louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00209352: Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
Official title: Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: VZV Infection After Bone Marrow Transplantation
Keywords: Varicella Zoster Virus Infection
VZV infection
Oral Acyclovir
Allogeneic Bone Marrow Transplantation
Allogeneic Hematopoietic Cell Transplantation
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Burroughs Wellcome
name: National Institutes of Health (NIH)
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.

Detailed description: Herpes zoster infection occurs in 30% of allogeneic hematopoietic cell transplant (HCT) recipients who had a history of varicella zoster virus (VZV) infection. A safe and effective prevention strategy has not been established.

77 marrow allograft recipients at risk for VZV reactivation were randomized to oral acyclovir 800 mg twice daily or placebo given from day 30 until day 365 and were followed for toxicity and clinical evidence of herpes zoster infection.

Eligibility criteria: Inclusion Criteria:

* 10 years or older
* Both sex (male or female)
* Allogeneic transplant patient for hematologic malignancy or aplastic anemia

Exclusion Criteria:

* Previous intolerance to acyclovir
* Patients who are unavailable for follow-up
* Patients in whom drug compliance may be a problem
* Evidence of active VZV infection
* VZV infection in the initial 1 month after transplant
* Pregnant women, lactating women, or those not using adequate contraception
* Creatinine \> 3.0 mg/dl.

Primary outcomes:
measure: VZV infection at one year
Secondary outcomes:
measure: VZV infection after discontinuation of prophylaxis
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Michael Boeckh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boeckh M, Kim HW, Flowers ME, Meyers JD, Bowden RA. Long-term acyclovir for prevention of varicella zoster virus disease after allogeneic hematopoietic cell transplantation--a randomized double-blind placebo-controlled study. Blood. 2006 Mar 1;107(5):1800-5. doi: 10.1182/blood-2005-09-3624. Epub 2005 Nov 10.
Clinical trial NCT05406752: Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
Official title: An Open-label, Single Treatment, Single Period, Single Buccal Dose Pharmacokinetic Study of Paracetamol Uniflash (125 mg/ 1.25 mL) in Healthy, Adult, Human Subjects Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Pain
Lead sponsor: Unither Pharmaceuticals, France
Sponsor class: INDUSTRY
Collaborators: name: Raptim Research
First posted: 2022-06-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.


Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant female human subjects, age 18 - 45 years.
* Body Mass Index between 18.5-30 Kg / m2 .
* Subjects with normal findings .
* Willingness to follow the protocol requirements

Exclusion Criteria:

* History of allergy or hypersensitivity intolerance to paracetamol and ethanol
* Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
* Lactating or nursing female subjects;
* History of difficulty in accessibility of veins in arms.

Primary outcomes:
measure: Paracetamol Peak Plasma Concentration (Cmax) After Single Dose
timeFrame: Up to 12 hours post dose
measure: Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose
timeFrame: Up to 12 hours post dose
Secondary outcomes:
measure: Number of Treatment-related Adverse Events
timeFrame: Up to 12 hours
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Raptim Research Pvt. Ltd.
Study officials:
References:
Clinical trial NCT03499652: Neonatal Bacterial Meningitis Cohort
Official title: A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Meningitis
Neonatal Infection
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
name: Children's Hospital of Fudan University
First posted: 2018-04-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible participants were full-term neonates, aged older than 3 days, who were suspected with BM and received LPs.

Brief summary: Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.

Detailed description: In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.

Eligibility criteria: Inclusion Criteria:

* Subject has a positive cerebrospinal fluid culture of bacterial pathogen(s)
* Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥ 20×106/L
* Subject has counts of white blood cells in cerebrospinal fluid ≥ 20×106/L and counts of neutrophils ≥ 10×106/L as well as suspected clinical symptoms

Exclusion Criteria:

* History of brain trauma, brain tumor, cerebral palsy, epilepsy, and ventricular shunt device
* History of accepting neurosurgery
* Subject has missing data

Primary outcomes:
measure: neonatal bacterial meningitis risk score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT04980352: Multi-dimensional Signatures for Precisely Predicting the Response and Prognosis of Lung Cancer Patients
Official title: Multi-dimensional Signatures for Precisely Predicting the Response and Prognosis of Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Response
Prognosis
Keywords: Multi-dimensional Signatures
NGS
Lung Cancer
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Renmin Hospital of Wuhan University
name: Wuhan TongJi Hospital
name: Wuhan University
First posted: 2021-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally-advanced or metastasis lung cancer

Brief summary: This study aims to determine the clinical effectiveness of multi-dimensional signatures in predicting response and prognosis of lung cancer patients. The study is a multi-center perspective research of treatment planning for patients with lung cancer. To characterize clinical effectiveness, the progression-free survival (PFS) and overall survival (OS) impacts of multi-dimensional signatures will be estimated.

Detailed description: Multi-dimensional signatures, including NGS-based genotyping, and other essential detections such as immunohistochemistry (IHC), provides an opportunity to improve outcomes for patients by tailoring treatments to each individual's genomic profile. This is a multi-center single arm research study integrating multi-dimensional signatures into clinical decision-making for patients with lung cancer. The clinical effectiveness of multi-dimensional signatures is unknown in the real-world of clinics. To identify a counterfactual for Pred-lung approach, matching methods combined with administrative healthcare data will be used. The survival impacts of Pred-lung approach compared to usual care in matched controls will then be estimated.

Eligibility criteria: Inclusion Criteria:

* Patients with locally-advanced or metastasis lung cancer
* Life expectancy \> 3 months

Exclusion Criteria:

* Age at diagnosis \<18
* refuse to enroll

Primary outcomes:
measure: PFS
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: OS
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT01268852: Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
Official title: Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Treatment
Fixed Appliances
Insignia
DamonQ Brackets
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare treatment between two appliance systems
Primary purpose: TREATMENT

Brief summary: The hypotheses tested in this study are: There is a statistical significant difference, in treatment duration and result of treatment in cases treated using traditional Damon Q brackets or using Insignia.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, both male and female
* No cleft lip or palate or other craniofacial anomalies
* Treatment with full fixed orthodontic appliances is indicated
* Complete permanent dentition except for upper second and all third molars
* Class I, Class II or Class III first molar relationship )1/2 pb or less off)
* No previous orthodontic treatment
* Age between 12 and 30 years of age
* Study models and lateral cephalograms taken not more than 1 month before selection
* Informed consent signed by patients and parents

Exclusion Criteria:

* Cleft lip and palate and craniofacial anomalies
* Syndromes affecting bone (formation) or teeth
* Agenesis of teeth
* Missing first molars
* No bridges or implants
* Orthognathic cases
* History of periodontal disease
* Intake of drugs affecting tooth movement and/or bone formation
* Pregnancy

Primary outcomes:
measure: Total treatment duration
timeFrame: treatment duration
Secondary outcomes:
measure: Quality of treatment
timeFrame: at start of treatment wand when finished treatment
measure: Difference between the planning and the outcome of treatment of the Insignia cases
timeFrame: at start of treatment
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Orthodontics and Craniofacial Biology
state: Gelderland
Study officials:
affiliation: Radboud university Medical centre Nijmegen, The Netherlands
name: Hero Breuning
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penning EW, Peerlings RHJ, Govers JDM, Rischen RJ, Zinad K, Bronkhorst EM, Breuning KH, Kuijpers-Jagtman AM. Orthodontics with Customized versus Noncustomized Appliances: A Randomized Controlled Clinical Trial. J Dent Res. 2017 Dec;96(13):1498-1504. doi: 10.1177/0022034517720913. Epub 2017 Jul 25.
Clinical trial NCT05554952: Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries
Official title: Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Indirect Pulp Capping
Pulpotomy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.

Detailed description: Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial

Eligibility criteria: Inclusion Criteria:

* - 4 to 6 years old patients presented with deep carious lesions in primary molars.
* Apparently healthy children (ASA I, II classification).
* Co-operative children (Rating 3 \& 4 according to Frankle classification)

Exclusion Criteria:

A) Clinical:

* Non restorable primary molars.
* Presence of clinical pathology.
* Presence of mobility or tenderness to percussion.

  * Spontaneous pain.

B) Radiographic:

* Pre-operative radiographs showed external or internal root resorption.
* Presence of furcal radiolucency.
* Presence of periapical radiolucency or widened periodontal ligament space
* More than one-third root resorption detected.

Primary outcomes:
measure: Clinical and radiographic evaluation
timeFrame: 2 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT03065452: Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant
Official title: Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Stenosis, Familial
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients who underwent open decompression surgery (laminotomy) were prospectively included in this study

Brief summary: Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most frequent indication for spinal surgery. When non-invasive treatments fail, decompression surgery is the gold standard therapy for the majority of patients and generally improves symptoms.

However, few studies have investigated the improvement in posture (radiological parameters) after surgery. In lumbar stenosis, patients may present a forward leaning posture (to relieve pain), which is responsible for sagittal imbalance.

The aim of this prospective study was to evaluate the repercussions of decompression surgery on sagittal balance and to compare these with aux clinical results. investigators included patients operated on for isolated lumbar canal stenosis.


Eligibility criteria: Inclusion Criteria:

1. Symptoms and signs of neurogenic claudication and radiological signs of central lumbar stenosis;
2. Patients undergoing open decompression surgery ≤ 3 levels,
3. All patients with symptoms that did not respond to at least 3 months of non-invasive treatment.

Exclusion Criteria:

Patients were excluded from the study if they had one or several of the following clinical and/or radiological criteria:

1. spondylolisthesis (disc slip \> 5 mm),
2. criteria showing instability (variation of \> 10° in the angle formed by the vertebral endplates on dynamic images).
3. scoliosis (Cobb angle \> 20 °).
4. Patients lost to follow-up were excluded.

Primary outcomes:
measure: Vertical sagittal axis
timeFrame: 12 months
Secondary outcomes:
measure: radiographic evaluation with EOS
timeFrame: 12 months
measure: Functional Interest
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
measure: Sagittal parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu de Dijon
Study officials:
References:
Clinical trial NCT06345352: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico)
Official title: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of the Admissions of Patients Accessing the PS: Construction and Validation of an Algorithm Based on Computerised Databases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Quality of Care
Evaluation
Emergency Department
Appropriateness
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients entering Emergency Department represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

Brief summary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Detailed description: The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

Exclusion Criteria:

* Voluntary removal of the patient;
* Sending home with instructions to return for further services

Primary outcomes:
measure: Algorithm creation
timeFrame: September 2020 - January 2024
measure: Algorithm validation
timeFrame: February 2024 - December 2024
measure: Algorithm application
timeFrame: January 2025 - December 2027
measure: Appropriateness estimation
timeFrame: January 2025 - December 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
state: MI
Study officials:
References:
Clinical trial NCT01526252: Reference Population for Speckle Tracking Imaging
Official title: Establishing a Reference Population for Normal Left Ventricular Function Parameters to Validate the Use of Two Dimensional Speckle Tracking Imaging Software in the Scar Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Function
Keywords: speckle tracking echocardiography
database
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal healthy males and females

Brief summary: The SCAR study uses a software program entitled QLAB, a proprietory program, developed by Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is minimal. Accumulation of data relevant for a population of subjects will provide a set of normal values for interpretation of 2DSTE and minimize any influences from differences in data produced from different companies. This data may also assist other researchers investigate other cardiac diseases and abnormalities.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 20 - 80 years at study entry
* Provide written informed consent and be able to comply with study procedures, including permission to access medical records
* Have a BMI index equal to or less than 35
* Less than 5% risk of developing coronary artery disease as determined using the Combined Diamond/Forrester and CASS data (ACC Stable CAD Guidelines)

Exclusion Criteria:

* Have taken cardioactive drugs within 6 months prior to examination

  * These include but are not limited to beta-blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors
* Currently clinically significant chronic or acute illness
* Documented cardiovascular disease
* Possess abnormal cardiac structure and function after examination with routine ECHO

  * This may include valvular defects, left ventricular hypertrophy, cardiomyopathies or pericardial disease
* Documented congenital heart conditions or defects
* History of diabetes
* Be unwilling to provide voluntary consent

Primary outcomes:
measure: Establishment of normal values data in males and females aged 20 - 80
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Terrence Ruddy, MD
role: PRINCIPAL_INVESTIGATOR
References: