louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01600768: Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gram-Negative Bacterial Infections
Keywords: focus of study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 100
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 purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).


Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years)
* Admitted on the intensive care unit
* Starting a treatment with beta-lactams antibiotics
* Signed informed consent
* Expected to live \> 3 days

Exclusion Criteria:

* renal insufficiency (estimated clearance \< 20 ML /MIN)
* renal replacement therapy
* ANC \< 1000 103 µl
* pregnancy
* drug abuse

Primary outcomes:
measure: serum concentrations of beta-lactams
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: Shu-Wen Lin, Pharm D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06961968: Open-Label Evaluation of Relapse Prevention in Patients With Schizophrenia
Official title: A Multicenter, Open-Label, Relapse Prevention Study in Patients With Schizophrenia Receiving Iloperidone Long-Acting Injection (LAI)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic Agents
Iloperidone
Long-Acting Injection
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-05-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the relative exposure of iloperidone long-acting injection (LAI) compared to oral iloperidone in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Males or females 18 to 65 years of age (inclusive)
* Diagnosed with schizophrenia per DSM-5 criteria
* In need of ongoing psychiatric treatment

Exclusion Criteria:

* DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months

Primary outcomes:
measure: Relative exposure at steady-state of iloperidone LAI compared to oral iloperidone
timeFrame: Up to 54 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06662968: A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy
Official title: A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenotonsillectomy
Keywords: Lollipops
Adenotonsillectomy
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 186
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and postoperative wound recovery rate.

Participants will be randomly allocated to two groups:a lollipop sucking group (Group A) and a control group (Group B), Two groups of children were sent to the recovery room (PACU) for observation after extubation . Group A patients were given lollipops for sucking after waking up, while Group B received routine nursing treatment.

The goal of this clinical trial is to explore whether lollipops have advantages in early postoperative feeding and alleviating postoperative agitation in children, and to provide reliable clinical evidence for the consumption of lollipops after surgery.


Eligibility criteria: Inclusion Criteria:

* patients who choose to have adenotonsillectomy surgery
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent

Exclusion Criteria:

* psychiatric disorders
* upper respiratory tract infection
* high risk of reflux aspiration
* carbohydrate malabsorption syndrome and other endocrine or genetic metabolic diseases (contraindications of lollipop ingredients)

Primary outcomes:
measure: Postoperative agitation score
timeFrame: Time Frame: intraoperative period,10 minutes-1 hours
measure: Incidence of nausea and vomiting
timeFrame: Postoperative 1 minute-5hours
Secondary outcomes:
measure: Spo2
timeFrame: Postoperative 1 minute - 5hours
measure: other adverse reactions
timeFrame: Postoperative 10 minutes - 3days
measure: the time of leaving the recovery room and the hospital
timeFrame: Postoperative 1 hour - 3days
measure: family satisfaction
timeFrame: Postoperative 5 hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04464668: Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health
Official title: Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Fecal Immunochemical Test
F.I.T.
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Staff and providers from the two participating Federally Qualified Health Care systems - Central Florida Health Centers and Manatee County Rural Health Services.

Brief summary: This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.

Detailed description: This study will not accrue individual patients. Instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.

Eligibility criteria: Inclusion Criteria:

* Staff and providers working in a clinic within one of the two participating systems
* Involved in adult patient care

Exclusion Criteria:

* Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening

Primary outcomes:
measure: Change in Colorectal Cancer Screening Rates - Initial FIT
timeFrame: Years 1-5
measure: Change in Colorectal Cancer Screening Rates - Repeat FIT
timeFrame: Years 1-5
Secondary outcomes:
measure: Differences in Screening Rates
timeFrame: Years 2-5
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Clement K Gwede, PhD MPH RN FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780868: External DCR Versus Canalicular SI With MMC in NLDO
Official title: External Dacryocystorhinostomy Versus Canalicular Silicone Intubation With Mitomycin C in Primary Acquired Nasolacrimal Duct Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Acquired Nasolacrimal Duct Obstruction
Keywords: External DCR, canalicular silicone intubation, Mitomycin C
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).
Primary purpose: TREATMENT

Brief summary: While external DCR is the gold standard procedure for primary NLDO as well as complicated cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence should be considered as an alternative as a safe and minimally invasive procedure.

Detailed description: Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).

Methods: the study was carried out at the department of Ophthalmology, Menoufia university Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases underwent external DCR and twenty-six cases underwent silicone intubation with MMC.

Eligibility criteria: Inclusion Criteria:

* primary acquired NLDO

Exclusion Criteria:

* All other secondary causes of NLDO

Primary outcomes:
measure: external DCR
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: canalicular silicone intubation with MMC
timeFrame: 2 years
Locations:
Study officials:
References:
Clinical trial NCT00556868: The Influence of Having Breakfast on Cognitive Performance and Mood
Official title: The Influence of Having Breakfast on Cognitive Performance and Mood in High School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Keywords: High school students
Boarding school
Breakfast
Fasting
Memory
Attention
Mood
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 104
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Breakfast is often labelled the most important meal of the day.

Parents and teachers quite often stress its importance for successful learning during the morning hours. With declining numbers of children and especially adolescents eating breakfast regularly, the study examines the influence of breakfast consumption on cognition and mood of high school students.


Eligibility criteria: Inclusion Criteria:

* Healthy high school students

Exclusion Criteria:

* Diabetes

Primary outcomes:
measure: Sustained attention, immediate memory, mood
timeFrame: 2 h
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Centre for Neuroscience and Learning
Study officials:
affiliation: Centre for Neuroscience and Learning, University of Ulm
name: Katharina A Widenhorn-Mueller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Neuroscience and Learning, University of Ulm
name: Katrin Hille, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Epidemiology, University of Ulm
name: Jochen Klenk, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Neuroscience and Learning, University of Ulm
name: Weiland Ulrike, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Widenhorn-Muller K, Hille K, Klenk J, Weiland U. Influence of having breakfast on cognitive performance and mood in 13- to 20-year-old high school students: results of a crossover trial. Pediatrics. 2008 Aug;122(2):279-84. doi: 10.1542/peds.2007-0944.
Clinical trial NCT00005468: Lipid Variability--Influence of Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate the variability of lipids and specifically the effects of stress on serum triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study.

Detailed description: BACKGROUND:

While researchers had documented some of the behavioral contributors to fluctuation in individuals' lipid levels (e.g., nutrition patterns, smoking, exercise), little attention had been given to psychosocial stress. Early reports utilizing accountants, race car drivers, and air traffic controllers provided some uncontrolled data associating stress with cholesterol increases. Yet, no empirical research on stress that concomitantly examined other related influences was available. This paucity of data was probably due to lack of objective measures of stress and difficulty in measuring lipid subfractions.

DESIGN NARRATIVE:

Based on the results of their pilot study, and their research observations, the investigators predicted significant positive associations between stress level and triglycerides. A total of 228 public accountants (148 men and 80 women to provide comparable power between the sexes) were recruited from the greater Birmingham, Alabama area. Participants were evaluated monthly for 18 months, across three stressful and non-stressful work intervals (i.e., tax seasons). The investigators also collected data (during this same time frame) to closely monitor the following variables that affect lipids: dietary intake (including alcohol, caffeine, total calories, total fat, saturated fat, and dietary cholesterol), smoking, and physical activity, and oral contraceptive use, pregnancy status and menstrual stage among the women. Additionally, a substudy presented a unique opportunity for them to investigate the relation between stress and triglyceride-rich lipoproteins in the formation of foam cells.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01875068: A Program of Physician Supervision to Improve the Quality of Patient Referrals From Nurse Practitioners and Physician Assistants
Official title: Implementing a Program of Physician Supervision to Improve the Quality of Patient Referrals From Nurse Practitioners and Physician Assistants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complex Patients
Keywords: referrals
nurse practitioners
physician assistants
consultative general internal medicine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators have previously demonstrated utilizing a validated tool, that the quality of referrals from nurse practitioners (NP) and physician assistants (PA) is less than referrals from physicians. The investigators hypothesize that with local physician input, the quality of referrals from nurse practitioners and physician assistants will improve. This is a prospective study comparing patient referrals from nurse practitioners and physician assistants with and without prior discussion with a local physician.


Eligibility criteria: All nurse practitioners and physician assistants in the Mayo Clinic Health System

Primary outcomes:
measure: Improved referrals from nurse practitioners and physician assistants to physicians as determined using a previously validated tool
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Lohr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03397368: Evaluation of Transperineal US in Stress Incontinence
Official title: Evaluation of Role of Transperineal US in Differentiating Degrees of Genuine Stress Incontinence in Females Diagnosed by Urodynamics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Incontinence, Female
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2018-01-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: females who are complaining from stress incontinence that did urodynamics study and proved to have a genuine stress incontinence and referred to do transperineal ultrasound

Brief summary: Stress urinary incontinence (SUI) has an observed prevalence of between 4%and 35%.Identified risk factors are aging, obesity and repeated pregnancies and deliveries.

Urodynamic remains the gold standard for diagnosis in the past years. Trans labial ultrasound appears to have a good role in diagnosing stress incontinence

Detailed description: A comparative observational cross sectional study will be conducted .

The symptom, or "subjective indicator of disease," of SUI is described as "the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing." 1 Stress urinary incontinence (SUI) has an observed prevalence of between 4% and 35%.

It's a social problem that causes hygienic problem that s distressing for females.

Urodynamic study is the gold standard for diagnosis of most types of urinary incontinence with some limitations as it's not done routinely in all cases of urinary incontinence according to the NICE guidelines 2 Translabial ultrasound is a simple, noninvasive, available, and reproducible method for qualitative and quantitative evaluation of the lower urinary tract in females.

Eligibility criteria: Inclusion Criteria:

females between 20-75 years old

* -Women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic.

Exclusion Criteria:

* -Known to be Diabetic
* Urge incontinence or mixed type
* Voiding dysfunction
* Neurological problems
* open suprapubic wound
* Previous surgery for POP(pelvic organ prolapse) or incontinence
* suspicion of pelvic malignancy

Primary outcomes:
measure: The number of participants who will be properly diagnosed to have genuine stress incontinence To determine the role of transperineal ultrasound in diagnosing stress incontinence
timeFrame: within a week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy Hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, M.s.c
role: STUDY_CHAIR
References:
Clinical trial NCT01629368: A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
Official title: A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, 18-65 years of age inclusive
* Non-smokers
* Body mass index (BMI) between 18 and 30 mg/m2 inclusive
* Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

* Evidence of any active or chronic disease
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
* History or presence of clinically significant psychiatric condition
* Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration time curve
timeFrame: Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: