison is lacking in literature

Eligibility criteria: Inclusion Criteria:

* children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones

Exclusion Criteria:

* Patients with grade 0-1 hydronephrosis
* fever, pyonephrosis or sepsis.
* any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).

Primary outcomes:
measure: Period to Return to Normal Creatinine
timeFrame: 1 week
measure: Complications of Each Drainage Method
timeFrame: 1 week
Secondary outcomes:
measure: The Number of Subsequent Interventions Needed for Clearance of Stones .
timeFrame: 6 months
Other outcomes:
measure: Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)
timeFrame: 1 week
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: Mohammed S ElSheemy, A professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: ElSheemy MS, Shouman AM, Shoukry AI, ElShenoufy A, Aboulela W, Daw K, Hussein AA, Morsi HA, Badawy H. Ureteric stents vs percutaneous nephrostomy for initial urinary drainage in children with obstructive anuria and acute renal failure due to ureteric calculi: a prospective, randomised study. BJU Int. 2015 Mar;115(3):473-9. doi: 10.1111/bju.12768. Epub 2014 Oct 20.
Clinical trial NCT06311630: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block vs FEMORAL BLOCK in Hip Fracture
Official title: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block With FEMORAL NERVE BLOCK in Patients With Hip Fracture Presenting to Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Fracture
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Hip fracture presenting to Emergency department

Brief summary: To study the analgesic effect of ultrasound guided PENG Block vs Femoral nerve block in patients with Hip fracture presenting to Emergency department

Detailed description: comparative study of analgesic effect of ultrasound guided PENG block vs femoral nerve block in patients presenting to emergency department

Eligibility criteria: Inclusion Criteria:

* Adults more than or equal to 18 yrs with Hip fracture
* patients who consent for procedure

Exclusion Criteria:

* history of allergy to local anaesthetics
* pregnant or lactating women
* infection or burns at injection site
* patients with polytrauma
* patients with hemodynamic instability
* patients with low GCS
* patients on anticoagulant or hematological disorders
* injuries with neurovascular compromise on affected limb
* patients with distorted anatomy

Primary outcomes:
measure: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block With FEMORAL NERVE BLOCK in Patients With Hip Fracture as assessed by NRS pain scoring scale by patient
timeFrame: 1 hour
Secondary outcomes:
measure: Time taken for each technique
timeFrame: 1 hour
measure: Time taken for adequate analgesia
timeFrame: 1hour
measure: Incidence of complications
timeFrame: 7 days
measure: To note if rescue analgesic is required
timeFrame: 1 hour
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee mission medical College and research centre
state: Kerala
Study officials:
name: Jogi Varghese, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06697730: Study of the Incidence and Prognosis of Intrahospital Acute Kidney Injury
Official title: Study of the Incidence and Prognosis of Intrahospital Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
hospitalized
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 43000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of all patients admitted to the reference hospital during the indicated time frame; in particular, all patients for whom sufficient data are available to establish the presence or absence of a diagnosis of AKI will be considered.

Brief summary: The goal of this observational study is to investigate the epidemiology of acute kidney injury in hospitalized patients. The main question it aims to answer is: how frequent is the development of acute kidney injury in patients who are hospitalized? Data from participants will be retrospectively collected from medical charts.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalised from 01/01/2019 to 31/12/2023
* Availability of a Hospital Discharge Form
* At least one serum creatinine (sCr) determination available

Exclusion Criteria:

* Day-hospital admission
* Discharge after an emergency room admission without hospital admission
* Stage IV and V CKD

Primary outcomes:
measure: Incidence of intra-hospital Acute Kidney Injury
timeFrame: From 01/01/2019 to 12/31/2023
Secondary outcomes:
measure: Incidence of Acute Kidney Injury in different hospital wards
timeFrame: From 01/01/2019 to 12/31/2023
measure: Association between Acute Kidney Injury development and major discharge diagnoses
timeFrame: From 01/01/2019 to 12/31/2023
measure: Rate of re-hospitalisation in Acute Kidney Injury (AKI) and non-AKI patients
timeFrame: From 01/01/2019 to 12/31/2023
measure: Intra-hospital mortality rate in patients who developed AKI compared to those who did not
timeFrame: From 01/01/2019 to 12/31/2023
measure: Incidence of AKI associated with thrombotic microangiopathy
timeFrame: From 01/01/2019 to 12/31/2023
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06878430: Reducing Risk of Stroke and DementIa in PatientS with COVert CERebrovascular Disease
Official title: Reducing Risk of Stroke and DementIa in PatientS with COVert CERebrovascular Disease: a Pilot and Development Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Covert Cerebrovascular Disease
Keywords: ccd
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2025-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People aged 65 years or older living in Scotland, UK

Brief summary: The purpose of the DISCOVER study is to pilot acceptable approaches to people with covert cerebrovascular disease (CCD) and their follow-up. This is the first step in designing efficient randomised trials of treatments to reduce the risk of stroke or dementia in people with CCD.

Detailed description: DISCOVER is a prospective cohort involving individuals with covert cerebrovascular disease (CCD) in NHS Lothian. Participants will be recruited through electronic health records and clinician collaborators. Participants will be monitored at 3 and 6 months and where possible 12 months to assess cognitive, functional, and vascular event outcomes.

Eligibility criteria: Inclusion Criteria:

* People who, at the time the letter is prepared or are identified by a clinician

  * Age ≥ 65 years
  * Have no known history of:

    * Stroke or TIA
    * Dementia
    * Parkinson's disease
    * Multiple sclerosis
    * Metastatic cancer (or non-meningioma brain tumour).
  * A CT or MRI scan report ≤5 years before study start date with of one or more of:

    * Cerebral small vessel disease
    * Deep old ischaemic stroke
    * Cortical old ischaemic stroke

Exclusion Criteria:

* Text of brain scan report unreadable
* Do not consent to take part in study procedures
* Unable to consent
* Unable to communicate by email, letter or telephone through language, speech disability or lack of address
* Unlikely to survive one year past enrolment in judgement of the study investigator

Primary outcomes:
measure: Functional scores
timeFrame: At 3, 6 and 12 months following enrolment
measure: Cognitive scores
timeFrame: At 3, 6 and 12 months following enrolment
measure: Speech samples
timeFrame: At 3, 6 and 12 months following enrolment
measure: Vascular events
timeFrame: At 3, 6 and 12 months following enrolment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00006330: Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Digoxin
Effect modifiers (Epidemiology)
Rosales
Drug Interaction
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-10-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.


Eligibility criteria: Inclusion Criteria:

* Healthy adult
* Not regularly taking any prescription or non-prescription medications (including natural products or supplements) and is willing to avoid all medications other than the study drugs during the study period.
* Willing to avoid drinking any alcohol throughout the study period.
* Does not currently smoke and is willing to avoid smoking during the study period.
* Willing to adhere to dietary restrictions as required during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Univ. of Michigan Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT01876030: Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dropped Foot
Keywords: Functional electrical stimulation (FES)
Sub acute stroke
Gait analysis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 40
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 investigators hypothesize that the gait pattern of following the utilization of a functional electrical stimulation device will be much improved when compared to the effect of regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages following stroke.


Eligibility criteria: Inclusion Criteria:

* Sub-acute stroke patients suffering a first stroke with clinical presentation, according to the WHO definitions
* Patients suffering from unilateral foot drop
* Independent ambulation before the stroke
* Cognitive and cooperative ability to follow simple instructions
* Neurological condition severity mild to moderate (between 3 and 15, according to the National Institutes of Health Stroke Scale; NIHSS).
* Ability to walk with or without a walking aid (cane, walker), with or without assistance. Functional Ambulation Classification (FAC) of at least 2
* Independently capable to understand an informed consent form.

Exclusion Criteria:

* Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions
* Orthopaedic injury to the paretic or non-paretic limbs
* Motor disability due to neurological diagnosis, e.g. multiple sclerosis, cerebral palsy, spinal cord injury, and Parkinson
* Peripheral injury of the peroneal nerve or sciatic nerve
* Pregnant or nursing females

Primary outcomes:
measure: Change in velocity of gait
timeFrame: Baseline, 4 weeks and 12 week follwing baseline
measure: Change in step length
timeFrame: Baseline, 4 and 12 weeks following baseline
Secondary outcomes:
measure: Gait symmetry
timeFrame: Baseline, 4 and 12 weeks following baseline
measure: Muscle activity patterns
timeFrame: Baseline, 4 and 12 weeks following baseline
measure: Functional assessment
timeFrame: At baseline, 4 and 12 weeks following baseline
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT06506825: Construction and Application of Database of Hebei Provincial Gastric Cancer Collaborative Network Driven by Artificial Intelligence Technology
Official title: The Fourth Hospital of Hebei Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: The Study Focuses on Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with gastric cancer

Brief summary: This clinical trial aims to construct and apply a collaborative network database for gastric cancer in Hebei Province, driven by artificial intelligence (AI) technology. The project seeks to integrate clinical data, genomic information, and treatment outcomes from multiple hospitals and research centers within the region. By leveraging advanced AI algorithms, the database will facilitate comprehensive data analysis to identify novel biomarkers, optimize therapeutic strategies, and improve patient outcomes. This initiative will also support real-time data sharing and collaboration among healthcare providers, researchers, and policymakers, ultimately enhancing the overall management and treatment of gastric cancer in Hebei Province.


Eligibility criteria: Inclusion Criteria:

All patients with gastric cancer

Exclusion Criteria:

None

Primary outcomes:
measure: 5-year overall survival
timeFrame: 2025-12-31
Secondary outcomes:
measure: 5-year recurrence-free survival
timeFrame: 2025-12-31
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Department of General Surgery
state: Hebei
Study officials:
References: