louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06213116: Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray
Official title: Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray Pre Endotracheal Intubation in Adult Undergoing General Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore Throat
Cough
Hoarseness
Hemodynamic Instability
Keywords: lignocaine
MADgic Atomizer
airway anesthesia
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized control study.
Primary purpose: TREATMENT

Brief summary: Comparing the efficacy between Lignocaine given via MADgic Atomizer and Lignocaine Pump Spray pre endotracheal intubation in adult undergoing General Anesthesia.

Detailed description: Comparing the efficacy of Lignocaine given via 2 device (Lignocaine Spray and MADGIC Atomizer) on hemodinamic parameters postintubations and severity grading of post operative sore throat, cough and hoarseness of voice.

Eligibility criteria: Inclusion Criteria:

* Adult with the age of 18 to 65 years old
* Gender of both male and female
* Planned for elective surgery scheduled at General Operation Theatre that require elective intubation for general anesthesia
* American Society Anaesthesiologist (ASA) preoperative physical status assessment of 1 and 2
* Airway assessment Malampati scoring 1and 2.

Exclusion Criteria:

* Pregnancy
* Known allergy or hypersensitivity to Lignocaine
* Pre existing sore throat or hoarseness of voice identified during preoperative assessment.
* The use of airway device other than endotracheal tube (ETT) such Laryngeal Mask airway/Supraglottic Device'
* Oral and neck surgery

Primary outcomes:
measure: Severity Grading of Post Operative Sore Throat
timeFrame: 24 hours
Secondary outcomes:
measure: Severity Grading of Post Operative Cough
timeFrame: 24 hours
measure: Severity grading of Hoarseness of voice
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kubang kerian
country: Malaysia
facility: University of Science Malaysia Hospital
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: rhendra hardy Mohamad Zaini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03778216: Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Official title: Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avoidant / Restrictive Food Intake Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5, no specialized intervention has yet been empirically studied. This randomized controlled crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention, Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients ages 5-12 years old.

Detailed description: Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN) diagnosed with ARFID and their families will be recruited will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID program either immediately after their screening or 3 months after assessment (i.e., to a usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.

There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3 months into treatment, and EOT. There will be 4 major assessment time points for those in Usual Care: Baseline, transition to treatment (3 months after the usual care period is complete), 3 months into treatment, and EOT. Both the child and the parent will complete measures at these time points. In addition, patients and parents will participate in ongoing qualitative assessments before treatment (BL), throughout treatment (every other session), and at EOT.

Eligibility criteria: Inclusion Criteria:

* children meeting DSM-V criteria for ARFID
* children between the ages of 5 to 12 years old

Exclusion Criteria:

* any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
* a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)

Primary outcomes:
measure: Estimated Body Weight (EBW)
timeFrame: following 6 months of treatment or 3 months of usual care
Secondary outcomes:
measure: Symptom Severity
timeFrame: following 6 months of treatment or 3 months of usual care
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: James D Lock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04022616: Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Official title: Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are being treated at the Ohio State Comprehensive Cancer Center and Stefanie Spielman Comprehensive Breast Center

Brief summary: Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Ability to give informed consent
* Stage I-III breast malignancy

Exclusion Criteria:

* Unable to tolerate venipuncture

Primary outcomes:
measure: Isolate unfavorable immune cells MDSC from the peripheral blood or tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells.
timeFrame: up to 1 year
Secondary outcomes:
measure: Isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood of study subjects who plan to start pre-operative chemotherapy for breast cancer to see if MDSC levels can predict who will respond to treatment. W
timeFrame: up to 1 year
measure: Isolate unfavorable immune cells MDSC from peripheral blood of study subjects who receive pre-operative chemotherapy for breast cancer to identify changes in MDSC levels during treatment can predict who will respond to treatment.
timeFrame: up to 1 year
measure: Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present.
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State Comprehensive Cancer Center
name: William Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wesolowski R, Stiff A, Quiroga D, McQuinn C, Li Z, Nitta H, Savardekar H, Benner B, Ramaswamy B, Lustberg M, Layman RM, Macrae E, Kassem M, Williams N, Sardesai S, VanDeusen J, Stover D, Cherian M, Mace TA, Yu L, Duggan M, Carson WE 3rd. Exploratory analysis of immune checkpoint receptor expression by circulating T cells and tumor specimens in patients receiving neo-adjuvant chemotherapy for operable breast cancer. BMC Cancer. 2020 May 19;20(1):445. doi: 10.1186/s12885-020-06949-4.
Clinical trial NCT06517316: Cosmetic Contact Lenses Post-Market Clinical Follow-up Study
Official title: Nelfilcon A Plano Cosmetic Contact Lenses Post-Market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cosmetic Appearance
Keywords: Eye color
Colored contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this post-market study is to gather long term performance and safety data on FreshLook® One-day Colors cosmetic contact lenses and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses in participants 12 years of age and older.

Detailed description: FreshLook® One-day Colors contact lenses and DAILIES FreshLook® ILLUMINATE contact lenses do not contain visual correction and are worn for cosmetic purposes only. Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of the study, approximately 1 year. This study will be conducted in the United States and Japan.

Eligibility criteria: Key Inclusion Criteria:

* Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form.
* Has never worn contact lenses before, with or without refractive error correction.
* Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of nelfilcon A plano cosmetic contact lenses.
* Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Pregnant and lactating women.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 1
measure: Incidence of microbial keratitis
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06167616: Infections and Latent Autoimmune Diabetes in Adults
Official title: Infections and Genetic Susceptibility in LADA and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Latent Autoimmune Diabetes in Adults
Type 2 Diabetes
Keywords: Latent Autoimmune Diabetes in Adults
Infections
Diabetes Mellitus
Type 2 diabetes
Case-Control Studies
register study
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Council for Working Life and Social Research
name: Novo Nordisk A/S
First posted: 2023-12-12
Enrollment: 5048
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 35 years or older, residing in Scania or Uppsala county.

Brief summary: Infections are proposed risk factors for type 1 diabetes in children. The investigators will examine whether a diagnosis of infectious disease also confers an increased risk of latent autoimmune diabetes in adults.

Detailed description: The investigators will use data from a population-based Swedish case-control study (ESTRID) with incident cases of LADA (n=597) and matched controls (n=2386). History of infectious disease are ascertained through national and regional patient registers. The investigators will estimate adjusted odds ratios (OR) with 95% CI for ≥1 respiratory (any/upper/lower), gastrointestinal, herpetic, other or any infectious disease episode, or separately, for 1 and ≥2 infectious disease episodes, within 0-1, 1-3, 3-5 and 5-10 years before LADA diagnosis/matching. Stratified analyses will be performed based on HLA risk genotypes and GADA levels.

Eligibility criteria: Inclusion Criteria:

* 35 years or older, residing in Scania or Uppsala county.

Exclusion Criteria:

* Less than 35 years

Primary outcomes:
measure: LADA
timeFrame: Up to 10 years
Secondary outcomes:
measure: Type 2 diabetes
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institute
Study officials:
affiliation: Karolinska Institutet
name: Sofia Carlsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00850616: Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
Official title: A Phase I Dose Ranging Study of the Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
HIV Infections
Keywords: HIV
HIV Seronegativity
Preventive Vaccine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine


Eligibility criteria: Inclusion Criteria:

* Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection
* Subject agrees to use an acceptable method of birth control through week 52 of the study

Exclusion Criteria:

* Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine
* Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
* Subject has known or suspected impaired immune function
* Subject has participated in any other HIV vaccine trial
* Female subject is pregnant or breastfeeding

Primary outcomes:
measure: Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
timeFrame: Week 30
measure: Immune response to MRKAd5+6 trigene vaccine
timeFrame: 30 week
Secondary outcomes:
measure: Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6
timeFrame: Week 30
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009 Sep;16(9):1285-92. doi: 10.1128/CVI.00144-09. Epub 2009 Jul 15.
Clinical trial NCT01878916: Plasma Vitamin and Homocysteine Levels and Thrombosis in Patients With Ph-negative MPNs
Official title: Plasma Cobalamin, Folate, Pyridoxine and Homocysteine Levels and Thrombosis in Patients With Philadelphia-chromosome-negative Myeloproliferative Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis
Keywords: the incidence of thrombosis,
the effect of Hcy on thrombosis formation,
the relation between Hcy and plasma vitamin levels,
to compare these results with the control group
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-06-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between January and June 2003, thirty-one new or formerly diagnosed MPN patients who consecutively visitted our clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.

Brief summary: Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine levels in MPNs, and to compare these results with the healthy controls.

Detailed description: Thirty-one new or formerly diagnosed MPN patients who consecutively visitted our outpatient clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.

Eligibility criteria: Inclusion Criteria:

Adult MPN patients and healthy controls who gave a written consent were included in the study.

Exclusion Criteria:

Exclusion criteria included not giving a written consent and using medications without an indication which may have an effect on plasma homocysteine and vitamin levels.

Primary outcomes:
measure: Thrombosis
timeFrame: at least 1 year
Secondary outcomes:
measure: High Hcy level
timeFrame: 1 year
Other outcomes:
measure: Death
timeFrame: 1 year
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University
name: Ahmet Emre Eskazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248716: Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron Deficiency
Anemia
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:

1. Iron deficiency with no anemia
2. anemia
3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.

The hypothesis is that a significant difference will be detected between the two preparations.


Eligibility criteria: Inclusion Criteria:

* Healthy toddlers age 9-18 months

Exclusion Criteria:

* Toddlers with: chronic diseases, prematurity, inherited hematological disease.

Primary outcomes:
measure: Hemoglobin
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Primary Pediatric Care Unit, Ben-Gurion University of the Negev
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Jacob Urkin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01110616: EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
Official title: A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dementia
Keywords: EEG Standardization
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and lorazepam.

This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged across a topographical region of interest is decreased 6 hours after administration of MK3134 compared to placebo.

The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG using two probe compounds: MK3134 and lorazepam.


Eligibility criteria: Inclusion Criteria:

* Subject is a male between 18 to 40 years of age
* The subject has a Body Mass Index (BMI) greater than or equal to 31 kg/m\^2 at the prestudy (screening) visit
* Subject has normal or corrected to normal visual and auditory acuity
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
* Subject is right-handed

Exclusion Criteria:

* Subject has permanent cosmetic or metallic objects in their body that can interfere with the measurements
* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of neoplastic disease
* Subject has a current diagnosis of or a prior history of sleep apnea
* Subject has a history of fainting during blood draws
* Subject has a history of significant head injury/trauma
* Subject has a current diagnosis of or history of Bipolar illness, Schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD), or claustrophobia
* Subject works a night shift and is not able to avoid night shift work within 3 days before each treatment visit
* Subject is currently a regular user of any illicit drugs or has a significant history of drug (including alcohol) abuse

Primary outcomes:
measure: EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo
timeFrame: Baseline and 6 hours
Secondary outcomes:
measure: EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo
timeFrame: Baseline and 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: