louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01564758: Post Marketing Surveillance Study on Linezolid
Official title: Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Positive Bacterial Infections
Keywords: non-interventional
non-comparative
open-label study
safety
Linezolid
gram positive infections
Filipino
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 99
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: Adult, Filipino patients diagnosed with gram positive infection

Brief summary: The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

Detailed description: The subjects were identified after the physician decided to prescribed the drug to the subject.

Eligibility criteria: Inclusion Criteria:

* Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
* Male or female, 18 years old and above

Exclusion Criteria:

* Known hypersensitivity
* Subjects diagnosed with pure gram-negative infection

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to End of Treatment (EOT) (Day 10 up to 28)
Secondary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: EOT (Day 10 up to 28)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03660358: Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation
Official title: Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infant
Keywords: preterm infants
kinesiotape
ventilation
respiratory muscles
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 42
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Kinesiotaping (KT) applied to the thorax is believed to enhance breathing by supporting the respiratory muscles. Infants born premature usually have respiratory problems because of depletion of surfactant and respiratory muscle weakness. Therefore, we are going to use KT for premature infants in NICU who are undergoing non-invasive ventilation. Forty-two participants divided into two groups. The first group will be applied KT to chest wall, abdomen and diaphragm, and the other group will not receive any KT application during non-invasive ventilation. KT application will be going on as long as the infant underwent non-invasive ventilation. We are going to measure blood gas parameters (pH, pCO2, pO2, base excess), respiration rate, peak heart rate, percentage of Fio2, FiO2/pO2 rate, PEEP and PIP values before non-invasive ventilation, 2 hours after non-invasive ventilation, within 72 hours and shortly before weaning from non-invasive ventilation.


Eligibility criteria: Inclusion Criteria:

* Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks.

Exclusion Criteria:

* Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.

Primary outcomes:
measure: arterial blood gas
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
state: Bahçelievler
Study officials:
affiliation: Associate Professor
name: Ayse Ecevit, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06238258: Dual Diagnosis Training Trial
Official title: Healthcare Outcomes of a Staff/Caregiver Training Program Focused on Challenging Behaivors for Adults With Developmental Disability and Co-occurring Mental Health Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Training Group
Keywords: intellectual disability
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a clinical trial, with participants undergoing the 16 hour SPECTROM training, and completing 2 assessments before and after training (the Psychotropic Knowledge Questionnaire-Revised and the Management of Aggression and Violence Attitude Scale-Revised-ID).


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are individuals who work in the 3 ARCA group homes or in the UNM psychiatric center and who are fluent in English and 18 years and older

Exclusion Criteria:

* All participants must be fluent in English because for this pilot study we do not have funds to translate study materials.

Primary outcomes:
measure: Knowledge Acquisition Post Training
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM Health Science Center
state: New Mexico
Study officials:
References:
Clinical trial NCT03272958: Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
Official title: Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Pemphigoid
Keywords: Pruritus
Bullous pemphigoid
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 63
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: All patients with a new diagnosis of bullous pemphigoid

Brief summary: Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.

The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.


Eligibility criteria: Inclusion Criteria:

* adult
* pruriginous bullous pemphigoid lately diagnosed.
* Without PB treatment
* MMS (Mini Mental State Examination) ≥ 21
* In hospitalization or consultation

Exclusion Criteria:

* pregnant woman
* nursing women

Primary outcomes:
measure: Clinical characteristics of pruritus in patients with bullous pemphigoid
timeFrame: Day1 ( when diagnosis of bullous pemphigoid is made)
Secondary outcomes:
measure: Impact of pruritus on quality of life in patients with bullous pemphigoid
timeFrame: Day 1 (when diagnosis of bullous pemphigoid is made )
measure: Impact of pruritus on quality of life in patients with bullous pemphigoid
timeFrame: Day1 (when diagnosis of bullous pemphigoid is made )
measure: Impact of pruritus on quality of life in patients with bullous pemphigoid
timeFrame: Day 1 (when diagnosis of bullous pemphigoid is made )
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Argenteuil
city: Bobigny
country: France
facility: AP-HP, Hôpital Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHRU de Brest
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: AP-HP, Hôpital Henri Mondor
city: Le Havre
country: France
facility: CHU Le Havre
city: Marseille
country: France
facility: HP-HM
city: Montpellier
country: France
facility: CHU de Montpellier
city: Niort
country: France
facility: CH de Niort
city: Paris
country: France
facility: AP-HP, Hôpital Cochin
city: Paris
country: France
facility: AP-HP, Hôpital Bichat
city: Reims
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
References:
Clinical trial NCT06087458: Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Official title: Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non- Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Perceive Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 will enroll in a dose escalation study model, followed by a Phase 2a cohort that will be randomized among two arms.
Primary purpose: TREATMENT

Brief summary: The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.

Detailed description: This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of escalating dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).

Eligibility criteria: Inclusion Criteria:

* Are ≥50 years of age at the time of consent.
* Are willing and able to understand and provide written informed consent.
* Are willing and able to return for scheduled treatment and follow-up examinations.
* Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
* Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
* Absence of signs of non-exudative MNV.
* Additional Ocular Inclusion Criteria for study eye.
* Meet certain genotype criteria for risk of AMD.

Exclusion Criteria:

* Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
* Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Primary outcomes:
measure: Safety and Tolerability as measured by frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: East Melbourne
country: Australia
facility: Cerulea Clinical Trials
state: Victoria
city: Melbourne
country: Australia
facility: Cabrini Research
state: Victoria
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center, Ophthalmology Division
Study officials:
affiliation: Perceive Biotherapeutics, Inc.
name: Anne Fung, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01716858: An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
Official title: Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Sulforaphane
Psychosis
Cognition
Oxidative stress
Antioxidant
Anti-inflammatory
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia for DSM-IV TR criteria
* Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone).
* Patients are stable for 4-weeks for antipsychotic medication.

Exclusion Criteria:

* Patients treated with clozapine
* Patients treated with two or more antipsychotic drugs
* Pregnant or breast-feeding women
* Patients treated with sulforaphane for more than 8-weeks in the past.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from baseline in PANSS scores at 8-weeks
Secondary outcomes:
measure: Cognition using CogState Research Battery
timeFrame: Change from baseline in the scores of the battery at 8-weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University Hospital
Study officials:
affiliation: Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
name: Masaomi Iyo, MD, PhD
role: STUDY_CHAIR
References:
citation: Shiina A, Kanahara N, Sasaki T, Oda Y, Hashimoto T, Hasegawa T, Yoshida T, Iyo M, Hashimoto K. An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. Clin Psychopharmacol Neurosci. 2015 Apr 30;13(1):62-7. doi: 10.9758/cpn.2015.13.1.62.
Clinical trial NCT05094258: Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.
Official title: Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Unicompartmental Knee osteoarthritis
Unicompartmental Knee prosthesis
Mobile insert
Fixed İnsert
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up
Primary purpose: TREATMENT

Brief summary: Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.

Detailed description: Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.

Eligibility criteria: Inclusion Criteria:

* Patients with degenerative knee arthritis with only one compartment affected

Exclusion Criteria:

* Inflammatory Arthritis
* Tricompartmental arthritis
* Patients with fixed varus deformity greater than -10 degrees
* Patients with fixed valgus deformity greater than -5 degrees
* Patients with knee range of motion less than 90 degrees
* Patients with more than 10 degrees of flexion contracture"

Primary outcomes:
measure: Short Form Health Survey (SF-36)
timeFrame: 0-1 year
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: 0-1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Volkan Ezici
state: Fatih
Study officials:
References:
Clinical trial NCT04734158: CORNEAL EPITHELIAL MAPPING IN DIABETICS
Official title: EVALUATION OF CORNEAL EPITHELIAL THICKNESS MAPPING IN DIABETIC PATIENTS USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND ITS CORRELATION TO MACULAR THICKNESS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cornea Epithelial Mapping
Keywords: cornea epithelium OCT diabetes
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 153
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It's a prospective cross section study. 159 eyes of 159 patients will be involved in this study, divided into three groups: (Group A) 53 eyes of diabetic patients with diabetic macular edema, (Group B) 53 eyes of diabetic patients without macular edema and (group C) 53 eyes of age matched control.

Brief summary: The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. The stem cells in the basal layer of the limbal epithelium hold a physiological significance in the renewal and metabolism of corneal epithelium, particularly under stressful situations.

Detailed description: The cornea in diabetic patients suffers from cellular dysfunction and dysfunctional repairal mechanisms, which include recurrent erosions, delayed wound healing, ulcers, and edema. In addition and undoubtedly related to epithelial dysfunction, alterations in epithelial basement membrane occur.

Eligibility criteria: Inclusion Criteria:

1. The patients aged between 40- 60 years old of both genders.
2. The patients in (Group A) should be diabetics for more than 10 years and free from any other systemic diseases with diabetic macular edema (by OCT).
3. The patients in (Group B) should be diabetics for more than 10 years and free from any other systemic diseases without diabetic macular edema (by OCT).
4. The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)

Exclusion Criteria:

1. Previous history of any intraocular surgery, intravitreal injection, laser or refractive surgery.
2. Ocular surface disorders (e.g. dry eye) or any corneal pathology.
3. Corneal scars or epithelial dystrophies.
4. Use of any topical medications.
5. Elevated IOP, pregnancy or lactation.

Primary outcomes:
measure: corneal epithelial thickness
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT00381758: The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
Official title: A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Methylphenidate
Metadate CD
Concerta
COMACS
Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 184
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.


Eligibility criteria: Inclusion Criteria:

* 6 -12 years of age, inclusive
* Have a diagnosis of ADHD
* Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.

Exclusion Criteria:

* IQ below 80.
* The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
* History of seizures (excluding uncomplicated childhood febrile seizures).
* Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
* Comorbid psychiatric diagnosis.
* Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.

Primary outcomes:
measure: School Day Efficacy
measure: SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
measure: 1.5 - 7.5 hours post-dosing
Secondary outcomes:
measure: SKAMP Attention Items, 1.5-12 hrs;
measure: PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
measure: SNAP IV (Swanson Nolan Pelham), day 3 & 7;
measure: Treatment Emergent Adverse Events, once weekly;
measure: Barkley Symptom scale, once weekly
measure: Patient Satisfaction,once weekly
measure: Parent Satisfaction & Treatment Preference once weekly
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: Simon Hatch
role: STUDY_DIRECTOR
References: