louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01351207: The Effect of Eggs on Postprandial Metabolism
Official title: The Effect of Eggs on Postprandial Metabolism: A Randomized, Controlled Crossover Pilot Study in Older, Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2011-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism when included with other cooked breakfast foods typically selected by older Americans.


Eligibility criteria: Inclusion Criteria:

* Men \& postmenopausal women, aged 50-70 years
* BMI 28-34 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications or laxatives (including fiber supplements)
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
* Regular use of oral steroids
* Regular daily intake of ≥ 2 alcoholic drinks
* Vegetarians
* Allergy to eggs
* Avoidance and/or intolerance of pork products
* No dietary supplements, including those containing any vitamins, minerals,herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Primary outcomes:
measure: Postprandial change in blood glucose concentration compared to placebo
timeFrame: 0-4 h
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Diane L. McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755307: Probiotics for Diaper Dermatitis
Official title: PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diaper Dermatitis
Keywords: diaper dermatitis
probiotics
children
Lead sponsor: University Maribor
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled clinical trial is to determine the effect of the probiotic OMNiBiOTiC® Panda in treating diaper dermatitis in children under the age of two years. The main question it aims to answer is:

Is the probiotic OMNiBiOTiC® Panda effective in reducing the duration of diaper dermatitis in children under the age of two years?

Researchers will compare the probiotic and placebo group to see if the duration of diaper dermatitis is significant among the two groups.

Participants will:

* receive 6 droplets daily of probiotic or placebo for 3 weeks and
* observe and record improvement of diaper rash symptoms each day using a diary.


Eligibility criteria: Inclusion Criteria:

* presence of diaper dermatitis
* age less than two years

Exclusion Criteria:

* previous use of probiotics
* age more than two years
* an acute bacterial infection
* chronic disease
* local use of antibiotics in the anogenital region

Primary outcomes:
measure: Duration of diaper dermatis
timeFrame: 3 weeks supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: University of Maribor, Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT00501007: Predictors of Treatment Outcome for Smokers With and Without Schizophrenia
Official title: Predictors of Treatment Outcome for Smokers With and Without Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Dependence
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-13
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals from mental health centers in Central New Jersey or non-psychiatric controls from the community

Brief summary: The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.

Detailed description: Please see brief summary above.

Eligibility criteria: Inclusion Criteria:

* Current smokers must be over the age of 18,
* Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group.
* Must smoke at least 10 cigarettes per day
* Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22.

Exclusion Criteria:

* Those unable to give informed consent.
* Psychotic disorders other than schizophrenia

Primary outcomes:
measure: Mirror-tracing Persistence (in Seconds)
timeFrame: baseline
Secondary outcomes:
measure: Persistence as a Prospective Predictor of Smoking Cessation
timeFrame: 6 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ Tobacco Dependence Clinic
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Marc L. Steinberg, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06293807: Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine
Official title: Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine: A Short-term Clinical Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontal Diseases
Keywords: Flap debridement
Flap osseous
Tooth extractions
Guided Tissue Regeneration
IV sedation
Local anesthesia
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo-controlled, parallel design study.
Primary purpose: TREATMENT

Brief summary: Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.

Detailed description: This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.

Eligibility criteria: Inclusion Criteria:

-Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and...

1. require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and...
2. require IV sedation and local anesthesia or local anesthesia only...
3. in either the maxillary or mandibular arch.

Exclusion Criteria:

1. Pregnancy, or those planning to become pregnant
2. allergy or any medical issue using Lidocaine or Bupivacaine
3. inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
4. non-English speaking
5. not possessing an I-phone or Android device
6. patients requiring narcotic for IV sedation
7. patients requiring either IV or oral steroids during the perioperative period

Primary outcomes:
measure: Change in pain using Visual Analog Scale (VAS)
timeFrame: Baseline to 48 hours
measure: Number of Ibuprofen administered
timeFrame: Baseline to 48 hours
measure: Number of Tylenol administered
timeFrame: Baseline to 48 hours
Secondary outcomes:
measure: Arch Response
timeFrame: Baseline to 48 hours
measure: Number of teeth
timeFrame: Baseline to 48 hours
measure: Type of procedure
timeFrame: Baseline to 48 hours
measure: Gender of patient
timeFrame: Baseline to 48 hours
measure: Age of patient
timeFrame: Baseline to 48 hours
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: David Deas, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04895007: Comparative Evaluation of Covid-19 Vaccines Response
Official title: Comparative Evaluation of Covid-19 Vaccines Response and Progression in Different Covid-19 Vaccines Groups
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Vaccines
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Any person, male or female, over 18 years of age.

Brief summary: Study Population

Population with vaccinated with three different Covid Vaccines (Inactive Vaccine (Sinovac Life Sciences, Beijing, China), recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V), mRNA Vaccine (Pfizer/BionTEC). This is multi center study, 5 centers will be joined to study from different part of the country. Approximately 1500 people will be enrolled to study.

Detailed description: Aim of Study

* to evaluate Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody response in different Vaccine Groups
* to evaluate progression of the vaccine response after 2, 6, and 12 Months after Vaccination in different Vaccine Groups, and compare antibody response in different Vaccines Group.
* It was also aimed to evaluate effect of the age, gender, co-morbid conditions such as COPD, DM, Heart Failure, Covid Infection on IgG Antibody and Neutralizing Antibody response.

Anti SARS CoV2 IgG antibody levels will be measured with chemiluminescence method (CHEM) by using ADVIA Centaur XP Immunassay System (Siemens Helthcare, GmbH, Germany) and Anti SARS CoV2 IgG reactive (Siemens Helthineers, GmbH, Germany).

Neutralizing Capacity of Anti-SARS-CoV-2 Antibodies against SARS CoV2 levels will be determined with ELISA method (ELx 808, ELISA Microplate Absorbance Reader, BioTek Instruments Inc, Winooski, VT, USA) by using Euroimmun SARS-CoV-2 NeutraLISA Assay (EUROIMMUN, Medizinische Labordiagnostika AG, Germany).

Eligibility criteria: Inclusion Criteria:

- Any person, male or female, over 18 years of age.

1. The patient has signed an informed consent form.
2. The patient was vaccinated with SARS-CoV-2 vaccine.

Exclusion Criteria:

* Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
* Person under safeguard of justice
* Person under guardianship or curator ship.

Primary outcomes:
measure: Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University
city: Konya
country: Turkey
facility: Selcuk University
city: Tekirdağ
country: Turkey
facility: Tekirdag Namık Kemal University, Faculty of Medicine
city: Trabzon
country: Turkey
facility: Karadeniz Technic University, Faculty of Medicine
Study officials:
References:
Clinical trial NCT04707807: Effects of Nightshift Work and Sleep Disturbances on Erectile Function
Official title: Effects of Nightshift Work and Sleep Disturbances on Erectile Function, Serum Testosterone Levels, Nocturia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
First posted: 2021-01-13
Enrollment: 300
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to enroll mainly working class men in our study. So we are going to be able to compare the erectile function status daytime workers with nightshifters. Unemployed, retired and students will be excluded form the study.

Brief summary: We aim to observe the unwanted effects of nightshift work and short term insomnia on erectile function of men aged between 25 to 60 years. We will also compare the levels of serum testosterone in the target group and compare it with the ones who don't work in hightshifts.


Eligibility criteria: Inclusion Criteria:

* Suffering from erectile dysfunction
* Mainly psychogenic ED
* Employed

Exclusion Criteria:

* Patients with major organic causes erectile dysfunction (Radical pelvic surgery/radiation therapy, uncontrolled diabetis mellitus, uncontrolled hypertension, New York Heart Association Class 3-4 heart failure, acute coronary syndrome within 3 months, dyslipidemia)
* NEET(Not in employment, education, training) patients

Primary outcomes:
measure: Erectile dysfunction
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bağcılar
country: Turkey
facility: Istanbul Medipol University Hospital
state: İstanbul
city: Istanbul
country: Turkey
facility: Cemil Tascioglu Cith Hospital
state: Sisli
Study officials:
References:
Clinical trial NCT05324007: Babies' Expectations About Racial Interactions
Official title: Babies' Expectations About Racial Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Behavior
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 128
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine whether infants view race as an inductively useful social cue to predict third-party social relationships.

Detailed description: Based on findings that infants expect more affiliation between same language speakers than different language speakers (i.e., infants will look longer at affiliation between different language speakers than same language speakers), this study will assess whether infants' expectations about intra- and inter-racial interactions will also follow the same pattern as language. After informed consent, participants who meet the eligibility requirements will be randomized into one of the 3 conditions: Watching (1) two White adults affiliating and disengaging, (2) two Black adults affiliating and disengaging, and (3) one White and one Black adults affiliating and disengaging.

Eligibility criteria: Inclusion Criteria:

* full term (at least 37 weeks at birth)
* no known developmental delays

Exclusion Criteria:

* not full term (less than 37 weeks at birth)
* known developmental delays

Primary outcomes:
measure: Participants' Average Time Spent Looking at Stimuli According to Condition
timeFrame: After the infants completed the study (which lasted about 10 minutes), two coders viewed the video recording of the session to measure infants' looking at the affiliation and disengagement stimuli.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Infant Learning and Development Laboratory at University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Hyesung G Hwang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644007: Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension
Official title: A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction Taking Antihypertensive Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Hypertension
SK3530
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 109
Sex: MALE
Minimum age (years): 19
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 to evaluate the efficacy and safety of SK3530 in men with ED and hypertension who were taking antihypertensive medication.

Detailed description: SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with hypertension, it is important to determine the efficacy and safety of SK3530 in men with ED taking antihypertensive medication.

Eligibility criteria: Inclusion Criteria:

* Hypertension patient taking stable hypertensive medication for at least 4 weeks
* Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period
* Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period

Exclusion Criteria:

* Lab abnormality
* Uncontrolled diabetic mellitus
* High or low blood pressure, orthostatic hypotension
* Hyper- or hypo-thyroidism

Primary outcomes:
measure: Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
timeFrame: 0, 4, 8, 12 week
Secondary outcomes:
measure: the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ)
timeFrame: 0, 4, 8, 12 W
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SK Chemicals Co., Ltd
Study officials:
affiliation: SNUH
name: Jae-Seung paick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06981507: Evaluation of the Effect of MARPE on Speech
Official title: Evaluation of the Effect of MARPE on Speech
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse Deficiency
Keywords: MARPE, Palatal Expansion, Orthodontics, Speech, Acoustic Analysis, Maxillary Transverse Deficiency
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) on speech characteristics in adolescent and young adult patients.

While MARPE is a widely used orthodontic procedure for treating maxillary transverse deficiency, its potential impact on speech production has not been thoroughly evaluated. The aim of this study is to assess whether MARPE treatment causes any temporary or long-term changes in speech patterns using acoustic and perceptual analysis methods.

Detailed description: This prospective clinical study aims to evaluate how Miniscrew-Assisted Rapid Palatal Expansion (MARPE) affects speech in adolescents and young adults with skeletal maxillary transverse deficiency.

Speech production relies on precise palatal anatomy and oral resonance. Since MARPE modifies the palatal structure through skeletal expansion, it may influence articulation and acoustic properties of speech. Despite its increasing use in orthodontics, the potential speech-related side effects of MARPE remain largely unexplored.

Participants aged 13-25 will undergo MARPE treatment as part of their standard orthodontic care. Speech recordings will be taken at three time points: before expansion (baseline), immediately after the active expansion phase, and after the retention period. Acoustic analysis and standardized perceptual speech evaluations will be conducted to detect any phonetic, articulatory, or resonance-related changes.

The results will help clinicians better understand the functional implications of MARPE on speech and provide guidance for counseling patients before treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with Class I malocclusion
* Presence of maxillary transverse deficiency
* Young adult patients aged 15 to 18 years
* No history of systemic disease, cleft lip/palate, or speech disorders
* No history of previous orthodontic treatment

Exclusion Criteria:

* Patients with any systemic disease
* Patients who smoke
* Patients with poor oral hygiene
* Patients with cooperation difficulties
* Patients with mental retardation or cognitive impairment

Primary outcomes:
measure: Speech Changes After MARPE Treatment
timeFrame: Baseline and 1 month after expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of Dentistry
state: Meram
Study officials:
References: