louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01379040: Volatile Organic Compounds in Cystic Fibrosis
Official title: Detection of Pulmonary Colonization in Cystic Fibrosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Pseudomonas Aeruginosa
Keywords: Cystic Fibrosis
Pseudomonas aeruginosa
Volatile Organic Compounds
Electronic nose
Gas Chromatography
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from Dr. Landon's primary care clinic.

Brief summary: This experiment is designed to test the effectiveness of a new electronic nose device, which allows a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of bacterial organisms in the lower respiratory tract. It consists of:

* A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air.
* Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography.
* Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection.

This study will test the hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling the "head space" above culture media of sputum provided by patients with cystic fibrosis. This study will test the additional hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath from the patient providing the sputum.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Cystic Fibrosis
* Must be able to give breath and sputum samples

Exclusion Criteria:

* Heavy smoker
* Inability to regularly give breath and sputum samples
* History of additional pulmonary disease

Primary outcomes:
measure: Bacterial Identification
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Pediatric Diagnostic Center
state: California
Study officials:
References:
citation: http://www.beehive.co.jp/est/samplePDF/CysticFibrosis.pdf
Clinical trial NCT05346640: Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Official title: Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Drop
Lead sponsor: Cionic, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A one-group, pre-test post-test study.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (FES) of the lower leg to improve gait in people with foot drop.

Detailed description: Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. All participants will receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets. Participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). The primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).

Eligibility criteria: Inclusion Criteria:

Adults aged 18-70

* Lower extremity impairment that makes walking difficult or uncomfortable
* Capable of sitting, standing, and walking independently or with assistance
* Able to walk at least 50 feet independently or with assistance
* Able to understand and follow basic instructions in English

Exclusion Criteria:

* Have non-reversible damage to the peripheral nervous system
* Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices
* Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent
* Have lower motor neuron disease or injury that may impair response to stimulation
* Are pregnant
* Are under the age of 18 years old
* Have skin conditions of the affected lower limb, including cuts, burns or lesions

Primary outcomes:
measure: Mean Dorsiflexion at Heel Strike
timeFrame: 60 minutes
measure: Mean Ankle Inversion During Swing Phase
timeFrame: 60 minutes
Secondary outcomes:
measure: Mean Foot Angle at Heel Strike
timeFrame: 60 minutes
measure: Mean Heel-Toe Time as a Percent of Gait Cycle
timeFrame: 60 minutes
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Cionic, Inc.
state: California
city: Cleveland
country: United States
facility: Cleveland State University
state: Ohio
Study officials:
References:
Clinical trial NCT06291740: Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department
Official title: Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma Exacerbation
Emergency Department
Nebulization
Keywords: asthma exacerbation
continuous nebulization
intermittent nebulization
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented.


Eligibility criteria: Inclusion Criteria:

* asthma exacerbation

Exclusion Criteria:

* life-threatening conditions requiring intubation
* allergy to steroid or its components
* patient under investigation of Corona Virus Disease, 2019 (COVID-19)
* pulmonary tuberculosis
* unable to cooperate for pulmonary function testing

Primary outcomes:
measure: Length of ED stay
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: pulmonary function test
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Hospital admission
timeFrame: through study completion, an average of 1 year
measure: ED revisit within 48 hours
timeFrame: through study completion, an average of 1 year
Locations:
Study officials:
affiliation: Faculty of Medicine, Thammasat university
name: Kumpol Kornthatchapong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05708040: Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
Official title: Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.


Eligibility criteria: Inclusion Criteria:

* Diagnostic criteria for DM1 according to ADA
* Candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team.
* Acceptance of participation in the study and signing of the informed consent

Exclusion Criteria:

* Gestation
* Institutionalization, serious or terminal illness or renal replacement therapy.
* Inability to undertake the training and / or acquire the degree of knowledge to use both systems
* Refusal to participate in the study or to sign the informed consent

Primary outcomes:
measure: Time in Range
timeFrame: 12 months
Secondary outcomes:
measure: A1c levels
timeFrame: 12 months
measure: Time below range
timeFrame: 12 months
measure: Time above range
timeFrame: 12 months
measure: Health-Related Quality of Life in Patients with Type 1 Diabetes
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
name: Lía Nattero-Chávez, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654640: The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Official title: Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
obesity
clozapine
metformin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2012-08-01
Enrollment: 15
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: The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

Detailed description: In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.

