louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00813410: Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Adipose Tissue of Diabetic Patients
Official title: A Single Center, Open-Labeled Exploratory Study to Evaluate a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue of Type-1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.

Detailed description: Glucose management in type 1 diabetic patients comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or continuous subcutaneous infusion.

The present study seeks to test an alternative treatment approach that combines glucose measurement and insulin delivery at a single subcutaneous tissue site, thereby circumventing the need for fingerstick blood glucose monitoring. Microperfusion and microdialysis probes are applied in type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site. The feasibility of estimating blood glucose concentrations from the glucose levels measured at the subcutaneous insulin delivery site is then assessed during an overnight fast and an oral glucose tolerance test.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus patients aged 18 - 65
* C-peptide negative (≤ 0.05 nmol/L)
* HbA1c (glycosylated haemoglobin A1c) \< 10%
* Body Mass Index: 21 - 30 kg/m2
* Informed consent obtained before any trial-related activities.

Exclusion Criteria:

* Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
* Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator
* Treatment with drugs that could interfere with glucose metabolism and subcutaneous insulin absorption
* Subject with mental incapacity or language barriers

Primary outcomes:
measure: glucose concentration at the subcutaneous insulin delivery site
timeFrame: 20 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
name: Thomas R. Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06194110: Comparing Stationary and Mobile Ergospirometry
Official title: Comparing the Results of a Stationary and a Mobile Ergospirometry System - a Randomized Crossover Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletes
Keywords: endurance trained
ergospirometry
Vo2peak
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2024-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy endurance trained male or female older than 18 years

Brief summary: The goal of this randomized crossover trial is to compare the results of a stationary and a mobile ergospirometry system in 20 healthy endurance trained participants. The main question it aims to answer is to investigate the differences in VO2-measurements between the mobile K5 and the stationary Quark ergospirometry system.

Participants will do a maximal ramp test followed by a sub maximal step test with 6 stages on two different days.

Detailed description: 20 endurance trained men and/or women will be recruited. A screening will be done before starting with the test protocol on the treadmill to ensure the suitability of the participants. The test protocol includes two parts. The first part is a maximal ramp test (+0.6km/h each minute until exhaustion). The second part includes a step test with 6 sub maximal stages - each lasting 5 minutes - at 50%, 55%, 60%, 70%, 75% and 80% of the maximal velocity achieved in the first part. There will be a short break between the ramp and the step test. The stationary and the mobile system are tested on 2 separate days with a break of 1-3 days in between. On the second day, procedure will be exactly the same for the participants.

Eligibility criteria: Inclusion Criteria:

* endurance trained (minimum two times endurance training per week)
* healthy as assessed by the physical-activity-readiness-questionnaire (PAR-Q)
* adequately informed and consent confirmed per signature

Exclusion Criteria:

* Pregnancy based on anamnesis
* acute illness, injury, infection, etc., which would impact the measurements

Primary outcomes:
measure: VO2 peak
timeFrame: during the last 30 seconds of the ramp test
Secondary outcomes:
measure: VO2
timeFrame: during the last 2 minutes of the step test
measure: VCO2
timeFrame: during the last 2 minutes of the step test
measure: Ventilation
timeFrame: during the last 2 minutes of the step test
measure: breathing frequency
timeFrame: during the last 2 minutes of the step test
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
References:
Clinical trial NCT03000010: Wound Vac Bandage Comparison After Spinal Fusion
Official title: Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Scoliosis
Keywords: Wound Vac
Neuromuscular Scoliosis
Posterior Spinal Fusion
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 41
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.

Detailed description: A prospective randomized controlled study: Patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. Both groups will undergo standard wound closure and dressing application before breaking the sterile field. The incisional VAC group will undergo placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to 75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours postoperatively. Remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. Patients will be followed for a minimum of 2 years postoperatively.

Eligibility criteria: Inclusion Criteria:

* any patient 17 years and younger
* neuromuscular scoliosis undergoing posterior spinal fusion

Exclusion Criteria:

* idiopathic and congenital scoliosis
* any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion)
* intraoperative dural tear
* documented allergy to adhesive dressings

Primary outcomes:
measure: Number of Participants With Wound Dehiscence or Infection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ying G Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03491410: Breast Cancer Active Surveillance, Alternative Option, Aspirin Included
Official title: Breast Cancer Active Surveillance Alternative Option, Can Aspirin Make the Difference?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: Metastatic
Active Surveillance
Lead sponsor: Centro Hospitalar Lisboa Ocidental
Sponsor class: OTHER_GOV
First posted: 2018-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental, clinical, and epidemiological studies have all demonstrated the strong association between chronic inflammation and cancer, and many studies have correlated the prolonged presence of the inflammatory milieu with an increased risk for developing cancer.(1) Although the potential mechanism for aspirin preventing breast cancer is not known, possible pathways may involve platelets, inflammation, cyclooxygenase (COX) 2, hormones, or PI3 kinase. (2).

In actual clinical practice there exist clear guidelines for the use of aspirin in colorectal cancer but no such guidelines exist for the use of aspirin in breast cancer patients.

In the Unit´s proper experience, in patients under active surveillance and metastatic ones some present very good responses both in the neoadjuvant and in the metastatic setting but investigators intend to provide evidence and not just the experience. This study patients are proposed to combine their standard treatment with aspirin.

Detailed description: Breast cancer patients with diagnosis of Ductal or Lobular Invasive Carcinoma or CDis that refuse to underwent surgery or are not qualified for, and independently of age or of their actual staging, are going to be allocated, randomly and in double masked way to one of two arms:

Arm 1: standard Unit´s protocol + placebo Arm 2: standard Unit´s protocol + aspirin

Eligibility criteria: Inclusion Criteria:

Every adult (above 18) y.o.patient with histologic diagnosis of Breast Cancer that refuse or is not suitable for surgical treatment, or with metastatic disease, remaining this way in an "active surveillance"

Exclusion Criteria:

Allergy or toxicity to aspirin

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Metastatic Disease Stability
timeFrame: 1 year
measure: Tumor response till patient decides to exit the active surveillance
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar Lisboa Ocidental
name: Zacharoula Sidiropoulou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen WY, Holmes MD. Role of Aspirin in Breast Cancer Survival. Curr Oncol Rep. 2017 Jul;19(7):48. doi: 10.1007/s11912-017-0605-6.
citation: Keibel A, Singh V, Sharma MC. Inflammation, microenvironment, and the immune system in cancer progression. Curr Pharm Des. 2009;15(17):1949-55. doi: 10.2174/138161209788453167.
Clinical trial NCT04210310: High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
Official title: A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Tinnitus
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.

Detailed description: This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose \& Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.

Eligibility criteria: Inclusion Criteria:

* Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.
* Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of \> 16.
* Subjects must have tinnitus loudness rating of \>4/10.

Exclusion Criteria:

* Subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition
* Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale.
* Those with tinnitus of a muscular or vascular etiology
* Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray.
* Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions.
* Subjects who suffer from migraines.
* Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
timeFrame: Baseline, Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: 222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health
state: New York
Study officials:
affiliation: NYU Langone
name: Lawrence Newman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06017310: Respiferon Project
Official title: Evaluation of the Type 1 IFN Response in Viral Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Viral Infection
Keywords: respiratory viruses
Nasal IFN-1 Score
Nasopharyngeal Swab
Replicative virus
Infectiousness
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at the Hospices Civils de Lyon (HCL) with respiratory infection symptoms.

Nasopharyngeal samples positive for the detection of a respiratory virus for which the viral culture has been carried out will be selected by the CRB. After informing the patients of the study, the IFN I/III response can be assessed on these same nasopharyngeal samples (no additional sample necessary).

The data thus obtained will allow to determine the capacity of the IFN I/III response to detect replicating viruses.

Brief summary: Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests.

To address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. Among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. This methodology's efficacy has been proven in the context of SARS-CoV-2 infections.

This study's objective is to assess the functionality of such a tool across a spectrum of Respiratory Viral Infections (RVIs) prevalent within a French population during the winter season.


Eligibility criteria: Inclusion Criteria:

* Positive nasopharyngeal samples for the detection of a virus, for which the replicative character has been established by the viral culture technique (500µL minimum required)
* Samples kept at the CRB since 2018
* Information to patients carried out and non-objection collected-

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Presence or Absence of a replicative virus detected by viral culture
timeFrame: One sample at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Infective Agents Institute, Croix rousse Hospital
state: Rhone
Study officials:
References:
Clinical trial NCT06715410: Carbon Dioxide Investigation
Official title: CO2 Pilot Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Tracheostomy
Laryngeal Mask
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The purpose of this clinical study is to collect parameter raw data for development and to evaluate the operational and functional features as well as ease of use of the system.
Primary purpose: DIAGNOSTIC

Brief summary: The investigational device enables monitoring of EtCO2, FiCO2 and respiration rate values.

The purpose of this clinical study is to collect parameter raw data for development, evaluate the operational and functional features of the investigational device as well as ease of use of the system.


Eligibility criteria: Inclusion Criteria:

* Adults and pediatric patients that are endotracheally intubated, tracheostomized or have a laryngeal mask or similar
* Tolerate airway adapter dead space of 6.7 ml
* Are above 10 kg
* 2 years of age of older
* Able to provide written informed consent or have a LDR to provide written informed consent
* Are being cared for in hospital unit and are expected to remain in the unit for the duration of the study procedure

Exclusion Criteria:

* Are known to be pregnant
* Are breastfeeding
* Are suffering from infection(s) or immunocompromised patients that require isolation.
* PI or designee decision due to subject health condition

Primary outcomes:
measure: Collection of data
timeFrame: From admission to discharge, maximum of 48 hours
Secondary outcomes:
measure: Evaluation of the performance and usability of CO2 measurement
timeFrame: From admission to discharge, maximum of 48 hours
Other outcomes:
measure: To collect safety information
timeFrame: From admission to discharge, maximum of 48 hours
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Tero Varpula, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470610: Administration of Vaginal and Rectal Progesterone During FET Cycles
Official title: Administration of Vaginal and Rectal Progesterone During Frozen Embryo Transfer Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Progesterone
HRT
frozen embryo transfer
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Autologuos spare embryos from previous IVF/ICSI cycles.

Brief summary: Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone.

Detailed description: Cohort of patients treated with autologous blastocyst at the Fertility clinic Skive Regional Hospital in HRT cycle. Estradiol stimulation started on second cycle day and on day 12 - 20 vaginal and rectal progesterone is added. Blastocyst transfer on 6th progesterone treatment day. Serum progesterone and hCG measurement 9 or 11 days after embryo transfer.

Eligibility criteria: Inclusion Criteria:

* Frozen embryo transfer cycles in HRT cycles

Exclusion Criteria:

* Donor frozen embryo transfer

Primary outcomes:
measure: ongoing pregnancy
timeFrame: 4 month
Secondary outcomes:
measure: pregnancy rate
timeFrame: 4 month
measure: Pregnancy loss
timeFrame: 4 month
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic Regional Hospital Skive
Study officials:
affiliation: Fertility Clinic Skive
name: Peter Humaidan, DMsc
role: STUDY_CHAIR
References: