louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03375840: Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time
Official title: Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Smoking, Cigarette
Keywords: pictorial warning labels
risk knowledge
emotion
memory
risk perceptions
quit intentions
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2017-12-18
Enrollment: 4424
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks. This trial tests memory for health risks immediately or after a six-week delay for US-representative adult smokers, US-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers. In addition, the trial tests the effects of different warning label components and the consequences of memory for labels on risk perceptions and quit intentions.


Eligibility criteria: Inclusion Criteria:

* 19-65 years old (adult samples)
* have smoked 100+ lifetime cigarettes (adult samples)
* currently smoke "every day" or "some days." (adult samples)
* 14-18 years old (teen sample)
* have ever smoked a cigarette (teen sample)

Exclusion Criteria:

• have not ever smoked a cigarette (all samples)

Primary outcomes:
measure: graphic warning label recall
timeFrame: immediately following last exposure or after 6-week delay
measure: smoking risk recognition
timeFrame: immediately following last exposure or after 6-week delay
Secondary outcomes:
measure: smoking risk perceptions
timeFrame: immediately following last exposure or after 6-week delay
measure: quit intentions
timeFrame: immediately following last exposure or after 6-week delay
Other outcomes:
Locations:
Study officials:
References:
citation: Peters E, Shoots-Reinhard B, Evans AT, Shoben A, Klein E, Tompkins MK, Romer D, Tusler M. Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time. Ann Behav Med. 2019 Mar 20;53(4):358-371. doi: 10.1093/abm/kay050.
Clinical trial NCT04431440: Silver Nanoparticles in Multidrug Resistant Bacteria
Official title: Bactericidal Effect of Silver Nanoparticles on Methecillin and Vancomycin Resistant Staphylococcus. Aureus (MRSA) Isolated From Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multidrug Resistent Bacteria
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill patients

Brief summary: Recently, silver nanoparticles (AgNPs) have been widely used in various applications as antimicrobial agents, anticancer, diagnostics, biomarkers, cell labels, and drug delivery systems for the treatment of various diseases. The present study investigated the bactericidal effect of AgNPs against Methecillin Resistant Staph. aureus (MRSA) and Vancomycin resistant Staph aureus (VRSA)


Eligibility criteria: Inclusion Criteria:

* Intensive care patients

Exclusion Criteria:

* none

Primary outcomes:
measure: bactericidal effect of silver nanoparticles on multidrug resistant bacteria
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Elsawy S, Elsherif WM, Hamed R. Effect of silver nanoparticles on vancomycin resistant Staphylococcus aureus infection in critically ill patients. Pathog Glob Health. 2021 Jul;115(5):315-324. doi: 10.1080/20477724.2021.1914412. Epub 2021 Apr 19.
Clinical trial NCT02251340: Randomized Controlled Trial of an Eczema Care Plan
Official title: Randomized Controlled Trial of an Eczema Care Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this project are to increase families' understanding of eczema and improve eczema management in the primary care setting. We have created an "Eczema Care Plan" similar to those used in the management of asthma. It gives specific instructions about medications, bathing and moisturizing, as well as when to seek further treatment. We will conduct a randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period. Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and (3) increase parental knowledge and confidence about eczema management. We also plan to track provider uptake and documentation of the plan and elicit feedback from parents and providers on the utility and feasibility of the plan.


Eligibility criteria: Inclusion Criteria:a) accompanying adult speaks English b) patient has a history of eczema c) patient is between the ages of 1 month and 16 years d) family is coming for an eczema visit or plans to discuss eczema e) accompanying adult is a primary caregiver f) child is not in foster care g) caregiver has not received an eczema care plan previously. -

Exclusion Criteria: a) accompanying adult does not speak English b) patient does not have a history of eczema c) patient is younger than 1 month or older than 16 years of age d) eczema will not be discussed at the visit e) accompanying adult is not the primary caregiver f) child is in foster care g) caregiver has received an eczema care plan previously.

Primary outcomes:
measure: proportion of patients with moderate/severe/very severe eczema
timeFrame: 1 month for each patient
measure: quality of life measured via validated survey
timeFrame: 1 month for each patient
measure: parental knowledge measured via survey
timeFrame: 1 month for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05440240: Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Official title: Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dupuytren Contracture
Dupuytren's Disease
Contracture
Joint Diseases
Musculoskeletal Diseases
Fibroma
Neoplasm, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases
Keywords: Percutaneous needle fasciotomy
Corticosteroid
Randomized controlled trial
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.


Eligibility criteria: Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \<20° passive extension deficit (PED), is a prerequisite for inclusion.

Inclusion Criteria:

* Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
* DC of either II-V finger
* Well-defined/palpable cord

Exclusion Criteria:

* Legally incapacitated
* Previous study inclusion with another finger ray
* Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture \< 20° PED regardless of the deficit in the PIP or DIP joint
* Previous hand surgery of the affected finger for any reason
* Known allergy to the study medication
* Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
* Pregnant or lactation
* Insulin dependent diabetes mellitus
* Ongoing systemic infection or local infection at the site of the procedure
* Rheumatoid arthritis
* Amyloidosis or mucopolysaccharidosis
* Unable to communicate, cooperate or participate in follow-up

Primary outcomes:
measure: Recurrence rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Regionshospitalet Horsens
name: Jeppe Lange, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02897440: Full Versus Partial Repairing of Soft Tissue Surrounding the Hip in Arthroplasty for Femoral Neck Fractures
Official title: Full Repairing Versus Partial Repairing of Soft Tissue Surrounding the Hip Joint in Hip Arthroplasty for Femoral Neck Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Neck Fracture
Keywords: Femoral Neck Fracture
Hip Arthroplasty
Repairing of soft tissue
Lead sponsor: First Hospitals affiliated to the China PLA General Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with femoral neck fractures undergoing hip arthroplasty through anteriorolateral approach.

Brief summary: A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ \<7, pathological fractures, non-walkers were excluded.

Detailed description: Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.

Eligibility criteria: Inclusion Criteria:

* Displaced femoral neck fracture
* Walker
* Hemiarthroplasty or Total Hip Arthroplasty
* Preiffer test \>7/10

Exclusion Criteria:

* Pathological fracture
* Non-walker
* Pfeiffer test \<7/10 indicating mental alteration

Primary outcomes:
measure: Trendelenburg Test
timeFrame: At 4 week postoperatively
measure: Abductor strength
timeFrame: At 4 week postoperatively
Secondary outcomes:
measure: WOMAC
timeFrame: At 2, 4, 6 weeks and 12 months postoperatively
measure: Quality of life (EQ-5D)
timeFrame: At 2, 4, 6 weeks and 12 months postoperatively
measure: Pain (Visual analouge scale)
timeFrame: At 2, 4, 6 weeks and 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06545240: Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives
Official title: Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Malnutrition
Keywords: mid-upper arm circumference
sensitivity
severe acute malnutrition
specificity
WHZ index
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 421
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted in the largest primary community health care facility in Cengkareng Jakarta and have 29.110 registered under-fives in its service area.

Brief summary: WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. However, several studies showed that this cut-off need to be evaluated as it has modest detection rate for SAM. This study aims to evaluate diagnostic value of MUAC with 11.5 cm cut-off compared to WHZ as gold standard to identify SAM. The sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as a standard cut-off will be evaluated.

This study also aim to find new cut-off value that may offer better diagnostic performance. The main research questions were:

What is the diagnostic accuracy of Mid-Upper Arm Circumference (MUAC) compared to the Weight for Height Z Score (WHZ) in identifying SAM in children, and what is the optimal MUAC cut-off value for enhanced diagnostic performance?


Eligibility criteria: Inclusion Criteria:

* under-fives that 6-59 months-old

Exclusion Criteria:

* ascites
* edema
* hydrocephalus
* tumor or oncologic diseases
* organomegaly
* uncooperative during measurement

Primary outcomes:
measure: Diagnostic value of MUAC in diagnosing SAM compare to WHZ-index
timeFrame: 2 months
Secondary outcomes:
measure: Finding new cut off value that offer better diagnostic performance using ROC
timeFrame: 2 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr Cipto Mangunkusumo
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Puskesmas Cengkareng
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT06850740: Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy
Official title: The Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has recently sparked great interest. In clinical practice, administering ondansetron before spinal anesthesia has produced promising results.

Detailed description: This prospective randomized double-blinded controlled study will be conducted on 46 patients undergoing inguinal herniorrhaphy at Suez Canal University Hospital and will be randomly assigned to one of the two groups using a table of random numbers. Group A (23 patients) will be administered 8 mg of ondansetron diluted in 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis to be finished in 10 minutes. Group B (23 patients) will be administered 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis, to be finished in 10 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for inguinal herniorrhaphy in Suez Canal University Hospitals
* Height: 150 to 180 cm.
* Body mass index (BMI): not more than 35 kg/m².
* Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients), ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).

Exclusion Criteria:

* Patients refused to participate in the study.
* Contraindications of spinal anesthesia.
* Known allergy to bupivacaine or ondansetron.
* Patients with a history of arrhythmia, especially those with prolonged QT intervals.

Primary outcomes:
measure: Ephedrine
timeFrame: From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors
Secondary outcomes:
measure: Nausea and vomiting
timeFrame: From the time of end of surgery till the pass of the first 24 hours postoperatively
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT03236740: OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS
Official title: Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Lead sponsor: S.C.B. Medical College and Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with PCOS according to the Rotterdam criteria

Exclusion Criteria:

* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
* Medical or surgical treatment of PCOS during the previous 3 months
* Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
* Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
* Inability to understand the proposal of the study precluding effective informed consent

Primary outcomes:
measure: Changes in ovarian stromal blood flow by using Doppler
timeFrame: 6 months
Secondary outcomes:
measure: Change in BMI as measured in kg/m2
timeFrame: 6 months
measure: Improvement in hirsutism measured by Modified Ferriman and Gallwey scores
timeFrame: 6 months
measure: Improvement in menstrual cycle pattern
timeFrame: 6 months
measure: Change in waist circumference (cm)
timeFrame: 6 months
measure: Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)
timeFrame: 6 months
measure: Change in blood level of Testosterone (nmol/L)
timeFrame: 6 months
measure: Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)
timeFrame: 6 months
measure: Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)
timeFrame: 6 months
measure: Changes in fasting serum insulin levels (mIU/L)
timeFrame: 6 months
measure: Changes in fasting serum glucose levels (mg/dL)
timeFrame: 6 months
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Cuttack
country: India
facility: SCB Medical College
state: Orissa
Study officials:
affiliation: SCB Medical College
name: Priyadarshini Tripathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01563640: Insecticidal School Uniforms for Dengue Prevention in Thailand
Official title: Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dengue
Keywords: dengue
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2012-03-27
Enrollment: 1825
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a randomised controlled trial that will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent high quality of insecticide impregnation with permethrin. A double-blind randomised cross-over trial at the school level will cover two dengue transmission seasons.


Eligibility criteria: Inclusion Criteria:

* pupils in participating schools

Exclusion Criteria:

* skin sensitivity, exema

Primary outcomes:
measure: insecticide:placebo incidence rate-ratio (per 1,000 person-years) of laboratory-confirmed dengue cases in school-aged children
timeFrame: up to 2 years
Secondary outcomes:
measure: comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Centre of Excellence for Vectors and Vector-Borne Diseases, Mahidol University
Study officials:
affiliation: Umeå University
name: Annelies Wilder-Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kittayapong P, Olanratmanee P, Maskhao P, Byass P, Logan J, Tozan Y, Louis V, Gubler DJ, Wilder-Smith A. Mitigating Diseases Transmitted by Aedes Mosquitoes: A Cluster-Randomised Trial of Permethrin-Impregnated School Uniforms. PLoS Negl Trop Dis. 2017 Jan 19;11(1):e0005197. doi: 10.1371/journal.pntd.0005197. eCollection 2017 Jan.
citation: Wilder-Smith A, Byass P, Olanratmanee P, Maskhao P, Sringernyuang L, Logan JG, Lindsay SW, Banks S, Gubler D, Louis VR, Tozan Y, Kittayapong P. The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand. Trials. 2012 Nov 15;13:212. doi: 10.1186/1745-6215-13-212.