Eligibility criteria: Inclusion Criteria:

* Age: 18 \~ 65
* Patient with schizophrenia according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* Patient taking clozapine 3months or more
* Patient increased in weight more than 10 % of that of before antipsychotics use

Exclusion Criteria:

* Patient taking other antipsychotics with clozapine
* Patient in treatment of diabetes
* Patient in treatment of dyslipidemia
* Allergy or hypersensitivity to metformin
* Pregnant or breast-feeding female patient.
* Patient with severe medical condition

Primary outcomes:
measure: change of weight
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Positive and Negative Symptom Scale(PANSS)
timeFrame: baseline, 12 weeks, 24 weeks
measure: MADRS(montgomery asberg depression rating scale)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Clinical Global Impression-severity(CGI-S)
timeFrame: baseline, 6 weeks, 24 weeks
measure: Clinical Global Impression-improvement(CGI-I)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Beck's Depression Inventory(BDI)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
timeFrame: baseline, 12 weeks, 24 weeks
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Short form(36) Health survey (SF-36)
timeFrame: baseline, 12 weeks, 24 weeks
measure: abdominal fat amount CT
timeFrame: baseline, 12 weeks, 24 weeks
measure: change of prevalence of metabolic syndrome
timeFrame: baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Min Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739440: Randomized Controlled Trial to Compare Two Anti-scorpion Serums
Official title: Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scorpion Sting
Lead sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Sponsor class: OTHER
First posted: 2008-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum

Detailed description: We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

This is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum.

Eligibility criteria: Inclusion Criteria:

* Sting scorpion
* Informed consent
* Age 15-60
* Either sex
* Resident in study area

Exclusion Criteria:

* Previous treatment with gammaglobulin
* Blood transfusion at any stage of life
* Sensitivity or intolerance to serums antiscorpion or horse products
* Pregnancy
* Some immunodeficiency

Primary outcomes:
measure: Resolution of signs and symptoms of scorpion envenomation
timeFrame: after treatment (expected average of 12 hrs)
Secondary outcomes:
measure: Evaluate the adverse events in every treated child
timeFrame: inmediately after treatment and until 5 days later
Other outcomes:
Locations:
Study officials:
affiliation: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
name: Jimenez C Ma. Eugenia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05640440: Executive Function Performance in Children Who Stutter
Official title: Executive Function Performance in Children Who Stutter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stuttering, Childhood
Executive Dysfunction
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 30 case group, 15 control group age range 7 yrs old and 15 yrs old

Brief summary: The study aims to asses the executive function in children who stutter for better management of those children

Detailed description: It is a case control study which will be done on 30 child who stutter and 15 normal child as a control group. Executive function testing will be done using computerized program called PEPL . Also, total intelligence quation(IQ) , verbal IQ, non verbal IQ will be assessed in both groups. stuttering severity will be assessed in case group.

Eligibility criteria: Inclusion Criteria:

1. Patient and volunteers age between 7 years and 15 years.
2. IQ ≥ 85.

Exclusion Criteria:

* History of secondary stuttering.
* Language impairment and other speech problem.
* Concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.

Primary outcomes:
measure: PEPL numerical stroop test
timeFrame: one year
measure: Cognitive flexibility function (sub-division of executive function testing)
timeFrame: one year
measure: Working memory score
timeFrame: one year
Secondary outcomes:
measure: Non word Repetation score(Fawzy et al., 2012)
timeFrame: one year
measure: Backward digit span score (Aboras et al., 2008)
timeFrame: one year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Rasha Mohamed Hashem
Study officials:
affiliation: ahlaama@yahoo.com
name: Ahlam A Nabieh, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01425840: Liposomal Lidocaine Gel for Oral Topical Anesthesia
Official title: Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anesthesia
Keywords: Lidocaine,
liposome encapsulation,
topical anesthesia,
palatal mucosa
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

Detailed description: This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Primary outcomes:
measure: The efficacy of topical anesthetics on the oral mucosa.
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School
state: São Paulo
Study officials:
References:
citation: Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.
Clinical trial NCT04499040: Clinical and Biological Characterization of Patients and Collection of Samples
Official title: Tricho-hepato-enteric Syndrome: From Abnormal RNA Decay to Disease Clinical and Biological Characterization of Patients and Collection of Samples -THE-RNA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricho Hepato Enteric Syndrome
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Objectives: Collect clinical and biological data about patients with SD/THE, collect samples of patients; create a secure on line database to collect worldwide data about SD/THE Partners : APHM, HCL, APHP

Currently10 patients (8 with TTC37 mutations and 2 with SKIV2l mutations) present a SD/THE and are managed in France in 5 different centers (Marseille, Paris Trousseau, Paris Necker, Paris Robert Debrés, and Lyon). Most of them are followed in hepato-gastro-enterology units for their intractable diarrhea. Three aspects of the disease: intractable diarrhea, immune defect and liver disease are responsible for the main part of the burden of the disease .For each aspect, the investigators will propose a close follow-up with collection of clinical, biochemical, functional and microbial data.

Collect of clinical date: during a programmed consultation clinical data about symptom will be collected twice a year. A detailed form will be used for better delineation of the symptoms. These data included growth, symptom (diarrhea, pain ...), and clinical signs. Most of these children have recurrent sample for follow up. During them some blood will be take for study the immune side but also the platelet function.


Eligibility criteria: Inclusion Criteria:

* patient \< 18 year-old
* patients with SD/THE

control group :

* patients with tufting enteropathy and short bowel syndrome.

Exclusion Criteria:

* child among whom the parents or the legal representatives refused that their child participates in this study

Primary outcomes:
measure: Assessment of detailed clinical characteristics of the phenotype of Tricho-hepato-enteric syndrome
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Jean-Olivier Arnaud
role: STUDY_DIRECTOR
References: