louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00632957: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses
Official title: Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Attachment Loss
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Research Resources (NCRR)
First posted: 2008-03-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
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 test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age, male or female
2. At least 20 natural teeth present at the time of periodontal examination
3. Be diagnosed with severe, chronic periodontitis;
4. Be willing to participate in the study

Exclusion Criteria:

1. \<18 years of age
2. Less than 20 natural teeth present at time of periodontal examination
3. Unable or unwilling to provide informed consent or follow study protocol
4. Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment
5. Use of systemic antibiotics within the last 3 months
6. Pregnancy as diagnosed by administered pregnancy test.
7. You are nursing a baby.
8. Are allergic to fish or fish products.
9. You are taking any other medications, such as dietary supplements, that could affect the outcome of the study

Primary outcomes:
measure: clinical attachment loss
timeFrame: baseline, 8, 16, 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky College of Dentistry
state: Kentucky
Study officials:
affiliation: University of Kentucky College of Dentistry
name: Dolph R. Dawson, DMD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky College of Dentistry
name: Jeff L. Ebersole, Ph.D
role: STUDY_CHAIR
affiliation: University of Kentucky College of Dentistry
name: M J Novak, Ph.D
role: STUDY_DIRECTOR
affiliation: University of Kentucky Division of Clinical Nutrition
name: Gilbert A. Boissonneault, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03364257: iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
Official title: National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Febrile Neutropenia
Acute Leukemia
Stem Cell Transplantation
Infection
Keywords: metagenomic
infection
diagnosis
Lead sponsor: Pathoquest
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 97
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with chemotherapy for Acute Leukaemia (AL) or Myelodysplastic Syndrome (MDS) or in the context of hematopoietic stem cell transplantation (HSCT), presenting a febrile neutropenic episode and suspected of infection

Brief summary: Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

Detailed description: Febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with iDTECT Blood on Study Day 1.

Eligibility criteria: Inclusion Criteria:

1. Age \> 5 years and weight \> 16 Kg
2. Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed
3. Patient presenting severe neutropenia (absolute neutrophil count \< 0.5 Giga/L) anticipated to be long lasting (\> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation
4. Febrile episode (oral temperature \> 38.3°C once, or 2 measures \> 38.0°C taken 2h apart).

Exclusion Criteria:

1. Known HIV infection or AIDS diagnosis
2. Already microbiologically confirmed infection
3. Patient status preventing the study test to be performed
4. Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation

Primary outcomes:
measure: Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion
timeFrame: 7 months
Secondary outcomes:
measure: Antiobiotic use
timeFrame: 9 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Necker
city: Paris
country: France
facility: Hospital Robert Debré
city: Paris
country: France
facility: Hospital Salpétrière
city: Paris
country: France
facility: Hospital Trousseau
city: Paris
country: France
facility: Hosptial Saint Louis
Study officials:
References:
Clinical trial NCT02524457: How Menopause Affects Lipid Metabolism in the Visceral Fat Depots
Official title: How Menopause Affects Lipid Metabolism in the Visceral Fat Depots
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insulin Sensitivity and Lipid Metabolism
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women from 45-55 years of age undergoing gynecological surgery for benign reasons.

Brief summary: The purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.

Detailed description: The study is a cross sectional study including 60 women between 45 and 55 years of age. Investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (HT). All the women are going through gynecological surgery for benign reasons. During the operation investigators will take a visceral fat biopsy from the omentum.

maximally 1 month before- or after the operation the subject will meet at the lab for further testing, including:

* Health examination
* Blood samples
* OGTT
* DXA scan
* VO2 max testing
* MRI of the abdomen
* hyperinsulinemic euglycemic clamp

Eligibility criteria: Inclusion Criteria:

* women
* 45-55 years old
* for HT treated women (HT more than 1 year)

Exclusion Criteria:

* Infections during the last month
* chronic disease
* claustrophobia
* smoking
* Alcoholic intake \> 14 servings
* hysterectomy before menopause
* oophorectomized
* early menopause (before 40 yrs)
* BMI \> 30

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Julie Abildgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abildgaard J, Pedersen AT, Green CJ, Harder-Lauridsen NM, Solomon TP, Thomsen C, Juul A, Pedersen M, Pedersen JT, Mortensen OH, Pilegaard H, Pedersen BK, Lindegaard B. Menopause is associated with decreased whole body fat oxidation during exercise. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1227-36. doi: 10.1152/ajpendo.00492.2012. Epub 2013 Apr 2.
citation: Abildgaard J, Henstridge DC, Pedersen AT, Langley KG, Scheele C, Pedersen BK, Lindegaard B. In vitro palmitate treatment of myotubes from postmenopausal women leads to ceramide accumulation, inflammation and affected insulin signaling. PLoS One. 2014 Jul 7;9(7):e101555. doi: 10.1371/journal.pone.0101555. eCollection 2014.
Clinical trial NCT06836557: Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
Official title: A Multicenter, Open Label, 3-Month Safety Study with Tradipitant in Patients with Idiopathic or Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Idiopathic Gastroparesis
Diabetic Gastroparesis
Gastroparesis
Keywords: gastroparesis
idiopathic
diabetic
tradipitant
nausea
vomiting
stomach
motility
functional
NK-1 antagonist
neurokinin 1 receptor
substance p
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
* A positive test for drugs of abuse at the screening or evaluation visits
* Pregnancy or nursing
* Evidence of uncontrolled blood glucose (including HbA1C \>11% at screening or metabolic crisis in past 60 days)

Primary outcomes:
measure: Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS
timeFrame: 12 weeks
measure: Number of participants with changes in vital signs identified as Clinically Notable Abnormal values
timeFrame: 12 weeks
measure: Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate
timeFrame: 12 weeks
measure: Number of participants with Clinically Notable Abnormal laboratory values
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis
timeFrame: 12 weeks
measure: To evaluate the efficacy of tradipitant in global improvement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Vanda Investigational Site
city: Liège
country: Belgium
facility: Vanda Investigational Site
city: Leipzig
country: Germany
facility: Vanda Investigational Site
Study officials:
affiliation: Vanda Pharmaceuticals
name: Vanda Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03719157: Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
Official title: Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Regional Anesthesia
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.


Eligibility criteria: Inclusion Criteria:

* ASA Status 1-2 patients Exclusion criteria
* Patients with a body mass index (BMI) of \>40kg/m2
* ASA score of \>III
* Previous abdominal surgery
* Pregnant or breastfeeding patients
* Patients with coagulopathy
* Known local anesthetic allergy
* infection at the injection site

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours
measure: Postoperative pain scores: NRS
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative nause and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi education and research hospital
Study officials:
References:
Clinical trial NCT01021657: Lipid Profile of Tenon's Capsule
Official title: Lipid Profile of Tenon's Capsule in Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Tenon's Capsule
Lipid profile
Assessment of lipid profile in Tenon's capsule in patients with Glaucoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2009-11-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffering from Glaucoma

Brief summary: The purpose of this study is to provide data on the lipid profile of the Tenon's capsule in Human glaucomatous eyes and to establish possible relationships with the short term outcome of filtration surgery.


Eligibility criteria: Inclusion Criteria:

* Glaucoma
* Eligibility for surgery

Exclusion Criteria:

* Patients without Glaucoma

Primary outcomes:
measure: To provide data on the lipid profile of the Tenon's capsule in Human glaucomatous eyes and to establish possible relationships with the short term outcome of filtration surgery.
timeFrame: 6 month later
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Unit CHU Dijon
Study officials:
affiliation: Ophthalmology unit CHU Dijon
name: Catherine Creuzot-Gracher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642057: Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements
Official title: Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hyperkinetic Movement Disorders
Keywords: chorea
dyskinesia
hyperkinetic
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-03-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Although the results of studies looking at tetrabenazine have shown its effectiveness in the management of hyperkinetic(too much) movement disorders, it has not been made available in the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of the protocol is to provide an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Detailed description: The purpose of the protocol is to provide compassionate use of an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Eligibility criteria: Inclusion Criteria:

* Subjects evaluated here at Baylor in the PDCMDC demonstrating need for tetrabenazine treatment.
* Willing to sign informed consent.
* Willing to comply with procedures required as part of this study.

Exclusion Criteria:

* Those subjects unwilling to comply with study requirements.
* Subjects unable to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03104257: The Neural Correlates of Cannabis Use
Official title: The Neural Correlates of Cannabis Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Dependence
Healthy
Keywords: Healthy Control, Cannabis, Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-04-07
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Research subjects can be both cannabis-using or non-cannabis using males and females between the ages of 18-65.

Brief summary: The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. This research will also examine associations between CB1R availability, neural oscillations and cognitive function.

Detailed description: The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed outpatient abstinence (confirmed by tracking creatinine adjusted urine THC-COOH levels). This research will also examine associations between CB1R availability, neural oscillations and cognitive function using \[11-C\]OMAR PET imaging and electroencephalography.

Eligibility criteria: Inclusion Criteria: Cannabis Dependent Subjects

* Current cannabis consumption
* Willing to abstain from cannabis use for four weeks

Inclusion Criteria for Healthy Controls

* No current cannabis consumption

Exclusion Criteria:

* MRI metal exclusions and claustrophobia
* Education completed is less than 12 years

Primary outcomes:
measure: CB1R availability using [11-C]OMAR PET imaging
timeFrame: Change in CB1R availability from baseline to 48 hours and 28 days
Secondary outcomes:
measure: Changes in Cognition during withdrawal using a computerized battery
timeFrame: Change in CB1R availability from baseline to 48 hours and 28 days
measure: Changes in brain rhythms measured by Electroencephalography
timeFrame: Change in CB1R availability from baseline to 48 hours and 28 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Conneticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Patrick Skosnik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445157: Reliability of the 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis
Official title: Reliability of the 4 Metre Gait Speed in Patients With Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Gait speed
Functional outcome measure
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2015-05-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with IPF according to NICE guidelines

Brief summary: This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).

Detailed description: This observational study is investigating a simple test of walking speed, measured using the 4 metre gait speed test (4MGS), in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of reliable measurements that can assess effectiveness of treatment. Slow walking speed has been shown to relate to poor outcomes in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD. The investigators are interested to see whether usual walking speed is a reliable measure in patients with IPF as this will help inform us of its potential use as an outcome measure. To do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet). Participants will be asked to do this twice with a rest in between if required. One week later, participants will be asked to repeat the walking tests again.

Eligibility criteria: Inclusion Criteria:

* IPF diagnosis according to NICE guidelines
* Provision of informed consent

Exclusion Criteria:

* Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)
* Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease)
* Any condition that precludes providing informed consent e.g. cognitive impairment or poor English

Primary outcomes:
measure: 4 metre gait speed
timeFrame: Change in gait speed measured at two timepoints one week apart
Secondary outcomes:
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
state: Middlesex
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundtion Trust
name: William DC Man, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: