louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00127608: Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Official title: An Open, Prospective, Non-prophylactic, Non Therapeutic Study for the Detection and Characterisation of Varicella Zoster Virus Collected From Dermal Lesions of Patients Who Are Diagnosed of Having Varicella/Breakthrough Varicella
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-08
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.

Detailed description: The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.

Eligibility criteria: Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.

Primary outcomes:
measure: Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
timeFrame: At Visit 1 (Day 0)
measure: Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
timeFrame: At Visit 1 (Day 0)
measure: Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
timeFrame: At Visit 1 (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Praha 8
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00524108: Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults
Official title: Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infections and Time to Re-Implantation in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventriculoperitoneal Shunt
Infection
Keywords: shunt
internal ventriculoperitoneal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: VP shunt infection

Brief summary: The objectives of this study are:

* To describe the incidence of clinical features in adults with internal ventriculoperitoneal (VP) shunt infections,
* To determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and
* To evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Detailed description: Information from medical records of patients seen by the PI will be collected and analyzed to describe the incidence of clinical features in adults with internal ventriculoperitoneal shunt infections, to determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and to evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.

Eligibility criteria: Inclusion Criteria:

* Adults (age \>= 18 yrs) with VP shunts (ventriculoatrial \[VA\], and other cerebrospinal fluid \[CSF\] catheters will not be included).
* Cases will include patients with a diagnosis of VP shunt infection.
* Controls will be patients with a clinical suspicion of shunt infections with negative CSF cultures.

Exclusion Criteria:

* Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Adarsh Bhimraj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097108: Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
Official title: One Arm, Open Label, Interventional, Non-comparative Study to Assess Changes in Lipids and Lipoproteins in HIV Infected Women With Hyperlipidemia After Switch From Boosted Protease Inhibitor to Raltegravir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV infection
Raltegravir
Switch
Hyperlipidemia
Women
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-03-26
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.

This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.


Eligibility criteria: Inclusion Criteria:

* Documented HIV-1 infection in female patients, age ≥18 years
* Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
* Plasma HIV viral load \<50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
* Fasting LDL cholesterol \>130 mg/dl
* Fasting triglycerides \<450 mg/dl

Exclusion Criteria:

* History of virological failure during previous antiretroviral therapy

Primary outcomes:
measure: Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
timeFrame: baseline to week 12
Secondary outcomes:
measure: Total Cholesterol Baseline and After 24 Weeks
timeFrame: baseline to week 24
measure: Triglycerides Baseline and After 24 Weeks
timeFrame: baseline to week 24
measure: High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks
timeFrame: baseline to week 24
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: PMU Salzburg
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Ottto Wagner Spital
Study officials:
affiliation: PMU Salzburg
name: Richard Greil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02799108: Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
Official title: Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Keywords: children
language
NIRS
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.


Eligibility criteria: Inclusion Criteria:

* children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated.

Exclusion Criteria:

* All children with severe congenital malformation
* Any refusal of a parent or child
* Any child with generalized epilepsy or diffuse interictal spikes
* Any child with a serious deterioration in the general condition and vital functions
* Any child with dermatitis of the face or scalp
* Children under 6 years

Primary outcomes:
measure: lateralization index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Fabrince WALLOIS, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473108: Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
Official title: Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Pharmacology
Keywords: Healthy volunteers, proof-of-concept trial, PK and PD
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.

Detailed description: Clinical pharmacology

Eligibility criteria: Inclusion Criteria:

* Healthy male white subjects
* 18 to 46 years of age
* Body mass index (BMI): 18 - 29.9 kg/m²

Exclusion Criteria:

* Clinically relevant findings in medical history or in the physical examination
* Systolic blood pressure below 100 or above 140 mmHg
* Diastolic blood pressure below 50 or above 90 mmHg
* Heart rate below 45 or above 95 beats / min

Primary outcomes:
measure: Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
timeFrame: Up to 26 hours post-dose
measure: AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
timeFrame: Up to 60 hours after administration
measure: Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
timeFrame: Up to 60 hours after administration
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Neuss
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01417208: Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
Official title: Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lower Extremity Diabetic Leg Wounds
Lower Extremity Venous Leg Wounds
Lower Extremity Mixed Aetiology Leg Wounds
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2011-08-16
Enrollment: 0
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 diabetic foot ulceration, venous or mixed aetiology lower limb ulceration who are receiving out-patient treatment from the Section of Wound Healing, Cardiff University, Wales.

Brief summary: The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.


Eligibility criteria: Inclusion Criteria:

* Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area \<100 cm2 and \<10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease).
* Wound present for \>30 days.
* Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings.
* Patient is able to comply with study protocol requirements.
* Patient is able to understand and provide written consent.

Exclusion Criteria:

* Patient has evidence of wound infection in the opinion of the physician.
* Patient has a thick eschar that persists after wound debridement.
* Patient has an HbA1C \>12%.
* Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis.
* Patient has untreated osteomyelitis.
* Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study.
* Patient is allergic to the wound care device or occlusive dressing.
* Patient has exposed blood vessels.
* Patient is pregnant or pregnancy is suspected.
* Patient is actively participating in other clinical trials that may interfere with their participation in this study.

Primary outcomes:
measure: Wound Closure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Section of Wound Healing
state: Wales
Study officials:
References:
Clinical trial NCT05425108: Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device
Official title: Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).


Eligibility criteria: Inclusion Criteria:

* Spherical equivalent -0.50 to -5.50 diopters
* visual acuity of at least 20/25 in each eye

Exclusion Criteria:

* history of ocular trauma or major eye surgery
* active ocular infection
* any prior history or participation in myopia control treatments within the past 3 months

Primary outcomes:
measure: Central axial length
timeFrame: 12 months
measure: Cycloplegic refraction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Vision Associates/Institute of Vision Research
state: New York
Study officials:
affiliation: Manhattan Vision Associates/Institute of Vision Research
name: Arkady Selenow, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06860308: The Effect of Norepinephrine on the Development of Pressure Injury
Official title: The Determination of the Effect of Norepinephrine Infusion on the Development of Pressure Injury Among Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Injury
Keywords: pressure injury
norepinephrine
vasopressor
intensive care
development
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population included all adult critically ill patients hospitalized in the 16-bed Adult ICU at the university hospital in Istanbul, Turkey. The ICU was 3rd level ICU where medical and surgical patients received life support treatments and care at the highest level. The study was conducted between May 2020 and March 2021.

Brief summary: Norepinephrine mainly increases mean arterial pressure among intensive care patients. It may be an essential risk factor in developing pressure injuries. However, there are still conflicting findings in the literature.

This study aimed to examine the effect of norepinephrine infusion on the development of pressure injuries among patients in adult intensive care.

This retrospective and correlational study was conducted between March 2021- May 2022. The electronic patient data were obtained from 289 adult patients (Case group n=149; control group n=149) treated with and without norepinephrine in the intensive care unit, respectively. The demographic and clinical characteristics were evaluated using descriptive statistical methods (number, percentage, mean, standard deviation). A logistic regression model was established to estimate the dependent variable (development of pressure injury) with the independent variables.


Eligibility criteria: Inclusion Criteria:

The sample consisted of all patients

* over 18 years old
* who did not have pressure injuries upon admission to the intensive care unit. Patients who received norepinephrine and received norepinephrine infusion for at least 48 hours during their stay in ICU were included in the case group (n=149), and patients who did not receive an infusion were included in the control group (n=140).

Exclusion Criteria:

The sample excluded of all patients

* less than 18
* who have pressure injuries during admission
* who had norepinephrine infusion less than48 hours during their stay in the intensive care unit.

Primary outcomes:
measure: development of pressure injury after admission to intensive care unit until discharge
timeFrame: after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. .
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
Study officials:
References:
Clinical trial NCT05338008: Intrawound Administration of Vancomycin in THA
Official title: Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 120
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 purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Age over 18;
2. Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head.

Exclusion Criteria:

1. Diminished mental capacity
2. Vancomycin allergy
3. Chronic kidney disease stage III and stage IV

Primary outcomes:
measure: Intra-articular vancomycin concentration
timeFrame: 2 hours, 8 hours and 24 hours postoperatively
measure: Serum vancomycin concentration
timeFrame: 2 hours, 8 hours and 24 hours postoperatively
measure: Renal function
timeFrame: Postoperative Day 1 and Day 3
measure: Blood loss
timeFrame: Postoperative Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The affiliated hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Shuai Xiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: