louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05919550: Clozapine-associated Infection
Official title: Clozapine-associated Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 26815616
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a possible drug-induced adverse effect

Brief summary: perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.


Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023
* Adverse events reported were including the MedDRA terms: infections (SOC)

Exclusion Criteria:

Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®
timeFrame: from the 01/01/1963 to the 11/04/2023
Secondary outcomes:
measure: investigate a potential dose-dependent effect
timeFrame: from the 01/01/1963 to the 11/04/2023
measure: Description of the clinical features of clozapine-related infections
timeFrame: from the 01/01/1963 to the 11/04/2023
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
state: Normandie
Study officials:
References:
Clinical trial NCT00233350: Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study
Official title: Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Neoplasms
Keywords: Neuronavigation
Ultrasound
Brain tumour surgery
Biopsy
Histopathology
Intraoperative imaging
3D ultrasound imaging
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-10-05
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were operated for intracranial high-grade gliomas (World Health Organisation(WHO) grade III/IV) in the 3-year period between January 1st 2007 and December 31st 2009 in the Department of Neurosurgery, St. Olavs University Hospital, Trondheim, Norway

Brief summary: 3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.

Detailed description: The degree of resection as judged by the surgeon is recorded at the end of surgery for each patient, and then compared with the postoperative MRI. Neurological status before and after surgery, QOL before surgery and at follow-up as well as survival is recorded.

Eligibility criteria: Inclusion Criteria:

* Supratentorial glioma

Exclusion Criteria:

* Not willing to participate in study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Geirmund Unsgaard, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Solheim O, Selbekk T, Jakola AS, Unsgard G. Ultrasound-guided operations in unselected high-grade gliomas--overall results, impact of image quality and patient selection. Acta Neurochir (Wien). 2010 Nov;152(11):1873-86. doi: 10.1007/s00701-010-0731-5. Epub 2010 Jul 21.
Clinical trial NCT01084850: Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects
Official title: Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Dystrophy
Keywords: Corneal endothelium
diabetes mellitus
corneal thickness
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting Frederiksberg hospital for any reason

Brief summary: The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.

Detailed description: Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once ("entry to study").

Eligibility criteria: Inclusion Criteria:

* Type II diabetes (diagnose confirmed by general practitioner)
* Controls with no diabetes (confirmed by blood testing).

Exclusion Criteria:

* Glaucoma
* Uveitis (current or previous)
* Corneal scaring
* Previous eye surgery

Primary outcomes:
measure: Corneal endothelium cell number
timeFrame: 1 year
Secondary outcomes:
measure: Corneal endothelium morphology
timeFrame: 1 year
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg University Eye Clinque
Study officials:
affiliation: Frederiksberg University Hospital, Eye Clinque
name: Jens C Norregaard, MD, phd
role: STUDY_CHAIR
References:
Clinical trial NCT06834750: The Application of Kinesio Taping Technique in the Early Upper Limb Functional Activities Induction of Hemiplegic Patients After Stroke
Official title: The Application of Kinesio Taping Technique in the Early Upper Limb Functional Activities Induction of Hemiplegic Patients After Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Infarction Recovery
Rehabilitation Treatment
Upper Extremity Motor Function
Emg Biofeedback
Keywords: Ischemia
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Infarction
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To observe the inducing and promoting effect of kinesio taping technique on the recovery of upper limb function in early-stage stroke patients.
2. To compare the different effects of kinesio tape and sports white tape on the induction and promotion of limb function in patients.
3. To verify that kinesio taping technique is a safe and promotable technical means for stroke patients.


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily participated in the experiment and signed informed consent
2. Diagnosed as a stroke patient
3. No other major cardiovascular and cerebrovascular diseases
4. First new stroke
5. After evaluation by evaluators, subjects had Brunnstrom stage \< 3

Exclusion Criteria:

1. The subject's compliance was poor
2. Increased muscle tone in the affected upper extremity
3. Subjects with skin allergies
4. Those who did not receive continuous treatment during the experiment

Primary outcomes:
measure: To observe the inducing and promoting effect of kinesio taping technique on the recovery of upper limb function in early-stage stroke patients.
timeFrame: Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge
Secondary outcomes:
measure: To compare the different effects of kinesio tape and sports white tape on the induction and promotion of limb function in patients.
timeFrame: Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge
Other outcomes:
Locations:
city: Yiwu
country: China
facility: 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References:
Clinical trial NCT01469650: Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Official title: Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: vitamin D3
prematurity
parathyroid hormone
25(OH)D
NICU hospitalization
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 32
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D \[25(OH)D\] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.

Detailed description: The specific aims of this study are to determine levels of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these infants.

Eligibility criteria: Inclusion Criteria:

* NICU hospitalized infants
* 23-32 weeks gestation

Exclusion Criteria:

* congential anomalies
* disorders of calcium metabolism
* inborn error of metabolism
* kidney disease
* liver disease
* use of steroids

Primary outcomes:
measure: Serum 25-hydroxy vitamin D [25(OH)D] Levels
timeFrame: 1 year
Secondary outcomes:
measure: Parathyroid Hormone Levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Corrine K Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Clinical trial NCT01844050: Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Chinese herbal medicine
diabetes symptoms
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
name: Shanghai Putuo District Center Hospital
First posted: 2013-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
* After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l\<2h PG\<16mmol/l
* Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
* Subject is willing to participate and capable of giving informed consent.

Exclusion Criteria:

* Those patients used any drugs for treatment of diabetes within one month.
* Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
* Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
* Women who were pregnant, lactating or planned pregnant.
* Allergic constitution and has a history of drug allergy.
* Combined with severe acute or chronic infections.

Primary outcomes:
measure: Change from Baseline Total score of diabetes symptoms at 4 weeks
timeFrame: 0 weeks(baseline), 2 weeks, 4 weeks
Secondary outcomes:
measure: Change from Baseline Fasting Blood Glucose at 4 weeks
timeFrame: 0 weeks(baseline), 2 weeks, 4 weeks
measure: Change from Baseline blood glucose at 2 hours after meal at 4 weeks
timeFrame: 0 weeks(baseline), 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Universitu of TCM
name: Kaixian Chen, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01498250: Microarray Analysis of microRNA Expression in Basal Cell Carcinoma
Official title: Microarray Analysis of microRNA Expression in Basal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with

Basal Cell Carcinoma

Brief summary: Perturbations in microRNA (miRNA) expression profiles has been reported for a variety of cancers. This study will be an exploratory analysis of miRNA expression in basal cell carcinoma by miRNA expression profiling using microarrays.

Detailed description: Perturbations in the expression profiles of microRNAs (miRNAs) have been reported for a variety of different cancers. Basal cell carcinoma (BCC) of the skin has not been systematically evaluated regarding differentially expressed miRNAs. Patients with BCC are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility criteria: Inclusion Criteria:

* Basal Cell Carcinoma

Exclusion Criteria:

* Other Skin Cancer than Basal Cell Carcinoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
state: NRW
Study officials:
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Falk G Bechara, PD Dr.
role: STUDY_DIRECTOR
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Peter Altmeyer, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Michael Sand, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sand M, Skrygan M, Sand D, Georgas D, Hahn SA, Gambichler T, Altmeyer P, Bechara FG. Expression of microRNAs in basal cell carcinoma. Br J Dermatol. 2012 Oct;167(4):847-55. doi: 10.1111/j.1365-2133.2012.11022.x. Epub 2012 Aug 20.
Clinical trial NCT02822950: A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Official title: A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of Avycaz in ICU Patients
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 10
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, IA infections and pneumonia (including VAP)
* Patients requiring intensive care (critically ill patients) in the med/surg ICU (APACHE II score ≥ 15)
* Patients prescribed Avycaz for their infection will receive FDA recommended dosages and times of administration
* Written informed consent

Exclusion Criteria:

* Pregnant Patients, patients older than 90 y/o, those with CrCl \< 30 mL/min, patients with a BMI \> 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study

Primary outcomes:
measure: Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
timeFrame: 2,4,6, 8 hours after receiving the drug
measure: Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
timeFrame: 2,4,6, 8 hours after receiving the drug
measure: Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients
timeFrame: 2,4,6, 8 hours after receiving the drug
measure: Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients
timeFrame: 2,4,6, 8 hours after receiving the drug
measure: Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients
timeFrame: 2,4,6, 8 hours after receiving the drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Michigan State University
name: Gary E Stein, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554150: Randomised Controlled Trial of Method of Levels Cognitive Therapy
Official title: A Randomised Controlled Trial Comparing Method of Levels Cognitive Therapy With a Contact Service for Improving Outcomes in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Depression
Anxiety
Keywords: Primary Health Care
Mental Health
Cognitive Therapy
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Method of Levels Cognitive Therapy is an effective intervention for treating clients with a range of presenting problems in primary care by comparing it with a waiting list control condition.


Eligibility criteria: Inclusion Criteria:

* Anyone presenting to primary care services with mild to moderate mental health problems with capacity to provide informed consent and does not meet exclusion criteria.

Exclusion Criteria:

* Has been accepted into secondary care services.
* Aged under 16 years.
* Have an organic basis for their mental health problems. That is, mental health problems that are primarily caused by an identifiable brain malfunction such as thyroid problems or brain injury.
* Unable to provide informed consent.
* Is not able to speak, read, write or understand written and verbal English.
* Individuals who will be unable to understand and/or answer therapist questions due to learning disabilities, brain injury or similar neurological difficulties.
* Cannot attend sessions at the appropriate clinic.

Primary outcomes:
measure: Patient Health Questionnaire mood subscale (PHQ-9)
timeFrame: up to 3 months
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Trafford Primary Care IAPT Services
Study officials:
affiliation: University of Manchester
name: Warren Mansell
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Sara Tai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05942950: Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey
Official title: Surgery or Casting in Older Adults With Intra-articular Distal Radius Fractures? A Surgeon Survey With Predictions of Treatment Outcomes in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fractures
Survey
Distal Radius Fracture
Keywords: distal radius fracture
surgeon survey
surgeon
survey
predicting outcomes
preferences
Lead sponsor: JointResearch
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma surgeons (in training) and orthopedic surgeons (in training)

Brief summary: The goal of this surgeon survey is to find out if orthopedic and trauma surgeons can predict outcomes in older adults with distal radius fractures. The main questions it aims to answer are:

* Can orthopedic and trauma surgeons effectively predict which treatment would benefit a patient the most in terms of good outcome versus poor outcome (based on Δ PRWE) following casting or surgical treatment for displaced intra-articular distal radius fractures?
* What are the perspectives of trauma surgeons and orthopedic surgeons on current literature?
* What factors direct trauma surgeons and orthopedic surgeons to surgery?


Eligibility criteria: Inclusion Criteria:

* Dutch orthopedic and trauma surgeons
* Residents
* Experience with at least five surgeries of distal radius fractures in the past 3 years

Exclusion Criteria:

* No experience with distal radius fractures

Primary outcomes:
measure: The percentage of correct predictions of the treatment outcome
timeFrame: From enrollment to the end of the data collection, up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
state: North-Holland
Study officials:
References: