louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00728273: Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children
Official title: Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Efficacy
Vietnam
school children
anemia
fortification
micronutrient
Lead sponsor: Neys-van Hoogstraten Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2008-08-05
Enrollment: 510
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.

Detailed description: Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.

Eligibility criteria: Inclusion Criteria:

* school children aged 6-8 years with written informed consent from parents/caregivers

Exclusion Criteria:

* hemoglobin concentrations \< 80g/L
* chronic disease
* congenital abnormalities
* mental or severe physical handicap
* severe malnutrition
* obesity
* receiving deworming within the previous 6 mo

Primary outcomes:
measure: Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement).
timeFrame: 4 months
Secondary outcomes:
measure: growth (especially weight), body composition (body fat)
timeFrame: 4 months
measure: prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in
timeFrame: 4 months
Other outcomes:
Locations:
city: Nakhon Pathom
country: Thailand
facility: Institute of Nutrition, Mahidol University
Study officials:
affiliation: Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand
name: Pattanee Winichagoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224873: Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET
Official title: Diagnosis of Sceletal Metastases in c. Mammae: 18F-NaF-PET/Lowdose-CT Versus 99mTc HDP Bone Scintigraphy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
bone metastasis
comparison of diagnostic methods
bone scintigraphy
fluoride PET/CT
FDG-PET/CT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 110
Sex: FEMALE
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: breast cancer patients who are treated at Rigshospitalet, DK

Brief summary: Breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is superior to bone scintigraphy with technetium. On the other side, the investigators would like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* histologically proven c. mammae
* clinically suspicion of bone metastases

Exclusion Criteria:

* age under 18 years
* diabetes mellitus
* pregnancy
* other known malignant disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Nuclear Medicine & PET, Rigshospitalet
Study officials:
affiliation: Dep. of Nuclear Medicine & PET, Rigshospitalet, Denmark
name: Christine Winkler, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04638673: NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Official title: Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus
Covid19
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-11-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.


Eligibility criteria: Inclusion Criteria:

* COVID positive
* At home
* Afebrile
* Anxiety
* Depression
* Vertigo
* Anosmia
* Headaches
* Irritability
* Cognitive Processing

Exclusion Criteria:

* Damage to left ear anatomy
* Unstable hemodynamic effects
* Ischemic or hemorrhagic stroke after developing COVID
* Unable to give consent, follow instructions
* Unable to read or write or speak English
* No access to home WiFi

Primary outcomes:
measure: Change in Score of Patient Health Questionnaire-9
timeFrame: Baseline and week 4 (End of Treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Mark S George, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badran BW, Huffman SM, Dancy M, Austelle CW, Bikson M, Kautz SA, George MS. A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms. Bioelectron Med. 2022 Aug 25;8(1):13. doi: 10.1186/s42234-022-00094-y.
citation: Badran BW, Huffman SM, Dancy M, Austelle CW, Bikson M, Kautz SA, George MS. A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms. Res Sq [Preprint]. 2022 Jun 21:rs.3.rs-1716096. doi: 10.21203/rs.3.rs-1716096/v1.
Clinical trial NCT06098573: Development and Evaluation of HighAlert
Official title: Development and Evaluation of 'High Alert', a Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis
Youth Drinking
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Canada, youth ages 16-24 have the highest rates of cannabis use, impaired driving, and express the least concern for driving under the influence of cannabis (DUIC). As such, developing effective and practical DUIC prevention efforts is crucial. This study aims to evaluate the effects of 'High Alert' in reducing 3-month risky cannabis use and DUIC among young Ontarian drivers. 'High Alert' is an interactive web-based smartphone application developed by the research team with the feedback of experts and youth. 'High Alert' modules focus on recognizing what constitutes risky cannabis use, the effects of cannabis on driving, the risks of DUIC, and strategies to avoid DUIC. A pilot randomized controlled trial will compare the effects of 'High Alert' with an active control (DUIC Information) and passive control (no contact). Overall, effectively preventing DUIC among youth is critically needed and time-sensitive.


Eligibility criteria: Inclusion:

* ages 18-24
* valid Ontario driver's license
* access to a motor vehicle
* report DUIC at least three times in the past three months
* proficient in English
* have a smartphone they can complete the intervention with.

Exclusion Criteria:

* Individuals under 18 and those over 24
* resides outside Ontario
* non-drivers

Primary outcomes:
measure: Past driving under the influence of cannabis
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
References:
Clinical trial NCT01131273: HIV Risk Reduction in Subutex Injectors in Tbilisi
Official title: Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: buprenorphine injecting
opiate dependence
HIV risk
treatment outcome
opiate dependence with buprenorphine injecting
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-05-26
Enrollment: 68
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.


Eligibility criteria: Inclusion Criteria:

* current opioid dependence;
* injecting buprenorphine 10 or more times in the last 30 days;
* between 25 and 50 years of age;
* buprenorphine and/or opiate positive urine test;
* not on methadone maintenance in last 4 weeks;
* stable address within Tbilisi and not planning to move;
* home or cellular phone number where can be reached;
* able to provide name of family member who knows whereabouts;
* willingness and ability to give informed consent.

Exclusion Criteria:

* currently dependent on alcohol, benzodiazepines or other CNS depressants;
* legan charges with impending incarceration;
* plans to move from Tbilisi within next 6 months;
* current participation in another treatment study;
* serious medical problems that would impair or make hazardous ability to participate;
* active TB;
* currently psychotic/suicidal;
* uncontrolled seizure disorder.

Primary outcomes:
measure: Buprenorphine injecting
timeFrame: 12 weeks
Secondary outcomes:
measure: HIV Risk
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Union Alternative Georgia
Study officials:
affiliation: University of Pennsylvania
name: Geroge Woody, MD
role: STUDY_DIRECTOR
References:
citation: Otiashvili D, Piralishvili G, Sikharulidze Z, Kamkamidze G, Poole S, Woody GE. Methadone and buprenorphine-naloxone are effective in reducing illicit buprenorphine and other opioid use, and reducing HIV risk behavior--outcomes of a randomized trial. Drug Alcohol Depend. 2013 Dec 1;133(2):376-82. doi: 10.1016/j.drugalcdep.2013.06.024. Epub 2013 Jul 31.
Clinical trial NCT04320173: Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects
Official title: An Open Label, Three-period, Single-application, Adhesion Performance Study ZTlido® (Lidocaine Topical System) 1.8% Compared to Lidoderm® (Lidocaine Patch 5%) and Versatis® (Lidocaine Medicated Plaster 5%) in Healthy, Adult, Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).


Eligibility criteria: Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
* Non-smokers
* Be at least 18 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
* Presence of any current dermatological condition including psoriasis, eczema, and atopic dermatitis
* Presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, irritated (e.g., redness, rash or having blister, etc.) or excessively oily skin at the application areas that may affect the application of the product or adhesion properties of the product.
* History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and do not involve the investigative site
* History of addiction, abuse, and misuse of any drug

Primary outcomes:
measure: Mean Adhesion Score (FDA scale)
timeFrame: 12 hours post-dose
measure: Mean Adhesion Score (EMA scale)
timeFrame: 12 hours post-dose
Secondary outcomes:
measure: Dermal Response Score
timeFrame: 12.5 and 14 hours post-dose
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
affiliation: TKL Research, Inc.
name: Phillip LaStella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.
Clinical trial NCT02749773: Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).


Eligibility criteria: Inclusion Criteria:

* Fertility treatment
* Antral follicle count

Exclusion Criteria:

* Women who refuse to participate

Primary outcomes:
measure: Oocyte Quality microscopic description.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yuval Atzmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atzmon Y, Michaeli M, Aslih N, Ruzov O, Rotfarb N, Shoshan-Karchovsky E, Shalom-Paz E. Degenerative Oocytes in the Aspirated Cohort Are Not Due to the Aspirating Needle: a Prospective Randomized Pilot Study with Sibling Oocytes. Reprod Sci. 2021 Jul;28(7):1882-1889. doi: 10.1007/s43032-020-00384-3. Epub 2020 Nov 10.
Clinical trial NCT01995773: Glucose Metabolism and Quality of Life in Healthy Women
Official title: Glucose Metabolism, Adrenal Function, Cortisol Metabolism, Body Composition Physical Activity, and Quality of Life in Healthy Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Healthy women
Quality of life
Glucose metabolism
Adrenal reactivity
Physical activity
Body Composition
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 healthy women with regular menstrual cycle, normal hair growth, and body mass index between 18 and 35 kg/m2

Brief summary: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of life.

In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels, cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical activity and quality of life is studied in 40 healthy women. The results will be compared with results from studies on women with PCOS in order to investigate any differences in these parametres.


Eligibility criteria: Inclusion Criteria:

* healthy
* No medications
* regular menstrual cycle
* no hair growth problems
* BMI 18-35 kg/m2

Exclusion Criteria:

* medication
* diabetes mellitus
* signs of PCOS
* BMI \< 18 or \> 35

Primary outcomes:
measure: Level of androgens
timeFrame: baseline
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline
measure: Body composition
timeFrame: baseline
measure: Bone density
timeFrame: baseline
measure: Glucose tolerance
timeFrame: 5 hours
Other outcomes:
measure: physical activity
timeFrame: one week
measure: adrenal activity
timeFrame: 1 hour
measure: Ovarian morphology
timeFrame: at baseline
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Hanne Mumm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mumm H, Altinok ML, Henriksen JE, Ravn P, Glintborg D, Andersen M. Prevalence and possible mechanisms of reactive hypoglycemia in polycystic ovary syndrome. Hum Reprod. 2016 May;31(5):1105-12. doi: 10.1093/humrep/dew046. Epub 2016 Mar 23.
Clinical trial NCT00971373: Pilot Study to Determine the Effectiveness of Antimicrobial Healthcare Worker's (HCW) Hands and Clothing
Official title: Pilot Study to Determine the Effectiveness of Antimicrobial Scrubs on Bacterial Burden of HCW's Hands and Clothing in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting
Keywords: antimicrobial
epidemiology
bacteriology
CFU
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial burden of HCW's hands and clothing in a clinical setting.

Detailed description: Goals of the pilot study:

* Compare CFU counts on antimicrobial vs standard scrubs in a clinical setting
* Assess CFU counts on the hands of HCWs wearing antimicrobial vs non-antimicrobial scrubs
* Assess HCW hand hygiene compliance during the study protocol
* Correlate device associated infection rates during protocol to historical controls
* Assess feasibility of applying protocol to a longer,12-24 month, prospective crossover-trial to definitively study and assess the impact of antimicrobial scrubs on HCW apparel and hand colonization, control of multi-drug resistance organisms, hand hygiene compliance, and device associated hospital acquired infection rates.

II. Design

Cross-over trial in an ICU or Hospital Ward

III. Outcome Measures

1. CFU count on participants

   1. Hands
   2. Scrubs
   3. Antimicrobial scrubs vs standard scrubs
2. Hand Hygiene Compliance
3. Device associated nosocomial infections rates

Eligibility criteria: Inclusion Criteria:

* HCWs in the MRICU

Exclusion Criteria:

* Under the age of 18 who is not a healthcare worker in the MRICU

Primary outcomes:
measure: Effectiveness of Antimicrobial impregnated scrubs
timeFrame: 4 months
Secondary outcomes:
measure: HCW hand and scrub average bacterial counts
timeFrame: 4 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Gonzalo Bearman, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: