louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04227834: Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education
Official title: Re-infection Rates of Soil-transmitted Helminth Infections Among School-aged Children Following a Single or a 4-monthly Health Hygiene Education: an Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helminthiasis
Ascaris Infection
Trichuris Infection
Hookworm Infections
Children, Only
Keywords: Soil-transmitted helminth
School-aged children
Health hygiene
Education
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 432
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Soil-transmitted helminth (STH) infections caused by Ascaris lumbricoides, Trichuris trichiura, or hookworm, affect approximately 1.5 millions individuals primarily in tropical and subtropical regions. STHs infections have been associated with delay in growth and development in children. The prevalence in Indonesia varied from 45% to 65%, but in poor sanitation areas the prevalence can increased to 80%. World Health Organization currently recommends mass treatment with benzimidazoles and health hygiene education to control the disease. In this study we evaluated the effectiveness of single and four-monthly health hygiene education to STH reinfection rates among school-aged children in Mandailing Natal district, North Sumatera province, Indonesia.

Detailed description: In this study we evaluate the prevalence of STH among school-aged children using Kato Katz examination prior to enrolment to the study. Two elementary schools in Mandailing Natal district, North Sumatera province, Indonesia have been selected and received either a single or repeated health hygiene education. Preliminary knowledge was also assessed using a questionnaire. Infected children received treatment of albendazole 400 mg for 3 days. Evaluation on reinfection status and STH knowledge is done at 4 month, 8 month and 12 months.

Eligibility criteria: Inclusion Criteria:

* Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole

Exclusion Criteria:

* Parents who refused to participate in the study
* Severe malnutrition
* Co-infected with other helminth infections

Primary outcomes:
measure: The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children
timeFrame: 12 months
Secondary outcomes:
measure: Prevalence of STHs among school-aged children prior to intervention
timeFrame: STH prevalence at month 0
measure: Knowledge of STHs prevention measures among school-aged children before and after intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Panyabungan
country: Indonesia
facility: Singkuang sub-district, Mandailing Natal district
state: North Sumatera
Study officials:
affiliation: Universitas Sumatera Utara
name: Rizky KA Nasution, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01087216: Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vitiligo
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion.

The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas.

Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.

The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation.


Eligibility criteria: Inclusion Criteria:

* Age between 18 at 85
* Not segmental Vitiligo of clinical diagnosis located on bony projections or of ends
* Two symmetrical plates of vitiligo of more than 4 cm ²

Exclusion Criteria:

* Pregnant women or breastfeeding.
* Vitiligo lesions on face and neck
* Personal history of skin cancer
* Photosensitize drugs
* Personal history of photodermatosis
* Personal history of keloids
* Concomitant treatment that could have an action on vitiligo (such as tacrolimus or pimecrolimus).

Primary outcomes:
measure: Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: PASSERON Ph Thierry, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02361216: Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
Official title: Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-02-11
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.


Eligibility criteria: Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

* The full face
* The full balding scalp
* A contiguous area of approximately 250 cm2 on the chest

Exclusion Criteria:

* Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
* Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
* Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
* Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Participants With Partial Clearance at Week 8
timeFrame: 8 weeks
measure: Percentage of Participants With Partial Clearance at Week 4
timeFrame: 4 weeks
measure: Percent Reduction From Baseline in AK Count
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
Study officials:
affiliation: Laser & Skin Surgery Center of Indiana,
name: C. William Hanke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01100216: Human Laboratory Study of Smokeless Tobacco Products
Official title: Human Laboratory Study of Smokeless Tobacco Products
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smokeless Tobacco
Keywords: smokeless tobacco
nicotine
snus
snuff
chewing tobacco
oral tobacco
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-04-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.

Detailed description: Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.

Eligibility criteria: Inclusion Criteria:

* Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT.
* Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant.
* Subjects will have used SLT for at least 1 year..
* Subjects will be English speaking and reading.
* Provide written informed consent.

Exclusion Criteria:

* Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months.
* Subjects who take medications that might affect the outcome of laboratory measures.
* Subjects with a history of major mood, thought, anxiety or attentional disorders.

Primary outcomes:
measure: Withdrawal Severity
timeFrame: Week 10
Secondary outcomes:
measure: Cognition Impairments
timeFrame: Week 10
measure: Startle Response
timeFrame: Week 10
measure: Reinforcement
timeFrame: Week 10
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Tobacco Research Center
state: Minnesota
Study officials:
affiliation: Dept. Psychiatry, University of Minnesota
name: Marc Mooney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02909816: Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
Official title: Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Carie; Orthodontics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 364
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients under 18 years
* Patients who have already failed dental care because of non-cooperation
* Patients with or without mental or cognitive disabilities (regardless of type)
* Patients with or without sedative premedication

Brief summary: The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.


Eligibility criteria: Inclusion Criteria:

* Patients under 18 years
* Use of nitrous oxide/oxygen analgesia/anxiolysis
* Any type of dental care

Exclusion Criteria:

* Use of midazolam
* Use of general anesthesia

Primary outcomes:
measure: occurrence of vomiting
timeFrame: from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Violaine Smaïl-Faugeron
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Violaine Smaïl-Faugeron, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907616: Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women
Official title: Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Food Selection
Food Preferences
Food Insecurity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Wholesome Wave
name: Hispanic Health Council, Inc.
First posted: 2023-06-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will include women enrolled during the second trimester of pregnancy who will be provided with a specific amount per month for 10 months to purchase produce. Women will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. The study will use a co-design approach to utilize feedback from potential participants as well as participants at multiple time points in the process to improve the intervention and make it more relevant and impactful to our population.

Detailed description: This protocol describes the implementation of an intervention to improve access to fruits and vegetables among pregnant Latina women in Hartford CT in partnership with Wholesome Wave of Bridgeport CT, a national leader in nutrition incentive programming and policy.

The target population are pregnant Latina women living in Hartford CT. Having access to the right foods as well as enough food during pregnancy promotes optimal fetal development. A prescription program that provides increased fruit and vegetable access to low-income pregnant women can help improve the diet of women during pregnancy.

Nutrition education sessions (either virtual or in person) will be attended by all participants with one session required and up to two additional sessions optional.

Fruits and vegetables may be purchased at diverse community locations or online for home delivery.

Eligibility criteria: Inclusion Criteria:

* during first or second trimester of pregnancy
* live in the city of Hartford
* low income (participating or enrolled in WIC, SNAP or Medicaid)
* speak English or Spanish.

Exclusion Criteria:

* Any individual not meeting any of this criterion will be excluded from the study.

Primary outcomes:
measure: Change in amount of produce purchased or accessed
timeFrame: baseline and month 10
measure: Change in Produce Intake
timeFrame: baseline and month 10
Secondary outcomes:
measure: Change in household food insecurity
timeFrame: baseline and month 10
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hispanic Health Council
state: Connecticut
Study officials:
affiliation: Yale University
name: Rafael Pérez-Escamilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06657924: Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
Official title: Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bleeding
Colorectal Disorders
Thromboembolism
Tranexamic Acid
Keywords: Tranexamic Acid
TXA
Bleeding
Colorectal Surgery
Thromboembolism
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention (TXA) and control (no TXA) cohorts
Primary purpose: PREVENTION

Brief summary: The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are:

* Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days)
* Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding)
* Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism)

Researchers will compare preoperative TXA to no TXA to answer the above questions.

Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.


Eligibility criteria: Inclusion Criteria:

1. Adults 18 years or older
2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Exclusion Criteria:

1. Creatinine clearance less than 30 mL/minute
2. Long-term dialysis
3. Known defective color vision (color blind)
4. Pregnancy
5. History of venous or arterial thromboembolism, or active thromboembolic disease
6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Primary outcomes:
measure: Perioperative change in hemoglobin
timeFrame: 60 days
Secondary outcomes:
measure: Rate of composite bleeding complication
timeFrame: Within 30 days postop
measure: Rate of composite thromboembolic event
timeFrame: Within 30 days postop
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kristen A Ban, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952224: Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance - Impact on Outcome
Official title: Prognostic Significance and Determinants of Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance in Acute Reperfused Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-Elevation Myocardial Infarction
Keywords: myocardial salvage
cardiovascular magnetic resonance
magnetic resonance imaging
myocardial infarction
prognosis
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 267
Sex: ALL
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: Cohort of patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention

Brief summary: In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. The aim of the present study is to determine the prognostic significance and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial infarction (STEMI).


Eligibility criteria: Inclusion Criteria:

* ST-elevation myocardial infarction \< 12 hours
* primary percutaneous coronary intervention

Exclusion Criteria:

* previous myocardial infarction
* prior fibrinolysis
* contraindications to CMR at study entry (such as implanted pacemakers, defibrillators, claustrophobia or metallic intracranial implants)

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Ingo Eitel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: STUDY_DIRECTOR
References:
citation: Eitel I, Desch S, de Waha S, Fuernau G, Gutberlet M, Schuler G, Thiele H. Long-term prognostic value of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. Heart. 2011 Dec;97(24):2038-45. doi: 10.1136/heartjnl-2011-300098. Epub 2011 Oct 11.
citation: Eitel I, Desch S, Fuernau G, Hildebrand L, Gutberlet M, Schuler G, Thiele H. Prognostic significance and determinants of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. J Am Coll Cardiol. 2010 Jun 1;55(22):2470-9. doi: 10.1016/j.jacc.2010.01.049.