louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05262179: A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
Official title: A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers
* Written informed consent to participate in the trial

Exclusion Criteria:

* Those who have a history of ophthalmic diseases and surgery within 5 years
* Smokers with an average daily smoking amount exceeding 10 cigarettes

Primary outcomes:
measure: Cmax,ss
timeFrame: Day8 of stage 2
measure: Tmax,ss
timeFrame: Day8 of stage 2
measure: t1/2,ss
timeFrame: Day8 of stage 2
measure: AUCτ,ss
timeFrame: Day8 of stage 2
measure: RAAUCτ
timeFrame: Day8 of stage 2
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Taejoon Pharmaceutical Co., Ltd.
Study officials:
References:
Clinical trial NCT03664479: Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study
Official title: A Double-blind, Parallel Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel Neuromuscular Electrical Stimulation (NMES), Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dysphagia
Keywords: stroke
cervical spinal cord injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders.

The purpose of this study is to investigate the difference in effect by the electric stimulation method and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

Detailed description: * Design: Prospective study
* Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=9)
* Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol
* Main outcome measures: high-resolution manometry(HRM) parameters, videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire

Eligibility criteria: Inclusion Criteria:

* patient who do not belong to the criteria excluded for subjects aged 19 years or older
* Patient who is confirmed to be dysphagia by videofluoroscopy
* Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury
* Those voluntarily agreeing to the clinical trial

Exclusion Criteria:

* Patient who refuse inspection, do not agree
* Simple "Commend obey", first step is impossible
* When instructions can not be executed due to dementia, psychiatric disorders, etc.
* Dysphagia occurs due to respiratory failure, neck surgery, etc.,
* Pregnant women and lactating women

Primary outcomes:
measure: pressure change
timeFrame: baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES.)
measure: videofluoroscopic dysphagia scale
timeFrame: baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES.
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jusuk Ryu, M.D. PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02411279: Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations
Official title: Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations Derived From Non Intrusive Sensors and Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Heart failure
telemonitoring
intrusive sensors
intrusive devices
Heart failure stage II
Heart failure stage III
heart disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population with heart failure stage II and III

Brief summary: Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.

The objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage II and III NYHA. It will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations.

Patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute HF.


Eligibility criteria: Inclusion Criteria:

* Population with heart failure stage II and III

Exclusion Criteria:

* Population whose age is less than 18 years

Primary outcomes:
measure: Anticipation and detection of heart failure with automatic treatment of information derived from non intrusive sensors and devices
timeFrame: patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B
Study officials:
affiliation: Strasbourg University Hospital, France
name: ANDRES Emmanuel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03412084: A "Stand Up and Move More" Intervention for Older Adults
Official title: Translating a "Stand Up and Move More" Intervention by State Aging Units to Older Adults in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Sedentary Lifestyle
physical function
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-01-26
Enrollment: 84
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.

Detailed description: Based on successful pilot research in Rock County, WI, and the receipt of funding from the National Institutes of Health, the investigators expanded research to additional counties in Wisconsin for a total of four counties (i.e., Dane, Iowa, Rock, and Vilas counties). Sample size will increase and participants will be randomly assigned to the intervention group (Stand Up and Move More group) or a wait-list control group (who receive the intervention after 12 weeks). The Stand Up and Move More intervention/workshop involves sessions once/week for four weeks with a refresher session at 8 weeks. Assessments will be conducted before the intervention/workshop begins, and then again at 4 weeks and 12 weeks. We have added several questionnaires to examine potential mediators of behavior change (e.g., self-efficacy, self-regulation, outcome expectancies).

Eligibility criteria: Inclusion Criteria:

* adults older than 55 yrs of age
* inactive or low active (i.e., less than 60 minutes of physical activity/week)
* residents of Dane, Iowa, Rock or Vilas counties, and
* residing in a home or an apartment.

Exclusion Criteria:

* low levels of sedentary behavior (less than or equal to 6 hours/day),
* recent hospitalization (i.e., past month),
* uncontrolled medical conditions including: uncontrolled hypertension, heart disease, actively receiving chemotherapy or palliative care for cancer, stage 4 liver disease, end-stage renal or pulmonary disease, severe arthritis or any other orthopedic condition that could be made worse by standing up and moving more;
* inability to stand up without assistance of another person, and
* inability to speak or hear spoken English.

Primary outcomes:
measure: Total Sedentary Time Per Day
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB) Score
timeFrame: Baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Kelli Koltyn
state: Wisconsin
Study officials:
affiliation: UW-Madison
name: Kelli Koltyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06795984: Is There a Correlation Between Endometrial CD56 Levels and the Unfavorable KIR AA Genotype in IVF Implantation Success?
Official title: Is There a Correlation Between Endometrial CD56 Levels and the Unfavorable KIR AA Genotype in IVF Implantation Success?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Rate IVF
Blastocyst IVF
Lead sponsor: Calla IVF Center
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 80 patients were included, with 40 in each group (KIR AA and non-KIR AA). All participants provided written informed consent, and the study protocol was approved by the institutional ethics committee.

Brief summary: This prospective observational study was conducted over 12 months and involved 80 IVF patients aged 20-40 years. Patients were divided into two groups based on KIR genotype (KIR AA and non-KIR AA). Endometrial biopsies were collected during the mid-luteal phase for immunohistochemical analysis of CD56+ NK cell levels. Statistical analyses, including logistic regression and ROC curve evaluation, assessed the relationship between CD56 levels, KIR genotype, and implantation success.


Eligibility criteria: Inclusion Criteria:

* Female patients aged 20-40 years.
* Normal uterine cavity confirmed by hysteroscopy or sonohysterography.
* At least three previous failed IVF cycles or a history of recurrent pregnancy loss (RPL).

Exclusion Criteria:

* uterine abnormalities,
* systemic autoimmune diseases,
* severe male infertility factors.

Primary outcomes:
measure: the relationship between endometrial CD56+ NK cells, KIR AA genotypes, and IVF success.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oradea
country: Romania
facility: Calla Ivf Center
state: Bihor
Study officials:
References:
Clinical trial NCT01472484: Impact of Bean Polyphenols and Phytic Acid on Iron Absorption
Official title: A Stable Iron Isotope Study to Investigate the Impact of Phytic Acid and Polyphenols on Iron Absorption From Beans in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Iron Isotope Enrichment
Keywords: beans
lpa mutant
polyphenols
phytic acid
stable iron isotopes
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have the potential to alleviate iron bioavailability problems associated with PA. These plants have normal phosphate levels, but reduced PA phosphate due to various modifications of the biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA concentration without any defects in terms of growth and yield.

Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the development of a variety which has the potential to improve the iron status of bean consuming populations.

The following study will evaluate the relative impact of PA and PP on iron absorption from beans by comparing iron absorption from four different bean varieties. Iron absorption from a bean with normal PA concentration and high PP concentration will be compared to iron absorption from a bean with normal PA and low PP concentration as well as to two lpa varieties, one with high and one with low PP concentration.


Eligibility criteria: Inclusion Criteria:

* Non-pregnant, non-lactating women
* Between 18 and 40 years
* Below 65kg

Exclusion Criteria:

* Metabolic, chronic and gastro-intestinal disease
* Long-term medication
* Blood donation within 6 month before the study

Primary outcomes:
measure: Shift in iron isotopic composition in blood after consumption of different bean varieties
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH
Study officials:
affiliation: ETH Zürich
name: Richard Hurrell, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petry N, Egli I, Campion B, Nielsen E, Hurrell R. Genetic reduction of phytate in common bean (Phaseolus vulgaris L.) seeds increases iron absorption in young women. J Nutr. 2013 Aug;143(8):1219-24. doi: 10.3945/jn.113.175067. Epub 2013 Jun 19.
Clinical trial NCT03946384: Mutation p.Ile112Thr : Discrepancy Between Factor IX Level and Bleeding Phenotype
Official title: Discrepancy Between Factor IX Level and Bleeding Phenotype
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia B
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia B

Brief summary: It appears that the mutation p.Ile112Thr in the factor IX gene confers a discrepancy between mild factor IX level and severe bleeding phenotype. Databases and litterature analysis are poor on this matter. The goal of this study is to compile bleeding phenotype in patients with this specific mutation to prove the clinico-biological discordance in order to improve patient care and follow-up.


Eligibility criteria: Inclusion Criteria:

* hemophilia B with p.Ile112Thr mutation on factor IX gene

Exclusion Criteria: None

Primary outcomes:
measure: Bleeding phenotype
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06261684: Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.
Official title: Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Plantar Wart
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:

1. Is Intralesional acyclovir safe for plantar warts?
2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older, of both genders, with plantar warts

Exclusion Criteria:

* Patients on systemic treatment for warts eg. Acitretin, Acyclovir
* Hypersensitivity to Acyclovir
* Previous treatment to the same wart during the last 3 months
* Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
* Pregnant and breastfeeding females
* Cognitively impaired patients

Primary outcomes:
measure: Cure rate
timeFrame: 10 weeks (5 sessions max)
measure: Recurrence rate
timeFrame: 24 weeks
measure: Patient satisfaction score
timeFrame: 10 weeks
Secondary outcomes:
measure: Correlation of treatment with number of ipsilateral warts
timeFrame: 10 weeks
measure: Correlation of treatment with age
timeFrame: 10 weeks
measure: Correlation of treatment with gender
timeFrame: 10 weeks
measure: Correlation of treatment with size of the wart
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospital
Study officials:
affiliation: Cairo University
name: Shahira Ramadan, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Yousra Azzazi, Lecturer
role: STUDY_DIRECTOR
References:
citation: Elsayed A, Nassar A, Marei A, Hoseiny HAM, Alakad R. Intralesional Acyclovir: A Potential Therapeutic Option for Cutaneous Warts. J Cutan Med Surg. 2022 Jan-Feb;26(1):25-30. doi: 10.1177/12034754211037998. Epub 2021 Aug 19.
citation: Garcia-Oreja S, Alvaro-Afonso FJ, Tardaguila-Garcia A, Lopez-Moral M, Garcia-Madrid M, Lazaro-Martinez JL. Efficacy of cryotherapy for plantar warts: A systematic review and meta-analysis. Dermatol Ther. 2022 Jun;35(6):e15480. doi: 10.1111/dth.15480. Epub 2022 Apr 6.
Clinical trial NCT06282484: A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions
Official title: A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Xanthoma
Helicobacter Pylori Infection
Gastric Cancer
Intestinal Metaplasia
Precancerous Lesions
Keywords: gastric cancer
helicobacter pylori
precancerous lesion
Gastric Xanthoma
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 1260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing upper gastrointestinal endoscopy at Xijing Hospital

Brief summary: To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.

Detailed description: This is a large-scale single center case-control study. Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results.Record the location and quantity of gastric xanthoma and situation of Helicobacter pylori infection in each patient.

Eligibility criteria: Inclusion Criteria:

1. Age range from 18 to 75 years old, regardless of gender;
2. Endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia Hyperplasia/gastric cancer
3. Voluntarily sign an informed consent form.

Exclusion Criteria:

1. Previously underwent upper gastrointestinal surgery
2. Previous diagnosis of malignant tumors
3. Individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons
4. Those who cannot be observed by endoscopy due to acute upper gastrointestinal bleeding or other reasons

Primary outcomes:
measure: corelation between the gastric xanthoma and gastric mucosa diseases
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Xijing Hosipital of Digestive Disease
name: Yongquan Shi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01451684: Development of a Non-invasive Prenatal Test
Official title: Development of a Non-invasive Prenatal Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnancy
fetus
euploid
Lead sponsor: Roche Sequencing Solutions
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include women who have a healthy pregnancy.

Brief summary: This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Detailed description: Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Eligibility criteria: Inclusion Criteria:

* Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
* Subject is able to provide informed consent
* Subject is ≥ 18 years of age
* Subject is at least 10 weeks gestation for general enrollment
* Subject has no known risk factors for chromosomal abnormalities of the fetus
* Subject has no suspected or confirmed fetal abnormalities

Exclusion Criteria:

* Subject is pregnant with more than two fetuses
* Subject is unwilling to undergo a blood draw

Primary outcomes:
measure: Absence of chromosomal abnormality
timeFrame: At time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Ariosa Diagnostics
state: California
Study officials:
affiliation: Ariosa Diagnostics
name: Tracy Roberts
role: STUDY_DIRECTOR
References: