louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05951972: Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract
Official title: Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: Weizmann Institute of Science
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess global small molecule profiles identified in the human gastrointestinal tract of healthy human volunteers.

Detailed description: The gut is home to an extensive interaction between the host and its microbiota, in different regions exposed to endogenous and exogenous signals, such as nutrition, medications, immune alterations, and geographical location-related factors. this study aims to characterize the small molecule profiles of a cohort of healthy individuals, including their polar, semi-polar, non-polar, and protein landscape. The investigators will develop a pipeline enabling to integrate these small molecule profiles with a variety of inter-individual readouts, as assessed in stools of healthy volunteers. Data will be used to characterize molecular patterns potentially associated with a variety of dietary, immune, and health-related human features, with an aim to characterize small molecules for future causative investigation.

Eligibility criteria: Inclusion Criteria:

* Normal BMI
* Age 18-70

Exclusion Criteria:

* Known food allergies to the tested food items
* Chronic constipation (less than one bowel movement every two days)
* Chronic treatment with any drug upon enrolment.
* The use of systemic antibiotics, probiotics, or proton pump inhibitors 3 months prior to enrollment.
* Diagnosis of type 1 or type 2 diabetes.
* Any chronic disease at the discretion of the study team- such as active or recent cancer, inflammatory bowel disease, systemic autoimmunity
* Any psychiatric disorders
* Alcohol or substance abuse
* Gut-related surgery, including bariatric surgery, but not including previous appendectomy.
* Pregnancy, breastfeeding, or fertility treatments 6 months prior to enrollment for female participants

Primary outcomes:
measure: Characterization of gut microbiota and associated molecules in the healthy human gastrointestinal tract upon nutritional supplementation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Weizmann Institute of Science
Study officials:
References:
Clinical trial NCT05964972: Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents
Official title: Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fall Patients
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fallers

Brief summary: Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.


Eligibility criteria: Inclusion Criteria:

* Resident of the elderly nursing home (EHPAD LES ORCHIDEES).
* Repeated nocturnal falls (more than 2 falls at night between 8 p.m. and 8 a.m.) during the last 12 months.
* Consent of the resident or his legal representative.
* Signature of informed consent
* French-speaking resident.

Exclusion Criteria:

* Refusal to participate in the study.
* Resident exclusive day faller.

Primary outcomes:
measure: number of falls
timeFrame: 6 month preceding and 6 month after
Secondary outcomes:
Other outcomes:
Locations:
city: Cagny
country: France
facility: Ehpad Les Orchidees
Study officials:
References:
Clinical trial NCT00238472: A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
Official title: A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
nateglinide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosed at least 1 year before inclusion
* Blood glucose criteria must be met
* Microalbuminuria criteria must be met

Exclusion Criteria:

* Pregnant or nursing females or females of childbearing potential not using a medically approved birth control method
* Blood glucose criteria outside the specified range
* Microalbuminuria criteria outside the specified range
* Serious cardiovascular events within the past 6 months
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in postprandial glomerular filtration rate at 12 weeks
Secondary outcomes:
measure: Change from baseline in fasting morning glomerular filtration rate at 12 weeks
measure: Change from baseline in postprandial renal plasma flow at 12 weeks
measure: Change from baseline in fasting morning renal plasma flow at 12 weeks
measure: Change from baseline in adjusted 2-hour postprandial glucose at 12 weeks
measure: Change in insulin AUC (0-240 minutes) at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04784169: Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Official title: Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CSF Leakage
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (CSF) leak, and the results were inconclusive. The overall purpose of this study was to assess the efficacy and safety of free middle turbinate flap in reparing CSF leak during an endoscopic approach.

Detailed description: Cerebrospinal fluid (CSF) rhinorrhea results from an abnormal communication between the sinonasal cavity and the subarachnoid space. It may occur spontaneously or secondary to accidental or iatrogenic trauma. CSF leak is a potentially devastating condition that can lead to ascending meningitis, pneumocephalus, and intracranial abscess. Surgical repair is recommended for most patients with CSF leaks to prevent the potential sequelae.

Multiple graft materials have been employed in the approach, including temporalis fascia, middle turbinate flap, fascia lata, fat, free cartilage or bone, vascularized nasoseptal flap and acellular skin grafts. Among these options, vascular nasoseptal ﬂaps are the most popular materials at present. Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat CSF rhinorrhea, and the results were inconclusive. There were a large number of cases using free middle turbinate flap for CSF rhinorrhea repair in our institution. The purpose of this study was to determine the efficacy and safety of the free middle turbinate flap for repair of CSF rhinorrhea.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing repairing of CSF leak under transsphenoidal approach
* Dural defect smaller than 1cm
* No extensive arachnoid dissection
* No dissection into a ventricle or cistern

Exclusion Criteria:

* High flow CSF leak

Primary outcomes:
measure: Number of Participants With Cerebrospinal Fluid (CSF) Leak
timeFrame: 1month
Secondary outcomes:
measure: Number of Participants With Postoperative Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: GAO HUI
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: GAO HUI
role: STUDY_CHAIR
References:
Clinical trial NCT02835469: A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility
Official title: Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 412
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fertility clinics

Brief summary: The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose


Eligibility criteria: Inclusion Criteria:

* Decision made to prescribe Menopur® multidose according to Summary of product characteristics
* The study cycle will be either

  * 1st controlled ovarian stimulation cycle ever, or
  * 2nd controlled ovarian stimulation cycle ever, or
  * 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)

Exclusion Criteria:

* Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
* Diagnosed as "poor responder", defined as either

  * \>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
  * any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
  * development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle
* Ovarian hyperstimulation syndrome (OHSS)

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10-11 weeks after embryo transfer
Secondary outcomes:
measure: Mean Follicle Stimulating Hormone (FSH) level
timeFrame: At baseline and last stimulation day (max 20 days after start of stimulation)
measure: Mean Luteinizing Hormone (LH) level
timeFrame: At baseline and last stimulation day (max 20 days after start of stimulation)
measure: Mean Estradiol 2 (E2) level
timeFrame: At baseline and last stimulation day (max 20 days after start of stimulation)
measure: Mean endometrial thickness
timeFrame: On last stimulation day (max 20 days after start of stimulation)
measure: Follicular development
timeFrame: On last stimulation day (max 20 days after start of stimulation)
measure: Number of oocytes retrieved
timeFrame: 36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration
measure: Fertilization rate
timeFrame: 1 day after oocyte retrieval
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: CL Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004569: Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-02-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. The effects on quality of life as well as societal costs have been well documented. The NYU Sleep Research Laboratory has spent the last several years working on the problem of improving the diagnosis of mild sleep disordered breathing which manifests as the upper airway resistance syndrome. Our approach has been to develop a non-invasive technique to detect increased upper airway resistance directly from analysis of the airflow signal. A characteristic intermittent change of the inspiratory flow contour, which is indicative of the occurrence of flow limitation, correlates well with increased airway resistance.

Currently all respiratory events are identified manually and totaled. This is time consuming and subject to variability. The objective of the present project is to improve upon the manual approach by implementing an artificially intelligent system for the identification and quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary signals collected during a routine sleep study. The utility of other reported indices of sleep disordered breathing obtained during a sleep study will be evaluated.

Successful development of an automated system that can identify and classify upper airway resistance events will simplify, standardize and improve the diagnosis of sleep disordered breathing, and greatly facilitate research and clinical work in this area. Using a physiological based determination of disease should allow better assessment of treatment responses in mild disease.


Eligibility criteria: Inclusion Criteria:

* Patients with sleep disordered breathing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Sleep Disorders Center
state: New York
Study officials:
References:
Clinical trial NCT00808769: Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Official title: Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Normal Healthy Subject Population
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.


Eligibility criteria: Inclusion Criteria:

* Normal subjects who are 18-65 years of age;
* Non-childbearing potential females or those using birth control

Exclusion Criteria:

* History of significant GI disease
* Any significant medical illness
* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
* Currently using GI medications
* GI disorder or surgery leading to impaired drug absorption

Primary outcomes:
measure: The Mean Percent Time Gastric pH > 4.0 on Day 1
timeFrame: continuously over a 24 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
Study officials:
affiliation: Procter and Gamble
name: John McRorie, PhD, FACG, AGAF
role: STUDY_DIRECTOR
References:
Clinical trial NCT05025969: Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Official title: Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for glioma or brain metastasis.

Brief summary: This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.

Detailed description: Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.

Eligibility criteria: Inclusion Criteria:

* Adult male or female subject;
* Glioma or brain metastasis operated on in our institution, histologically confirmed (WHO classification 2016);
* Subject with a frozen tumour sample \< 5 years old;
* Subject for whom all clinico-radiological data are available;
* Subject affiliated to a health insurance scheme;
* Subject who has been informed of the research and who has not indicated his opposition to the use of his medical data and who has signed a consent for the use of his tumour sample.

Exclusion Criteria:

* Patient under legal protection, guardianship or deprived of liberty by judicial or administrative decision
* Biological samples not available and/or in insufficient quantity for analysis

Primary outcomes:
measure: NTRK Fusion
timeFrame: through study completion, an average of 12 months
Secondary outcomes:
measure: NTRK Fusion identification in brain metastasis and primary tumor
timeFrame: through study completion, an average of 12 months
measure: Progression-free survival in patients with NTRK gene fusion
timeFrame: Month 6
measure: Progression-free survival in patients with NTRK gene fusion
timeFrame: Month 12
measure: Overall survival in patients with NTRK gene fusion.
timeFrame: through study completion, an average of 12 months
measure: Specific radiological criterion (T1)
timeFrame: through study completion, an average of 12 months
measure: Specific radiological criterion (T2)
timeFrame: through study completion, an average of 12 months
measure: Specific radiological criterion (FLAIR)
timeFrame: through study completion, an average of 12 months
measure: Specific radiological criterion (perfusion)
timeFrame: through study completion, an average of 12 months
measure: Incidence of other genomic alterations
timeFrame: through study completion, an average of 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Privé Clairval
Study officials:
affiliation: Hôpital Privé Clairval
name: Philippe METELLUS, MD PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452669: VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation
Official title: Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
ARDS
Lead sponsor: Aerogen Pharma Limited
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2020-06-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo controlled study comparing study treatment group to placebo controls who received SOC
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether inhaled epoprostenol given via a breath actuated delivery system will help improve oxygen levels and treatment outcomes in patients with COVID-19 who are on mechanical ventilation.

Detailed description: This study will evaluate the potential therapeutic benefit of VentaProst in treating patients with COVID-19 at risk for respiratory and/ or cardiac/circulatory failure. This is a double-blind, placebo controlled study of VentaProst in 10 confirmed COVID-19 patients compared to 10- COVID-19 placebo patients to assess the efficacy and safety of VentaProst given over 10 days at varying doses.

Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 positive by RT-PCR test
* Patients who require invasive mechanical ventilation.
* Consent or professional consent obtained

Exclusion Criteria:

* Patients on ECMO support.
* Patients receiving another inhalation research medication or inhaled nitric oxide.
* Not expected to survive for 48 hours.
* Allergy to Epoprostenol and its diluent

Primary outcomes:
measure: Reduction in Respiratory Failure
timeFrame: 10 days
measure: Reduction in Cardiac/Circulatory Failure
timeFrame: 10 days
Secondary outcomes:
measure: Improvement in Oxygenation
timeFrame: 10 days
measure: Improved Clinical Outcomes
timeFrame: 28 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Veronica Franco, MD
role: PRINCIPAL_INVESTIGATOR
References: