louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01817244: A Long Term Effect of Collaborative Care on Depression Treatment in a Community Dwelling Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: care management
depression
elderly
Korea
Lead sponsor: National Clinical Research Coordination Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2013-03-25
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when they committed suicide. Therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.


Eligibility criteria: Inclusion Criteria:

* 60 and older
* current major or minor depression

Exclusion Criteria:

* severe cognitive dysfunction
* severe auditory dysfunction
* history of psychosis

Primary outcomes:
measure: Hamilton Depression Scale (HAMD)
timeFrame: 6 months after baseline
Secondary outcomes:
measure: suicide ideation
timeFrame: 6 months after baseline
measure: treatment compliance
timeFrame: at 6 months from baseline
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Kunkuk University of Chungju Hospital
state: Choong-Book
Study officials:
References:
Clinical trial NCT06654544: Epidemiology of Intracerebral Hemorrhage
Official title: Prevalence and Clinical Features of Intracerebral Hemorrhage Among Stroke Patients Admitted to Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ICH - Intracerebral Hemorrhage
Keywords: prevalence
ich
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke Patients

Brief summary: Exploring the risk factors and associations of intracerebral hemorrhage

Detailed description: Exploring the clinical characteristics and prevalence of intracerebral hemorrhage in Assiut University

Eligibility criteria: Inclusion Criteria:

* both sex
* Age ≥ 18
* patients diagnosed with non traumatic hemorrhagic stroke on brain computed tomography scan

Exclusion Criteria:

* presence of space occupying lesion visible on brain computed tomography scan
* preceding brain trauma or post traumatic cerebral hemorrhagic stroke
* presence of ischemic stroke
* presence hemorrhagic transformation on top of acute ischemic stroke

Primary outcomes:
measure: Volume of Intracerebral Hemorrhage Among Stroke Patients Admitted to Assiut University Hospital
timeFrame: At time of enrollment of study and after 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Norhan MH Bakri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ahmed NasrEldein, Ass.Professor
role: STUDY_DIRECTOR
References:
citation: An SJ, Kim TJ, Yoon BW. Epidemiology, Risk Factors, and Clinical Features of Intracerebral Hemorrhage: An Update. J Stroke. 2017 Jan;19(1):3-10. doi: 10.5853/jos.2016.00864. Epub 2017 Jan 31.
Clinical trial NCT01732744: A Castor Bean Solution for Cleaning Dentures
Official title: A Castor Bean Solution Reduces Complete Denture Biofilm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostheses-related Infections
Keywords: biofilm, castor bean, sodium hypochlorite, alkaline peroxide
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of complete denture biofilm, comparing it with two products available on the market (sodium hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed to brush their dentures after meals and once a day, for a period of 07 days, immerse them in the following solutions: A - Control: Physiological solution(20 minutes). B - Polident alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based solution(20 minutes). The participants immersed their dentures in each of the solutions, according to a randomized sequence. For biofilm quantification, before (Baseline) and after the use of each product, the internal surfaces of maxillary complete dentures were revealed (1% neutral red), photographed and the stained biofilm was quantified with the aid of software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .

Detailed description: The study sought to minimize the occurrence of bias, and whenever possible sought to "blind" the parties involved (researchers, volunteers and statisticians), since none of them had knowledge of the allocation of treatments. The present study also followed the criteria described in the CONSORT Declaration

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders, age-range 45 years and over, completely edentulous, in a good state of general health, wearers of maxillary complete dentures fabricated of heat polymerized acrylic resin and acrylic artificial teeth.

Exclusion Criteria:

* Dentures that had been used for less than 03 years, and broken, fractured or relined dentures.

Primary outcomes:
measure: Denture area covered with biofilm
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Ingrid M Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03479944: Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®
Official title: Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 57
Sex: ALL
Minimum age (years): 20
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 cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.

Detailed description: Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.

Eligibility criteria: Inclusion Criteria:

* Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes;
* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
* Calculated lens power within the available range;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any pathology that could reduce visual potential;
* Hypotony or the presence of a corneal implant;
* Residual, recurrent, active ocular or eyelid disease;
* Poorly dilating pupil;
* Any contraindication to cataract;
* Eyes with two different levels of cataract grade;
* Pregnant, or planned pregnancy during the study;
* Expected to require an ocular surgical treatment at any time during the study;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day 0 (operative day)
Secondary outcomes:
measure: Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit
timeFrame: Preoperative, Day 150-210 (post-operative)
measure: Percentage of Average Torsional Amplitude
timeFrame: Day 0 (operative day)
Other outcomes:
Locations:
city: Iizuka City
country: Japan
facility: Alcon Investigative Site
state: Fukuoka
Study officials:
affiliation: Alcon, A Novartis Division
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT01888744: Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist
Official title: The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Reproductive Endocrinology
Fertility
Optimal Stimulation Protocol
Keywords: Intracytoplasmic sperm injection (ICSI)
PGD
GnrH agonist
GnRH antagonist
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Detailed description: Patients will be randomized at the outpatient clinic in two groups.

Eligibility criteria: Inclusion Criteria:

* ≤ 39 years the day of oocyte retrieval
* BMI ≤ 29
* cycle rank 1
* menstrual cycle 25-36 days
* PGD or preimplantation genetic screening (PGS) requested
* ICSI
* Single embryo transfer (SET) on day 5

Exclusion Criteria:

* Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)
* Hormonal disturbances
* Endometriosis grade III and IV

Primary outcomes:
measure: Number of day 3 embryos for biopsy available
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Number of mature cumulus-oocyte complexes
timeFrame: up to 6 weeks
measure: clinical pregnancy rate
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine
Study officials:
References:
Clinical trial NCT06060444: Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
Official title: Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug-Induced Movement Disorder
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Neurocrine Biosciences
First posted: 2023-09-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs). DIMDs can be disabling, and prevention is important; but these disorders are often under-reported, under-recognized and poorly managed. Interprofessional telemedicine for movement disorders is feasible and may provide similar care as in-person visits; however, the majority of studies to date have shown benefit in Parkinson's disease and further validation in other movement disorders is necessary.

In this randomized controlled trial the aim is to study the acceptability, feasibility, and patient and clinician outcomes when a neurological consultation is provided for patients with DIMDs either in-person or through telemedicine. The investigators will apply the evaluation framework RE-AIM (Reach and Effectiveness, Adoption, Implementation, and Maintenance) to comprehensively assess the factors that may impact study success and program implementation. Mixed methods will be implemented to gather outcome data from mental health clinicians that refer patients and the patient participants.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Willing and able to provide consent
* Willing to have their Mental Health Clinician (MHC) share sensitive clinical information with the Neurology team
* Able to travel to Neurology clinic
* Have connectivity to Zoom using wi-fi or cellular data, either at home or a comfortable and private setting (such as MHC office)

Exclusion Criteria:

* Currently hospitalized
* Neurologist determines patient requires care outside of the scope of the study

Primary outcomes:
measure: Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 12 months
Secondary outcomes:
measure: Effectiveness; PROMIS 29+2 V2.1
timeFrame: 12 months
measure: Effectiveness; referral forms and visit notes
timeFrame: 12 months
measure: Effectiveness; visit notes
timeFrame: 12 months
measure: Effectiveness; MHC survey and Qualitative Interviews
timeFrame: 12 months
Other outcomes:
measure: Reach
timeFrame: 12 months
measure: Adoption
timeFrame: 12 months
measure: Implementation
timeFrame: 12 months
measure: Maintenance; MHC survey and qualitative interviews
timeFrame: 12 months
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References:
Clinical trial NCT03817944: Effects of Coffee Consumption on Health Among Adults
Official title: Placebo-controlled Study on Intervention Effect of Coffee on Glucose and Lipid Homeostasis Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health
Keywords: body weight
glucose
lipid
metabolites
gut microbiota
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 156
Sex: ALL
Minimum age (years): 17
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to research the changes of typical thermal processing food intervention on health outcome, metabolites, and gut microbiota, in order to explore the molecular mechanism of interaction between maillard reaction associated hazards and complex food matrix, and provide scientific basis and reference model for combining food nutrition and safety protection.


Eligibility criteria: Inclusion Criteria:

* Non-smoking, non-occupational exposed healthy volunteers, 18.5\<BMI\<30 kg/m\^2, were screened. If the evaluation of disease history, blood biochemistry and blood routine was normal, the volunteers were considered healthy.

Exclusion Criteria:

* The main exclusion criteria included people with high exposure to cold and fever, recent drug intake (including dietary supplement intake), alcohol intake, vegetarians, pregnancy, high-temperature processed meat and beverages such as coffee and milk tea.

Primary outcomes:
measure: Change in blood glucose from baseline
timeFrame: 8 weeks
measure: Change in blood lipids from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Urinary biomarkers levels of acrylamide, furans, and furfuryl alcohol
timeFrame: 8 weeks; 24 hours
measure: Change of metabolites
timeFrame: 8 weeks
measure: Change in gut microbiota
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang university
Study officials:
References:
Clinical trial NCT02438644: Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina
Official title: Observational Study of the Effectiveness and Safety of Vismodegib (Erivedge) in Patients Treated in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is characterized by patients who are prescribed vismodegib in Argentina, according to standard of care and in line with the current SPC and local labeling. Data collection will be prospective except in the cases when a treating physician contacts the vendor for the first time after the patient has started treatment with vismodegib. In these cases the vendor will retrospectively collect data from the start of treatment. Only patients with laBCC or mBCC will be considered in the effectiveness analysis.

Brief summary: This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.


Eligibility criteria: Inclusion Criteria:

* Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling
* Diagnosis of laBCC or mBCC for the effectiveness analysis

Exclusion Criteria:

* None specified

Primary outcomes:
measure: Response rate as assessed by the treating physician
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Duration of treatment
timeFrame: Approximately 12 months
measure: Duration of response as assessed by the treating physician
timeFrame: Approximately 12 months
measure: Incidence of adverse events
timeFrame: Approximately 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00987844: Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation
Official title: A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Lead sponsor: Movetis
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 1775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).


Eligibility criteria: Inclusion Criteria:

1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
2. Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.

Exclusion Criteria:

1. Patient with impaired renal function
2. Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
3. Female of childbearing potential without adequate contraceptive protection during the study.
4. Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.

Primary outcomes:
measure: Safety: adverse events, lab tests, vital signs, ECGs
timeFrame: 24 months
Secondary outcomes:
measure: Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride
timeFrame: 24 months
measure: Pharmacokinetics: Prucalopride plasmaconcentrations
timeFrame: 24 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.
Clinical trial NCT06883344: Automated Insulin for Management of Intrapartum Glycemia
Official title: Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes (T1D)
Pregnancy
Pre-Gestational Diabetes
Keywords: Pregnancy
Intrapartum glycemic management
Neonatal hypoglycemia
Perinatal care
Diabetes in pregnancy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are

* What are the neonatal glycemic outcomes with use of AID systems during labor/delivery?
* Do patients report higher birth satisfaction with use of AID systems during labor/delivery?
* Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery?

Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.


Eligibility criteria: Inclusion Criteria:

* Known diagnosis of type 1 diabetes ≥ 1 year
* Current use of commercially available AID system ≥ 6 months
* Currently pregnant at ≥ 34 weeks
* Singleton pregnancy
* English- or Spanish-speaking

Exclusion Criteria:

* Planned cesarean delivery
* Use of medications known to interfere with glucose metabolism
* Intrauterine fetal demise
* Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare

Primary outcomes:
measure: First neonatal glucose value
timeFrame: Within 2 hours of birth
Secondary outcomes:
measure: Birth Satisfaction Scale Revised (BSS-R) score
timeFrame: Within 2 weeks of delivery
measure: CGM-derived glycemic parameters
timeFrame: From admission to labor/delivery unit to birth of infant
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ivonne Verduzco, MD
role: PRINCIPAL_INVESTIGATOR
References: