louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04204291: Project A4sc - An Atlas of Airways at a Single Cell Level
Official title: Project A4sc - An Atlas of Airways at a Single Cell Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory System
Keywords: lung
nasal mucosa
respiratory mucosa
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail.

The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing).

The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.


Eligibility criteria: Inclusion Criteria:

* age \<40 years
* non-smoker
* absence of known acute or chronic disease
* absence of symptoms suggestive of progressive disease
* normal clinical examination

Exclusion Criteria:

* recent rhino-bronchial infection (\<6 weeks)
* mental disability
* pregnant women (a urine test will be performed for all women of childbearing age)

Primary outcomes:
measure: Number of samples usable
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Sylvie LEROY, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00596791: Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
Official title: Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Open-Angle Glaucoma
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 150
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: The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. - Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

Primary outcomes:
measure: Change from screening in ocular symptoms and signs
timeFrame: at week 6 and 12
Secondary outcomes:
measure: Safety and Quality of life parameters.
timeFrame: From Screening (visit 1) to visits at week 2, 6 and 12.
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Finn-Medi Research Oy
Study officials:
affiliation: Finn-Medi Research, Finland
name: Hannu Uusitalo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03598491: Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
Official title: Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Swallowing Disorder
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 755
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the inpatients and outpatients who referred for video-fluoroscopic-swallowing study

Brief summary: In traditional video-fluoroscopic-swallowing study, a lipid-soluble contrast (barium sulfate) has been used more than 30 years. However, it can cause chemical pneumonitis and subsequently impair reliability of video-fluoroscopic-swallowing study if aspirated. The authors reviewed the safety and usefulness of an water soluble agent-based swallowing test.

Detailed description: Parallel-group, case-controlled trial was conducted from September 2015 to November 2017. All the patients who referred for video-fluoroscopic-swallowing study were screened.

Based on the pre-emptive evaluation, high-risky patients were allocated to iohexol (Omnipaque)-used video-fluoroscopic-swallowing study and others were allocated to barium sulfate-used video-fluoroscopic-swallowing study.

Statistical Package for the Social Sciences 24 was used to perform statistical analysis for the data. Quantitative data were presented as mean ± standard errors.

Eligibility criteria: Inclusion Criteria:

* All the patients who referred for video-fluoroscopic-swallowing study

Exclusion Criteria:

* none

Primary outcomes:
measure: Laryngeal protection
timeFrame: within 1 hour after video-fluoroscopic-swallowing study
Secondary outcomes:
measure: Oral feeding
timeFrame: within 1 week before video-fluoroscopic-swallowing study
Other outcomes:
measure: Tracheostomy
timeFrame: within 1 day before video-fluoroscopic-swallowing study
measure: Allergic reaction
timeFrame: within 2 days before video-fluoroscopic-swallowing study
measure: Symptoms of chemical pneumonitis
timeFrame: within 1 week before video-fluoroscopic-swallowing study
measure: Hospital stay
timeFrame: within 1 day after discharge
measure: Days to discharge
timeFrame: within 1 day after discharge
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Hwang CH. Swallowing study using water-soluble contrast agents may increase aspiration sensitivity and antedate oral feeding without respiratory and drug complications: A STROBE-compliant prospective, observational, case-control trial. Medicine (Baltimore). 2022 Jul 8;101(27):e29422. doi: 10.1097/MD.0000000000029422.
Clinical trial NCT05366491: IL-38 Evaluation as a Biomarker in Pediatric Asthma
Official title: Serum Human IL-38 Levels in Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 103
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to investigate the associations between serum IL-38 levels and different variables of asthma in children such as laboratory variables, pulmonary function test results, the diagnosis of asthma, and in correlation with disease severity.


Eligibility criteria: Inclusion Criteria:

* patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
* Age group:6-14 years

Exclusion Criteria:

* Malignancy
* Chronic inflammatory diseases

Primary outcomes:
measure: serum IL-38 levels
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Asmaa Kamal
Study officials:
affiliation: Assistant professor
name: Asmaa Kamal, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712491: Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
Official title: A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Age-related Macular Degeneration
Choroidal Neovascularization
Keywords: wet AMD
CNV
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: MacuSight, Inc.
First posted: 2008-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
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 determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility criteria: Inclusion Criteria include, but are not limited to:

* Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration
* Visual acuity of 20/50 to 20/200 in study eye

Exclusion Criteria:

* Any other ocular disease that could compromise vision in the study eye
* History of any prior treatment for choroidal neovascularization in the study eye
* Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration

Primary outcomes:
measure: Best-corrected visual acuity by ETDRS
timeFrame: 180 days
Secondary outcomes:
measure: Best-corrected visual acuity by ETDRS
timeFrame: 60 days, 120 days
measure: Safety across injection routes
timeFrame: Through 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
Study officials:
affiliation: MacuSight, Inc.
name: Joel Naor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03181191: The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
Official title: The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2017-06-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion

Detailed description: Aim: to delineate the anatomical origin, the molecular structure and precursors, the regulation and the (patho-) physiological implications of gut-derived glucagon.

Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy controls (age 18-80, BMI \<30) with normal kidney and liver parameters and hgb\> 6.5 - will be included. The participants will each undergo one screening day and one study day including a gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the upper gastrointestinal tract. These biopsies will be analysed with different techniques including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-) analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses will be collected 15, 30 and 45 min after the glucose infusion.

Eligibility criteria: Inclusion Criteria:

* normal kidney function, normal liver function, normal hemoglobin levels

Exclusion Criteria:

* diabetes type 1, first degree relatives with type 2 diabetes

Primary outcomes:
measure: gut-derived glucagon
timeFrame: 1 year
Secondary outcomes:
measure: Oral glucose tolerance test
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Filip Knop, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06926491: Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
Official title: A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Achondroplasia
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia


Eligibility criteria: Inclusion Criteria:

1. Patients who are between 2.5 and 17.5 years old of age at the time of provisional registration. Patients who meet certain criteria in terms of Tanner stage and bone age.
2. Patients who have been diagnosed with achondroplasia through genetic testing.

Exclusion Criteria:

1. Patients who meet the criteria for a certain height determined by age and gender in the "Growth Chart for Patients with Achondroplasia" at the time of the pre-registration examination
2. Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination.
3. Patients who have had previous osteotomy or who are scheduled to undergo osteotomy or epiphyseal growth inhibition during the study period. Epiphyseal growth inhibition in which the plate was removed more than 26 weeks prior to the pre-registration examination will not be excluded if the patient has completely healed without sequelae, based on the judgment of the investigator or sub-investigator.

Primary outcomes:
measure: Change from baseline in annualized height velocity
timeFrame: Pre-dose, Week 52
Secondary outcomes:
measure: Height Z-score using growth tables in patients with achondroplasia and the change from baseline
timeFrame: Pre-dose, Week 52
Other outcomes:
Locations:
city: Ōbu
country: Japan
facility: Aichi Children's Health and Medical Center
state: Aichi
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Waizumi
country: Japan
facility: Osaka Women's and Children's Hospital
state: Osaka
city: Fuchū
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: ISEIKAI International General Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Yu Sato
role: STUDY_DIRECTOR
References:
Clinical trial NCT00965991: Metformin Compared to Glyburide in Gestational Diabetes
Official title: A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational diabetes
Metformin
Glyburide
oral agents
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 149
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal outcomes.

Detailed description: Pregnant women are screened with a one hour 50g glucose challenge. Women with values of 130 mg/dl or greater are then given a 100g glucose tolerance test. Two abnormal values are diagnostic of gestational diabetes. all women are initially counseled on diet and exercise. Women who fail to maintain a fasting of \<105mg/dl and 2 hr postprandial \< 120 mg/dl are offered participation in the study. Women were randomized to either metformin or glyburide via a computer generated randomization. Women who fail to meet glycemic goals after receiving the maximum dose of study medication were considered treatment failures and insulin therapy was initiated.

Eligibility criteria: Inclusion Criteria:

* Gestational diabetes not controlled with diet and exercise

Exclusion Criteria:

* history of alcohol misuse
* history of drug misuse
* Chronic hypertension requiring medication
* Renal failure
* Hepatic disease or dysfunction
* Known fetal anomaly
* Inability to give consent
* known allergy to metformin or glyburide

Primary outcomes:
measure: Number of Participants Assessed for Glucose Control
timeFrame: fasting and 2 hour postprandial blood glucose
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Diabetes in Pregnancy Clinic
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Lisa E Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
Clinical trial NCT04684680: The Role of Zamzam Water in Idiopathic Oligohydramnios
Official title: Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oligohydramnios
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of drinking zamzam water versus tap water in increasing the AF index in women with oligohydramnios.

Detailed description: Oligohydramnios refers to decrease in amniotic fluid and it is defined as a deepest fluid pocket of less than 2 cm or an amniotic fluid index of 5 cm or less. Oligohydramnios complicates 0.5% to 8% of pregnancies, and 12 % if postdates When it occurs in first half of pregnancy it is associated with birth defects while in second half it causes poor fetal growth, malpresentations , FHR decelerations , MAS , Fetal suicidal syndrome and increases cesarean section and management and prognosis depend on gestational age

Eligibility criteria: Inclusion Criteria:

* pregnant female with idiopathic oligohydramnios

Exclusion Criteria:

* patients with medical disorder
* congenital anomalies
* premature rupture of membrane
* Patient refuse to participate

Primary outcomes:
measure: amniotic fluid index
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT04307680: Evaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female
Official title: Evaluation and Comparison of Short-term Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this prospective, randomized controlled study is to evaluate and compare efficacy between the most available conservative treatment (magnetic stimulation and Kegel exercise) for stress urinary incontinence in Croatia. We will assess quality-of-life, patient global improvement, and vaginal pressure measured with perineometer in three different time points: at the enrollment, after 8 weeks of treatment and 3 months after the both treatments are done.


Eligibility criteria: Inclusion Criteria:

* urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history.

Exclusion Criteria:

* urinary tract malignancies, vulvovaginitis, current uroinfection, previous pelvic surgeries, neurologic and psychiatric diseases, previous conservative treatment of stress urinary incontinence in less than 6 months, Stage III and IV of genital prolapse, latex allergy.

Primary outcomes:
measure: Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment
timeFrame: 8 weeks from the start of the treatment
Secondary outcomes:
measure: Greater proportion of increased perineometry value in magnetic stimulation arm group
timeFrame: 8 weeks
measure: Greater proportion of better patient global improvement in magnetic stimulation arm group
timeFrame: 3 months from treatment finish
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb, Croatia
Study officials:
References: